"Implantable Cardioverter-Defibrillator in Patients with Congestive Heart Failure". The New England Journal of Medicine. 2005. 352(3):225-237.
Links to original sources: Wiki Journal Post Full Journal Article
In patients with NYHA class II or III congestive heart failure (CHF) and a left ventricular ejection fraction (LVEF) of 35 percent or less, does implantable cardioverter-defibrillator (ICD) therapy improve survival compared to amiodarone or placebo?
In patients with NYHA class II or III CHF and an LVEF of 35 percent or less, implantation of a conservatively programmed, shock-only ICD reduced overall mortality by 23 percent, while amiodarone had no favorable effect on survival.
The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) evaluated the impact of amiodarone or an ICD on survival in a broad population of patients with mild-to-moderate heart failure. The key findings from the trial indicated that ICD therapy significantly decreased the relative risk of death by 23 percent, whereas amiodarone did not show any survival benefit.
At the time of writing, there were no specific guidelines provided from this trial. However, these results would typically inform guidelines recommending ICD insertion for patients with CHF and reduced LVEF.
- Multicenter, double-blind, parallel group, randomized, placebo-controlled trial - N=2,521 patients with recent CHF in NYHA class II or III - Placebo (n=847), amiodarone (n=845), and ICD (n=829) - Median follow-up: 45.5 months
- Inclusion criteria: Age ≥18 years, NYHA class II or III chronic CHF due to ischemic or nonischemic causes, and LVEF ≤35% - Exclusion criteria: None detailed in the provided summary - Baseline characteristics: Median LVEF 25%, 70% were in NYHA class II, 30% in NYHA class III. The cause of CHF was ischemic in 52% and nonischemic in 48%.
- Patients were stabilized on conventional CHF therapy, including beta-blockers and ACE inhibitors, then randomized to amiodarone, placebo, or ICD. - Amiodarone and placebo were given in a double-blind fashion. The dosage was based partly on weight.
- Primary outcome: Death from any cause. - Secondary outcomes: Not specified in the provided summary.
- The ICD programming was conservative, using shock-only therapy, making its applicability to more advanced device programming and capabilities in clinical practice limited. - The subgroup analysis showing the lack of benefit in NYHA class III CHF patients for ICD therapy was unexpected and should be interpreted with caution until replicated in other studies.
- Supported by grants from the NHLBI, National Institutes of Health, and by Medtronic, Wyeth–Ayerst Laboratories, and Knoll Pharmaceuticals. - Further disclosures include a variety of financial relationships with sponsoring companies by several authors.
- The article's full text provides deep insights and further detailed results, available at [DOI link].