新型跨导管边缘到边缘 mitra 修复系统在具有功能性 mitra 反患者的一年结果
Kai Xu1, Da Zhu2, Hong Jiang3
1General Hospital of Northern Theater Command, Shenyang, Liaoning, China.
概括
在心力衰竭患者中,SQ-Kyrin-M系统有效地治疗了严重的功能性额头吐 (FMR),在跨导管边缘到边缘修复 (TEER) 后,症状显著改善,不良事件减少.
科学领域:
- 心脏病学 心脏病学
- 干预心脏病学 干预心脏病学
- 医疗器械 医疗器械
背景情况:
- 过导管边缘到边缘修复 (TEER) 为症状性心力衰竭患者提供了改善的结果,这些患者具有功能性腹反 (FMR),难以接受指导方针导向医学治疗 (GDMT).
- 该SQ-Kyrin-M系统代表了一种新的TEER设备,专门针对FMR.
研究的目的:
- 评估SQ-Kyrin-M系统在患有严重症状性FMR的患者中的安全性和有效性.
- 评估综合所有原因死亡率和心力衰竭在干预后一年住院治疗的初级终点.
主要方法:
- 一个多中心,前性,单臂研究,涉及125名患者,尽管最大GDMT,但患有严重的症状性FMR.
- 主要终点:综合所有原因死亡率和1年内心力衰竭住院治疗率.
- 由心声回声核实验室和临床事件委员会进行独立评估.
主要成果:
- 一年主要终点率为16.0%,主要不良事件率为10.4%.
- 94.2%的患者实现了2+以上的额头腹,并进行了显著的左心室逆向重塑.
- 患者报告的结果有所改善,包括堪萨斯城心肌病问卷得分 (+15.9分) 和6分钟步行距离 (+46.7米),NYHA类从I/II类的30.4%提高到84.4%.
结论:
- 该SQ-Kyrin-M系统在治疗严重的FMR中证明了安全性和有效性.
- 这种透导管中枢修复系统支持了在FMR患者中TEER干预的日益增长的证据基础.
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