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J Am Coll Cardiol, 2003; 41:1573-1582, doi:10.1016/S0735-1097(03)00253-5 © 2003 by the American College of Cardiology Foundation |
¶#,*
* Department of Health Policy, Management and Evaluation/Clinical Epidemiology, Toronto, Canada
Institute for Clinical Evaluative Sciences, Toronto, Canada
Division of Cardiology, University Health Network-Toronto General Hospital, Toronto, Canada
Heart and Stroke/Richard Lewar Centre of Excellence and Toronto General Hospital, Toronto, Canada
|| Electrophysiology and Arrhythmia Service, Division of Cardiology, St. Michael’s Hospital, Toronto, Canada
¶ Department of Medicine, Sunnybrook and Women’s College Health Science Centre, Toronto, Canada
# Division of Cardiology, Schulich Heart Centre, Sunnybrook and Women’s College Health Science Centre, Toronto, Canada
Manuscript received June 11, 2002; revised manuscript received January 1, 2003, accepted January 30, 2003.
* Reprint requests and correspondence: Dr. David A. Alter, Institute for Clinical Evaluative Sciences, G-106, 2075 Bayview Avenue, Toronto, Ontario, M4N 3M5, Canada.
david.alter{at}ices.on.ca
OBJECTIVES: The aim of this study was to compare the effectiveness of the implantable cardioverter defibrillator (ICD) and medical strategies for prevention of arrhythmic events and death.
BACKGROUND: The ICD is a potential strategy to reduce mortality in patients at risk of sudden death.
METHODS: The MEDLINE, EMBASE, and Cochrane Library electronic databases were searched from January 1966 to April 2002. All published randomized controlled trials comparing ICD implantation with medical therapy were reviewed. Four independent reviewers extracted data on all-cause mortality, nonarrhythmic death, and arrhythmic death using a standardized protocol.
RESULTS: Nine studies including over 5,000 patients were synthesized using both fixed-effects and random-effects models. The primary and secondary prevention trials showed a significant benefit of the ICD with respect to arrhythmic death, with relative risks (RR) of 0.34 and 0.50, respectively (both p < 0.001). The mortality benefit of the ICD was entirely attributable to a reduction in arrhythmic death (all trials: p < 0.00001). Whereas the secondary prevention trials exhibited a robust decrease in all-cause ICD mortality (RR 0.75; p < 0.001), the pooled primary prevention trials demonstrated decreased all-cause ICD mortality (RR 0.66; p < 0.05) which was dependent on selected individual trials. The disparity in ICD-related mortality reductions in the primary prevention trials was related to variability in the incidence of arrhythmic death between individual studies.
CONCLUSIONS: Although the ICD decreases the risk of arrhythmic death, its impact on all-cause mortality is related to the underlying risk of arrhythmia-related death relative to competing causes. Given the cost of the device strategy, policies of targeted intervention based on the future risk of arrhythmia are warranted.
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