SCD-HeFT

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Bardy GH, et al. "Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure". The New England Journal of Medicine. 2005. 252(3):225-37.
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Contents

Clinical Question

In patients with systolic dysfunction and NYHA II-III symptoms, how does amiodarone or ICD implantation compare to placebo in reducing mortality all-cause mortality?

Bottom Line

SCD-HeFT demonstrated that ICDs reduced mortality compared to conventional therapy or amiodarone among patients with symptomatic systolic HF.

Major Points

Prophylactic ICD placement in post-MI patients with LVEF ≤30% was shown to improve survival in MADIT-II (2002). The role of ICDs and the antiarrhythmic amiodarone was unclear in those with heart failure with reduced EF regardless of MI history.

Single-lead, shock-only ICD therapy reduces mortality by 23% compared to conventional therapy or amiodarone in stable NYHA class II or III HF with EF <35%. Amiodarone conferred no survival benefit compared to placebo.

Guidelines

  • ICD therapy is indicated in patients with LVEF≤35% due to prior MI who are ≥40 days post-MI and are in NYHA functional Class II or III (ACC/AHA/HRS; IA)[1].
  • ICD therapy is indicated in patients with LV dysfunction due to prior MI who are ≥40 days post-MI, have an LVEF≤30%, and are in NYHA functional Class I (ACC/AHA/HRS; IA).

Design

  • Multicenter, double-blinded, parallel-group, randomized, placebo-controlled trial
  • N=2,521
    • Amiodarone (n=845)
    • Shock-only ICD (n=829)
    • Placebo (n=847)
  • Enrollment: 1997-2001
  • Median follow up: 45.5 months
  • Primary outcome: All-cause mortality

Population

Inclusion Criteria

  • Age >18 years
  • NYHA class II-III chronic stable CHF (ischemic or nonischemic)

Baseline Characteristics

  • Median LVEF: 25%
  • NYHA class II: 30%
  • NYHA class III: 30%
  • Ischemic CHF: 52%
  • ACE inhibitor: 85%
  • ACE inhibitor or ARB: 96%
  • Beta-blocker: 69%
  • Spironolactone: 19%
  • Loop diuretics: 82%
  • Aspirin: 56%
  • Statin: 38%

Interventions

  • Randomized to ICD vs. amiodarone vs. placebo; all patients received conventional medical therapy as well
  • All patients had EKG, 6-minute walk test, 24h Holter monitoring, LFTs, TFTs, and CXR

Outcomes

Primary Outcomes

All-cause mortality
ICD vs. placebo
22% vs. 29% (HR 0.77; 97.5% CI 0.62-0.96; P=0.007)
Amiodarone vs. placebo
28% vs. 29% (HR 1.06; 97.5% CI 0.86-1.30; P=0.53)

Funding

Funding from NHLBI, NIH, Medtronic, Wyeth–Ayerst Laboratories, and Knoll Pharmaceuticals.

Further Reading

  1. Epstein, AE et al. "AHA practice guideline: Executive summary." Circulation (2008):117:2820-2840.