Vascular closure after TAVI: assessing the safety and efficacy of a collagen-based device in a real-world population

Abstract

Abstract Background Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of symptomatic severe aortic stenosis. However, the high rates of vascular complications (5-20%) associated with the large-bore access hinder clinical outcomes. There are several options available for access site closure, including MANTA, a dedicated collagen plug-based device that showed promising results in recent trials. Purpose We sought to evaluate the safety and efficacy of large calibre arteriotomy closure with MANTA during transfemoral TAVI in a real-world cohort. Methods We retrospectively analysed all consecutive patients who underwent transfemoral TAVI access closure with the MANTA device in our centre between March 2020 and May 2022. The primary safety endpoints were the rates of closure device failure, and access-related vascular and bleeding complications. The secondary endpoint was periprocedural all-cause mortality. All endpoints were defined according to the Valve Academic Research Consortium (VARC) 3 criteria. Results A total of 299 patients were included, mean age of 81.09 ± 6.34 years, 50.5% females, median EuroSCORE II of 3.11% [IQR 2.08–4.75]. Approximately two-thirds were under antithrombotic treatment (36.4% on oral anticoagulation and 33.0% on antiplatelet therapy). Closure device failure occurred in 8.4% cases (n=25), nevertheless only one required bailout surgical closure. Vascular complications occurred in 11.4% (n=34), most minor and related to the access site (9.0%, n=27): arterial occlusion (5.0%, n=15), haematomas (3.0%, n=9) and pseudoaneurysms (1.0%, n=3). Bleeding complications occurred in 4.3% (n=13), most VARC type 1 (3.3%, n=10). Both smaller minimal femoral artery diameter (6.6 ± 1.1 mm vs 7.7 ± 1.4mm, p<0.001) and bigger sheath to femoral artery diameter ratio (0.76 ± 0.15 vs 0.68 ± 0.14, p=0.02) were associated with device failure. The secondary endpoint occurred in 7 patients (2.3%), both from cardiovascular (aortic dissection, n=3; ischemic stroke; n=2) and non-cardiovascular causes (sepsis, n=2). Device failure did not prolong the index hospitalization (4.00, IQR 3.00-5.00 days vs 4.00, IQR 3.00-5.00; p=0.36). Conclusions In a large real-world cohort, MANTA was a safe and effective solution for femoral arteriotomy closure after TAVI. Device failure was infrequent, rarely associated with severe complications and did not lengthen the hospital stay.