Review of 387 isolated mitral valve replacements by the Model 6120 Starr-Edwards prosthesis.

Between February, 1965, and July, 1980, 387 patients underwent an isolated mitral valve replacement with the non-cloth covered Starr-Edwards ball valve (Model 6120) at the University of Louvain. The mean age of the patients was 48.765 years. The overall operative mortality was 6.1%. The mean age of the patients who died was 52.3 years and all but four were in New York Heart Association (NYHA) Functional Class III or IV. The actuarial survival rate is 78% at 5 years after operation, 72% at 10 years, and 70% at 13 years. The overall incidence of thromboembolic complications is 3.4% per patient-year with a total follow-up of 1,675 patient-years. Valve dysfunction has never occurred, and endocarditis, hemolysis, and paravalvular leakage have never reached a significant incidence. Hemodynamics investigations show a residual diastolic gradient of 6.6 mm Hg for the size 3M valves and 7.92 mm Hg for the size 2M valves. These current data over an extended follow-up interval (15 years) indicate that the Starr-Edwards Model 6120 prosthesis continues to perform satisfactorily in terms of mortality and morbidity, and there have been no instance of late failure due to valve dysfunction.