Safety and efficacy of transcatheter aortic valve replacement using Sapien 3 balloon-expandable valve in type 0 bicuspid aortic valve stenosis patients.

BACKGROUND

Data regarding the safety and efficacy of balloon expandable valves (BEVs) for transcatheter aortic valve replacement (TAVR) in patients with Sievers type 0 bicuspid aortic valve (BAV) stenosis remain limited.

AIMS: This study aims to evaluate the clinical outcomes of BEVs implantation in patients with Sievers type 0 BAV.

METHODS

We conducted a multicenter, retrospective study across 28 centers in China between October 2020 and March 2023. Consecutive patients with Sievers type 0 BAV anatomy undergoing TAVR with the Edwards Sapien 3 BEV were enrolled.

RESULTS

The study included 131 patients with Sievers type 0 BAV (mean age 69.8 ± 7.5 years; 52.7 % male). The lateral-lateral type predominated (86.3 %). Calcification distribution analysis identified the superior leaflet margin as the most primary site (62.6 %). All procedures utilized femoral artery access. High implantation depth (The ratio of the aortic side of the prosthetic valve to the outflow tract side is > 8:2) was achieved in 80.2 % of cases. Prosthetic valves smaller than 26 mm were implanted in nearly half of the patients (49.6 %). The 30-day all-cause mortality rate was 0.8 %, with no incidence of disabling stroke. The overall technical success rate was 98.5 %.

CONCLUSION

The findings of this study demonstrate that BEVs implantation in patients with Sievers type 0 BAV is associated with favorable safety and efficacy outcomes. These results provide valuable insights for current TAVR practice in this specific patient population.