Long-term experience with first generation porcine valve xenografts enabled identification of the major limitations to their durability: (1) prosthetic-ventricular mismatch due to the high profile of the
stent in patients with
mitral stenosis and a small left ventricle; (2) high-pressure fixation with loss of natural
collagen crimping in the fibrosa, and wash-out of
proteoglycans in the spongiosa; (3) xenograft tissue
autolysis, due to the long interval between animal slaughter and aortic valve removal fixation; (4) muscle shelf in the right coronary cusp, which created a gradient and could undergo accelerated calcification and/or
spontaneous perforation with time; (5) a flexible
polypropylene stent, which could creep or even fracture with consequent inward bending of the
stent; (6) progressive time-related dystrophic calcification; (7) host fibrous tissue ingrowth. An awareness of these limitations stimulated technical modifications, which frequently brought about distinct improvements: (1) the reduction of the
stent profile eliminated the problem of mismatch, but resulted in a higher tendency towards cusp
prolapse and earlier commissural tearing; (2) natural
collagen waviness,
proteoglycans and cusp extensibility were preserved by employing low or even zero pressure during the fixation process; (3) earlier valve fixation enabled preservation of cell integrity; (4) a new orifice for small valves was designed by replacing the right muscular cusp, thus achieving less gradient and avoiding muscle-shelf-related complications; (5)
polypropylene was replaced by
Delrin as
stent material; (6)
calcium-retarding agents like T6 and
toluidine blue were applied during commercial processing and storage in order to mitigate tissue mineralization.(ABSTRACT TRUNCATED AT 250 WORDS)