Vascular Closure Devices For Axillary Artery Access: A Systematic Review and Meta-Analysis.

ABSTRACT

PURPOSE: To evaluate the technical success and complication rates of vascular closure devices (VCDs) in the axillary artery. MATERIALS AND METHODS: MEDLINE and Embase were searched independently by two reviewers to identify observational studies from inception through October 2021. The following outcomes were meta-analyzed technical success, hematoma, dissection, pseudoaneurysm, infection, and local neurological complications. Complications were also graded as mild, moderate, and severe. A logistic regression evaluating the influence of sheath size for the outcome of technical success rate was performed using individual patient-level data. RESULTS: Of 1496 unique records, 20 observational studies were included, totaling 915 unique arterial access sites. Pooled estimates were as follows technical success 84.8% (95% confidence interval [CI] 78%-89.7%, I2=60.4%), hematoma 7.9% (95% CI 5.8%-10.6%, I2=0%), dissection 3.1% (95% CI 1.3%-7.3%, I2=0%), pseudoaneurysm 2.7% (95% CI 1.3%-5.7%, I2=0%), infection <1% (95% CI 0%-5.7%, I2=20.5%), and local neurological complications 2.7% (95% CI 1.7%-4.4%, I2=0%). There was a significant negative association between sheath size and technical success rate (odds ratio [OR] 0.87 per 1 French (Fr) increase in sheath size, 95% CI 0.80-0.94, p=0.0005). Larger sheath sizes were associated with a greater number of access-site complications (adjusted odds ratio [aOR] 1.21 per 1 Fr increase sheath size, 95% CI 1.04-1.40, p=0.013). CONCLUSIONS: Off-label use of VCDs in the axillary artery provides an 85% successful closure rate and variable complication rate, depending on the primary procedure and sheath size. Larger sheaths were associated with a lower technical success and greater rate of access-related complications. CLINICAL IMPACT Safe arterial access is the foundation for arterial intervention. While the common femoral artery is a well established access site, alternative arterial access sites capable of larger sheath sizes are needed in the modern endovascular era. This article provides the largest synthesis to date on the use of vascular closure devices for percutaneous axillary artery access in endovascular intervention. It should serve clinicians with added confidence around this approach in terms of providing a reference for technical success and complications. Clinically, this data is relevant for patient consent purposes as well as for practice quality improvement in setting safety standards for this access site.