Rassaf Tienush, Balzer Jan, Zeus Tobias, Rammos Christos, Shayganfar Sascha, Hall Silke V, Wagstaff Rabea, Kelm Malte
Medical Faculty, Department of Medicine, Division of Cardiology, Pulmonology, and Vascular Medicine, University Hospital Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany.
Catheter Cardiovasc Interv. 2014 Oct 1;84(4):E38-42. doi: 10.1002/ccd.25570. Epub 2014 Jul 4.
To characterize the safety and efficacy of deep sedation (DS) as compared to general anaesthesia (GA) in percutaneous mitral valve repair (PMVR) using the MitraClip system.
PMVR with the MitraClip system has emerged as a therapeutic alternative to surgical valve repair in high-risk patients. The PMVR procedure is typically performed under GA. Due to their high surgical risk, avoidance of GA in many of those patients would be desirable.
In an open-label observational study 21 patients with severe mitral regurgitation were randomized to either GA or DS using propofol. Primary endpoints of this comparison were related to safety with rate of conversion from DS to GA, bleeding, aspiration, and pneumonia. Secondary endpoints were related to efficacy with procedural, in-hospital, and mid-term outcome at 1 month.
All clips have been implanted successfully in both groups. No conversion from DS to GA was necessary. Four patients undergoing GA suffered from upper respiratory tract infections and two from peripheral vascular complications during placement of central venous catheter for GA. Short- and mid-term efficacy were comparable in both groups with a reduced hospital stay in the DS group.
PVMR in high-risk patients performed under DS is as safe and effective as with GA, preventing complications related to GA and shortening hospital stay.
比较在使用MitraClip系统进行经皮二尖瓣修复术（PMVR）时，深度镇静（DS）与全身麻醉（GA）的安全性和有效性。
对于高危患者，使用MitraClip系统进行PMVR已成为手术瓣膜修复的一种治疗替代方案。PMVR手术通常在GA下进行。由于这些患者手术风险高，许多患者希望避免使用GA。
在一项开放标签观察性研究中，21例严重二尖瓣反流患者被随机分为使用丙泊酚进行GA或DS的两组。该比较的主要终点与安全性相关，包括从DS转换为GA的比率、出血、误吸和肺炎。次要终点与1个月时的手术、住院和中期结局的有效性相关。
两组所有夹子均成功植入。无需从DS转换为GA。4例接受GA的患者在放置GA中心静脉导管期间患上呼吸道感染，2例出现外周血管并发症。两组的短期和中期疗效相当，DS组住院时间缩短。
高危患者在DS下进行的PVMR与GA一样安全有效，可预防与GA相关的并发症并缩短住院时间。
