In simplified transaxillary TAVI using vascular closure devices, MANTA and ProGlide VCDs 'performed well in terms of vascular and bleeding complications,' with a 30-day axillary major vascular complication rate of 3.1% and no major bleeding complications.
Key Findings
Results
The 30-day axillary major vascular complication rate was low at 3.1% in simplified transaxillary TAVI using vascular closure devices.
Only 1 of 32 patients experienced an axillary major vascular complication by 30 days per VARC-3 definitions.
No major bleeding complications occurred in any patient.
All-cause 30-day mortality was 3.1% (1/32).
The study enrolled consecutive severe aortic stenosis patients unsuitable for both surgery and transfemoral access from January 2022 to January 2024.
Results
VCD failure occurred in 25.0% of cases overall and was numerically more frequent with ProGlide than MANTA.
VCD failure occurred in 8 of 32 cases (25.0%).
ProGlide failure rate was 31.3% (5/16) compared to MANTA failure rate of 18.8% (3/16).
MANTA (collagen-based plug) and ProGlide (suture-based system) were each used in 50.0% of cases (n=16 each).
The difference in failure rates between devices was described as 'numerically more frequent' but no formal statistical comparison was reported.
Results
A covered stent was required for definitive axillary haemostasis in 12.5% of cases.
4 of 32 patients required a covered stent for definitive haemostasis.
The authors concluded that simplified TAx-TAVI 'requires advanced access-site management skills, including covered stent use.'
This finding underscores the need for operators to be prepared for bailout endovascular techniques even with successful VCD use.
Results
Overall VARC-3 device success was 96.9% in simplified transaxillary TAVI.
31 of 32 patients achieved VARC-3 device success.
The patient cohort had a mean age of 77 years and was 31.3% female.
Local anaesthesia with conscious sedation was used in 21.9% of cases (n=7), reflecting a minimalist approach in a subset of patients.
New permanent pacemaker implantation was required in 12.5% of patients (4/32).
Results
NYHA functional class improved by at least one category in 68.8% of patients at 30 days.
22 of 32 patients showed improvement of at least one NYHA class by 30 days post-TAx-TAVI.
All patients enrolled had severe aortic stenosis and were deemed unsuitable for both surgical valve replacement and transfemoral TAVI access.
This functional improvement indicates clinical benefit of the procedure in this high-risk population.
Methods
The axillary artery access approach was performed fully percutaneously using vascular closure devices approved for femoral use in an off-label manner.
Both the MANTA collagen-based plug and the double ProGlide suture-based system are approved for femoral arteriotomy closure but were used off-label for axillary access.
The registry study design enrolled consecutive patients from January 2022 to January 2024 at a single center.
VCD selection was at the operator's discretion.
The study population represented patients with no suitable alternative access, making this an important real-world dataset for a challenging cohort.
What This Means
This research describes how a heart valve replacement procedure called transcatheter aortic valve implantation (TAVI) can be performed through the armpit artery (axillary artery) when the more common route through the groin artery is not suitable. In this study of 32 patients who were also too high-risk for open-heart surgery, doctors used two types of wound-closure devices — originally designed and approved for closing groin artery punctures — to seal the armpit artery after the procedure. The study found that serious artery-related complications were rare (occurring in only 1 patient, or 3.1%), and no patients had major bleeding complications. Nearly 69% of patients felt meaningfully better in terms of breathing and activity tolerance within 30 days.
However, the wound-closure devices did fail to work as intended in about 1 in 4 patients (25%), and in 12.5% of cases, doctors needed to place a small metal tube called a covered stent to fully stop the bleeding at the access site. The suture-based closure device (ProGlide) failed slightly more often (31%) than the plug-based device (MANTA, 19%), though the study was too small to draw firm statistical conclusions from this difference. One patient died within 30 days, and about 1 in 8 patients needed a permanent pacemaker.
This research suggests that using these closure devices through the armpit artery — even though they are not officially approved for this purpose — appears to be a reasonably safe option for patients who have no other suitable access route for valve replacement. However, the findings also highlight that this approach should only be performed by experienced teams who are prepared to handle complications, including the use of covered stents as a backup measure. The results contribute important real-world safety data for this challenging patient population.
Lauten P, Bleiziffer S, Costello-Boerrigter L, Göbel B, Albert C, Al Jassem M, et al.. (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