E. Pettenazzo et al., Is the tricuspid position suitable for testing replacement bioprosthetic valves in the sheep model?, J HEART V D, 10(4), 2001, pp. 513-519
Background and aim of the study: Glutaraldehyde may promote calcification i
n xenograft tissue by the action of toxic aldehyde group residues involved
in the cross-link process. Post-fixation treatment with homocysteic acid (H
A) neutralizes this toxicity by bonding aldehyde groups, and enhances bioco
mpatibility on, the basis of strongly electronegative sulfonic groups. Prev
ious studies in a rat subcutaneous model showed significant longterm mitiga
tion of mineralization of glutaraldehyde-fixed pericardium treated with HA.
This study aimed to assess the anticalcific efficacy of HA in a valvular i
mplant in growing sheep, and establish if the tricuspid position is suitabl
e for testing replacement bioprosthetic valves.
Methods: Eleven stented 25 mm Pericarbon (R) bioprostheses (seven HA-treate
d, four standard) were implanted in the tricuspid position of growing sheep
. Infective endocarditis occurred in four prostheses. Among the remaining s
even, three (two HA-treated, one standard) were explanted at 91 days (mid-t
erm), and four (two HA-treated, two standard) at 140-141 days (long-term).
All explants were studied by gross, X-ray, light, transmission and scanning
electron microscopy, as well as by atomic absorption spectroscopy.
Results: No histological. and ultrastructural difference in tissue preserva
tion were - observed between HA-treated and standard Pericarbon (R) biopros
theses, either in the mid or long term. The mean calcium content of inid-te
rm, HA-treated explants was 9.55 mg/g compared with 16.26 mg/g in mid-term
standard explants. Only one late standard explant failed as a result of Sev
ere stenosis caused by massive dystrophic calcification. Among four late ex
plants, two showed significant increase in mineralization (HA-treated, 87.4
5 mg/g.- standard, 181.20 mg/g), while two showed calcium contents similar
to those in mid-term explants, (HA-treated, 11.96 mg/g; standard, 17.32 mg/
g).
Conclusion: Post-fixation treatment with HA preserves structural properties
, after tricuspid implantation in growing sheep, The tricuspid implant in t
he sheep model failed to reproduce remarkable accelerated progressive calci
fication in all xenografts so as to demonstrate a significant difference be
tween HA and standard explants. The tricuspid position - for testing replac
ement bioprosthetic valves should be abandoned, and investigations repeated
, with the prosthesis, in, the initial position.