Prosthetic Heart Valve Anti Coagulation Use During Pregnancy Wael Al Husami Md

8/3/2019 Prosthetic Heart Valve Anti Coagulation Use During Pregnancy Wael Al Husami Md

1/78

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


2/78

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


3/78

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.

AlAl--HusamiHusami


4/78

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.

AlAl--HusamiHusami


5/78

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


6/78

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
http://www.aats.org/index.html


7/78

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
http://www.aats.org/index.htmlhttp://www.aats.org/index.htmlhttp://www.aats.org/index.htmlhttp://www.aats.org/index.htmlhttp://www.aats.org/index.htmlhttp://www.aats.org/index.html


8/78

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
http://www.aats.org/index.htmlhttp://www.aats.org/index.htmlhttp://www.aats.org/index.htmlhttp://www.aats.org/index.htmlhttp://www.aats.org/index.htmlhttp://www.aats.org/index.htmlhttp://www.aats.org/index.html


9/78

Choice of ProsthesisChoice of Prosthesis

Durability of Prosthesis.

Necessity foranticoagulationanticoagulation.

Risk of Thrombo-embolism & Bleeding.

Re-operation rate .

Hemodynamic Performance.

Possible future pregnancy.

AlAl--HusamiHusami


10/78

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.

AlAl--HusamiHusami


11/78

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.

AlAl--HusamiHusami

P iP i H t ftH t ft


12/78

PorcinePorcine HeterograftsHeterografts

Hancock valveHancock valve Medtronic Intact valveMedtronic Intact valve

CarpenterCarpenter--Edwards valvesEdwards valves

Braunwald E, Heart Disease. 7th edition. 2005;1553 621AlAl--HusamiHusami


13/78

AnnAnn ThoracThorac SurgSurg 1995;60: S2211995;60: S221--88

Durability of the Hancock Bioprosthesis Compared With

Standard Aortic Valve Bioprostheses

AlAl--HusamiHusami


14/78

AnnAnn ThoracThorac SurgSurg 1995;60: S2211995;60: S221--88AlAl--HusamiHusami

2 S lS l iP i


15/78

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


16/78

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


17/78

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.

AlAl--HusamiHusami


18/78

CarpenterCarpenter--EdwardsEdwards

Bovine Pericardial ValveBovine Pericardial Valve

LaheyLahey ClinicClinic CathCath Lab. 2006Lab. 2006AlAl--HusamiHusami


19/78

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


20/78

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


21/78

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.

AlAl--HusamiHusami


22/78

Disadvantages:

Not on shelf.

Re-operation difficult.

Homograft ( Allograft) Aortic ValvesHomograft ( Allograft) Aortic Valves

AlAl--HusamiHusami


23/78

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

AlAl--HusamiHusami

55 P i di lP i di l A t ftA t ft


24/78

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

AlAl--HusamiHusami

66-- PulmonaryPulmonary AutograftsAutografts


25/78

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.

AlAl--HusamiHusami

Th R dTh R d


26/78

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.

AlAl--HusamiHusami

Th R dTh R d


27/78


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.

AlAl--HusamiHusami

Th R dTh R d


28/78


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


29/78

Does pregnancyaccelerate the rate

of bioprosthetic

SVD?

AlAl--HusamiHusami

Does pregnancy accelerate the rate


30/78

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?

AlAl--HusamiHusami

Reports Failed to Support theReports Failed to Support the


31/78

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

AlAl--HusamiHusami

Freedom from Structural ValveFreedom from Structural Valve


32/78

Freedom from Structural ValveFreedom from Structural Valve

DeteriorationDeterioration

Jamieson et al. AnnJamieson et al. Ann ThTh Surg.1995Surg.1995

PregnantPregnantNonNon--PregnantPregnant

AlAl--HusamiHusami


33/78

Early Mortality for reEarly Mortality for re--operationoperation

Ann Thorac Surg Jamieson et al. 1995;60:S282-7AlAl--HusamiHusami


34/78

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

AlAl--HusamiHusami


35/78

Choice of ProsthesisChoice of Prosthesis

Durability of Prosthesis.

