Purpose: The aim of this study is to assess the effectiveness and safety of the use of Vasoseal ES collagen plug in heavily anticoagulated patients with high risk of complications at the vascular access site who had undergone vascular radiological intervention.
Materials and methods: Between January 2002 and March 2003 180 consecutive transfemoral arterial accesses in 169 patients subjected to vascular radiological procedures were performed (bilateral access was performed in 11 patients): 140 percutaneous transluminal angioplasties and 40 transarterial chemoembolisations. All the patients who underwent angioplasty were given 3,000 IU of sodic heparin intravenously during the procedure and later a prolonged antiaggregant therapy was undertaken (ticlopidine 500 mg/day and aspirin 150 mg/day). The sheaths were removed at the end of the surgical manoeuvre and two cartridges of collagen were positioned on the external surface of the artery. The mean values of platelets and partial thromboplastin time were 42,000/ml and 170 s, respectively, in cirrhotic patients against 250,000/ml and 200 s in patients with peripheral arteriopathy. The next day a colour Doppler examination was performed at the puncture site.
Results: The technique proved successful in 89.4% of cases (161/180). In 19/180 vascular accesses placement of the haemostatic cartridges was not possible owing to the inability to compress the common femoral artery proximal to the release site (4/19), owing to a pre-existing haematoma (5/19) and owing to the limited presence of subcutaneous tissue (10/19). The mean time required for the placement of Vasoseal ES was 4 min. The mean time-to-haemostasis was 6 min. The mean time-to-mobilisation was 4 hr. Only in two patients was there an onset of a pseudoaneurysm of the right common femoral artery; the lesions were treated with ultrasonography -guided compression. In addition, 16 small local haematomas were recorded. In 4 cases early re-puncture of the femoral artery was performed (24-48 hr following the use of the device) without consequences.
Conclusions: Vasoseal ES is a safe collagen closure device characterised by a high success rate. In anticoagulated patients the device can reduce the time-to-mobilisation and the incidence of complications.