Safety and Effectiveness of Closure Devices Applied to a Stented Common Femoral Artery: A Retrospective Analysis.

Abstract

Bailout stenting of the common femoral artery (CFA) may become necessary with failed balloon angioplasty or atherectomy or in case of bleeding requiring a covered stent over the arteriotomy site. Reaccessing the CFA through a previously placed stent may occur during angiography. The safety and effectiveness of applying a closure device, or manual compression to achieve hemostasis through an accessed stented CFA are unknown. All patients in our practice that underwent CFA stenting were identified using billing records for 3 years (January 1, 2010-February 28, 2013). Patients were included if there has been documentation of access through the stented CFA segment on angiography. In-hospital and up to 2 weeks postdischarge major adverse events were recorded from medical records. A total of 48 patients were included in the study. The mean age was 65.9 ± 10.9 years, males 60.4%. Perclose (Abbott Vascular, Santa Clara, CA) was used in 85.7%, AngioSeal (St. Jude Medical, St. Paul, MN) in 8.3%, Mynx (Access Closure, Santa Clara, CA) in 2%, and manual compression in 4% of the patients. Major adverse events consisted of in-hospital mortality in two patients: one probably related to index access-site thrombosis complicated by subsequent acute renal failure following reintervention; the other mortality was related to major bleeding possibly related to the index access site. The remaining patients had no adverse events and there were no reported problems at 2 weeks follow-up. Accessing and applying closure device in stented CFA can be accomplished successfully in approximately 96% of the patients with low major adverse events.