在患有高风险的症状性先天性主动脉反 (ALIGN- AR) 患者中进行过导管主动脉植入:一项前性多中心单臂研究
Torsten P Vahl1, Vinod H Thourani2, Raj R Makkar3
1Columbia University Irving Medical Center, New York, NY, USA.
Lancet (London, England)
|March 29, 2024
概括
在高风险患者中,透过导管的大动脉植入 (TAVI) 具有治疗严重大动脉吐的前景. 这种创新疗法为手术提供了可行的替代方案,
科学领域:
- 心血管医学
- 干预心脏病学
- 医疗器械
背景情况:
- 手术是对主动脉吐的标准治疗方法.
- 对于不适合手术的高风险患者,需要通过导管治疗.
- 现有的跨导管面临着栓塞和回的挑战.
研究的目的:
- 评估Trilogy跨导管心脏治疗纯主动脉吐的安全性和有效性.
- 评估高风险的患者进行大动脉置换手术.
主要方法:
- 预期的多中心单臂研究 (ALIGN- AR试验).
- 招募了180名症状为中度至重度或重度主动脉吐的患者.
- 评估30天的安全性和1年的死亡率与性能目标相比.
主要成果:
- 在95%的患者中取得技术上的成功.
- 达到了主要安全终点 (27% 的事件) 和疗效终点 (7. 8% 一年死亡率).
- 在24%的患者中新植入起器.
结论:
- 对于患有先天性主动脉吐的高风险患者来说,
- 观察到有希望的短期结果和左心室重塑的迹象.
- 长期跟踪对于确认持续的益处至关重要.
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