Use of the 8-F angio-seal vascular closure device in large-caliber arteriotomies.

PURPOSE: To evaluate the feasibility and safety of using the 8-F Angio-Seal vascular closure device (VCD) to seal large-caliber (>8-F) access sites during percutaneous endovascular interventions.

METHODS: A retrospective review was undertaken of 42 consecutive patients (34 men; mean age 67.8 years, range 36-94) undergoing percutaneous peripheral interventions with sheaths ranging from 9-F to 12-F and subsequent closure using 8-F Angio-Seal VCDs. Single-wall puncture (n = 48) of the common femoral artery was guided by ultrasound in 46 cases and palpation in 2. Forty procedures required therapeutic heparinization during the interventional procedure; protamine was administered in only 5. Per protocol, manual pressure was held for 15 minutes. Clinical and/or imaging follow-up was available in all cases within 3 months after the procedure.

RESULTS: Immediate technical success was achieved in all cases, with hemostasis obtained within 5 minutes (no oozing or hematoma). The overall complication rate was 4.1% (2/48); one hematoma requiring surgical repair occurred 10 hours after VCD deployment. An asymptomatic pseudoaneurysm was discovered on follow-up imaging and was treated with ultrasound-guided thrombin injection with complete resolution.

CONCLUSION: The use of the 8-F Angio-Seal VCD to close large-caliber arteriotomies ranging from 9-F to 12-F is feasible and safe, with a low complication rate.