用Eos系统替换关节的跨关节透气管的一年结果:MISCEND研究
Raj Makkar1, Moody M Makar1, Sabah Skaf1
1Cedars-Sinai Medical Center, Los Angeles, California, USA.
JACC. Cardiovascular interventions
|September 24, 2025
概括
使用Eos系统进行过导管中枢置换 (TMVR) 表明可行性,并改善了患者的功能. 然而,左心室伪动脉瘤的担忧导致了研究的终止,指导了未来的设备开发.
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:
- 透导管 mitra 置换 (TMVR) 为患有 mitra 吐 (MR) 的高风险患者提供了一个潜在的解决方案.
- 埃奥斯系统代表了TMVR的新型跨导管装置.
研究的目的:
- 为了评估30天和1年的安全性和性能结果的转移骨EosTMVR系统.
- 评估接受TMVR的患者的临床,心声学,功能和生活质量改善.
主要方法:
- 在MISCEND研究中,在单臂多中心环境中对EosTMVR系统进行了前性评估.
- 关键的终点包括设备的成功,手术的成功,MR的严重程度和30天的主要不良事件.
- 一年后的长期结果包括功能状态和生活质量.
主要成果:
- 在60名患者中观察到100%的设备和程序成功率.
- 6分钟的步行距离和生活质量在1年后显著改善.
- 30天复合主要不良事件发生率为43.3%,1年死亡率为20.3%,左心室伪动脉瘤发生率为10.0%.
结论:
- 埃奥斯TMVR系统在患有甲骨管吐的患者中证明了可行性和功能改善.
- 左心室伪动脉瘤出现了安全问题,导致该研究的入学停止.
- 这项研究的学习将为未来TMVR技术的发展提供信息.
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