经导管二尖瓣置换术治疗二尖瓣关闭不全的安全性及有效性:Meta分析

Safety and effectiveness of transcatheter mitral valve replacement in the treatment of mitral regurgitation:a Meta-analysis

目的应用Meta分析评价经导管二尖瓣置换术(TMVR)治疗二尖瓣关闭不全(MR)的安全性及有效性。方法计算机检索PubMed、EMbase、the Cochrane Library、Web of Science、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、维普(VIP)、万方数据库(Wanfang Data),检索时限均从建库至2023年9月,由2名研究员独立筛选文献、提取资料后,采用MINORS评价工具评价纳入研究的质量,并采用Stata 17.0软件进行Meta分析,并根据手术路径进行亚组分析。结果最终纳入9篇研究,共计635例样本量。Meta分析结果显示:瓣膜置入成功率的合并结果为96.2%[95%CI(93.3%~98.4%)]。亚组分析结果显示,经心尖成功率为94.7%[95%CI(87.7%~99.2%)],经股成功率为92.5%[95%CI(80.7%~99.5%)]。此外术后30 d死亡率的合并结果为9.1%[95%CI(4.4%~15.0%)],术后30 d纽约心脏病协会心功能分级≤Ⅱ级的合并结果为68.4%[95%CI(61.5%~75.0%)],术后30 d内大出血的合并结果为20.9%[95%CI(9.8%~34.3%)],术中中转开胸的合并结果为3.0%[95%CI(0.0%~9.0%],术后30 d新发心房颤动的合并结果为12.2%[95%CI(5.3%~21.1%)],30 d脑血管事件的合并结果为1.3%[95%CI(0.2%~3.0%)],术后1年死亡率的合并结果为28.0%[95%CI(23.4%~32.8%)]。结论应用TMVR治疗MR安全有效。本研究在研究数量及质量上有限,存在一定的局限性,尚需更大样本量的随机对照试验加以证实。

Objective The purpose of this Meta-analysis is to evaluate safety and eff ectiveness of transcatheter mitral valve replacement(TMVR)in the treatment of mitral regurgitation(MR).Methods Eight electronic databases including PubMed,EMbase,The Cochrane Library,Web of Science,CNKI,CBM,VIP and Wanfang data were searched from inception until September 2023.Two authors independently assessed the quality using the Methodological index for non-randomized studies(MINORS),after screening the literature and extracting the data.Then,Meta-analysis was performed by using Stata 17.0 software.Subgroup meta-analysis of studies exclusively by transapical(TA)and transfemoral(TF).Results Nine studies were included with 635 samples.Meta-analysis results showed that an incidence of device success was 96.2%[95%CI(93.3%–98.4%)].The success rate of the TA subgroup was 94.7%[95%CI(87.7%–99.2%)],and TF subgroup was 92.5%[95%CI(80.7%–99.5%)].In addition,the 30-day all-cause mortality was 9.1%[95%CI(4.4%-15.0%)],the 30-day New York Heart Association class≤Ⅱwas 68.4%[95%CI(61.5%-75.0%)],the 30-day major or worse bleeding was 20.9%[95%CI(9.8%-34.3%)],the incidence rate of conversion to thoracotomy was 3.0%[95%CI(0.0%-9.0%)],the incidence rate of new-onset atrial fi brillation was 12.2%[95%CI(5.3%-21.1%)],the incidence rate of cerebrovascular accident was 1.3%[95%CI(0.2%-3.0%)],and the 1-year all-cause mortality was 28.0%[95%CI(23.4%-32.8%)].Conclusions TMVR for MR is safe and yields good results.some limitations can not be overcomed because of the capacity and the quality,consequently The results should be validated by large-scale multicenter randomized controlled trial studies in the future.