Background: Four collaborating centers pooled their results with the Sorin Bicarbon Bileaflet valve.
Material and methods: Between 6/91 and 11/95, 431 patients, 235 males and 196 females, underwent valve replacement using the new Sorin prosthesis; age range: 16-88, mean 61.4 yrs.
Operations: AVR - 206, MVR - 177, TVR - 1, DVR - 47. Additional procedures - 139: CAB -117, valve repair - 22. AV sizes: 19-27, MV sizes: 21-33.
Results: Thirty day mortality was 4.3%. Early complications included: CVA - 1.4%, +ve blood culture - 2%, reop for bleeding - 5%. Late complications: infective endocarditis - 2.3%, valve thrombosis - 0.2%, thromboemboli - 2.5%, major bleeding - 1.6%, reoperation - 3%, late deaths (all causes) - 4.3%. No structural deterioration has been reported with this valve and acceptable gradients have been observed. Hemolysis is negligible.
Conclusions: Based on this intermediate experience the Sorin Bicarbon prosthesis is well-designed with good hemodynamic properties, and an acceptably low incidence of complications.