What were the results of the MADITII study of implantable cardioverter-defibrillators (ICD)?

Updated: Feb 13, 2017
  • Author: Daniel M Beyerbach, MD, PhD; Chief Editor: Jeffrey N Rottman, MD  more...
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Answer

The Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) in 2002 markedly expanded the potential pool of ICD recipients. MADIT II randomized patients with prior myocardial infarction and LVEF at or below 30% to ICD therapy or a control group. Nonsustained VT or inducible VT at EPS was not required. Patients who received an ICD had a 31% reduction in mortality rate. An important aspect of MADIT II was that subjects in both arms of the trial were well managed medically with a high rate of beta-blocker, angiotensin-converting enzyme (ACE) ̶ inhibitor, and cholesterol-lowering medication usage. [18]

Information regarding cost implications of ICDs continues to emerge. The MADIT II study showed that prophylactic implantation of a defibrillator reduced the rate of mortality in patients with a previous myocardial infarction and low LVEF. The cost analysis phase of the study showed that during the 3.5-year period of the study, the average survival gain for the defibrillator arm was 0.167 years (2mo), the additional costs were $39,200, and the incremental cost-effectiveness ratio (iCER) was $235,000 per year-of-life saved. In 3 alternative projections to 12 years, this ratio ranged from $78,600 to $114,000. Estimated cost per life-year saved is relatively high at 3.5 years, but projected costs are substantially lower over the course of longer time horizons. [19]


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