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用于手术高风险患者严重症状性二尖瓣反流的MitraClip:一项全面的系统评价

MitraClip for severe symptomatic mitral regurgitation in patients at high surgical risk: a comprehensive systematic review.

作者信息

Philip Femi, Athappan Ganesh, Tuzcu E Murat, Svensson Lars G, Kapadia Samir R

机构信息

Department of Cardiovascular Medicine and Cardiothoracic Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.

出版信息

Catheter Cardiovasc Interv. 2014 Oct 1;84(4):581-90. doi: 10.1002/ccd.25564. Epub 2014 Jul 2.

DOI:10.1002/ccd.25564
PMID:24905665
Abstract

BACKGROUND

The optimal treatment of patients with severe mitral regurgitation (MR) at high surgical risk (HSR) is unknown. Recently, the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study suggested MitraClip (MC) was a safe and effective treatment option.

METHODS

We performed a search strategy for MC or mitral valve surgery (MVS) in patients at HSR for surgical mortality (logistic EuroSCORE >18 or STS score > 10) using Medline databases, proceedings of international meetings, and the STS database. We identified 21 studies utilizing MC (n = 3,198) and MVS (n = 3,265, >90% from the STS database) from 2003 to 2013. Information about patient characteristics, surgical risk, and 30-day and 1-year outcomes were extracted.

RESULTS

Patients who underwent MC or MVS had a mean age of 74 ± 10 years with no differences in surgical risk, NYHA class, or MR grade (P = 0.46). Technical success was achieved in 96% of patients undergoing MC versus 98% in the MVS group (P = 0.45). Patients undergoing MC were treated with one or two MC in 90% (n = 2,878) with only a few requiring repeat MC (0.4%, n = 13) or mitral surgery (0.3%, n = 52) at 30 days. The pooled event rates for mortality was 3.2% (95% CI [2.5-4.2]), stroke was 1.1% (95% CI [0.7-0.2]) at 30 days. At 31 days to 1 year, the pooled event rate for mortality was 13.0% [95% CI (9-18.3)], stroke was 1.6% [95% CI (0.8-3.2)], and repeat MVS was 1.3% [95% CI (0.7-2.6)] with the majority of patients in the mild/moderate MR grade and NYHA class after MC. The 30-day event rates for mortality and stroke were 16.8% (95% CI [14-19]) and 4.5% (95% CI [3.9-5.3]) after MVS, respectively.

CONCLUSION

Based on high risk MC studies and high risk MVS data predominantly from STS database, patients with severe MR who are at HSR can be effectively treated with MC or MVS. MC can be safely implanted in high risk patients with relatively low mortality and stroke risk.

摘要

背景

对于手术风险高(HSR)的严重二尖瓣反流(MR)患者,最佳治疗方案尚不清楚。最近,EVEREST II(血管内缘对缘修复)高风险研究表明,MitraClip(MC)是一种安全有效的治疗选择。

方法

我们使用Medline数据库、国际会议论文集和STS数据库,对手术风险高(手术死亡风险评分:逻辑欧洲心脏手术风险评估系统>18或胸外科医师协会评分>10)的患者进行MC或二尖瓣手术(MVS)的检索策略。我们确定了2003年至2013年期间利用MC(n = 3198)和MVS(n = 3265,>90%来自STS数据库)的21项研究。提取了有关患者特征、手术风险以及30天和1年结局的信息。

结果

接受MC或MVS治疗的患者平均年龄为74±10岁,手术风险、纽约心脏协会心功能分级或MR分级无差异(P = 0.46)。接受MC治疗的患者中96%技术成功,MVS组为98%(P = 0.45)。接受MC治疗的患者中90%(n = 2878)使用一个或两个MC,30天时只有少数患者需要重复MC(0.4%,n = 13)或二尖瓣手术(0.3%,n = 52)。30天时,合并死亡率为3.2%(95%CI[2.5 - 4.2]),卒中率为1.1%(95%CI[0.7 - 1.2])。在31天至1年时,合并死亡率为13.0%[95%CI(9 - 18.3)],卒中率为1.6%[95%CI(0.8 - 3.2)],重复MVS率为1.3%[95%CI(0.7 - 2.6)],MC治疗后大多数患者为轻度/中度MR分级和纽约心脏协会心功能分级。MVS后30天的死亡率和卒中率分别为16.8%(95%CI[14 - 19])和4.5%(95%CI[3.9 - 5.3])。

结论

基于高风险MC研究和主要来自STS数据库的高风险MVS数据,手术风险高的严重MR患者可通过MC或MVS得到有效治疗。MC可安全植入手术风险高、死亡率和卒中风险相对较低的患者体内。

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