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在加拿大实际临床应用中,使用MitraClip装置进行经导管二尖瓣缘对缘修复术的疗效与安全性。

Efficacy and Safety of Transcatheter Mitral Valve Edge-to-Edge Repair with a MitraClip Device in Real-World Canadian Practice.

作者信息

Mehta Shamir R, Asgar Anita, Boone Robert, Rodes-Cabau Josep, Cohen Eric A, Czarnecki Andrew, Labinaz Marino, Lavi Shahar, Piazza Nicolo, Bainey Kevin R, Bagai Akshay, Paradis Jean-Michel, Schwalm J D, Wright Douglas, Nguyen Helen, McCready Tara, Mian Rajibul, Webb John, Fam Neil

机构信息

Population Health Research Institute, Hamilton, Ontario, Canada.

Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.

出版信息

CJC Open. 2025 May 22;7(8):1048-1054. doi: 10.1016/j.cjco.2025.05.008. eCollection 2025 Aug.

DOI:10.1016/j.cjco.2025.05.008
PMID:40894844
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12399131/
Abstract

BACKGROUND

Mitral transcatheter edge-to-edge repair (M-TEER) is a treatment option for patients with symptomatic mitral regurgitation (MR). The real-world experience with M-TEER in Canada has not been reported previously.

METHODS

We conducted an observational study of 1191 patients from 11 Canadian centres undergoing M-TEER with a MitraClip device (Abbott, location). M-TEER databases from each centre were collected centrally and merged into a single Canada-wide database. The primary outcome was MR severity before M-TEER vs at up to 1 year after M-TEER. Secondary outcomes included hospitalizations for heart failure (HF) and New York Heart Association (NYHA) functional class.

RESULTS

MR etiology was degenerative in 41%, and functional in 59%. The mean age was 76 years, and 36% were women. The proportion with MR ≥ 3+ was 97.3% before vs 11.0% at up to 1 year after M-TEER (absolute risk difference [ARD] 86.4%, < 0.001). Hospitalization for HF occurred in 50.7% before vs 10.3% at up to 1 year after M-TEER (ARD 40.4%, < 0.001), with similar benefit in patients with functional (ARD 44.8%, 95% confidence interval 39.5-50.1) and degenerative (ARD 34.8%, 95% confidence interval 29.0-40.6) MR. NYHA class III-IV HF was present in 82.8% before vs in 16.6% at up to 1 year after M-TEER (ARD 66.2%, < 0.001). Single-leaflet detachment (1.0%) and mitral valve surgery (2.2%) were infrequent. Mortality was 1.3% in-hospital, and 12.7% at 1 year.

CONCLUSIONS

In this first national registry of patients undergoing M-TEER in Canada, M-TEER resulted in a sustained reduction in MR and was associated with reduced HF hospitalizations and improvement in NYHA functional class, with a high degree of safety. This benefit was consistent in patients with functional and degenerative MR.

摘要

背景

二尖瓣经导管缘对缘修复术(M-TEER)是有症状二尖瓣反流(MR)患者的一种治疗选择。此前加拿大尚未报道过M-TEER的真实世界经验。

方法

我们对来自加拿大11个中心的1191例接受MitraClip装置(雅培公司,所在地)进行M-TEER治疗的患者进行了一项观察性研究。每个中心的M-TEER数据库集中收集并合并成一个全加拿大范围的数据库。主要结局是M-TEER术前与术后长达1年时的MR严重程度。次要结局包括因心力衰竭(HF)住院情况和纽约心脏协会(NYHA)心功能分级。

结果

MR病因中退行性病变占41%,功能性病变占59%。平均年龄为76岁,女性占36%。M-TEER术前MR≥3+的比例为97.3%,术后长达1年时为11.0%(绝对风险差异[ARD]86.4%,<0.001)。HF住院率术前为50.7%,术后长达1年时为10.3%(ARD 40.4%,<0.001),在功能性MR(ARD 44.8%,95%置信区间39.5-50.1)和退行性MR(ARD 34.8%,95%置信区间29.0-40.6)患者中获益相似。NYHA III-IV级HF术前占82.8%,术后长达1年时占16.6%(ARD 66.2%,<0.001)。单叶瓣脱离(1.0%)和二尖瓣手术(2.2%)发生率较低。住院死亡率为1.3%,1年死亡率为12.7%。

结论

在加拿大首个接受M-TEER治疗患者的全国性登记研究中,M-TEER使MR持续降低,并与HF住院率降低和NYHA心功能分级改善相关,安全性高。这种获益在功能性和退行性MR患者中是一致的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/def5/12399131/aa63e6b4a0f9/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/def5/12399131/554789c548a6/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/def5/12399131/08665e5f8b36/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/def5/12399131/aa63e6b4a0f9/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/def5/12399131/554789c548a6/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/def5/12399131/08665e5f8b36/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/def5/12399131/aa63e6b4a0f9/gr3.jpg

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