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Observational Study
. 2025 Dec 15:441:133792.
doi: 10.1016/j.ijcard.2025.133792. Epub 2025 Aug 18.

Clinical outcomes in women and men with raphe-type bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement

Mauro Gitto  1 , Won-Keun Kim  2 , Andrea Buono  3 , Tommaso Fabris  4 , Chiara De Biase  5 , Giuliano Costa  6 , Nicholas Montarello  7 , Pier Pasquale Leone  1 , Andrea Scotti  8 , Michele Bellamoli  3 , Mesfer Alfadhel  9 , Ofir Koren  10 , Simone Fezzi  11 , Barbara Bellini  12 , Mauro Massussi  13 , Giulia Costa  14 , Chiara Fraccaro  4 , Alessandro Mazzapicchi  15 , Enrico Giacomin  16 , Francesco Burzotta  17 , Andrea Zito  17 , Carlo Trani  17 , Riccardo Gorla  18 , Karsten Hug  19 , Carlo Briguori  20 , Francesco Tartaglia  21 , Luca Bettari  3 , Michele Colucci  3 , Emmanuel Villa  3 , Damiano Regazzoli  21 , Ciro Pollio Benvenuto  3 , Mauro Boiago  4 , Gianmaria Calamita  21 , Matthias Renker  22 , Mario Garcia Gomez  23 , Alfonso Ielasi  24 , Uri Landes  25 , Tobias Rheude  19 , Michael Joner  19 , Luca Testa  18 , Ignacio Amat Santos  23 , Francesco Saia  15 , Luca Favero  16 , Lin Bai  26 , Mao Chen  26 , Marianna Adamo  13 , Marco De Carlo  14 , Matteo Montorfano  27 , Raj R Makkar  10 , Darren Mylotte  28 , Dan Blackman  9 , Marco Barbanti  6 , Ole De Backer  7 , Didier Tchetche  5 , Giuseppe Tarantini  4 , Azeem Latib  8 , Diego Maffeo  3 , Antonio Mangieri  29 , Roxana Mehran  30
Affiliations
Observational Study

Clinical outcomes in women and men with raphe-type bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement

Mauro Gitto et al. Int J Cardiol. .

Abstract

Background: There is paucity of data regarding sex-related differences among patients with bicuspid aortic valve (BAV) undergoing transcatheter aortic valve replacement (TAVR).

Methods: The AD-HOC was an observational, retrospective, investigator-initiated registry enrolling consecutive patients with Sievers type 1 BAV stenosis who underwent TAVR at 24 international centers from 2016 to 2023. The primary endpoint was major adverse events (MAEs), including death, neurologic events and heart failure hospitalization.

Results: Of 980 included patients, 364 (37 %) were women. As compared to men, women had lower prevalence of associated comorbidities, smaller aortic dimensions and lower calcific burden on the raphe. After propensity score adjustment, Valve Academic Research Consortium-3 (VARC-3) defined technical success (93.7 % vs. 95.8 %, adjusted odds ratio [adj. OR]: 0.37, 95 % confidence intervals [CI]: 0.17-0.81) and device success (83.5 % vs. 86.6 %, adj, OR: 0.61, 95 % CI: 0.38-0.98) were lower in women, who also had more major periprocedural bleedings. There were no sex-differences in 3-year MAEs (19.7 % in women vs. 25.6 % in men, adjusted hazard ratio [adj. HR]: 0.75, 95 % CI: 0.47-1.20). Predictors of MAEs in men included diabetes, chronic obstructive pulmonary disease and severe aortic valve calcifications. Conversely, in women, chronic kidney disease was an independent predictor of MAEs and hemodynamic valve performance and higher baseline mean aortic gradients had a protective effect.

Conclusions: Women undergoing TAVR for raphe-type BAV stenosis had lower technical and device success, but similar long-term clinical outcomes compared to men. Prognostic determinants differed between sexes, including clinical comorbidities in men and poor hemodynamic valve performance in women.

Keywords: Bicuspid aortic valve; Sievers type 1; Transcatheter aortic valve replacement; VARC-3; Women.

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Conflict of interest statement

Declaration of competing interest WK reports personal fees from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, HID Imaging, Meril Life Sciences. WK received institutional grant from Boston Scientific. BB reports consultant fees from Medtronic. TR received speaker fees from Astra Zeneca, Abbott and SIS Medical and travel support from SIS Medical and Boston Scientific; not related to the current work. MM reports consultant fees from Abbott, Boston Scientific, Medtronic and Kardia. RM reports institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Insel Gruppe AG, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Philips, Transverse Medical, Zoll; personal fees from ACC, Boston Scientific, California Institute for Regenerative Medicine (CIRM), Cine-Med Research, Janssen, WebMD, SCAI; consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, Beth Israel Deaconess, CardiaWave, CeloNova, Chiesi, Concept Medical, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, Philips; Equity <1 % in Applied Therapeutics, Elixir Medical, STEL, CONTROLRAD (spouse); Scientific Advisory Board for AMA, Biosensors (spouse). The other authors declare no conflicts of interest to disclose.

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