用一个完全可回收的自我扩展的短框架科学冠替换透气管大动脉门,用于严重的大动脉狭窄
Yang Chen1,2, Qingrong Liu1,3, Hongliang Zhang1
1Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
International journal of surgery (London, England)
|November 25, 2025
概括
新型ScienCrown跨导管大动脉置换系统 (TAVR) 在严重的大动脉狭窄症 (AS) 患者中显示出出色的安全性和有效性. 一年后的结果显示,死亡率,血液动力学和生活质量有显著改善.
科学领域:
- 心血管医学 心血管医学
- 干预心脏病学 干预心脏病学
- 医疗器械技术 医疗器械技术
背景情况:
- 过导管大动脉置换 (TAVR) 对于治疗严重的大动脉狭窄症 (AS) 至关重要.
- 在TAVR的技术挑战需要专门的设备.
- ScienCrown系统是一个新的,完全可回收的,自我扩展的,短的TAVR设备.
研究的目的:
- 评估ScienCrown TAVR系统的安全性和有效性.
- 评估严重AS患者的临床结果和血液动力学性能.
主要方法:
- 一项前性多中心单臂研究 (NCT05202977) 招募了128名症状严重的AS患者.
- 患者使用ScienCrown进行TAVR.
- 主要终点是1年内全因死亡率.
主要成果:
- 设备成功率为99.20%,手术成功率为96.88%.
- 一年全因死亡率为5.47%,明显低于25%的绩效目标.
- 在血液动力学和生活质量方面观察到显著改善;中风,心肌梗塞和中等水平的准膜泄漏率很低.
结论:
- 该ScienCrown系统在患有严重AS的患者中证明了良好的安全性和有效性.
- 该设备在1年后提供了持续的临床和血液动力学益处.
- 双主动脉和三主动脉患者的结局类似.
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