One year hemodynamic performance of the Perimount Magna pericardial xenograft and the Medtronic Mosaic bioprosthesis in the aortic position: a prospective randomized study.

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.

RCT Entities:   Population Interventions Outcomes