Abstract 659: Effectiveness of Implantable Cardioverter Defibrillators in Women - A Meta-Analysis of Randomized Controlled Trials
Introduction: Numerous clinical trials have established a role for implantable cardioverter defibrillators (ICDs) for prevention of sudden cardiac death (SCD) in patients with heart failure. However, questions remain regarding the clinical benefit of these therapies in different patient subgroups. Specifically, the role of ICDs in women with heart failure for prevention of sudden cardiac death has not been well established.
Hypothesis: We assessed the hypothesis that ICDs reduce all cause mortality in women with congestive heart failure with systolic dysfunction.
Methods: We searched MEDLINE (1966–2002), EMBASE (1980–2002), the Cochrane Controlled Trials Register, The National Institute of Health Clinical trails.gov database, the US Food and Drug Administration Web site, and reports presented at scientific meetings (1994–2002). Search items included implantable defibrillators, congestive heart failure, and randomized controlled trials. Eligible studies were randomized controlled trials of implantable defibrillators for the primary prevention of sudden cardiac death in patients with congestive heart failure due to systolic dysfunction. Eligible studies reported all cause mortality as an outcome. Of the relevant reports initially identified, 5 randomized trials of 939 total patients were included in the meta-analysis. Trial reports were reviewed independently by 2 investigators in a blinded standardized manner.
Results: Pooled data from the 5 selected studies showed that there is no statistically significant decrease in all cause mortality in women with congestive heart failure who receive ICDs. (hazard ratio , 0.89 ; 95% confidence interval, 0.65–1.21)
Conclusions: ICD therapy does not reduce all cause mortality in women with heart failure due to systolic dysfunction. These results emphasize the support for a large trial evaluating the role of ICDs in women with congestive heart failure for primary prevention of SCD.