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BACKGROUND There are few clinical studies on late follow-up of the Omnicarbon monoleaflet valve. We report our 10-year experience with this valve in the aortic position and also compare late hemodynamic performance of this valve with that of the CarboMedics valve in the aortic position. METHODS From January 1985 to June 1995, 117 consecutive patients underwent aortic valve replacement (AVR) with the Omnicarbon valve. There were 66 men and 51 women aged 13 to 69 years (mean age, 50 +/- 12 years). They were divided into three groups: group 1 (43 patients) had isolated AVR, group 2 (36) had AVR and concomitant operations, and group 3 (38) had combined AVR and mitral valve replacement. Follow-up was 96.6% complete and consisted of 882.7 patient-years (range, 2.5 to 10.6 years; mean follow-up, 7.5 +/- 2.7 years). RESULTS There were three early deaths (2.6%) and 18 late deaths (2.0%/patient-year) ten of which were due to valve-related causes and eight, non-valve-related causes. Survival rates at 10 years in groups 1, 2, and 3 were 77.6%, 82.4%, and 78.6%, respectively. The overall rates of freedom from valve-related complications in groups 1, 2, and 3 at 10 years were 77.4%, 100%, and 80.9%, respectively. The rates of freedom from the following complications in groups 1, 2, and 3 at 10 years were as follows: thromboembolism--94.8%, 100%, and 89.4%, respectively; valvar thrombosis--95.0%, 100%, and 100%; anticoagulant-related hemorrhage--93.6%, 100%, and 93.4%; prosthetic valve endocarditis--93.0%, 100%, and 97.2%; and reoperation--90.6%, 100%, and 97.2%. There were no significant differences between groups. All survivors showed marked improvement in New York Heart Association functional class, from 86% in classes III and IV preoperatively to 96% in classes I and II postoperatively. The Omnicarbon valve exhibited no significant difference in hemodynamic performance after isolated AVR compared with the CarboMedics bileaflet valve at the same follow-up periods. CONCLUSIONS This 10-year study confirms that the Omnicarbon valve is a durable prosthesis and provides excellent functional improvement with low rates of thromboembolism and valvar thrombosis in the aortic position.
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