Glutaraldehyde release from vascular prostheses of biologic origin.

The inhibition of growth by adult human venous endothelial cells in culture forms the basis of a sensitive assay of glutaraldehyde (GA) concentration, valid between 0 and 5 parts per million. This cytotoxicity assay was used to measure residual (unbound) GA in commercial vascular prostheses of biologic origin following manufacturer-recommended rinsing procedures, from which as much as 13.8 ppm GA per gram of tissue per 24 hours continued to be released after 1 month. A brief (1 hour) exposure of cultured endothelial cells to 2 ppm GA delayed growth, while continuous exposure to 4 ppm totally prevented growth for at least 12 days. Endothelial cells exposed to GA demonstrated a reduced efficiency of attachment to standard test surfaces, although prior GA treatment of these surfaces was not detrimental to subsequent cell attachment. GA release from vascular prostheses may contribute to their lack of endothelial cell coverage in human implants and may be indicative of collagen cross-link instability. If so, in vitro cytotoxicity may be helpful in identifying the potential for aneurysm formation in preserved biologic grafts.