Key result
Low-profile TAVI devices linked to ~35% fewer major vascular complications versus high-profile devices.
Why the study?
Vascular complications after transfemoral TAVI are associated with impaired outcomes, but pooled rates and comparisons across device generations and profiles were unclear.
What is the rate of major vascular complications after transfemoral TAVI, and how is it affected by device generation, profile, and operator experience?
Meta-Analysis (n=14,308)
What is the rate of major vascular complications after transfemoral TAVI, and how is it affected by device generation, profile, and operator experience?
Absolute Event Rate: 5.51% vs 8.46%
p-value: p=0.0015
The rate of major vascular complications after transfemoral TAVI is 7.71%, with significant reductions observed with the use of newer generation, lower-profile devices and increased operator experience.
Supports preferential selection of low-profile, newer-generation devices for transfemoral TAVI to reduce major VCs; extends CEC-adjudicated evidence on temporal and device-related improvements.
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.
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Rahhab et al. (2019) conducted a meta-analysis in Transfemoral Transcatheter Aortic Valve Implantation (n=14,308). Low-profile TAVI devices vs. High-profile TAVI devices was evaluated on in-hospital/30-day major vascular complications (p=0.0015). Low-profile TAVI devices were associated with a significantly lower rate of major vascular complications compared to high-profile devices (5.51% vs. 8.46%, p=0.0015).
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