Carpentier-Edwards aortic pericardial bioprosthetic valve as a valid control in preclinical in vivo ovine studies

Laura Harvey, Richard W Bianco, Matthew Lahti, John Carney, Lindsey Zhang, Nicholas A Robinson

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Abstract To progress into clinical practice, a bioprosthetic heart valve must first pass through the preclinical evaluation phase. The International Standards Organization (ISO) recommends implantation of concurrent controls in any evaluation of a new or modified heart valve. A total of 8 adult sheep underwent aortic valve replacement, receiving either the CE Perimount Magna 3000 aortic pericardial bioprosthetic valve or the CE Perimount RSR aortic pericardial bioprosthetic valve, Model 2800. We performed serial blood sampling, echocardiography, angiography and necropsy after euthanasia. All 8 sheep survived until the end of their study term. Our 2-dimensional echocardiographic analysis showed a mean pressure gradient of 37.4±6.0 mmHg at 14 days and 37.0±5.9 mmHg at 90 days; mean cardiac output was 10.0±2.8 l/min at 14 days and 9.6±1.6 l/min at 90 days. Angiography before euthanasia showed a mean aortic transvalvular gradient of 32.3±15.3 mmHg. At euthanasia, we saw no evidence of calcification in any of the valves. In our study, we found that both models of the CE bioprosthetic heart valve we tested proved to be valid controls, in the aortic position, in sheep - with no evidence of calcification. Most important, the valves we tested had a few model-related problems, allowing a clear determination of their suitability for introduction into a clinical trial. Investigators now have additional insight into the safety of these 2 models of valves and perhaps will be able to reduce the number of controls implanted.

Original languageEnglish (US)
Article number69835
Pages (from-to)192-199
Number of pages8
JournalEuropean Journal of Pharmacology
Volume759
DOIs
StatePublished - Jul 15 2015

Bibliographical note

Publisher Copyright:
© 2015 Elsevier B.V.

Copyright:
Copyright 2016 Elsevier B.V., All rights reserved.

Keywords

  • Aortic valve replacement
  • Calcification
  • Perimount
  • Thrombosis

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