Key result
The 21 mm Edwards Lifescience pericardial valve yielded lower early mean gradients than the Medtronic Mosaic valve (17.4 vs 20.3 mmHg; P<0.05), though hemodynamics were similar by annulus diameter.
Why the study?
Does the Edwards Lifescience pericardial bioprosthesis improve hemodynamic performance compared to the Medtronic Mosaic porcine bioprosthesis in patients undergoing aortic valve replacement?
RCT (n=86)
Intra-operative randomization
Does the Edwards Lifescience pericardial bioprosthesis improve hemodynamic performance compared to the Medtronic Mosaic porcine bioprosthesis in patients undergoing aortic valve replacement?
Absolute Event Rate: 17.4% vs 20.3%
p-value: p=<0.05
The hemodynamic performance of Edwards Lifescience pericardial and Medtronic Mosaic porcine bioprostheses is comparable when matched by actual aortic annulus diameter rather than labeled valve size.
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Matching by annulus diameter rather than labeled size eliminates apparent hemodynamic differences; challenges prior valve comparisons in AVR.
R. Seitelberger (2004) conducted an RCT in Aortic valve replacement (n=86). Edwards Lifescience pericardial (ELP) bioprosthesis vs. Medtronic Mosaic porcine (MM) bioprosthesis was evaluated on Mean gradient for 21 mm valve early postoperatively (mmHg) (p=<0.05). The 21 mm Edwards Lifescience pericardial valve yielded lower early mean gradients than the Medtronic Mosaic valve (17.4 vs 20.3 mmHg; P<0.05), though hemodynamics were similar by annulus diameter.
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