In vitro and in vivo evaluation of a small caliber vascular prosthesis fixed with a polyepoxy compound

A small caliber vascular prosthesis obtained from an ovine internal thoracic artery (3.8-4.5 mm ID) fixed with a polyepoxy compound and treated with heparin has been evaluated. Cytocompatibility was evaluated in vitro using human endothelial cells (HEC). HEC were obtained from human saphenous vein and cultivated in culture medium supplemented with 25% human serum. Graft segments were rinsed using a standard protocol proposed by the manufacturer. Tissue reaction was tested on a rabbit model of subcutaneous implantation. The patency rate and healing patterns were evaluated comparatively with polytetrafluorethylene (PTFE) 4 mm ID prosthesis in a canine model of carotid interposition. Cytocompatibility assay showed that there was low adhesion on vascular grafts (20 +/- 2% of endothelial cells seeded) and no growth of HEC on the graft surface. The graft patency rate was 55% in both groups, and actuarial freedom from occlusion was not different at 3 months (37.7 +/- 15% in Denacol-fixed grafts versus 38.1 +/- 14% in PTFE). Histological studies on the biological grafts shows a frequent neointimal hyperplasia at the anastomosis (5/12), a lack of endothelial cells lining the graft surface, a good preservation of the media, and a moderate inflammatory response in the adventicia. The Denacol-fixed graft has presented excellent surgical properties and preservation of the histological structure. Nevertheless, the patency rate was not improved when compared with the PTFE control graft.