Predictors of Hemostasis Failure with Angio-Seal Device in a Real-World Setting for Infrainguinal Revascularization Procedures

Background: To evaluate the outcomes of the Angio-Seal closure device in a real-world clinical setting among patients with symptomatic peripheral arterial disease undergoing infrainguinal revascularization. Methods: A retrospective review over a 5-year period was conducted to identify patients who underwent endovascular infrainguinal revascularizations where Angio-Seal was chosen as a first-intention device for achieving hemostasis. The primary endpoints were technical and clinical success. All procedures were routinely performed under ultrasound guidance. Results: A total of 321 procedures met the inclusion criteria. Mean age was 76 ± 10 years and 60% were male. Wall calcifications near the puncture site were recorded in 11.2%, and prior ipsilateral groin intervention in 12.8%. An antegrade approach was used in 70% of cases; common femoral artery and superficial femoral artery puncture sites accounted for 80.4% and 19.6%, respectively, with off-label in 20.6% of procedures. The complication rate was 5.3%, with 16 cases requiring surgical conversion and one managed endovascularly. Groin hematoma occurred in 3.1% and occlusion in 2.2% of cases among those 5 from calcified plaques dissection and 2 from anchor-collagen plug migration into the vessel. Device deployment failure occurred in 2 cases (0.6%), both managed with manual compression. During follow-up no late access site complications were observed. Calcification near the puncture site was the only independent predictive factor of vascular access complications (P < 0.001). Conclusion: Angio-Seal was safe and effective for infrainguinal revascularizations including situations considered at high risk for failure. Calcifications adjacent to the puncture site emerged as the sole independent risk factor for vascular access-related complications.