Abstract
BackgroundThe pericardial tissue is commonly used to produce bio-prosthetic cardiac valves and patches in cardiac surgery. The procedures adopted to prepare this tissue consist in treatment with aldehydes, which do not prevent post-graft tissue calcification due to incomplete xeno-antigens removal. The adoption of fixative-free decellularization protocols has been therefore suggested to overcome this limitation. Although promising, the decellularized pericardium has not yet used in clinics, due to the absence of proofs indicating that the decellularization and cryopreservation procedures can effectively preserve the mechanical properties and the immunologic compatibility of the tissue.Principal FindingsThe aim of the present work was to validate a procedure to prepare decellularized/cryopreserved human pericardium which may be implemented into cardiovascular homograft tissue Banks. The method employed to decellularize the tissue completely removed the cells without affecting ECM structure; furthermore, uniaxial tensile loading tests revealed an equivalent resistance of the decellularized tissue to strain, before and after the cryopreservation, in comparison with the fresh tissue. Finally, immunological compatibility, showed a minimized host immune cells invasion and low levels of systemic inflammation, as assessed by tissue transplantation into immune-competent mice.ConclusionsOur results indicate, for the first time, that fixative-free decellularized pericardium from cadaveric tissue donors can be banked according to Tissue Repository-approved procedures without compromising its mechanical properties and immunological tolerance. This tissue can be therefore treated as a safe homograft for cardiac surgery.
Highlights
Pericardium is employed in cardiac surgery to repair congenital heart defects or to perform valve reconstruction
Our results indicate, for the first time, that fixative-free decellularized pericardium from cadaveric tissue donors can be banked according to Tissue Repository-approved procedures without compromising its mechanical properties and immunological tolerance
This tissue can be treated as a safe homograft for cardiac surgery
Summary
Pericardium is employed in cardiac surgery to repair congenital heart defects or to perform valve reconstruction. The technology commonly used to produce heart valves leaflets from animal-derived pericardium consists in treating the tissue with low concentration aldehydes (e.g. glutaraldehyde, GA), necessary to create chemical bonds among the extracellular matrix (ECM) components, thereby further increasing the tissue mechanical resistance, and to prevent acute host immune rejection [1]. Clinical data from long term follow up of patients receiving pericardium-made bioprosthetic valves, has clearly indicated a severe impact of structural valve deterioration (SVD) and calcification, due to permanence of fixative remnants having potent cytotoxic effects. The pericardial tissue is commonly used to produce bio-prosthetic cardiac valves and patches in cardiac surgery. The procedures adopted to prepare this tissue consist in treatment with aldehydes, which do not prevent postgraft tissue calcification due to incomplete xeno-antigens removal. The decellularized pericardium has not yet used in clinics, due to the absence of proofs indicating that the decellularization and cryopreservation procedures can effectively preserve the mechanical properties and the immunologic compatibility of the tissue
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