Abstract
Valve degeneration and dysfunction affect an increasing number of aging patients in the developed countries, while congenital and rheumatic diseases affect younger patients worldwide. When possible, valvular disease is treated by valve repair; however, severe pathologies require a surgical or transcatheter valve replacement procedure. Nowadays, clinical-grade valvular prostheses consist of mechanical or bioprosthetic valves, which still present serious disadvantages, such as thrombogenicity and limited durability.
In this chapter, we describe how tissue-engineered heart valves (TEHVs) can solve the shortcomings of current clinically adopted valvular replacements by providing a prosthesis with potential regenerative and remodeling capabilities and, hence, a lifelong durability. Different tissue engineering (TE) approaches, such as in vitro, in vivo, and in situ are described, with particular focus on preclinical and clinical validation of TEHVs. In this context, we will also discuss in silico, in vitro, and in vivo models that can be used to manufacture TEHVs, test their functionality, and predict their remodeling before moving to preclinical and clinical settings. Finally, we address the scientific, regulatory, and clinical challenges that pace the safe clinical translation of TEHVs.
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S.P. Hoerstrup is a shareholder at Xeltis BV and LifeMatrix AG. M.Y. Emmert is a shareholder at LifeMatrix AG. The other authors have nothing to disclose.
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Fioretta, E.S., Motta, S.E., Gähwiler, E.K.N., Poulis, N., Emmert, M.Y., Hoerstrup, S.P. (2021). Heart Valve Bioengineering. In: Eberli, D., Lee, S.J., Traweger, A. (eds) Organ Tissue Engineering. Reference Series in Biomedical Engineering(). Springer, Cham. https://doi.org/10.1007/978-3-030-44211-8_4
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