Successful off-label use of vascular closure devices in fully percutaneous transaxillary aortic valve implantation.
P, L., S, B., LC, C.B., B, G., C, A., M, A.J., D, G.L., B, S., & H, L. (2026). Successful off-label use of vascular closure devices in fully percutaneous transaxillary aortic valve implantation.. Open heart. https://doi.org/10.1136/openhrt-2026-004150
P L, S B, LC CB, B G, C A, M AJ, et al. Successful off-label use of vascular closure devices in fully percutaneous transaxillary aortic valve implantation.. Open heart. 2026; doi: 10.1136/openhrt-2026-004150
P L, S B, LC CB, et al. Successful off-label use of vascular closure devices in fully percutaneous transaxillary aortic valve implantation.[J]. Open heart. 2026. DOI: 10.1136/openhrt-2026-004150.
@article{p2026,
author = {Lauten P and Bleiziffer S and Costello-Boerrigter LC and Göbel B and Albert C and Al Jassem M and Gonzalez-Lopez D and Schieffer B and Lapp H},
title = {Successful off-label use of vascular closure devices in fully percutaneous transaxillary aortic valve implantation.},
journal = {Open heart},
year = {2026},
doi = {10.1136/openhrt-2026-004150},
note = {PMID: 42425724},
}
TY - JOUR AU - Lauten P AU - Bleiziffer S AU - Costello-Boerrigter LC AU - Göbel B AU - Albert C AU - Al Jassem M AU - Gonzalez-Lopez D AU - Schieffer B AU - Lapp H TI - Successful off-label use of vascular closure devices in fully percutaneous transaxillary aortic valve implantation. T2 - Open heart PY - 2026 DO - 10.1136/openhrt-2026-004150 AN - PMID:42425724 ER -
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.