Background: The Freestyle valve is a porcine aortic root fixed with net zero pressure across the cusps and treated with the anticalcification agent alpha-aminooleic acid. We evaluated the hemodynamic function of this stentless valve.
Methods: We implanted the valve into 80 consecutive patients scheduled to receive a bioprosthesis. Sixty-nine patients were more than 70 years old and 14 had calcified aortic sinuses. The "cylinder within a cylinder" implantation technique was used. Twenty-seven patients received coronary grafts, and 3 had mitral repair. All patients were studied echocardiographically during week 1 and 41 were studied at 6 months.
Results: Median ischemic time for isolated aortic valve replacement was 44 minutes. There were four hospital deaths, none valve related. No patient had more than trivial aortic regurgitation. Mean systolic gradients for valve sizes 21 to 25 mm fell significantly with time (p < or = 0.05) due to remodeling of the porcine root and early regression of left ventricular hypertrophy. Late hemodynamic function was equivalent to an aortic homograft.
Conclusions: The Freestyle valve is easily implanted and has excellent hemodynamics. Transvalvular gradients decrease progressively.