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瓣环成形术中使用延展夹臂行二尖瓣缘对缘修复术:来自多中心观察性研究的早期经验。

Edge-to-Edge Mitral Valve Repair With Extended Clip Arms: Early Experience From a Multicenter Observational Study.

机构信息

Department of Cardiology, University Hospital, University of Bern, Bern, Switzerland.

Medizinische Klinik und Poliklinik I, Ludwig Maximilians Universität München, München, Germany.

出版信息

JACC Cardiovasc Interv. 2019 Jul 22;12(14):1356-1365. doi: 10.1016/j.jcin.2019.03.023. Epub 2019 May 22.

Abstract

OBJECTIVES

The aim of this study was to investigate the technical success and efficacy of mitral valve edge-to-edge repair using extended clip arms.

BACKGROUND

A new iteration of the MitraClip system, the MitraClip XTR, was introduced in 2018 with the aim of addressing technical limitations observed with previous versions.

METHODS

Patients having received at least 1 new implant for the treatment of symptomatic mitral regurgitation (MR) were eligible for this study.

RESULTS

Among the 107 patients (mean age 76 ± 9 years, 69% men) included in this study, the etiology of MR was balanced, with one-half (n = 53 [50%]) classified as secondary and the remaining 54 patients having either primary (n = 40 [37%]) or mixed (n = 14 [13%]) disease. The mean number of devices implanted was 1.5 ± 0.6. Multiple device implantation was required in 46 patients (43%). Single-leaflet device attachment occurred in 4 patients and leaflet injury in 2 additional patients, requiring surgical conversion in 4 patients. Among the 102 patients discharged alive without mitral valve surgery, 95 (93%) had MR ≤2+ and 79 (77%) had MR ≤1+. The mean transmitral gradient increased from 1.9 ± 1.0 mm Hg at baseline to 3.5 ± 1.8 mm Hg at discharge (p < 0.001).

CONCLUSIONS

Technical success with the new mitral valve repair system with extended clip arm was achieved in 93% of the patients. MR ≤2+ was obtained in 95 patients (93%) and MR ≤1+ in 79 (77%). The main reasons for procedural failure were acute single-leaflet device attachment associated with leaflet damage or isolated leaflet injury and often required surgical correction.

摘要

目的

本研究旨在探讨使用扩展夹臂进行二尖瓣瓣对瓣修复的技术成功率和疗效。

背景

2018 年推出了 MitraClip 系统的新一代产品 MitraClip XTR,旨在解决前几代产品观察到的技术限制。

方法

接受至少 1 个新植入物治疗有症状的二尖瓣反流(MR)的患者符合本研究的入选标准。

结果

在这项研究中,纳入了 107 名患者(平均年龄 76 ± 9 岁,69%为男性),MR 的病因是平衡的,其中一半(n=53[50%])为继发性,其余 54 名患者为原发性(n=40[37%])或混合性(n=14[13%])疾病。植入设备的平均数量为 1.5 ± 0.6。46 名患者(43%)需要进行多次设备植入。4 名患者发生单叶瓣装置附着,2 名患者发生瓣叶损伤,4 名患者需要手术转换。在 102 名存活出院且未行二尖瓣手术的患者中,95 名(93%)患者的 MR≤2+,79 名(77%)患者的 MR≤1+。跨二尖瓣梯度从基线时的 1.9 ± 1.0mmHg 增加到出院时的 3.5 ± 1.8mmHg(p<0.001)。

结论

新的二尖瓣修复系统使用扩展夹臂的技术成功率达到了 93%。95 名(93%)患者获得了 MR≤2+,79 名(77%)患者获得了 MR≤1+。手术失败的主要原因是急性单叶瓣装置附着伴瓣叶损伤或孤立瓣叶损伤,通常需要手术矫正。

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