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

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.