European real world transcatheter aortic valve implantation: Systematic review and meta-analysis of European national registries

Abstract Objective: Transcatheter aortic valve implantation (TAVI) has been adopted rapidly in Europe despite the paucity of randomized studies. TAVI registries represent a real-world scenario thus providing the evidence for the treatment of high-risk patients. We undertook a meta-analysis of published European national TAVI registries to assess current results of TAVI technologies in Europe. Methods: Electronic databases were searched. The review focused on the comparison of the following TAVI technologies: transfemoral (TF) and transapical (TA) SAPIEN and CoreValve implantation. Individual event rates for outcomes of interest were pooled using a mixed effect model. Results: A total of 7 European national TAVI registries (UK, Swiss, Belgium, Italy, Spain, France, Germany) were identified including a total of 9786 patients who received TF SAPIEN  (n=2885), TA SAPIEN  (n=2252) and CoreValve (n=4649) implantation. Pooled incidence of 30 day mortality was 0.08 [95%Confidence Interval (CI): 0.05-0.11], 0.12 [95%CI: 0.07-0.19] and 0.06 [95%CI: 0.03-0.11] for TF SAPIEN, TA SAPIEN and CoreValve respectively (test for subgroup difference P=0.18) and high heterogeneity across European country was found. Pooled incidence of stroke was comparable among the TAVI technologies (test for subgroup difference P=0.79) as well as the incidence of postprocedural paravalvular leak ≥ 2 (P=0.9). CoreValve increased the risk of pacemaker implantation requirement (test for subgroup difference P<0.0001). Conclusions: Trans-vascular TAVI approaches were associated with a lower early mortality regardless of the type of device used. There was a marked heterogeneity among European countries for early mortality.