Key result
The 25-mm Mitris bioprosthesis had the lowest peak/mean gradient and largest surgical opening area compared to 27-mm Epic and Mosaic valves in a porcine model.
Why the study?
To evaluate three commercially available mitral bioprostheses of comparable measured internal diameters under controlled, stable hemodynamic and surgical conditions pre- and postvalve implantation.
Do different commercially available mitral bioprostheses of similar labeled size have comparable hemodynamics and anatomic dimensions in a porcine model?
RCT (n=12)
randomized
Do different commercially available mitral bioprostheses of similar labeled size have comparable hemodynamics and anatomic dimensions in a porcine model?
Marked variations exist in hemodynamics, valve opening area, and anatomic dimensions between similar-sized commercial mitral bioprostheses, suggesting a need for standardization.
Answers are grounded in this paper and cite their sources.
Porcine data caution against assuming mitral bioprosthesis equivalence; leaves open standardization and human outcome studies.
Background/Aim To evaluate three mitral bioprostheses (of comparable measured internal diameters) under controlled, stable, hemodynamic and surgical conditions by bench, echocardiographic, computerized tomography and autopsy comparisons pre- and postvalve implantation. Methods Fifteen similar-sized Yorkshire pigs underwent preprocedural computerized tomography anatomic screening. Of these, 12 had consistent anatomic features and underwent implantation of a mitral bioprosthesis via thoracotomy on cardiopulmonary bypass (CPB). Four valves from each of three manufacturers were implanted in randomized fashion: 27-mm Epic, 27-mm Mosaic, and 25-mm Mitris bioprostheses. After CPB, epicardial echocardiographic studies were performed to assess hemodynamic function and define any paravalvular leaks, followed by postoperative gated contrast computerized tomography. After euthanasia, animals underwent necropsy for anatomic evaluation. Results All 12 animals had successful valve implantation with no study deaths. Postoperative echocardiographic trans-valve gradients varied among bioprosthesis manufacturers. The 25-mm Mitris (5.1 ± 2.7)/(2.6 ± 1.3 torr) had the lowest peak/mean gradient and the 27-mm Epic bioprosthesis had the highest (9.2 ± 3.7)/(4.6 ± 1.9 torr). Surgical valve opening area (SOA) varied with the 25-mm Mitris having the largest SOA (2.4 ± 0.15 cm2) followed by the 27-mm Mosaic (2.04 ± 0.23 cm2) and the 27-mm Epic (1.8 ± 0.27 cm2) valve. Bench device orthogonal internal diameter measurements did not match manufacturer device size labeling: 25-mm Mitris (23 × 23 mm), 27-mm Mosaic (23 × 22 mm), 27-mm Epic (21 × 21 mm). Conclusions Current advertisement/packaging of commercial surgical mitral valves is not uniform. This study demonstrates marked variations in hemodynamics, valve opening area and anatomic dimensions between similar sized mitral bioprostheses. These data suggest a critical need for standardization and close scientific evaluation of surgical mitral bioprostheses to ensure optimal clinical outcomes.
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Wang et al. (2021) reported an RCT. 25-mm Mitris bioprosthesis vs. 27-mm Epic and 27-mm Mosaic bioprostheses was evaluated on Hemodynamic function (trans-valve gradients) and surgical valve opening area. The 25-mm Mitris bioprosthesis had the lowest peak/mean gradient and largest surgical opening area compared to 27-mm Epic and Mosaic valves in a porcine model.
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