Transcatheter Aortic Valve Replacement With Balloon- Versus Self-Expandable Bioprostheses for the Treatment of Bicuspid Aortic Valve Stenosis
- PMID: 40820731
- DOI: 10.1161/CIRCULATIONAHA.124.069323
Transcatheter Aortic Valve Replacement With Balloon- Versus Self-Expandable Bioprostheses for the Treatment of Bicuspid Aortic Valve Stenosis
Abstract
Background: Differences between balloon- and self-expandable transcatheter heart valves (BE-THVs and SE-THVs, respectively) may influence the outcomes of transcatheter aortic valve replacement for bicuspid aortic valve (BAV) stenosis.
Methods: Consecutive patients undergoing transcatheter aortic valve replacement with BE-THV or SE-THV for computed tomography-diagnosed bicuspid aortic valve stenosis at 29 centers were included. The primary outcome was death or stroke. After propensity score matching in 10 data sets generated by multiple imputation, outcomes from transcatheter aortic valve replacement to 3-year follow-up were computed by multivariable binomial logistic mixed-effects models, multivariable linear mixed-effects models, or multivariable frailty models accounting for center-related influences and residual confounding effects (doubly robust adjustment). The results were replicated by inverse probability of treatment weighting and multivariable adjustment.
Results: A total of 1443 consecutive patients with bicuspid aortic valve stenosis undergoing BE-THV (n=860) or SE-THV (n=583) implantation were included. In-hospital and 30-day death or stroke did not significantly differ between BE-THV and SE-THV groups (5.1% versus 6.1%; hazard ratio after propensity score matching, 1.02 [95% CI, 0.51-2.02]). BE-THV implantation was associated with higher annulus rupture and mean transvalvular gradient compared with SE-THV implantation. In contrast, SE-THV implantation was associated with higher additional valve implantation and paravalvular regurgitation compared with BE-THV implantation. The results were consistent across the statistical methods used and between early- and new-generation THVs. At 30 days, pacemaker implantation was lower in the BE-THV group compared with the SE-THV group (11.9% versus 18.6%; hazard ratio after propensity score matching, 0.58 [95% CI, 0.36-0.93]). This result did not depend on the statistical method used. At 3 years, consistent with the 1- and 2-year analyses, death or stroke was not significantly different between the BE-THV and SE-THV groups (23.7% versus 26.2%; hazard ratio after propensity score matching, 0.99 [95% CI, 0.65-1.51]). Death or stroke across major clinical, anatomical, functional, and procedural conditions was consistent with the main analysis. After inverse probability of treatment weighting and multivariable adjustment, these conclusions remained unchanged.
Conclusions: In patients undergoing transcatheter aortic valve replacement for bicuspid aortic valve stenosis, death or stroke does not significantly differ between those receiving a BE-THV and those receiving an SE-THV over a follow-up of 3 years. BE-THV is associated with higher transvalvular mean gradient and more frequent annulus rupture, whereas SE-THV is associated with more frequent moderate to severe aortic regurgitation, additional THV implantation, and permanent pacemaker implantation.
Keywords: aortic valve stenosis; bicuspid aortic valve disease; transcatheter aortic valve replacement.
Conflict of interest statement
Dr Xhepa reports lecture fees and honoraria from AstraZeneca, Boston Scientific, and SIS Medical not related to the current work; he reports proctor fees as well as financial support for attending meetings and/or travel expenses from Abbott Vascular. Dr Michel is a proctor for Boston Scientific. Dr Meier is supported by the Swiss National Science Foundation (grant P2LAP3_199561). Dr Ludwig reports travel compensation from Edwards LifeSciences, advisory fees from Bayer, speaker honoraria from Abbott, and funding from the German Heart Foundation. Dr Ludwig is a consultant for NVT. Dr Ancona received consultant fees from Abbott and Abiomed. Dr Tchetche is a consultant for Edwards and Medtronic. Dr Montorfano is a proctor for Kardia, Abbott, and Boston Scientific. Dr Van Mieghem has received research grant support from Abbott Vascular, Medtronic, Boston Scientific, Edwards Lifesciences, Daiichi Sankyo, and Astra Zeneca and consultancy fees from Amgen, Anteris, JenaValve, Siemens, Abbott Vascular, Medtronic, Boston Scientific, Daiichi Sankyo, PulseCath BV, and Abiomed. Dr Schofer received travel support from Abbott, Edwards LifeSciences, and Boston Scientific; speaker honoraria from Boston Scientific, Edwards LifeSciences, and HighLife; and proctor fees from Edwards LifeSciences. Dr Neumann reports speaker honoraria from Amgen, Boston Scientific, and Daiichi Sankyo; consultancy fees from Novartis and Meril; speaker honoraria paid to his institution from Ferrer and Amgen; and research grants from Bayer Healthcare, Boston Scientific, Biotronik, Edwards Lifesciences, Abbott, and Medtronic. Dr Windecker reports research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Farapulse Inc, Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave; he served as advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; he is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Sondergaard is an employee of Abbott; he collected data for the study before assuming his current position. Dr Webb is a consultant for Edwards Lifesciences and has received research funding from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Tarantini received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific. Dr Pilgrim reports research, travel, or educational grants to the institution without personal remuneration from Biotronik, Boston Scientific, Edwards Lifesciences, as well as speaker fees and consultancy fees to the institution from Biotronik, Boston Scientific, Edwards Lifesciences, Abbott, Medtronic, Biosensors, and Highlife. Dr Kasel is a proctor and consultant for Edwards Lifesciences. Dr Byrne reports research or educational funding to the institutions of employment (Mater Private Network and Royal College of Surgeons in Ireland University) from Abbott Vascular, Biosensors, Boston Scientific, and Translumina, none of which affect in any way on his personal remuneration; he does not receive personal fees from any medical device or pharmaceutical company. The other authors report no conflicts.
Comment in
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Defining Optimal Treatment Strategies for Bicuspid Aortic Valve Stenosis With Balloon- and Self-Expandable Transcatheter Heart Valves.Circulation. 2025 Sep 9;152(10):658-660. doi: 10.1161/CIRCULATIONAHA.125.075818. Epub 2025 Sep 8. Circulation. 2025. PMID: 40920842 No abstract available.