Suitability of a 7-F ExoSeal Vascular Closure Device for Femoral Artery Punctures Made by 8-F or 9-F Introducer Sheaths

Abstract

Purpose: To establish the safety and efficacy of the 7-F ExoSeal device for the closure of femoral puncture sites made by 8-F or 9-F introducer sheaths. Methods: Between January 2013 and December 2016, 332 patients (mean age 68.4±12.1 years; 195 men) underwent neurointerventional procedures via percutaneous puncture of the common femoral artery and an 8-F (n=272, 81.9%) or 9-F (n=60, 18.1%) introducer. The access sites were sealed with a 7-F ExoSeal in all cases. Procedure success and closure-related complication rates were evaluated, and risk factors for complications were analyzed by comparing patient characteristics between those who did and did not experience complications. Results: Procedure success rates were 99.3% in the 8-F group and 100% in the 9-F group. The overall complication rate was 6.3% (n=17; all in the 8-F group), of which 13 (4.8%) were minor sequelae, including access-site hematoma (n=8), oozing (n=3), pseudoaneurysm (n=1), and retroperitoneal bleeding (n=1). Among the 4 (1.5%) major complications were 3 instances of bleeding requiring a blood transfusion and 1 surgical vascular repair. No complications were observed in the 9-F group. Patients who experienced complications had significantly longer activated clotting times (262±46 vs 218±55 seconds; p<0.001) compared with patients without complications. Conclusion: A 7-F ExoSeal vascular closure device is safe and effective for the closure of femoral puncture sites made by 8-F or 9-F introducer sheaths.