Key result
The Edwards Perimount Magna valve was hemodynamically superior to the Medtronic Mosaic at 1 year, with a lower mean gradient (10.2 vs 17.1 mmHg) and larger effective orifice area (P<0.0001).
Why the study?
Does the Edwards Perimount Magna bioprosthesis improve hemodynamic performance compared to the Medtronic Mosaic bioprosthesis in patients undergoing aortic valve replacement?
RCT (n=86)
Stratified by aortic annulus diameter
Does the Edwards Perimount Magna bioprosthesis improve hemodynamic performance compared to the Medtronic Mosaic bioprosthesis in patients undergoing aortic valve replacement?
The Edwards Perimount Magna bioprosthesis demonstrated superior hemodynamic performance and a lower incidence of patient-prosthesis mismatch compared to the Medtronic Mosaic bioprosthesis at one year post-aortic valve replacement.
Answers are grounded in this paper and cite their sources.
May favor Edwards Perimount Magna selection in AVR; confirms hemodynamic superiority versus Medtronic Mosaic in this RCT.
We compared the hemodynamic performance of the Edwards Perimount Magna (EPM) and the Medtronic Mosaic (MM) bioprostheses according to the patient aortic annulus diameter (AAD). Eighty-six patients undergoing aortic valve replacement were prospectively assigned to receive either an EPM-valve (n=43) or an MM-bioprosthesis (n=43). Randomization was performed after measuring the AAD and patients were grouped according to their AAD: <22 mm (n=12), 22-23 mm (n=31) and >23 mm (n=43). Echocardiographic assessment was performed one year postoperatively. The mean AAD (EPM 23.9+/-2.1 mm vs. MM 23.6+/-2.3 mm) and mean valve size implanted (EPM 22.6+/-2.1 mm vs. MM 23.3+/-2.1 mm) were comparable in both groups. The EPM-group showed significantly lower mean gradient (EPM 10.2+/-3.2 mmHg vs. MM 17.1+/-8.2 mmHg) and larger effective orifice area (EOA) (EPM 1.99+/-0.4 cm(2) vs. MM 1.69+/-0.4 cm(2), P<0.0001). The EPM-valve was superior with respect to mean pressure gradient and EOA in all AAD. This difference was statistically significant in AAD of 22-23 mm (EPM 9.6+/-3.0 mmHg vs. MM 18.2+/-8.6 mmHg; EPM 1.82+/-0.3 cm (2) vs. MM 1.51+/-0.2 cm (2)) and >23 mm (EPM 9.9+/-3.1 mmHg vs. MM 14.2+/-5.6 mmHg; EPM 2.18+/-0.4 cm(2) vs. MM 1.94+/-0.5 cm(2)). Patient-prosthesis mismatch was present in 26.8% (MM) vs. 6.9% (EPM) of the patients (P=0.01). When the same AAD is taken as a reference, the EPM-valve was hemodynamically superior to the MM-bioprosthesis. The EPM-prosthesis significantly reduced the incidence of PPM.
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Dalmau et al. (2007) conducted an RCT in Aortic valve replacement (n=86). Edwards Perimount Magna (EPM) bioprosthesis vs. Medtronic Mosaic (MM) bioprosthesis was evaluated on Hemodynamic performance (mean gradient and effective orifice area) (p=<0.0001). The Edwards Perimount Magna valve was hemodynamically superior to the Medtronic Mosaic at 1 year, with a lower mean gradient (10.2 vs 17.1 mmHg) and larger effective orifice area (P<0.0001).
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