OBJECTIVE: 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. METHODS: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. RESULTS: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. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: W G Daniel; H Baumgartner; C Gohlke-Bärwolf; P Hanrath; D Horstkotte; K C Koch; A Mügge; H J Schäfers; F A Flachskampf Journal: Clin Res Cardiol Date: 2006-11 Impact factor: 5.460
Authors: Christian Bruch; Daniela Kauling; Holger Reinecke; Markus Rothenburger; Hans Heinrich Scheld; Günter Breithardt; Thomas Wichter Journal: Clin Res Cardiol Date: 2006-10-30 Impact factor: 5.460