Postinterventional transcutaneous suture of femoral artery access sites in patients with peripheral arterial occlusive disease: a study of 930 patients.

The purpose of this study was to evaluate a percutaneous vascular suture (PVS) device in patients with peripheral arterial occlusive disease (PAOD) for achievement of immediate hemostasis at the vascular access site and early ambulation of fully anticoagulated patients after peripheral interventional procedures. From June 1995 to March 2000, a vascular suture using a PVS device (6-10 Fr) was applied in 930 patients with PAOD. All patients had received an endoluminal intervention in the pelvic and/or the contralateral femoropopliteal region via a retrograde access through the common femoral artery (CFA). The incidence of complications within 12 hr after intervention, prior to discharge, and at 30-day follow-up was assessed employing clinical examination, treadmill test, and color Doppler ultrasound and the safety of the PVS device was determined. The efficacy of the system was measured by the percentage of achieved immediate hemostasis and early ambulation. PVS was technically successful in 92.2% independently from the degree of calcification at the access site. In 7.8%, an appropriate suture delivery could not be performed and these patients were successfully treated by conventional compression technique. Device malfunction or insufficient suture closure occurred in 1.7% and 2.1%, respectively. In 7.0%, groin-related complications occurred. Ambulation within 2-4 hr after successful suture was possible in 96.1%. All patients were free of any local symptoms at 30-day follow-up. The PVS device provides a safe and effective solution to achieve immediate hemostasis, thus permitting early ambulation in fully anticoagulated patients with PAOD after peripheral interventional procedures.