prosthetic heart valve anti coagulation use during pregnancy wael al husami md
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Prosthetic Heart Valves andAnticoagulation use duringPregnancy
WaelWaelAlAl--HusamiHusami MD, FACCMD, FACC
Interventional Cardiology and Vascular MedicineInterventional Cardiology and Vascular Medicine
LaheyLaheyClinic Medical CenterClinic Medical Center
Tufts University School of MedicineTufts University School of Medicine
BostonBoston
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OverviewOverview
1.1. Historical Perspective.Historical Perspective.
2. Bioprostheses (Tissue valves).3. Mechanical prostheses.
4. Selection of PHV in women of childbearing agewho desire to become pregnant.
5. Maternal and fetal risks associated with
pregnancy in patients with PHV.6. Management of patients with PHV during
pregnancy.AlAl--HusamiHusami
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Historical PerspectiveHistorical Perspective
1953: Development of the heart/lung
machine (cardiopulmonary bypass)allowed intra-cardiac procedures to be
performed. Later, improvements (cardio-plegia) led to
asystolic arrest.
1960: First Cardiac Valve Replacement.
1968: Coronary Artery Bypass Surgery.
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Classification of Prosthetic Heart
Valves
1- Biological or tissue valves, with
flexible leaflet occluders of animal or
human origin.
2- Mechanical prostheses, with rigid,manufactured occluders.
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DefinitionsDefinitionsAutograft valve refers to a translocation
within the same individual, eg, of thepulmonary valve into the aortic valve
position.
Autologous (or autogenous) tissue valve
involves fabricating a valve from thepatients own nonvalvular tissue, eg,
pericardium.AlAl--HusamiHusami
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DefinitionsDefinitionsCont.Cont.
Homograft (or allograft) valve refers to
transplantation from a donor of the same species;
eg, a donors aortic or pulmonary valve into a
recipients aortic or pulmonary position.
Heterograft (or xenograft) valve is a transplant
from another species, either an intact valve, eg, aporcine aortic valve, or a valve fashioned from
heterologous tissue, eg, bovine pericardium.AlAl--HusamiHusami
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DefinitionsDefinitions
Complications of Prosthetic Heart ValvesComplications of Prosthetic Heart Valves
StructuralStructural valvularvalvulardeterioration (SVD)deterioration (SVD):: any change inany change in
function of an operated valve resulting from anfunction of an operated valve resulting from an intrinsicintrinsicabnormality causingabnormality causing stenosisstenosis or regurgitation.or regurgitation.
Nonstructural dysfunction :Nonstructural dysfunction : any abnormality resulting inany abnormality resulting instenosisstenosis or regurgitation of the operated valve thator regurgitation of the operated valve that is notis not
intrinsicintrinsic to the valve itself exclusive of thrombosis andto the valve itself exclusive of thrombosis andinfection. This includesinfection. This includes inappropriateinappropriate sizing, also calledsizing, also called
valve prosthesisvalve prosthesispatient mismatch.patient mismatch.
the American Association for Thoracic Surgery (AATS) and the Socthe American Association for Thoracic Surgery (AATS) and the Society of Thoracic Surgeonsiety of Thoracic Surgeons
(STS) Guidelines for Clinical Reporting. In 1988(STS) Guidelines for Clinical Reporting. In 1988AlAl--HusamiHusami
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DefinitionsDefinitions
Complications of Prosthetic Heart ValvesComplications of Prosthetic Heart Valves Cont.Cont.
Valve thrombosis:Valve thrombosis: any thrombus, in the absence ofany thrombus, in the absence of
infection, attached to or near an operated valve thatinfection, attached to or near an operated valve thatoccludes part of the blood flow path or interferesoccludes part of the blood flow path or interfereswith function of the valve.with function of the valve.
EmbolismEmbolism is any embolic event that occurs in theis any embolic event that occurs in theabsence of infection after the immediateabsence of infection after the immediate
perioperativeperioperativeperiod. This includes any new,period. This includes any new,temporary or permanent, focal or globaltemporary or permanent, focal or globalneurological deficit and peripheral embolic event.neurological deficit and peripheral embolic event.
the American Association for Thoracic Surgery (AATS) and the Socthe American Association for Thoracic Surgery (AATS) and the Society of Thoracic Surgeonsiety of Thoracic Surgeons
(STS) Guidelines for Clinical Reporting. In 1988(STS) Guidelines for Clinical Reporting. In 1988AlAl--HusamiHusami
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Choice of ProsthesisChoice of Prosthesis
Durability of Prosthesis.
