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Multicenter Study
. 2025 Sep;106(3):1746-1757.
doi: 10.1002/ccd.31742. Epub 2025 Jul 3.

Long-Term Durability of Transcatheter Aortic Valves in Patients With Bicuspid Aortic Stenosis

Affiliations
Multicenter Study

Long-Term Durability of Transcatheter Aortic Valves in Patients With Bicuspid Aortic Stenosis

Yuheng Jia et al. Catheter Cardiovasc Interv. 2025 Sep.

Abstract

Background: Data concerning the long-term durability of transcatheter aortic valves (TAVs) in patients with bicuspid aortic stenosis (AS) are lacking.

Aims: The study aims to report data on long-term valve durability following transcatheter aortic valve replacement (TAVR) in bicuspid AS.

Methods: This multicentre registry included patients who underwent TAVR for bicuspid AS with at least 2-year echocardiographic follow-up. The incidence of structural valve deterioration (SVD), bioprosthetic valve dysfunction (BVD), and bioprosthetic valve failure (BVF) was determined according to Valve Academic Research Consortium (VARC)-3 criteria.

Results: Among 894 patients (mean age: 75.6 years; 39% female), the median echocardiographic follow-up was 48.7 months with a 5-year cumulative incidence of moderate-to-severe SVD, severe SVD, severe BVD, and BVF of 8.1%, 3.2%, 11.4%, and 6.1%, respectively. Younger age (≤ 75 years) was associated with a higher likelihood of reintervention (HR 2.40, log-rank p = 0.04). TAV downsizing was associated with higher rates of moderate-to-severe SVD (HR 3.05, log-rank p < 0.001), severe BVD (HR 2.07, log-rank p = 0.003), and BVF (HR 3.25, log-rank p = 0.002). In the sub-group with small annuli (area ≤ 430 mm2), implantation of balloon-expandable TAVs was associated with a higher rate of BVD in comparison with self-expanding TAVs (HR: 3.27, log-rank p = 0.008).

Conclusions: TAVs demonstrated favorable 5-year durability in patients with bicuspid AS, although younger patients were more likely to require valve reintervention. Nominal TAV sizing was associated with better durability outcomes as compared to TAV downsizing. Self-expanding valves were associated with superior hemodynamics in patients with small annuli.

Keywords: aortic stenosis; bicuspid aortic valve; transcatheter aortic valve replacement; valve durability.

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Conflict of interest statement

