Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
JACC Clin Electrophysiol. 2019 Feb;5(2):152-161. doi: 10.1016/j.jacep.2018.11.011. Epub 2019 Jan 30.
This study sought to synthesize the available evidence on the use of the wearable cardioverter-defibrillator (WCD).
Observational WCD studies for the prevention of sudden cardiac death have provided conflicting data. The VEST (Vest Prevention of Early Sudden Death) trial was the first randomized controlled trial (RCT) showing no reduction in sudden cardiac death as compared to medical therapy only.
We searched PubMed, EMBASE, and Google Scholar for studies reporting on the outcomes of patients wearing WCDs from January 1, 2001, through March 20, 2018. Rates of appropriate and inappropriate WCD therapies were pooled. Estimates were derived using DerSimonian and Laird's method.
Twenty-eight studies were included (N = 33,242; 27 observational, 1 RCT-WCD arm). The incidence of appropriate WCD therapy was 5 per 100 persons over 3 months (95% confidence interval [CI]: 3.0 to 6.0, I = 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 to 2.0) as compared with observational studies (11 per 100 persons over 3 months; 95% CI: 11.0 to 20.0; I = 93%). The incidence of inappropriate therapy was 2 per 100 persons over 3 months (95% CI: 1.0 to 3.0; I = 93%). Mortality while wearing WCD was rare at 0.7 per 100 persons over 3 months (95% CI: 0.3 to 1.7; I = 94%).
The rate of appropriately treated WCD patients over 3 months of follow-up was substantial; higher in-observational studies as compared with the VEST trial. There was significant heterogeneity. More RCTs are needed to justify continued use of WCD in primary prevention.
本研究旨在综合现有关于可穿戴式除颤器(WCD)应用的证据。
观察性 WCD 研究在预防心脏性猝死方面提供了相互矛盾的数据。VEST(背心预防早期猝死)试验是首个随机对照试验(RCT),与仅接受药物治疗相比,并未降低心脏性猝死的发生率。
我们检索了 PubMed、EMBASE 和 Google Scholar 数据库,以获取自 2001 年 1 月 1 日至 2018 年 3 月 20 日期间报告 WCD 患者结局的研究。汇总了 WCD 治疗的恰当和不恰当比例。采用 DerSimonian 和 Laird 法计算估计值。
共纳入 28 项研究(N = 33242;27 项观察性研究,1 项 RCT-WCD 臂)。3 个月内恰当 WCD 治疗的发生率为每 100 人 5 例(95%置信区间:3.0 至 6.0,I² = 93%)。在缺血性心肌病研究中,VEST 试验中的恰当 WCD 治疗发生率较低(3 个月内每 100 人 1 例;95%置信区间:1.0 至 2.0),而观察性研究中的发生率较高(3 个月内每 100 人 11 例;95%置信区间:11.0 至 20.0;I² = 93%)。不恰当治疗的发生率为每 100 人 3 个月内 2 例(95%置信区间:1.0 至 3.0;I² = 93%)。佩戴 WCD 期间的死亡率罕见,每 100 人 3 个月内 0.7 例(95%置信区间:0.3 至 1.7;I² = 94%)。
3 个月的随访中,恰当治疗的 WCD 患者比例较高;与 VEST 试验相比,观察性研究更高。存在显著的异质性。需要更多的 RCT 来证明 WCD 在一级预防中的持续应用是合理的。