下一代左耳关闭装置的主要结果评估:PINNACLE FLX试验的结果
Saibal Kar1,2, Shephal K Doshi3, Ashish Sadhu4
1Los Robles Regional Medical Center, Thousand Oaks, CA (S.K.).
Circulation
|April 6, 2021
概括
对于心房患者来说, 这种装置有效地关闭左心房附属体, 这项研究证实了它的高成功率和低并发症风险.
科学领域:
- 心脏病学
- 医疗器械
- 预防血栓形成
背景情况:
- 左心房塞是一种替代口服抗凝药,可降低非膜性心房动 (AF) 的血栓栓塞风险.
- 2015年批准的WATCHMAN设备是美国主要使用的LAA封闭设备.
- 在PINNACLE FLX研究中,研究了下一代WATCHMAN FLX设备.
研究的目的:
- 评估WATCHMAN FLX LAA关闭装置的安全性和有效性
- 评估其作为非药物替代品的适用性.
- 确定设备是否符合预先定义的安全性和有效性性能目标.
主要方法:
- 美国FDA的一项前性,非随机的多中心研究.
- 主要安全终点:在手术后7天内死亡,中风,全身栓塞或设备/手术相关事件的组合.
- 主要疗效终点:通过心声扫描在12个月后成功关闭LAA (周围器件流量≤5毫米).
主要成果:
- 平均年龄为73. 8岁,平均CHA2DS2- VASc评分为4. 2
- 主要安全终点发生率为0. 5% (性能目标为4. 2%),P< 0. 0001.
- 主要有效性终点 (LAA关闭) 的发生率为100% (性能目标为97.0%),P< 0. 0001.
结论:
- 使用WATCHMAN FLX设备关闭下一代LAA显示不良事件的发生率很低.
- 观察到高成功解剖LAA关闭率.
- 该设备达到预先定义的安全性和有效性性能目标.
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