The ex-vivo-shunt-model: novel approach for assessing the thrombogenicity of vascular implants

OBJECTIVE: Disadvantages associated with commercially available vascular implants necessitate alternative strategies to develop new vascular prostheses. Although many tissue characterizing strategies have been defined, no valid test for thrombogenicity exists. Here we introduce a novel concept for thrombogenicity testing of vascular implants METHODS: Silastic tubes were implanted into the carotid arteries of 12 sheep. After placing these shunts, tc99m-labeled platelets were administered and test-vessels were put in between the shunts. Native autologous (n=6), as well as native/acellularized allogeneic (n=6/n=6), and xenogeneic (n=6/n=6) carotid arteries and allogeneic (n=6/n=6) and xenogeneic (n=6/n=6) carotid arteries reseeded with allogeneic endothelial-cells, fibroblasts and myocytes were evaluated. Number and time course of intra-operatively deposited platelets were evaluated with a Geiger-counter; certain areas of platelet deposition located, envisioned and characterized by a gamma-camera and scanning electron-microscopy afterwards. RESULTS: Counter results revealed no significant different platelet depositions when comparing silastic tubes with either autologous or allogeneic native carotid arteries. However, starting 5 minutes after placement, acellularized/reseeded allogeneic (p=0.001/p=0.00004), and xenogeneic (p=0.0001/p=0.01) carotid arteries showed significantly more platelet depositions than native autologous carotides. Moreover, it was possible to show that almost no platelets adhere to native vessels or silastic tubes, thus proving the test method itself. CONCLUSION: The Ex-Vivo-Shunt-Model is a valid method to measure and envision the intrinsic thrombogenicity of vascular implants.