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.
Bibliographical noteFunding Information:
Funding for this study was provided by private medical device companies seeking regulatory approval for their devices, the producer of the valves involved in this study was not involved in funding.
- Aortic valve replacement