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心脏再同步治疗不适用的扩张型心肌病患者使用心脏收缩力调制的全因死亡率结局:随机对照试验的更新荟萃分析

All-Cause Mortality Outcomes of Usage of Cardiac Contractility Modulation in Patients With Dilated Cardiomyopathy Ineligible for Cardiac Re-Synchronization Therapy: An Updated Meta-Analysis of Randomized Controlled Trials.

作者信息

Nadeem Muhammad, Tariq Ezza Fatima, Aslam Hafiz M, Illahi Yasir, Shah Rehan

机构信息

Advanced Heart Failure, University of Kentucky College of Medicine, Lexington, USA.

Internal Medicine, Nishtar Medical University and Hospital, Multan, PAK.

出版信息

Cureus. 2020 Sep 24;12(9):e10627. doi: 10.7759/cureus.10627.

Abstract

Introduction Dilated cardiomyopathy has been associated with remarkably high mortality despite guideline-directed therapy. This study compares the all-cause mortality rate between a cardiac contractility modulation group and a standard therapy group in patients with dilated cardiomyopathy who were monitored via follow-up for 12 weeks or more. Materials and methods We conducted a systematic search of Medline (PubMed) and Cochrane Central Register of Controlled Trials for abstracts and fully published studies (from inception to October 2018). We searched for articles comparing cardiac contractility modulation device therapy with standard therapy for patients with dilated cardiomyopathy between September 1, 2018, and October 30, 2018. Only fully published randomized clinical trials comparing all-cause mortality outcomes of device therapy and standard therapy for patients with dilated cardiomyopathy were included in our meta-analysis. A total of 673 studies were identified. Studies that were systematic reviews or meta-analyses, study designs or protocols, trials on other regimens, wherein medical therapy was not compared, or wherein the primary outcome of mortality was not assessed, were excluded. Data were abstracted by two independent reviewers. A random-effect model using the Mantel-Haenszel method calculated the weighted risk ratio (RR). Statistical analyses were performed using Review Manager 5.3 (The Nordic Cochrane Centre, The Cochrane Collaboration; Copenhagen). The primary outcome of interest was a comparison of all-cause mortality between the two groups when patients were monitored via follow-up for 12 weeks or more. Results Four fully published randomized clinical trials met the inclusion criteria of our analysis. A random-effect model using the Mantel-Haenszel method calculated the weighted RR. Our analysis included a total of 930 patients. The cardiac contractility modulation therapy group showed no significant reduction in all-cause mortality compared to the standard therapy group (RR, 0.63; 95% CI, 0.29-1.35; P = .23). However, the trend was toward device therapy. Tests for statistical heterogeneity did not show any significant heterogeneity (P = .82, I = 0%). Conclusions Cardiac contractility modulation device therapy is not associated with significant all-cause mortality reduction in patients with dilated cardiomyopathy. Our meta-analysis underscores the need for a large randomized controlled trial on the efficacy of cardiac contractility modulation in a population with dilated cardiomyopathy who are ineligible for cardiac resynchronization therapy.

摘要

引言

尽管有指南指导的治疗,扩张型心肌病的死亡率仍显著较高。本研究比较了在随访12周或更长时间的扩张型心肌病患者中,心脏收缩力调制组和标准治疗组之间的全因死亡率。

材料与方法

我们对Medline(PubMed)和Cochrane对照试验中央注册库进行了系统检索,以查找摘要和全文发表的研究(从创刊到2018年10月)。我们检索了2018年9月1日至2018年10月30日期间比较扩张型心肌病患者心脏收缩力调制装置治疗与标准治疗的文章。我们的荟萃分析仅纳入了比较扩张型心肌病患者装置治疗和标准治疗全因死亡率结果的全文发表的随机临床试验。共识别出673项研究。排除了系统评价或荟萃分析、研究设计或方案、其他治疗方案的试验(未比较药物治疗)或未评估死亡率主要结局的研究。数据由两名独立的评审员提取。使用Mantel-Haenszel方法的随机效应模型计算加权风险比(RR)。使用Review Manager 5.3(北欧Cochrane中心,Cochrane协作网;哥本哈根)进行统计分析。感兴趣的主要结局是在随访12周或更长时间时两组之间全因死亡率的比较。

结果

四项全文发表的随机临床试验符合我们分析的纳入标准。使用Mantel-Haenszel方法的随机效应模型计算加权RR。我们的分析共纳入930例患者。与标准治疗组相比,心脏收缩力调制治疗组的全因死亡率没有显著降低(RR,0.63;95%CI,0.29-1.35;P = 0.23)。然而,趋势是倾向于装置治疗。统计异质性检验未显示任何显著异质性(P = 0.82,I² = 0%)。

结论

心脏收缩力调制装置治疗与扩张型心肌病患者全因死亡率的显著降低无关。我们的荟萃分析强调了对不适合心脏再同步治疗的扩张型心肌病患者进行心脏收缩力调制疗效的大型随机对照试验的必要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88d3/7584294/b597dee38971/cureus-0012-00000010627-i01.jpg

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