M. Valente et al., PATHOLOGY OF THE PERICARBON(R) BOVINE PERICARDIAL XENOGRAFT IMPLANTEDIN HUMANS, Journal of heart valve disease, 7(2), 1998, pp. 180-189
Background and aims of the study: Pericarbon(R) is a new-generation bo
vine pericardial bioprosthesis designed to withstand mechanical wear.
Following optimal in vitro testing and animal experiments, clinical tr
ials were initiated in many European centers and explants sent to our
department Par pathological evaluation. This included gross, radiograp
hic, histologic and ultrastructural investigations. Methods: Between 1
986 and 1996, 24 bioprostheses (eight aortic, II mitral, two mitro-aor
tic, one tricuspid) were collected from 22 patients (10 males and 12 f
emales; mean age 57.0 +/- 18.9 years) either at autopsy (nine) or reop
eration (15). Results: Ten bioprostheses explanted <2 months after sur
gery were either normal or failed because of surgical problems or non-
structural causes. Among the other 14 bioprostheses (mean placement 41
.9 +/- 23.6 months; range: 7 to 90 months), structural deterioration o
ccurred in seven and was due to dystrophic calcification with stenosis
in five (three aortic, two Mitral), mixed lesion in one (mitral), and
incompetence in one by calcium-related commissural tear (mitral). At
the ultrastructural level, calcification was detected either on cell d
ebris or upon collagen fibers. No bioprosthesis failed because of fibr
ous tissue overgrowth. Of the remaining seven bioprostheses, vegetativ
e endocarditis occurred in two, thrombosis in one, and aseptic paraval
vular leak in one; whereas three showed no signs of dysfunction. Concl
usions: This pathologic experience with the Pericarbon valve showed ca
lcification to be the main cause of late structural failure, causing m
ainly cusp stiffness and bioprosthesis stenosis. Tissue rupture or abr
upt dysfunction never occurred. Thus, prevention of mineralization rem
ains the main challenge.