Implications of the Multicenter Automatic Defibrillator Implantation Trial-II.

TO THE EDITOR: Dr. Al-Khatib and colleagues (1) are to be commended for their evaluation of the cost-effectiveness of implantable cardioverter defibrillators (ICDs) in the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II. At 20 months, mortality was 14.2% in the ICD group and 19.8% in the controls, an absolute difference of 5.6 percentage points (2). The cost of treatment in the ICD group was estimated at $131 490 compared with $40 661 in the medical therapy group—a difference of $90 829 for a gain in life-years of 1.8 years (1). The authors found ICDs to be marginally cost-effective, with a base-case estimate of the incremental cost-effectiveness ratio of $50 500 per life-year gained. Sensitivity analysis suggested that the ratio could vary greatly depending on the assumptions made. The ratio was especially sensitive to the effectiveness of the ICD. The MADIT-II population comprised patients who had a previous myocardial infarction (MI) and whose left ventricular ejection fraction was 0.3 or less (2). Patients with a history of MI have been shown to benefit from -blockade and angiotensin-converting enzyme inhibition. More recently, aldosterone blockade has been shown to be both efficacious and cost-effective (3, 4). In the Epleronone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS), patients with ejection fractions of 0.4 or less and evidence of heart failure were randomly assigned to receive eplerenone or placebo 3 to 14 days after MI. After a mean duration of 16 months, the absolute difference in survival was 2.3% (3). If one uses the Worcester Heart Attack database to project survival, the gain with eplerenone was 0.1337 year. The added cost was $1391, which translates to an incremental cost-effectiveness ratio of $10 402 per life-year gained (4). It has been shown that ICDs do not reduce overall mortality within the first month after acute MI (5), and they do not favorably affect any mortality rate other than that associated with arrhythmic death (sudden cardiac death). Eplerenone reduces both all-cause mortality and sudden cardiac death, doing so almost immediately after MI (3, 6). Differences in the populations and methods of these 2 studies make a direct comparison difficult; however, it is clear that pharmacotherapy is often more cost-effective than implantable devices or surgical interventions (7). There is tremendous concern over the cost of pharmacotherapy (8), which may be related to the fact that pharmaceuticals have not been traditionally covered by Medicare. Recent legislation will change that concern in large measure. However, when pharmacotherapy is life-saving and cost-effective, society should be encouraged to make such therapy available to all who need it.