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TranscatheterAorticValveImplantation:
RecentClinicalDataHasanJilaihawi,MDCedars-SinaiMedicalCenter,LosAngelesObjectivesTounderstandthedevicesandapproachesavailabletotreataorticstenosisbytranscatheterapproachTobeunderstandtheclinicaloutcomesthatareimportantafterTranscatheterAorticValveImplantation(TAVI)TobeawareofrecentclinicaldatapertainingtotheaboveoutcomesToappreciatetheoutstandingquestionstobeansweredinfuturestudiesFirstTAVI-DrAnderson1992FirstSuccessfulTranscatheter
AorticValveImplant
AntegradeCribier-EdwardsFirstUKcase2007:RetrogradeCorevalve
90yoldladyTAVI:DesignsEdwards-Cribier/Edwards-SapienCOREVALVE Panaguia 3F SORIN CORAZONE SADRAMedical ValveXchange DirectFlow LutterTAVI:PostCEmarkdevicesMedtronic-CoreValveselfexpandablePorcinepericardiumRetrogradeTransaxillary18FrNorapidpacing10,000+patientsEdwards-SapienBalloonexpandableBovinepericardiumRetrograde(ante.)Transapical22/24Fr(soon18/19Fr)Rapidpacing10,000+patientsRapidevolutionoftheCorevalvedeviceOngoingevolutionoftheEdwardsdesignEdwards-Sapien:ApproachesMedtronicCorevalve:ApproachesTransaxillaryTransfemoral(Directaortic)CorevalveorEdwards?
AcomplementaryapproachtoTAVIforoptimaloutcomeJilaihawietal,JACCInterventions,InpressTAVIOutcomes:
Whatclinicalresultsareimportant?ProceduralsuccessMortalityStroke,disablingstrokeMyocardialinfarctionVascularcomplicationHemodynamicfunctionFunctionalstatusPermanentpacemakerQualityofLifeTAVI:ClinicaldatasequenceEnrollmentcompleteSeptember2021AwaitingfinalapprovalPostCEregistryongoingPostCEmarkEuropeannationregistries1.ImprovingproceduralsuccessSummary:proceduralsuccess(n=279)(n=772)(n=833)(n=872)(n=248)(n=1038)(n=1483)SummaryderivedfrommultipledataEuroPCR20212.Mortality:Thestandardissethigh
OpenAVRisasafeprocedureinselectedelderlypatientsOperativemortalityinoctogenarianspriorto200011.5% LogeaisetalJHeartValveDisease1995
13.7% GehlotetalJThoracCardiovascSurg1996
8% AtkinsetalAnnThoracSurg199716.7% BloomsteinetalAnnThoracSurg2001AVR+/-otherproceduresinoctogenariansisgettingsafer8.5% ChiappiniB2004–115octogenarians,AVR71pts, AVR+CABG44pts8.8% CollartF2005–213octogenarians,AVR159pts,MVR 42pts,AVR+MVR14pts4.6% DavidTE2006–132octogenarians,AVR95pts,MVR36 selectedpatients8% UrsoS2007–100octogenarians,isolatedAVR9% MelbySJ2007–245octogenarians,AVR140pts, AVR+CABG105pts
13% KohlP2007–220octogenarians,AVR162pts,AVR+CABG 58pts2.Mortality:CorevalvepostCEmarkexpandedevaluationn=1483SchulerTCT20212.MortalitypostEdwardsSOURCEregistryThomasetal,Circulation20212.MortalityinSOURCEat12months2.Mortality(30d)andlearningcurve
VancouverEdwardsexperiencen=250WebbTCT20212.Registrysummary:30daymortality(n=279)(n=772)(n=833)(n=872)(n=248)(n=1038)(n=1483)SummaryderivedfrommultipledataEuroPCR20213.StrokeCorevalveMRIstudy73%clinicallysilentcerebralembolismClinicalsymptomsofneurologicaldeficitspersistedinonly3.6%threemonthsafterTAVI.Ghanemetal,JACC20213.StrokeMRIstudyvs21surgicalpatients10Corevalve,22EdwardsNewfociofrestricteddiffusiononMRIin84%ofTAVIvs48%AVR(p=0.011)NoclinicalstrokesinTAVIarmvs1(5%insurgical)At3monthMRI-noresidualsignalchangeassociatedwiththemajority(80%)ofthefocidetectedintheperiproceduralperiodKahlertetal,Circulation20213.Summary:Stroke(n=279)(n=772)(n=833)(n=872)(n=248)(n=1038)(n=1483)SummaryderivedfrommultipledataEuroPCR20214.MyocardialinfarctionNocleardefinitionIncidencepostTAVInotfrequentlymentionedinliteratureForcoronaryocclusion0.9%inCorevalvepostCEexpandedevaluation1.2%inFrenchregistry5.Vascularcomplication-mortalityREVIVE/REVIVALVascularcomplicationNovascularcomplication5.Vascularcomplications-SOURCEThomas,PCR095.FemoralvascularcomplicationsnownotassociatedwithincreaseddeathSOURCEregistry,Thomas,EuroPCR20215.Summary:Vascularcomplication(n=279)(n=772)(n=833)(n=872)(n=248)(n=1038)(n=1483)SummaryderivedfrommultipledataEuroPCR2021n/a6.Hemodynamics
PARTNEREUn=130deBruyneTCT20216.Valvearea-PooledEdwardsPooledREVIVE,REVIVAL,TRAVERCE,PARTNEREU6.HemodynamicsCorevalveSchuler,TCT20216.Hemodynamicsprosthesis-patientmismatchStentedStentlessClavelJACC2021JilaihawiEHJ2021TzikasAJC20217.FunctionalstatusandCorevalve7.Functionalstatus-EdwardsPARTNEREUdeBruyneTCT20218.Pacemaker-PARTNEREU1Dawkinsetal,AnnThoracSurgdeBruyneTCT20218.Corevalve-pacemakerSerruys,TCT2021EdwardsTAVIoutcomesLeonTCT20219.Qualityoflife-PARTNEREUdeBruyneTCT20219.CorevalveQOLUssiaetal,EHJ2021FDA“Percutaneousvalvetechnologyqualifiesasenoughofadeparturefromcurrentstandardofcareclinicalpracticethatanydeviceofthisnaturewillneedtobeevaluatedthrougharandomized,controlledclinicaltrial〞USPARTNERLeonTCT2021TAVIoutcomes?
RecentclinicaldataProceduralsuccess>95%MortalityAround10%orlessStroke<5%Myocardialinfarctioncoronaryobstructionaround1%Vascularcomplicationaround5-10%Hemodynamicfunction-AVA≥1.5sqcm,betterthansurgicalvalvePermanentpacemaker<10%Edwardsvs20-30%CorevalveFunctionalstatusimprovedinmajorityQualityofLifeimprovedinmajorityWilloutcomescontinuetoimprove
withon
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