Necessity foranticoagulationanticoagulation.
Risk of Thrombo-embolism & Bleeding.
Re-operation rate .
Hemodynamic Performance.
Possible future pregnancy.
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Tissue Valves1.1. PorcinePorcine HeterograftsHeterografts..
2.2. StentlessStentless PorcinePorcine XenograftsXenografts..
3.3. Pericardial (Pericardial (XenograftXenograft) Aortic valves.) Aortic valves.4.4. Homograft ( Allograft) Aortic Valves.Homograft ( Allograft) Aortic Valves.
5.5. PericardialPericardial AutograftAutograft Valves.Valves.6.6. PulmonaryPulmonary AutograftsAutografts /The Ross procedure./The Ross procedure.
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11-- StentedStented Porcine aorticPorcine aortic
HeterograftsHeterograftsWidely used for theWidely used for the mitralmitral & the aortic& the aortic
positions.positions.Mounted on rigid or flexible stents to whichthe leaflets and sewing ring are attached.
Most of the information regardingpregnancy in women with bioprosthetic
valves has been obtained in women withporcine heterografts.
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P iP i H t ftH t ft
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PorcinePorcine HeterograftsHeterografts
Hancock valveHancock valve Medtronic Intact valveMedtronic Intact valve
CarpenterCarpenter--Edwards valvesEdwards valves
Braunwald E, Heart Disease. 7th edition. 2005;1553 621AlAl--HusamiHusami
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AnnAnn ThoracThorac SurgSurg 1995;60: S2211995;60: S221--88
Durability of the Hancock Bioprosthesis Compared With
Standard Aortic Valve Bioprostheses
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AnnAnn ThoracThorac SurgSurg 1995;60: S2211995;60: S221--88AlAl--HusamiHusami
2 S lS l iP i
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22-- StentlessStentless PorcinePorcine
XenograftsXenografts::Since theSince the stentstent adds to the obstruction & increaseadds to the obstruction & increase
stress on the leaflets,stress on the leaflets, stentlessstentless valves have beenvalves have beendeveloped for the aorticdeveloped for the aorticpostionpostion..
More physiological flow& lowMore physiological flow& low transvalvulartransvalvulargradients thangradients than stentedstentedporcine valves.porcine valves.
Provide superior hemodynamic profile compared
to stented porcine aortic heterografts especially in
patients with small aortic root *
*Hvass et al. J Thorac Cardiovasc Surg 1999;117:26772AlAl--HusamiHusami
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StentlessStentless PorcinePorcine XenograftsXenografts::
St. Jude MedicalSt. Jude Medical stentlessstentless valvevalve EdwardsEdwards stentlessstentless valvevalve
Medtronic Freestyle valveMedtronic Freestyle valve
Braunwald E, Heart Disease. 7th edition. 2005;1553 621AlAl--HusamiHusami
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33-- Pericardial (Pericardial (XenograftXenograft))
Aortic valvesAortic valvesBovine pericardial valves are fabricated ratherBovine pericardial valves are fabricated rather
than harvested directly.than harvested directly.Good longGood long--term durability that appears to beterm durability that appears to be
equivalent or better than that of theequivalent or better than that of theprocineprocinebioprosthesisbioprosthesis
Greater risk to develop MS.Greater risk to develop MS.
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CarpenterCarpenter--EdwardsEdwards
Bovine Pericardial ValveBovine Pericardial Valve
LaheyLahey ClinicClinic CathCath Lab. 2006Lab. 2006AlAl--HusamiHusami
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Figure 5. Freedom from structural valve deterioration (SVD)Figure 5. Freedom from structural valve deterioration (SVD)
for porcine and pericardial aortic valve replacement patients.for porcine and pericardial aortic valve replacement patients.
