Preventing Sudden Cardiac Preventing Sudden Cardiac Death Death

Role of the Implantable Role of the Implantable CardioverterCardioverter DefibrillatorDefibrillator

HelbertHelbert Acosta MDAcosta MDCardiovascular Medicine, PC October 8, 2005Cardiovascular Medicine, PC October 8, 2005

SCD DEFINITIONSCD DEFINITION

UNEXPECTED DEATH DUE TO UNEXPECTED DEATH DUE TO CARDIAC CAUSES CARDIAC CAUSES

INVOLVING ABRUPT LOSS INVOLVING ABRUPT LOSS OF CONCIOUSNESS DUE TO OF CONCIOUSNESS DUE TO DISRUPTION IN CEREBRAL DISRUPTION IN CEREBRAL BLOOD FLOW OCCURING BLOOD FLOW OCCURING

WITHIN ONE HOUR OF THE WITHIN ONE HOUR OF THE ONSET OF ACUTE ONSET OF ACUTE

SYMPTOMSSYMPTOMS

Myerburg RJ, Castellanos A. In Braunwald E,ed. Heart Disease, 6th edn. WB saunders,2001

EPIDEMIOLOGY OF SCDEPIDEMIOLOGY OF SCD340,000 to 400,000 out340,000 to 400,000 out--ofof--hospital or in an ED cardiac hospital or in an ED cardiac arrests per year in U.S.arrests per year in U.S.

At least 50 % of SCD are due At least 50 % of SCD are due lethal arrhythmiaslethal arrhythmias

80 % of arrhythmic SCD 80 % of arrhythmic SCD are associated to CADare associated to CAD

95% out95% out--ofof--hospital mortalityhospital mortality

Given high mortality, goal is Given high mortality, goal is preventionprevention

EPIDEMIOLOGY OF SUDDEN EPIDEMIOLOGY OF SUDDEN DEATHDEATH

Myerburg RJ , Castellanos A. Cardiac arrest and CSD. In Braunwald E,. Heart Disease.6th edn. WB saunders,20001 (modified)

General population

CAD risk factors

Prior coronary event

EF < 35% and CHF

Prior out-of-hospital cardiac arrest

Prior MI, low EF, VT

ARRHYTHMIC SUDDEN DEATHARRHYTHMIC SUDDEN DEATH

PICTURE OF VT PICTURE OF VT The underlying The underlying arrhythmia in arrhythmia in approximately 80% approximately 80% of SCD was VT/VFof SCD was VT/VF

BradyarrhythmiasBradyarrhythmias and and pulselesspulseless eletricaleletricalactivity represent activity represent 15 15 –– 20 %20 %BayesBayes de Luna A, et al . Am Heart j de Luna A, et al . Am Heart j 1989;117:1511989;117:151

Ventricular Tachycardia

Ventricular fibrillation

Mechanisms of SCDMechanisms of SCDANATOMIC/ FUNCTIONAL SUBSTRATEANATOMIC/ FUNCTIONAL SUBSTRATECADCADCardiomypathyCardiomypathy ( dilated ( dilated hypertrophichypertrophic))RV RV dysplasiadysplasiaPrimary electrophysiological conditionPrimary electrophysiological conditioninflamatoryinflamatory.. etc... etc.

ARRHYTHMIA MECHANISMSARRHYTHMIA MECHANISMS

ReentryReentryAutomaticityAutomaticityTrigger activity Trigger activity

TRIGGERSTRIGGERSElectrolyte abnormalities, PH, pO2Electrolyte abnormalities, PH, pO2IschemiaIschemiaDrug Drug NeuroendocrineNeuroendocrineHemodynamicHemodynamicArising , stretch, sleepArising , stretch, sleep

LETHAL ARRHYTHMIA

Zipes and Wellens. Circ 1998; 98:2334

ANATOMIC/FUNCTIONAL ANATOMIC/FUNCTIONAL SUBSTRATESUBSTRATE

Hypertrophic CardiomyopathyMyocardial infarction

ARRHYTHMOGENIC RIGHT ARRHYTHMOGENIC RIGHT VENTRICULAR DYSPLASIAVENTRICULAR DYSPLASIA

EPSYLOM WAVE

Primary electrophysiological Primary electrophysiological AbnormalityAbnormality

Brugada syndromeLong Qt syndrome

OTHER ABNORMALITIES OF OTHER ABNORMALITIES OF UNKNOWN ETIOLOGYUNKNOWN ETIOLOGY

FATY INFILTRATION AND FIBROSIS OF FATY INFILTRATION AND FIBROSIS OF THE SPECIALIZED CONDUCTION THE SPECIALIZED CONDUCTION SYSTEM OF THE HEARTSYSTEM OF THE HEART

