那些患者適合行血管內(nèi)瓣膜植入術(shù)

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

(TF)經(jīng)心尖(TA)Edward’sSapienTHV歐洲患者能夠承受ＴＦ和ＴＡ的費(fèi)用TF和TA在美國重點(diǎn)試驗(yàn)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(duì)照的病例研究USIDE試驗(yàn)即將開展>2,000移植物那些患者適合行經(jīng)導(dǎo)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(zhuǎn)診外科醫(yī)生對(duì)主動(dòng)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(fēng)險(xiǎn)

預(yù)測%死亡率年齡STSEuroSCORE(相加)EuroSCORE(對(duì)數(shù))Ambler(UK)NorthernNewEnglandNewYorkStateProvidenceHealthSystem風(fēng)險(xiǎn)預(yù)測方法中存在的問題危險(xiǎn)因素沒有納入到風(fēng)險(xiǎn)計(jì)算法我們?nèi)绾卧u(píng)估風(fēng)險(xiǎn)?主動(dòng)脈診所2-3心臟病學(xué)家2-3外科醫(yī)生2研究協(xié)調(diào)者AVR的風(fēng)險(xiǎn)年齡(90)和危險(xiǎn)因素相同糖尿病，房顫

高血壓，輕度的腎功能受損AVR的風(fēng)險(xiǎn)年齡(90)和預(yù)計(jì)風(fēng)險(xiǎn)(12%)相同一位通過“眼球試驗(yàn)”，另一位沒通過由于多個(gè)生理系統(tǒng)機(jī)能下降導(dǎo)致對(duì)外界應(yīng)激因子的抵抗能力及儲(chǔ)備下降的生物學(xué)綜合征，從而使機(jī)體對(duì)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(biāo)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?dòng)能力(Katz)洗澡,進(jìn)食,穿著虛弱表型體力活動(dòng)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(yàn)室AlbuminFEV1CrClBNP健康狀況沒有受損完全依靠護(hù)理人員，無法活動(dòng)17AVR風(fēng)險(xiǎn)年齡90STS風(fēng)險(xiǎn)12%虛弱指數(shù)７年齡90STS風(fēng)險(xiǎn)

12%虛弱指數(shù)1PARTNERIDE試驗(yàn)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(dǎo)管AVR試驗(yàn)

DallasScreeningLog

2006．１２-2008．１０

n=292AnnThoracSurgNovember2008總結(jié)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