BACKGROUND AND AIMS OF THE STUDY:Bovine and porcine pericardial tissues stabilized by dye-mediated photooxidation have found application as bioprosthetic heart valve material.

METHODS:To help predict clinical performance, a series of tests were performed to assess the biocompatibility and immunologic properties of these materials.

RESULTS AND CONCLUSIONS:Photooxidized bovine or porcine pericardium sterilized with an iodine-based solution were found to be non-cytotoxic, non-hemolytic, and non-mutagenic. Oil or saline extracts of these tissues passed tests for intracutaneous toxicity (irritation), acute systemic toxicity, and subchronic toxicity. Histopathology of 90-day implants of these tissues in the rabbit model demonstrated no significant macroscopic reaction and only slight microscopic response. Using a rabbit model to assess immune response, both bovine and porcine pericardial tissues elicited low levels of antibody. Furthermore, tissue photooxidation or iodine sterilization did not increase the overall level of antibodies. Glutaraldehyde-treated tissue also elicited low antibody levels which were higher than photooxidized tissue-induced levels. Absorption studies indicated that the photooxidation process may generate new epitopes, possibly collagen cross-links. Using the juvenile sheep model to assess in vivo performance, bioprosthetic valves made with photooxidized tissue were implanted and allowed to serve as functional implants for up to two years. Upon explant, the photooxidized pericardial leaflets were found to be non-calcific and partially covered with a layer of host cells. Histological cross-sections stained with von Willebrand's factor confirmed this layer as endothelial cells.

译文

研究的背景和目的 : 通过染料介导的光氧化作用稳定的牛和猪心包组织已被用作生物人工心脏瓣膜材料。
方法 : 为了帮助预测临床表现,进行了一系列测试以评估这些材料的生物相容性和免疫学特性。
结果和结论 : 发现用碘基溶液灭菌的光氧化牛或猪心包具有非细胞毒性,非溶血性,和非诱变性。这些组织的油或盐水提取物通过了皮内毒性 (刺激),急性全身毒性和亚慢性毒性的测试。在兔模型中,这些组织的90天植入物的组织病理学没有明显的宏观反应,只有轻微的微观反应。使用兔模型评估免疫反应,牛和猪心包组织均引起低水平的抗体。此外,组织光氧化或碘灭菌不会增加抗体的总体水平。戊二醛处理的组织也引起低抗体水平,该水平高于光氧化组织诱导的水平。吸收研究表明,光氧化过程可能会产生新的表位,可能是胶原蛋白交联。使用幼年绵羊模型评估体内性能,将用光氧化组织制成的生物人工瓣膜植入并作为功能性植入物长达两年。外植体后,发现光氧化的心包小叶是非钙化的,并部分覆盖有一层宿主细胞。用von Willebrand因子染色的组织学横截面证实了该层为内皮细胞。

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