Vascular Complications after Transfemoral Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-Analysis

Abstract

ABSTRACT Background: Vascular complications (VCs) after transcatheter aortic valve implantation (TAVI) are associated with impaired outcome. We performed a meta-analysis to determine in-hospital/30-day major VCs rate after transfemoral-TAVI adjudicated by an independent clinical-event-committee, and to compare the major VCs rate with regard to consecutive generations of balloon-expandable and self-expanding platforms, device profile, experience and patient risk-profile. Methods: A systematic, computerized search with predefined criteria was performed in PubMed, Embase and Cochrane on March 27, 2018. The overall pooled proportion of VC was calculated using a random-effects model. Subgroups were examined based on sheath size, STS-score and start-date of inclusion (early (< January 2012); late-phase (≥ January 2012) studies). Results: A total of 24 studies with 14308 patients were included. The pooled major VCs rate was 7.71% and was lower in low-profile vs. high-profile device studies (5.51% vs. 8.46%, p = 0.0015). Major VCs rate decreased significantly with transition to newer generation balloon-expandable valves ((Sapien vs. Sapien XT (15.18% vs. 8.48%, p < 0.00001); Sapien XT vs. Sapien 3 (8.48% vs. 4.48%, p = 0.005)) and there was a tendency towards fewer major VCs in EvolutR vs. CoreValve (5.98% vs. 7.97%, p = 0.094). Major VC rate was lower in late-phase vs. early-phase studies (5.82% vs. 7.84%, p = 0.048) and a tendency towards a lower rate was seen in intermediate vs. high-risk studies (7.09% vs. 9.62%, p = 0.059). Conclusion: The pooled rate of independently adjudicated major VCs after transfemoral-TAVI was 7.71%. Experience and device profile are associated with fewer major VCs.