Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

BackgroundThe aim of the study was 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.MethodsA 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 end points were minor access vascular complications, transient peripheral nerve injury, stroke, and influence on periprocedural outcomes of puncture technique.ResultsThree 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. The closure success rate was 84.6%, with 5 open conversions (1.5%), 45 adjunctive endovascular procedures (13.6%), and 1 nerve injury (0.3%). Secondary closure success was obtained in 325 patients (98%) after 7 bare stenting, 37 covered stenting, and 1 thrombin injection. Introducer sheaths 16F or larger (odds ratio, 3.70; 95% confidence interval, 1.22-11.42) and balloon-assisted hemostasis (odds ratio, 4.45; 95% confidence interval, 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 sheaths smaller than 16F, performed after the first 5 procedures in each center. Temporary nerve injury and stroke were observed in 2% and 4% of patients, respectively.ConclusionsPercutaneous 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 or larger are required.

Original publication

DOI

10.1016/j.jvs.2021.08.089

Type

Journal article

Journal

Journal of vascular surgery

Publication Date

03/2022

Volume

75

Pages

868 - 876.e3

Addresses

Division of Vascular Surgery, IRCCS San Raffaele Scientific Institute, Milano, Italy. Electronic address: bertoglio.luca@hsr.it.

Keywords

of the PAXA Collaborators, Aorta, Thoracic, Axillary Artery, Aortic Valve, Humans, Heart Valve Diseases, Aortic Diseases, Postoperative Complications, Punctures, Treatment Outcome, Catheterization, Peripheral, Blood Vessel Prosthesis Implantation, Registries, Risk Assessment, Risk Factors, Retrospective Studies, Stents, Time Factors, Aged, Aged, 80 and over, United States, Europe, Female, Male, Endovascular Procedures