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CardiacTransplantationandMechanicalCirculatorySupportAndrewBoyle,MDAssociateProfessorofMedicineMedicalDirectorofHeartFailure,CardiacTransplantation,andMechanicalCirculatorySupportDivisionofCardiologyUniversityofMinnesotaCardiacTransplantationandMe1MetabolicStressTestingManciniDetal.Circulation1991;83:778-786.Group1:peakVO2<14Group2:peakVO2>14Group3:rejectedforOHTxMetabolicStressTestingMancin2AGEDISTRIBUTIONOFHEARTRECIPIENTS

(1/1982-6/2003)%of

TransplantsJHeartLungTranspl.2004;23:796-803.AGEDISTRIBUTIONOFHEARTRECI3DIAGNOSISINADULTHEARTTRANSPLANTSDIAGNOSISINADULTHEARTTRANS4

HEARTTRANSPLANTATION

Kaplan-MeierSurvival

(1/1982-6/2006)JHeartLungTransplant2008;27:937-983.HEARTTRANSPLANTATION

Kapl5UMNCardiacTransplantSurvivalUMNCardiacTransplantSurviva6NUMBEROFHEARTTRANSPLANTSREPORTEDBYYEAR

JHeartLungTransplant2008;27:937-983NUMBEROFHEARTTRANSPLANTSRE7HEARTTRANSPLANTS:

DonorAgebyYearofTransplantJHeartLungTranspl.2004;23:796-803.HEARTTRANSPLANTS:

DonorAge8DescriptionofUNOSStatusLevelsStatusIARHCinplaceand:twoormoreinotropesregardlessofdoseIVmilrinoneatleast0.5mcg/kg/minIVdobutamineatleast7.5mcg/kg/min30daysfollowingmedicalstabilizationafterVADimplantationStatusIB

inotrope-dependentLVADnotmeetingcriteriaforIAstatusNoadvantageforbeinghospitalizedStatusII

Notinotrope-dependentandnoVADPriorityonUNOSlistbasedonstatuslevelanddurationoftimeinthatstatuslevelNocreditgivenfortimeatalowerstatuslevelDescriptionofUNOSStatusLev9StevensonLWetal.Circulation2003;108:492-7.InotropicTherapyfor

End-StageHeartFailureStevensonLWetal.Circulatio10UniversityofMinnesotaVADImplantsUniversityofMinnesotaVADIm11HeartMateIIHeartMateII12PulsatilevsContinuousFlowLVADsPulsatile/VolumeDisplacementContinuous/RotaryPulsatilevsContinuousFlowL13HeartMateIIasBTTMillerL,BoyleA,etal.NEJM2007;357:893.HeartMateIIasBTTMillerL,B14HeartMateIIBTTClinicalTrial

AdverseEventRatesAdverseEventHMII(62ptyrs)(n=133)HMVE1(86ptyrs)(n=280)%reductionBleedingrequiringsurgery0.781.4747Percutaneousleadinfection0.373.4989Stroke0.190.4457Non-strokeneurological0.260.6761RVfailurerequiringRVAD0.080.3073Events/PatientYear1FrazierOH,etal.JThorCVSurg2001MillerL,JohnR,BoyleA,etal.NEJM2007;357:893.HeartMateIIBTTClinicalTria15HMIIasBTTinWomenOutcomesatoneyearPamboukianS,BoyleA,etal.Circulation.2008;118:S-1016HMIIasBTTinWomenOutcomes16VentrAssistasBridgetoTransplantVentrAssistasBridgetoTrans17VentrAssistComponentsImplantablebloodpumpPoweredviapercutaneousleadControllerlogs

parameters&alarmsBatteryorACpowersupplyLaptopPCforclinicianuseBloodpumpOutflowcannulaControllerandbatteryreceptaclePercutaneousleadInflowcannulaVentrAssistComponentsImplant18SummaryTotalnumberofpatientsimplanted421Longestsupportduration(d)1594Meansupportduration(d)219Numberofpatientscurrentlysupported180VentrAssistSupportDuration>6months192>12months67>24months16WorldwideVentrAssistExperience**Asof3/3/09SummaryTotalnumberofpatient19StudyOutcomes:InterimAnalysisPopulation(n=98)BoyleAetal.ACCLateBreakingClinicalTrial2009.StudyOutcomes:InterimAnalys20NewestVAD:HeartwareNewestVAD:Heartware21VADsvsCRT