Gao et al. J Am Coll Cardiol 2004;44:3848AlAl--HusamiHusami
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Gao et al. ConcludedConcluded
Freedom from structural deterioration andFreedom from structural deterioration and
reoperationreoperation makes pericardial valvesmakes pericardial valvesbioprosthesisbioprosthesis of choice for aortic valveof choice for aortic valve
replacement.replacement.
The 10The 10--year results for the pericardial valveyear results for the pericardial valve
continue to demonstrate a strong performance,continue to demonstrate a strong performance,
which may broaden its indication to youngerwhich may broaden its indication to youngerpatients with aortic valve disease.patients with aortic valve disease.
Gao et al. J Am Coll Cardiol 2004;44:3848AlAl--HusamiHusami
44 H ft ( All ft) A tiHomograft ( Allograft) Aortic
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44-- Homograft ( Allograft) AorticHomograft ( Allograft) AorticValves:Valves:
First tissue valve to be used in 1960.First tissue valve to be used in 1960.
Harvested from cadavers within 24 hrs of donor death.Harvested from cadavers within 24 hrs of donor death.
Advantages:
HemodynamicsHemodynamics are superior toare superior to stentedstentedporcine valves andporcine valves and
similar tosimilar to stentlessstentlessporcine valves.porcine valves.
LowLow ThrombogenicityThrombogenicity
Extremely low rate of infection and are indicated forExtremely low rate of infection and are indicated forpatients with native or prosthetic valvepatients with native or prosthetic valve endocarditisendocarditis..
Preferable substitute for AVR in younger patients.
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Disadvantages:
Not on shelf.
Re-operation difficult.
Homograft ( Allograft) Aortic ValvesHomograft ( Allograft) Aortic Valves
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Homograft Aortic ValveHomograft Aortic Valve Durability
M.OM.OBrienBrien et al J. Heart V.et al J. Heart V. DisDis 2001;10:3342001;10:334--345345
1,022 patients mean age 47yrs: Actuarial Survival1,022 patients mean age 47yrs: Actuarial Survival
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55 P i di lP i di l A t ftA t ft
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55-- PericardialPericardial AutograftAutograft
Valves:Valves:PatientPatients own pericardium is inserted intos own pericardium is inserted into
a frame, then used into either the aortic ora frame, then used into either the aortic orthethe mitralmitralpositionposition
LongLong--term durability appears to beterm durability appears to beexcellentexcellent
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66-- PulmonaryPulmonary AutograftsAutografts
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66 PulmonaryPulmonary AutograftsAutografts
(The Ross procedure)(The Ross procedure)
The patientThe patients own Pulmonary valve is removeds own Pulmonary valve is removed
and used to replace the Aortic valve, then theand used to replace the Aortic valve, then theaortic homograft valve is then inserted intoaortic homograft valve is then inserted into
Pulmonary position.Pulmonary position.
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Th R dTh R d
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The Ross procedureThe Ross procedure cont.cont.
AdvantagesAdvantagesViable aortic valve
NonthrombogenicNonthrombogenicRisk ofRisk ofendocarditisendocarditis is low.is low.
No anticoagulation.anticoagulation.LongLong--term durability appears to beterm durability appears to beexcellent.excellent.
It can be used in children, adolescents, andIt can be used in children, adolescents, andyoung women who wish to be a pregnant.young women who wish to be a pregnant.
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The Ross procedureThe Ross procedure cont.cont.
DisadvantagesDisadvantages
Longer operation.
High incidence of Pulmonary homograftHigh incidence of Pulmonary homograft
stenosisstenosis..
High re-operation in this group of patients
because of progression of aortic regurgitation.
Concomitant severe mitral valve
regurgitation.
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The Ross procedureThe Ross procedure cont.cont.
Contraindications:Contraindications:Bicuspid valves and dilated aortic roots,Bicuspid valves and dilated aortic roots,
because the implanted pulmonary artery tissuebecause the implanted pulmonary artery tissueexposed to higher aortic pressures leading toexposed to higher aortic pressures leading to
significant dilation of thesignificant dilation of the autograftautograft..
Marfans Syndrome.
Some connective tissue disease (R.arthritis/
SLE).
Active rheumatic heart disease.
Triple vessel CAD/ Mitral v. dis..AlAl--HusamiHusami
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Does pregnancyaccelerate the rate
of bioprosthetic
SVD?
