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植入式心脏复律除颤器用于缺血性或非缺血性心肌病患者的一级预防:系统评价和荟萃分析。

Implantable Cardioverter-Defibrillators for Primary Prevention in Patients With Ischemic or Nonischemic Cardiomyopathy: A Systematic Review and Meta-analysis.

机构信息

From Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network, Collegium Medicum in Bydgoszcz, Dr Antoni Jurasz Memorial University Hospital, and Nicolaus Copernicus University, Bydgoszcz, Poland; University of Nicolaus Copernicus, Torun, Poland; Catholic University, Rome, Italy; University of Bari, Bari, Italy; Inova Heart and Vascular Institute and SIRIO MEDICINE Research Network, Falls Church, Virginia; and George Mason University, Fairfax, Virginia.

出版信息

Ann Intern Med. 2017 Jul 18;167(2):103-111. doi: 10.7326/M17-0120. Epub 2017 Jun 27.

Abstract

BACKGROUND

Implantable cardioverter-defibrillators (ICDs) have a role in preventing cardiac arrest in patients at risk for life-threatening ventricular arrhythmias.

PURPOSE

To compare ICD therapy with conventional care for the primary prevention of death of various causes in adults with ischemic or nonischemic cardiomyopathy.

DATA SOURCES

MEDLINE, Cochrane Central Register of Controlled Trials, Google Scholar, and EMBASE databases, as well as several Web sites, from 1 April 1976 through 31 March 2017.

STUDY SELECTION

Randomized controlled trials, published in any language, comparing ICD therapy with conventional care and reporting mortality outcomes (all-cause, sudden, any cardiac, or noncardiac) in the primary prevention setting.

DATA EXTRACTION

2 independent investigators extracted study data and assessed risk of bias.

DATA SYNTHESIS

Included were 11 trials involving 8716 patients: 4 (1781 patients) addressed nonischemic cardiomyopathy, 6 (4414 patients) ischemic cardiomyopathy, and 1 (2521 patients) both types of cardiomyopathy. Mean follow-up was 3.2 years. An overall reduction in all-cause mortality, from 28.26% with conventional care to 21.37% with ICD therapy (hazard ratio [HR], 0.81 [95% CI, 0.70 to 0.94]; P = 0.043), was found. The magnitude of reduction was similar in the cohorts with nonischemic (HR, 0.81 [CI, 0.72 to 0.91]) and ischemic (HR, 0.82 [CI, 0.63 to 1.06]) disease, although the latter estimate did not reach statistical significance. The rate of sudden death fell from 12.15% with conventional care to 4.39% with ICD therapy (HR, 0.41 [CI, 0.30 to 0.56]), with a similar magnitude of reduction in patients with ischemic (HR, 0.39 [CI, 0.23 to 0.68]) and those with nonischemic disease (HR, 0.44 [CI, 0.17 to 1.12]). Noncardiac and any cardiac deaths did not differ significantly by treatment.

LIMITATION

Heterogeneous timing of ICD placement; heterogeneous pharmacologic and resynchronization co-interventions; trials conducted in different eras; adverse events and complications not reviewed.

CONCLUSION

Overall, primary prevention with ICD therapy versus conventional care reduced the incidence of sudden and all-cause death.

PRIMARY FUNDING SOURCE

None.

摘要

背景

植入式心脏复律除颤器(ICD)在预防有致命性室性心律失常风险的患者发生心脏骤停方面发挥作用。

目的

比较 ICD 治疗与常规护理在预防成人缺血性或非缺血性心肌病患者各种原因导致的死亡方面的作用。

数据来源

1976 年 4 月 1 日至 2017 年 3 月 31 日期间 MEDLINE、Cochrane 对照试验中心注册数据库、Google Scholar 和 EMBASE 数据库以及其他几个网站。

研究选择

比较 ICD 治疗与常规护理并报告初级预防中死亡率(全因、突然、任何心脏或非心脏)结局的随机对照试验,不论语言如何发表。

数据提取

2 名独立的调查员提取了研究数据并评估了偏倚风险。

数据综合

共纳入 11 项试验,涉及 8716 例患者:4 项(1781 例)涉及非缺血性心肌病,6 项(4414 例)涉及缺血性心肌病,1 项(2521 例)同时涉及两种类型的心肌病。平均随访时间为 3.2 年。与常规护理组(28.26%)相比,ICD 治疗组(21.37%)全因死亡率降低(风险比[HR],0.81[95%置信区间,0.70 至 0.94];P=0.043)。在非缺血性(HR,0.81[CI,0.72 至 0.91])和缺血性(HR,0.82[CI,0.63 至 1.06])疾病患者中,这种降低的幅度相似,尽管后一种估计未达到统计学意义。常规护理组的猝死率从 12.15%降至 ICD 治疗组的 4.39%(HR,0.41[CI,0.30 至 0.56]),缺血性(HR,0.39[CI,0.23 至 0.68])和非缺血性疾病(HR,0.44[CI,0.17 至 1.12])患者的降低幅度相似。非心脏和任何心脏死亡的发生率治疗间无显著差异。

局限性

ICD 放置时机不同;药物和再同步化联合干预不同;在不同时代进行的试验;未审查不良事件和并发症。

结论

总的来说,与常规护理相比,ICD 治疗的一级预防降低了猝死和全因死亡的发生率。

主要资金来源

无。

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