From January 1979 to December 1990, 397 consecutive patients (mean age, 55 +/- 11 years) underwent mitral valve replacement with the St. Jude Medical valve. Associated procedures performed were 174 multiple valve replacements, 24 coronary artery bypass graftings, 25 tricuspid repairs, and 13 left ventricular myectomies. The continuous intravenous administration of heparin was started on the first postoperative day and maintained until effective oral anticoagulation, started on the seventh day, was achieved (INR, 3 to 4.5). Follow-up consisted of 2,402 patient-years (pt-y) (mean, 6.1 +/- 0.2 years) and was 97% complete. The early (30-day) mortality was 3.5%; the 5-year and 10-year actuarial survivals were 86% +/- 4% and 73% +/- 6%, respectively. Survival was less in patients who had been in an advanced preoperative functional class (p = 0.02) and in those who underwent multiple valve replacements (p = 0.05). The 5-year and 10-year survivals in patients who underwent isolated mitral valve replacement and who were in preoperative New York Heart Association functional class II and III, were 90% +/- 5% and 82% +/- 7%, respectively. The early and late mortality and the incidence of deaths resulting from heart failure and sudden deaths were higher in patients who had undergone multiple valve replacements (p = 0.05). In terms of all deaths, 47% (36/77) were valve related (including 12 sudden deaths, 0.50%/pt-y). Thromboembolic complications occurred in 44 patients, and these were broken down as follows: embolism, 1.46%/pt-y, and valve thrombosis, 0.37%/pt-y.(ABSTRACT TRUNCATED AT 250 WORDS)