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Does pregnancy accelerate the rate
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SVD bioprostheses
Hanania et al. 7 74Kadri et al. 4 14
Sbarouni et al. 17 49Born et al. 33 20
Lee et al. 44 5757
graft survival rate 17% in two
pregnancy vs 55% in onepregnancy.
Badduke et al. 88 17 37 pregnancies.10 SVD per 70 Non-pregnant
p g y
of bioprosthetic SVD?
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Reports Failed to Support theReports Failed to Support the
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Reports Failed to Support theReports Failed to Support the
previous studiesprevious studiesPreg. Non-
Preg
SVD
PregPreg..
SVD
NonNon
Avila et al. 48 37 27% 30% Re-operation(8% in both
groups)
Jamieson et al. 53 202 51% 41%
Salazar et al. 58 107 3.5%Per
patient-
year
3.4%Per
patient-year
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Freedom from Structural ValveFreedom from Structural Valve
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Freedom from Structural ValveFreedom from Structural Valve
DeteriorationDeterioration
Jamieson et al. AnnJamieson et al. Ann ThTh Surg.1995Surg.1995
PregnantPregnantNonNon--PregnantPregnant
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Early Mortality for reEarly Mortality for re--operationoperation
Ann Thorac Surg Jamieson et al. 1995;60:S282-7AlAl--HusamiHusami
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In Summary
Deterioration of bioprosthetic heart valves
during pregnancy has been reported in severalstudies, but could not be confirmed by others.
Although most available data might support
an accelerated SVD of bioprosthetic valves
during pregnancy, this could simply reflect the
well-established deterioration of tissue valvesin young individuals.
Elkayam et al. JACC Vol. 46, No. 3, 2005
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Choice of ProsthesisChoice of Prosthesis
Durability of Prosthesis.
Necessity foranticoagulationanticoagulation.
Risk of Thrombo-embolism & Bleeding.
Re-operation rate .
Hemodynamic Performance.
Possible future pregnancy.
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ThromboembolicThromboembolic EventEvent
Circulation North et al.1999;99;2669-2676AlAl--HusamiHusami
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Tissue Valves
First 3First 3postoppostop. Months, the. Months, the
thromboembolicthromboembolic rate is high for thatrate is high for that
anticoagulation is required whileanticoagulation is required whilesewing ring becomessewing ring becomes endothelializedendothelialized..
ThromboembolicThromboembolic event is 1event is 1--2/ 1002/ 100patientspatients--years.years.
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Early Mortality forEarly Mortality for
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Early Mortality forEarly Mortality for
rere--operationoperationBecause women of childbearing age who
receive bioprosthetic valves are likely to needre-operation, the risk associated with a second
surgery has to be considered when a PHV is
being selected.
Early mortality for re-operation in such patient
populations has been reported to be 3.8% inone study (1) and 8.7% in another(2).
(1) Jamieson et al. Ann Thorac Surg 1995;60 S2827
(2) Badduke J ThoracCardiovasc Surg 1991;102:17986AlAl--HusamiHusami
H d i P fil
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Hemodynamic Profile
HemodynamicHemodynamicprofiles are similar toprofiles are similar to
those of comparable sized.those of comparable sized.
The hemodynamic profile of the stented
porcine heterografts is, in general,
inferior to that of low profile
mechanical prostheses of comparable
size.Vongpatanasin et al. N Engl J Med 1996;335:40716
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M h i l P h
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Mechanical ProsthesesMechanical Prostheses
CagedCaged--ballball
TiltingTilting--discdisc
BileafletBileaflet valvesvalves
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StarrStarr--EdwardsEdwards
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StarrStarr EdwardsEdwards
CagedCaged--ballball
The oldest prosthetic valve in continuousThe oldest prosthetic valve in continuous
use.use.
Has the longest record of predictableHas the longest record of predictable
performance of any artificial valve.performance of any artificial valve.
Were extensively used in women ofWere extensively used in women of
childchild--bearing age & during pregnancy.bearing age & during pregnancy.
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C dC d b ll Di db ll Di d t
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CagedCaged--ball Disadvantagesball Disadvantages
Bulky, therefore, it is not suitable for:Bulky, therefore, it is not suitable for:
11-- MitralMitralposition in patient with small LVposition in patient with small LVcavity.cavity.
