Transcatheter aortic valve-in-valve implantation for failed surgical aortic bioprostheses using the Navitor platform: early outcomes in a consecutive single-center cohort.

Robert Sobczyński, Jarosław Trębacz, Paweł Kleczyński, Bogusław Kapelak, Maciej Stąpór, Filip Dudkowski, Janusz Konstanty-Kalandyk, Jacek Legutko
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Abstract

Introduction: Transcatheter heart valve implantation into a failed surgical heart valve (THV-in-SHV) is an established reintervention strategy for degenerated aortic bioprostheses; however, early procedural outcomes, discharge hemodynamics, and standardized safety remain clinically relevant in routine practice.

Material and methods: We retrospectively analyzed consecutive patients who underwent aortic THV-in-SHV with the Navitor platform between 2022 and 2025. The primary endpoint was the mean aortic gradient at discharge. Secondary endpoints included peak gradient, maximum transvalvular velocity (Vmax), paravalvular leak (PVL), Valve Academic Research Consortium-3 (VARC-3) early safety, and time from surgical aortic valve replacement (SAVR) to reintervention according to leaflet mounting.

Results: Thirty patients were included (age, 72.5 ± 9.2 years; 73.3% male). At discharge, the mean and peak aortic gradients were 16.8 ± 6.7 mmHg and 30.0 ± 11.7 mmHg, respectively. Paravalvular leak was absent, trace, or mild in 96.7%, with no severe PVL. Early safety according to VARC-3 was achieved in 86.7%. Mortality and stroke occurred in 3.3% each, and bleeding type ≥ 2 occurred in 6.7%. No acute kidney injury (AKI) stage 3, renal replacement therapy (RRT), major vascular complications, device-related intervention, or new permanent pacemaker implantation occurred. Smaller surgical valves were associated with higher residual gradients, whereas outside-mounted bioprostheses showed a shorter time to reintervention than inside-mounted designs.

Conclusions: Aortic THV-in-SHV with the Navitor platform was associated with acceptable discharge hemodynamics, low rates of clinically relevant PVL, and favorable early safety according to VARC-3. Residual gradients were driven primarily by surgical valve size despite the intra-annular design.

使用Navitor平台的经导管主动脉瓣内植入失败的外科主动脉生物假体:连续单中心队列的早期结果
导言:经导管心脏瓣膜植入失败的外科心脏瓣膜(THV-in-SHV)是一种针对退行性主动脉生物假体的再干预策略;然而,在常规实践中,早期手术结果、出院血流动力学和标准化安全性仍然具有临床相关性。材料和方法:我们回顾性分析了2022年至2025年间使用Navitor平台连续接受主动脉THV-in-SHV的患者。主要终点是出院时的平均主动脉梯度。次要终点包括峰值梯度、最大经瓣速度(Vmax)、瓣旁泄漏(PVL)、瓣膜学术研究联盟-3 (VARC-3)早期安全性,以及从手术主动脉瓣置换术(SAVR)到根据小叶安装再干预的时间。结果:纳入30例患者(年龄72.5±9.2岁,男性73.3%)。出院时,主动脉梯度平均值和峰值分别为16.8±6.7 mmHg和30.0±11.7 mmHg。96.7%的患者瓣旁漏无、微量或轻微,无严重PVL。根据VARC-3的早期安全性达到86.7%。死亡率和卒中发生率各为3.3%,≥2型出血发生率为6.7%。无急性肾损伤(AKI) 3期、肾脏替代治疗(RRT)、主要血管并发症、器械相关干预或新的永久性起搏器植入。较小的手术瓣膜与较高的残余梯度相关,而外部安装的生物假体比内部安装的设计显示更短的再干预时间。结论:根据VARC-3,使用Navitor平台的主动脉THV-in-SHV与可接受的血流动力学、低临床相关PVL率以及良好的早期安全性相关。尽管采用了环内设计,但残余梯度主要受手术瓣膜大小的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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