Background: The aim of the study was to evaluate rest and exercise performance and left ventricular mass regression of the Medtronic Advantage (Medtronic, Inc, Minneapolis, MN) prosthesis in the aortic position at 1 year at a single center as part of a multicenter, prospective clinical trial.
Methods: Between May 2002 and June 2003, 63 consecutive patients underwent aortic valve replacement with a Medtronic Advantage prosthesis (84.1% male; mean age, 56.0 +/- 9.7 years; ejection fraction, 56.5 +/- 15.8%). Valve lesions were stenosis (n = 20), mixed (n = 34), and insufficiency (n = 9). Concomitant procedures were performed in 34.9%. Follow-up was 100% complete. Echocardiographic data were obtained early postoperatively and at 1 year, combined with stress echocardiography by treadmill. Mean pressure gradients, stroke volume, and left ventricular mass were determined by echocardiography. Data are presented as mean +/- standard deviation.
Results: Operative mortality was 0%. Valve-related complications were observed in 2 patients (endocarditis, n = 1; thromboembolic event, n = 1). There was no case of antithromboembolic hemorrhage, prosthesis-related explant, or reoperation. One patient showed moderate paravalvular regurgitation. Mean pressure gradients 1 year postoperatively ranged from 6.3 to 11.0 mm Hg across all valve sizes. Left ventricular mass regression at 1 year was 18.4% across all valve sizes (p < 0.001). No severe patient-prosthesis mismatch (effective orifice area index < or = 0.65 cm2/m2) could be observed.
Conclusions: After 1 year, the Medtronic Advantage valve shows comparable transvalvular mean pressure gradients across the valve sizes used during rest and exercise. This is accompanied by a significant left ventricular mass regression, an important indicator for long-term survival.