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使用当代专用装置的经导管二尖瓣置换术:系统评价与荟萃分析

Transcatheter Mitral Valve Replacement Using Contemporary Dedicated Devices: A Systematic Review and Meta-Analysis.

作者信息

Zorman Mark J, Dangas Katerina, Vibhishanan Jonathan, Castle James, Eastwick-Jones Kate, Coronelli Marco, Alabdaljabar Mohamad S, Foster Kaleb, Silva Danuzia, Patel Parth, Johns Emma, Piankova Palina, Ordóñez-Mena José, Dawkins Sam, Newton James, Eleid Mackram F, Guerrero Mayra E, Cahill Thomas J

机构信息

Oxford Heart Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.

出版信息

Struct Heart. 2025 Jul 15;9(9):100702. doi: 10.1016/j.shj.2025.100702. eCollection 2025 Sep.

Abstract

BACKGROUND

Dedicated transcatheter mitral valve replacement (TMVR) devices have emerged as a promising strategy for treating mitral regurgitation (MR) in high-risk patients with complex native valve anatomy. Early experience spans multiple devices utilizing both transapical and transseptal access. The aim of this study was to evaluate procedural, 30-day, and midterm outcomes of TMVR with contemporary dedicated mitral devices in patients with native MR.

METHODS

A systematic search of Medline, Embase, and Cochrane Library (January 2010-January 2025) was conducted. Pooled outcome estimates were derived using random-effects models, excluding legacy devices and cases of mitral stenosis.

RESULTS

Thirteen studies (914 patients) were included in the analysis. The mean age was 75.4 years, and 69.8% had functional or mixed MR. Technical success was 96.3%. Residual MR was mild or less in 99% of patients at 30 days and 98% at 1 year. All-cause mortality was 11.0% at 30 days and 26.4% at 1 year. Over a mean follow-up of 12.1 months, rates of heart failure (HF) hospitalizations, cerebrovascular events, and valve reinterventions were 26.2, 5.6, and 6.0 events per 100 patient-years, respectively. Compared with transseptal access, transapical showed higher 30-day major bleeding (19.2% vs. 10.4%, = 0.03) and all-cause mortality at 30 days (14.0% vs. 4.7%, ​<0.001) and 1 year (27.7% vs. 13.1%, = 0.005). Midterm rates of HF readmissions, major bleeding, and valve reinterventions were comparable between access routes.

CONCLUSIONS

Contemporary dedicated TMVR devices demonstrate high technical success and sustained MR reduction. Transseptal access is associated with lower morbidity and mortality. Further research is needed to improve longer-term mortality and HF hospitalizations following TMVR with dedicated mitral devices.

摘要

背景

专用经导管二尖瓣置换术(TMVR)设备已成为治疗具有复杂天然瓣膜解剖结构的高危患者二尖瓣反流(MR)的一种有前景的策略。早期经验涵盖了多种使用经心尖和经房间隔入路的设备。本研究的目的是评估使用当代专用二尖瓣设备进行TMVR治疗天然MR患者的手术、30天和中期结果。

方法

对Medline、Embase和Cochrane图书馆(2010年1月至2025年1月)进行系统检索。使用随机效应模型得出汇总结果估计值,排除传统设备和二尖瓣狭窄病例。

结果

分析纳入了13项研究(914例患者)。平均年龄为75.4岁,69.8%的患者为功能性或混合性MR。技术成功率为96.3%。99%的患者在30天时残余MR为轻度或更低,1年时为98%。30天全因死亡率为11.0%,1年时为26.4%。在平均12.1个月的随访中,心力衰竭(HF)住院率、脑血管事件和瓣膜再次干预率分别为每100患者年26.2、5.6和6.0次事件。与经房间隔入路相比,经心尖入路在30天时显示出更高的大出血发生率(19.2%对10.4%,P = 0.03)以及30天和1年时的全因死亡率(30天时为14.0%对4.7%,P<0.001;1年时为27.7%对13.1%,P = 0.005)。两种入路的中期HF再入院率、大出血率和瓣膜再次干预率相当。

结论

当代专用TMVR设备显示出较高的技术成功率和持续的MR降低效果。经房间隔入路与较低的发病率和死亡率相关。需要进一步研究以改善使用专用二尖瓣设备进行TMVR后的长期死亡率和HF住院情况。

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