Bardy GH, Lee KL, Mark DB, et al: Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352(3):225-37.
Kadish A: Prophylactic defibrillator implantation-toward an evidence-based approach. N Engl J Med 2005;352(3):285-87 (editorial).
The authors recruited 2,521 patients with congestive heart failure (CHF) and a left ventricular ejection fraction (LVEF) of <= 35% to test whether amiodarone therapy or an implantable cardioverter-defibrillator (ICD) would improve outcomes. After random assignment to conventional therapy plus amiodarone, or conventional therapy plus a programmed ICD, patients were followed for an average of 45 months. There were 244 deaths (29%) in the placebo group, 240 (28%) in the amiodarone group, and 182 (22%) in the ICD group. In these patients with NY Heart Association Class II or III CHF, amiodarone had no favorable effect on survival (p = 0.53), but single-lead shock-only ICD reduced overall mortality by 23%. The benefit from ICD use did not vary by ischemic or nonischemic cause of CHF and occurred despite an acute device complication rate of 5%. These findings raise the standard of care for many patients with CHF. A preliminary ruling indicates Medicare and Medicaid coverage may be extended to patients with LVEF < 31% to allow a single-chamber ICD as long as they are enrolled in a prospective registry.