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Navitor与Evolut经导管主动脉瓣假体的短期临床结果比较。

A Comparison of Short-Term Clinical Outcomes Between the Navitor and Evolut Transcatheter Aortic Valve Prostheses.

作者信息

Campanella Caterina, Kaiser Katherine, Voss Stephanie, Burri Melchior, Erlebach Magdalena, Puluca Nazan, Wirth Felix, Krane Markus, Ruge Hendrik

机构信息

Department of Cardiovascular Surgery, Institute Insure, German Heart Center Munich, School of Medicine & Health, Technical University of Munich, 80636 Munich, Germany.

DZHK (German Centre for Cardiovascular Research)-Partner Site Munich Heart Alliance, 10785 Berlin, Germany.

出版信息

J Clin Med. 2025 Aug 21;14(16):5890. doi: 10.3390/jcm14165890.

Abstract

The novel Navitor intra-annular self-expandable transcatheter aortic valve prosthesis is designed to improve coronary access, reduce paravalvular leaks, and enhance hemodynamic performance. Comparative data with the established Evolut platform (R, Pro, FX) are still lacking. This study aimed to evaluate the short-term clinical outcomes of Navitor (NAV) versus Evolut transcatheter heart valves. We conducted a single-center analysis of patients undergoing transfemoral TAVR between January 2015 and May 2024. A propensity score matching protocol including 18 baseline variables was used to balance baseline characteristics. Clinical outcomes were assessed using VARC-3 criteria. Of 1067 TAVR patients, 210 were analyzed after matching-70 with the Nav valve and 140 with the Evolut valve. Baseline characteristics were comparable between groups, with a mean age of 80.9 ± 6.5 years in the NAV group and 80.7 ± 6.7 years in the Evolut group ( = 0.9). Both groups had an intermediate STS predicted risk of mortality, 3.9 ± 3.4% for NAV and 3.9 ± 3.2% for Evolut ( = 1.0). The effective aortic annulus diameter was comparable between the NAV (23.9 ± 1.5 mm) and Evolut group (23.9 ± 2.4 mm, = 0.8). Hemodynamic performance at discharge was similar, with mean gradients of 7.5 ± 2.8 mmHg (NAV) vs. 7.4 ± 3.7 mmHg (Evolut, = 0.9). Valve orifice areas and paravalvular leak rates showed no difference between the groups. Device success rates at discharge were good for both THVs: 89.3% for Evolut and 91.4% for NAV ( = 0.8). Disabling stroke occurred less frequently in the NAV group (0.0% vs. 7.1%, = 0.033), while other early safety outcomes and 30-day mortalities were similar. The Navitor valve offers comparable hemodynamic performance, paravalvular leak rates, and procedural success to the Evolut platform. While early safety outcomes were largely similar, the Navitor valve was associated with a lower 30-day disabling stroke rate.

摘要

新型Navitor瓣环内自膨胀经导管主动脉瓣假体旨在改善冠状动脉通路、减少瓣周漏并提高血流动力学性能。目前仍缺乏与成熟的Evolut平台(R、Pro、FX)的对比数据。本研究旨在评估Navitor(NAV)与Evolut经导管心脏瓣膜的短期临床结局。我们对2015年1月至2024年5月间接受经股动脉经导管主动脉瓣置换术(TAVR)的患者进行了单中心分析。采用包含18个基线变量的倾向评分匹配方案来平衡基线特征。使用VARC-3标准评估临床结局。在1067例TAVR患者中,匹配后分析了210例——70例使用Nav瓣膜,140例使用Evolut瓣膜。两组间基线特征具有可比性,NAV组的平均年龄为80.9±6.5岁,Evolut组为80.7±6.7岁(P = 0.9)。两组的胸外科医师协会(STS)预测死亡风险均为中等,NAV组为3.9±3.4%,Evolut组为3.9±3.2%(P = 1.0)。NAV组(23.9±1.5 mm)与Evolut组(23.9±2.4 mm,P = 0.8)的有效主动脉瓣环直径具有可比性。出院时的血流动力学性能相似,平均跨瓣压差分别为7.5±2.8 mmHg(NAV)和7.4±3.7 mmHg(Evolut,P = 0.9)。两组间瓣膜开口面积和瓣周漏率无差异。两种经导管心脏瓣膜出院时的器械成功率均良好:Evolut为89.3%,NAV为91.4%(P = 0.8)。NAV组致残性卒中的发生率较低(0.0%对7.1%,P = 0.033),而其他早期安全性结局和30天死亡率相似。与Evolut平台相比,Navitor瓣膜在血流动力学性能、瓣周漏率和手术成功率方面相当。虽然早期安全性结局在很大程度上相似,但Navitor瓣膜的30天致残性卒中发生率较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f5b/12387559/04768753d537/jcm-14-05890-g001.jpg

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