Toxic reactions evoked by glutaraldehyde‐fixed pericardium and cardiac valve tissue bioprosthesis

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Abstract
Bovine pericardial tissue and tissue-derived bioprosthesis fixed in glutaraldehyde and stored in either glutaraldehyde or formaldehyde can induce cytotoxic reactions even after prolonged washing due to the slow leaching of the chemicals used for crosslinking and sterilizing. Sequential rinsing for up to 60 min was still not sufficient to eliminate cytotoxic effects. On the other hand, satisfactory results were obtained when cardiac valves made from glutaraldehyde fixed pericardium were stored in a solution containing 0.02% of propyl-hydroxy-benzoate and 0.18% methyl-hydroxy-benzoate. The valves stored in this solution and rinsed three times for 1 min in normal saline showed few signs of residual cytotoxicity. Rinsing in a solution containing glycine was partially effective in neutralizing the cytotoxic effect, and this or similar approaches offer good possibilities. The use of Chang cells grown in culture provides an excellent quantitative assay for the assessment of residual cytotoxicity and for evaluating the host response to different methods of fixation, storage, and rinsing of tissue derived bioprosthesis.