During the past 25 years, numerous studies relating to medical device biocompatibility have appedared world-wide. Development of biomaterials for grafting cardiovascular applications has contributed to an increase in knowledge of the compatibility between synthetic or biological surfaces and blood. The biocompatibility of one of the materials most commonly used in the fabrication of xenograft heart valves, bovine pericardium, treated with glutaraldehyde and formaldehyde is assessed comparison to a synthetic material, Dacron(R) tricot. An in vitro tissue culture assay, by the agar overlay method, using RC-IAL and Hela cell lines, was applied to treated pericardium and attested the intense toxicity of the treating agents. The subcutaneous grafting of treated pericardium and Dacron(R) was carried out in Wistar rats of 1 to 3 months of age. After the use of the usual histological methods, an evaluation of hematoxylin-eosin stained specimens demonstrated an absence of histocompatibility, mainly as regards for the formaldehyde treated pericardium. Comparatively, the evaluation of implanted Dacron(R) confirmed it's perfect biocompatibility. In conclusion, some improvement in xenograft heart valves is necessary, before the surgical implantation procedure takes place.
Heart valve prosthesis; Bioprosthesis; Material testingt
