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Perfusion for congenital heart surgeryNotes on cardiopulmonary bypass for a complex patient population
Perfusion for congenital heart surgeryNotes on cardiopulmonary bypass for a complex patient population
Gregory S Matte ccp Lp FppCo-ChiefClinical Coordinator for PerfusionBoston Childrenrsquos HospitalBoston MA USA
Copyright copy 2015 by John Wiley amp Sons Inc All rights reserved
Published by John Wiley amp Sons Inc Hoboken New JerseyPublished simultaneously in Canada
No part of this publication may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopying recording scanning or otherwise except as permitted under Section 107 or 108 of the 1976 United States Copyright Act without either the prior written permission of the Publisher or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center Inc 222 Rosewood Drive Danvers MA 01923 (978) 750-8400 fax (978) 750-4470 or on the web at wwwcopyrightcom Requests to the Publisher for permission should be addressed to the Permissions Department John Wiley amp Sons Inc 111 River Street Hoboken NJ07030 (201) 748-6011 fax (201) 748-6008 or online at httpwwwwileycomgopermissions
The contents of this work are intended to further general scientific research understanding and discussion only and are not intended and should not be relied upon as recommending or promoting a specific method diagnosis or treatment by health science practitioners for any particular patient The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties including without limitation any implied warranties of fitness for a particular purpose In view of ongoing research equipment modifications changes in governmental regulations and the constant flow of information relating to the use of medicines equipment and devices the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine equipment or device for among other things any changes in the instructions or indication of usage and for added warnings and precautions Readers should consult with a specialist where appropriate The fact that an organization or Website is referred to in this work as a citation andor a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make Further readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read No warranty may be created or extended by any promotional statements for this work Neither the publisher nor the author shall be liable for any damages arising herefrom
For general information on our other products and services or for technical support please contact our Customer Care Department within the United States at (800) 762-2974 outside the United States at (317) 572-3993 or fax (317) 572-4002
Wiley also publishes its books in a variety of electronic formats Some content that appears in print may not be available in electronic formats For more information about Wiley products visit our web site at wwwwileycom
Library of Congress Cataloging-in-Publication DataMatte Gregory S author Perfusion for congenital heart surgery notes on cardiopulmonary bypass for a complex patient population Gregory S Matte p cm Includes bibliographical references and index ISBN 978-1-118-90079-6 (cloth)I Title [DNLM 1 Heart Defects Congenitalndashsurgery 2 Infant 3 Cardiopulmonary Bypassndashinstrumentation 4 Cardiopulmonary Bypassndashmethods 5 Child 6 Perfusionndashmethods WS 290] RD59835C67 6174prime12ndashdc23 201404632610 9 8 7 6 5 4 3 2 1
1 2015
To Bridget Nicholas and Justin for their love support and regular reminders that we are all lifelong students
vii
Foreword x
Preface xi
Acknowledgments xii
1 Equipment for bypass 1Oxygenators 1Arterial line filters 12Tubing packs 13Cardioplegia systems 16The heartndashlung machine 17The heater-cooler system 19Cannulae 20
2 Priming the bypass circuit 27Prime constituents 27Steps for priming 28
3 The bypass plan 33Communication agreement for case 33Anticoagulation management 35Blood gas management 40
Carbon dioxide management 40Oxygenation strategy 42
Hematocrit management 45Blood pressure management 47Temperature management 49Flow rates regional perfusion and hypothermic circulatory arrest 52Methods of ultrafiltration 55
Before bypass 55On bypass 55After bypass 56
SMUF specifications 59Standard and augmented venous return 60
Standard venous return with gravity siphon drainage 60Augmented venous return 60
The prebypass checklist 63The surgical safety checklist for congenital heart surgery 65
4 Typical phases of cardiopulmonary bypass 72Commencement of bypass 72Standard support phase of bypass 74Termination of bypass 76Post bypass 78
5 Additional notes based on bypass tasks 79Prebypass 79
Heartndashlung machine (HLM) 79Reoperations 79Cannulation 79Transfusion during cannulation 80
On bypass 80Verification of adequate drainage when caval tapes are used 80Blood gas management 80Cardioplegia delivery 81Planned circulatory arrest 81Induced ventricular fibrillation 82Administration of blood products 82Atrial line placement 82LV vent placement 83Bed rotation during bypass 83
6 Bypass considerations based on diagnosis 85Anomalous coronary arteries 86Aortic regurgitationinsufficiency 89Aortic stenosis 91Aortopulmonary collaterals 93Aortopulmonary window 95Atrial septal defect 96Cardiomyopathy requiring orthotopic heart transplantation 99
Contents
viii Contents
Coarctation of the aorta 100Common atrioventricular canal defect 102Cor triatriatum 104Corrected transposition of the great arteries (L-TGA Levo-TGA or C-TGA) or congenitally corrected TGA 105Critical aortic stenosis 107Double chambered right ventricle 109Double inlet left ventricle 110Double outlet left ventricle 111Double outlet right ventricle 112Ebsteinrsquos anomaly 113Hypoplastic left heart syndrome 114
Stage 1 (Norwood) procedure 115Hybrid stage 1 palliation 117Stage 2 or bidirectional Glenn shunt 117Fontan procedure (total cavopulmonary anastomosis) 119
Interrupted aortic arch 121Left superior vena cava 123Lung transplantation 124Mitral regurgitationinsufficiency 125Mitral stenosis 126Patent ductus arteriosus 127Pulmonary artery abnormalities 128Pulmonary atresia 129
Pulmonary atresia with an intact ventricular septum 129Pulmonary atresia with ventricular septal defect 130
Pulmonary regurgitationinsufficiency 132Pulmonary stenosis 133Pulmonary vein stenosis or pulmonary venous obstruction 134Tetralogy of Fallot 136Total anomalous pulmonary venous return and partial anomalous pulmonary venous return 138d-Transposition of the great arteries 140Tricuspid atresia 142Tricuspid regurgitationinsufficiency 143Truncus arteriosus 144Ventricular septal defect 146
7 Notes on select issues during bypass 148Blood pressure higher than expected 148Blood pressure lower than expected 149Bypass circuit pressure higher than expected 151Bypass circuit pressure lower than expected 152
Central venous pressure elevated 153Heat exchange issue (slow cooling or warming) 154NIRS values lower than expected 155PaCO2 higher than expected 157PaCO2 lower than expected 159PaO2 lower than expected 160Reservoir volume acutely low 161
8 Notes on select emergency procedures during bypass 163Arterial pump failure (roller head) 164Failure to oxygenate 165Massive air embolization 166Acute aortic dissection at the initiation of bypass 168Venous air lock 169Inadvertent arterial decannulation 170Inadvertent venous decannulation 171
9 Brief overview of named procedures and terms 172Alfieri stitch 172Batista procedure 172Bentall procedure 172Bidirectional Glenn shunt 172BlalockndashHanlon procedure 172BlalockndashTaussig shunt (BTS) 173Brock procedure 173Central shunt 173Cone procedure 173Cox maze procedure 173DamusndashKayendashStansel anastomosis 173Double switch procedure 173Fontan procedure 174Gott shunt 174HemindashFontan procedure 174Holmes heart 174Jatene operation 174Kawasaki disease 174Kawashima procedure 175(Diverticulum of) Kommerell 175Konno procedure 175LeCompte maneuver 175LeCompte procedure 175Manougian procedure 175Marfanrsquos syndrome 175Maze procedure 175Mustard procedure 176
Contents ix
Nicks procedure 176Nikaidoh procedure 176Noonan syndrome 176Norwood operation 176Pannus 176Pentalogy of Cantrell 176Potts shunt 177Rashkind procedure 177Rastelli operation 177Ross procedure 177Sano shunt 177Scimitar syndrome 177Senning operation 177Shonersquos complex 178Takeuchi procedure 178TaussigndashBing anomaly 178Trusler repair 178
Van Praagh classification 178Warden procedure 178Waterston shunt 178Williams syndrome 178Yasui procedure 179
10 Abbreviations for congenital heart surgery 180
11 Recommended reference books 186
12 Comprehensive experience-based equipment selection chart select medications administered during bypass 187
Index 190
x
The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself
There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an
essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients
James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School
Chief Division of Cardiac Anesthesia
Francis X McGowan Jr MDChair in Cardiac Anesthesia
Boston Childrenrsquos Hospital
Foreword
xi
Preface
There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run
The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most
common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings
Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass
Gregory S Matte CCP LP FPP
Disclaimer
Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk
xii
Acknowledgments
A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago
I am also deeply indebted to the following individuals who provided feedback regarding the content of this book
andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers
Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc
1
The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass
Oxygenators
The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system
The oxygenator membranebull Membrane oxygenators allow for diffusion of gas
oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)
bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates
bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity
bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions
bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion
bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended
bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection
bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas
Equipment for bypassChapTEr 1
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
Perfusion for congenital heart surgeryNotes on cardiopulmonary bypass for a complex patient population
Perfusion for congenital heart surgeryNotes on cardiopulmonary bypass for a complex patient population
Gregory S Matte ccp Lp FppCo-ChiefClinical Coordinator for PerfusionBoston Childrenrsquos HospitalBoston MA USA
Copyright copy 2015 by John Wiley amp Sons Inc All rights reserved
Published by John Wiley amp Sons Inc Hoboken New JerseyPublished simultaneously in Canada
No part of this publication may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopying recording scanning or otherwise except as permitted under Section 107 or 108 of the 1976 United States Copyright Act without either the prior written permission of the Publisher or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center Inc 222 Rosewood Drive Danvers MA 01923 (978) 750-8400 fax (978) 750-4470 or on the web at wwwcopyrightcom Requests to the Publisher for permission should be addressed to the Permissions Department John Wiley amp Sons Inc 111 River Street Hoboken NJ07030 (201) 748-6011 fax (201) 748-6008 or online at httpwwwwileycomgopermissions
The contents of this work are intended to further general scientific research understanding and discussion only and are not intended and should not be relied upon as recommending or promoting a specific method diagnosis or treatment by health science practitioners for any particular patient The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties including without limitation any implied warranties of fitness for a particular purpose In view of ongoing research equipment modifications changes in governmental regulations and the constant flow of information relating to the use of medicines equipment and devices the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine equipment or device for among other things any changes in the instructions or indication of usage and for added warnings and precautions Readers should consult with a specialist where appropriate The fact that an organization or Website is referred to in this work as a citation andor a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make Further readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read No warranty may be created or extended by any promotional statements for this work Neither the publisher nor the author shall be liable for any damages arising herefrom
For general information on our other products and services or for technical support please contact our Customer Care Department within the United States at (800) 762-2974 outside the United States at (317) 572-3993 or fax (317) 572-4002
Wiley also publishes its books in a variety of electronic formats Some content that appears in print may not be available in electronic formats For more information about Wiley products visit our web site at wwwwileycom
Library of Congress Cataloging-in-Publication DataMatte Gregory S author Perfusion for congenital heart surgery notes on cardiopulmonary bypass for a complex patient population Gregory S Matte p cm Includes bibliographical references and index ISBN 978-1-118-90079-6 (cloth)I Title [DNLM 1 Heart Defects Congenitalndashsurgery 2 Infant 3 Cardiopulmonary Bypassndashinstrumentation 4 Cardiopulmonary Bypassndashmethods 5 Child 6 Perfusionndashmethods WS 290] RD59835C67 6174prime12ndashdc23 201404632610 9 8 7 6 5 4 3 2 1
1 2015
To Bridget Nicholas and Justin for their love support and regular reminders that we are all lifelong students
vii
Foreword x
Preface xi
Acknowledgments xii
1 Equipment for bypass 1Oxygenators 1Arterial line filters 12Tubing packs 13Cardioplegia systems 16The heartndashlung machine 17The heater-cooler system 19Cannulae 20
2 Priming the bypass circuit 27Prime constituents 27Steps for priming 28
3 The bypass plan 33Communication agreement for case 33Anticoagulation management 35Blood gas management 40
Carbon dioxide management 40Oxygenation strategy 42
Hematocrit management 45Blood pressure management 47Temperature management 49Flow rates regional perfusion and hypothermic circulatory arrest 52Methods of ultrafiltration 55
Before bypass 55On bypass 55After bypass 56
SMUF specifications 59Standard and augmented venous return 60
Standard venous return with gravity siphon drainage 60Augmented venous return 60
The prebypass checklist 63The surgical safety checklist for congenital heart surgery 65
4 Typical phases of cardiopulmonary bypass 72Commencement of bypass 72Standard support phase of bypass 74Termination of bypass 76Post bypass 78
5 Additional notes based on bypass tasks 79Prebypass 79
Heartndashlung machine (HLM) 79Reoperations 79Cannulation 79Transfusion during cannulation 80
On bypass 80Verification of adequate drainage when caval tapes are used 80Blood gas management 80Cardioplegia delivery 81Planned circulatory arrest 81Induced ventricular fibrillation 82Administration of blood products 82Atrial line placement 82LV vent placement 83Bed rotation during bypass 83
6 Bypass considerations based on diagnosis 85Anomalous coronary arteries 86Aortic regurgitationinsufficiency 89Aortic stenosis 91Aortopulmonary collaterals 93Aortopulmonary window 95Atrial septal defect 96Cardiomyopathy requiring orthotopic heart transplantation 99
Contents
viii Contents
Coarctation of the aorta 100Common atrioventricular canal defect 102Cor triatriatum 104Corrected transposition of the great arteries (L-TGA Levo-TGA or C-TGA) or congenitally corrected TGA 105Critical aortic stenosis 107Double chambered right ventricle 109Double inlet left ventricle 110Double outlet left ventricle 111Double outlet right ventricle 112Ebsteinrsquos anomaly 113Hypoplastic left heart syndrome 114
Stage 1 (Norwood) procedure 115Hybrid stage 1 palliation 117Stage 2 or bidirectional Glenn shunt 117Fontan procedure (total cavopulmonary anastomosis) 119
Interrupted aortic arch 121Left superior vena cava 123Lung transplantation 124Mitral regurgitationinsufficiency 125Mitral stenosis 126Patent ductus arteriosus 127Pulmonary artery abnormalities 128Pulmonary atresia 129
Pulmonary atresia with an intact ventricular septum 129Pulmonary atresia with ventricular septal defect 130
Pulmonary regurgitationinsufficiency 132Pulmonary stenosis 133Pulmonary vein stenosis or pulmonary venous obstruction 134Tetralogy of Fallot 136Total anomalous pulmonary venous return and partial anomalous pulmonary venous return 138d-Transposition of the great arteries 140Tricuspid atresia 142Tricuspid regurgitationinsufficiency 143Truncus arteriosus 144Ventricular septal defect 146
7 Notes on select issues during bypass 148Blood pressure higher than expected 148Blood pressure lower than expected 149Bypass circuit pressure higher than expected 151Bypass circuit pressure lower than expected 152
Central venous pressure elevated 153Heat exchange issue (slow cooling or warming) 154NIRS values lower than expected 155PaCO2 higher than expected 157PaCO2 lower than expected 159PaO2 lower than expected 160Reservoir volume acutely low 161
8 Notes on select emergency procedures during bypass 163Arterial pump failure (roller head) 164Failure to oxygenate 165Massive air embolization 166Acute aortic dissection at the initiation of bypass 168Venous air lock 169Inadvertent arterial decannulation 170Inadvertent venous decannulation 171
9 Brief overview of named procedures and terms 172Alfieri stitch 172Batista procedure 172Bentall procedure 172Bidirectional Glenn shunt 172BlalockndashHanlon procedure 172BlalockndashTaussig shunt (BTS) 173Brock procedure 173Central shunt 173Cone procedure 173Cox maze procedure 173DamusndashKayendashStansel anastomosis 173Double switch procedure 173Fontan procedure 174Gott shunt 174HemindashFontan procedure 174Holmes heart 174Jatene operation 174Kawasaki disease 174Kawashima procedure 175(Diverticulum of) Kommerell 175Konno procedure 175LeCompte maneuver 175LeCompte procedure 175Manougian procedure 175Marfanrsquos syndrome 175Maze procedure 175Mustard procedure 176
Contents ix
Nicks procedure 176Nikaidoh procedure 176Noonan syndrome 176Norwood operation 176Pannus 176Pentalogy of Cantrell 176Potts shunt 177Rashkind procedure 177Rastelli operation 177Ross procedure 177Sano shunt 177Scimitar syndrome 177Senning operation 177Shonersquos complex 178Takeuchi procedure 178TaussigndashBing anomaly 178Trusler repair 178
Van Praagh classification 178Warden procedure 178Waterston shunt 178Williams syndrome 178Yasui procedure 179
10 Abbreviations for congenital heart surgery 180
11 Recommended reference books 186
12 Comprehensive experience-based equipment selection chart select medications administered during bypass 187
Index 190
x
The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself
