European real world trans-catheter aortic valve implantation: systematic review and meta-analysis of European national registries.
Krasopoulos G., Falconieri F., Benedetto U., Newton J., Sayeed R., Kharbanda R., Banning A.
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.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.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.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.