Background and aim of the study: Previous studies have shown that the Carpentier-Edwards Magna (CEM) valve is an excellent bioprosthesis in terms of its systolic performance; indeed, it has been described as 'a stented valve with stentless performance'. However, valve performance is not only a matter of gradients; it is also necessary to evaluate the diastolic-phase performance. Previous in-vitro studies have shown that the CEM has an excessive total regurgitant volume. Hence, the study aim was to compare the hydrodynamics of the CEM, with the newly evolved version of this valve, the CEM Ease (CEME).
Methods: The CEM and CEME valves (both 21 mm) were tested in the aortic chamber (23 mm diameter) of the Sheffield pulse duplicator. The tests were carried out at increasing pulse rates (PR; 70-100 beats/min), and at each pulse rate the valve was tested at different stroke volumes (SVs; 45-65 ml). The forward-flow pressure drop, closing leakage volumes and effective orifice area (EOA) were recorded.
Results: The CEM and CEME valves showed a comparable systolic-phase performance, there being no significant differences in terms of transvalvular gradient, EOA and stroke work loss, regardless of the PR and SV. In fact, the new CEME exhibited a significantly improved diastolic performance, with the total regurgitant volume being significantly lower, due especially to a reduced leakage volume and, to a lesser extent, a reduced closing volume.
Conclusion: The study results indicated that the new CEME valve would maintain the excellent systolic performance of the previous CEM model, but with a significantly improved diastolic performance.