TY - JOUR
T1 - Carpentier-Edwards aortic pericardial bioprosthetic valve as a valid control in preclinical in vivo ovine studies
AU - Harvey, Laura
AU - Bianco, Richard W
AU - Lahti, Matthew
AU - Carney, John
AU - Zhang, Lindsey
AU - Robinson, Nicholas A
N1 - Publisher Copyright:
© 2015 Elsevier B.V.
Copyright:
Copyright 2016 Elsevier B.V., All rights reserved.
PY - 2015/7/15
Y1 - 2015/7/15
N2 - 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.
AB - 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.
KW - Aortic valve replacement
KW - Calcification
KW - Perimount
KW - Thrombosis
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U2 - 10.1016/j.ejphar.2015.03.033
DO - 10.1016/j.ejphar.2015.03.033
M3 - Article
C2 - 25814251
AN - SCOPUS:84937759817
SN - 0014-2999
VL - 759
SP - 192
EP - 199
JO - European Journal of Pharmacology
JF - European Journal of Pharmacology
M1 - 69835
ER -