Design, manufacturing and testing of a green non-isocyanate polyurethane prosthetic heart valve

Sofia F. Melo; Alicia Nondonfaz; Abdelhafid Aqil; Anna Pierrard; Alexia Hulin; Céline Delierneux; Bartosz Ditkowski; Maxime Gustin; Maxime Legrand; Bibian M. E. Tullemans; Sanne L. N. Brouns; Alain Nchimi; Raoul Carrus; Astrid Dejosé; Johan W. M. Heemskerk; Marijke J. E. Kuijpers; Jan Ritter; Ulrich Steinseifer; Johanna C. Clauser; Christine Jérôme; Patrizio Lancellotti; Cécile Oury

doi:10.1039/D3BM01911J

Design, manufacturing and testing of a green non-isocyanate polyurethane prosthetic heart valve†

Sofia F. Melo,

^a Alicia Nondonfaz,^a Abdelhafid Aqil,^b Anna Pierrard,

^b Alexia Hulin,^a Céline Delierneux,^a Bartosz Ditkowski,^a Maxime Gustin,^a Maxime Legrand,^c Bibian M. E. Tullemans,^d Sanne L. N. Brouns,^d Alain Nchimi,^a Raoul Carrus,^c Astrid Dejosé,^c Johan W. M. Heemskerk,^d Marijke J. E. Kuijpers,^d Jan Ritter,^e Ulrich Steinseifer,^e Johanna C. Clauser,

^e Christine Jérôme,^b Patrizio Lancellotti ‡^a and Cécile Oury

‡*^a

Author affiliations

* Corresponding authors

^a Laboratory of Cardiology, GIGA-Cardiovascular Sciences, University of Liège, Avenue de l'Hôpital 11, B34, 4000 Liège, Belgium
E-mail: cecile.oury@uliege.be

^b Center for Education and Research on Macromolecules (CERM), CESAM Research Unit, Department of Chemistry, University of Liège, Allée du 6 août 13, B6a, 4000 Liège, Belgium

^c Sirris, Liège Science Park, Rue du Bois Saint-Jean 12, 4102 Seraing, Belgium

^d Cardiovascular Research Institute Maastricht (CARIM), Department of Biochemistry, Maastricht University, Universiteitssingel 50, 6200 MD Maastricht, The Netherlands

^e Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Medical Faculty RWTH Aachen University, Pauwelsstraße 20, 52074 Aachen, Germany

Abstract

The sole effective treatment for most patients with heart valve disease is valve replacement by implantation of mechanical or biological prostheses. However, mechanical valves represent high risk of thromboembolism, and biological prostheses are prone to early degeneration. In this work, we aim to determine the potential of novel environmentally-friendly non-isocyanate polyurethanes (NIPUs) for manufacturing synthetic prosthetic heart valves. Polyhydroxyurethane (PHU) NIPUs are synthesized via an isocyanate-free route, tested in vitro, and used to produce aortic valves. PHU elastomers reinforced with a polyester mesh show mechanical properties similar to native valve leaflets. These NIPUs do not cause hemolysis. Interestingly, both platelet adhesion and contact activation-induced coagulation are strongly reduced on NIPU surfaces, indicating low thrombogenicity. Fibroblasts and endothelial cells maintain normal growth and shape after indirect contact with NIPUs. Fluid-structure interaction (FSI) allows modeling of the ideal valve design, with minimal shear stress on the leaflets. Injection-molded valves are tested in a pulse duplicator and show ISO-compliant hydrodynamic performance, comparable to clinically-used bioprostheses. Poly(tetrahydrofuran) (PTHF)-NIPU patches do not show any evidence of calcification over a period of 8 weeks. NIPUs are promising sustainable biomaterials for the manufacturing of improved prosthetic valves with low thrombogenicity.

Biomaterials Science

Design, manufacturing and testing of a green non-isocyanate polyurethane prosthetic heart valve†

Abstract

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Design, manufacturing and testing of a green non-isocyanate polyurethane prosthetic heart valve

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