Ectrrooawapawh

M

Ff(Agcspslc

H2

0d

Elective High-Risk Percutaneous Coronary Interventions Supported byExtracorporeal Life Support

Jindra Vainer, MDa, Vincent van Ommen, MD, PhDa, Jos Maessen, MD, PhDb, Gijs Geskes, MDb,Leon Lamerichs, RNa, and Johannes Waltenberger, MD, PhDa,*

This study investigated the feasibility of high-risk percutaneous coronary intervention(PCI) in hemodynamically unstable patients supported by modified cardiopulmonarybypass (extracorporeal life support [ELS]). Over a 38-month period, 15 patients (10 men,5 women, mean age 72 � 9 years, mean ejection fraction 34 � 15%, angina pectoris NewYork Heart Association class III to IV) who were not eligible for coronary artery bypassgrafting because of high co-morbidity underwent elective high-risk PCI supported by ELS.All lesions were technically challenging. ELS perfusion cannulas in the femoral artery andvein were surgically inserted and removed. Procedural success was achieved in 14 of 15patients. After a mean perfusion duration of 88 � 37 minutes, all patients were weanedfrom the ELS in the catheterization laboratory. The patients were ventilated for 5.1 � 3.3hours. Blood transfusion was given to 8 patients. Apart from 2 groin bleedings, no othercomplications occurred. Patients left our hospital after 3.2 � 2.8 days. Of the 4 patients whodied during the 15 � 12-month follow-up, 1 died of a noncardiac cause. In conclusion, inhighly selected patients ineligible for bypass surgery, ELS-supported PCI can be performedwith promising short- and long-term clinical outcomes. This complex procedure is a safealternative whenever other options for revascularization are exhausted. © 2007 Elsevier

Inc. All rights reserved. (Am J Cardiol 2007;99:771–773)

AtgPcpca

gpamaflFnannClbthtmmotNa

xtracorporeal life support (ELS) represents a modifiedardiopulmonary bypass, enabling mechanical support tohe failing circulation independent of cardiac output orhythm.1,2 Venous blood from the inferior caval vein or theight atrium is oxygenated in an extracorporeal membranexygenator and returned to the circulation through the fem-ral artery into the abdominal aorta. ELS is well establisheds a mechanical support for failing circulation in childrenith heart disease. Low cardiac output, unexpected cardiac

rrest, failure to wean from cardiopulmonary bypass, dis-roportional cyanosis, and refractory arrhythmias are otherccepted indications for ELS.1–3 In the present pilot study,e evaluated the role of ELS in patients undergoing electiveigh-risk percutaneous coronary intervention (PCI).

ethods and Results

rom February 2003 to March 2006, 4,000 PCIs were per-ormed in our institution. During this period, 15 patients0.4 %) were treated with planned PCI supported by ELS.ll patients in whom intervention (coronary artery bypassrafting or PCI) was considered were discussed by a teamonsisting of 1 interventional cardiologist and 1 cardiacurgeon. The selected suitable candidates for ELS-sup-orted PCI were reconsidered by another team of 2 cardiacurgeons and 2 interventional cardiologists to prevent se-ection bias. Patient selection was based on symptomaticoronary artery disease (angina pectoris New York Heart

Departments of aCardiology and bCardiothoracic Surgery, Universityospital, Maastricht, The Netherlands. Manuscript received August 24,006; revised manuscript received and accepted October 9, 2006.

*Corresponding author: Tel: 31-43-387-5106; fax: 31-43-387-5104.

vE-mail address: j.waltenberger@cardio.azm.nl (J. Waltenberger).

002-9149/07/$ – see front matter © 2007 Elsevier Inc. All rights reserved.oi:10.1016/j.amjcard.2006.10.034

ssociation [NYHA] class III to IV) in which noninvasivereatment options were exhausted, coronary artery bypassrafting was refused by surgeons as a nonviable option, andCI was deemed to have an unacceptably high risk ofomplications even with use of an intra-aortic balloonump. All lesions were technically challenging (i.e., soleirculation, main stem bifurcation), where calcificationnd/or severe angulations precluded fast intervention.

