Three-year clinical results with the Monostrut Björk-Shiley prosthesis.

Between November 1981 and June 1983, 351 patients underwent valve replacement with the Monostrut Björk-Shiley prosthesis. There were 214 aortic valve replacements, 101 mitral valve replacements, and 31 double (aortic and mitral) valve replacements. Four patients had valve implanted in the tricuspid position, and one patient underwent exchange of a valved, extracardiac conduit. Mean age was 61 years (range 2 to 78) and 186 (53%) were male. Concomitant procedures were performed in 52 patients (15%) and 17 (5%) were emergency operations. Early mortality (4.3%) was related to New York Heart Association Functional Class IV, emergency operation, or the presence of a concomitant procedure. Follow-up was 100% and covered 870 patients-years (mean 2.6 years per operative survivor). Postmortem examination was performed in 38 (79%) of the 48 fatalities. Only one patient suffered a sudden, unexplained death. The 3 year survival rate (early mortality excluded) was 88.6% (aortic valve replacement 89.2%, mitral valve replacement 89.3%, and double valve replacement 82.5%). The 3 year freedom from thromboembolism in patients receiving anticoagulants was as follows: aortic valve replacement 97.5%, mitral valve replacement 92.8%, and double valve replacement 100%. There were no instances of valve thrombosis or fatal embolism. In contrast, there were two instances of aortic valve thrombosis among 34 patients having aortic valve replacement without anticoagulation. The 3 year freedom from valve failure (modified Stanford definition) was as follows: aortic valve replacement 96.0%, mitral valve replacement 93.9%, and double valve replacement 89.7%. There were no mechanical failures. In conclusion, the Monostrut Björk-Shiley valve showed a low incidence of complications. There were no mechanical failures, no fatal emboli, and, when anticoagulants were administered, no valve thromboses.