那些患者适合行血管内瓣膜植入术

MichaelMack,M.D.Dallas,TXCribieretal.Circulation2002;106:3006-3008CoreValveEdwardsSapienTHV经股动脉

(TF)经心尖(TA)Edward’sSapienTHV欧洲患者能够承受ＴＦ和ＴＡ的费用TF和TA在美国重点试验范围内(PARTNER)>459例患者

(>45%)>2,000移植物CoreValve瓣膜置换系统既往都是无对照的病例研究USIDE试验即将开展>2,000移植物那些患者适合行经导管ＡＶＲ?问题问题Wedon’tturndownanyone!

心内科医生-是!!但是我们见到的ＡＳ患者中，至少有１／３的患者没有被转诊外科医生对主动脉狭窄的看法1993-2003740患者

AVA<0.8cm2287(38.7%)行

AVRAnnalsThoracicSurgery,2006问题STS单纯根据年龄的ＡＶＲ死亡风险

预测%死亡率年龄STSEuroSCORE(相加)EuroSCORE(对数)Ambler(UK)NorthernNewEnglandNewYorkStateProvidenceHealthSystem风险预测方法中存在的问题危险因素没有纳入到风险计算法我们如何评估风险?主动脉诊所2-3心脏病学家2-3外科医生2研究协调者AVR的风险年龄(90)和危险因素相同糖尿病，房颤

高血压，轻度的肾功能受损AVR的风险年龄(90)和预计风险(12%)相同一位通过“眼球试验”，另一位没通过由于多个生理系统机能下降导致对外界应激因子的抵抗能力及储备下降的生物学综合征，从而使机体对不良事件的耐受能力下降。什么是衰弱?FriedLPetal,JGerontology2001;56A:M146-56CraigSmith,M.D.衰弱的指标副作用

(DeathorInstitutionalization)根据“虚弱指数”CraigSmith,M.D.临床虚弱指数(1-7)日常活动能力(Katz)洗澡,进食,穿着虚弱表型体力活动体力水平体能测试握力

(握力器)从椅子上站立4米不行距离试验室AlbuminFEV1CrClBNP健康状况没有受损完全依靠护理人员，无法活动17AVR风险年龄90STS风险12%虚弱指数７年龄90STS风险

12%虚弱指数1PARTNERIDE试验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

经导管AVR试验

DallasScreeningLog

2006．１２-2008．１０

n=292AnnThoracSurgNovember2008总结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