Patients were pretreated with clopidogrel. Heparin wasiven to achieve activated clotting times �300 seconds. PCIrocedure was performed using a 7Fr guiding catheter fromfemoral or brachial approach. Under global anaesthesia onechanical ventilation, surgical cannulation of the femoral

rtery and femoral vein was used to gain access. Underuoroscopy, an arterial cannula (Bio-Medicus, One-Pieceemoral Arterial Cannulae 19Fr to 21Fr, Medtronic, Min-eapolis, Minnesota) was placed in the abdominal aorta andvenous cannula (Bio-Medicus, One-Piece Femoral Ve-

ous Cannula 27Fr, Medtronic; or Dual Stage femoral ve-ous cannula 29/32Fr, Edwards Lifesciences, LLC, Irvine,alifornia) was advanced into the right atrium. Proper se-

ection and placement of cannulas allowed redirecting thelood flow up to complete unloading of the heart and over-aking of blood circulation by an ELS system in case ofeart failure. A standardized ELS circuit including a cen-rifugal pump (Bio-Medicus BPX80, Medtronic) with aembrane oxygenator (Quadrox D, Maquet, Rastatt, Ger-any) was used in all patients. Arterial partial pressure of

xygen and mixed venous saturation were monitored con-inuously by inline probes (CDI 500, Terumo, Somerset,ew Jersey). Initial flow was maintained at 2 to 2.5 L/min

nd venous saturation at 60% to 70%. In case of decreased

enous saturation and/or arterial pressure, blood flow and

www.AJConline.org

otwrt

Ecibdrsm2p(sisdbaicqrta87pov21w

dp2Ib

D

MctImdfaciaavgsclspbaprscpda

TP

P

111111

mc coronar

772 The American Journal of Cardiology (www.AJConline.org)

xygenation were adjusted accordingly. After ELS was ini-iated, PCI was performed. After PCI, the patient waseaned from the ELS circuit and cannulas were surgically

emoved. Weaning from mechanical ventilation followedhe procedure depending on patient condition.

Fifteen patients (10 men, 5 women) were treated withLS-supported PCI. Mean age was 72 � 9 years. Patientharacteristics and procedural and follow-up data are listedn Table 1. Femoral access was used in 13 patients and arachial approach was necessary in 2. A single vessel wasilated in 4 patients, 2 vessels in 5, and 3 vessels in theemaining 6 patients. Seven patients received drug-elutingtents. Mean fluoroscopy time was 22 � 14 minutes andean perfusion duration was 88 � 37 minutes. On average,

.1 vessels were dilated and 2.1 stents were placed peratient. Procedural success was achieved in all but 1 patientpatient 1; Table 1). In this patient with decompensatedchizophrenia and after successful right coronary artery stent-ng, occlusive dissection occurred during dilatation of aeverely calcified and angulated left main/left anterior descen-ent coronary artery trajectory. After exhausting all catheter-ased treatment options, a venous graft was placed on the leftnterior descending coronary artery directly in the catheter-zation laboratory. Two patients developed an electrome-hanical dissociation during PCI, but ELS generated ade-uate support until mechanical cardiac activity wasestored. All patients were weaned from ELS in the cathe-erization laboratory and from mechanical ventilation onverage after 5.1 � 3.3 hours. Transfusion was necessary inpatients. Brief transient inotropic support was required inpatients. There were no in-hospital deaths, and no single

eriprocedural infarction was diagnosed. There was 1 casef local groin bleeding that did not require surgical inter-ention. Patients left our institution on average after 3.2 �.8 days. Four patients died during a mean follow-up of5 � 12 months. There were 3 presumably cardiac deaths (1

able 1atient characteristics

atient No. Age(yrs)/Sex

BMI LVEF RiskFactors

AnemiaV

1 55M 24.9 64 D,C,S,F �2 55M 24.9 26 H,C �3 67F 31.2 50 H,S,F �4 69M 31.3 25 D,C �5 69M 26.6 23 C,S,F �6 71M 28.4 18 �7 72M 23.1 16 �8 73M 22.9 46 �9 74F 35.3 45 D,H,C �0 74F 29.0 50 H,S �1 75M 26.1 37 C,S �2 75M 26.4 13 H,C �3 81F 27.9 21 C,F �4 82M 27.1 39 H,S �5 88M 27.7 40 H,S �

