Background and aim of the study: The study aim was to investigate the echocardiographic Doppler-derived hemodynamic results at one-year follow up at a single center for patients receiving the Medtronic ADVANTAGE aortic prosthetic heart valve. This study was part of a multi-center, prospective clinical evaluation of the ADVANTAGE bileaflet mechanical heart valve.
Methods: Echocardiographic data were obtained one year postoperatively from 40 patients who underwent aortic valve replacement between November 1999 and March 2000. Data collected were in accordance with the Food and Drug Administration guidelines for clinical trials.
Results: The in-vivo mean pressure gradients for valves implanted in the aortic position ranged from 11.2 mmHg for size 21 valves to 6.1 mmHg for size 29 valves, and the corresponding in-vivo effective orifice area ranged from 1.5 to 3.6 cm2.
Conclusion: Early results of the study showed hemodynamic performance of the ADVANTAGE aortic valve to be comparable with that of other bileaflet valves in current clinical use.