使用快速部署用于大动脉狭窄症的大动脉置换的中期结果:TRANSFORM试验
S Chris Malaisrie1, Mubashir A Mumtaz2, Glenn R Barnhart3
1Division of Cardiac Surgery, Northwestern University, Chicago, Ill.
JTCVS open
|February 29, 2024
概括
动脉替换 (AVR) 的快速部署 (RDV) 显示了低的长期不良事件率. 这项研究证实了RDV的持久安全性和血液动力学性能,在手术后的7年内.
科学领域:
- 心血管外科心血管外科
- 干预心脏病学 干预心脏病学
- 生物材料科学 生物材料科学
背景情况:
- 快速部署门 (RDVs) 的目的是减少大动脉门置换 (AVR) 的手术时间.
- 有限的长期数据存在RDV结果.
- 这项研究提供了7年对RDV使用的随访数据.
研究的目的:
- 评估长期 (7年) 快速部署门在大动脉门更换中的安全性和有效性.
- 评估结构的恶化,重新干预,扩张和死亡率.
- 为了分析血液动力学性能和随着时间的推移而出现的准膜泄漏.
主要方法:
- 预期的,非随机的,多中心的,单臂试验 (TRANSFORM).
- 植入的stented牛心膜带一个气球可扩展的密封框架.
- 通过8年收集885名患者的年度临床和心声回声数据.
主要成果:
- 7年后,没有结构的恶化率为97.5%,重新干预率为95.7%,扩张率为97.8%.
- 隔离AVR的7年全因死亡率为76.0%,同时发生AVR的68.2%.
- 观察到稳定的血液动力学性能,平均梯度为11.1mmHg,有效孔面积为1.6厘米; 88.6%的人没有/有痕迹的准膜泄漏.
结论:
- 使用RDVs进行的大动脉置换与晚期不良事件的低率有关.
- 研究的手术心周组织门平台显示出高达7年的优秀和稳定的血液动力学性能.
- RDVs代表了一种安全而有效的选择,用于以持久的长期结果更换大动脉.
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