Module 3 ICD Indications and Clinical Studies ACCAHA

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Module 3: ICD Indications and Clinical Studies

Module 3: ICD Indications and Clinical Studies

ACC/AHA Indications – Class I – Conditions for which there is evidence and/or general

ACC/AHA Indications – Class I – Conditions for which there is evidence and/or general agreement that a pacemaker is beneficial – Class II – Conditions for which there is conflicting evidence about the benefits of a pacemaker Class IIa – Weight of evidence/opinion in favor of benefits Class IIb – Benefits are less well established by evidence/opinion – Class III – Conditions for which there is evidence and/or general agreement that a pacemaker is not useful/effective and in some cases may be harmful 2 Document identifier

Leading Causes of Death in the US 0% 5% Source: Sudden Cardiac Arrest Foundation

Leading Causes of Death in the US 0% 5% Source: Sudden Cardiac Arrest Foundation 3 Document identifier 10% 15% 20% 25%

Arrhythmic Cause of Sudden Cardiac Arrest 12% Other Cardiac Cause 88% Arrhythmic Cause 4

Arrhythmic Cause of Sudden Cardiac Arrest 12% Other Cardiac Cause 88% Arrhythmic Cause 4 Albert CM. Circulation. 2003; 107: 2096 -2101 Document identifier .

Underlying Arrhythmias of Sudden Cardiac Arrest Torsades de Pointes 13% Bradycardia 17% VT 62%

Underlying Arrhythmias of Sudden Cardiac Arrest Torsades de Pointes 13% Bradycardia 17% VT 62% 5 Bayés de Luna A. Am Heart J. 1989; 117: 151 -159. Document identifier Primary VF 8%

Indications: Secondary vs. Primary Prevention ICD implant Indications Secondary prevention ICD implantation improves survival

Indications: Secondary vs. Primary Prevention ICD implant Indications Secondary prevention ICD implantation improves survival in patients with a history of life-threatening ventricular arrhythmia. Primary Prevention ICD implantation also improves survival as primary prophylaxis against Sudden Cardiac Death in patients at high risk for ventricular tachyarrhythmias. 6 Document identifier

Secondary Prevention Indication Rules § Rule #1 – Survival of SCD episode (not due

Secondary Prevention Indication Rules § Rule #1 – Survival of SCD episode (not due to reversible cause) § Rule #2 – VT or VF induced at EP study when drugs are ineffective § Rule #3 – NSVT with CAD/prior MI that is not suppressible by antiarrhythmic therapy 7 Document identifier

ICD Trials: Secondary Prevention AVID: Antiarrhythmics Versus Implantable Defibrillators CASH: The Cardiac Arrest Study

ICD Trials: Secondary Prevention AVID: Antiarrhythmics Versus Implantable Defibrillators CASH: The Cardiac Arrest Study Hamburg CIDS: The Canadian Implantable Defibrillator Study 8 Document identifier

AVID Mortality Reduction ICD vs. Antiarrhythmic Drug History of VF, VT with syncope or

AVID Mortality Reduction ICD vs. Antiarrhythmic Drug History of VF, VT with syncope or sustained VT with EF<40% Mortality reduction with ICD 1 year: 39% 2 years: 27% 3 years: 31% NEJM 1997; 337: 1576 -1583 9 Document identifier

CASH 24% Mortality Reduction with ICD Survivors of cardiac arrest secondary to sustained ventricular

CASH 24% Mortality Reduction with ICD Survivors of cardiac arrest secondary to sustained ventricular arrhythmia 10 Circulation. 2000; 102: 748 -754 Document identifier

CIDS 20% Mortality reduction with ICD CIDs substantiated the efficacy of ICD over Amiodarone

CIDS 20% Mortality reduction with ICD CIDs substantiated the efficacy of ICD over Amiodarone as seen in AVID 11 Document identifier Circulation 2000 101: 1297 -1302

Secondary Prevention Summary % Mortality Reduction Overall Death 100 90 80 70 60 50

Secondary Prevention Summary % Mortality Reduction Overall Death 100 90 80 70 60 50 40 30 20 10 0 2 3 12 Document identifier 61 56 31 AVID at 3 Years 1 Arrhythmic Death 28 CASH at 3 Years The AVID Investigators. NEJM. 1997; 337: 1576 -1583. Kuck K. Circ. 2000; 102: 748 -754. Connolly S. Circ. 2000; 101: 1297 -1302. 33 20 CIDS at 2 Years

Primary Prevention ICD Indications § Rule #1 – Left ventricular ejection fraction (LVEF) of

Primary Prevention ICD Indications § Rule #1 – Left ventricular ejection fraction (LVEF) of 35% or less § Rule #2 – New York Heart Association class II or III heart failure OR – History of myocardial infarction (s/p 40 days) 13 § Rule #3 – Medically optimized Document identifier

ICD Trials: Primary Prevention CABG-Patch: Coronary Artery Bypass Graft Patch DEFINITE: Defibrillators in Non-Ischemic

