Percutaneous Repair or Surgery for Mitral Regurgitation
Percutaneous Repair or Surgery for Mitral Regurgitation
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DOI：
10.1056/nejmoa1009355
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发表时间：
2011-04-14
影响因子：
158.5
通讯作者：
Mauri, Laura
中科院分区：
文献类型：
--
作者：
Feldman, Ted;Foster, Elyse;Mauri, Laura
可以通过研究性程序来完成背景米布尔阀修复，该程序涉及经皮植入夹子的经皮植入，该夹子抓住并近似于二尖瓣的边缘，在反流喷射的起源处。 +或4+）二尖瓣反流的比例为2：1的比例，要么接受经皮修复或用于修复或替换二尖瓣的常规手术。功效的主要综合终点是免于死亡，脱离二尖瓣功能障碍的手术以及12个月的3级或4级二尖瓣反流。主要的安全终点是在30天内进行重大不良事件的综合。恢复12个月，经皮疗法组的疗效主要终点率为55％，手术组为73％（p = 0.007） 。主要终点组成部分的各个速率如下：死亡，每组6％；二尖瓣功能障碍的手术，20％对2％；和3级或4+二尖瓣反流，21％和20％。经皮治疗组的15％患者发生了重大不良事件，在30天内，手术组的患者中有48％发生（P
BACKGROUNDMitral-valve repair can be accomplished with an investigational procedure that involves the percutaneous implantation of a clip that grasps and approximates the edges of the mitral leaflets at the origin of the regurgitant jet.METHODSWe randomly assigned 279 patients with moderately severe or severe (grade 3+ or 4+) mitral regurgitation in a 2: 1 ratio to undergo either percutaneous repair or conventional surgery for repair or replacement of the mitral valve. The primary composite end point for efficacy was freedom from death, from surgery for mitral-valve dysfunction, and from grade 3+ or 4+ mitral regurgitation at 12 months. The primary safety end point was a composite of major adverse events within 30 days.RESULTSAt 12 months, the rates of the primary end point for efficacy were 55% in the percutaneous-repair group and 73% in the surgery group (P = 0.007). The respective rates of the components of the primary end point were as follows: death, 6% in each group; surgery for mitral-valve dysfunction, 20% versus 2%; and grade 3+ or 4+ mitral regurgitation, 21% versus 20%. Major adverse events occurred in 15% of patients in the percutaneous-repair group and 48% of patients in the surgery group at 30 days (P