EUR HEART J:可重新定位和完全可回收主动脉瓣的安全性和有效性:RESPOND研究

2017-06-26 xiangting MedSci原创

RESPOND的结果证实了,在常规临床实践中使用Lotus瓣进行TAVI的安全性和有效性。

RESPOND是一项前瞻性、开放标签的单臂研究,旨在评估在治疗主动脉瓣狭窄患者的常规临床实践中,经导管主动脉瓣植入(TAVI)可重新定位和完全可回收的lotus瓣后的结局。 

RESPOND在欧洲、新西兰和拉丁美洲纳入1014名患者; 996名患者植入了Lotus瓣(平均年龄80.8岁;女性占50.8%;胸外科协会评分为6.0±6.9)。29.2%的患者尝试重新定位,成功率达99%。在30天(主要终点),意向治疗人群的全因死亡率为2.6%(P?<0.001,vs.预先确定的表现得分)。97.3%的患者完成了临床30天随访。在接受lotus瓣的患者中,30天的总体和致残卒中率分别为3.0%和2.2%。所有患者中30天永久起搏器植入率为30.0%,从未安装过起搏器的患者为34.6%。基线和放电前的超声心动图数据由独立的核心实验室进行评估。平均主动脉瓣梯度从基线的37.7±15.2 mmHg下降到出院时的10.8±4.6 mmHg( P<0.001)。主动脉瓣面积从基线的0.7±0.2 cm2增加到1.8±0.4 cm2(P< ?0.001)。在出院时,92%的患者无瓣膜渗漏(PVL); 没有患者存在严重PVL,0.3%的患者出现中度PVL,7.7%的患者有轻度PVL。RESPOND的临床随访延长至5年。

RESPOND的结果证实了,在常规临床实践中使用Lotus瓣进行TAVI的安全性和有效性

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    2017-06-29 大爰

    好文章学习了谢谢分享!

    0

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    2017-06-28 zhaojie88
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    2017-06-28 slcumt