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TheEPshow:
Riskstratificationforsuddendeath
TheEPshow:
RiskstratificatiRiskstratificationforsuddendeathRiskstratificationforsuddenHistoricallookatearlymarkersBeganduringthemid-1980swithaprospectivestudyofabout1000postinfarctionpatients
Measured24-hourHolterrecordingsforventricularprematurebeatfrequency
Determinedejectionfraction
Ascertainedseveralother
routineclinicalparametersMossHistoricallookatearlymarkeHistoricallookatearlymarkersFoundinverserelationshipbetweentheejectionfractionandtotalmortalityaswellassuddendeath
Cutpointbetween30%and40%
Recentstudies,includingMADITI
andII,grewoutofthisearlyworkMossHistoricallookatearlymarkeSerialelectrophysiologytestingMechanisticallydriven
Suddendeathinpostinfarctionpatientspredominatelyduetoventriculartachycardia
Ifyoucouldinduceventriculartachycardiaandintroduceadrugthatsuppressesthisability,youcouldmonitorefficacyGoldSerialelectrophysiologytestiReviewingCASTCardiacArrhythmiaSuppressionTrial(CAST)
LargerandomizedtrialthatlookedatwhethersuppressingventricularectopyafterMIreducessuddendeathTrialstoppedbecauseantiarrhythmicagentsassociatedwithincreasedmortalityReviewingCASTCardiacArrhythmReviewingCAST"Thissetthestageformovingfromantiarrhythmicagentstodevicetherapy."MossReviewingCAST"ThissetthestReviewingCASTCouldtheseresultsberelatedtothedrugsselected?
SubsequenttrialsconfirmedthatthiswasnotthecasePrystowskyReviewingCASTCouldtheseresuMADITIWouldanICDorconventionaltherapyimprovesurvivalinthishigh-riskpopulation?
Randomlyassigned196patientswithpriorMIand:
NYHAfunctionalclass1,2,or3
Aleftventricularejectionfraction<35%
Anepisodeofasymptomaticunsustainedventriculartachycardia
Inducible,nonsuppressibleventriculartachyarrhythmiaonelectrophysiologicstudyMADITIWouldanICDorconventMADITIfindingsGroupTotaldeathsCardiacdeathsDefibrillator1511Conventionaltherapy3927*Average27-monthfollow-up
MADITIfindingsGroupTotaldeaMADITIInhigh-riskpatientswithpriorMI,prophylactictherapywithanICDleadstoimprovedsurvivalcomparedwithconventionalmedicaltherapyMADITIInhigh-riskpatientswMUSTT
MulticenterUnsustainedTachycardiaTrial(MUSTT),arandomizedcontrolledtrial
Canelectrophysiologicallyguidedantiarrhythmictherapyreducetheriskofsuddendeath?
Lookedatcoronaryarterydiseasepatientswithaleftventricularejectionfraction<40%andasymptomaticunsustainedventriculartachycardiaMUSTT
MulticenterUnsustainedMUSTTEndpointCardiacarrestor
arrhythmiadeathEP-guided
therapy(%)25Noantiarrhythmic
therapy(%)32Relativerisk0.7395%CI0.53-0.99MUSTTEndpointCardiacarrestoMUSTTTherapywithimplantabledefibrillators,butnotwithantiarrhythmicdrugs,reducestheriskofsuddendeathinhigh-riskpatientswithcoronarydisease
MUSTTTherapywithimplantableUnsustainedVT"Ithinkit'sarelativelyweakriskstratifier.Andasyoupointout,itwasbothfrustratingandcumbersome."GoldUnsustainedVT"Ithinkit'saMADITIIRandomizedtrialevaluatingtheeffectofanimplantabledefibrillatoronsurvival
1232patientswithpriorMIandaleftventricularejectionfractionof<30%
Patientsrandomlyassignedina3:2ratiotoreceiveICDorconventionalmedicaltherapyMADITIIRandomizedtrialevaluMADITmortalityratesMADITmortalityratesMADITII"Thisreallyintroducedasimplifiedstratificationapproach."MossMADITII"ThisreallyintroduceMADITIIandCMS"TheytookaconservativepositionandsaidthattheyweregoingtoreimburseonlyforMADITIIpatientswhohadaQRSduration>120millisecondsandthattheywouldrevisitthiswhenSCD-HeFTdatawerepresented."MossMADITIIandCMS"TheytookacSCD-HeFTSuddenCardiacDeathinHeartFailureTrial(SCD-HeFT)
