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JACC Cardiovasc Interv:新型ARTO系统治疗功能性二尖瓣返流安全有效

2015-08-10 徐媛媛译 MedSci原创

新型ARTO系统可改善二尖瓣返流(FMR),因此,本研究评估了新型ARTO系统对心力衰竭患者和功能性二尖瓣返流的治疗效果。 MAVERIC试验是一项前瞻性,非随机化的研究。关键入选标准为患者均为收缩性心衰、NYHA心功能II~IV级、功能性二尖瓣返流等级大于2级、左心室射血分数小于等于40%、左室舒张末期内径在50 mm~75 mm之间。主要安全性终点是30天主要不良事件,有效性终点为二尖瓣返流

新型ARTO系统可改善二尖瓣返流(FMR),因此,本研究评估了新型ARTO系统对心力衰竭患者和功能性二尖瓣返流的治疗效果。

MAVERIC试验是一项前瞻性,非随机化的研究。关键入选标准为患者均为收缩性心衰、NYHA心功能II~IV级、功能性二尖瓣返流等级大于2级、左心室射血分数小于等于40%、左室舒张末期内径在50 mm~75 mm之间。主要安全性终点是30天主要不良事件,有效性终点为二尖瓣返流减少、左室容量及心功能改善。

11名患者接受ARTO系统,而且没有不良事件。当30天时,有了明显的改善。有效返流口面积(30.3 ± 11.1 mm(2)降低至13.5 ± 7.1 mm(2) )、返流体积(45.4 ± 15.0 ml降低至 19.5 ± 10.2 ml)及二尖瓣环前后直径(45.0 ± 3.3 mm 降低至38.7 ± 3.0 mm)均有所下降,研究者还观察到患者左室收缩末期容量(77.5 ± 24.3 ml/m(2)降低至68.5 ± 21.4 ml/m(2), )与舒张末期容量(118.7 ± 28.6 ml/m(2)降低至103.9 ± 21.2 ml/m(2). )的改善。81.8%患者基线心功能为NYHAIII或IV级,18.2%为I或II级;30天时,45.5%心功能为III或IV级,54.6%为I或II级。90%患者基线功能性二尖瓣返流等级为3~4以上,30天时82%功能性二尖瓣返流等级为1~2以上。

以上研究结果表明,新型ARTO系统够安全有效的治疗功能性二尖瓣返流。

原始出处

Rogers JH1, Thomas M2, Morice MC3, Narbute I4, Zabunova M4, Hovasse T3, Poupineau M5, Rudzitis A4, Kamzola G4, Zvaigzne L4, Greene S6, Erglis A4.Treatment of Heart Failure With Associated Functional Mitral Regurgitation Using the ARTO System: Initial Results of the First-in-Human MAVERIC Trial (Mitral Valve Repair Clinical Trial).JACC Cardiovasc Interv. 2015 Jul;8(8):1095-104

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    2015-12-12 quxin068
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    2015-09-30 hbwxf
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    2015-08-12 zhaojie88
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    2015-08-12 wwzzly
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