All patients had a previous myocardial infarction.BMI � body mass index; C � hypercholesterolemia; COPD � chronicellitus; F � positive family history for coronary artery disease; H � hype

oronary artery; LVEF � left ventricular ejection fraction; RCA � right

eek and 3 and 31 months after the procedure); 1 patient l

ied from lung cancer 3 months after PCI. Of 11 livingatients, 9 remained in angina pectoris NYHA class I to II,patients had recurrent anginal complaints of NYHA class

II, and in 1 of these patients reintervention was performedecause of focal restenosis.

iscussion

echanical support of circulation could prevent seriousomplications due to cardiovascular collapse in case ofemporary decreased perfusion complicating high-risk PCI.ntra-aortic balloon pump is widely accepted as a supportiveeasure, but it is insufficient to compensate for severe

ecreases in cardiac output during ischemia,3–6 and there-ore, is no real option for our patient population. A potentiallternative could be the Impella system (e.g., Impella Re-over LP2.5, Aachen, Germany).7 This ventricular unload-ng assist device is based on a microaxial rotary blood pumpnd can deliver an output up to 2.5 L/min. Lack of oxygen-tion is a conceptual disadvantage of any circulatory leftentricular assist device. A viable solution to support oxy-enation and circulation is to use an ELS system. The ELSystem used in our study is capable of producing sufficientardiac output (up to 4.5 L/min) independent of cardiac andung functions.8–11 The surgical approach to the groin ves-els enabled meticulous hemostasis after the procedure. Aercutaneous introduction technique, especially when com-ined with special vascular closure devices, is an attractivelternative. In emergency cases, a percutaneous approach isreferred in our institution. Procedural success and follow-upesults are promising in our limited cohort. General anaesthe-ia, mechanical ventilation, a surgical approach with sizableannulas and blood transfusion, and a time-consuming com-lex procedure limit widespread use of this combined proce-ure. However, using improved technology (mobile compactutomatic ELS devices and special vascular closure devices for

eralisease

CVA COPD RenalInsufficiency

Drug-ElutingStents

No. ofStents

� � � � 1� � � � 1� � � � 3� � � � 2� � � � 1� � � � 3� � � � 1� � � � 2� � � � 3� � � � 3� � � � 3� � � � 4� � � � 3� � � � 1� � � � 1

tive pulmonary disease; CVA � cerebrovascular accident; D � diabetesn; LAD � left anterior descending coronary artery; LCx � left circumflexy artery; S � smoking.

Periphessel D

���������������

obstrucrtensio

arge cannulas) and increasing experience should result in an

etthsrnEn

APN

1

1

T(

773Coronary Artery Disease/High-Risk PCI Supported by ELS

ven lower complication rate. The 1 reintervention secondaryo restenosis might have been prevented in our pilot cohort byhe use of drug-eluting stents. Taken together, ELS permitsigh-risk PCI with good procedural and acceptable long-termuccesses. The present pilot study has its limitations, mainlyelated to a small and nonrandomized patient group, which didot allow drawing firm conclusions concerning the necessity ofLS in this patient category. A future randomized study will beecessary to answer this question.

cknowledgment: The authors thank the Department oferfusion, University Hospital Maastricht, Maastricht, Theetherlands, for dedicated support.

1. Conrad SA, Rycos PT, Dalton H. Extracorporeal life support registryreport 2004. ASAIO J 2005;51:4–10.

2. Rich PB, Bock P. Extracorporeal life support for severe adult respi-ratory failure. Curr Opin Anaesthesiol 2003;16:105–111.

