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Implantable Cardioverter Defibrillators to Prevent Sudden Cardiac Death: Background

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

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Implantable Cardioverter Defibrillators to Prevent Sudden Cardiac Death: Background

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  1. 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

  2. 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

  3. Defibrillation Treats Malignant Cardiac Arrhythmias

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

  5. 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;27:419-431. The Johns Hopkins Hospital

  6. ICDs for Secondary SCD Prevention AVID Investigators. N Engl J Med 1997;337: 1576-83.

  7. ICDs for Primary Prevention: Dual Evolution Eligible Population for 1o Prevention ICD 1996 2010

  8. ICDs: Rapidly Evolving Technology http://commons.wikimedia.org/wiki/File:Edison_and_phonograph_edit2.jpg http://commons.wikimedia.org/wiki/File:Ipod-icon.svg

  9. MADIT I: ICDs Prevent Death in Ischemic LVSD 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. Moss AJ et al. N Engl J Med 1996;335:1933-40.

  10. More Studies, More Success Buxton AE et al. NEJM 1999;341:1882-1890. Moss AJ et al. NEJM 2002;346:877-83. Bardy GH et a. NEJM 2005;352:225-37.

  11. Primary Prevention ICDs:Cost-Effective ICER for ICD ($ per QALY) SCD-HeFT MADIT II MUSTT MADIT I ICD-Associated Reduction in Death Risk (%) Sanders GD et al. NEJM 2005;353:1471-80.

  12. 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

  13. 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

  14. CMS Coverage for ICDs Expands in Response to RCTs http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=20.4&ncd_version= 3&basket =ncd%3A20%2E4%3A3%3AImplantable+Automatic+Defibrillators

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

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

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

  18. Where are We Now? http://commons.wikimedia.org/wiki/File:Demeter_Pio-Clementino_Inv254.jpg http://commons.wikimedia.org/wiki/File:Maes_Old_Woman_Dozing.jpg

  19. 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

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