SINUS NODE SINUS NODE AV NODE AV NODE HIS BUNDLEHIS BUNDLEBUNDLE BRANCHES BUNDLE BRANCHES

SymptomsSymptoms

None!!!!None!!!!

Inventor of the ICDInventor of the ICD

Michel Mirowski1924-1990

First human implantIn 1980

1985 FDA approval

Implantation nowImplantation nowPicture Picture

ICD componentsICD components

How do How do ICDsICDs work?work?

LESS THAN PERFECT LESS THAN PERFECT Painful shock Painful shock Emotional stressEmotional stressAnxietyAnxietyDepression Depression Driving limitations Driving limitations Job limitations Job limitations

ProPro--ArrhythmicArrhythmicMalfunction (recalls)Malfunction (recalls)Complications related to Complications related to implantimplant

ROLE OF ANTIARRHYTHMIC MEDICATIONSROLE OF ANTIARRHYTHMIC MEDICATIONS

No differenceNo difference12001200Amiodarone/plaebAmiodarone/plaeboo

CAMIATCAMIAT

No differenceNo difference15001500AmiodaroneAmiodarone/placebo/placebo

EMIAT EMIAT

34% mortality 34% mortality reductionreduction

12001200AmiodaroneAmiodarone/place/placebobo

GESICAGESICA

No differenceNo difference674674AmiodaroneAmiodarone/place/placebobo

CHFCHF--STATSTAT

No difference No difference 15181518DofetilideDofetilide/placebo/placeboDIAMONDDIAMOND--CHFCHF

↑↑(in treatment arm)(in treatment arm)

546546dd--Sotalol/placeboSotalol/placeboSWORDSWORD

↑↑(treatment arm )(treatment arm )

14981498Encainide,FlecainiEncainide,Flecainidede/placebo/placebo

CASTCAST-- 11

Effect in Effect in MortalityMortality

N of N of ptspts

Anti Anti arrhythmicarrhythmic

StudyStudy

EFFECT OF MEDICATIONS IN EFFECT OF MEDICATIONS IN PREVENTING SUDDEN CARDIAC DEATHPREVENTING SUDDEN CARDIAC DEATH

BETA BLOCKERS BETA BLOCKERS GoldstienSGoldstienS et al, JACC, 2001et al, JACC, 2001

ACE INHIBITORS ACE INHIBITORS Sudden Death: RR 20%Sudden Death: RR 20%Cardiovascular Death RR 18%Cardiovascular Death RR 18%

DomanskiDomanski et al, JACC 1999et al, JACC 1999

STATINSSTATINS

BIDIL (HYDRALAZINE+ ISOSORBIDE)BIDIL (HYDRALAZINE+ ISOSORBIDE)

SPIRINOLACTONESPIRINOLACTONE

MERIT-HF TRIAL

RR=39%

TO WHOM THE ICD TO WHOM THE ICD SHOULD BE OFFEREDSHOULD BE OFFERED

??

LANDMARK TRIALSLANDMARK TRIALSSecondary Prevention TrialsSecondary Prevention Trials( post VT/VF arrest)( post VT/VF arrest)

AVID AVID : : AntiarrhythmicsAntiarrhythmics Vs ICDVs ICD

CASH : CASH : Cardiac arrest study Cardiac arrest study HamburgHamburg

CIDS : CIDS : Canadian Implantable Canadian Implantable defibrillator Studydefibrillator Study

Primary Prevention trialsPrimary Prevention trialsPts at high risk for SCDPts at high risk for SCD

MADIT I MADIT I ( ( MulticenterMulticenter Automatic Defibrillator Automatic Defibrillator implantation)implantation)

MUSTT MUSTT ( ( MulticenterMulticenter UnsustainedUnsustained Tachycardia Trial)Tachycardia Trial)

MADIT IIMADIT II

SCDSCD--HeFTHeFT ( Sudden cardiac Death Heart failure ( Sudden cardiac Death Heart failure Trial)Trial)

Secondary Prevention trialsSecondary Prevention trials

NoNoNoNoYes Yes Sign.Sign.

