Meta-Analysis of Comparison Between Self-Expandable and Balloon-Expandable Valves for Patients Having Transcatheter Aortic Valve Implantation

Abstract

Two different devices, 1 self-expanding and 1 balloon-expandable, have been developed for patients who underwent transcatheter aortic valve implantation with contrasting data about efficacy and safety. Pubmed, Medline, and Google Scholar were systematically searched for studies of these different devices, with data derived from randomized controlled trial or registries with multivariate analysis. All-cause death at 30 days and at follow-up were the primary end points, whereas postprocedural moderate or severe aortic regurgitation (AR), stroke, major vascular complications, bleedings, and pacemaker implantation the secondary ones. Six studies with 957 self-expanding and 947 balloon-expandable valves were included: 1 randomized controlled trial and 5 observational studies. At 30 days follow-up, rates of death did not differ between self-expanding and balloon-expandable valves (odds ratio [OR] 0.74, 95% confidence interval [CI] 0.47 to 1.17), whereas balloon expandable reduced rates of moderate or severe AR (OR 0.51, 95% CI 0.27 to 0.99) and of pacemaker implantation (OR 0.28, 95% CI 0.17 to 0.47). After a follow-up of 360 days (300 to 390), rates of all-cause death did not differ between the 2 groups. In conclusion, risks of moderate or severe AR and pacemaker implantation were lower with the balloon-expandable devices without an impact on 30 days and midterm mortality.