title: Decellularized Cryopreserved Allografts as Off-the-Shelf Allogeneic Alternative for Heart Valve Replacement: In Vitro Assessment Before Clinical Translation.
abstract: Cryopreserved allogeneic conduits are the elective biocompatible choice among currently available substitutes for surgical replacement in end-stage valvulopathy. However, degeneration occurs in 15 years in adults or faster in children, due to recipient's immunological reactions to donor's antigens. Here, human aortic valves were decellularized by TRICOL, based on Triton X-100 and sodium cholate, and submitted to standard cryopreservation (TRICOL-human aortic valves (hAVs)). Tissue samples were analyzed to study the effects of the combined procedure on original valve architecture and donor's cell removal. Residual amounts of nucleic acids, pathological microorganisms, and detergents were also investigated. TRICOL-hAVs proved to be efficaciously decellularized with removal of donor's cell components and preservation of valve scaffolding. Trivial traces of detergents, no cytotoxicity, and abrogated bioburden were documented. TRICOL-hAVs may represent off-the-shelf alternatives for both aortic and pulmonary valve replacements in pediatric and grown-up with congenital heart disease patients.
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Via Giustiniani 2, 35128, Padua, Italy. laura.iop@unipd.it.|Cardiovascular Regenerative Medicine Group, Venetian Institute of Molecular Medicine, Via G. Orus 2, Padua, 35129, Italy. laura.iop@unipd.it.
authors.forename: Laura
authors.identifier: http://orcid.org/0000-0002-7034-9414
authors.initials: L
authors.lastname: Iop
authors.affiliation: Treviso Tissue Bank Foundation, Ca' Foncello Hospital, Piazzale Ospedale, 31100, Treviso, Italy. apaolin@fbtv-treviso.org.
authors.forename: Adolfo
authors.initials: A
authors.lastname: Paolin
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Via Giustiniani 2, 35128, Padua, Italy.|Cardiovascular Regenerative Medicine Group, Venetian Institute of Molecular Medicine, Via G. Orus 2, Padua, 35129, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Aguiari
authors.affiliation: Treviso Tissue Bank Foundation, Ca' Foncello Hospital, Piazzale Ospedale, 31100, Treviso, Italy.
authors.forename: Diletta
authors.initials: D
authors.lastname: Trojan
authors.affiliation: Treviso Tissue Bank Foundation, Ca' Foncello Hospital, Piazzale Ospedale, 31100, Treviso, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Cogliati
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Via Giustiniani 2, 35128, Padua, Italy.|Cardiovascular Regenerative Medicine Group, Venetian Institute of Molecular Medicine, Via G. Orus 2, Padua, 35129, Italy.
authors.forename: Gino
authors.initials: G
authors.lastname: Gerosa
mesh_terms: D000293:Adolescent; D000328:Adult; D064591:Allografts; D001021:Aortic Valve / Q000166:cytology / Q000637:transplantation*; D001705:Bioprosthesis; D015925:Cryopreservation; D003902:Detergents / Q000737:chemistry; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D017830:Octoxynol / Q000737:chemistry; D011474:Prosthesis Design; D020358:Sodium Cholate / Q000737:chemistry; D014022:Tissue Survival; D014184:Transplantation, Homologous
chemical_list: D003902:Detergents; D017830:Octoxynol; D020358:Sodium Cholate
keywords: Biocompatibility; Cryopreservation; Decellularization; Heart valves; Off-the-shelf solutions; Valve replacement