Six year clinical study of use of the Omniscience valve prosthesis in 219 patients

A 6 year experience of cardiac valve replacement with the Omniscience prosthesis is described. A total of 253 valves were inserted in 219 patients. The survivors were followed up for a total of 536 patient-years and for a mean of 2.8 years. The follow-up was 97.6% complete. Analyses were performed in accordance with recommended criteria regarding definitions of complications and grading thromboembolic events for severity and analysis of anticoagulant status. Results are described both in terms of actuarial and linearized rates. For the patients at risk, actuarial survival at the end of 5 years was 87.9 +/- 3.1% overall, 90.4 +/- 3.0% for single valve (aortic 88 +/- 5%, mitral 93.3 +/- 4%) replacement and 71 +/- 11% for multiple valve replacement. The actuarial rates of freedom from complications were as follows: endocarditis 95.7 +/- 1.8% (aortic 94 +/- 3.5%, mitral 100%), periprosthetic leak 98 +/- 1% (aortic 96.2 +/- 2.6%, mitral 100%), thromboembolism 95.2 +/- 2.3% (aortic 90.9 +/- 4.6%, mitral 96.7 +/- 3.3%), valve thrombosis 98.7 +/- 0.9% (aortic 100%, mitral 100%), anticoagulant-induced bleeding 90.3 +/- 2.6% and all valve-related complications 79.4 +/- 3.6% (aortic 78.8 +/- 3.6%, mitral 85.9 +/- 4.5%). The functional improvement in patients was very satisfactory and the risk of reoperation was 1.1% per patient-year. Over a 6 year time frame, the Omniscience valve has given excellent clinical performance.