There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an
essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients
James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School
Chief Division of Cardiac Anesthesia
Francis X McGowan Jr MDChair in Cardiac Anesthesia
Boston Childrenrsquos Hospital
Foreword
xi
Preface
There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run
The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most
common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings
Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass
Gregory S Matte CCP LP FPP
Disclaimer
Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk
xii
Acknowledgments
A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago
I am also deeply indebted to the following individuals who provided feedback regarding the content of this book
andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers
Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc
1
The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass
Oxygenators
The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system
The oxygenator membranebull Membrane oxygenators allow for diffusion of gas
oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)
bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates
bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity
bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions
bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion
bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended
bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection
bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas
Equipment for bypassChapTEr 1
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
Perfusion for congenital heart surgeryNotes on cardiopulmonary bypass for a complex patient population
Gregory S Matte ccp Lp FppCo-ChiefClinical Coordinator for PerfusionBoston Childrenrsquos HospitalBoston MA USA
Copyright copy 2015 by John Wiley amp Sons Inc All rights reserved
Published by John Wiley amp Sons Inc Hoboken New JerseyPublished simultaneously in Canada
No part of this publication may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopying recording scanning or otherwise except as permitted under Section 107 or 108 of the 1976 United States Copyright Act without either the prior written permission of the Publisher or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center Inc 222 Rosewood Drive Danvers MA 01923 (978) 750-8400 fax (978) 750-4470 or on the web at wwwcopyrightcom Requests to the Publisher for permission should be addressed to the Permissions Department John Wiley amp Sons Inc 111 River Street Hoboken NJ07030 (201) 748-6011 fax (201) 748-6008 or online at httpwwwwileycomgopermissions
The contents of this work are intended to further general scientific research understanding and discussion only and are not intended and should not be relied upon as recommending or promoting a specific method diagnosis or treatment by health science practitioners for any particular patient The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties including without limitation any implied warranties of fitness for a particular purpose In view of ongoing research equipment modifications changes in governmental regulations and the constant flow of information relating to the use of medicines equipment and devices the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine equipment or device for among other things any changes in the instructions or indication of usage and for added warnings and precautions Readers should consult with a specialist where appropriate The fact that an organization or Website is referred to in this work as a citation andor a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make Further readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read No warranty may be created or extended by any promotional statements for this work Neither the publisher nor the author shall be liable for any damages arising herefrom
For general information on our other products and services or for technical support please contact our Customer Care Department within the United States at (800) 762-2974 outside the United States at (317) 572-3993 or fax (317) 572-4002
Wiley also publishes its books in a variety of electronic formats Some content that appears in print may not be available in electronic formats For more information about Wiley products visit our web site at wwwwileycom
Library of Congress Cataloging-in-Publication DataMatte Gregory S author Perfusion for congenital heart surgery notes on cardiopulmonary bypass for a complex patient population Gregory S Matte p cm Includes bibliographical references and index ISBN 978-1-118-90079-6 (cloth)I Title [DNLM 1 Heart Defects Congenitalndashsurgery 2 Infant 3 Cardiopulmonary Bypassndashinstrumentation 4 Cardiopulmonary Bypassndashmethods 5 Child 6 Perfusionndashmethods WS 290] RD59835C67 6174prime12ndashdc23 201404632610 9 8 7 6 5 4 3 2 1
1 2015
To Bridget Nicholas and Justin for their love support and regular reminders that we are all lifelong students
vii
Foreword x
Preface xi
Acknowledgments xii
1 Equipment for bypass 1Oxygenators 1Arterial line filters 12Tubing packs 13Cardioplegia systems 16The heartndashlung machine 17The heater-cooler system 19Cannulae 20
2 Priming the bypass circuit 27Prime constituents 27Steps for priming 28
3 The bypass plan 33Communication agreement for case 33Anticoagulation management 35Blood gas management 40
Carbon dioxide management 40Oxygenation strategy 42
Hematocrit management 45Blood pressure management 47Temperature management 49Flow rates regional perfusion and hypothermic circulatory arrest 52Methods of ultrafiltration 55
Before bypass 55On bypass 55After bypass 56
SMUF specifications 59Standard and augmented venous return 60
Standard venous return with gravity siphon drainage 60Augmented venous return 60
The prebypass checklist 63The surgical safety checklist for congenital heart surgery 65
4 Typical phases of cardiopulmonary bypass 72Commencement of bypass 72Standard support phase of bypass 74Termination of bypass 76Post bypass 78
5 Additional notes based on bypass tasks 79Prebypass 79
Heartndashlung machine (HLM) 79Reoperations 79Cannulation 79Transfusion during cannulation 80
On bypass 80Verification of adequate drainage when caval tapes are used 80Blood gas management 80Cardioplegia delivery 81Planned circulatory arrest 81Induced ventricular fibrillation 82Administration of blood products 82Atrial line placement 82LV vent placement 83Bed rotation during bypass 83
6 Bypass considerations based on diagnosis 85Anomalous coronary arteries 86Aortic regurgitationinsufficiency 89Aortic stenosis 91Aortopulmonary collaterals 93Aortopulmonary window 95Atrial septal defect 96Cardiomyopathy requiring orthotopic heart transplantation 99
Contents
viii Contents
Coarctation of the aorta 100Common atrioventricular canal defect 102Cor triatriatum 104Corrected transposition of the great arteries (L-TGA Levo-TGA or C-TGA) or congenitally corrected TGA 105Critical aortic stenosis 107Double chambered right ventricle 109Double inlet left ventricle 110Double outlet left ventricle 111Double outlet right ventricle 112Ebsteinrsquos anomaly 113Hypoplastic left heart syndrome 114
Stage 1 (Norwood) procedure 115Hybrid stage 1 palliation 117Stage 2 or bidirectional Glenn shunt 117Fontan procedure (total cavopulmonary anastomosis) 119
Interrupted aortic arch 121Left superior vena cava 123Lung transplantation 124Mitral regurgitationinsufficiency 125Mitral stenosis 126Patent ductus arteriosus 127Pulmonary artery abnormalities 128Pulmonary atresia 129
Pulmonary atresia with an intact ventricular septum 129Pulmonary atresia with ventricular septal defect 130
Pulmonary regurgitationinsufficiency 132Pulmonary stenosis 133Pulmonary vein stenosis or pulmonary venous obstruction 134Tetralogy of Fallot 136Total anomalous pulmonary venous return and partial anomalous pulmonary venous return 138d-Transposition of the great arteries 140Tricuspid atresia 142Tricuspid regurgitationinsufficiency 143Truncus arteriosus 144Ventricular septal defect 146
7 Notes on select issues during bypass 148Blood pressure higher than expected 148Blood pressure lower than expected 149Bypass circuit pressure higher than expected 151Bypass circuit pressure lower than expected 152
Central venous pressure elevated 153Heat exchange issue (slow cooling or warming) 154NIRS values lower than expected 155PaCO2 higher than expected 157PaCO2 lower than expected 159PaO2 lower than expected 160Reservoir volume acutely low 161
8 Notes on select emergency procedures during bypass 163Arterial pump failure (roller head) 164Failure to oxygenate 165Massive air embolization 166Acute aortic dissection at the initiation of bypass 168Venous air lock 169Inadvertent arterial decannulation 170Inadvertent venous decannulation 171
9 Brief overview of named procedures and terms 172Alfieri stitch 172Batista procedure 172Bentall procedure 172Bidirectional Glenn shunt 172BlalockndashHanlon procedure 172BlalockndashTaussig shunt (BTS) 173Brock procedure 173Central shunt 173Cone procedure 173Cox maze procedure 173DamusndashKayendashStansel anastomosis 173Double switch procedure 173Fontan procedure 174Gott shunt 174HemindashFontan procedure 174Holmes heart 174Jatene operation 174Kawasaki disease 174Kawashima procedure 175(Diverticulum of) Kommerell 175Konno procedure 175LeCompte maneuver 175LeCompte procedure 175Manougian procedure 175Marfanrsquos syndrome 175Maze procedure 175Mustard procedure 176
