早期的结果与下一代双密封左前庭尾封闭器:来自VERITAS研究的结果
Devi Nair1, Xavier Freixa2, Christopher R Ellis3
1St. Bernard's Heart and Vascular Center, Jonesboro, Arkansas, USA.
JACC. Clinical electrophysiology
|February 17, 2026
概括
维里塔斯研究表明,下一代双密封左心房尾阻塞 (LAAO) 装置具有99.8%的植入成功率和出色的短期安全性. 该设备为心房动患者提供了一个有前途的中风预防策略.
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:
- 穿皮左心房尾阻塞 (LAAO) 是一种替代性中风预防方法,用于无法使用口服抗凝药的心房患者.
- 当前的LAAO设备可能会导致周边设备泄漏和心周溢出.
- 在VERITAS研究中,Abbott公司研究了下一代双密封LAAO设备.
研究的目的:
- 为了评估下一代双密封LAAO设备的安全性和有效性.
- 评估VERITAS研究的主要终点和关键临床结果,直到手术后45天.
主要方法:
- 一项前性,全球性,多中心,单臂研究,涉及400名心房患者.
- 患者使用Amulet 360双密封装置进行LAAO.
- 主要安全性终点评估了7天内的不良事件; 主要有效性终点评估了LAAO (泄漏≤5毫米) 在45天通过透食管心声学.
主要成果:
- 植入成功率为99.8% (399/400名患者).
- 主要安全终点发生率为0.0%.
- 100%达到主要有效性终点,其中93.9%在45天内达到完全LAAO (0毫米泄漏). 心周溢出发生在0.5%的患者中,与设备相关的血栓发生在2.4%的患者中.
结论:
- 维里塔斯研究证实了下一代双密封LAAO设备的高植入成功率.
- 该设备表现出有利的短期安全性和密封性.
- 这项技术为心房动中风预防提供了潜在的改进选择.
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