Simplified percutaneous transaxillary TAVI - Comparison of a Pure Plug-Based versus a Primary Suture-Based Vascular Closure Device Strategy

Background:
The axillary artery is an alternative access route for patients needing transcatheter aortic valve replacement (TAVR), but who have unfavorable femoral arteries. Simplified trans-axillary TAVR is a completely percutaneous approach with vascular closure device (VCD) techniques used to close the arteriotomy. There are clinically relevant concerns regarding potential major vascular complications with this technique. We report here our successful, early experience with simplified TAx-TAVR using plug-based large bore and suture-based VCDs. 

Methods:
After obtaining consent, all consecutive patients who underwent simplified TAx-TAVR were enrolled. At the operator’s discretion, the patients underwent vascular closure with with either a collagen plug-based large bore vascular closure device (MANTA, Teleflex, Wayne, PA) or with a suture-based vascular closure device (ProGlide, Abbott Cardiovascular; Illinois). The primary outcome of interest was the overall incidence of axillary access-related major vascular complications directly after intervention and at 30 days post-procedure. Secondary outcomes examined included a composite early safety endpoint, axillary access-site related vascular/bleeding complications, and short-term mortality.  

Results: 
Between January 2022 and January 2024, simplified TAx-TAVR with VCD use was performed in 32 patients (mean age of 77 years / 31.3 % female). 50.0 % received MANTA, 50.0 % received ProGlide. Conscious sedation and general anaesthesia were used in 21.8 % (n = 7) and 78.2% (n = 25), respectively. A covered stent was needed for complete axillary hemostasis in 12.5 % (n =2). Device success was achieved in 93.7% (n = 30/32). The 30-day axillary artery major vascular complication rate was 3.1% (n=1). There were no major bleeding complications noted post-procedure or during follow-up. Mortality rates at 30 days and six months were 3.1 % (n=1) and 6.2 % (n=2), respectively.  

Conclusions: 
In our earliest patients treated with simplified percutaneous TAx-TAVR, the MANTA and ProGlide VCDs performed well in terms of vascular and bleeding complications. This alternative TAx-TAVR approach does require proficiency in advanced access site management, including the possible use of covered stents. Importantly, our results show that these VCD systems, which are primarily approved for femoral use, can be safely used when axillary access is necessary.