A propensity-matched comparison of plug- versus suture-based vascular closure after TAVI.

Abstract

Background: Vascular access site complications are associated with increased morbidity and mortality after transcatheter aortic valve implantation (TAVI). Current results comparing strategies with plug- (P-VCD; MANTA) and suture-based vascular closure devices (S-VCD; Perclose ProGlide) remain inconsistent.

Aims: It was our aim to assess the incidence of access-related vascular complications after P-VCD or S-VCD strategies after transfemoral TAVI.

Methods: The Plug or sUture based vascuLar cloSurE after TAVI (PULSE) registry retrospectively evaluated 10,120 consecutive patients who had undergone transfemoral TAVI at 10 centres from 2016 to 2021. A propensity score was used to match 900 P-VCD patients with 1,800 S-VCD patients in a 1:2 fashion. The primary outcome measures were major and minor access-related vascular complications at the primary access site, adjudicated according to Valve Academic Research Consortium 3 definitions.

Results: The median age was 81.8 years, 46.4% of patients were female, and the median European System for Cardiac Operative Risk Evaluation II was 3.50%. In matched P-VCD and S-VCD groups, large-bore access-related complications occurred in 14.9% vs 10.3% (p<0.001; major: 3.6% vs 4.6%; p=0.218; minor: 11.3% vs 5.8%; p<0.001) of patients. Bleeding accounted for most of these complications (9.6% vs 7.2%; p=0.028) and was treated with endovascular balloon inflation (5.4% vs 2.6%; p<0.001), stent implantation (4.7% vs 0.7%; p<0.001) or surgical repair (0.7% vs 1.7%; p=0.03).

Conclusions: P-VCD were associated with higher rates of primary access-related vascular complications, driven by minor complications, compared to S-VCD. Endovascular treatment was more common after P-VCD failure.