Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.
Europace. 2010 Nov;12(11):1564-70. doi: 10.1093/europace/euq329.
Much controversy exists concerning the efficacy of primary prophylactic implantable cardioverter-defibrillators (ICDs) in patients with low ejection fraction due to coronary artery disease (CAD) or dilated cardiomyopathy (DCM). This is also related to the bias created by function improving interventions added to ICD therapy, e.g. resynchronization therapy. The aim was to investigate the efficacy of ICD-only therapy in primary prevention in patients with CAD or DCM.
Public domain databases, MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials, were searched from 1980 to 2009 for randomized clinical trials of ICD vs. conventional therapy. Two investigators independently abstracted the data. Pooled estimates were calculated using both fixed-effects and random-effects models. Eight trials were included in the final analysis (5343 patients). Implantable cardioverter-defibrillators significantly reduced the arrhythmic mortality [relative risk (RR): 0.40; 95% confidence interval (CI): 0.27-0.67] and all-cause mortality (RR: 0.73; 95% CI: 0.64-0.82). Regardless of aetiology of heart disease, ICD benefit was similar for CAD (RR: 0.67; 95% CI: 0.51-0.88) vs. DCM (RR: 0.74; 95% CI: 0.59-0.93).
The results of this meta-analysis provide strong evidence for the beneficial effect of ICD-only therapy on the survival of patients with ischaemic or non-ischaemic heart disease, with a left ventricular ejection fraction ≤ 35%, if they are 40 days from myocardial infarction and ≥ 3 months from a coronary revascularization procedure.
由于冠状动脉疾病 (CAD) 或扩张型心肌病 (DCM),左心室射血分数低的患者中,初级预防植入式心脏复律除颤器 (ICD) 的疗效存在很大争议。这也与 ICD 治疗中添加的功能改善干预措施(如再同步治疗)造成的偏差有关。目的是研究 ICD 单一疗法在 CAD 或 DCM 患者中的一级预防效果。
从 1980 年到 2009 年,在公共领域数据库、MEDLINE、EMBASE 和 Cochrane 对照试验中心注册库中搜索 ICD 与常规治疗比较的随机临床试验。两名调查员独立提取数据。使用固定效应和随机效应模型计算汇总估计值。最终分析纳入了 8 项试验(5343 例患者)。ICD 显著降低心律失常死亡率[相对风险 (RR):0.40;95%置信区间 (CI):0.27-0.67]和全因死亡率 (RR:0.73;95% CI:0.64-0.82)。无论心脏病的病因如何,CAD (RR:0.67;95% CI:0.51-0.88)与 DCM (RR:0.74;95% CI:0.59-0.93)的 ICD 获益相似。
这项荟萃分析的结果为 ICD 单一疗法对缺血性或非缺血性心脏病、左心室射血分数≤35%的患者的生存有益提供了有力证据,如果他们距心肌梗死 40 天且距冠状动脉血运重建术≥3 个月。