Contents ix
Nicks procedure 176Nikaidoh procedure 176Noonan syndrome 176Norwood operation 176Pannus 176Pentalogy of Cantrell 176Potts shunt 177Rashkind procedure 177Rastelli operation 177Ross procedure 177Sano shunt 177Scimitar syndrome 177Senning operation 177Shonersquos complex 178Takeuchi procedure 178TaussigndashBing anomaly 178Trusler repair 178
Van Praagh classification 178Warden procedure 178Waterston shunt 178Williams syndrome 178Yasui procedure 179
10 Abbreviations for congenital heart surgery 180
11 Recommended reference books 186
12 Comprehensive experience-based equipment selection chart select medications administered during bypass 187
Index 190
x
The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself
There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an
essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients
James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School
Chief Division of Cardiac Anesthesia
Francis X McGowan Jr MDChair in Cardiac Anesthesia
Boston Childrenrsquos Hospital
Foreword
xi
Preface
There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run
The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most
common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings
Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass
Gregory S Matte CCP LP FPP
Disclaimer
Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk
xii
Acknowledgments
A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago
I am also deeply indebted to the following individuals who provided feedback regarding the content of this book
andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers
Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc
1
The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass
Oxygenators
The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system
The oxygenator membranebull Membrane oxygenators allow for diffusion of gas
oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)
bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates
bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity
bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions
bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion
bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended
bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection
bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas
Equipment for bypassChapTEr 1
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
Copyright copy 2015 by John Wiley amp Sons Inc All rights reserved
Published by John Wiley amp Sons Inc Hoboken New JerseyPublished simultaneously in Canada
No part of this publication may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopying recording scanning or otherwise except as permitted under Section 107 or 108 of the 1976 United States Copyright Act without either the prior written permission of the Publisher or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center Inc 222 Rosewood Drive Danvers MA 01923 (978) 750-8400 fax (978) 750-4470 or on the web at wwwcopyrightcom Requests to the Publisher for permission should be addressed to the Permissions Department John Wiley amp Sons Inc 111 River Street Hoboken NJ07030 (201) 748-6011 fax (201) 748-6008 or online at httpwwwwileycomgopermissions
The contents of this work are intended to further general scientific research understanding and discussion only and are not intended and should not be relied upon as recommending or promoting a specific method diagnosis or treatment by health science practitioners for any particular patient The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties including without limitation any implied warranties of fitness for a particular purpose In view of ongoing research equipment modifications changes in governmental regulations and the constant flow of information relating to the use of medicines equipment and devices the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine equipment or device for among other things any changes in the instructions or indication of usage and for added warnings and precautions Readers should consult with a specialist where appropriate The fact that an organization or Website is referred to in this work as a citation andor a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make Further readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read No warranty may be created or extended by any promotional statements for this work Neither the publisher nor the author shall be liable for any damages arising herefrom
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Wiley also publishes its books in a variety of electronic formats Some content that appears in print may not be available in electronic formats For more information about Wiley products visit our web site at wwwwileycom
Library of Congress Cataloging-in-Publication DataMatte Gregory S author Perfusion for congenital heart surgery notes on cardiopulmonary bypass for a complex patient population Gregory S Matte p cm Includes bibliographical references and index ISBN 978-1-118-90079-6 (cloth)I Title [DNLM 1 Heart Defects Congenitalndashsurgery 2 Infant 3 Cardiopulmonary Bypassndashinstrumentation 4 Cardiopulmonary Bypassndashmethods 5 Child 6 Perfusionndashmethods WS 290] RD59835C67 6174prime12ndashdc23 201404632610 9 8 7 6 5 4 3 2 1
1 2015
To Bridget Nicholas and Justin for their love support and regular reminders that we are all lifelong students
vii
Foreword x
Preface xi
Acknowledgments xii
1 Equipment for bypass 1Oxygenators 1Arterial line filters 12Tubing packs 13Cardioplegia systems 16The heartndashlung machine 17The heater-cooler system 19Cannulae 20
2 Priming the bypass circuit 27Prime constituents 27Steps for priming 28
3 The bypass plan 33Communication agreement for case 33Anticoagulation management 35Blood gas management 40
Carbon dioxide management 40Oxygenation strategy 42
Hematocrit management 45Blood pressure management 47Temperature management 49Flow rates regional perfusion and hypothermic circulatory arrest 52Methods of ultrafiltration 55
Before bypass 55On bypass 55After bypass 56
SMUF specifications 59Standard and augmented venous return 60
Standard venous return with gravity siphon drainage 60Augmented venous return 60
The prebypass checklist 63The surgical safety checklist for congenital heart surgery 65
4 Typical phases of cardiopulmonary bypass 72Commencement of bypass 72Standard support phase of bypass 74Termination of bypass 76Post bypass 78
5 Additional notes based on bypass tasks 79Prebypass 79
Heartndashlung machine (HLM) 79Reoperations 79Cannulation 79Transfusion during cannulation 80
On bypass 80Verification of adequate drainage when caval tapes are used 80Blood gas management 80Cardioplegia delivery 81Planned circulatory arrest 81Induced ventricular fibrillation 82Administration of blood products 82Atrial line placement 82LV vent placement 83Bed rotation during bypass 83
6 Bypass considerations based on diagnosis 85Anomalous coronary arteries 86Aortic regurgitationinsufficiency 89Aortic stenosis 91Aortopulmonary collaterals 93Aortopulmonary window 95Atrial septal defect 96Cardiomyopathy requiring orthotopic heart transplantation 99
Contents
viii Contents
Coarctation of the aorta 100Common atrioventricular canal defect 102Cor triatriatum 104Corrected transposition of the great arteries (L-TGA Levo-TGA or C-TGA) or congenitally corrected TGA 105Critical aortic stenosis 107Double chambered right ventricle 109Double inlet left ventricle 110Double outlet left ventricle 111Double outlet right ventricle 112Ebsteinrsquos anomaly 113Hypoplastic left heart syndrome 114
Stage 1 (Norwood) procedure 115Hybrid stage 1 palliation 117Stage 2 or bidirectional Glenn shunt 117Fontan procedure (total cavopulmonary anastomosis) 119
Interrupted aortic arch 121Left superior vena cava 123Lung transplantation 124Mitral regurgitationinsufficiency 125Mitral stenosis 126Patent ductus arteriosus 127Pulmonary artery abnormalities 128Pulmonary atresia 129
Pulmonary atresia with an intact ventricular septum 129Pulmonary atresia with ventricular septal defect 130
Pulmonary regurgitationinsufficiency 132Pulmonary stenosis 133Pulmonary vein stenosis or pulmonary venous obstruction 134Tetralogy of Fallot 136Total anomalous pulmonary venous return and partial anomalous pulmonary venous return 138d-Transposition of the great arteries 140Tricuspid atresia 142Tricuspid regurgitationinsufficiency 143Truncus arteriosus 144Ventricular septal defect 146
7 Notes on select issues during bypass 148Blood pressure higher than expected 148Blood pressure lower than expected 149Bypass circuit pressure higher than expected 151Bypass circuit pressure lower than expected 152
Central venous pressure elevated 153Heat exchange issue (slow cooling or warming) 154NIRS values lower than expected 155PaCO2 higher than expected 157PaCO2 lower than expected 159PaO2 lower than expected 160Reservoir volume acutely low 161
8 Notes on select emergency procedures during bypass 163Arterial pump failure (roller head) 164Failure to oxygenate 165Massive air embolization 166Acute aortic dissection at the initiation of bypass 168Venous air lock 169Inadvertent arterial decannulation 170Inadvertent venous decannulation 171