LargestofthetrialsinvolvingICDtherapywithalongerpatientfollow-upthanpreviousstudies
SCD-HeFTSuddenCardiacDeathiSCD-HeFTComparedall-causemortalityin
>2500patients
WithNYHAclass2to3HF
LVEF<35%
PatientsrandomizedtoreceiveICD,amiodarone,orplaceboontopofstandardmedicaltherapySCD-HeFTComparedall-causemorSCD-HeFTall-causemortality
SCD-HeFTall-causemortality
SCD-HeFTICDcutsall-causemortalityby23%in
NYHAclass2to3heartfailure
SCD-HeFTICDcutsall-causemorWhat'sapayertodo?"Thetrialsweredesignedspecificallytoanswerthemajorquestionofdefibrillatorsandtheirroletoreducetotalmortality.Ithinkthetrials,asyoupointout,areconcordantinthatregard,andIthinkthatitwouldbereasonablethatthatwouldbeanindicationforpaying."GoldWhat'sapayertodo?"ThetriaWhat'sapayertodo?"Gettingintosubsetswhenit'snotreallyprespecifiedthat'swhatyou'relookingforispotentiallyverytreacherousandcanbemisleading."MossWhat'sapayertodo?"GettingThefutureManyhavebecomecynicalasnoninvasivetestafternoninvasivetestfailedtoliveuptoitsexpectations
ButIremainoptimisticGoldThefutureManyhavebecomecynQuestionAretherepatientsinMADITIIwhoare:
"Toohealthy"tobenefitfromanICD?
"Toosick"forone?PrystowskyQuestionAretherepatientsinLatestlookatMADITIIThebenefitfromICDwasentirelyinthepatientswhocarriedoneormoreriskfactors
The20%ofthepopulationthatcarriednoriskfactorsachievednobenefitwhatsoeverMossLatestlookatMADITIIThebeSummarySeveraldecadesofresearchhaveputriskstratifierstothetest
Ejectionfractionremainssupremeasanoninvasivetest
We'veidentifiedthebenefactorsofICDtherapy
AndrealizedthatantiarrhythmicdrugstopreventsuddendeatharenotasimportantasoncethoughtSummarySeveraldecadesofreseInconclusionDespite
somanynoninvasivetestsfailingtoliveupto
expectations,
manystillshowpromiseHotoffthepress!Newsoon-to-be-publisheddatawillshowthatcombinationsofriskstratifiersmayhelppinpointpatientswhowillderivethemostandleastbenefitfromanICDPrystowskyInconclusionDespite
somanynTheEPshow:
Riskstratificationforsuddendeath
TheEPshow:
RiskstratificatiRiskstratificationforsuddendeathRiskstratificationforsuddenHistoricallookatearlymarkersBeganduringthemid-1980swithaprospectivestudyofabout1000postinfarctionpatients
Measured24-hourHolterrecordingsforventricularprematurebeatfrequency
Determinedejectionfraction
Ascertainedseveralother
routineclinicalparametersMossHistoricallookatearlymarkeHistoricallookatearlymarkersFoundinverserelationshipbetweentheejectionfractionandtotalmortalityaswellassuddendeath
Cutpointbetween30%and40%
Recentstudies,includingMADITI
andII,grewoutofthisearlyworkMossHistoricallookatearlymarkeSerialelectrophysiologytestingMechanisticallydriven
Suddendeathinpostinfarctionpatientspredominatelyduetoventriculartachycardia
Ifyoucouldinduceventriculartachycardiaandintroduceadrugthatsuppressesthisability,youcouldmonitorefficacyGoldSerialelectrophysiologytestiReviewingCASTCardiacArrhythmiaSuppressionTrial(CAST)
LargerandomizedtrialthatlookedatwhethersuppressingventricularectopyafterMIreducessuddendeathTrialstoppedbecauseantiarrhythmicagentsassociatedwithincreasedmortalityReviewingCASTCardiacArrhythmReviewingCAST"Thissetthestageformovingfromantiarrhythmicagentstodevicetherapy."MossReviewingCAST"ThissetthestReviewingCASTCouldtheseresultsberelatedtothedrugsselected?
