Division of Cardiovascular Medicine, Davis Medical Center, University of California, Sacramento CA, USA.
Eur Heart J. 2011 Oct;32(19):2350-7. doi: 10.1093/eurheartj/ehr101. Epub 2011 May 23.
MitraClip therapy consists of percutaneous edge-to-edge coaptation of the mitral leaflets that is analogous to the surgical Alfieri technique. The safety profile of the MitraClip device is favourable, and survival outcomes in high-surgical-risk patients are superior to historical controls. However, questions remain regarding long-term efficacy and durability. In the U.S.A., the MitraClip device has been studied in a safety and feasibility trial, a randomized pivotal trial against surgical mitral valve repair, and a non-randomized high-risk registry. In addition, the MitraClip now has over 2 years of CE-mark approval and a rapidly expanding clinical experience in Europe, primarily in patients at high risk for surgery. A dedicated multidisciplinary team is necessary, as well as thoughtful patient selection, familiarity with the technical aspects of the procedure including transesophageal ultrasound imaging and post-procedure monitoring. Currently available clinical data are herein reviewed, with emphasis on the current role of MitraClip therapy in relation to existing surgical techniques. Since the MitraClip procedure is still relatively new, continued investigation is required to further define patient populations that will benefit most.
MitraClip 治疗包括经皮二尖瓣边缘对边缘的贴合,类似于外科 Alfieri 技术。MitraClip 装置的安全性良好,高手术风险患者的生存率优于历史对照。然而,长期疗效和耐久性仍存在疑问。在美国,MitraClip 装置已在安全性和可行性试验、与外科二尖瓣修复的随机关键试验以及非随机高危注册研究中进行了研究。此外,MitraClip 现在已经获得 CE 标志批准超过 2 年,并且在欧洲的临床经验迅速扩大,主要是在手术风险高的患者中。需要一个专门的多学科团队,以及对患者进行深思熟虑的选择,熟悉包括经食管超声心动图成像和术后监测在内的手术技术方面。目前对现有临床数据进行了审查,重点是 MitraClip 治疗与现有外科技术的关系。由于 MitraClip 手术仍相对较新,需要进一步研究来进一步确定受益最大的患者人群。