Morphological survey of a new pericardial valve prosthesis (Pericarbon): long-term animal experimental model

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Abstract
A long-term experimental morphological study was carried out in 22 adultsheep to evaluate a new pericardial valve prosthesis (Pericarbon), whichhad been implanted in the tricuspid or mitral position. This prostheticdevice differs substantially from others in that its construction designconsists of two sheets of glutaraldehyde- fixed bovine pericardium and alow-profile flexible plastic stent (Delrin) covered by a pyrolytic carboncoated dacron fabric; one pericardium sheet forms the three cusp valve andis sutured to the second, which lines the inner surface of the plasticstent. Twenty animals were sacrificed at fixed intervals, while 2 are stillliving at about 3 years post-surgery. Tricuspid explants (mean duration,295 days) showed significant fibrous sheathing and a mean calcium X-rayscore of 1.75. Mitral medium-term explants (mean duration, 325 days) hadfairly well preserved pliability and a mean calcium X-ray score of 2.5.Long-term explants (mean duration, 467 days) were all stiffened bycalcification (mean score, 3.75). None of the explants had tears orperforations. Medium or long-term mechanical failure was not observed. Asignificant host tissue reaction took place in the tricuspid but not in themitral position. Calcification mainly involved the collagen fibres andincreased progressively with time. Ultrastructural studies invariablydisclosed fair preservation of graft tissue structures, surfacereendothelization and initial nuclei of calcification within the collagenfibres. These morphological findings confirm the potential advantages ofthis new prosthetic device and warrant long-term clinical trials to testits actual durability.

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