20% 20% over 3 yrsover 3 yrs

23%23%over 5 yrsover 5 yrs

31% 31% at 3 yrsat 3 yrs

Survival benefitSurvival benefit

33%33%61%61%47%47%Decrease in Decrease in arrhythmic deatharrhythmic death

34%34%46%46%32%32%Mean Mean LVEFLVEF

VT/VF VT/VF SyncopeSyncope

Cardiac Cardiac arrestarrest

VF/VTVF/VTTYPE OF PTTYPE OF PT

CIDSCIDSN=659N=659

CASHCASHN= 288N= 288

AVID AVID N= 1016N= 1016

Primary Prevention ICD TrialsPrimary Prevention ICD Trials( Post MI at high risk)( Post MI at high risk)

31%31%72% SCD72% SCD60% MORTALITY60% MORTALITY

54%54%Mortality Mortality ReductionReduction

ICD ICD vsvsConvConv. Rx. Rx

EP GUIDED Vs EP GUIDED Vs placeboplacebo

ICD Vs Drug RxICD Vs Drug RxDesignDesign

<30%<30%<40%<40%<35%<35%LVEFLVEF

CAD/MI>1 MONTHCAD/MI>1 MONTHCAD/NSVT/+EPSCAD/NSVT/+EPSCAD/MI/NSVTCAD/MI/NSVT+EPS+EPSType of ptType of pt

MADIT IIMADIT II(2002)(2002)

N= 1232N= 1232

MUSTTMUSTT

n= 704n= 704

MADIT IMADIT IN=196N=196

Secondary Prevention trialsSecondary Prevention trials

NoNoNoNoYes Yes Sign.Sign.

20% 20% over 3 yrsover 3 yrs

23%23%over 5 yrsover 5 yrs

31% 31% at 3 yrsat 3 yrs

Survival benefitSurvival benefit

33%33%61%61%47%47%Decrease in Decrease in arrhythmic deatharrhythmic death

34%34%46%46%32%32%Mean Mean LVEFLVEF

VT/VF VT/VF SyncopeSyncope

Cardiac Cardiac arrestarrest

VF/VTVF/VTTYPE OF PTTYPE OF PT

CIDSCIDSN=659N=659

CASHCASHN= 288N= 288

AVID AVID N= 1016N= 1016

ISCHEMIC VS ISCHEMIC VS NONISCHEMIC NONISCHEMIC

CARDIOMYOPATHYCARDIOMYOPATHY

Primary Prevention ICD Trails in Primary Prevention ICD Trails in CHFCHF

Reduction of Reduction of 23% of all 23% of all cause mortalitycause mortality

80 % reduction 80 % reduction in in arrharrh deathdeath

ResultsResults

Standard Standard vsvsAmiodaroneAmiodarone vsvsICDICD

Standard Standard vsvsICDICD

TherapyTherapy

LVEF<35%LVEF<35%LVEF<35%LVEF<35%NSVTNSVT

Type of ptType of pt

SCDSCD--HeFTHeFTN=2500N=2500

DEFINITIVEDEFINITIVEN=458N=458

Sudden cardiac Death in Heart Sudden cardiac Death in Heart Failure Trial (SCDFailure Trial (SCD--HeFTHeFT))

2521 pts2521 ptsIschIsch CPM : 52%CPM : 52%NonNon--IschIsch CMP:48%CMP:48%

847 847 →→ stand Rx + stand Rx + pbpb845 845 →→ stand + stand + AmioAmio829 829 →→ stand + ICDstand + ICD

ROLE OF BIVENTRICULAR ROLE OF BIVENTRICULAR PACING ON SCDPACING ON SCD

CrtCrt picturepicture

Two trials addressing effect in mortalityTwo trials addressing effect in mortality

COMPANIONCOMPANION

CARECARE--HF HF

COMPANION TRIALCOMPANION TRIALIschemic and nonIschemic and non--ischemic ischemic LVEFLVEF≤≤ 35%35%QRS >120 msQRS >120 msP End point : All cause mortalityP End point : All cause mortality

first hospitalizationfirst hospitalization

S End Point : all cause mortalityS End Point : all cause mortalityCRT 24 % (p .059)CRT 24 % (p .059)CRT+ICD 36% (p .003)CRT+ICD 36% (p .003)

