Six years clinical experience with the Omniscience cardiac valve

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.