那些患者適合行血管內(nèi)瓣膜植入術

MichaelMack,M.D.Dallas,TXCribieretal.Circulation2002;106:3006-3008CoreValveEdwardsSapienTHV經(jīng)股動脈

(TF)經(jīng)心尖(TA)Edward’sSapienTHV歐洲患者能夠承受ＴＦ和ＴＡ的費用TF和TA在美國重點試驗范圍內(nèi)(PARTNER)>459例患者

(>45%)>2,000移植物CoreValve瓣膜置換系統(tǒng)既往都是無對照的病例研究USIDE試驗即將開展>2,000移植物那些患者適合行經(jīng)導管ＡＶＲ?問題問題Wedon’tturndownanyone!

心內(nèi)科醫(yī)生-是!!但是我們見到的ＡＳ患者中，至少有１／３的患者沒有被轉診外科醫(yī)生對主動脈狹窄的看法1993-2003740患者

AVA<0.8cm2287(38.7%)行

AVRAnnalsThoracicSurgery,2006問題STS單純根據(jù)年齡的ＡＶＲ死亡風險

預測%死亡率年齡STSEuroSCORE(相加)EuroSCORE(對數(shù))Ambler(UK)NorthernNewEnglandNewYorkStateProvidenceHealthSystem風險預測方法中存在的問題危險因素沒有納入到風險計算法我們?nèi)绾卧u估風險?主動脈診所2-3心臟病學家2-3外科醫(yī)生2研究協(xié)調(diào)者AVR的風險年齡(90)和危險因素相同糖尿病，房顫

高血壓，輕度的腎功能受損AVR的風險年齡(90)和預計風險(12%)相同一位通過“眼球試驗”，另一位沒通過由于多個生理系統(tǒng)機能下降導致對外界應激因子的抵抗能力及儲備下降的生物學綜合征，從而使機體對不良事件的耐受能力下降。什么是衰弱?FriedLPetal,JGerontology2001;56A:M146-56CraigSmith,M.D.衰弱的指標副作用

(DeathorInstitutionalization)根據(jù)“虛弱指數(shù)”CraigSmith,M.D.臨床虛弱指數(shù)(1-7)日?；顒幽芰?Katz)洗澡,進食,穿著虛弱表型體力活動體力水平體能測試握力

(握力器)從椅子上站立4米不行距離試驗室AlbuminFEV1CrClBNP健康狀況沒有受損完全依靠護理人員，無法活動17AVR風險年齡90STS風險12%虛弱指數(shù)７年齡90STS風險

12%虛弱指數(shù)1PARTNERIDE試驗Co-principalInvestigators:

MartinB.Leon,MDInterventionalCardiology

CraigSmith,MD,CardiacSurgeon

ColumbiaUniversityPopulation:HighRisk/Non-OperableSymptomatic,CriticalCalcificAorticStenosisNoNotinStudyNo

VSTransapicalAVRControl1:1RandomizationCohortATAPoweredtobePooledwithTFYesCohortBNoASSESSMENT:OperabilityCohortAn=upto690ptsn=350ptsTotaln=1040ASSESSMENT:TransfemoralAccessTransfemoralAVRControl

VSYes1:1RandomizationCohortATFPoweredIndependentlyPrimaryEndpoint:AllCauseMortality

(Non-inferiority)MedicalManagementControlASSESSMENT:TransfemoralAccess

VSTransfemoral1:1RandomizationYesPrimaryEndpoint:AllCauseMortality(Superiority)TwoTrials:IndividuallyPoweredCohorts

(CohortsA&B)UpdateSEPT2008PARTNER

經(jīng)導管AVR試驗

DallasScreeningLog

2006．１２-2008．１０

n=292AnnThoracSurgNovember2008總結WhoisaCandidateforanEndovascularValve?MichaelMack,M.D.Dallas,TXCribieretal.Circulation2002;106:3006-3008TranscatheterAorticValveImplantationCoreValveEdwardsSapienTHVTransfemoral(TF)Transapical(TA)TranscatheterAorticValves

ClinicalExperienceEdward’sSapienTHVCommercialApprovalinEuropeforTFandTAApproachesTFandTAinUSPivotalTrial(PARTNER)>459patientsenrolled(>45%)>2,000implantsCoreValveRevalvingSystemCommercialApprovalinEuropeforTFAnecdotalTAcasesUSIDETrialimminent>2,000implantsWhoAreSuitableCandidatesforTranscatheterAVR?InoperablePatientsHighRiskOperablePatientsQuestionsArethere“inoperable”patientswithaorticstenosis?Can“veryhighrisk”patientsforAVRbeidentified?QuestionsArethere“inoperable”patientswithaorticstenosis?Can“veryhighrisk”patientsforAVRbeidentified?Wedon’tturndownanyone!

