Long‐term behavior of bovine collagen membrane used as vascular substitute. Experimental study in rats

The aim of the present study was to evaluate the sequence of the immediate and the mid/long-term organization of the blood interface of a collagenous membrane used as vascular substitute in rats. The implants were prepared from calf skin type I insoluble collagen, obtained after acidic dispersion, in absence of chemical or tanning treatment. They were used to patch an aortic defect by means of microsurgical techniques. The animals were sequentially sacrificed for immediate hemocompatibility studies at 10 s, 30 s, 10 min, 3 h, and 6 h, for long-term analyses of the organization of the blood material interface at the 7th, 15th, 45th, 60th, 90th day following the surgery and each month until 14 months after aortic replacement. The superficial immediate events at the blood patch interface demonstrated erythrocytes heavily engulfed in a thin but dense fibrin mesh both at the patch and at the adjacent aortic wall surfaces. Neither adherent platelet nor platelet aggregate were detectable on the collagen patch surface. This fibrinoerythrocytic membrane covered the patch completely at 60 s and at 3 h the deposit was limited to 5-6 erythrocyte layers as confirmed by histology. It did not further develop on the 7th day. At the blood-collagen interface there progressively developed a tissue composed of active myofibroblasts, collagen bundles, and elastic fibers. After 4 months, nests of fibroendothelial cells were present, and between 6 and 14 months surface cell differentiation, although complete on the adjacent aorta was still incomplete on the bovine collagen patch, amorphous fibers, and fibroendothelial cells coexisting. Heterologous patch debris were still present 14 months after implantation and were associated with macroscopic and ultrastructural calcification, which need further investigations concerning the exact nature and mechanism of mineralization of vascular substitutes of biological nature.