Eight-year follow-up after prospectively randomized implantation of different mechanical aortic valves

Abstract

The aim of this prospectively randomized study was to evaluate the hemodynamic and functional outcomes after aortic valve replacement with three different bileaflet mechanical valves. From March 1996 to August 1998, 300 consecutive patients were randomly assigned to receive ATS (n = 100), Carbomedics (n = 100), or St Jude Medical Hemodynamic Plus (n = 100) mechanical aortic valve replacement. There were no significant differences regarding patient age (61 +/- 8 years), gender, NYHA, aortic valve pathology, ventricular morphology, ejection fraction and requirement for additional procedures at implant. Mean follow-up extends to 95 +/- 21 months at a total of 2,891 patients years and is in 95.3% complete. Implanted valve sizes were comparable at 24 +/- 2 mm (ATS), 23.7 +/- 1.6 mm (CM), and 23.6 +/- 1.9 mm (SJMHP) (NS). Follow-up results were: transvalvular flow velocities 2.3/2.3/2.2 m/s, ejection fraction 64/59/63%, trivial transvalvular incompetence 3/3/2; paravalvular leak 2/3/2; freedom of reoperation 100/99/99%, NYHA functional status 1.5/1.8/1.6, overall survival 86.4/82.8/80.6%, freedom from thrombembolic events 100/96/98%, freedom from hemorrhage 100/100/99%, freedom from all valve related events was 100/96/98%; respectively (NS). There were no episodes of endocarditis. Ninety-four percent of the patients were satisfied with the procedure enjoying an enhanced daily life activity. There are no clinically relevant differences among the tested bileaflet aortic valves. Regardless of valve type, there was a rather low complication rate in this relatively young population. All three bileaflet prostheses are well suited for aortic valve replacement.