Cardiologist-True!!Butweneverreferatleast1/3ofthepatientswithASweseeSurgeon’sViewofAorticStenosis“Inoperable”isinthe…ConclusionSurgerywasdeniedin33%ofelderlypatientswithsevere,symptomaticAS.OlderageandLVdysfunctionwerethemoststrikingcharacteristicsofpatientswhoweredeniedsurgery,whereascomorbidityplayedalessimportantrole.1993-2003740patientswithAVA<0.8cm2287(38.7%)underwentAVRAnnalsThoracicSurgery,2006QuestionsArethere“inoperable”patientswithaorticstenosis?Can“veryhighrisk”patientsforAVRbeidentified?IsolatedAorticValveReplacement

OperativeMortality-STSDatabaseSTSPredictedRiskofMortalitywithAVRBasedonAgeAlone%MortalityAgeAorticValveSurgery

PredictiveRiskAlgorithmsSTSEuroSCORE(additive)EuroSCORE(logistic)Ambler(UK)NorthernNewEnglandNewYorkStateProvidenceHealthSystemProblemswithRiskAlgorithmsAllriskalgorithmsarebasedonoperatedpatientsanddon’tfactorin“inoperable“patientsOutcomesotherthan30daymortalityarenotpredictedDischargedisposition,QualityofLifenotpredictedManyriskvariablesnotincludedRiskFactorsNotIncludedinRiskAlgorithmsPorcelainAortaPreviousMediastinalRadiation(Lymphoma)MultiplePreviousSternotomiesWithOpenGraftsAdvancedLiverDisease/CirrlosisFrailty/Debility/ImmobilityHowDoWeEvaluateRisk?AorticValveClinic2-3Cardiologists2-3Surgeons2ResearchCoordinatorsRiskofAVRSameage(90)andriskfactorsDiabetes,atrialfibrillation,hypertension,mildrenalinsufficiencyRiskofAVRSameage(90)andpredictedrisk(12%)Onepassesthe“eyeballtest”;onedoesn’tAbiologicsyndromeofdecreasedreserveandresistancetostressors,resultingfromcumulativedeclinesacrossmultiplephysiologicsystems,andcausingvulnerabilitytoadverseoutcomes.WhatisFrailty?FriedLPetal,JGerontology2001;56A:M146-56CraigSmith,M.D.FrailtyIndicesWelldocumentedandvalidatedingeriatricpopulationsCorrelatewellwithdeathorinstitutionalizationwithin6-12monthsNotvalidatedinpatientswithaorticstenosisNotvalidatedinpostproceduraloutcomesAdverseOutcomes(DeathorInstitutionalization)Basedon“FrailityIndex”CraigSmith,M.D.ClinicalFrailtyIndex(1-7)ActivitiesofDailyLiving(Katz)Bathing,feeding,dressingFrailtyPhenotypePhysicalActivityEnergylevelPhysicalPerformanceTestsGripstrength(dynanometer)Chairrise4meterwalkLabsAlbuminFEV1CrClBNPHealthy,noimpairmentTotallydependentoncaregivers,immobile17RiskofAVRAge90STSRisk12%FrailtyIndex7Age90STSRisk12%FrailtyIndex1ThePARTNERIDETrialCo-principalInvestigators:

MartinB.Leon,MDInterventionalCardiology

CraigSmith,MD,CardiacSurgeon

ColumbiaUniversityPopulation:HighRisk/Non-OperableSymptomatic,CriticalCalcificAorticStenosisNoNotinStudyNo

VSTransapicalAVRControl1:1RandomizationCohortATAPoweredtobePooledwithTFYesCohortBNoASSESSMENT:OperabilityCohortAn=upto690ptsn=350ptsTotaln=1040ASSESSMENT:TransfemoralAccessTransfemoralAVRControl

VSYes1:1RandomizationCohortATFPoweredIndependentlyPrimaryEndpoint:AllCauseMortality

(Non-inferiority)MedicalManagementControlASSESSMENT:TransfemoralAccess

VSTransfemoral1:1RandomizationYesPrimaryEndpoint:AllCauseMortality(Superiority)TwoTrials:IndividuallyPoweredCohorts

(CohortsA&B)UpdateSEPT2008PARTNERTranscatheterAVRTrial

DallasScreeningLog

August