The quality of evidence is downgraded by study limitations (unclear allocation concealment and lack of blinding).
A Cochrane review [Abstract] 1 included 2 studies with a total of 86 subjects. Both studies included participants with Brugada syndrome who were randomized to implantable cardiac defibrillator (ICD) versus β-blocker therapy for secondary prevention for sudden cardiac death.
ICD therapy reduced mortality (0% with ICD versus 18% with medical therapy; RR 0.11, 95% CI 0.01 to 0.83; 2 studies, n=86). There was no statistically significant difference in combined fatal and non-fatal cardiovascular events (26% with ICD versus 18% with medical therapy; RR 1.49, 95% CI 0.66 to 3.34; 2 studies, n=86). The rates of adverse events were higher in the ICD group, but these results were imprecise (28% with ICD versus 10% with medical therapy; RR 2.44, 95% CI 0.92 to 6.44; 2 studies, n=86). For secondary outcomes, the risk of non-fatal cardiovascular events was higher in the ICD group, but these results were imprecise and were driven entirely by appropriate ICD-termination of cardiac arrhythmias (26% with ICD versus 0% with medical therapy; RR 11.4, 95% CI 1.57 to 83.3; 2 trials, 86 participants). Approximately 25% of the ICD group experienced inappropriate ICD firing, all of which was corrected by device reprogramming. No data were available for quality of life or cost.
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