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经导管二尖瓣修复术的机构经验和临床结果:TVT 注册研究的新见解。

Institutional Experience With Transcatheter Mitral Valve Repair and Clinical Outcomes: Insights From the TVT Registry.

机构信息

Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri.

Duke University and Duke Clinical Research Institute, Durham, North Carolina.

出版信息

JACC Cardiovasc Interv. 2019 Jul 22;12(14):1342-1352. doi: 10.1016/j.jcin.2019.02.039.

DOI:10.1016/j.jcin.2019.02.039
PMID:31320029
Abstract

OBJECTIVES

The aim of this study was to examine the relation between institutional experience and procedural results of transcatheter mitral valve repair.

BACKGROUND

Transcatheter mitral valve repair for the treatment of mitral regurgitation (MR) is a complex procedure requiring navigation of the left atrium, left ventricle, and mitral valve apparatus using echocardiographic guidance.

METHODS

MitraClip procedures from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were stratified into tertiles on the basis of site-specific case sequence (1 to 18, 19 to 51, and 52 to 482). In-hospital outcomes of procedural success, procedural time, and procedural complications were examined. To evaluate the learning curve for the procedure, generalized linear mixed models were developed using case sequence number as a continuous variable.

RESULTS

MitraClip procedures (n = 12,334) performed at 275 sites between November 2013 and September 2017 were analyzed. Optimal procedural success (≤1+ residual MR without mortality or need for cardiac surgery) increased across tertiles of case experience (62.0%, 65.5%, and 72.5%; p < 0.001), whereas procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or need for cardiac surgery) also increased across tertiles of case experience, but the differences were smaller (91.2%, 91.2%; and 92.9%; p = 0.006). In the learning-curve analysis, visual inflection points for procedural time, procedural success, and procedural complications were evident after about 50 cases, with continued improvements observed up to 200 cases.

CONCLUSIONS

For transcatheter mitral valve repair with the MitraClip, increasing institutional experience was associated with improvements in procedural success, procedure time, and procedural complications. The impact of institutional experience was larger when considering the goal of achieving optimal MR reduction.

摘要

目的

本研究旨在探讨机构经验与经导管二尖瓣修复术程序结果之间的关系。

背景

经导管二尖瓣修复术治疗二尖瓣反流(MR)是一项复杂的手术,需要在超声心动图引导下经房间隔、左心室和二尖瓣装置进行导航。

方法

根据特定部位的病例序列(1 至 18、19 至 51 和 52 至 482),对胸外科医师协会/美国心脏病学会 TVT(经导管瓣膜治疗)注册处的 MitraClip 手术进行三分位分层。检查手术成功率、手术时间和手术并发症的住院结果。为了评估该手术的学习曲线,使用病例序列数作为连续变量开发了广义线性混合模型。

结果

分析了 2013 年 11 月至 2017 年 9 月期间在 275 个部位进行的 MitraClip 手术(n=12334)。随着病例经验的三分位数增加,最佳手术成功率(≤1+残余 MR 且无死亡或需要心脏手术)也随之增加(62.0%、65.5%和 72.5%;p<0.001),而手术时间和手术并发症则减少。可接受的手术成功率(≤2+残余 MR 且无死亡或需要心脏手术)也随着病例经验的三分位数增加而增加,但差异较小(91.2%、91.2%和 92.9%;p=0.006)。在学习曲线分析中,手术时间、手术成功率和手术并发症的视觉拐点在大约 50 例后出现,在观察到 200 例后继续改善。

结论

对于 MitraClip 经导管二尖瓣修复术,机构经验的增加与手术成功率、手术时间和手术并发症的改善相关。在考虑实现最佳 MR 减少的目标时,机构经验的影响更大。

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