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经导管主动脉瓣置换术(TAVI)联合 ACURATE neo 经导管心脏瓣膜在特殊人群中的应用:一项系统评价。

TAVI with the ACURATE neo transcatheter heart valve in special populations: A systematic review.

机构信息

First Department of Cardiology, National and Kapodistrian University, "Hippokration" Hospital, Athens, Greece; Athens Naval and Veterans Hospital, Athens, Greece.

First Department of Cardiology, National and Kapodistrian University, "Hippokration" Hospital, Athens, Greece; Department of Cardiology, 424 General Military Training Hospital, Thessaloniki, Greece.

出版信息

Hellenic J Cardiol. 2022 Jul-Aug;66:67-71. doi: 10.1016/j.hjc.2022.04.005. Epub 2022 May 1.

Abstract

The ACURATE neo transcatheter aortic valve is a self-expanding device suitable for both transfemoral and transapical approach, but specific groups of patients are under-represented in clinical trials. We aim to provide a comprehensive systematic review on TAVI with ACURATE neo in those special populations. TAVI in bicuspid aortic valve, TAVI in patients with small aortic annulus, TAVI for pure aortic regurgitation and valve-in-valve procedures, were systematically reviewed. The primary endpoint was device success as defined by VARC-2 criteria. The secondary endpoints were safety and performance outcomes according to VARC-2 consensus document.ACURATE neo exhibited similar outcomes in bicuspid vs tricuspid aortic valve except for pre and post-dilatation rates in one observational study. Lower mean aortic gradient and higher pre-dilatation rates with comparable safety outcomes were described for ACURATE neo when compared to Lotus and Evolut-R for bicuspid aortic valve stenosis. 2 studies compared ACURATE in small aortic annuli. ACURATE neo showed lower transvalvular gradients and lower patient prosthesis mismatch rates compared to Sapien 3 and when compared to Evolut R/ Evolut PRO/ Portico, results were similar except for pre-dilatation rates. 3 studies investigated ACURATE neo for pure aortic regurgitation and one for valve-in-valve procedure and demonstrated safety and efficacy, with the exception of malposition events in patients designated for higher valve deployment in the valve-in-valve implantation study.ACURATE neo valve may be a feasible and safe option for patients with bicuspid anatomy, small aortic annulus, previously implanted bioprosthetic aortic valve and pure aortic regurgitation. REGISTRATION NUMBER: Available at https://osf.io/aus26 (DOI 10.17605/OSF.IO/AUS26).

摘要

经导管主动脉瓣置换术(TAVI)使用 ACURATE neo 治疗特殊人群的系统评价

摘要

ACURATE neo 是一种自膨式经导管主动脉瓣,适用于经股动脉和经心尖两种途径,但是临床试验中特定人群的代表性不足。我们旨在对这些特殊人群中行 TAVI 使用 ACURATE neo 的情况进行全面的系统评价。对二叶式主动脉瓣、主动脉瓣环较小、单纯主动脉瓣反流和瓣中瓣手术等情况下行 TAVI 的相关研究进行了系统回顾。主要终点是根据 VARC-2 标准定义的器械成功。次要终点是根据 VARC-2 共识文件报告的安全性和性能结果。

在一项观察性研究中,除了预扩张率之外,二叶式主动脉瓣与三叶式主动脉瓣相比,ACURATE neo 的器械成功率相似。与 Lotus 和 Evolut-R 治疗二叶式主动脉瓣狭窄相比,ACURATE neo 的平均主动脉瓣跨瓣压差较低,预扩张率较高,安全性结果相似。2 项研究比较了 ACURATE neo 在小主动脉瓣环中的应用。与 Sapien 3 相比,ACURATE neo 的跨瓣压差较低,患者-假体不匹配率较低,与 Evolut R/Evolut PRO/Portico 相比,结果相似,除了预扩张率。3 项研究探讨了 ACURATE neo 治疗单纯主动脉瓣反流,1 项研究探讨了瓣中瓣手术,均显示了安全性和疗效,但在瓣中瓣植入研究中,有较高瓣膜展开设计的患者中出现了瓣膜错位事件。

ACURATE neo 瓣膜对于二叶式解剖结构、主动脉瓣环较小、先前植入的生物瓣和单纯主动脉瓣反流的患者可能是一种可行和安全的选择。注册号:可在 https://osf.io/aus26(DOI 10.17605/OSF.IO/AUS26)上获取。

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