ArticleOpen heart2026
Successful off-label use of vascular closure devices in fully percutaneous transaxillary aortic valve implantation.
Article in Open heart, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe axillary artery is an alternative access- site for transcatheter aortic valve implantation (TAVI) when femoral arteries are unfavourable. Simplified transaxillary-TAVI (TAx-TAVI) is performed completely percutaneously, using vascular closure device (VCD) techniques for arteriotomy closure. Concerns exist regarding major vascular complications with this technique. This registry-study describes off-label VCD use during simplified TAx-TAVI.
methodsConsecutive severe aortic stenosis patients unsuitable for both surgery and transfemoral access were enrolled in our heart valve registry and underwent simplified TAx-TAVI using VCDs for arteriotomy closure. At the operator's discretion, closure was performed with a collagen-based plug (MANTA) or a suture-based system (double ProGlide). The primary endpoint was axillary access-related major vascular complications in hospital and at 30 days according to Valve Academic Research Consortium (VARC-3) definitions. Secondary endpoints included axillary access-site bleeding and all-cause mortality during hospitalisation to 30 days post-TAx-TAVI.
resultsFrom January 2022 to January 2024, 32 patients (mean age 77 years, 31.3% female) underwent simplified TAx-TAVI using VCDs. MANTA and ProGlide were each used in 50.0% of cases (n=16). Local anaesthesia with conscious sedation was used in 21.9% (n=7). Overall VARC-3 device success was 96.9% (31/32). VCD failure occurred in 25.0% (8/32) and was numerically more frequent with ProGlide (31.3%) than MANTA (18.8%). A covered stent was required for definitive axillary haemostasis in 12.5% (4/32). The 30-day axillary major vascular complication rate was 3.1% (1/32). No major bleeding complications occurred. All-cause 30-day mortality was 3.1% (1/32). New permanent pacemaker implantation occurred in 12.5% (4/32). At 30 days, New York Heart association (NYHA) class improved by at least one category in 68.8% (22/32).
conclusionsIn these simplified TAx-TAVI cases, MANTA and ProGlide VCDs performed well in terms of vascular and bleeding complications. Simplified TAx-TAVI requires advanced access-site management skills, including covered stent use. We found VCDs approved for femoral use safe with axillary access.
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