Transarterial TAVI approaches were associated with low early mortality, with pooled 30-day mortality rates of 0.08 for TF-SAPIEN, 0.12 for TA-SAPIEN, and 0.06 for CoreValve.
Meta-Analysis (n=9,786)
Yes
Does the type of TAVI strategy (TF-SAPIEN, TA-SAPIEN, or CoreValve) affect 30-day mortality and complications in patients undergoing TAVI in real-world European registries?
Transarterial TAVI approaches are associated with low early mortality regardless of device type, though CoreValve has a higher risk of pacemaker implantation and there is significant regional heterogeneity in mortality across Europe.
Absolute Event Rate: 0.08% vs 0.12%
p-value: p=0.18
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.
Krasopoulos et al. (Tue,) conducted a meta-analysis in Aortic valve stenosis (n=9,786). Transcatheter aortic valve implantation (TF-SAPIEN, TA-SAPIEN, CoreValve) vs. Comparison between TAVI strategies was evaluated on 30-day mortality (p=0.18). Transarterial TAVI approaches were associated with low early mortality, with pooled 30-day mortality rates of 0.08 for TF-SAPIEN, 0.12 for TA-SAPIEN, and 0.06 for CoreValve.