SubsequenttrialsconfirmedthatthiswasnotthecasePrystowskyReviewingCASTCouldtheseresuMADITIWouldanICDorconventionaltherapyimprovesurvivalinthishigh-riskpopulation?
Randomlyassigned196patientswithpriorMIand:
NYHAfunctionalclass1,2,or3
Aleftventricularejectionfraction<35%
Anepisodeofasymptomaticunsustainedventriculartachycardia
Inducible,nonsuppressibleventriculartachyarrhythmiaonelectrophysiologicstudyMADITIWouldanICDorconventMADITIfindingsGroupTotaldeathsCardiacdeathsDefibrillator1511Conventionaltherapy3927*Average27-monthfollow-up
MADITIfindingsGroupTotaldeaMADITIInhigh-riskpatientswithpriorMI,prophylactictherapywithanICDleadstoimprovedsurvivalcomparedwithconventionalmedicaltherapyMADITIInhigh-riskpatientswMUSTT
MulticenterUnsustainedTachycardiaTrial(MUSTT),arandomizedcontrolledtrial
Canelectrophysiologicallyguidedantiarrhythmictherapyreducetheriskofsuddendeath?
Lookedatcoronaryarterydiseasepatientswithaleftventricularejectionfraction<40%andasymptomaticunsustainedventriculartachycardiaMUSTT
MulticenterUnsustainedMUSTTEndpointCardiacarrestor
arrhythmiadeathEP-guided
therapy(%)25Noantiarrhythmic
therapy(%)32Relativerisk0.7395%CI0.53-0.99MUSTTEndpointCardiacarrestoMUSTTTherapywithimplantabledefibrillators,butnotwithantiarrhythmicdrugs,reducestheriskofsuddendeathinhigh-riskpatientswithcoronarydisease
MUSTTTherapywithimplantableUnsustainedVT"Ithinkit'sarelativelyweakriskstratifier.Andasyoupointout,itwasbothfrustratingandcumbersome."GoldUnsustainedVT"Ithinkit'saMADITIIRandomizedtrialevaluatingtheeffectofanimplantabledefibrillatoronsurvival
1232patientswithpriorMIandaleftventricularejectionfractionof<30%
Patientsrandomlyassignedina3:2ratiotoreceiveICDorconventionalmedicaltherapyMADITIIRandomizedtrialevaluMADITmortalityratesMADITmortalityratesMADITII"Thisreallyintroducedasimplifiedstratificationapproach."MossMADITII"ThisreallyintroduceMADITIIandCMS"TheytookaconservativepositionandsaidthattheyweregoingtoreimburseonlyforMADITIIpatientswhohadaQRSduration>120millisecondsandthattheywouldrevisitthiswhenSCD-HeFTdatawerepresented."MossMADITIIandCMS"TheytookacSCD-HeFTSuddenCardiacDeathinHeartFailureTrial(SCD-HeFT)
LargestofthetrialsinvolvingICDtherapywithalongerpatientfollow-upthanpreviousstudies
SCD-HeFTSuddenCardiacDeathiSCD-HeFTComparedall-causemortalityin
>2500patients
WithNYHAclass2to3HF
LVEF<35%
PatientsrandomizedtoreceiveICD,amiodarone,orplaceboontopofstandardmedicaltherapySCD-HeFTComparedall-causemorSCD-HeFTall-causemortality
SCD-HeFTall-causemortality
SCD-HeFTICDcutsall-causemortalityby23%in
NYHAclass2to3heartfailure
SCD-HeFTICDcutsall-causemorWhat'sapayertodo?"Thetrialsweredesignedspecificallytoanswerthemajorquestionofdefibrillatorsandtheirroletoreducetotalmortality.Ithinkthetrials,asyoupointout,areconcordantinthatregard,andIthinkthatitwouldbereasonablethatthatwouldbeanindicationforpaying."GoldWhat'sapayertodo?"ThetriaWhat'sapayertodo?"Gettingintosubsetswhenit'snotreallyprespecifiedthat'swhatyou'relookingforispotentiallyverytreacherousandca
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