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Lancet:TriClip边缘修复系统治疗三尖瓣返流

2019-11-08 MedSci MedSci原创

TricIP系统对降低三尖瓣反流严重程度是安全和有效的。在术后6个月,患者可获得显著的临床改善

三尖瓣返流是一种常见病,其发病率高,死亡率高且治疗方法少。TRILUMINATE试验的目的是评估TriClip(一种微创经导管三尖瓣修复系统)对减少三尖瓣返流的安全性和有效性。

TRILUMINATE试验在欧洲和美国的21个医疗中心进行。中度或重度三尖瓣返流、纽约心脏协会II级或更高级别的患者参与,患者接受TriClip三尖瓣修复系统,接受边缘到边缘修复。研究人员采用5级分级方案(轻度、中度、重度、极重和难以治愈的)对三尖瓣返流进行分级,主要疗效终点为术后30天的三尖瓣返流严重程度至少降低一级。

85名患者(平均年龄77.8岁;56名[66%]女性)入选,并接受了成功的TriClip治疗。在接受超声心动图的83例患者中,71例(86%)的三尖瓣返流严重程度至少降低了1级,达到预先设定的疗效终点。1名患者在6个月的随访前退出,没有发生重大不良事件,被排除在主要安全终点分析之外。6个月时,84名患者中有3名(4%)出现严重不良事件,达到预先设定的安全性终点。72例患者中5例(7%)出现粘连。未发生围手术期死亡、转手术、器械栓塞、心肌梗死或中风。6个月时,84例患者中有4例(5%)死亡。

TricIP系统对降低三尖瓣反流严重程度是安全和有效的。在术后6个月,患者可获得显著的临床改善。

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    2020-05-11 howi
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    2019-11-09 天地飞扬

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