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COMPANIONandCARE-HFEricPrystowskyMD Director,ClinicalElectrophysiologyLaboratory StVincentHospital Indianapolis,IN

HughCalkinsMD Director,ElectrophysiologyLab JohnsHopkinsUniversityMedicalCenter Baltimore,MDJohnClelandMD ProfessorofCardiology HullUniversity KingstonuponHull,UK

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COMPANIONandCARE

Useofcardiacresynchronizationtherapy(CRT)inCOMPANION

andCARE-HF

UseofcardiacresynchronizatBriefhistoryLargegroupofpatientsinneedofICDsforprimarypreventionNeweraofbiventricularpacingtoimproveHFsymptomsCOMPANIONandCARE-HFBriefhistoryLargegroupofp

ComparisonofMedicalTherapy,Pacing,andDefibrillationinHeartFailure

COMPANION

ComparisonofMedicalTherapCOMPANIONDesignParallel,randomizedclinicaltrialin1600patientswithmoderateorsevereheartfailurewithQRS>120msandPRinterval>150ms(BristowMRetal.NEnglJMed2004;350:2140-2150)Patientsrandomizedina1:2:2fashiontooptimalmedicaltherapy;optimaldrugtherapyplusCRT;oroptimaldrugtherapyplusCRTwithanICD(CRT-D)COMPANIONDesignResultsPrimaryendpointCombinationofall-causedeathandall-causehospitalizationsreduced19%intheCRTstudyarmand20%intheCRT-DstudyarmDeathfromorhospitalizationforHFreduced34%inCRTgroupand40%inCRT-DgroupResultsPrimaryendpointResultsSecondaryendpointCRTaloneassociatedwithanonsignificanttrendtowarda24%reductioninall-causemortality,asecondaryendpointofthestudyCRTwithadefibrillatorreducedall-causemortality36%,ahighlysignificantresultResultsSecondaryendpointSignificantreductions"Thisstudyshowedinalargepopulationofpatientsthatresynchronizationtherapyimprovessurvivalandreduceshospitalization."Survivalbenefitlimitedto

thosewithCRTandICDCalkinsSignificantreductions"ThisstCRTchallengesImplantingthecoronarysinusleadDifficultyinvolvesnotgettingtheleadin,butgettingitintherightplaceToachieveeffectiveresynchronization,theleadneedstobeimplantedinalateralbranchofthecoronarysinusRequiresexperiencedimplanterCRTchallengesImplantingthec

Cardiac

Resynchronization

HeartFailure

CARE-HF

CardiacResynchronization

HeCARE-HFRationaleCardiacdyssynchronyaprobleminalargenumberofpatientswithHFandleftventricularsystolicdysfunctionPreviousstudieshavesuggestedthatCRTcanimprovesymptoms,qualityoflife,andexercisecapacityNoconclusiveevidenceofaneffectonhospitalizationsormortality

CARE-HFRationaleCARE-HFDesignRandomized,controlled,open-label,blinded-end-pointstudyRandomizedpatientstocontinuewithmedicaltherapyortoreceiveCRTIncluded813patientswithNYHAclass3-4HFdespitestandarddrugtherapy,anLVEF<35%,andQRSdurationofatleast120msCARE-HFDesignCARE-HFPatientswithaQRSduration<150mswererequiredtohaveechocardiographicconfirmationofventriculardyssynchronyPrimaryendpointwasall-causemortality/unplannedhospitalizationforCVeventCARE-HFPatientswithaQRSdurStrengthsofCARE-HFStudydetailsLargecontrolgroupImplantsuccessrate96%Long-termfollow-up,withanaverageof2.5yearsAverageageofpatient67yearsOnly40%ofpatientstaking>80mgfurosemide(mostcommondosewas40mgdaily)StrengthsofCARE-HFStudydetaClelandJGFetal.NEnglJMed2005;352:1539-1549Primaryandsecondaryoutcomesin

CARE-HFOutcomesHazardratio(95%CI)pAll-causemortality/unplannedhospitalizationforCVevent

0.63(0.51-0.77)

<0.0001All-causemortality0.64(0.48-0.85)0.0019All-causemortality/HFhospitalization0.54(0.43-0.68)<0.0001ClelandJGFetal.NEnglJMeOtherimprovementsCRTgroupalsobenefitedsignificantlywithimprovedLVEF,NYHAclass,end-systolicvolume,mitral-valvefunction,bloodpressure,andquality-of-lifeindices

Dramaticimprovementsat18monthsinlevelsofN-terminalpro-B-typenatriureticpeptide(NT-proBNP)OtherimprovementsCRTgroupalProblemsencounteredLeadproblems27lead-relatedproblems,suchasfractureordisplacement,inthe409patientsrandomizedtoCRTNumberofcasesofcoronarysinusdissection,noneofwhichcauseddeathOneprocedure-relateddeathineachgroupProblemsencounteredLeadproblPossibleremission"Ithinkweseeasubstantialproportionofpatientswhobecomeasymptomaticandwhosecardiacfunctionisnormalizedbythistherapy."

PossibilityofHF"remission"

ClelandPossibleremission"IthinkweWhattherapy?NoquestiontothevalueofCRT,butcandidatesforCRTarealsocandidatesforICDtherapyThequestionthenbecomes,whichtreatmentdotheyreceive?Whattherapy?NoquestiontothTreatingpatients"It'safairlyeasydecision."Realdifferencecomesdowntocost,

buttheaddedprotectionofthe

ICDwarrantstheuseofCRT

withadefibrillatorCalkinsTreatingpatients"It'safairlOtherissuesMorbidityThereisthepossibilityofinappropriateshocksfromtheICDinhealthypatientswhomightnotstandtobenefitfromitsadditionInstudiesusingolderdevices,themorbidityfromthedefibrillatorwasunacceptableOtherissuesMorbidityIfmoneywerenotanissue...CRTwithnewerdefibrillatorsdoesprovideanadditionalbenefitButcostintheUKremainsan

issue,andIwouldcontinuetobe

selectiveaboutwhichpatients

receivedCRTwithdefibrillator

backupClelandIfmoneywerenotanissue..Patientselection

HaveyoulearnedanythingfromthestudiesthatwouldhelpyouselectpatientsforaCRT-Dimplant? -Prystowsky

Thebriefanswertothatisnotyet. -ClelandPatientselection

HaveyouleaInappropriateshocksNotacaseofinappropriateshocksbutinappropriateprogrammers

EPsprogrammingdevicesthatdeliverinappropriateshocksmorethan5%ofthetimeneedtogobacktoschoolPrystowskyInappropriateshocksNotacaseInappropriateshocks"Itirksmeattimesbecausepeoplethrowthatupasareasonnottogetadefibrillator,butIsaygetabetterimplanter,getasmarterdoctor." -Prystowsky"Butnoteverybodycancometoyourcenterandbenefitfromyourexpertise." -ClelandInappropriateshocks"ItirksmLookingtothefutureInterestingissueasnoteverybodywithawideQRSbenefits,andevensomewithanarrowQRSbenefitfromCRTPathophysiologysuggestsapplyingtherapyearlier,topatientsinNYHAclass2,topreventprogressionofHFLookingtothefutureInterestiLookingtothefuture"ThefactthatCARE-HFwassopositiveinarathermilderpopulationth