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

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.