In vitro testing of bioprostheses: influence of mechanical stresses and lipids on calcification.

BACKGROUND: Structural valve deterioration of bioprostheses is mainly caused by the progressive development of calcification. Mechanical stresses or lipid deposits in porcine aortic leaflets have been proposed as major factors contributing to the calcification process.
METHODS: A new test protocol consisting of nondestructive holographic interferometry, which allows a quantitative deformation analysis of heart valves, and accelerated dynamic in vitro calcification was used. The rapid calcification fluid contained a final combined calcium and phosphorus concentration of 130 (mg/dL)2 in barbital buffer solution. The calcification of 32 bioprostheses donated by different manufacturers (SJM Bioimplant, Biocor standard, Biocor No-React, Carpentier-Edwards SAV, Bravo, pericardial prototype) was assessed after up to 25 x 10(6) cycles by microradiography and the areas of calcification were compared with the holographic interferograms. The distribution of lipid droplets of four porcine prostheses were visualized by Sudan III stain before the calcification process.
RESULTS: Most of the tested bioprostheses had areas presenting with stress concentrations, and the dynamic in vitro testing resulted in leaflet calcification corresponding to the holographic irregularities. A strong correlation between calcification and stress distribution or lipid accumulation was found (r = 0.72; r = 0.81, respectively). After 19 x 10(6) cycles, the Carpentier-Edwards SAV and the pericardial valves had significantly less calcification than other prostheses tested (p = 0.003), but the variation among individual prostheses from the same manufacturer was even more pronounced.
CONCLUSIONS: Mechanical stresses or lipid accumulation seems to play an important role in the calcification process of bioprostheses. Quality control of bioprosthetic valves using holographic interferometry has the potential to predict calcification before implantation.