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(Circulation. 2006;114:135-142.)
© 2006 American Heart Association, Inc.

Health Services and Outcomes Research

Cost-Effectiveness of Defibrillator Therapy or Amiodarone in Chronic Stable Heart Failure

Results From the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)

Daniel B. Mark, MD, MPH; Charlotte L. Nelson, MS; Kevin J. Anstrom, PhD; Sana M. Al-Khatib, MD; Anastasios A. Tsiatis, PhD; Patricia A. Cowper, PhD; Nancy E. Clapp-Channing, RN, MPH; Linda Davidson-Ray, MA; Jeanne E. Poole, MD; George Johnson, BSEE; Jill Anderson, RN; Kerry L. Lee, PhD; Gust H. Bardy, MD, for the SCD-HeFT Investigators

From the Outcomes Research Group (D.B.M., K.J.A., P.A.C., N.C.C., L.D.R.), Duke Clinical Research Institute (K.L.L., C.L.N.); the Division of Cardiology, Department of Medicine, Duke University Medical Center (D.B.M., S.M.A.), Durham, NC; the Department of Statistics, North Carolina State University (A.A.T.), Raleigh, NC; The Seattle Institute for Cardiac Research (G.J., J.A., G.H.B.), Seattle, Wash; and The University of Washington Medical Center (G.H.B., J.E.P.), Seattle, Wash.

Correspondence to Dr Daniel B. Mark, Outcomes Research Group, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715. E-mail daniel.mark{at}duke.edu

Received August 9, 2005; revision received April 21, 2006; accepted April 28, 2006.

Background— In the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), implantable cardioverter-defibrillator (ICD) therapy significantly reduced all-cause mortality rates compared with medical therapy alone in patients with stable, moderately symptomatic heart failure, whereas amiodarone had no benefit on mortality rates. We examined long-term economic implications of these results.

Methods and Results— Medical costs were estimated by using hospital billing data and the Medicare Fee Schedule. Our base case cost-effectiveness analysis used empirical clinical and cost data to estimate the lifetime incremental cost of saving an extra life-year with ICD therapy relative to medical therapy alone. At 5 years, the amiodarone arm had a survival rate equivalent to that of the placebo arm and higher costs than the placebo arm. For ICD relative to medical therapy alone, the base case lifetime cost-effectiveness and cost-utility ratios (discounted at 3%) were $38 389 per life-year saved (LYS) and $41 530 per quality-adjusted LYS, respectively. A cost-effectiveness ratio <$100 000 was obtained in 99% of 1000 bootstrap repetitions. The cost-effectiveness ratio was sensitive to the amount of extrapolation beyond the empirical 5-year trial data: $127 503 per LYS at 5 years, $88 657 per LYS at 8 years, and $58 510 per LYS at 12 years. Because of a significant interaction between ICD treatment and New York Heart Association class, the cost-effectiveness ratio was $29 872 per LYS for class II, whereas there was incremental cost but no incremental benefit in class III.

Conclusions— Prophylactic use of single-lead, shock-only ICD therapy is economically attractive in patients with stable, moderately symptomatic heart failure with an ejection fraction 35%, particularly those in NYHA class II, as long as the benefits of ICD therapy observed in the SCD-HeFT persist for at least 8 years.

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