Related Experiment Video
Updated: Jul 12, 2026
Fully Endoscopic Mitral Valve Repair with Percutaneous Cannulation of Groin Vessels
Published on: May 26, 2023
Successful off-label use of vascular closure devices in fully percutaneous transaxillary aortic valve implantation
Philipp Lauten1,2, Sabine Bleiziffer3, Lisa C Costello-Boerrigter4
1Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany Philipp.lauten@zentralklinik.de.
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.
