The Starr-Edwards model 6000 valve. A fifteen-year follow-up of the first successful mitral prosthesis

The Starr-Edwards Model 6000 mitral valve was the first successful mitral prosthesis. A fifteen year follow-up of 110 patients undergoing isolated mitral valve replacement with this prosthesis from 1960 to 1966 is presented. There were 22 (20%) operative and 37 (42%) late deaths at a mean of 8.6 years postoperatively. Preoperative variables leading to late death and thromboembolism are analyzed. Seventeen of 25 operative survivors had improvement in their NYHA Functional Class status and eight others remained unchanged an average of 13.1 years after surgery. There are 5000 patients world-wide currently relying on this prosthesis. Despite a high rate of thromboembolism in the past, elective replacement is not recommended except in selected patients.