Short-Term, Mid-Term, and Long-Term Outcomes of Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expanding Valves: A Meta-Analysis of Randomized Controlled Trials

Abstract

Background: Comparisons of outcomes after transcatheter aortic valve replacement with balloon-expandable (BEV) versus self-expanding (SEV) valves are limited.

Hypothesis: This study aimed to compare clinical and hemodynamic outcomes of BEV and SEV at short-term (30 days), midterm (1 year), and long-term (> 1 year) endpoints.

Methods: PubMed, Embase, Scopus, and Cochrane Library databases were searched until July 2024 for randomized controlled trials. Random-effect model (DerSimonian-Laird method) was used to pool the risk ratios (RR), mean differences, and 95% confidence intervals (CI).

Results: A total of 10 studies comprising 4325 patients (2295 BEV, 2030 SEV) were included. In short-term, cardiovascular (RR: 0.56, 95% CI: 0.36-0.87) and all-cause mortality (RR: 0.54, 95% CI: 0.35-0.81) were lower in the BEV group. Risk of moderate to severe paravalvular leak (PVL) was lower among BEV patients in short-term (RR: 0.28, 95% CI: 0.17-0.49) and long-term (RR: 0.28, 95% CI: 0.1-0.79). A limited number of studies showed a greater risk of clinical valve thrombosis on BEV in midterm and long-term. The need for permanent pacemaker implantation was lower in BEV at both short-term (RR: 0.56, 95% CI: 0.37-0.87), and midterm (RR: 0.78, 95% CI: 0.64-0.94). The SEV group had a larger effective orifice area with lower mean transvalvular pressure gradient at all endpoints.

Conclusions: BEV is associated with reduced risk of clinical outcomes in short-term; however, most differences diminish in longer evaluations, except for moderate to severe PVL, which remains elevated for SEV. SEVs had better hemodynamic results and lower risk of clinical valve thrombosis.

Keywords: TAVR; aortic stenosis; balloon‐expandable valves; meta‐analysis; self‐expanding valves; transcatheter aortic valve replacement.