N Eng J Med. 2004. 350; 2140

CARECARE--HEF TRIALHEF TRIAL813 PTS813 PTSCLASS IIICLASS III--IVIVCRT CRT vsvs STANDARD RXSTANDARD RXEF<35%, QRS>120msEF<35%, QRS>120msP. end point:P. end point:

All cause mortAll cause morthospitalizationhospitalization

Cleland JGF et al. N Eng J Med 2005;352:1539

View Slide

EP STUDYEP STUDY

STRIP INDUCING VTSTRIP INDUCING VT

NON INVASIVE RISK NON INVASIVE RISK STRATIFICATIONSTRATIFICATION

HRVHRV

T WAVE ALTERNANT T WAVE ALTERNANT

HR TURBULENCEHR TURBULENCE

SIGNAL AVERAGE ECGSIGNAL AVERAGE ECG

ACC/AHA GUIDELINES 2002ACC/AHA GUIDELINES 2002CLASS ICLASS I

Cardiac arrest de to VF or VTCardiac arrest de to VF or VT

Spontaneous VT + structural heart diseaseSpontaneous VT + structural heart disease

spontaneous VT with normal heart no amenable for other treatspontaneous VT with normal heart no amenable for other treatmentment

syncope + induction of VT or VF on EPSsyncope + induction of VT or VF on EPS

NonsustainedNonsustained VT, post MI, LV VT, post MI, LV dysf.,Idysf.,I nduciblenducible VT or VF VT or VF ( no suppressible by class I ( no suppressible by class I antiarrhythmicantiarrhythmic) )

ACC/AHA GUIDELINES 2002ACC/AHA GUIDELINES 2002

CLASS CLASS IIaIIa

CLASS II bCLASS II bCCardiac arrest presumed due to VF and EPS can not be doneardiac arrest presumed due to VF and EPS can not be doneVT + syncope awaiting heart transplantVT + syncope awaiting heart transplantFamilial or inherited Familial or inherited condcond. :Long QT, HCM. :Long QT, HCMNonsustNonsust. VT, CAD, LV . VT, CAD, LV dysfdysf., EPS + VT/VF., EPS + VT/VFRecurrent syncope of Recurrent syncope of unknwonunknwon etiology, EPS+,LV etiology, EPS+,LV dysfdysf..syncope + FH of unexplained sudden deathsyncope + FH of unexplained sudden death + + BrugadaBrugada ecgecg

LVEF LVEF ≤≤ 30 , 1 mo post MI and 3 mo post CABG30 , 1 mo post MI and 3 mo post CABG

ACC/AHA GUIDELINESACC/AHA GUIDELINES

CLASS IIICLASS IIISyncope of undetermined cause, normal heart, EPS Syncope of undetermined cause, normal heart, EPS ––Incessant VT or VFIncessant VT or VFVT curable with ablation or surgery ( WPW, RVOT VT) VT curable with ablation or surgery ( WPW, RVOT VT) VT or VF due transient or reversible cause VT or VF due transient or reversible cause

( ( AMI,electroliteAMI,electrolite imbalance ..)imbalance ..)Psychiatric or terminal illnesses Psychiatric or terminal illnesses

ACC/AHA GUIDELINES 2002ACC/AHA GUIDELINES 2002

CLASS CLASS IIaIIa

CLASS II bCLASS II bCCardiac arrest presumed due to VF and EPS can not be doneardiac arrest presumed due to VF and EPS can not be doneVT + syncope awaiting heart transplantVT + syncope awaiting heart transplantFamilial or inherited Familial or inherited condcond. :Long QT, HCM. :Long QT, HCMNonsustNonsust. VT, CAD, LV . VT, CAD, LV dysfdysf., EPS + VT/VF., EPS + VT/VFRecurrent syncope of Recurrent syncope of unknwonunknwon etiology, EPS+,LV etiology, EPS+,LV dysfdysf..syncope + FH of unexplained sudden deathsyncope + FH of unexplained sudden death + + BrugadaBrugada ecgecg

LVEF LVEF ≤≤ 30 , 1 mo post MI and 3 mo post CABG30 , 1 mo post MI and 3 mo post CABG

