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基于 MitraClip 导管的二尖瓣修复系统的临床试验经验。

Clinical trial experience with the MitraClip catheter based mitral valve repair system.

机构信息

Dipartimento Cardio-Toraco-Vascolare, San Raffaele Hospital, Milan, Italy.

出版信息

Int J Cardiovasc Imaging. 2011 Dec;27(8):1155-64. doi: 10.1007/s10554-011-9872-8. Epub 2011 Apr 19.

Abstract

Severe mitral regurgitation (MR) confers a poor prognosis, in particular for patients with heart failure. Based on the results of the Euro Heart Survey, a large proportion of patients with mitral regurgitation is not referred to surgery and many other patients are rejected for cardiac surgery due to the high surgical risk or co-pathologies. Improving ventricular function with ACE inhibitors, beta-blockers and CRT may reduce mitral regurgitation, but for most patients a mechanical intervention is ultimately preferable. Mitral valve surgery is invasive and requires a long recovery period; therefore, less invasive and effective approaches are highly desirable, particularly in high risk patients. Therefore, new techniques have been recently developed to treat MR with percutaneous approach. The MitraClip device (Abbott Vascular, Menlo Park, CA) is used to treat both functional and degenerative mitral valve regurgitation. Its safety and efficacy has been initially tested in the Endovascular Valve Edge-to-Edge REpair Study (EVEREST), while MitraClip has been compared to surgery in the EVEREST II randomized trial. Besides EVEREST trials, safety and efficacy of the device as well as its health economic value is under evaluation in ongoing registries. Although the field of catheter based management of MR is at an early stage, initial clinical results have demonstrated that catheter based approaches can reduce MR, suggesting there is a great deal of potential for clinical benefit to patients with MR.

摘要

严重二尖瓣反流(MR)预后不良,特别是心力衰竭患者。根据欧洲心脏调查的结果,很大一部分二尖瓣反流患者未被转诊手术,许多其他患者因手术风险高或合并症而被拒绝心脏手术。使用 ACE 抑制剂、β受体阻滞剂和 CRT 改善心室功能可能会减少二尖瓣反流,但对于大多数患者,最终还是需要机械干预。二尖瓣手术具有侵入性,需要较长的恢复期;因此,非常需要微创且有效的方法,特别是在高危患者中。因此,最近已经开发了一些新技术,通过经皮途径治疗 MR。MitraClip 装置(雅培血管,门洛帕克,CA)用于治疗功能性和退行性二尖瓣反流。其安全性和有效性最初在经皮二尖瓣瓣环成形术边缘到边缘修复研究(EVEREST)中进行了测试,而 MitraClip 在 EVEREST II 随机试验中与手术进行了比较。除 EVEREST 试验外,该装置的安全性和有效性及其健康经济学价值也在正在进行的注册研究中进行评估。尽管基于导管的 MR 管理领域处于早期阶段,但最初的临床结果表明,基于导管的方法可以减少 MR,这表明对 MR 患者具有很大的临床获益潜力。

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