在小大动脉 Annuli 的 Evolut PRO 和 SAPIEN ULTRA 性能: OPERA-TAVI 注册表
Andrea Scotti1, Matteo Sturla1, Giuliano Costa2
1Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
JACC. Cardiovascular interventions
|March 13, 2024
概括
在患有小主动脉环的患者中,最新的跨导管主动脉置换器件显示出类似的有效性. 自扩展具有更好的设备性能,但与气球可扩展相比,增加了中风和泄漏风险.
科学领域:
- 心脏病学 心脏病学
- 干预心脏病学 干预心脏病学
- 医疗器械 医疗器械
背景情况:
- 过导管大动脉置换 (TAVR) 是大动脉狭窄的关键治疗方法.
- 较新的TAVR平台在患有小主动脉环形患者的性能尚不清楚.
研究的目的:
- 为了比较自扩展 (SE) Evolut PRO/PRO+和气球可扩展 (BE) SAPIEN ULTRA TAVR设备在患有小主动脉环的患者中的有效性和性能.
主要方法:
- 对OPERA-TAVI注册表数据的分析.
- 251对患者的倾向性得分匹配 (1:1) 的大动脉环形面积<430 mm2.
- 主要终点:一年的综合疗效和30天的设备相关结果.
主要成果:
- 在SE和BE组之间的1年初级有效性复合结果中没有显著差异 (10.8%与11.2%,P=0.91).
- SE Evolut 门显示了更有利的30天设备导向结果 (4.8%与10.4%,P=0.027),但失效性中风和膜漏洞的比率更高.
- 蜜蜂树ULTRA具有更高的假肢-患者不匹配率和残留梯度.
结论:
- 使用最新代设备的TAVR在患有小主动脉环形患者中是安全的.
- SE平台表现出优越的血液动力学性能,但携带更高的风险中风和副膜泄漏.
- 需要进一步的随机试验来证实这些发现,并指导临床决策.
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