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. (C) 2020 Elsevier Inc. All rights reserved.