Key result
SAPIEN 3 TAVR in bicuspid valves shows similar 30-day mortality to tricuspid valves.
Why the study?
China's patient population presents distinct challenges in TAVR, including higher prevalence of bicuspid aortic valves and severe calcification, requiring real-world evaluation of the SAPIEN 3 valve.
Does transfemoral TAVR with the SAPIEN 3 valve have comparable safety and efficacy in patients with bicuspid versus tricuspid severe aortic stenosis?
Cohort (n=1,642)
Yes
Does transfemoral TAVR with the SAPIEN 3 valve have comparable safety and efficacy in patients with bicuspid versus tricuspid severe aortic stenosis?
Effect estimate: OR 1.51 (95% CI 0.42 to 5.36)
Absolute Event Rate: 0.7% vs 0.8%
p-value: p=0.531
Transfemoral TAVR with the SAPIEN 3 valve is safe and feasible in Chinese patients with severe bicuspid aortic stenosis, yielding 30-day mortality comparable to tricuspid patients, though with a higher risk of conversion to open surgery.
May support SAPIEN 3 TAVR feasibility in bicuspid valves; leaves open questions on conversion risk pending randomized data.
Background: Transcatheter aortic valve replacement (TAVR) has emerged as the preferred treatment for symptomatic severe aortic stenosis (AS). However, China’s unique patient population presents distinct challenges, including a higher prevalence of bicuspid aortic valves (BAVs) and severe valve calcification. This study used real-world clinical data from Chinese patients to assess the safety and efficacy of the SAPIEN 3 balloon-expandable transcatheter heart valve (THV) in TAVR, particularly in patients with BAVs. Methods: This retrospective, multicenter study enrolled consecutive severe AS patients treated with SAPIEN 3 THVs via a transfemoral approach from June 2020 to March 2024. The primary endpoint was 30-day mortality, while secondary endpoints included procedural mortality, procedural success, conversion to surgery, coronary artery occlusion, THV-in-THV deployment, permanent pacemaker implantation, and paravalvular leaks (PVLs). Results: Among the 1642 enrolled patients, 56.0% had BAVs, and 44.0% had tricuspid aortic valves (TAVs). The 30-day mortality rate was 0.90%. Propensity score matching revealed no statistically significant differences between patients with BAVs and TAVs in terms of 30-day mortality (odds ratio (OR): 1.51, 95% confidence interval (CI): 0.42 to 5.36; p = 0.531), immediate procedural mortality, procedural success, coronary artery occlusion, THV-in-THV deployment, permanent pacemaker implantation, or moderate to severe PVLs. However, a significant difference was found in the conversion rate to open surgery (OR: 5.07, 95% CI: 1.11 to 23.2; p = 0.036). Conclusions: This study demonstrates the safety and feasibility of SAPIEN 3 balloon-expandable THVs in TAVR for Chinese patients with severe AS, including those with BAV stenosis. These findings challenge historical relative contraindications for TAVR in BAV patients and highlight the potential of TAVR in diverse patient populations. Larger prospective studies with extended follow-ups are needed to refine patient selection and evaluate longer-term outcomes.
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Dong et al. (2025) conducted a cohort in Severe symptomatic aortic stenosis (n=1,642). Transcatheter aortic valve replacement with SAPIEN 3 in bicuspid aortic valves vs. Transcatheter aortic valve replacement with SAPIEN 3 in tricuspid aortic valves was evaluated on 30-day mortality (OR 1.51, 95% CI 0.42 to 5.36, p=0.531). Transcatheter aortic valve replacement with the SAPIEN 3 valve in patients with bicuspid aortic valves resulted in similar 30-day mortality compared to those with tricuspid valves (OR 1.51).
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