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QUARTERLY FOCUS ISSUE: HEART RHYTHM DISORDERS: STATE-OF-THE-ART PAPER

Indications for Implantable Cardioverter-Defibrillators Based on Evidence and Judgment

Division of Cardiology, University of Miami Miller School of Medicine, Miami, Florida

Manuscript received December 29, 2008; revised manuscript received March 20, 2009, accepted March 24, 2009.

^_* Reprint requests and correspondence: Dr. Robert J. Myerburg, Professor of Medicine and Physiology, Division of Cardiology (D-39), University of Miami Miller School of Medicine, P.O. Box 016960, Miami, Florida 33101 (Email: rmyerbur{at}med.miami.edu).

Implantable cardioverter-defibrillators (ICDs) are generally reliable medical devices that have the potential to add quality years of life for appropriate candidates. Indications for ICDs have emerged from a series of randomized clinical trials, observational data from cohorts of high-risk patients with less common diseases, and expert opinion based on limited data in uncommon disorders. The randomized trials are limited by inadequate stratification designs that resulted from insufficient funding availability. The result was outcomes that led to uneven applications, based in part on post-implant experience of device utilization. In this document, we explore the basis for the features of the evidence available to support ICD use, the role of clinical judgment in circumstances in which data are limited or lacking, and the need for additional research to improve the specificity of indications. Directions for new research initiatives are considered. In addition, a general overview of a clinical research paradigm is presented, in which the research and health care delivery arms of the health care enterprise combine in research design and funding, as the latter bears the impact of the outcomes of the former. Impact estimates during the design of trials, considering reasonable contingencies for outcomes, are suggested as a means of justifying the size, scope, and appropriate costs of studies. If we who are involved in clinical research and health care delivery do not resolve this problem, for both ICDs and other new therapies that appear in the future, society will do it for us.

Key Words: implantable cardioverter-defibrillators • indications • review

Abbreviations and Acronyms   CAD = coronary artery disease   CMS = Center for Medicare and Medicaid Services   EF = ejection fraction   HCM = hypertrophic cardiomyopathy   ICD = implantable cardioverter-defibrillator   MI = myocardial infarction   NYHA = New York Heart Association   PVC = premature ventricular complex   SCD = sudden cardiac death   VF = ventricular fibrillation   VT = ventricular tachycardia

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