European real world trans-catheter 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. TAVI national registries can augment understanding of technologies and represent real-world experience, providing further clinical insights. We undertook a meta-analysis of published European national TAVI registries to assess current results following TAVI in Europe.

Methods: Electronic databases were searched. The review focused on the comparison of the following TAVI strategies: transfemoral (TF) and transapical (TA) SAPIEN and CoreValve implantation. Individual event rates for outcomes of interest were pooled using a mixed effect model.

Results: Seven 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); there was high heterogeneity across European countries. Pooled incidence of stroke was comparable among the TAVI strategies (test for subgroup difference P = 0.79); the incidence of post-procedural moderate paravalvular leak ≥ 2 (P = 0.9) was similar across groups. CoreValve implantation was associated with an increased risk of pacemaker implantation (0.22 [95% CI: 0.19-0.26]; test for subgroup difference P < 0.0001). The lowest 30-day mortality was associated with TAVI performed in Spain (b coefficient -4.3; P = 0.03), in Italy (b coefficient -2.1; P < 0.0001), in UK (b coefficient -1.95; P = 0.01) and in France (b coefficient -2.8; P = 0.03). The German registry has the highest mortality for every TAVI strategy amongst all other European registries and especially for the TA-SAPIEN group.

Conclusions: Transarterial TAVI approaches were associated with a low early mortality regardless of the type of device used. There was marked heterogeneity among European countries for early mortality.

Keywords: Aortic stenosis; Metanalysis; Registry; TAVI; TAVR; Transcatheter aortic valve implantation.

Fig. 1

Outline of the systematic review process

Fig. 2

Meta-analysis for proportions of 30-day mortality

Fig. 3

Bubble plot. Display the adjusted association between logistic EuroSCORE, 30-day mortality (left) and 1-year mortality (right)

Fig. 4

Meta-analysis for proportions of stroke

Fig. 5

Meta-analysis for proportions of pacemaker requirement

Fig. 6

Meta-analysis for proportions of Incidence of paravalvular leak ≥ 2

Fig. 7

Meta-analysis for proportions of 1-year mortality