Safety and Efficacy of Femoral Artery Closure with the FemoSeal Device After Cerebral Thrombectomy Using an 8 French Sheath.

Abstract

To evaluate the feasibility and safety of using the FemoSeal vascular closure device (VCD) to seal 8F access sites during mechanical thrombectomy for stroke. A retrospective review of a prospective database was undertaken to evaluate the safety and efficacy of femoral arterial closure using FemoSeal device in all patients who underwent mechanical thrombectomy using an 8F sheath between January 2015 and July 2017. Efficacy endpoints were the successful deployment of the system and haemostasis success. Safety endpoints included the incidence of in hospital access site haematoma >5 cm, bleeding complications, pseudoaneurysms, arteriovenous fistula, infection, or other complications requiring surgery. 197 patients (96 men; mean age 68 years, range 25-99) were included. Successful haemostasis with FemoSeal was obtained in 98.9% of the patients. Only one haematoma >5 cm (0.5%) was observed, which reabsorbed spontaneously without issue. Nine haematomas <5 cm (4.5%) were also found. No major complications requiring surgical repair or transfusion were observed. There were no pseudoaneurysms, arteriovenous fistulae, or infections. The use of the FemoSeal device to close an 8F access sheath puncture site is feasible and safe, with a low complication rate.