Quarterly Focus Issue: Heart Rhythm Disorders
State-of-the-Art Paper
Indications for Implantable Cardioverter-Defibrillators Based on Evidence and Judgment

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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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Dr. Myerburg is supported in part by a grant from the Leducq Foundation (Network on Sudden Cardiac Death), by the Florida Heart Research Foundation, and by the American Heart Association Chair in Cardiovascular Research at the University of Miami Miller School of Medicine; he has also received consulting fees during the past 24 months from Boston Scientific Corporation, Proctor and Gamble, GlaxoSmithKline Pharmaceuticals, and Sanofi-Aventis, and lecture fees from Boston Scientific Corporation, General Electric Company, and St. Jude Medical Corporation. Dr. Reddy has received consulting fees and grants from St. Jude, and speaker honoraria from Medtronic and Boston Scientific.