Wearable Cardioverter-Defibrillator for Prevention of Sudden Cardiac Death

Study Questions:

What is the current evidence on the use of the wearable cardioverter-defibrillator (WCD)?

Methods:

The authors performed a systematic review and meta-analysis of studies found on PubMed, EMBASE, and Google Scholar.

Results:

There were 28 studies (32,426 patients, 27 observational, 1 randomized controlled trial). The incidence of appropriate WCD therapy was 5 per 100 persons over 3 months (95% confidence interval [CI], 3.0-6.0; I2 = 93%). In studies on ischemic cardiomyopathy, the appropriate WCD therapy incidence was lower in the VEST trial (1 per 100 persons over 3 months, 95% CI, 1.0-2.0) as compared with observational studies (11 per 100 persons over 3 months, 95% CI, 11.0-20.0; I2 = 93%). The incidence of inappropriate therapy was 2 per 100 persons over 3 months (95% CI, 1.0-3.0; I2 = 93%). Mortality while wearing WCD was rare; 0.7 per 100 persons over 3 months (95% CI, 0.3-1.7; I2 = 94%).

Conclusions:

The rate of appropriately treated WCD patients was significantly higher in observational studies compared with the only randomized trial (VEST).

Perspective:

All studies on the use of WCD, except the VEST trial, are observational studies, and many demonstrate poor methodology, selection bias, and confounding. VEST is the only randomized controlled trial evaluating the benefit of WCD in patients post-myocardial infarction and ejection fraction ≤35% as compared with medical therapy alone. It reported no difference in sudden cardiac death mortality, a scaled down primary endpoint from the original all-cause mortality. Current guidelines give a Class IIa recommendation for the use of WCD in secondary prevention when implantable cardioverter-defibrillator removal is required and a Class IIb recommendation for all other scenarios, including primary prevention in individuals considered at high risk. The current analysis reminds us that the vast majority of the studies do not provide rigorous evidence in favor or against the use of the WCD. Current prescription of WCD in primary prevention is not a reflection of the body of evidence, but rather, as the authors point out, the expression of finality of sudden death.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Prevention, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure

Keywords: Acute Coronary Syndrome, Arrhythmias, Cardiac, Cardiomyopathies, Death, Sudden, Cardiac, Defibrillators, Implantable, Electric Countershock, Heart Failure, Myocardial Infarction, Primary Prevention, Secondary Prevention


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