Nguyen Elaine, Weeda Erin R, Kohn Christine G, D'Souza Benjamin A, Russo Andrea M, Noreika Stacey, Coleman Craig I
Department of Pharmacy Practice, Idaho State University College of Pharmacy, Meridian, ID, USA.
Department of Pharmacy Practice, The Medical University of South Carolina, Charleston, SC, USA.
J Innov Card Rhythm Manag. 2018 May 15;9(5):3151-3162. doi: 10.19102/icrm.2018.090506. eCollection 2018 May.
Wearable cardioverter-defibrillators (WCDs) protect patients from sudden cardiac death (SCD) by detecting and treating life-threatening ventricular tachycardia/fibrillation (VT/VF). Recently, two large studies evaluating WCDs were published. However, the results of older and newer studies have yet to be systematically summarized. The objective of the current study was to conduct a meta-analysis assessing the use and effectiveness of WCDs. We searched MEDLINE and Scopus (January 1998-July 2017) as well as the gray literature. We included registry/observational studies that (1) evaluated adult patients using WCDs; (2) provided data on one or more outcomes of interest; and (3) were full-text studies published in English. We calculated pooled incidence and/or rate [with 95% confidence intervals (CIs)] estimates from nonoverlapping populations using a random-effects meta-analysis model. Statistical heterogeneity was assessed via the I statistic. We identified 11 studies (19,882 patients) with nonoverlapping populations/endpoints; seven of them evaluated WCD use across various indications, while the remaining studies restricted their focus to a single indication. Most of the studies were retrospective (82%) and multicenter (64%) in nature, with 45% using manufacturers' registry data. The median duration of WCD use was three or more months in nine (82%) studies, and daily wear time ranged from a mean/median of 17 hours to 24 hours per day across included studies. Seven (64%) studies reported a mean/median daily wear time of more than 20 hours. This meta-analysis showed that the incidences of all-cause and SCD-related mortality among WCD patients were 1.4% (95% CI: 0.7%-2.4%) and 0.2% (95% CI: 0.1%-0.3%), respectively. VT/VF occurred in 2.6% (95% CI: 1.8%-3.5%) of patients. Across patients, 1.7% (95% CI: 1.4%-2.0%) received appropriate WCD treatment, corresponding to a rate of 9.1 patients/100 person-years (95% CI: 6.2-11.9 patients/100 person-years). Successful VT/VF termination following appropriate treatment occurred in 95.5% of patients (95% CI: 92.0%-98.0%) and the incidence of inappropriate treatment was infrequent (0.9%; 95% CI: 0.5%-1.4%). A moderate-to-high degree of statistical heterogeneity was observed in pooled analyses of mortality, VT/VF occurrence, and appropriate/inappropriate treatment (I ≥ 41% for all). In conclusion, WCDs appear to be successful in terms of terminating VT/VF in patients with an elevated risk of SCD and are appropriate for use while long-term risk management strategies are being identified.
可穿戴式心脏复律除颤器（WCD）通过检测和治疗危及生命的室性心动过速/心室颤动（VT/VF）来保护患者免受心源性猝死（SCD）。最近，两项评估WCD的大型研究发表了。然而，新旧研究的结果尚未得到系统总结。本研究的目的是进行一项荟萃分析，评估WCD的使用情况和有效性。我们检索了MEDLINE和Scopus（1998年1月至2017年7月）以及灰色文献。我们纳入了注册/观察性研究，这些研究（1）评估了使用WCD的成年患者；（2）提供了一项或多项感兴趣结局的数据；（3）是英文发表的全文研究。我们使用随机效应荟萃分析模型，从非重叠人群中计算合并发病率和/或率[95%置信区间（CI）]估计值。通过I统计量评估统计异质性。我们确定了11项研究（19882例患者），其人群/终点不重叠；其中7项评估了WCD在各种适应症中的使用情况，而其余研究则将重点限制在单一适应症上。大多数研究本质上是回顾性的（82%）和多中心的（64%），45%使用制造商的注册数据。在9项（82%）研究中，WCD使用的中位持续时间为3个月或更长时间，纳入研究中每日佩戴时间的均值/中位数范围为每天17小时至24小时。7项（64%）研究报告的每日佩戴时间均值/中位数超过20小时。这项荟萃分析表明，WCD患者的全因死亡率和SCD相关死亡率分别为1.4%（95%CI：0.7%-2.4%）和0.2%（95%CI：0.1%-0.3%）。2.6%（95%CI：1.8%-3.5%）的患者发生VT/VF。在所有患者中，1.7%（95%CI：1.4%-2.0%）接受了适当的WCD治疗，相当于9.1例患者/100人年的发生率（95%CI：6.2-11.9例患者/100人年）。适当治疗后成功终止VT/VF的患者占95.5%（95%CI：92.0%-98.0%），不适当治疗的发生率较低（0.9%；95%CI：0.5%-1.4%）。在死亡率汇总分析、VT/VF发生情况以及适当/不适当治疗中观察到中度至高度的统计异质性（所有I≥41%）。总之，WCD在终止SCD风险升高患者的VT/VF方面似乎是成功的，并且在确定长期风险管理策略时适合使用。