22-- AorticAorticpostionpostion in patient with a small aorticin patient with a small aorticannulus, or those requiring a valveannulus, or those requiring a valve--aortic archaortic archcomposite graft.composite graft.
The incidence ofThe incidence oftheromboembolismtheromboembolism isisslightly higher than other mechanicalslightly higher than other mechanical
prostheses valves.prostheses valves.AlAl--HusamiHusami
C dC d b llb ll
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CagedCaged--ballball
LaheyLahey ClinicClinic CathCath Lab. 2006Lab. 2006AlAl--HusamiHusami
Bil fl tBileaflet lal es
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BileafletBileaflet valvesvalves
St. JudeSt. Jude BileafletBileaflet valves are the most widelyvalves are the most widely
used.used.Less bulkyLess bulky
Lower profile than cagedLower profile than caged--ball, and are thereforeball, and are thereforehas superiorhas superiorhemodynamicshemodynamics..
Favorable flow characteristics especially in theFavorable flow characteristics especially in the
smaller sizes and causes a lowersmaller sizes and causes a lowertransvalvulartransvalvular
pressure gradient & cardiac output. Therefore, itpressure gradient & cardiac output. Therefore, it
is useful in children.is useful in children.AlAl--HusamiHusami
Bil fl tBil fl t V lV l
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BileafletBileaflet ValvesValves Cont.Cont.
ThrombogenicityThrombogenicity inin MitralMitralposition is < other prosthetics.position is < other prosthetics.
The leaflets swing apart duringopening, creating 3 flow areas,
1 central and 2 peripheral.
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St JudeSt Jude BileafletBileaflet valvevalve
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St. JudeSt. Jude BileafletBileaflet valvevalve
LaheyLahey Clinic EP Lab. 2006Clinic EP Lab. 2006AlAl--HusamiHusami
TiltingTilting discdisc
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TiltingTilting--discdisc
11--Omniscience valve :Omniscience valve :
The disc swings to an 80 degreeThe disc swings to an 80 degreeangle, providing a large centralangle, providing a large central
flow orifice.flow orifice.22--MedtronicMedtronic--Hall valve:Hall valve:
Has a central perforation toHas a central perforation toimprove theimprove the HemodynamicsHemodynamics..
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Mechanical PHVs Problems during
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Pregnancy
Risk of thromboembolism and maternalbleeding.
On Fetal, increased risk of :
1- Fetal loss.
2- Prematurity.
3- Low birth weight.
4- Birth defects.5- Mortality.
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Summary &
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y
RecommendationsThe selection of PHV for women of childbearingThe selection of PHV for women of childbearing
age remains difficult and needs to beage remains difficult and needs to beindividualized.individualized.
Bileaflet mechanical valves provide a superb record
of durability, excellent hemodynamic profile, and
relatively small risk of thromboembolic and
bleeding complications with carefulanticoagulation.
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Summary and Recommendations
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Summary and RecommendationsCont.
In women who are not interested inanticoagulation or for whom close follow-up isnot possible, a tissue valve is preferred.
In the aortic position, homografts, pericardial
valves, and stentless porcine xenografts havenot been extensively used in pregnancy.
(Ross procedure) is associated with higher rate
of SVD and need for re-operation comparedwith the new-generation mechanical prostheses.
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Preconception evaluation
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and consultationCareful history & physical examination.
Echo-Doppler study to evaluate cardiac and valvularfunction.
Exercise testing with maximum oxygen consumption,
can provide an objective estimation of functionalcapacity.
The patient and her family should be advised on
potential complications that might occur duringpregnancy.
Marked impairment of LV function, symptomatic (class
III and IV) should be advised against pregnancy.AlAl--HusamiHusami
MANAGEMENT OF
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COMPLICATIONS
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Effect ofEffect of ValvularValvular Heart DiseaseHeart Disease(VHD) on Maternal Outcome of(VHD) on Maternal Outcome of
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(VHD) on Maternal Outcome of(VHD) on Maternal Outcome of
PregnancyPregnancy
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Safe Drugs
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Safe Drugs
1- Digoxin
2- Diuretics
3- Nitrates4- Hydralazine
5- beta blockers.
