From University of Rochester Medical Center, Cardiology Division, Heart Research Follow-up Program, Rochester, NY.
Circulation. 2015 Oct 27;132(17):1613-9. doi: 10.1161/CIRCULATIONAHA.115.015677. Epub 2015 Aug 27.
Prospective data on the safety and efficacy of the wearable cardioverter defibrillator (WCD) in a real-world setting are lacking. The Prospective Registry of Patients Using the Wearable Defibrillator (WEARIT-II) Registry was designed to provide real-world data on the WCD as a strategy during a period of risk stratification.
The WEARIT-II Registry enrolled 2000 patients with ischemic (n=805, 40%), or nonischemic cardiomyopathy (n=927, 46%), or congenital/inherited heart disease (n=268) prescribed WCD between August 2011 and February 2014. Clinical data, arrhythmia events, implantable cardioverter defibrillator implantation, and improvement in ejection fraction were captured. The median age was 62 years; the median ejection fraction was 25%. The median WCD wear time was 90 days, with median daily use of 22.5 hours. There was a total of 120 sustained ventricular tachyarrhythmias in 41 patients, of whom 54% received appropriate WCD shock. Only 10 patients (0.5%) received inappropriate WCD therapy. The rate of sustained ventricular tachyarrhythmias by 3 months was 3% among patients with ischemic cardiomyopathy and congenital/inherited heart disease, and 1% among nonischemic patients (P=0.02). At the end of WCD use, 840 patients (42%) were implanted with an implantable cardioverter defibrillator. The most frequent reason not to implant an implantable cardioverter defibrillator following WCD use was improvement in ejection fraction.
The WEARIT-II Registry demonstrates a high rate of sustained ventricular tachyarrhythmias at 3 months in at-risk patients who are not eligible for an implantable cardioverter defibrillator, and suggests that the WCD can be safely used to protect patients during this period of risk assessment.
缺乏可穿戴式除颤器（WCD）在真实环境中的安全性和有效性的前瞻性数据。前瞻性佩戴式除颤器患者登记（WEARIT-II）登记旨在提供 WCD 作为风险分层期间的策略的真实世界数据。
WEARIT-II 登记在 2011 年 8 月至 2014 年 2 月期间招募了 2000 名患有缺血性（n=805，40%）、非缺血性心肌病（n=927，46%）或先天性/遗传性心脏病（n=268）的患者，处方 WCD。收集临床数据、心律失常事件、植入式心脏复律除颤器植入和射血分数改善情况。中位年龄为 62 岁；中位射血分数为 25%。WCD 佩戴时间中位数为 90 天，中位每日使用 22.5 小时。41 名患者共发生 120 次持续性室性心动过速，其中 54%接受了适当的 WCD 电击。只有 10 名患者（0.5%）接受了不适当的 WCD 治疗。缺血性心肌病和先天性/遗传性心脏病患者在 3 个月时持续性室性心动过速的发生率为 3%，而非缺血性患者为 1%（P=0.02）。WCD 使用结束时，840 名患者（42%）植入了植入式心脏复律除颤器。WCD 使用后不植入植入式心脏复律除颤器最常见的原因是射血分数改善。
WEARIT-II 登记表明，在不符合植入式心脏复律除颤器条件的高危患者中，3 个月时持续性室性心动过速的发生率较高，这表明 WCD 可安全用于在此风险评估期间保护患者。