9 Brief overview of named procedures and terms 172Alfieri stitch 172Batista procedure 172Bentall procedure 172Bidirectional Glenn shunt 172BlalockndashHanlon procedure 172BlalockndashTaussig shunt (BTS) 173Brock procedure 173Central shunt 173Cone procedure 173Cox maze procedure 173DamusndashKayendashStansel anastomosis 173Double switch procedure 173Fontan procedure 174Gott shunt 174HemindashFontan procedure 174Holmes heart 174Jatene operation 174Kawasaki disease 174Kawashima procedure 175(Diverticulum of) Kommerell 175Konno procedure 175LeCompte maneuver 175LeCompte procedure 175Manougian procedure 175Marfanrsquos syndrome 175Maze procedure 175Mustard procedure 176
Contents ix
Nicks procedure 176Nikaidoh procedure 176Noonan syndrome 176Norwood operation 176Pannus 176Pentalogy of Cantrell 176Potts shunt 177Rashkind procedure 177Rastelli operation 177Ross procedure 177Sano shunt 177Scimitar syndrome 177Senning operation 177Shonersquos complex 178Takeuchi procedure 178TaussigndashBing anomaly 178Trusler repair 178
Van Praagh classification 178Warden procedure 178Waterston shunt 178Williams syndrome 178Yasui procedure 179
10 Abbreviations for congenital heart surgery 180
11 Recommended reference books 186
12 Comprehensive experience-based equipment selection chart select medications administered during bypass 187
Index 190
x
The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself
There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an
essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients
James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School
Chief Division of Cardiac Anesthesia
Francis X McGowan Jr MDChair in Cardiac Anesthesia
Boston Childrenrsquos Hospital
Foreword
xi
Preface
There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run
The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most
common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings
Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass
Gregory S Matte CCP LP FPP
Disclaimer
Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk
xii
Acknowledgments
A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago
I am also deeply indebted to the following individuals who provided feedback regarding the content of this book
andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers
Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc
1
The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass
Oxygenators
The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system
The oxygenator membranebull Membrane oxygenators allow for diffusion of gas
oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)
bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates
bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity
bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions
bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion
bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended
bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection
bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas
Equipment for bypassChapTEr 1
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
To Bridget Nicholas and Justin for their love support and regular reminders that we are all lifelong students
vii
Foreword x
Preface xi
Acknowledgments xii
1 Equipment for bypass 1Oxygenators 1Arterial line filters 12Tubing packs 13Cardioplegia systems 16The heartndashlung machine 17The heater-cooler system 19Cannulae 20
2 Priming the bypass circuit 27Prime constituents 27Steps for priming 28
3 The bypass plan 33Communication agreement for case 33Anticoagulation management 35Blood gas management 40
Carbon dioxide management 40Oxygenation strategy 42
Hematocrit management 45Blood pressure management 47Temperature management 49Flow rates regional perfusion and hypothermic circulatory arrest 52Methods of ultrafiltration 55
Before bypass 55On bypass 55After bypass 56
SMUF specifications 59Standard and augmented venous return 60
Standard venous return with gravity siphon drainage 60Augmented venous return 60
The prebypass checklist 63The surgical safety checklist for congenital heart surgery 65
4 Typical phases of cardiopulmonary bypass 72Commencement of bypass 72Standard support phase of bypass 74Termination of bypass 76Post bypass 78
5 Additional notes based on bypass tasks 79Prebypass 79
Heartndashlung machine (HLM) 79Reoperations 79Cannulation 79Transfusion during cannulation 80
On bypass 80Verification of adequate drainage when caval tapes are used 80Blood gas management 80Cardioplegia delivery 81Planned circulatory arrest 81Induced ventricular fibrillation 82Administration of blood products 82Atrial line placement 82LV vent placement 83Bed rotation during bypass 83
6 Bypass considerations based on diagnosis 85Anomalous coronary arteries 86Aortic regurgitationinsufficiency 89Aortic stenosis 91Aortopulmonary collaterals 93Aortopulmonary window 95Atrial septal defect 96Cardiomyopathy requiring orthotopic heart transplantation 99
Contents
viii Contents
Coarctation of the aorta 100Common atrioventricular canal defect 102Cor triatriatum 104Corrected transposition of the great arteries (L-TGA Levo-TGA or C-TGA) or congenitally corrected TGA 105Critical aortic stenosis 107Double chambered right ventricle 109Double inlet left ventricle 110Double outlet left ventricle 111Double outlet right ventricle 112Ebsteinrsquos anomaly 113Hypoplastic left heart syndrome 114
Stage 1 (Norwood) procedure 115Hybrid stage 1 palliation 117Stage 2 or bidirectional Glenn shunt 117Fontan procedure (total cavopulmonary anastomosis) 119
Interrupted aortic arch 121Left superior vena cava 123Lung transplantation 124Mitral regurgitationinsufficiency 125Mitral stenosis 126Patent ductus arteriosus 127Pulmonary artery abnormalities 128Pulmonary atresia 129
Pulmonary atresia with an intact ventricular septum 129Pulmonary atresia with ventricular septal defect 130
Pulmonary regurgitationinsufficiency 132Pulmonary stenosis 133Pulmonary vein stenosis or pulmonary venous obstruction 134Tetralogy of Fallot 136Total anomalous pulmonary venous return and partial anomalous pulmonary venous return 138d-Transposition of the great arteries 140Tricuspid atresia 142Tricuspid regurgitationinsufficiency 143Truncus arteriosus 144Ventricular septal defect 146
7 Notes on select issues during bypass 148Blood pressure higher than expected 148Blood pressure lower than expected 149Bypass circuit pressure higher than expected 151Bypass circuit pressure lower than expected 152
Central venous pressure elevated 153Heat exchange issue (slow cooling or warming) 154NIRS values lower than expected 155PaCO2 higher than expected 157PaCO2 lower than expected 159PaO2 lower than expected 160Reservoir volume acutely low 161
8 Notes on select emergency procedures during bypass 163Arterial pump failure (roller head) 164Failure to oxygenate 165Massive air embolization 166Acute aortic dissection at the initiation of bypass 168Venous air lock 169Inadvertent arterial decannulation 170Inadvertent venous decannulation 171
9 Brief overview of named procedures and terms 172Alfieri stitch 172Batista procedure 172Bentall procedure 172Bidirectional Glenn shunt 172BlalockndashHanlon procedure 172BlalockndashTaussig shunt (BTS) 173Brock procedure 173Central shunt 173Cone procedure 173Cox maze procedure 173DamusndashKayendashStansel anastomosis 173Double switch procedure 173Fontan procedure 174Gott shunt 174HemindashFontan procedure 174Holmes heart 174Jatene operation 174Kawasaki disease 174Kawashima procedure 175(Diverticulum of) Kommerell 175Konno procedure 175LeCompte maneuver 175LeCompte procedure 175Manougian procedure 175Marfanrsquos syndrome 175Maze procedure 175Mustard procedure 176
Contents ix
Nicks procedure 176Nikaidoh procedure 176Noonan syndrome 176Norwood operation 176Pannus 176Pentalogy of Cantrell 176Potts shunt 177Rashkind procedure 177Rastelli operation 177Ross procedure 177Sano shunt 177Scimitar syndrome 177Senning operation 177Shonersquos complex 178Takeuchi procedure 178TaussigndashBing anomaly 178Trusler repair 178
Van Praagh classification 178Warden procedure 178Waterston shunt 178Williams syndrome 178Yasui procedure 179
10 Abbreviations for congenital heart surgery 180
11 Recommended reference books 186
12 Comprehensive experience-based equipment selection chart select medications administered during bypass 187
Index 190
x
The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself
There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an
essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients
James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School
Chief Division of Cardiac Anesthesia
Francis X McGowan Jr MDChair in Cardiac Anesthesia
Boston Childrenrsquos Hospital
Foreword
xi
Preface
There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run
The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most
common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings
Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass
Gregory S Matte CCP LP FPP
Disclaimer
Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk
xii
Acknowledgments
A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago
I am also deeply indebted to the following individuals who provided feedback regarding the content of this book
andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers
Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc
1
The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass
Oxygenators
The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system
The oxygenator membranebull Membrane oxygenators allow for diffusion of gas
oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)
bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates
bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity
bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions
bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion
bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended
bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection
bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas
Equipment for bypassChapTEr 1
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
vii
Foreword x
Preface xi
Acknowledgments xii
1 Equipment for bypass 1Oxygenators 1Arterial line filters 12Tubing packs 13Cardioplegia systems 16The heartndashlung machine 17The heater-cooler system 19Cannulae 20
2 Priming the bypass circuit 27Prime constituents 27Steps for priming 28
3 The bypass plan 33Communication agreement for case 33Anticoagulation management 35Blood gas management 40
Carbon dioxide management 40Oxygenation strategy 42
Hematocrit management 45Blood pressure management 47Temperature management 49Flow rates regional perfusion and hypothermic circulatory arrest 52Methods of ultrafiltration 55
Before bypass 55On bypass 55After bypass 56
SMUF specifications 59Standard and augmented venous return 60
Standard venous return with gravity siphon drainage 60Augmented venous return 60
The prebypass checklist 63The surgical safety checklist for congenital heart surgery 65
4 Typical phases of cardiopulmonary bypass 72Commencement of bypass 72Standard support phase of bypass 74Termination of bypass 76Post bypass 78
5 Additional notes based on bypass tasks 79Prebypass 79
Heartndashlung machine (HLM) 79Reoperations 79Cannulation 79Transfusion during cannulation 80
On bypass 80Verification of adequate drainage when caval tapes are used 80Blood gas management 80Cardioplegia delivery 81Planned circulatory arrest 81Induced ventricular fibrillation 82Administration of blood products 82Atrial line placement 82LV vent placement 83Bed rotation during bypass 83
6 Bypass considerations based on diagnosis 85Anomalous coronary arteries 86Aortic regurgitationinsufficiency 89Aortic stenosis 91Aortopulmonary collaterals 93Aortopulmonary window 95Atrial septal defect 96Cardiomyopathy requiring orthotopic heart transplantation 99
Contents
viii Contents
Coarctation of the aorta 100Common atrioventricular canal defect 102Cor triatriatum 104Corrected transposition of the great arteries (L-TGA Levo-TGA or C-TGA) or congenitally corrected TGA 105Critical aortic stenosis 107Double chambered right ventricle 109Double inlet left ventricle 110Double outlet left ventricle 111Double outlet right ventricle 112Ebsteinrsquos anomaly 113Hypoplastic left heart syndrome 114
Stage 1 (Norwood) procedure 115Hybrid stage 1 palliation 117Stage 2 or bidirectional Glenn shunt 117Fontan procedure (total cavopulmonary anastomosis) 119
Interrupted aortic arch 121Left superior vena cava 123Lung transplantation 124Mitral regurgitationinsufficiency 125Mitral stenosis 126Patent ductus arteriosus 127Pulmonary artery abnormalities 128Pulmonary atresia 129
Pulmonary atresia with an intact ventricular septum 129Pulmonary atresia with ventricular septal defect 130
Pulmonary regurgitationinsufficiency 132Pulmonary stenosis 133Pulmonary vein stenosis or pulmonary venous obstruction 134Tetralogy of Fallot 136Total anomalous pulmonary venous return and partial anomalous pulmonary venous return 138d-Transposition of the great arteries 140Tricuspid atresia 142Tricuspid regurgitationinsufficiency 143Truncus arteriosus 144Ventricular septal defect 146
7 Notes on select issues during bypass 148Blood pressure higher than expected 148Blood pressure lower than expected 149Bypass circuit pressure higher than expected 151Bypass circuit pressure lower than expected 152
Central venous pressure elevated 153Heat exchange issue (slow cooling or warming) 154NIRS values lower than expected 155PaCO2 higher than expected 157PaCO2 lower than expected 159PaO2 lower than expected 160Reservoir volume acutely low 161
8 Notes on select emergency procedures during bypass 163Arterial pump failure (roller head) 164Failure to oxygenate 165Massive air embolization 166Acute aortic dissection at the initiation of bypass 168Venous air lock 169Inadvertent arterial decannulation 170Inadvertent venous decannulation 171
9 Brief overview of named procedures and terms 172Alfieri stitch 172Batista procedure 172Bentall procedure 172Bidirectional Glenn shunt 172BlalockndashHanlon procedure 172BlalockndashTaussig shunt (BTS) 173Brock procedure 173Central shunt 173Cone procedure 173Cox maze procedure 173DamusndashKayendashStansel anastomosis 173Double switch procedure 173Fontan procedure 174Gott shunt 174HemindashFontan procedure 174Holmes heart 174Jatene operation 174Kawasaki disease 174Kawashima procedure 175(Diverticulum of) Kommerell 175Konno procedure 175LeCompte maneuver 175LeCompte procedure 175Manougian procedure 175Marfanrsquos syndrome 175Maze procedure 175Mustard procedure 176
Contents ix
Nicks procedure 176Nikaidoh procedure 176Noonan syndrome 176Norwood operation 176Pannus 176Pentalogy of Cantrell 176Potts shunt 177Rashkind procedure 177Rastelli operation 177Ross procedure 177Sano shunt 177Scimitar syndrome 177Senning operation 177Shonersquos complex 178Takeuchi procedure 178TaussigndashBing anomaly 178Trusler repair 178
Van Praagh classification 178Warden procedure 178Waterston shunt 178Williams syndrome 178Yasui procedure 179
10 Abbreviations for congenital heart surgery 180
11 Recommended reference books 186
12 Comprehensive experience-based equipment selection chart select medications administered during bypass 187
Index 190
x
The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself
There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an
essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients
James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School
Chief Division of Cardiac Anesthesia
Francis X McGowan Jr MDChair in Cardiac Anesthesia
Boston Childrenrsquos Hospital
Foreword
xi
Preface
There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run
The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most
common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings
Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass
Gregory S Matte CCP LP FPP
Disclaimer
Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk
xii
Acknowledgments
A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago
I am also deeply indebted to the following individuals who provided feedback regarding the content of this book
andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers
Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc
1
The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass
Oxygenators
The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system
The oxygenator membranebull Membrane oxygenators allow for diffusion of gas
oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)
bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates
bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity
bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions
bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion
bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended
bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection
bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas
Equipment for bypassChapTEr 1
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
viii Contents
Coarctation of the aorta 100Common atrioventricular canal defect 102Cor triatriatum 104Corrected transposition of the great arteries (L-TGA Levo-TGA or C-TGA) or congenitally corrected TGA 105Critical aortic stenosis 107Double chambered right ventricle 109Double inlet left ventricle 110Double outlet left ventricle 111Double outlet right ventricle 112Ebsteinrsquos anomaly 113Hypoplastic left heart syndrome 114
Stage 1 (Norwood) procedure 115Hybrid stage 1 palliation 117Stage 2 or bidirectional Glenn shunt 117Fontan procedure (total cavopulmonary anastomosis) 119
Interrupted aortic arch 121Left superior vena cava 123Lung transplantation 124Mitral regurgitationinsufficiency 125Mitral stenosis 126Patent ductus arteriosus 127Pulmonary artery abnormalities 128Pulmonary atresia 129
Pulmonary atresia with an intact ventricular septum 129Pulmonary atresia with ventricular septal defect 130
Pulmonary regurgitationinsufficiency 132Pulmonary stenosis 133Pulmonary vein stenosis or pulmonary venous obstruction 134Tetralogy of Fallot 136Total anomalous pulmonary venous return and partial anomalous pulmonary venous return 138d-Transposition of the great arteries 140Tricuspid atresia 142Tricuspid regurgitationinsufficiency 143Truncus arteriosus 144Ventricular septal defect 146
7 Notes on select issues during bypass 148Blood pressure higher than expected 148Blood pressure lower than expected 149Bypass circuit pressure higher than expected 151Bypass circuit pressure lower than expected 152
Central venous pressure elevated 153Heat exchange issue (slow cooling or warming) 154NIRS values lower than expected 155PaCO2 higher than expected 157PaCO2 lower than expected 159PaO2 lower than expected 160Reservoir volume acutely low 161
8 Notes on select emergency procedures during bypass 163Arterial pump failure (roller head) 164Failure to oxygenate 165Massive air embolization 166Acute aortic dissection at the initiation of bypass 168Venous air lock 169Inadvertent arterial decannulation 170Inadvertent venous decannulation 171