2005 ACC/AHA HEART FAILURE 2005 ACC/AHA HEART FAILURE GUIDELINES SUMMARYGUIDELINES SUMMARY

WHAT DO WE DO NOW ?WHAT DO WE DO NOW ?SELECTION OF PTSELECTION OF PT-- INDICATIONSINDICATIONS

IN PTS WITH IN PTS WITH PERMANENTLY PERMANENTLY DECREASED LVEF < 30 % DECREASED LVEF < 30 % REGARDLESS THE REGARDLESS THE ETIOLOGY OR FUNCTIONAL ETIOLOGY OR FUNCTIONAL CLASS ICD IS INDICATEDCLASS ICD IS INDICATED

IF LVEF > 30 < 35 % , IF LVEF > 30 < 35 % , FUNCTIONAL CLASS HAS FUNCTIONAL CLASS HAS TO BE II OR III TO BE TO BE II OR III TO BE CANDIDATE FOR A CANDIDATE FOR A DEFIBRILLATOR DEFIBRILLATOR

CADCAD , LVEF >35 AND < 45%, LVEF >35 AND < 45%NO SYNCOPE . NO NO SYNCOPE . NO

NONSUSTAINED VT = NONSUSTAINED VT = OBSERVATION , HOLTER Q 6 OBSERVATION , HOLTER Q 6 MONTHSMONTHS

NONSUSTAINED VT AND OR NONSUSTAINED VT AND OR SYNCOPE = EPS , IF SYNCOPE = EPS , IF POSiTIVEPOSiTIVEICDICDIF NEGATIVE MEDICAL Rx VS IF NEGATIVE MEDICAL Rx VS ICDICD

Non ischemicNon ischemic, LVEF > 35%, NO , LVEF > 35%, NO VT , NO SYNCOPE= VT , NO SYNCOPE= OBSERAVTIONOBSERAVTIONIF SYNCOPE OR VT ICD IF SYNCOPE OR VT ICD COULD BE CONSIDEREDCOULD BE CONSIDERED

ExamplesExamples47 YO FEMALE WITH 47 YO FEMALE WITH NONISCHEMIC CMP, NONISCHEMIC CMP, LVEF 28 %.LVEF 28 %.

NO SYNCOPE NO VTNO SYNCOPE NO VT

68 YO MALE S/P MI 68 YO MALE S/P MI LVEF 43%. HOLTER: LVEF 43%. HOLTER: NONSUSTAINED VTNONSUSTAINED VT

57 YO FEMALE, HTN, 57 YO FEMALE, HTN, CHF DEVELOPED CHF DEVELOPED SUDDEN VF ARREST , SUDDEN VF ARREST , k+ 2.1 ON DIURETICSk+ 2.1 ON DIURETICSLVEF 47% LVEF 47%

Larsen et al, Circulation 2002

Total cost ICD - total cost conventional therapy

average total survival benefit

additional cost of ICD therapy

year of life saved=

Cost EffectivenessCost Effectiveness

ICD THERAPY FOR PRIMARY PREVENTION OF SUDDEN DEATH IS CONSIDERED COST EFFECTIVE

ICD COST $ 20.000 TO $ 30.000 PER YEAR OF LIFE SAVED

COST EFFECTIVENESS OF ICDCOST EFFECTIVENESS OF ICD

QUESTIONS?QUESTIONS?

HOW OLD IS TOO OLD?HOW OLD IS TOO OLD?

PICTURE OF MY 104 YEAR OLD PICTURE OF MY 104 YEAR OLD PATIENT PATIENT

History of Fibrillation and History of Fibrillation and DefibrillationDefibrillation

Carl Ludwig (1816-1895) and his discoveryOf electrical stimulus-induced ventricular fibrillation1850

American thoracic surgeon saved the first human Life by this method. 1947 University hospital of Cleveland

Total average cost over 3Total average cost over 3--year followyear follow--upup$85,522 ICD$85,522 ICD$71,421 medical therapy$71,421 medical therapy

Average survival benefit 0.21 years Average survival benefit 0.21 years C/E ratio: $66,677 per year of life savedC/E ratio: $66,677 per year of life saved

Larsen et al, Circulation 2002

AVID: Cost EffectivenessAVID: Cost Effectiveness