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Pulse Duplicator Hydrodynamic Testing of Bioengineered Biological Heart Valves

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Abstract

There are many heart valve replacements currently available on the market; however, these devices are not ideal for pediatric patients with congenital heart valve defects. Decellularized valve substitutes offer potential for improved clinical outcomes and require pre-clinical testing guidelines and testing systems suitable for non-crosslinked, biological heart valves. The objective of this study was to assess the hydrodynamic performance of intact, bioengineered pulmonary valves using a custom pulse duplicator capable of testing intact biological valved conduits. The mechanical behavior of valve associated sinus and arterial tissue was also evaluated under biaxial loading. Cryopreserved, decellularized, extracellular matrix (ECM) conditioned and glutaraldehyde fixed valves showed reduced pressure gradients and increased effective orifice area for decellularized and ECM conditioned valves. ECM conditioning resulted in increased elastic modulus but decreased stretch in circumferential and longitudinal directions under biaxial loading. Overall, decellularization and ECM conditioning did not compromise the scaffolds, which exhibited satisfactory bench top performance.

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Acknowledgments

This work was partially funded through generous grant support from the Katherine B. Richardson Foundation at Children’s Mercy.

Conflict of Interest

Authors Buse, Hopkins and Converse are listed inventors on pending patent 14/390,170. Author Hopkins is a listed inventor on the following patents: 10/0035344 A1; 12/813,487; 2010/0042120 A1; 6,652583 B2; 2009257400; 20130280319 A1. Author Hopkins reports grants from LifeNet Health, outside of the submitted work. Author Hilbert declares that he has no conflict of interest.

Statement of Human Studies

No human studies were carried out by the authors for this article.

Statement of Animal Studies

All institutional and national guidelines for the care and use of laboratory animals were followed and approved by the appropriate institutional committees.

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Authors and Affiliations

  1. Cardiac Regenerative Surgery Research Laboratories of The Ward Family Heart Center, Children’s Mercy Kansas City, 2401 Gillham Road, Kansas City, MO, 64108, USA

    Eric E. Buse, Stephen L. Hilbert, Richard A. Hopkins & Gabriel L. Converse

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  1. Eric E. Buse
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Correspondence to Gabriel L. Converse.

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Associate Editor Ajit P. Yoganathan oversaw the review of this article.

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Buse, E.E., Hilbert, S.L., Hopkins, R.A. et al. Pulse Duplicator Hydrodynamic Testing of Bioengineered Biological Heart Valves. Cardiovasc Eng Tech 7, 352–362 (2016). https://doi.org/10.1007/s13239-016-0275-9

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