Evolut PRO/PRO+ 与 Evolut R 系统相比,用于跨导管大动脉更换
Sukhdeep Bhogal1, Toby Rogers2, Ilan Merdler1
1Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
International journal of cardiology
|July 21, 2023
概括
在治疗严重的大动脉狭窄时,Evolut PRO/PRO+ 跨导管大动脉的安全性和疗效与 Evolut R 相同. 包括死亡率和门功能在内的结果在30天和1年后是相似的.
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
- 生物医学工程 生物医学工程
背景情况:
- 自扩展的CoreValve Evolut PRO/PRO+ 跨导管大动脉是为了解决 Evolut R 模型的局限性而开发的.
- Evolut PRO/PRO+具有较低的输送配置和所有门尺寸的外部组织包裹,增强了其设计.
- 本研究将Evolut PRO/PRO+与Evolut R系统的安全性和有效性进行比较.
研究的目的:
- 评估和比较Evolut PRO/PRO+跨导管大动脉系统与Evolut R系统的安全性和有效性.
- 评估临床结果,包括死亡率和并发症,在手术后的30天和1年.
- 分析30天和1年的心声回声学参数,以确定血液动力学性能.
主要方法:
- 从EPROMPT注册表的300名患者 (Evolut PRO/PRO+) 和242名历史对照 (Evolut R) 的倾向-得分匹配分析.
- 根据胸部外科医生协会预测死亡风险得分进行1:1匹配,以平衡基线特征.
- 关键的终点包括住院安全,30天和1年的全因死亡率以及30天和1年的心声回声评估.
主要成果:
- 在心脏病死亡 (0.5%对0.5%),中风 (1.6%对2.8%),危及生命的出血 (1.1%对3.3%),主要血管并发症 (0.5%对0.9%) 或心脏起器植入 (16.9%对13.6%) 之间没有观察到显著差异.
- 所有原因的死亡率在30天 (0.5%对1.4%) 和1年 (1.8%对4.1%) 时是相似的.
- 一年后,心声图的结果,包括中度的准膜泄漏 (5.7%与2.6%) 和平均梯度 (7.27与8.84 mmHg) 是可比的.
结论:
- Evolut PRO/PRO+系统是一种安全有效的选择,用于治疗严重的大动脉狭窄,正如这项大型观察性研究所证实的那样.
- 该系统显示了与Evolut R.相比的30天和1年死亡率.
- 与Evolut R相比,Evolut PRO/PRO+实现了与Evolut R相似的1年心声回声学血液动力学结果,验证了其临床性能.
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