在高风险和不可手术的严重大动脉狭窄患者中使用SAPIEN 3跨导管大动脉置换的一年临床结果
在PubMed上查看摘要
概括
此摘要是机器生成的。在高风险患者中,用SAPIEN 3系统进行透导动脉置换可改善存活率和症状缓解. 这项研究证实了其对大动脉狭窄治疗的安全性和有效性.
科学领域
- 心血管医学
- 干预心脏病学
- 医疗器械
背景情况
- 最初的PARTNER试验报告了一年死亡率为24% (高风险) 和31% (无法手术).
- 尽管 SAPIEN 3 TAVR 系统的30天效果充满希望,但其长期效果仍然不太清楚.
研究的目的
- 评估SAPIEN 3跨导管大动脉置换系统在高风险和不可手术的大动脉狭窄患者中的1年临床结果和安全性.
- 在该患者群体中评估TAVR后的生存率,不良事件和症状改善.
主要方法
- 在2013年10月至2014年9月期间,美国29个高风险或不可操作的患者注册.
- 独立委员会对重大临床事件进行判断,核心实验室对1年随访后的心声结果进行分析.
主要成果
- 一年全因生存率为总体85. 6%,高风险组为87. 3%,无手术子组为82. 3%.
- 没有观察到严重的膜泄漏;中度泄漏 (2. 7%) 与死亡率的增加有关.
- 患者症状显著改善,从NYHA类III/ IV改善到7. 7% (P< 0. 0001),堪萨斯城心肌病问卷得分从46. 9提高到72. 4 (P< 0. 0001).
结论
- 由于并发症率较低,SAPIEN 3 TAVR系统在高危和不可手术的患者中显示出较低的一年死亡率.
- 中度漏与死亡率的增加有关,而轻度漏没有显著的关联.
- 这些发现支持TAVR与SAPIEN 3装置作为高风险和不可手术的大动脉狭窄患者的首选疗法,反射装置和程序进步.
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