Implantable Cardioverter Defibrillators to Prevent Sudden Cardiac Death: Background Frederick A. Masoudi, MD, MSPH Associate Professor of Medicine (Cardiology) University of Colorado Denver & Colorado Cardiovascular Outcomes Research Group (C-COR) AHRQ Annual Meeting, Bethesda, MD Wednesday, September 21, 2011

Disclosures Frederick A Masoudi, MD, MSPH: Implantable Cardioverter Defibrillators for Primary Prevention Research Grants: AHRQ, NHLBI Contracts: American College of Cardiology Foundation (Senior Medical Officer, National Cardiovascular Data Registries); Oklahoma Foundation for Medical Quality

Defibrillation Treats Malignant Cardiac Arrhythmias

Implantable Cardioverter Defibrillators (ICDs) : Preventing Sudden Cardiac Death (SCD)

The ICD: Revolution in Preventing Sudden Cardiac Death First ICD implantation: Johns Hopkins Hospital 2/4/1980 Implantation criteria: –>=2 cardiac arrests –Not associated with myocardial infarction –Documented ventricular fibrillation Cannom DS and Prystowsky E. PACE 2004;27: The Johns Hopkins Hospital

ICDs for Secondary SCD Prevention AVID Investigators. N Engl J Med 1997;337:

ICDs for Primary Prevention: Dual Evolution Eligible Population for 1 o Prevention ICD

ICDs: Rapidly Evolving Technology

MADIT I: ICDs Prevent Death in Ischemic LVSD Moss AJ et al. N Engl J Med 1996;335: Enrollment criteria: NYHA functional class I-III Prior myocardial infarction LVEF <0.35 Documented asymptomatic non-sustained VT Inducible, non-suppressible ventricular tachyarrhythmia on EP study (on procainamide) Results: 54% relative reduction (23% absolute reduction) in the risk of death from all causes.

More Studies, More Success STUDYYEARPOPULATIONOUTCOMERR/ARR MUSTT (EPS vs. no AAR) 1999 CAD LVEF <0.40 NSVT Inducible VT Death (arrhythmic) Cardiac arrest 0.24 ( )* ARR 19.5% MADIT-II2002 Prior MI LVEF <0.30 NYHA I-III No EPS required Death (any) 0.69 ( ) ARR: 5.4% SCD- HeFT 2005 NYHA II-III HF LVEF <0.35 Includes non-ischemic Death (any) 0.77 ( ) ARR: 7.2% Buxton AE et al. NEJM 1999;341: Moss AJ et al. NEJM 2002;346: Bardy GH et a. NEJM 2005;352:

Primary Prevention ICDs: Cost-Effective Sanders GD et al. NEJM 2005;353: ICD-Associated Reduction in Death Risk (%) ICER for ICD ($ per QALY) MADIT I MUSTT MADIT IISCD-HeFT

ACC/AHA Guideline Recommendations for Primary Prevention ICD Therapy Jessup M et al. J Am Coll Cardiol 2009;53 Epstein AE et al. Circulation. 2008;117

Current Indications for ICDs “Secondary prevention” for patients who have been successfully resuscitated from SCD “Primary Prevention” for patients without a history of SCD but at high risk, including some patients with: –Severe left ventricular dysfunction (LVSD) –Long QT syndrome –Arrhythmogenic RV dysplasia –Hypertrophic cardiomyopathy

CMS Coverage for ICDs Expands in Response to RCTs YearCovered Indication 1999Documented familial or inherited high-risk conditions (HCM or LQTS) 2003 Prior MI >40 days prior to implantation LVEF <0.35 Inducible sustained VT/VF at EPS If LVEF 120 ms, then EPS not needed 2005 Ischemic CM, NYHA II-III, LVEF <0.35 Non-ischemic CM >9 months, NYHA II-III, LVEF <0.35 Meeting CRT criteria and NYHA IV 3&basket =ncd%3A20%2E4%3A3%3AImplantable+Automatic+Defibrillators

Theory and Practice “In theory there is no difference between theory and practice. In practice there is.” --Yogi Berra

Clinical Trials to the Real World Big “Voltage Loss” Older Hospitalized Patients with HF n=20,388 Subjects meeting SOLVD enrollment criteria n= 3,579 (18%) Preserved EF n=10,943 (54%) Exclusionary condition n= 523 (3%) Contraindication n=3,566 (17%) Age > 80 n= 1,777 (9%) Masoudi FA et al. Am Heart J 2003;146:250–7.

Theory and Practice Collide Al-Khatib SM et al. JAMA 2011;305:43-49.

Where are We Now?

Expanding Knowledge of ICDs in the Real World Assessing ICD shocks: Cardiovascular Research Network (CVRN) Longitudinal Study of ICDs Comparative effectiveness in the elderly: Outcomes of ICDs in Medicare population Outcomes in Clinical Subgroups: Bayesian statistical methods with patient- level data from clinical trials