Long-term experience with the omniscience cardiac valve.

Abstract

BACKGROUND AND AIMS OF THE STUDY: This study reports mortality and morbidity rates observed with the Omniscience valve prosthesis. Complication rates were calculated from a prospective, long-term follow up study of patients with the Omniscience valve prosthesis in the aortic, mitral, or both aortic and mitral positions. METHODS: The Omniscience heart valve was implanted into 200 consecutive patients (42.5% aortic valve replacement (AVR); 51.5% mitral valve replacement (MVR); 6% AVR/MVR), with an average age of 57 +/- 12 years, at the author's institution. Patients were checked regularly at a clinic which specialized in prosthetic valve follow up. Only one patient was lost to follow up during this 13-year period (99.5% completeness of follow up). RESULTS: The total follow up was 1475 patient-years (pt-yr); mean follow up 8.0 +/- 2.9 years. Survival probability at 12 years, including freedom from both early and late mortalities, was 67.1 +/- 6.7% for AVR and 62.8 +/- 6.0% for MVR patients. There were no structural valve failures. Twelve-year freedom from thromboembolism was 85.5 +/- 5.0% and 85.2 +/- 6.5% for AVR and MVR, respectively. For thromboembolism + anticoagulation-related hemorrhage, the 12-year freedom rates were 79.4 +/- 5.3% for AVR and 77.3 +/- 6.7% for MVR patients. CONCLUSIONS: The Omniscience valve demonstrated a low risk of late complications, comparable with that of other modern mechanical valves. Omniscience valve patients also exhibited excellent hematology values and good functional improvement during this long-term prospective follow up. It is concluded that the Omniscience valve has satisfactory long-term clinical performance in both the aortic and mitral positions.