Outcomes of ultrasound-guided and conventional Angio-Seal closure following antegrade femoral artery access: a systematic review and meta-analysis of observational studies with an exploratory indirect comparison.

Abstract

Purpose: Vascular closure devices (VCDs), particularly the Angio-Seal device, are widely used for rapid hemostasis following antegrade femoral artery access during peripheral vascular interventions. However, the comparative safety and efficacy of ultrasound-guided vs. conventional non-ultrasound-guided antegrade femoral access closure with Angio-Seal have not been quantified. This meta-analysis synthesizes available evidence comparing these approaches in patients undergoing antegrade femoral artery access closure with Angio-Seal devices.

Methods: Relevant studies were systematically identified through searches of the PubMed and Google Scholar databases. Studies examining the Angio-Seal closure device for antegrade femoral artery access closure with ultrasound-guided and conventional (without ultrasound guidance) techniques and comparing the two techniques were included. Given the limited direct comparative evidence, pooled outcomes from ultrasound-guided and non-ultrasound-guided cohorts were evaluated. The primary endpoints were technical success rates, major complications, and minor complications. Study quality was assessed using the Newcastle-Ottawa Scale, and data were extracted systematically. A meta-analysis was conducted using random-effects models, with odds ratios (ORs) and 95% confidence intervals (CIs) as effect measures. In addition, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) analysis of the certainty of the obtained evidence was performed.

Results: The search identified 15 studies comprising 4,782 antegrade femoral access closures using the Angio-Seal device. The pooled technical success rate was 96.3% (95% CI: 0.93-0.98), with considerable heterogeneity (I²: 86%). Major complications were rare, with a pooled rate of 1.1% (95% CI: 0.01-0.02), whereas minor complications occurred in 3.4% (95% CI: 0.03-0.09) of procedures. Substantial and considerable hetereneity was observed for major and minor complications (I²: 66% and 90%, respectively). Comparative analysis demonstrated higher technical succes with ultrasound-guided closure than with conventional techniques, corresponding to significantly lower odds of technical failure with ultrasound guidance (OR: 0.13, 95% CI: 0.019-0.962; P = 0.014; GRADE certainty: very low) and significant reduction in the rate of major complications(OR: 0.2, 95% CI: 0.072-0.558; P = 0.00027; GRADE analysis: low); minor complication rates were similar between techniques (OR: 0.82, 95% CI: 0.567-1.19; P = 0.3).

Conclusion: Angio-Seal closure following antegrade femoral access demonstrates high technical success and low complication rates across available studies. Ultrasound-guided deployment was associated with higher technical success and reduced major complications in the pooled analysis. However, the evidence is derived primarily from observational studies with considerable heterogeneity, and further prospective studies are needed to confirm these findings.

Clinical significance: These findings support integrating ultrasound guidance into routine antegrade femoral artery closures to improve procedural safety and enhance operator confidence. Adoption of ultrasound-guided closure techniques may contribute to improved patient outcomes and better post-procedural recovery rates in vascular populations.