A Six-Year Experience with the Omnicarbon Valve in North American Patients

Aim: We studied the results of an all‐carbon monoleaflet valve prosthesis (the Omnicarbon) in a North American population. Methods: Patients were recalled to our valve clinic for complete evaluation, including echocardiography, laboratory tests, and physician examination. This experience includes 108 Omnicarbon valve implants. We report the results of single aortic (AVR) or mitral (MVR) valve replacement. Results: Patients' ages ranged from 40 to 83 (mean: 63 ± 9 years), and most were male (60%, 59/98). Preoperatively, 71% were NYHA Classes III/IV, while most patients are now Classes I/II (86%). AVR predominated (63%, 62/98), and many patients (44%, 43/98) underwent cardiac procedures either previously or concomitant with valve replacement. Hospital mortality was 6.1% (6/98). Predicted hospital mortality using the Parsonnet additive risk model averaged 12.1%. Currently, four patients cannot be located (96% accountability). Overall, hematology indicated low hemolysis—lactate dehydrogenase: 691 ± 184 IU/L (112%± 30% upper normal), reticulocytes: 1.8%± 0.7%, and red blood cells (106/mm3): 4.41 ± 0.50 (males)/4.16 ± 0.50 (females). International normalized ratio averaged 2.67 ± 0.72. Doppler echocardiography values were acceptable and comparable to other mechanical valves. Five‐year survival (hospital death included) is 86%± 4%. At 5 years, freedom from any thromboembolic event is 99%± 1%, and freedom from bleeding is 97%± 2%. Endocarditis and nonstructural dysfuction also occurred at low rates (99%± 1% freedom at five years), and no structural failure or hemolytic anemia was observed during the 343 patient‐years (mean: 3.7 ± 1.6 years). Conclusions: Good hematology and hemodynamics, along with remarkably low complication rates, demonstrate that the Omnicarbon valve meets contemporary performance expectations.