In Vitro Calcification of Bioprosthetic Heart Valves: Test Fluid Validation on Prosthetic Material Samples. 2021

N Kiesendahl, and C Schmitz, and M Menne, and T Schmitz-Rode, and U Steinseifer
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute Aachen, RWTH Aachen University, Pauwelsstraße 20, 52074, Aachen, Germany.

Calcification is a major failure mode of bioprosthetic heart valves. So far, cost and time saving in vitro analyses of calcification potentials are unreliable, mostly due to superficial or spontaneous precipitation of the applied fluids. In this study, we developed a near-physiological non-spontaneously precipitating fluid for an accelerated in vitro calcification assessment, and validated it by analyzing the calcification potential of two prosthetic materials within two reference-tests. The first test focused on the comparison of four calcification fluids under dynamic contact with n=12 commercial bovine pericardium patches. The second one focused on the validation of the most appropriate fluid by analyzing the calcification potential of pericardium vs. polyurethane. The patches were mounted in separate test compartments and treated simultaneously with the respective fluids at an accelerated test frequency. Calcification propensity and progression were detected macroscopically and microscopically. Structural analyses of all deposits indicated hydroxyapatite by X-ray powder diffraction, which is also most commonly observed in vivo. Histological examination by von Kossa staining showed matrix internal and superficial calcifications, depending on the fluid composition. The present study reveals promising results towards the development of a meaningful, cost and time saving in vitro analysis of the calcification potential of bioprosthetic heart valves.

UI MeSH Term Description Entries
D008422 Materials Testing The testing of materials and devices, especially those used for PROSTHESES AND IMPLANTS; SUTURES; TISSUE ADHESIVES; etc., for hardness, strength, durability, safety, efficacy, and biocompatibility. Biocompatibility Testing,Biocompatible Materials Testing,Hemocompatibility Testing,Testing, Biocompatible Materials,Testing, Hemocompatible Materials,Hemocompatibility Testings,Hemocompatible Materials Testing,Materials Testing, Biocompatible,Materials Testing, Hemocompatible,Testing, Biocompatibility,Testing, Hemocompatibility,Testing, Materials,Testings, Biocompatibility
D011232 Chemical Precipitation The formation of a solid in a solution as a result of a chemical reaction or the aggregation of soluble substances into complexes large enough to fall out of solution. Precipitation, Chemical
D002113 Calcification, Physiologic Process by which organic tissue becomes hardened by the physiologic deposit of calcium salts. Bone Mineralization,Calcification, Physiological,Physiologic Calcification,Mineralization, Bone,Physiological Calcification
D002417 Cattle Domesticated bovine animals of the genus Bos, usually kept on a farm or ranch and used for the production of meat or dairy products or for heavy labor. Beef Cow,Bos grunniens,Bos indicus,Bos indicus Cattle,Bos taurus,Cow,Cow, Domestic,Dairy Cow,Holstein Cow,Indicine Cattle,Taurine Cattle,Taurus Cattle,Yak,Zebu,Beef Cows,Bos indicus Cattles,Cattle, Bos indicus,Cattle, Indicine,Cattle, Taurine,Cattle, Taurus,Cattles, Bos indicus,Cattles, Indicine,Cattles, Taurine,Cattles, Taurus,Cow, Beef,Cow, Dairy,Cow, Holstein,Cows,Dairy Cows,Domestic Cow,Domestic Cows,Indicine Cattles,Taurine Cattles,Taurus Cattles,Yaks,Zebus
D006350 Heart Valve Prosthesis A device that substitutes for a heart valve. It may be composed of biological material (BIOPROSTHESIS) and/or synthetic material. Prosthesis, Heart Valve,Cardiac Valve Prosthesis,Cardiac Valve Prostheses,Heart Valve Prostheses,Prostheses, Cardiac Valve,Prostheses, Heart Valve,Prosthesis, Cardiac Valve,Valve Prostheses, Cardiac,Valve Prostheses, Heart,Valve Prosthesis, Cardiac,Valve Prosthesis, Heart
D006351 Heart Valves Flaps of tissue that prevent regurgitation of BLOOD from the HEART VENTRICLES to the HEART ATRIA or from the PULMONARY ARTERIES or AORTA to the ventricles. Cardiac Valves,Cardiac Valve,Heart Valve,Valve, Cardiac,Valve, Heart,Valves, Cardiac,Valves, Heart
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D001705 Bioprosthesis Prosthesis, usually heart valve, composed of biological material and whose durability depends upon the stability of the material after pretreatment, rather than regeneration by host cell ingrowth. Durability is achieved 1, mechanically by the interposition of a cloth, usually polytetrafluoroethylene, between the host and the graft, and 2, chemically by stabilization of the tissue by intermolecular linking, usually with glutaraldehyde, after removal of antigenic components, or the use of reconstituted and restructured biopolymers. Glutaraldehyde-Stabilized Grafts,Heterograft Bioprosthesis,Porcine Xenograft Bioprosthesis,Xenograft Bioprosthesis,Bioprostheses,Bioprostheses, Heterograft,Bioprostheses, Porcine Xenograft,Bioprostheses, Xenograft,Bioprosthesis, Heterograft,Bioprosthesis, Porcine Xenograft,Bioprosthesis, Xenograft,Glutaraldehyde Stabilized Grafts,Glutaraldehyde-Stabilized Graft,Graft, Glutaraldehyde-Stabilized,Grafts, Glutaraldehyde-Stabilized,Heterograft Bioprostheses,Porcine Xenograft Bioprostheses,Xenograft Bioprostheses,Xenograft Bioprostheses, Porcine,Xenograft Bioprosthesis, Porcine

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