9 Brief overview of named procedures and terms 172Alfieri stitch 172Batista procedure 172Bentall procedure 172Bidirectional Glenn shunt 172BlalockndashHanlon procedure 172BlalockndashTaussig shunt (BTS) 173Brock procedure 173Central shunt 173Cone procedure 173Cox maze procedure 173DamusndashKayendashStansel anastomosis 173Double switch procedure 173Fontan procedure 174Gott shunt 174HemindashFontan procedure 174Holmes heart 174Jatene operation 174Kawasaki disease 174Kawashima procedure 175(Diverticulum of) Kommerell 175Konno procedure 175LeCompte maneuver 175LeCompte procedure 175Manougian procedure 175Marfanrsquos syndrome 175Maze procedure 175Mustard procedure 176
Contents ix
Nicks procedure 176Nikaidoh procedure 176Noonan syndrome 176Norwood operation 176Pannus 176Pentalogy of Cantrell 176Potts shunt 177Rashkind procedure 177Rastelli operation 177Ross procedure 177Sano shunt 177Scimitar syndrome 177Senning operation 177Shonersquos complex 178Takeuchi procedure 178TaussigndashBing anomaly 178Trusler repair 178
Van Praagh classification 178Warden procedure 178Waterston shunt 178Williams syndrome 178Yasui procedure 179
10 Abbreviations for congenital heart surgery 180
11 Recommended reference books 186
12 Comprehensive experience-based equipment selection chart select medications administered during bypass 187
Index 190
x
The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself
There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an
essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients
James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School
Chief Division of Cardiac Anesthesia
Francis X McGowan Jr MDChair in Cardiac Anesthesia
Boston Childrenrsquos Hospital
Foreword
xi
Preface
There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run
The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most
common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings
Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass
Gregory S Matte CCP LP FPP
Disclaimer
Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk
xii
Acknowledgments
A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago
I am also deeply indebted to the following individuals who provided feedback regarding the content of this book
andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers
Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc
1
The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass
Oxygenators
The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system
The oxygenator membranebull Membrane oxygenators allow for diffusion of gas
oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)
bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates
bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity
bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions
bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion
bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended
bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection
bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas
Equipment for bypassChapTEr 1
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
Contents ix
Nicks procedure 176Nikaidoh procedure 176Noonan syndrome 176Norwood operation 176Pannus 176Pentalogy of Cantrell 176Potts shunt 177Rashkind procedure 177Rastelli operation 177Ross procedure 177Sano shunt 177Scimitar syndrome 177Senning operation 177Shonersquos complex 178Takeuchi procedure 178TaussigndashBing anomaly 178Trusler repair 178
Van Praagh classification 178Warden procedure 178Waterston shunt 178Williams syndrome 178Yasui procedure 179
10 Abbreviations for congenital heart surgery 180
11 Recommended reference books 186
12 Comprehensive experience-based equipment selection chart select medications administered during bypass 187
Index 190
x
The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself
There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an
essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients
James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School
Chief Division of Cardiac Anesthesia
Francis X McGowan Jr MDChair in Cardiac Anesthesia
Boston Childrenrsquos Hospital
Foreword
xi
Preface
There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run
The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most
common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings
Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass
Gregory S Matte CCP LP FPP
Disclaimer
Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk
xii
Acknowledgments
A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago
I am also deeply indebted to the following individuals who provided feedback regarding the content of this book
andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers
Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc
1
The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass
Oxygenators
The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system
The oxygenator membranebull Membrane oxygenators allow for diffusion of gas
oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)
bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates
bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity
bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions
bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion
bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended
bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection
bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas
Equipment for bypassChapTEr 1
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
x
The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself
There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an
essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients
James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School
Chief Division of Cardiac Anesthesia
Francis X McGowan Jr MDChair in Cardiac Anesthesia
Boston Childrenrsquos Hospital
Foreword
xi
Preface
There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run
The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most
common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings
Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass
Gregory S Matte CCP LP FPP
Disclaimer
Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk
xii
Acknowledgments
A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago
I am also deeply indebted to the following individuals who provided feedback regarding the content of this book
andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers
Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc
1
The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass
Oxygenators
The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system
The oxygenator membranebull Membrane oxygenators allow for diffusion of gas
oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)
bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates
bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity
bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions
bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion
bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended
bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection
bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas
Equipment for bypassChapTEr 1
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
xi
Preface
There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run
The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most
common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings
Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass
Gregory S Matte CCP LP FPP
Disclaimer
Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk
xii
Acknowledgments
A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago
I am also deeply indebted to the following individuals who provided feedback regarding the content of this book
andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers
Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc
1
The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass
Oxygenators
The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system
The oxygenator membranebull Membrane oxygenators allow for diffusion of gas
oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)
bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates
bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity
bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions
bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion
bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended
bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection
bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas
Equipment for bypassChapTEr 1
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
xii
Acknowledgments
A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago
I am also deeply indebted to the following individuals who provided feedback regarding the content of this book
andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers
Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc
1
The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass
Oxygenators
The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system
The oxygenator membranebull Membrane oxygenators allow for diffusion of gas
oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)
bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates
bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity
bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions
bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion
bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended
bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection
bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas
Equipment for bypassChapTEr 1
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc
1
