MitraClip装置经导管二尖瓣边缘对边缘修复的有效性和安全性在加拿大的实际应用

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

CJC Open Pub Date : 2025-08-01 DOI:10.1016/j.cjco.2025.05.008

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

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引用次数: 0

摘要

背景：二尖瓣经导管边缘到边缘修复（M-TEER）是治疗症状性二尖瓣反流（MR）患者的一种治疗选择。加拿大M-TEER的实际经验以前没有报道过。方法：我们对来自加拿大11个中心的1191例患者进行了一项观察性研究，这些患者使用MitraClip装置（Abbott, location）接受M-TEER治疗。每个中心的M-TEER数据库集中收集，并合并为一个加拿大范围的数据库。主要结局是M-TEER前MR严重程度与M-TEER后1年的MR严重程度。次要结局包括因心力衰竭（HF）住院和纽约心脏协会（NYHA）功能分级。结果smr病因中退行性占41%，功能性占59%。平均年龄为76岁，其中36%为女性。术前MR≥3+的比例为97.3%，M-TEER后1年为11.0%(绝对风险差[ARD] 86.4%, P <；0.001)。术前HF住院率为50.7%，而M-TEER术后1年内住院率为10.3% (P <；0.001)，在功能性（ARD 44.8%， 95%可信区间39.5-50.1）和退行性（ARD 34.8%， 95%可信区间29.0-40.6）患者中，NYHA III-IV级HF的发生率为82.8%，而在M-TEER后1年内为16.6% (ARD 66.2%, P <；0.001)。单小叶脱离（1.0%）和二尖瓣手术（2.2%）少见。住院死亡率为1.3%，1年死亡率为12.7%。结论：在加拿大第一个接受M-TEER的国家登记患者中，M-TEER导致MR持续降低，并与HF住院率降低和NYHA功能分级改善相关，具有高度的安全性。这种益处在功能性和退行性MR患者中是一致的。

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

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%, P < 0.001). Hospitalization for HF occurred in 50.7% before vs 10.3% at up to 1 year after M-TEER (ARD 40.4%, P < 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%, P < 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.

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