Percutaneous transluminal dilatation of inadvertent partial or complete occlusion of the femoral artery caused by Angio-Seal deployment for puncture site closure after cardiac catheterization.

BACKGROUND: The use of access-site closure devices in interventional cardiology has expanded rapidly in the past several years. Initial reports indicated remarkable safety with these devices but there are a small number of major complications. This single-center, retrospective study was carried out to investigate the efficacy of percutaneous transluminal angioplasty (PTA) of inadvertent occlusion or severe stenosis of the femoral artery after deployment of the Angio-Seal closure device. From April 1995 to August 2009 a total of 8,587 Angio-Seal devices were deployed immediately after cardiac catheterization. Within 7 days after deployment, clinical signs of acute arterial occlusion or severe stenosis of the femoral artery were evident in 6 patients (0.07%). They were immediately referred for diagnostic angiography and subsequent PTA. Angiography revealed occlusion of the femoral artery at the puncture site level in 4 patients and a severe stenosis in 2 patients. Using a cross-over access from the opposite groin, PTA of the closed or highly stenosed femoral artery was feasible in all cases. At routine follow up 12 months thereafter, there was no clinical evidence of symptomatic restenosis. Inadvertent occlusion or high-grade stenosis of the femoral artery after Angio-Seal closure device deployment is a rare but severe complication. PTA appears to be a safe and effective method of treatment, avoiding surgical removal of the plug.