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Contraindicated Drugs:
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Contraindicated Drugs:
1- ACE inhibitors: neonatal anuria, renal failure, limbdeformities, cranial ossification deficits, and lung
hypoplasia, renal tubularrenal tubulardysplasiadysplasia, prolonged neonatal, prolonged neonatalhypotension, and patenthypotension, and patent ductusductus arteriosusarteriosus..
2- Angiotensin receptor antagonist.3- Amiodarone: changes in fetal thyroid function,Congenital hypothyroidism, Mental Retardation.
4- Sodium Nitroprusside: animal study showedadverse fetal effect.
55-- StatinsStatins:: Sever CNS defects and limb deformities.Sever CNS defects and limb deformities.AlAl--HusamiHusami
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Anticoagulant use DuringAnticoagulant use During
Pregnancy in Women withPregnancy in Women with
ValvularValvularHeart DiseaseHeart Disease
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HematologicHematologic Changes DuringChanges During
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PregnancyPregnancy
Clotting factor concentrationClotting factor concentration(Fibrinogen, Von(Fibrinogen, Von WillebrandWillebrand Factor,Factor,Factor VIII)Factor VIII)
Platelet adhesiveness.Platelet adhesiveness. FibrinolysisFibrinolysis..
Protein S activity.Protein S activity.Stasis throughout vascular bed.Stasis throughout vascular bed.
risk thrombosis & embolism.risk thrombosis & embolism.
AlAl--HusamiHusami
Prosthetic Valve ThrombosisProsthetic Valve Thrombosis
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Prosthetic Valve ThrombosisProsthetic Valve Thrombosis
Pregnancy is associated with an increased
incidence of thromboembolism due to ahypercoagulable state.
Thromboembolic events occur in 7%-23%of patients, one-half of them with valve
thrombosis.1-4% maternal mortality.
Chan WS, ArchChan WS, Arch IntInt Med 2000; 160(2): 191Med 2000; 160(2): 191--66AlAl--HusamiHusami
Prosthetic Valve ThrombosisProsthetic Valve Thrombosis
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Cont.Cont.
Patients at high risk:Patients at high risk:
11-- Older generation valve in theOlder generation valve in the mitralmitralposition.position.
22-- Multiple prosthetic valves.Multiple prosthetic valves.
Most effective anticoagulant has theMost effective anticoagulant has the
highest risk of fetal complications.highest risk of fetal complications.
Chan WS, ArchChan WS, Arch IntInt Med 2000; 160(2): 191Med 2000; 160(2): 191--66AlAl--HusamiHusami
Prosthetic Valve ThrombosisProsthetic Valve Thrombosis
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Cont.Cont.
S&S:S&S: SuddenSudden dyspneadyspnea, Muffled sounds & New, Muffled sounds & New
murmurs.murmurs.
Complications:peripheral embolization and
bleeding, were reported in 18% and death in 5.6%.
DxDx:: TEE.TEE.
Rx:Rx: ThrombolyticThrombolytic agent for 24agent for 24--72 hrs, heparin &72 hrs, heparin &
Aspirin.Aspirin.
SurgerySurgery is required foris required fornonrespondersnonresponders & mobile& mobilethrombi &thrombi & in whom thrombolysis is contraindicated.
AlAl--HusamiHusami
WarfarinWarfarin AnticoagulationAnticoagulation
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WarfarinWarfarin AnticoagulationAnticoagulation
Low molecular weightLow molecular weight-- Crosses placenta.Crosses placenta.
Effect greater in the fetus than the mother,Effect greater in the fetus than the mother, VitVit KK
dependent factors in fetal liver.dependent factors in fetal liver.Fetal Complications: spontaneous abortions, stillbirths,Fetal Complications: spontaneous abortions, stillbirths,hemorrhage,hemorrhage, warfarinwarfarin embryopathiesembryopathies ((chondromalaciachondromalacia
punctatapunctata, stippled epiphyses and nasal and limb, stippled epiphyses and nasal and limbhypoplasiahypoplasia, CNS abnormalities, optic atrophy,, CNS abnormalities, optic atrophy,microcephalymicrocephaly, mental retardation,, mental retardation, spasticityspasticity,, hypotoniahypotonia,,
and Low IQ).and Low IQ).RetroplacentalRetroplacental hemorrhage.hemorrhage.
