JACC:经导管三尖瓣瓣膜成形术的早期可行性研究

2017-04-10 MedSci MedSci原创

SCOUT试验的30天结果证实了新型经导管装置的安全性,该装置降低了TA和EROA,增加了LVSV,改善了QoL。

SCOUT(经皮三尖瓣瓣膜成形术用于治疗慢性功能性三尖瓣反流)试验是一项关于经导管使三尖瓣环(TA)褶皱并减少三尖瓣反流(TR)设备早期可行性的前瞻性、多中心研究。

研究人员共纳入2015年11月至2016年6月期间的15名NYHA心功能分级II级以上,TR中度以上的患者。分别在试验开始和第30天对患者进行超声心动图检查(TA直径、有效回流孔面积[EROA],左心室搏出量[LVSV])和评估生活质量(QoL)(NYHA心功能分级,明尼苏达心力衰竭问卷[MLHFQ]和6分钟步行测试[6MWT])。

所有患者(平均73.2±6.9岁,女性87%)均成功的进行了装置植入,没有死亡、中风、出血、填塞或瓣膜再介入。30天的技术成功率为80%,其中3名患者为单体环形分离器无需再介入,其余的12名患者TA明显减少(12.3±3.1cm2对11.3±2.7cm2;P = 0.019);EROA(0.51±0.18 cm2对0.32±0.18 cm2; P = 0.020),LVSV显著升高(63.6±17.9ml对71.5±25.7ml,P = 0.021)。在意向治疗队列中,NYHA心功能分级(>1级,P= 0.001),MLHFQ(47.4±17.6对20.9±14.8;P <0.001)和6分钟步行试验(245.2±110.1对298.0±107.6;P =0.008)有明显改善。

SCOUT试验的30天结果证实了新型经导管装置的安全性,该装置降低了TA和EROA,增加了LVSV,改善了QoL。

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    2017-05-08 hbwxf
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    2017-04-12 lsj631
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