for

NYHAClassIVHeartFailureVADsvsCRT

for

NYHAClassI222YearMortalitywithCRT/CRT-DinNYHAClassIVPatientsLindenfeldJetal.Circulation2007;115:204-212.2YearMortalitywithCRT/CRT-23COMPANIONNYHAClassIVPatientsLindenfeldJetal.Circulation2007;115:204-212.COMPANIONNYHAClassIVPatien24ImprovementinMedianDistanceWalkedinSixMinutes:HeartMateIIvsCRT/CRT-DBoyleAetal.PresentedatACC2008.ImprovementinMedianDistance25ConclusionsTesttodeterminecandidacyfortransplantismetabolicstresstestMediansurvivalpost-transplantis10yearsFrequencyoftransplantationisdecliningLongterminotropictherapynotverysuccessfulContinuousflowVADsshowgoodlongtermsurvivalwithreducedadverseeventsVADsnowapprovedforBSAaslowas1.2CRTforNYHAClassIVheartfailurenotterriblyeffectiveConclusionsTesttodeterminec26CardiacTransplantationandMechanicalCirculatorySupportAndrewBoyle,MDAssociateProfessorofMedicineMedicalDirectorofHeartFailure,CardiacTransplantation,andMechanicalCirculatorySupportDivisionofCardiologyUniversityofMinnesotaCardiacTransplantationandMe27MetabolicStressTestingManciniDetal.Circulation1991;83:778-786.Group1:peakVO2<14Group2:peakVO2>14Group3:rejectedforOHTxMetabolicStressTestingMancin28AGEDISTRIBUTIONOFHEARTRECIPIENTS

(1/1982-6/2003)%of

TransplantsJHeartLungTranspl.2004;23:796-803.AGEDISTRIBUTIONOFHEARTRECI29DIAGNOSISINADULTHEARTTRANSPLANTSDIAGNOSISINADULTHEARTTRANS30

HEARTTRANSPLANTATION

Kaplan-MeierSurvival

(1/1982-6/2006)JHeartLungTransplant2008;27:937-983.HEARTTRANSPLANTATION

Kapl31UMNCardiacTransplantSurvivalUMNCardiacTransplantSurviva32NUMBEROFHEARTTRANSPLANTSREPORTEDBYYEAR

JHeartLungTransplant2008;27:937-983NUMBEROFHEARTTRANSPLANTSRE33HEARTTRANSPLANTS:

DonorAgebyYearofTransplantJHeartLungTranspl.2004;23:796-803.HEARTTRANSPLANTS:

DonorAge34DescriptionofUNOSStatusLevelsStatusIARHCinplaceand:twoormoreinotropesregardlessofdoseIVmilrinoneatleast0.5mcg/kg/minIVdobutamineatleast7.5mcg/kg/min30daysfollowingmedicalstabilizationafterVADimplantationStatusIB

inotrope-dependentLVADnotmeetingcriteriaforIAstatusNoadvantageforbeinghospitalizedStatusII

Notinotrope-dependentandnoVADPriorityonUNOSlistbasedonstatuslevelanddurationoftimeinthatstatuslevelNocreditgivenfortimeatalowerstatuslevelDescriptionofUNOSStatusLev35StevensonLWetal.Circulation2003;108:492-7.InotropicTherapyfor

End-StageHeartFailureStevensonLWetal.Circulatio36UniversityofMinnesotaVADImplantsUniversityofMinnesotaVADIm37HeartMateIIHeartMateII38PulsatilevsContinuousFlowLVADsPulsatile/VolumeDisplacementContinuous/RotaryPulsatilevsContinuousFlowL39HeartMateIIasBTTMillerL,BoyleA,etal.NEJM2007;357:893.HeartMateIIasBTTMillerL,B40HeartMateIIBTTClinicalTrial

AdverseEventRatesAdverseEventHMII(62ptyrs)(n=133)HMVE1(86ptyrs)(n=280)%reductionBleedingrequiringsurgery0.781.4747Percutaneousleadinfection0.373.4989Stroke0.190.4457Non-strokeneurological0.260.6761RVfailurerequiringRVAD0.080.3073Events/PatientYear1FrazierOH,etal.JThorCVSurg2001MillerL,JohnR,BoyleA,etal.NEJM2007;357:893.HeartMateIIBTTClinicalTria41HMIIasBTTinWomenOutcomesatoneyearPamboukianS,BoyleA,etal.Circulation.2008;118:S-1016HMIIasBTTinWomenOutcomes42VentrAssistasBridgetoTransplantVentrAssistasBridgetoTrans43VentrAssistComponentsImplantablebloodpumpPoweredviapercutaneousleadControllerlogs

parameters&alarmsBatteryorACpowersupplyLaptopPCforclinicianuseBloodpumpOutflowcannulaControllerandbatteryreceptaclePercutaneousleadInflowcannulaVentrAssistComponentsImplant44SummaryTotalnumberofpatientsimplanted421Longestsupportduration(d)1594Meansupportduration(d)219Numberofpatientscurrentlysupported180VentrAssistSupportDuration>6months192>12months67>24months16WorldwideVentrAssistExperience**Asof3/3/09SummaryTotalnumberofpatient45StudyOutcomes:InterimAnalysisPopulation(n=98)BoyleAetal.ACCLateBreakingClinicalTrial2009.StudyOutcomes:InterimAnalys46NewestVAD:HeartwareNewestVAD:Heartware47VADs

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