Division of Cardiology, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
Division of Cardiology, UCLA (University of California, Los Angeles).
JAMA Cardiol. 2017 Jun 1;2(6):685-688. doi: 10.1001/jamacardio.2017.0630.
Conflicting data have emerged on the efficacy of implantable cardioverter defibrillators (ICDs) for primary prevention of sudden cardiac death (primary prevention ICDs) in patients with nonischemic cardiomyopathy.
To investigate the association of primary prevention ICDs with all-cause mortality in patients with nonischemic cardiomyopathy.
PubMed was searched from January 1, 2000, through October 31, 2016, for the terms implantable defibrillator OR implantable cardioverter defibrillator AND non-ischemic cardiomyopathy. Additional references were identified from bibliographies of pertinent articles and queries to experts in this field.
Inclusion criteria consisted of a randomized clinical trial design and comparison of the ICD with medical therapy (control) in at least 100 patients with nonischemic cardiomyopathy. In addition, studies had to report on all-cause mortality during a follow-up period of at least 12 months and be published in English. The search yielded 10 studies, of which only 1 met the inclusion criteria. A search of bibliographies of pertinent articles and queries of experts in this field led to 3 additional studies.
The PRISMA guidelines were used to abstract data and assess data quality and validity. Data were pooled using fixed- and random-effects models.
The primary end point was all-cause mortality. Before data collection started, primary prevention ICDs were hypothesized to reduce all-cause mortality among patients with nonischemic cardiomyopathy.
Four randomized clinical trials met the selection criteria and included 1874 unique patients; 937 were in the ICD group and 937 in the control group. Pooling data from these trials showed a significant reduction in all-cause mortality with an ICD (hazard ratio, 0.75; 95% CI, 0.61-0.93; P = .008; P = .87 for heterogeneity).
Primary prevention ICDs are efficacious at reducing all-cause mortality among patients with nonischemic cardiomyopathy. These findings support professional guidelines that recommend the use of ICDs in such patients.
在非缺血性心肌病患者中，植入式心脏复律除颤器（ICD）用于一级预防心源性猝死（一级预防 ICD）的疗效存在相互矛盾的数据。
研究一级预防 ICD 与非缺血性心肌病患者全因死亡率的相关性。
从 2000 年 1 月 1 日至 2016 年 10 月 31 日，通过 PubMed 搜索了植入式除颤器或植入式心脏复律除颤器和非缺血性心肌病的术语。从相关文章的参考文献和对该领域专家的查询中确定了其他参考文献。
纳入标准包括随机临床试验设计，以及至少 100 例非缺血性心肌病患者中 ICD 与药物治疗（对照组）的比较。此外，研究必须报告至少 12 个月的随访期间的全因死亡率，并且必须用英文发表。搜索产生了 10 项研究，其中只有 1 项符合纳入标准。对相关文章的参考文献进行搜索和对该领域专家的查询导致了另外 3 项研究。
使用 PRISMA 指南提取数据并评估数据质量和有效性。使用固定效应和随机效应模型对数据进行汇总。
主要终点是全因死亡率。在开始收集数据之前，假设一级预防 ICD 可降低非缺血性心肌病患者的全因死亡率。
四项符合选择标准的随机临床试验纳入了 1874 例独特患者；937 例在 ICD 组，937 例在对照组。汇总这些试验的数据显示，ICD 可显著降低全因死亡率（危险比，0.75；95%CI，0.61-0.93；P = .008；P = .87 用于异质性）。
一级预防 ICD 可有效降低非缺血性心肌病患者的全因死亡率。这些发现支持专业指南，建议在这些患者中使用 ICD。
