Efficacy and safety of transcatheter aortic valve implantation in patients with severe bicuspid aortic stenosis

Background: Bicuspid aortic valve (BAV) is common congenital malformation, bicuspid aortic stenosis accounts for a substantial proportion of patients with aortic valve stenosis (AS). Bicuspid AS are more likely to have aortic dilatation with slightly less elliptical annuli, which might lead to paravalvular aortic valve regurgitation (AR) and permanent pacemaker implantation (PPM) after TAVI with higher mortality. Our study aims to understand the therapeutic efficacy and safety of transcatheter aortic valve implantation (TAVI) with a supra-annular structure-based sizing strategy in Chinese AS patients with BAV versus tricuspid aortic valve (TAV). Methods: Seventy-four consecutive tricuspid AS patients and 44 bicuspid AS patients were included and enrolled in the study for analysis. Both groups underwent TAVI performed using balloon sizing less than mild paravalvular AR to assess the proper prosthesis size. The myocardial function within 1 year postoperative were sequentially evaluated using the New York Heart Association (NYHA) class, and echocardiography measurements. The incidence rates of complications at 30 days and 1 year were analyzed. During the 1-year follow-up, the time of death from any cause or complications in both groups was recorded. Results: The study found that the percentage of patients with class III-IV of NYHA dropped after TAVI in both groups, and no significant difference between both groups at 1 year. Compared with the tricuspid AS group patients, Bicuspid group patients had more improvement in mean aortic valve gradient from baseline to 1year (-47.47 +/- 13.38 vs. -50.22 +/- 19.25 mmHg, P<0.05). There were no significant differences in 30-day and one-year compliance outcomes except a lower incidence of AR at post-procedure and 30 days in the tricuspid AS group as the Bicuspid AS group. There were no statistically significant differences in the time of death from any cause or significant complications between groups. Conclusions: TAVI has acceptable therapeutic efficacy and safety and is feasible for AS patients with BAV in China.