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ICDs vs. Amiodarone for Patients with HF and LV Dysfunction
Both implantable cardioverter-defibrillator (ICD) therapy and pharmacologic therapy with amiodarone have been shown to prevent sudden death and prolong survival in specific patient populations. Now, in a head-to-head, partially industry-supported, multicenter trial, researchers compared these therapies in 2521 heart failure (HF) patients with left-ventricular ejection fractions (LVEFs) 
35% (median, 25%).
Subjects were randomized to receive conventional HF therapy plus a placebo drug; conventional therapy plus amiodarone; or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD. Placebo and amiodarone were administered in double-blind fashion. All subjects were in NYHA class II (70%) or III (30%); roughly half had ischemic HF.
During a median follow-up of 46 months, all-cause mortality incidence was significantly lower in the ICD group (22%) than in the amiodarone (28%) and placebo (29%) groups. Five-year estimates showed the hazard ratio for death to be 23% lower with ICD therapy than with placebo (absolute difference, 7.2%), with no difference between amiodarone and placebo. The findings held regardless of the cause of HF (ischemic vs. nonischemic).
Comment: This landmark study provides compelling evidence that prophylactic ICD therapy improves survival in patients with ischemic or nonischemic class II–III heart failure and LVEFs 35%. Given findings from this and other primary-prevention studies (e.g., Journal Watch Cardiology Jun 18 2004), physicians should consider referring appropriate HF patients to an electrophysiologist for possible prophylactic ICD implantation. An editorialist reminds us, however, that ICD therapy is not for all patients with LV dysfunction and that ICDs are not beneficial immediately after MI. Another accompanying article outlines the rationale for the decision by the Centers for Medicare & Medicaid Services to expand ICD coverage to the population studied in the current trial.
— Hugh Calkins, MD
Published in Journal Watch Cardiology December 30, 2005
Citation(s):
Bardy GH et al. for the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005 Jan 20; 352:225-37.
- Original article (Subscription may be required)
- Medline abstract (Free)
Kadish A. Prophylactic defibrillator implantation — Toward an evidence-based approach. N Engl J Med 2005 Jan 20; 352:285-7.
- Original article (Subscription may be required)
- Medline abstract (Free)
McClellan MB and Tunis SR. Medicare coverage of ICDs. N Engl J Med 2005 Jan 20; 352:222-4.
- Original article (Subscription may be required)
- Medline abstract (Free)