Safety and effectiveness of ultrasound-guided percutaneous versus open brachial artery access: results of the multicenter prospective ARCHIBAL study Percutaneous/open brachial artery access.

Abstract

Background: Although brachial access has become increasingly used in percutaneous endovascular procedures, results from head-to-head comparisons between open (OBA) and ultrasound-guided percutaneous (PBA) brachial accesses are limited in the literature. The objective of our multicenter, prospective, non-interventional ARCHIBAL study was to compare the safety and efficacy of OBA and PBA to perform peripheral arterial interventions.

Methods: From July 2019 to January 2021, all patients needing peripheral endovascular procedures with brachial artery access were consecutively included in the study by 15 surgeons in 14 centers. Procedures were done with 4F-8F introducer sheaths. Arterial closure was done by conventional arterial sutures for OBA and compression or vascular closure devices for PBA. The primary endpoint was the rate of access site complications occurring up to 30 days post-operatively. Secondary endpoints were the occurrence of adverse events and the overall rates of clinical success of brachial access cannulation and technical success.

Results: Among the 251 included patients (mean age, 69.9 years; males 70.5%), 122 (48.6%) had an OBA and 129 (51.4%) a PBA, without significant differences in baseline demographic and clinical characteristics. 38.6% of the patients had the procedure for more than one indication. Clinical success was achieved in all patients and technical success in 244 patients (97.2%). No death, cerebral, cardiac, or embolic complications were reported. Access site complications (primarily hematomas) were significantly (P=0.02) more frequent in the PBA (8/1296.2%) than the OBA group (1/125, (0.8%) or when using introducer sheaths >6F for OBA or vascular closure devices for PBA.

Conclusion: Our prospective study confirmed the safety and effectiveness of brachial access and showed the benefit in terms of safety of OBA vs PBA even when PBA was ultrasound-guided and performed by trained surgeons. It encourages the use of OBA and ultrasound guidance when using PBA. Large and/or randomized studies should be performed to support these results.