title: Six years clinical experience with the Omniscience cardiac valve.
abstract: Clinical data on the Omniscience valve prosthesis were obtained from 194 patients (92 mitral valve replacements, 65 aortic valve replacements, 11 tricuspid valve replacements and 26 multiple valve replacements). Follow-up was 98% complete for a total of 443 patient-years with a mean of 2.6 years and maximum of six years. The mean age of patients was 50.3 +/- 14.5 years, with a range of two months to 75 years. Seventy-five percent of patients were in NYHA functional class III-IV preoperatively; postoperatively, over 93% of patients were in class I-II. Hospital mortality was 12.4% and late mortality was 3.2% per patient-year. The linearized rates for complications were as follows (per patient-year): thromboembolism 2.9%; valve thrombosis 0.7%; anticoagulant bleeding 2.7%; endocarditis 0.9%; pannus formation 0.2%; periprosthetic leak 0.5%. All significant valve related complications occurred at a rate of 5.9% per patient-year. The complications were fatal at a rate of 1.1% per patient-year and the risk of reoperation on the valve site was 1.1% per patient-year. Actuarial survival at six years was 84.8% +/- 5% for the whole group (88.6 +/- 5.7% for aortic, 84.3 +/- 9.4% for mitral valve replacement, 86.0 +/- 5.5% for single valve replacement and 77.1 +/- 10.2% for multiple valve replacements). Based on the duration of the study and absence of restrictive selection criteria, these clinical data demonstrated a reliable degree of safety and performance for this prosthesis.
authors.affiliation: University of Alberta Hospital, Edmonton.
authors.forename: A
authors.initials: A
authors.lastname: Damle
authors.forename: E
authors.initials: E
authors.lastname: Gelfand
authors.forename: J
authors.initials: J
authors.lastname: Callaghan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001021:Aortic Valve; D002648:Child; D002675:Child, Preschool; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000009:adverse effects* / Q000401:mortality; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve; D013923:Thromboembolism / Q000209:etiology; D014261:Tricuspid Valve