美国首次使用护身符的经验:来自EMERGE LAA后审批研究的早期见解
Mohamad Alkhouli1, James V Freeman2, Christopher R Ellis3
1Mayo Clinic, Rochester, Minnesota, USA.
JACC. Cardiovascular interventions
|February 4, 2024
概括
护身符左心室尾 (LAA) 遮器在现实世界中使用时显示出良好的安全性和有效性. 操作人员的经验显著减少了心周溢出等并发症,这表明该设备的学习曲线.
科学领域:
- 心脏病学 心脏病学
- 医疗器械 医疗器械
- 临床研究 临床研究
背景情况:
- 护身符封闭器根据护身符IDE试验获得了FDA批准.
- 该装置用于左心房附属体封闭.
研究的目的:
- 评估美国"护身符"封闭器在批准后的早期结果.
- 使用来自国家心血管数据注册局 (LAA Occlusion Registry) 的数据.
主要方法:
- 包括试图从2021年8月到2022年12月植入护身符封闭器的患者.
- 通过45天评估安全复合终点 (死亡,中风,血栓塞,设备/程序事件) 和重大不良事件.
- 根据操作员经验分层的结果:早期 (<10例),中度 (10-29例) 和高 (30+例).
主要成果:
- 5499名患者进行了植入试验,植入成功率为95.8%.
- 程序后的完全关闭率为97.2%,45天后为87.1%.
- 安全复合事件发生率为0.76%;主要不良事件为2.9%在医院和5.7%在45天,主要是出血和心周溢血 (PE).
结论:
- 该EMERGE研究表明,护身符遮器在现实世界中具有良好的安全性和有效性.
- 增加操作者经验与改善的植入成功率和降低的PE率相关.
- 建议在植入这种双闭合机制装置时使用学习曲线效应.
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