Meta-analysis Comparing Outcomes of Self-Expanding Versus Balloon-Expandable Valves for Transcatheter Aortic Valve Implantation

There are two commercially available transcatheter heart valve systems: balloon expandable valves (BEV) and self-expanding valves (SEV). However, there is a paucity of randomized trials comparing both systems. Electronic databases (Medline, the Cochrane Library, Web of Science, and clinicaltrials.gov) and major conference proceedings were searched for randomized trials of patients with symptomatic severe aortic stenosis and received transcatheter aortic valve implantation (TAVI) with a SEV or BEV or surgical aortic valve replacement. The main efficacy outcomes were all-cause mortality and stroke at the longest available follow-up. The main analysis was performed using a random-effects network meta-analysis complemented by several subgroup and sensitivity analyses. Ten trials with 9,439 patients (mostly undergoing transfemoral TAVI) were included. At a median of 27 months, there was no difference between BEV and SEV valves in terms of all-cause mortality (odds ratio [OR] 1.05, 95% confidence interval [CI] 0.79 to 1.42). The incidence of any stroke was higher with BEV (OR 1.51, 95% CI 1.01 to 2.26), but there was no difference in the incidence of disabling stroke. At 30-days, BEV valves were associated with lower incidence of new permanent pacemaker placement (OR 0.50, 95% CI 0.32 to 0.79) and moderate/severe paravalvular regurgitation (OR 0.39, 95% CI 0.22 to 0.68). In conclusion, in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI, SEV and BEV were associated with similar all-cause mortality. BEV were associated with a higher incidence of any stroke driven by nondisabling strokes, but lower incidence of new permanent pacemaker placement and moderate/severe paravalvular regurgitation compared with SEV.