3. Pagani FD, Lynch W, Swaniker F, Dyke D, Bartlett R, Koelling T,Moscucci M, Deeg GM, Bolling S, Monaghan H, Aaronson K. Extra-corporeal life support to the left ventricular assist device bridge toheart transplant: a strategy to optimize survival and resource utiliza-tion. Circulation 1999;19(suppl):II-206–II-210.

4. Aguirre FV, Kern MJ, Bach R, Donohue T, Caracciolo E, Flynn MS,

able 1continued)

Left MainCoronary

LAD LCx RCA VenousBypass Graft

FluoroscopyTime (mins)

PerfusTime (m

� � � � � 52.2 185� � � � � 9.5 75� � � � � 44.8 111� � � � � 26.7 105� � � � � 7.1 40� � � � � 25.6 75� � � � � 29.1 82� � � � � 9.8 57� � � � � 31.7 110� � � � � 31.5 112� � � � � 12.1 55� � � � � 17.5 67� � � � � 15.8 55� � � � � 5.6 125� � � � � 17.4 61

Wolford T. Intraaortic balloon pump support during high-risk coronaryangioplasty. Cardiology 1994;84:175–186.

5. Brigouri C, Sarais C, Pagnotta P, Airoldi F, Liistro F, Sgura F, SpanosV, Carlino M, Montorfano M, Di Mario C, Colombo A. Electiveversus provisional intra-aortic ballon pumping in high-risk percutane-ous transluminal coronary angioplasty. Am Heart J 2003;145:700–707.

6. Schreiber TL, Kodall UR, O’Neil WW, Gangadharan V, Puchrowicz-Ochocki SB, Grines CL. Comparison of acute results of prophylacticintraaortic balloon pumping with cardiopulmonary support for percu-taneous transluminal coronary angioplasty (PTCA). Catheter Cardio-vasc Diagn 1998;45:115–119.

7. Henriques JPS, Remmelink M, Baan J, van der Schaaf RJ, Vis MM,Koch KT, Scholten EW, de Mol BAJM, Tijssen JGP, Piek JJ, deWinter RJ. Safety and feasibility of elective high-risk percutaneouscoronary intervention procedures with left ventricular support of theImpella Recover LP 2.5. Am J Cardiol 2006;97:990–992.

8. Guarneri EM, Califano JR, Schatz RA, Teirstein PS. Utility of standbycardiopulmonary support for elective coronary interventions. CatheterCardiovasc Intervent 1999;46:32–35.

9. Vogel RA, Tomasso CL. Elective supported angioplasty: initialreport of the National Registry. Catheter Cardiovasc Diagn 1990;20:22–26.

0. Shawl FA, Quyyumi AA, Bajaj S, Hoff SB, Dougherty KG. Percuta-neous cardiopulmonary bypass-supported coronary angioplasty in pa-tients with unstable angina pectoris or myocardial infarction and leftventricular fraction �25%. Am J Cardiol 1996;77:14–19.

1. Suarez de Lezo J, Pan M, Medina A, Pavlovic D, Romero M, SeguraJ, Ruiz M, Ojeda S, Munoz J, Rodriguez M. Percutaneous cardiopul-monary support in critical patients needing coronary interventions with

VentilationDuration (h)

Intensive CareStay (h)

Follow-up(mos)

CardiacDeath (mos)

NoncardiacDeath (mos)

9.0 22 29 � �3.0 21 3 � �5.7 41 14 � �

13.0 24 24 � �2.0 6 5 � �2.5 24 3 3 �3.0 21 31 31 �2.5 4 13 � �4.0 21 18 � �9.0 20 4 � �7.0 23 3 � 32.8 21 8 � �8.0 12 31 � �3.0 20 33 � �2.5 24 1 0.25 �

ionins)

stents. Catheter Cardiovasc Intervent 2002;57:467–475.