环内自扩展或气球可扩展的TAVI在小环内:NAVULTRA注册表
Stefano Cannata1,2, Ibrahim Sultan3, Nicolas M Van Mieghem4
1Unit of Interventional Cardiology, Department of Cardiothoracic Surgery, IRCCS-ISMETT (Mediterranean Institute for Transplantation and Advanced Specialized Therapies), Palermo, Italy.
概括
通过导管的大动脉植入 (TAVI) 通过Navitor (NAV) 和SAPIEN 3 Ultra (ULTRA) 门在小的大动脉环中显示出类似的1年生存率. NAV提供了更好的血液动力学,但增加了轻微的准膜泄漏和永久心脏起器植入率.
科学领域:
- 心脏病学 心脏病学
- 干预心脏病学 干预心脏病学
- 心脏外科手术 心脏外科手术
背景情况:
- 自扩展的Navitor (NAV) 和气球可扩展的SAPIEN 3 Ultra (ULTRA) 跨导管心脏门 (THV) 在患有小主动脉环的患者中的比较数据有限.
- 严重的大动脉狭窄需要有效的治疗,特别是在具有具有挑战性的解剖特征的患者中,如小的大动脉环.
研究的目的:
- 为了评估和比较透过导管的大动脉植入 (TAVI) 的临床结果,使用年内NAV和ULTRA THVs.
- 评估这些THV在被诊断患有严重大动脉狭窄和小大动脉环形患者的安全性和有效性.
主要方法:
- 对来自NAVULTRA注册的患者进行了倾向匹配的分析,大动脉环面积≤430 mm2,接受TAVI.
- 主要终点包括1年死亡率,所有原因死亡率的复合,致残性中风或心力衰竭住院治疗,以及30天的设备导向结果.
- 评估的面向设备的结果包括假肢患者不匹配,膜漏洞 (PVL) 和平均跨膜梯度.
主要成果:
- 一年后,在NAV和ULTRA之间没有发现所有原因死亡率 (8.8%与9.0%,p=0.585) 或复合终点 (11.3%与11.8%,p=0.149) 的显著差异.
- NAV显示出优异的设备导向结果 (6.0%与29.3%,p<0.01),以较低的平均梯度 (7.3 mmHg与12.7 mmHg,p<0.01) 和减少假肢患者不匹配为特征.
- 然而,与ULTRA组相比,NAV组的轻度PVL (33.5%与23.2%,p<0.05) 和永久心脏起器植入 (PPI) (20.1%与11.9%,p<0.01) 发生率较高.
结论:
- 无论是NAV还是ULTRATHV,在接受TAVI的小大动脉环形患者中,都提供了可比的1年临床结果.
- NAV显示出增强的血液动力学性能,由较低的梯度和较少的假肢患者不匹配证明.
- 这些NAV的好处伴随着轻度膜漏水的风险增加以及需要永久性起器植入的需要.
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