Bicarbon valve -- European multicenter clinical evaluation.

ABSTRACT

OBJECTIVE: Fifteen collaborating centers in eight countries present their pooled experience with the new Bicarbon bileaflet valve. METHODS: Between 4/90 and 4/96, 1351 patients, 806 males and 545 females, aged 10 to 83, mean 58.4 +/- 12.4, underwent valve implantation. OPERATIONS aortic valve replacement (AVR), 726; mitral valve replacement (MVR), 475; double valve replacement (DVR), 150. Additional procedures CABG, 211; TV repair, 64; other, 152. RESULTS: Mortality 67 early (seven valve related) and 56 late (40 valve related). Valve thrombosis six obstructive, three non-obstructive; embolism nine major cerebral, 37 other. Major bleeding 29. Hemolysis two clinically significant. Non-structural dysfunction 24 paravalvular leaks, one leaflet interference. No structural failure! Endocarditis 24. Reoperation 48 22 non-structural dysfunctions, 14 endocarditis, seven thrombosis and embolism, five other. Estimated 5-year freedom from valve-related deaths is 97.2% for AVR and 92.4% for MVR; 4-year freedom from valve related deaths for DVR is 90.5%. Mean calculated NYHA improvement is 1.24. CONCLUSIONS: The Bicarbon mechanical prosthesis is well designed, durable, has good hemodynamic features and an acceptably low incidence of complications.