Off-Label Use of the 8-F Angio-Seal for Closure of Greater than 8-F Common Femoral Arterial Access: A Systematic Review and Meta-Analysis

Abstract

Purpose: To evaluate the safety of >8-F access closures using 8-F Angio-Seal.

Materials and methods: An electronic search was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines using Web of Science, Embase, Scopus, and PubMed databases from inception until January 17, 2022. Actionable and nonactionable bleeding events were defined in conjugation with the Bleeding Academic Research Consortium definition. Prevalence rates with corresponding 95% CIs were calculated using R software version 4.2.2. Eight articles, with 422 patients, were included in the analysis.

Results: The overall groin adverse event rate was 5.92% (95% CI, 3.01-11.34). The most commonly reported adverse events were any bleeding (5.74%; 95% CI, 3.23-10.00) (nonactionable bleeding, 0.96% [95% CI, 0.10-8.30]; actionable bleeding, 2.30% [95% CI, 0.89-5.84]), pseudoaneurysm (1.18%; 95% CI, 0.49-2.81), and groin hematoma (1.28%; 95% CI, 0.23-6.79). The least commonly reported adverse events were device failure and vessel occlusion/stenosis, with rates 0.29% (95% CI, 0.01-7.41) and 0.45% (95% CI, 0.02-7.74), respectively. No studies recorded events regarding the following adverse events: mortality, infection, deep venous thrombosis, and retroperitoneal hematoma. Moreover, the results showed significant differences, based on the sheath size used, in actionable bleeding (P = .04) and the rate of need for surgical repair (P < .01).

Conclusions: Common femoral artery access of >8-F can be effectively closed with the Angio-Seal with comparable outcomes to those of <8 F; however, larger access approaching 14 F is associated with a significant increase in morbidity. Further safety is needed, especially for the larger access sizes.