气球可扩展的Myval Octacor与自扩展的Evolut PRO/PRO+和Acurate Neo2:倾向匹配分析的短期结果
Elisabetta Moscarella1,2, Alfonso Ielasi3, Won-Keun Kim4
1Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
概括
与自扩张相比,Myval Octacor在过导管主动脉植入 (TAVI) 中表现得更好,安全性结果相似. 需要进一步的随机研究来证实TAVI程序的这些发现.
科学领域:
- 心血管医学
- 干预心脏病学
- 生物材料工程
背景情况:
- 通过导管的大动脉植入 (TAVI) 正在扩展到年轻,风险较低的患者中,需要优化手术和血液动力学结果.
- Myval Octacor气球可扩展 (BEV) 的目的是减少对膜反 (PVL),节拍器植入 (PPI) 和改善血液动力学.
- 对于Myval Octacor与当代的自扩张超门 (SEV) 进行比较的数据有限,例如Evolut PRO/ PRO+和Acurate Neo2.
研究的目的:
- 为了比较 Myval Octacor BEV 与 SEV 的安全性,疗效和短期临床结果.
- 在TAVI后30天评估装置成功,技术成功,门性能和早期安全终点.
主要方法:
- 与NEOPRO2注册中的SEV接受者相比,Myval Octacor患者的前性多中心注册.
- 使用倾向分数匹配来调整组之间的基线差异.
- 主要终点:30天的门学术研究联盟-3 (VARC-3) 设备的成功. 二级终点:技术上的成功,门的性能和早期的安全性.
主要成果:
- 与SEV相比,Myval Octacor的30天VARC-3器件的成功率更高 (97%与88%,p=0. 024).
- 在Myval Octacor组中观察到较低中度至重度PVL的趋势 (1%对7%,p=0. 06).
- 使用Myval Octacor的有效孔面积较大;死亡率,中风,PPI和心脏病发作率在30天后相似.
结论:
- 在TAVI中,Myval Octacor的早期安全性和有效性与超年性SEV相美.
- 在设备的成功和血液动力性能方面,Myval Octacor具有潜在的优势.
- 需要进行更大规模的随机试验来验证TAVI程序的这些发现.
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