Transfemoral Valve-in-Valve TAVI with MyVal for Failed Surgical Aortic Bioprostheses: Procedural Outcomes, Serial Hemodynamics, and Anatomy-Based Determinants of Residual Gradient

Background/Objectives: Valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) is an established treatment for failed surgical aortic bioprostheses, but dedicated data on the MyVal platform remain limited. We evaluated outcomes, hemodynamics, residual gradient, and an exploratory matched comparison with ACURATE neo2. Methods: This prospective, single-center cohort included consecutive patients with failed surgical aortic bioprostheses treated with MyVal ViV-TAVI between July 2022 and June 2025. Outcomes were reported according to VARC-3. Results: Sixty-eight patients were included (age 77 ± 7 years; 51.5% women; EuroSCORE II 7.3 ± 1.8%). Technical success was 100%, with no 30-day death, stroke, myocardial infarction, second-valve implantation, or emergency surgical conversion. Mean gradient decreased from 38.0 ± 9.5 mmHg at baseline to 6.7 ± 2.1 mmHg post-procedure and remained low at 1 year (8.1 ± 2.5 mmHg; overall p < 0.001). AVA increased from 0.80 ± 0.23 cm2 to 1.98 ± 0.19 cm2 post-procedure and was 1.86 ± 0.23 cm2 at 1 year (overall p < 0.001). Smaller true internal diameter independently predicted elevated 1-year gradient (adjusted OR per 1-mm decrease 1.33, 95% CI 1.04–1.78; p = 0.028). In the exploratory matched comparison, safety and hemodynamic outcomes did not differ significantly between MyVal and ACURATE neo2. At a median follow-up of 12.8 months, all-cause mortality and heart failure hospitalization were each 4.4%. Conclusions: In this prospective single-center cohort, MyVal ViV-TAVI was associated with high procedural success and favorable 1-year hemodynamic outcomes, with residual gradient driven mainly by small surgical valve true internal diameter.