[Ten years experience with the St. Jude Medical valve prosthesis for mitral valve replacement]

During the 10-year period between 1980 and December 1989, isolated mitral valve replacement (MVR) with the St. Jude Medical (SJM) valve prosthesis was performed on 404 patients at our hospital, and a long-term postoperative follow-up was conducted. There were 161 males and 243 females ranged in age from 1 year to 73 years. Early operative mortality was 5.2%. Follow-up period for 383 patients who discharged from the hospital was 1970.7 patient-years. Twenty of these patients died during the follow-up period, and a late mortality rate was 5.2%. During 10 years, thromboembolic event occurred in 8 patients. Four patients had anticoagulant-related bleeding, 4 had paravalvular leak, and 5 underwent re-operations. There was neither structural valve failure nor prosthetic valve endocarditis. Therefore, the actuarial survival rate and the valve-related death-free rate at 10 years were 83.2%, and 96.8%. Of the patients who survived, New York Heart Association class improved significantly (93% in classes II and III preoperatively and 71% in class I postoperatively). Linearized rates for thromboembolism, anticoagulant-related bleeding, and hemolysis were 0.41%, 0.20% and 0.36%/100 patient-years, respectively. The actuarial estimate of incidence free from all complications was 92.0% at 10 years. On the basis of this 10 years' experience, we believe that the SJM valve prosthesis is an excellent mechanical prosthesis for mitral valve replacement, in terms of hemodynamic performance and low thrombogenicity in patients receiving anticoagulants.