Quantification of the edge effect in calcified bioprosthetic tissues

In bioprosthetic tissue samples that had been implanted in the subcutaneous space of rats, and recurring pattern of calcification was observed. In this pattern, which we call the edge effect, the interior of the tissue is calcified and is surrounded and separated from the subcutaneous fluid by a zone that is free from calcification. The edge effect has been qualitatively described in the literature for subcutaneous implants and for valve leaflets, and it may be related to the mechanism of calcification for these materials. The thickness of the calcification free outer layer was quantified for glutaraldehyde treated bovine pericardium, glycerol treated bovine pericardium, glutaraldehyde treated human dura mater, and glycerol treated human dura mater. The edge effect values were found to be unique and consistent for each material type, and they were inversely related to the shrinkage temperatures and the calcium contents of the materials. It was determined that the chemical treatment was more important than the tissue type in determining the edge effect value.