WilliamWilliam GaaschGaasch (( LaheyLahey Clinic),Clinic),
Jess MandelJess MandelAlAl--HusamiHusami
WarfarinWarfarin EmbryopathiesEmbryopathies
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Warfarin Embryopathiesy p
Exposure 6Exposure 6--12 weeks gestation.12 weeks gestation.
Past reported 30% risk.Past reported 30% risk.
Incidence 4Incidence 4--10%10%
Oakley et al: Br Heart J 1995Oakley et al: Br Heart J 1995
Dose related, low risk with< 5 mg/dayDose related, low risk with< 5 mg/day
Vitale et al: J AmVitale et al: J Am CollColl Cardio 1999Cardio 1999
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UF Heparin in PregnancyUF Heparin in Pregnancy
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p g yp g y
High molecular weight, dose notHigh molecular weight, dose not
cross placenta.cross placenta.Short half life.Short half life.
Variable responseVariable response-- dose adjusted,dose adjusted,
Close PTT monitoring.Close PTT monitoring.
Treatment of choiceTreatment of choice-- late pregnancy,late pregnancy,
delivery.delivery.AlAl--HusamiHusami
UF Heparin in PregnancyUF Heparin in Pregnancy Cont.Cont.
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p g yp g y
risk of prosthetic valve thrombosisrisk of prosthetic valve thrombosis
thrombothrombo--embolic events,embolic events, maternal &maternal &fetal mortality.fetal mortality.
Long term use not recommendedLong term use not recommendedOsteoporosis= 30%, sterile abscesses.Osteoporosis= 30%, sterile abscesses.
risk of maternal hemorrhage bleeding atrisk of maternal hemorrhage bleeding atutroplacentalutroplacentaljunction.junction.
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Uncertainty RegardingUncertainty Regarding
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LMWHLMWHDose not cross the placenta, noDose not cross the placenta, no teratogenicteratogenic
effects.effects.AntithromboticAntithromboticprotection.protection.
Potential advantages.Potential advantages. Bioavailability, administration ease.Bioavailability, administration ease.
Osteoporosis & Thrombocytopenia.Osteoporosis & Thrombocytopenia.
MelissariMelissari E;E; ThrombThromb&& HemostHemost 19921992AlAl--HusamiHusami
Uncertainty RegardingUncertainty Regarding
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LMWHLMWH Cont.Cont.Weight based administration inadequate inWeight based administration inadequate in
pregnancy.pregnancy.**Measurement of antiMeasurement of anti--XaXa activity necessaryactivity necessary
to ensure adequate anticoagulation into ensure adequate anticoagulation inpregnancy.pregnancy.
Peak( 4 hr post) antiPeak( 4 hr post) anti--XaXa level= 1.0 U/ml.level= 1.0 U/ml.Avoid excessive AC, antiAvoid excessive AC, anti--XaXa level>1.5level>1.5
U/ml.U/ml.Barbour L: Am JBarbour L: Am J ObstetObstet GynecolGynecol 2004.2004.AlAl--HusamiHusami
Complications ofComplications ofEnoxaparinEnoxaparin
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Use During Pregnancy.Use During Pregnancy.
Pregnancies 624Pregnancies 624Hemorrhagic events 72(10.4%)Hemorrhagic events 72(10.4%)
Serious Hemorrhage 11(1.6%)Serious Hemorrhage 11(1.6%) Neonatal hemorrhage 14(2.0%) Neonatal hemorrhage 14(2.0%)
Major Congenital abnormalities 17(2.5%)Major Congenital abnormalities 17(2.5%)
LepercqLepercqj, Br Jj, Br J ObstetObstet GynecGynec 2001; 108(11): 11342001; 108(11): 1134--4040AlAl--HusamiHusami
Congenital Anomalies with useCongenital Anomalies with use
ofofLovenoxLovenox in Pregnant Womenin Pregnant Women
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ofo Lovenoxove o in Pregnant Womeneg Wo e
2002:2002:
There have been reports of congenital anomalies in infantsThere have been reports of congenital anomalies in infants
born to women who receivedborn to women who received enoxaparinenoxaparin during pregnancyduring pregnancyincluding cerebral anomalies, limb anomalies,including cerebral anomalies, limb anomalies, hypospadiashypospadias,,peripheral vascular malformation,peripheral vascular malformation, fibroticfibrotic dysplasiadysplasia, and, andcardiac defect. A cause and effect relationship has not beencardiac defect. A cause and effect relationship has not been
established nor has the incidence been shown to be higher thanestablished nor has the incidence been shown to be higher thanin the general population.in the general population.
