Long-term experience with the omniscience cardiac valve.
OBJECTIVE
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.
Teijeira
F J
FJ
Division of Cardiovascular and Thoracic Surgery, Faculty of Medicine, Centre Universitaire de Sante de l'Estrie, Sherbrooke, Quebec, Canada.
D000328:Adult; D000368:Aged; D001021:Aortic Valve / Q000601:surgery*; D002318:Cardiovascular Diseases / Q000209:etiology / Q000401:mortality; D002423:Cause of Death; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000175:diagnosis / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery*; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D015996:Survival Rate; D013997:Time Factors