Key result
Off-label vascular closure devices during transaxillary TAVI yield a 3.1% 30-day major vascular complication rate.
Why the study?
Simplified transaxillary TAVI is performed fully percutaneously with vascular closure devices, but concerns exist regarding major vascular complications with this technique.
Does the off-label use of vascular closure devices for arteriotomy closure prevent major vascular complications in patients undergoing fully percutaneous transaxillary TAVI?
Observational (n=32)
Does the off-label use of vascular closure devices for arteriotomy closure prevent major vascular complications in patients undergoing fully percutaneous transaxillary TAVI?
Off-label use of femoral vascular closure devices for fully percutaneous transaxillary TAVI appears safe with a low rate of major vascular complications, though device failure requiring covered stents occurs in a minority of cases.
Supports cautious use of off-label VCDs for percutaneous TAx-TAVI amid vascular concerns; leaves open need for dedicated safety trials.
Background The 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. Methods Consecutive 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. Results From 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). Conclusions In 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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Lauten et al. (2026) conducted an observational in Severe aortic stenosis (n=32). Vascular closure devices (MANTA or ProGlide) during simplified transaxillary-TAVI was evaluated on Axillary access-related major vascular complications in hospital and at 30 days according to VARC-3 definitions. Off-label use of vascular closure devices during simplified transaxillary-TAVI resulted in a 30-day axillary major vascular complication rate of 3.1%.
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