Annette Maznyczka reports travel grants from Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Arif Khokhar has received speaker fees from Boston Scientific and consulting fees from Machnet Medical. Stefan Toggweiler has received honoraria from Medtronic, Boston Scientific, Biosensors, Edwards Lifesciences, Hi‐D Imaging, Abbott Vascular, Medira, Shockwave, Teleflex, atHeart Medical, Cardiac Dimensions, Polares Medical, Amarin, Sanofi, AstraZeneca, ReCor Medical, Daiichi Sankyo, Bayer, Armira; has received institutional research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, Fumedica, Novartis, Boehringer Ingelheim, Polares Medical, and holds equity in Hi‐D Imaging. Marianna Adamo has reported speaker honoraria from Abbott Vascular and Edwards Lifesciences. Matteo Montorfano received consultant fees from Abbott, Boston Scientific, Kardia, and Medtronic. Martin Swaans has received consultancy fees from Abbott Vascular, Bioventrix, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, GE Healthcare, Medtronic, Philips Healthcare, P&F, and Siemens Healthcare. Joanna Wykrzykowska has received an institutional grant from Medtronic and speaker's honoraria (also to the institution) from Boston Scientific and Sinomed. Tau Hartikainen has received travel grants from Boston Scientific and Novartis. Stephane Noble has received an institutional grant from Abbott, consulting and speaker fees from Medtronic, and travel support to attend meetings from Edwards Lifesciences and Abbott. Darren Mylotte reports institutional research grants from Boston Scientific and Medtronic; and is a consultant for Boston Scientific, Medtronic, and MicroPort. Stephen Brecker has received grant support, consultant, and speaker fees from Medtronic. Pierfrancesco Agostoni has received consulting fees from Abbott, Boston Scientific, iVascular, Teleflex, and Terumo. Matjaž Bunc has served as a consultant or proctor for Medtronic, Edwards Lifesciences, Abbott, Medtronic, and Meril. Hélène Eltchaninoff received honoraria for lectures from Edwards Lifesciences. Daniel Blackman reports consulting fees from Medtronic Plc. and Abbott Vascular, honoraria from Medtronic Plc., Abbott Vascular, and Edwards Lifesciences, and participation in data safety/monitoring/advisory board for Medtronic Plc. and Abbott Vascular. Nicolas Van Mieghem has received institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Meril, Pie Medical, PulseCath BV, Teleflex, and consultancy fees from Abbott, Abiomed, Alleviant Medical Inc., AncorValve, Anteris, Approxima Srl, Bolt Medical, Boston Scientific, Daiichi Sankyo, LUMA Vision, Materialise, Medtronic, Pie Medical, Polares, PulseCath BV, Siemens. Won‐Keun Kim reports proctor/speaker fees/advisory board participation for Abbott, Boston Scientific, Edwards Lifesciences, and Meril Life Sciences. Thomas Pilgrim reports research, travel, or educational grants to the institution without personal remuneration from Biotronik, Boston Scientific, Edwards Lifesciences, and ATSens; speaker fees and consultancy fees to the institution from Biotronik, Boston Scientific, Edwards Lifesciences, Abbott, Medtronic, Biosensors, and Highlife. Bernard Prendergast has received lecture fees from Edwards Lifesciences; and has served on a trial steering committee for Medtronic and a data safety and monitoring committee for Valvosoft. Didier Tchétché is a consultant for Abbott Vascular, Edwards Lifesciences, Medtronic, Boston Scientific, T‐Heart, and Caranx Medical. Ole De Backer received institutional research grants and consulting fees from Abbott, Boston Scientific, and Medtronic. The other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Study design. The study population was derived from a cohort of patients with bicuspid AS who underwent TAVR with echocardiographic follow‐up beyond 2 years. The key endpoints of this study were VARC‐3‐defined structural valve deterioration (SVD), bioprosthetic valve dysfunction (BVD), and bioprosthetic valve failure (BVF). AS, aortic stenosis; STS, Society of Thoracic Surgeons; TAVR, transcatheter aortic valve replacement; VARC, Valve Academic Research Consortium. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 2
Figure 2
Cumulative incidence of SVD, BVD, and BVF following TAVR in bicuspid AS. Kaplan−Meier curves illustrating the 5‐year cumulative incidence rates of moderate‐to‐severe SVD, severe SVD, severe BVD, and BVF. The cumulative incidences for each component are listed in the accompanying tables. AR, aortic regurgitation; AS, aortic stenosis; BVD, bioprosthetic valve dysfunction; BVF, bioprosthetic valve failure; PVL, paravalvular leak; SVD, structural valve deterioration. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 3
Figure 3
Impact of patient characteristics on TAV durability in bicuspid AS. Kaplan−Meier curves illustrating the 5‐year cumulative incidences of moderate‐to‐severe SVD, severe BVD, and BVF comparing (A) younger (≤ 75 years) versus older (> 75 years) patients, (B) Sievers type 0 versus type 1 bicuspid AS patients, and (C) patients with annulus area ≤ 430 and > 430 mm2. AS, aortic stenosis; BVD, bioprosthetic valve dysfunction; BVF, bioprosthetic valve failure; SVD, structural valve deterioration; TAV, transcatheter aortic valve. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 4
Figure 4
Impact of procedural techniques on TAV durability in bicuspid AS. Kaplan−Meier curves illustrating the 5‐year cumulative incidences of moderate‐to‐severe SVD, severe BVD, and BVF comparing (A) self‐expanding valves (SEV) and balloon‐expandable valves (BEV), (B) TAV nominal sizing and TAV downsizing, and (C) TAVR with and without TAV post‐dilatation. AS, aortic stenosis; BVD, bioprosthetic valve dysfunction; BVF, bioprosthetic valve failure; SVD, structural valve deterioration; TAV, transcatheter aortic valve. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 5
Figure 5
Impact of valve design on TAV durability in bicuspid anatomical subgroups. Kaplan−Meier curves illustrating the 5‐year cumulative incidences of moderate‐to‐severe SVD, severe BVD, and BVF following the use of SEV and BEV in (A) Sievers type 1 anatomy, (B) patients with smaller annuli (area ≤ 430 mm2), and (C) larger annuli (area > 540 mm2). BEV, balloon‐expandable valve; BVD, bioprosthetic valve dysfunction; BVF, bioprosthetic valve failure; SEV, self‐expanding valve; SVD, structural valve deterioration; TAV, transcatheter aortic valve. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 6
Figure 6
Impact of post‐procedural PPM on TAV durability. Kaplan−Meier curves illustrating the impact of immediate postprocedure PPM on 5‐year cumulative incidences of moderate‐to‐severe SVD, severe SVD, and BVF. AS, aortic stenosis; BMI, body mass index; BVD, bioprosthetic valve dysfunction; BVF, bioprosthetic valve failure; iEOA, indexed effective orifice area; PPM, prosthesis‐patient mismatch; SVD, structural valve deterioration; TAV, transcatheter aortic valve. [Color figure can be viewed at wileyonlinelibrary.com]
Central Illustration 1
Central Illustration 1
Long‐term durability of transcatheter aortic valves (TAVs) in patients with bicuspid AS. [Color figure can be viewed at wileyonlinelibrary.com]

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