The Wearable Cardioverter-Defibrillator
Is It Now the Standard of Care?
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Article, see p 635
The wearable cardioverter-defibrillator (WCD) was approved by the US Food and Drug Administration in 2001. Since then, use of the WCD has grown steadily, and the device is now also available in Australia, Europe, Israel, Japan, and Singapore. Earlier this year, the American Heart Association published a science advisory that rated the use of the WCD as it is reasonable (Class IIa) or may be considered (Class IIb) in several specific patient categories.1 At this point, many clinicians worldwide wonder if the WCD has become standard of care. Are we delivering inadequate care if we do not offer the WCD to our patients?
The WCD received US Food and Drug Administration approval (as durable medical equipment) primarily on the basis of the demonstration of shock efficacy in controlled laboratory settings. The first systematic clinical evaluation was the WEARIT/BIROAD study (Wearable Defibrillator Investigative Trial and Bridge to ICD in Patients at Risk of Arrhythmic Death), a nonrandomized, noncontrolled series published in 2004.2 It followed up 289 patients at high risk for sudden cardiac death (SCD) who were given the WCD. In this population, 6 of 8 (75%) defibrillation attempts were successful. The 6 sudden deaths all occurred in patients not wearing the WCD as instructed. This was the first study to demonstrate the feasibility and reasonable efficacy of the WCD.
Since the WEARIT/BIROAD study, there has been a steady stream of observational research supporting the use of the WCD in a variety of clinical settings. It has been studied specifically in patients with recent myocardial infarction (MI), newly diagnosed cardiomyopathy, recent revascularization, peripartum cardiomyopathy, nonischemic cardiomyopathy, congenital structural heart disease, and inherited arrhythmias.3–8 Aggregate US nationwide data from the manufacturer (ZOLL, Pittsburg, PA) registry have also been reported.9 These data showed …