在高风险的患有心房的患者中使用AMPLATZER护身符装置进行左心房尾闭塞,这些患者正在接受跨导管大动脉干预:一项随机试点研究
Philipp Jakob1, Priska Heinz2, Yiqi Gong1
1Department of Cardiology, University Heart Center, University Hospital Zurich and the Center for Translational and Experimental Cardiology (CTEC), University of Zurich, Zurich, Switzerland.
Structural heart : the journal of the Heart Team
|December 1, 2025
概括
对于接受TAVI的严重大动脉狭窄和心房的患者,将左心房尾闭塞 (LAAO) 与标准治疗相结合,与单独TAVI相比,主要终点率相似. 这项试点研究表明,组合方法的安全性和有效性概况相似.
科学领域:
- 心脏病学 心脏病学
- 干预心脏病学 干预心脏病学
- 电子生理学 电子生理学
背景情况:
- 患有严重的大动脉狭窄和心房动 (AF) 的患者在跨导管大动脉干预 (TAVI) 期间面临出血和脑血管事件的风险增加.
- 左心房尾阻塞 (LAAO) 是一个潜在的策略,以减轻这些风险的AF患者接受TAVI.
研究的目的:
- 评估LAAO与TAVI一起用于AF患者的安全性和有效性.
- 为了比较TAVI + LAAO联合策略与TAVI后的标准医学治疗 (SMT).
主要方法:
- 一个由研究者发起的,随机的,多中心的,开放标签的试点研究.
- 81名高风险患者被随机分配到TAVI + LAAO或TAVI + SMT.
- 主要终点是脑血管事件,外周栓塞,严重出血或1年内心血管死亡率的复合.
主要成果:
- 主要终点发生在TAVI + LAAO组的33%,而TAVI + SMT组的37% (调整后OR,0.87;P=0.77).
- 在LAAO组中,出血率相似 (13%对17%),没有非程序性出血.
- 脑血管事件在各组之间没有显著差异 (10%对2.4%). 每个协议的分析也显示了可比的初级终点率.
结论:
- 在接受TAVI的高风险AF患者中,联合LAAO和早期口服抗凝药停止策略与SMT的TAVI相比,表现出类似的初级终点率.
- 这项试点研究表明,将LAAO与TAVI结合在一起的可行性和可比结果.
- 需要进一步的研究,以在更大的试验中证实这些发现.
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