BICARBON VALVE - EUROPEAN MULTICENTER CLINICAL-EVALUATION

Objective: Fifteen collaborating centers in eight countries present th eir pooled experience with the new Bicarbon(TM) bileaflet valve. Metho ds: Between 4/90 and 4/96, 1351 patients, 806 males and 545 females, a ged 10 to 83, mean 58.4 +/- 12.4, underwent valve implantation. Operat ions: aortic valve replacement (AVR), 726; mitral valve replacement (M VR), 475; double valve replacement (DVR), 150. Additional procedures: CABG, 211; TV repair, 64; other, 152. Results: Mortality: 67 early (se ven valve related) and 56 late (40 valve related). Valve thrombosis: s ix obstructive, three non-obstructive; embolism: nine major cerebral, 37 other. Major bleeding: 29. Hemolysis: two clinically significant. N on-structural dysfunction: 24 paravalvular leaks, one leaflet interfer ence, No structural failure! Endocarditis: 24. Reoperation 48: 22 non- structural dysfunctions, 14 endocarditis, seven thrombosis and embolis m, five other. Estimated 5-year freedom from valve-related deaths is 9 7.2% for AVR and 92.4% for MVR; 4-year freedom from valve related deat hs for DVR is 90.5%, Mean calculated NYHA improvement is 1.24. Conclus ions: The Bicarbon mechanical prosthesis is well designed, durable, ha s good hemodynamic features and an acceptably low incidence of complic ations. (C) 1998 Elsevier Science B.V. All rights reserved.