The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass
Oxygenators
The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system
The oxygenator membranebull Membrane oxygenators allow for diffusion of gas
oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)
bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates
bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity
bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions
bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion
bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended
bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection
bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas
Equipment for bypassChapTEr 1
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
Arterial limbVenous limb
Gas source and13ow meter
Arterial line lterwith bypass loopclamped
Oxygenator withintegrated heatexchanger Angledports are for waterlines
LV vent pump head
Arterial pump head
Integrated cardiotomy venous reservoir (CVR)
Cardiotomy lter
Suction pump head
Field suction
LV vent
Suction pump head
Venous reservoir and lter
Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)
A A A
BB
B
Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
TOP VIEW
SIDE VIEW
Nonlteredluer lock
Auxiliary port14rdquondash38rdquo
Sampling line
Venous bloodsampling line connection
Two luer lockson venous inlet
Thermistor probe
Venous blood inlet port
Three ltered luer locksto cardiotomy lter
Five suction ports
Quick prime port
Purge line fromthe oxygenator
Vent port
Venous blood inlet port
Cardiotomy lter
Purge line
Guide hole for holder
Clamp
Connecting ring
One way valve
Heat exchanger
Gas inlet port
Arterial lter
Water inlet port
Gas exchangemodule
Water outletport
Luer port (for recirculation or blood cardioplegia)Thermistor probe
Blood outlet portGas outlet portDetachable connector
One-way valve
Blood inletport
Sampling line-arterial side
Reservoiroutlet port
Samplingsystem
Hardshellreservoir
Oxygenatorwith integratedarterial lter
Sampling line-venous side
Venous lter
Detachableconnector
Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved
Gas ow
Blood ow
Gas ow
Blood ow
Gas transfer only
True membrane oxygenators
Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments
Microporous membrane oxygenators
Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass
Figure 14 Primary types of oxygenators currently in use
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
4 Chapter 1
exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance
bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices
bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)
bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF
bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator
bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14
bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit
bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs
bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane
bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function
bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since
Oxygenator bundle
Oxygenator bundle
Heat exchanger
Heat exchanger
Heat exchanger
Heat exchanger
Oxygenator inlet
Oxygenator inlet
Oxygenator outlet
Oxygenator outlet
Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice
Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle
Oxygenator
Oxygenator bundle
Figure 15 Simplified schematic of blood flow paths through an oxygenator
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
Tab
le 1
1 O
xyge
nato
rs r
ated
up
to ~
2 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce
fact
or
at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed
blo
od
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w r
ang
e (L
PM)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
D10
00
2231
Up
to 0
730
00
6550
0Ye
sN
o10
Up
to 1
4 L
PM
with
a m
ax
VQ
of
21
Up
to 2
8 L
PM
with
a m
ax
VQ
of
41
Sorin
Liili
put
D90
10
3460
08
200
072
675
Yes
No
15U
p to
16
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal
038
380
2ndash1
570
00
6280
0Ye
sN
o15
01ndash
30
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i N
eona
tal w
ith
inte
grat
ed A
LF
038
400
2ndash1
570
00
6280
0Ye
sYe
s33
microm2
0 cm
215
01ndash
30
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX05
05
430
1ndash1
535
00
6510
00Ye
sN
o15
005
ndash5
min
imum
02
V
Q
5 LP
M f
or 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX05
05
430
1ndash1
535
00
6510
00Ye
sYe
s32
microm1
30 c
m2
150
05ndash5
m
inim
um 0
2
VQ
5 LP
M f
or 1
0s
do n
ot r
epea
t
Sorin
D10
10
6187
Up
to 2
560
00
615
00Ye
sN
o30
Up
to 5
LPM
w
ith a
max
V
Q o
f 2
1
Up
to 1
0 LP
M
with
a m
ax
VQ
of
41
Med
tron
icPi
xie
067
480
1ndash2
0N
ot
spec
ified
065
1200
Yes
No
20U
p to
40
LPM
w
ith a
max
V
Q o
f 2
1
Non
e sp
ecifi
ed
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
Tab
le 1
2 O
xyge
nato
rs r
ated
~2
to ~
5 LP
M
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
art
eria
l fi
lter
po
re s
ize
surf
ace
area
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
g
as f
low
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Lilli
put
D90
20
6410
5U
p to
23
200
048
1800
Yes
No
200
Up
to 4
6
LPM
with
a
max
V
Q o
f 21
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-i Pe
diat
ric0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-i Pe
diat
ric
with
inte
grat
ed A
LF0
899
02ndash
28
1500
062
1700
Yes
Yes
33 microm
55
cm2
300
1ndash5
6N
one
spec
ified
Maq
uet
Qua
drox
-iD P
edia
tric
(p
olym
ethy
lpen
tene
)0
881
02ndash
28
1500
062
1700
Yes
No
300
1ndash5
6N
one
spec
ified
Med
tron
icM
inim
ax0
814
90
5ndash2
3N
ot
spec
ified
045
2000
No
No
150
Non
e sp
ecifi
edN
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt1
317
50
5ndash5
030
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i Sm
all
Adu
lt w
ith in
tegr
ated
A
LF
13
295
05ndash
50
3000
062
4200
Yes
with
V
HK
200
1 re
serv
oir
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Sorin
Insp
ire 6
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
14
184
284
w
ith A
LFU
p to
60
4300
06
4500
Yes
Opt
iona
l38
microm6
8 cm
215
0U
p to
12
LPM
not
to
exc
eed
21
VQ
Up
to 1
2 LP
M
not
to e
xcee
d 2
1 V
Q
Teru
mo
Cap
iox
RX15
30
15
135
05ndash
4 5
LPM
w
ith a
ssis
ted
veno
us
drai
nage
1400
06
3000
Yes
No
700
5ndash15
15 L
PM fo
r 10s
do
not
rep
eat
Teru
mo
Cap
iox
RX15
40
15
135
05ndash
50
1400
06
4000
Yes
No
200
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
tTe
rum
oC
apio
x FX
15 3
01
514
40
5ndash4
5 L
PM
with
ass
iste
d ve
nous
dr
aina
ge
1400
06
3000
Yes
Yes
32 microm
360
cm
270
05ndash
1515
LPM
for 1
0s
do n
ot r
epea
t
Teru
mo
Cap
iox
FX15
40
15
144
05ndash
50
1400
053
4000
Yes
Yes
32 microm
360
cm
220
00
5ndash15
15 L
PM fo
r 10s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
Tab
le 1
3 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t I o
f II)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as n
ote
d)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
p
ore
siz
esu
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Sorin
Insp
ire 8
(opt
iona
l in
tegr
ated
art
eria
l fil
ter)
175
219
351
w
ith A
LFU
p to
80
4300
053
4500
Yes
Opt
iona
l38
microm
97 c
m2
150
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QM
aque
tQ
uadr
ox-i
Adu
lt1
821
50
5ndash7
040
000
642
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
No
300
Up
to 1
5N
one
spec
ified
Maq
uet
Qua
drox
-i A
dult
with
inte
grat
ed A
LF1
833
50
5ndash7
060
000
6242
00Ye
s w
ith
VH
K 2
001
rese
rvoi
r
Yes
40 microm
430
cm
230
0U
p to
15
Non
e sp
ecifi
ed
Maq
uet
Qua
drox
-iD A
dult
(pol
ymet
hylp
ente
ne)
18
215
05ndash
70
4000
06
4200
Yes
with
V
HK
200
1 re
serv
oir
No
300
Up
to 1
5N
one
spec
ified
Teru
mo
SX18
18
270
05ndash
70
2200
05
4000
Yes
No
200
05ndash
2020
LPM
for
10
s
do n
ot r
epea
tSo
rinPr
imO
2X1
8725
0U
p to
814
000
4443
00Ye
sN
o25
0U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinA
pex
HP
187
250
Up
to 8
1400
048
4000
Yes
No
200
U
p to
16
LPM
no
t to
exc
eed
21
VQ
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
QSo
rinSy
nthe
sis
250
0 w
ith
inte
grat
ed A
LFU
p to
814
000
3643
00Ye
sYe
s40
microm4
00 c
m2
300
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Up
to 1
6 LP
M
not
to e
xcee
d 2
1 V
Q
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
Tab
le 1
4 O
xyge
nato
rs r
ated
up
to 8
LPM
(Par
t II
of II
)
Man
ufa
ctu
rer
Oxy
gen
ato
r (m
icro
po
rou
s p
oly
pro
pyl
ene
exce
pt
as
no
ted
)
Oxy
gen
ato
r b
un
dle
(m
2 )O
xyg
enat
or
pri
me
volu
me
Man
ufa
ctu
rer
reco
mm
end
ed
blo
od
flo
w
ran
ge
(LPM
)
Hea
t ex
chan
ger
si
ze (
cm2 )
Hea
t ex
chan
ger
p
erfo
rman
ce f
acto
r at
man
ufa
ctu
rer
max
imu
m
reco
mm
end
ed b
loo
d
flo
w r
ate
Res
ervo
ir
cap
acit
y (m
L)
Co
mp
atib
le
wit
h
vacu
um
as
sist
ed
dra
inag
e
Inte
gra
ted
ar
teri
al f
ilter
po
re
size
su
rfac
e ar
ea
Min
imu
m
op
erat
ing
vo
lum
e
Gas
flo
w
ran
ge
(LPM
)
Max
imu
m
tem
po
rary
gas
fl
ow
fo
r su
spec
ted
w
etti
ng
ou
t o
f o
xyg
enat
or
Med
tron
icA
ffin
ity N
T2
527
01
0ndash7
0N
ot
spec
ified
045
4000
Yes
No
200
10ndash
70
Non
e sp
ecifi
ed
Med
tron
icA
ffin
ity F
usio
n2
526
01
0ndash7
040
000
5545
00Ye
sYe
s25
microm v
ia
oxyg
enat
or b
undl
e20
0N
one
spec
ified
Non
e sp
ecifi
ed
Teru
mo
Cap
iox
RX25
25
250
05ndash
70
2000
053
4000
Yes
No
200
05ndash
2020
LPM
for
10s
do
not
rep
eat
Teru
mo
Cap
iox
FX25
25
260
05ndash
70
2000
053
4000
Yes
Yes
32 microm
600
cm
220
00
5ndash20
20 L
PM f
or 1
0s
do n
ot r
epea
tTe
rum
oSX
252
534
00
5ndash7
022
000
540
00Ye
sN
o20
00
5ndash20
20 L
PM f
or
10 s
do
not
repe
at
top related