An implantable cardioverter-defibrillator but not amiodarone reduced risk for death in congestive heart failure.

and commentary also appear in ACP Journal Club. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . For correspondence: Dr G H Bardy, Seattle Institute for Cardiac Research, Seattle, WA, USA. [email protected] Sources of funding: National Institutes of Health; Medtronic; Wyeth-Ayerst Laboratories; Knoll Pharmaceuticals. Amiodarone (Amio) or a conservatively programmed, shock only implantable cardioverter defibrillator (ICD) v placebo for congestive heart failure at median 46 months* Outcome Amio ICD Placebo RRR (95% CI) NNT (CI) All cause mortality 9.5% 9.7% 1.6% (216 to 17) NS 7.2% 9.7% 25% (10 to 38) 41 (25 to 108) *NS = not significant. Other abbreviations defined in glossary; RRR, NNT, and CI calculated from data in article. Commentary T he SCD-HeFT trial provides evidence for prophylactic use of ICDs. The historical importance of SCD-HeFT and its effect on clinical practice must account for the trial’s immediate influence on Medicare guidelines. SCD-HeFT reinforced earlier studies on the use of prophylactic ICDs in ischaemic and non-ischaemic cardiomyopathy. The inclusion and exclusion criteria of SCD-HeFT were rapidly incorporated into Medicare’s reimbursement plan. According to the Centres for Medicare and Medicaid (CMS), these changes in ICD eligibility will increase the number of potential ICD patients by one third, to a total of 500 000. CMS also mandated that the single chamber, less expensive ICD that was used in SCD-HeFT be used unless otherwise justified. Despite using single chamber ICDs, the diagnosis-related group cost of US $25 000 to $30 000 per ICD is still a concern. SCD-HeFT also included an amiodarone arm, which showed no benefit in the primary prevention of sudden cardiac death (SCD). The large size of the SCD-HeFT trial clarifies questions asked by previous smaller and sometimes conflicting studies of amiodarone for SCD prophylaxis. This lack of survival benefit will probably end almost a decade of research in SCD prevention with amiodarone. Although the SCD-HeFT trial provided many answers in SCD prevention, the methods used to identify patients with the highest risk are still primitive. Further trials will help determine whether the specific exclusions of SCD-HeFT have biological meaning and justification as implantation and reimbursement criteria. Andrew Corsello, MD Maine Medical Centre Portland, Maine, USA 1 Moss AJ, Zareba W, Hall WJ, et al. N Engl J Med 2002;346:877–83. 2 Kadish A, Dyer A, Daubert JP, et al. N Engl J Med 2004;350:2151–8. 3 Centers for Medicare and Medicaid Services. Medicare news. www.cms.hhs.gov/media/press/release.asp?Counter = 1331 (accessed 6 Jun, 2005). THERAPEUTICS 109 EBM Volume 10 August 2005 www.evidence-basedmedicine.com group.bmj.com on September 26, 2017 Published by http://ebm.bmj.com/ Downloaded from