Necessity foranticoagulationanticoagulation.

Risk of Thrombo-embolism & Bleeding.

Re-operation rate .

Hemodynamic Performance.

Possible future pregnancy.

AlAl--HusamiHusami


36/78

ThromboembolicThromboembolic EventEvent

Circulation North et al.1999;99;2669-2676AlAl--HusamiHusami

i l


37/78

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.

AlAl--HusamiHusami

Early Mortality forEarly Mortality for


38/78

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


39/78

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

AlAl--HusamiHusami


40/78

AlAl--HusamiHusami

M h i l P h


41/78

Mechanical ProsthesesMechanical Prostheses

CagedCaged--ballball

TiltingTilting--discdisc

BileafletBileaflet valvesvalves

AlAl--HusamiHusami

StarrStarr--EdwardsEdwards


42/78

StarrStarr EdwardsEdwards


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.

AlAl--HusamiHusami

C dC d b ll Di db ll Di d t


43/78

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


44/78


LaheyLahey ClinicClinic CathCath Lab. 2006Lab. 2006AlAl--HusamiHusami

Bil fl tBileaflet lal es


45/78

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


46/78

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.

AlAl--HusamiHusami

St JudeSt Jude BileafletBileaflet valvevalve


47/78

St. JudeSt. Jude BileafletBileaflet valvevalve

LaheyLahey Clinic EP Lab. 2006Clinic EP Lab. 2006AlAl--HusamiHusami

TiltingTilting discdisc


48/78

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..

AlAl--HusamiHusami

Mechanical PHVs Problems during


49/78

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.

AlAl--HusamiHusami

Summary &


50/78

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.

AlAl--HusamiHusami

Summary and Recommendations


51/78

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.

AlAl--HusamiHusami

Preconception evaluation


52/78

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


53/78

COMPLICATIONS

AlAl--HusamiHusami

Effect ofEffect of ValvularValvular Heart DiseaseHeart Disease(VHD) on Maternal Outcome of(VHD) on Maternal Outcome of


54/78

(VHD) on Maternal Outcome of(VHD) on Maternal Outcome of

PregnancyPregnancy

AlAl--HusamiHusami

Safe Drugs


55/78

Safe Drugs

1- Digoxin

2- Diuretics

3- Nitrates4- Hydralazine

5- beta blockers.

AlAl--HusamiHusami

Contraindicated Drugs:


56/78

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


57/78

Anticoagulant use DuringAnticoagulant use During

Pregnancy in Women withPregnancy in Women with

ValvularValvularHeart DiseaseHeart Disease

AlAl--HusamiHusami

HematologicHematologic Changes DuringChanges During


58/78

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


59/78


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



60/78

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



61/78

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


62/78

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


63/78

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

AlAl--HusamiHusami

UF Heparin in PregnancyUF Heparin in Pregnancy


64/78

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.


65/78

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.

AlAl--HusamiHusami

Uncertainty RegardingUncertainty Regarding


66/78

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


67/78

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


68/78

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


69/78

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
http://www.fda.gov/default.htm


70/78

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

AlAl--HusamiHusami
http://www.fda.gov/default.htm


71/78

AlAl--HusamiHusami

20032003 AHA/ACC


72/78

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,


73/78

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


74/78

Heart ValveHeart Valve

Elkayam et al.et al. JACC Aug.,2005AlAl--HusamiHusami

Anticoagulation in PregnancyAnticoagulation in Pregnancy


75/78

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.


76/78

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.

AlAl--HusamiHusami


77/78

AlAl--HusamiHusami


78/78

Prosthetic Heart Valve Anti Coagulation Use During Pregnancy Wael Al Husami Md

Documents

Transcript of Prosthetic Heart Valve Anti Coagulation Use During Pregnancy Wael Al Husami Md