ICD Trials: Primary Prevention CABG-Patch: Coronary Artery Bypass Graft Patch DEFINITE: Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation Trial DINAMIT: The Defibrillator in Acute Myocardial Infarction Trial MADIT I: Multicenter Automatic Defibrillator Implantation Trial I MADIT II: Multicenter Automatic Defibrillator Implantation Trial II SCD-He. FT: Sudden Cardiac Death in Heart Failure Trial 14 Document identifier

CABG-Patch Prophylactic use of ICD with patient at time of CABG NEJM 1997; 337:

CABG-Patch Prophylactic use of ICD with patient at time of CABG NEJM 1997; 337: 1569 -1575 15 Document identifier

DEFINITE *NIDCM, LVEF <36% and PVC or NSVT (NIDCM = Non-ischemic dilated cardiac myopathy)

DEFINITE *NIDCM, LVEF <36% and PVC or NSVT (NIDCM = Non-ischemic dilated cardiac myopathy) 35% Reduction in All Cause Mortality 16 Document identifier NEJM 2004; 350: 2151 -8 20% Reduction in SCD from arrhythmia

DINAMIT 6 – 40 days post MI, LVEF ≤ 35% 17 Document identifier NEJM

DINAMIT 6 – 40 days post MI, LVEF ≤ 35% 17 Document identifier NEJM 2004; 351, 24

MADIT 55% Mortality Reduction NEJM 1996; 335 18 Document identifier

MADIT 55% Mortality Reduction NEJM 1996; 335 18 Document identifier

MADIT II 30% Mortality Reduction Post MI and LVD 19 Document identifier NEJM 2002;

MADIT II 30% Mortality Reduction Post MI and LVD 19 Document identifier NEJM 2002; 346

SCD-He. FT 23% mortality reduction Primary prevention: ICM and NICM N Engl. J Med.

SCD-He. FT 23% mortality reduction Primary prevention: ICM and NICM N Engl. J Med. 2005; 352: 225 -237. 23% Reduction in All Cause Mortality For ICD Therapy (p-value 0. 007) 20 Document identifier

The Details § 2, 521 patients followed for a minimum of 45. 5 months

The Details § 2, 521 patients followed for a minimum of 45. 5 months § Randomized for Amiodarone, placebo, or ICD § Significant reduction in all cause mortality over a placebo or Amiodarone by 23%. – Ischemic or nonischemic dilated cardiomyopathy – New York Heart Association (NYHA) class II and III heart failure – Ejection fraction (EF) ≤ 30% – No history of prior sustained ventricular tachycardia (VT)/VF 21 Document identifier

CMS: Centers for Medicare & Medicaid Services § Yes! We will pay for ICDs!!

CMS: Centers for Medicare & Medicaid Services § Yes! We will pay for ICDs!! 22 Document identifier

% Mortality Reduction w/ ICD Rx Primary vs. Secondary Prevention 75 % 54 %

% Mortality Reduction w/ ICD Rx Primary vs. Secondary Prevention 75 % 54 % 76 % 55 % 31 % Mortality Reduction w/ ICD Rx 27 months 56% 31% 2 39 months 23 33% 28% 20% 6 3 Years 7 3 Years 1 Moss AJ. N Engl J Med. 1996; 335: 1933 -40. 2 Buxton AE. N Engl J Med. 1999; 341: 1882 -90. 3 Moss AJ. N Engl J Med. 2002; 346: 877 -83 4 Moss AJ. Presented before ACC 51 st Annual Scientific Sessions, Late Breaking Clinical Trials, March 19, 2002. 5 The AVID Investigators. N Engl J Med. 1997; 337: 1576 -83. 6 Kuck K. Circ. 2000; 102: 748 -54. 7 Connolly S. Circ. 2000: 101: 1297 -1302. Document identifier 3, 4 20 months 59% 5 3 Years 61 % ICD mortality reductions in primary prevention trials are equal to or greater than those in secondary prevention trials.

ACC/AHA classifications based on studies Indication Class Supporting Studies Structural heart disease, sustained VT

ACC/AHA classifications based on studies Indication Class Supporting Studies Structural heart disease, sustained VT Class I AVID, CASH, CIDS Syncope of undetermined origin, inducible VT or VF at EPS Class I CIDS LVEF <35% due to prior MI, at least 40 days post-MI, NYHA Class II or III Class I SCD-He. FT LVEF ≤ 35%, NYHA Class II or III Class I SCD-He. FT LVEF ≤ 30% due to prior MI, at least 40 days post-MI Class I MADIT II LVEF <40% due to prior MI, inducible VT or VF at EPS Class I MADIT, MUSTT 25 Document identifier

New Directions § PAINFREE RX II: Pacing Fast VT Reduces Shock Therapies § EMPIRIC:

New Directions § PAINFREE RX II: Pacing Fast VT Reduces Shock Therapies § EMPIRIC: Preventing Shocks After ICD Implantation by a Strategy of Standardized ICD Programming § PREPARE: Primary Prevention Parameters Evaluation trial of implantable cardioverter defibrillators to reduce patient morbidity § MADIT RIT: Strategic programming: – Standard – Delayed therapy – High rate detection 26 Document identifier