title: Comparative results with the St. Jude Medical and Medtronic Hall mechanical valves.
abstract: This study compared the clinical performance of the St. Jude Medical and Medtronic Hall mechanical valves in isolated aortic or mitral valve replacement. From 1984 to 1993, 349 St. Jude Medical valves (aortic 237, mitral 112) and 465 Medtronic Hall valves (aortic 272, mitral 193) were implanted in 814 patients at the University of Ottawa Heart Institute. The patients had similar preoperative characteristics. The hospital mortality rate for aortic valve replacement was 3.4% with the St. Jude Medical valve and 5.8% with the Medtronic Hall valve (p = 0.26) and the rate for mitral valve replacement was 8.9% with the St. Jude Medical valve and 11.9% with the Medtronic Hall valve (p = 0.54). Actuarial estimates of survival and freedom from complications were calculated. At 5 years the actuarial probability of survival (including hospital deaths) for aortic valve replacement was 86% +/- 3% with the St. Jude Medical valve and 68% +/- 4% with the Medtronic Hall valve (p = 0.0001) and for mitral valve replacement was 75% +/- 7% with the St. Jude Medical valve and 70% +/- 4% with the Medtronic Hall valve (p = 0.54). The most common cause of late death was cardiac failure and no deaths were caused by structural failure. The 5-year probability of freedom from bleeding after aortic valve replacement was 99% +/- 1% with the St. Jude Medical valve and 95% +/- 2% with the Medtronic Hall valve (p = 0.06) and after mitral valve replacement 99% +/- 1% with the St. Jude Medical valve and 97% +/- 2% with the Medtronic Hall valve (p = 0.37). The 5-year probability of freedom from thromboembolism after aortic valve replacement was 88% +/- 4% with the St. Jude Medical valve and 81% +/- 3% with the Medtronic Hall valve (p = 0.08) and after mitral valve replacement was 85% +/- 7% with the St. Jude Medical valve and 77% +/- 5% with the Medtronic Hall valve (p = 0.17). Reoperation was uncommon and there were no cases of structural valve failure. The 5-year actuarial estimate of freedom from reoperation therefore for aortic valve replacement was 99% +/- 1% with the St. Jude Medical valve and 96% +/- 2% with the Medtronic Hall valve (p = 0.09) and for mitral valve replacement was 98% +/- 2% with the St. Jude Medical valve and 95% +/- 3% with the Medtronic Hall valve (p = 0.40).(ABSTRACT TRUNCATED AT 400 WORDS)
authors.affiliation: Department of Surgery, University of Ottawa Heart Institute, Ottawa Civic Hospital, Ontario, Canada.
authors.forename: R G
authors.initials: RG
authors.lastname: Masters
authors.forename: A L
authors.initials: AL
authors.lastname: Pipe
authors.forename: V M
authors.initials: VM
authors.lastname: Walley
authors.forename: W J
authors.initials: WJ
authors.lastname: Keon
mesh_terms: D000206:Actuarial Analysis; D001021:Aortic Valve / Q000601:surgery; D016009:Chi-Square Distribution; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery; D011336:Probability; D011475:Prosthesis Failure; D012086:Reoperation; D015996:Survival Rate; D013923:Thromboembolism / Q000209:etiology