Clinical experience with the Omnicarbon prosthetic heart valve.

The Omnicarbon prosthetic heart valve (Medical Inc., Inver Grove Heights, Minn.) was implanted in 124 patients (mean age 53 +/- 11 years); 66 of them had aortic valve replacement, 40 had mitral valve replacement, and 18 had both aortic and mitral valve replacement. Preoperatively 76.6% were in New York Heart Association class 3 or 4, and 84.7% were in class 1 or 2 after the operation. There were six (4.8%) early deaths and seven late deaths. Survival was 85% +/- 6% at 6 years in the aortic valve replacement group, 94% +/- 4% at 3 years in the mitral valve replacement group, and 78% +/- 11% at 4 years in the double valve replacement group. Freedom from cardiac death was 89% +/- 4% at 6 years (2.0% per patient-year) in the aortic valve replacement group, 94% +/- 4% at 3 years (1.8% per patient-year) in the mitral valve replacement group, and 78% +/- 11% at 4 years (5.7% per patient-year) in the double valve replacement group. There were six valve-related complications. Freedom from valve-related complications was 92% +/- 4% at 6 years (1.5% per patient-year) in the aortic valve replacement group, 97% +/- 3% at 3 years (1.8% per patient-year) in the mitral valve replacement group, and 83% +/- 11% at 4 years (5.7% per patient-year) in the double valve replacement group. Cerebral hemorrhage was seen in two patients in the aortic valve replacement group. Freedom from all events was 80% +/- 7% at 6 years in the aortic valve replacement group, 88% +/- 6% at 3 years in the mitral valve replacement group, and 78% +/- 11% at 4 years in the double valve replacement group. Elevation of the postoperative serum lactate dehydrogenase levels was minimal in all groups. The maximum opening angle at rest was 60.0 +/- 8.9 degrees in the aortic position and 54.1 +/- 6.6 degrees in the mitral position. In conclusion, the Omnicarbon prosthesis had excellent postoperative clinical status and negligible hemolysis.