Incidence of vascular injuries after use of the Angio-Seal closure device following endovascular procedures in a single center.

INTRODUCTION: Percutaneous closure devices have been used to obtain rapid hemostasis and early mobilization of the patient after arterial catheterization. However, we observed challenging problems with the sealing procedure that require further surgical intervention. The present report is a retrospective analysis of the patterns of injury and the final outcome of four cases of femoral artery injury following the use of Angio-Seal.
METHODS: During the last 24 months, in a group of 175 patients (131 men, 44 women; median age 68.4 years, range 47-81 years) underwent percutaneous closure after diagnostic (n = 53) or therapeutic (n = 122) endovascular procedures. Among them we observed four patients (three men, one woman; median age 65.2 +/- 10.8 years, range 47-75 years) who developed severe limiting claudication and required vascular repair of an iatrogenic vascular injury following deployment of the Angio-Seal. They had a femoral thrombosis due to narrowing/severe intimal dissection.
RESULTS: All patients required operative intervention with removal of the device. We performed femoropopliteal thrombectomy and common femoral endarterectomy with patch angioplasty (n = 2), resection of the femoral bifurcation and reimplantation of the deep femoral artery (n = 1), and femoral bifurcation endarterectomy with direct arterial suture (n = 1). The median hospital stay was 6.5 +/- 3.8 days (range 4-12 days). Limb salvage was achieved in all of the surviving patients at a mean follow-up of 7 months (range 1-12 months).
CONCLUSIONS: Vascular injuries are uncommon after use of the hemostasis closure device. When they occur, however, they are likely to require challenging surgical correction.