July 2003:July 2003:
Pregnant women withPregnant women with thromboembolicthromboembolic disease, includingdisease, includingthose with mechanical prosthetic heart valves, and those withthose with mechanical prosthetic heart valves, and those withinherited or acquiredinherited or acquired thrombophiliasthrombophilias, also have increased risk, also have increased riskof other maternal complications and fetal loss regardless of theof other maternal complications and fetal loss regardless of the
type of anticoagulant used.type of anticoagulant used.FDA Precautions for use ofFDA Precautions for use ofLovenoxLovenox in Pregnant Womenin Pregnant WomenAlAl--HusamiHusami
FDA Precautions for use ofFDA Precautions for use of
LovenoxLovenox in Pregnant Womenin Pregnant Women
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LovenoxLovenox in Pregnant Womenin Pregnant Women
20022002
The use ofThe use of
lovenoxlovenox
injection is notinjection is not
recommended forrecommended for thromboprophylaxisthromboprophylaxis inin
patients with prosthetic heart valves.patients with prosthetic heart valves.
July 2003July 2003The use ofThe use ofLovenoxLovenox injection forinjection for
thromboprophylaxisthromboprophylaxis in pregnant womenin pregnant womenwith mechanical prosthetic heart valves haswith mechanical prosthetic heart valves hasnot been adequately studiednot been adequately studied
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AlAl--HusamiHusami
20032003 AHA/ACC
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Scientific Statement onScientific Statement on WarfarinWarfarinUFH/LMWH throughout pregnancy.UFH/LMWH throughout pregnancy.
WarfarinWarfarin throughout pregnancy switch tothroughout pregnancy switch to
UFH/LMWH at wk 38.UFH/LMWH at wk 38.
UFH/LMWH first trimester,UFH/LMWH first trimester, warfarinwarfarin 22ndnd
trimester, UFH/LMWH at wk 38.trimester, UFH/LMWH at wk 38.
* Premature labor common, recommendation* Premature labor common, recommendation
to switch at week 36.to switch at week 36.
Hirsh et al Circulation April 1, 2003AlAl--HusamiHusami
American College of ChestPhysicians recommendations,
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y ,published in 2004
Ginsberg JS, Chest 2001;119:122SGinsberg JS, Chest 2001;119:122S--131S131SAlAl--HusamiHusami
Anticoagulation Prophylaxis inAnticoagulation Prophylaxis inPregnant Women With a ProstheticPregnant Women With a Prosthetic
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Heart ValveHeart Valve
Elkayam et al.et al. JACC Aug.,2005AlAl--HusamiHusami
Anticoagulation in PregnancyAnticoagulation in Pregnancy
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Summary and ConclusionsSummary and ConclusionsDecision regarding AC for PHV in pregnancyDecision regarding AC for PHV in pregnancy
requires detailed discussion.requires detailed discussion.
Insufficient data to predict efficacy & safety ofInsufficient data to predict efficacy & safety of
any regimen.any regimen.Risk of AC in pregnant pt was PHV related toRisk of AC in pregnant pt was PHV related to
inadequate dosing & monitoring.inadequate dosing & monitoring.Meticulous monitoring must be emphasized.Meticulous monitoring must be emphasized.
AlAl--HusamiHusami
Summary and ConclusionsSummary and Conclusions Cont.Cont.
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Low dose Aspirin:Low dose Aspirin:
11-- SafeSafe-- antithromboticantithrombotic effect has not proven.effect has not proven.
22-- Recommended for pt with shunts,Recommended for pt with shunts, cynosiscynosis &&biological valves.biological valves.
33--PossiblePossible incidence ofincidence ofpreeclampsiapreeclampsia..LMWHLMWH
Not enough information available in 2008.Not enough information available in 2008.
ThrombolyticThrombolytic therapytherapyEmergency use only.Emergency use only.
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