Balloon vs. self-expanding valves for transcatheter aortic valve implantation in bicuspid aortic stenosis: a meta-analysis.

Abstract

Aims: Bicuspid aortic valve (BAV) is a common congenital heart disease. However, pivotal randomized trials of transcatheter aortic valve replacement (TAVR) have excluded this population. There remains a lack of consensus on the optimal choice between balloon-expandible valves (BEVs) and self-expanding valves (SEVs) in this setting. This study aimed to compare the efficacy and safety of BEVs vs. SEVs in patients with BAV stenosis.

Methods: A systematic search using four databases, including PubMed, Embase, Web of Science, and Cochrane CENTRAL, was conducted from inception to 26 November, 2024. Studies comparing the outcome of BEVs and SEVs in patients with BAV stenosis were included.

Results: Nineteen studies comprising 3794 participants were included in this meta-analysis. Procedural mortality did not differ significantly between BEVs and SEVs [odds ratio (OR), 1.06; 95% confidence interval (95% CI) 0.42-2.69, P = 0.91]. Similarly, no differences were observed in all-cause mortality at 1 year or 3 years. BEVs were associated with a lower risk of permanent pacemaker implantation (OR, 0.60; 95% CI 0.48-0.76, P < 0.01) and moderate to severe paravalvular leakage (OR, 0.44; 95% CI 0.23-0.85, P = 0.01) compared with SEVs. However, BEVs were associated with a higher risk of annular rupture (OR, 2.80; 95% CI 1.05-7.49, P = 0.04).

Conclusion: BEVs and SEVs demonstrate similar survival outcomes from the procedural period up to 3 years of follow-up. However, the risk profiles for specific complications differ between the valve types. Valve selection for TAVR in patients with BAV stenosis should be considered based on individual anatomical characteristics and the associated risk of specific complications.