Percutaneous Transaxillary Access for Endovascular Aortic Procedures in the Multicenter International PAXA Registry.

Abstract Introduction The aim of the study is to demonstrate the safety and effectiveness of a suture-mediated vascular closure device to perform hemostasis after an axillary artery access during endovascular procedures on the aortic valve, the aorta and its side branches. Methods A physician-initiated, international, multicenter, retrospective registry was designed to evaluate the success rate(VARC-2 reporting standards) of percutaneous transaxillary access closure with a suture-mediated closure device. Secondary endpoints were: minor access vascular complications, transient peripheral nerve injury, stroke, and influence on periprocedural outcomes of puncture technique. Results Three hundred thirty-one patients(median age 76 years, 69.2% males) in 11 centers received a percutaneous transaxillary access during endovascular cardiac (n=166) or vascular (n=165) procedures. Closure success rate was 84.6%, with 5 open conversion(1.5%), 45 adjunctive endovascular procedures(13.6%) and one nerve injury(0.3%). Secondary closure success was obtained in 325 patients(98%) after 7 bare stenting, 37 covered stenting and one thrombin injection. Introducer sheaths ≥16F(OR:3.70; 95%CI 1.22-11.42) and balloon-assisted hemostasis(OR: 4.45; 95%CI: 1.27–15.68) were associated with closure failure. A threshold of five percutaneous axillary accesses was associated with decreased rates of open conversion but not with increased primary closure success. Primary closure success was 90.3% in the 175 patients with Conclusions Percutaneous transaxillary aortic procedures, in selected patients, can be performed with low rates of open conversion. The need for additional endovascular bailout procedures is not negligible when introducers sheaths ≥16F are required.