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经皮缘对缘二尖瓣修复治疗功能性和退行性二尖瓣反流的疗效:系统评价和荟萃分析。

Outcome after percutaneous edge-to-edge mitral repair for functional and degenerative mitral regurgitation: a systematic review and meta-analysis.

机构信息

Interventional Cardiology Unit, Humanitas Clinical and Research Center, Rozzano, Italy.

Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.

出版信息

Heart. 2018 Feb;104(4):306-312. doi: 10.1136/heartjnl-2017-311412. Epub 2017 Jun 29.

Abstract

OBJECTIVES

Differences in terms of safety and efficacy of percutaneous edge-to-edge mitral repair between patients with functional and degenerative mitral regurgitation (MR) are not well established. We performed a systematic review and meta-analysis to clarify these differences.

METHODS

PubMed, EMBASE, Google scholar database and international meeting abstracts were searched for all studies about MitraClip. Studies with <25 patients or where 1-year results were not delineated between MR aetiology were excluded. This study is registered with PROSPERO.

RESULTS

A total of nine studies investigating the mid-term outcome of percutaneous edge-to-edge repair in patients with functional versus degenerative MR were included in the meta-analysis (n=2615). At 1 year, there were not significant differences among groups in terms of patients with MR grade≤2 (719/1304 vs 295/504; 58% vs 54%; risk ratio (RR) 1.12; 95% CI: 0.86 to 1.47; p=0.40), while there was a significantly lower rate of mitral valve re-intervention in patients with functional MR compared with those with degenerative MR (77/1770 vs 80/818; 4% vs 10%; RR 0.60; 95% CI: 0.38 to 0.97; p=0.04). One-year mortality rate was 16% (408/2498) and similar among groups (RR 1.26; 95% CI: 0.90 to 1.77; p=0.18). Functional MR group showed significantly higher percentage of patients in New York Heart Association class III/IV (234/1480 vs 49/583; 16% vs 8%; p<0.01) and re-hospitalisation for heart failure (137/605 vs 31/220; 23% vs 14%; p=0.03). No differences were found in terms of single leaflet device attachment (25/969 vs 20/464; 3% vs 4%; p=0.81) and device embolisation (no events reported in both groups) at 1 year.

CONCLUSIONS

This meta-analysis suggests that percutaneous edge-to-edge repair is likely to be an efficacious and safe option in patients with both functional and degenerative MR. Large, randomised studies are ongoing and awaited to fully assess the clinical impact of the procedure in these two different MR aetiologies.

摘要

目的

在功能性和退行性二尖瓣反流(MR)患者中,经皮缘对缘二尖瓣修复的安全性和疗效差异尚不清楚。我们进行了一项系统评价和荟萃分析,以阐明这些差异。

方法

检索PubMed、EMBASE、Google Scholar 数据库和国际会议摘要,以获取所有关于 MitraClip 的研究。排除了病例数<25 例或 1 年结果未按 MR 病因划分的研究。本研究已在 PROSPERO 注册。

结果

共有 9 项研究纳入了经皮缘对缘修复治疗功能性与退行性 MR 患者的中期结果的荟萃分析(n=2615)。1 年时,MR 分级≤2 的两组间患者无显著差异(719/1304 与 295/504;58%与 54%;风险比(RR)1.12;95%CI:0.86 至 1.47;p=0.40),而功能性 MR 患者的二尖瓣再介入率明显低于退行性 MR 患者(77/1770 与 80/818;4%与 10%;RR 0.60;95%CI:0.38 至 0.97;p=0.04)。1 年死亡率为 16%(408/2498),两组间相似(RR 1.26;95%CI:0.90 至 1.77;p=0.18)。功能性 MR 组纽约心脏协会(NYHA)心功能分级 III/IV 级的患者比例明显更高(234/1480 与 49/583;16%与 8%;p<0.01)和因心力衰竭再住院的患者比例也更高(137/605 与 31/220;23%与 14%;p=0.03)。1 年时,单叶器械附着(25/969 与 20/464;3%与 4%;p=0.81)和器械栓塞(两组均无报告)方面无差异。

结论

这项荟萃分析表明,经皮缘对缘修复在功能性和退行性 MR 患者中可能是一种有效且安全的选择。目前正在进行大型随机研究,以充分评估该手术在这两种不同 MR 病因中的临床影响。

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