In Situ Remodeling Overrules Bioinspired Scaffold Architecture of Supramolecular Elastomeric Tissue-Engineered Heart Valves.

In situ tissue engineering that uses resorbable synthetic heart valve scaffolds is an affordable and practical approach for heart valve replacement; therefore, it is attractive for clinical use. This study showed no consistent collagen organization in the predefined direction of electrospun scaffolds made from a resorbable supramolecular elastomer with random or circumferentially aligned fibers, after 12 months of implantation in sheep. These unexpected findings and the observed intervalvular variability highlight the need for a mechanistic understanding of the long-term in situ remodeling processes in large animal models to improve predictability of outcome toward robust and safe clinical application.
Competing Interests: This research forms part of the iValve-II project, powered by Health∼Holland, top sector Life Sciences and Health (Grant number TTTI1403B), supported by the Dutch Ministry of Economic Affairs. This work was supported by the Netherlands Cardiovascular Research Initiative (CVON 2012-01): The Dutch Heart Foundation, Dutch Federation of University Medical Centers, the Netherlands Organization for Health Research and Development, the Royal Netherlands Academy of Sciences, and by the Gravitation Program “Materials Driven Regeneration,” funded by the Netherlands Organization for Scientific Research (024.003.013). Dr. Aikawa is supported by grants from the National Institutes of Health (R01 HL114805, R01 HL136431, R01 HL147095). Dr. Bouten is a shareholder of Xeltis BV. Drs. Tristan and Mes are employees of Suprapolix BV. Dr. Brugmans is an employee of Xeltis BV. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(© 2020 The Authors.)