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Among the various prototype vascular prostheses that have been developed over recent years as small vessel substitutes, the Vascugraft polyurethane device produced by Braun-Melsungen AG has a number of attractive features. As well as having high mechanical compliance similar to that of the arterial tree, it has been manufactured from a specially synthesized poly(ester urethane) with improved biostability and its microfibrous structure provides a highly porous wall with open communicating pores. With a view to evaluating the in vivo biofunctionality and biostability of this prosthesis in the dog, 10 mm diameter grafts were implanted as thoraco-abdominal bypasses for prescheduled periods of 1 months and 12 months, and their performance monitored in terms of gross morphology, histology and the measurement of the chemical and physical properties of the explanted and cleaned specimens. Both grafts were patent at retrieval. Each had a smooth and glistening flow surface without organized mural thrombi and showed the development of a thin collagenous internal capsule with the presence of endothelial-like cells. Both grafts were well encapsulated externally and revealed a small distal bend or kink which is frequently observed by any thoraco-abdominal bypass in dogs. The fresh explanted prostheses were cleaned by a new enzyme treatment which provided specimens for microscopic, mechanical and thermal analyses, as well as studies of the surface and bulk chemistry. By comparing the results from the explanted and cleaned material with those of the virgin prosthesis, we have observed some deterioration in the integrity of the microfibrous structure, some loss in mechanical performance, marginal changes in molecular weight, and an apparent microphase separation of the hard and soft segment domains at a depth of a few microns. While the biofunctionality of a 10 mm calibre device has been demonstrated, additional in vivo studies are recommended to assess the biofunctionality at different diameters and the biostability over longer periods of implantation.
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