From March 1978-86, 590 St. Jude prostheses (232 aortic, 232 mitral, and 63 double aortic-mitral) were implanted in 527 patients (mean age 63 years) and followed for up to 8 years (mean 33 months; three lost; 99% complete). The early (30-day) mortality rate was 8.9% and was strongly associated with preoperatively depressed left ventricular function (ejection fraction less than 0.55), ischemic mitral regurgitation, and advanced functional class (IV) (p less than 0.05). Actuarial survival rates at 5 years were 72% +/- 4%, 72% +/- 8%, and 63 +/- 4% after aortic, double, and mitral valve replacement (p less than 0.01). There have been no structural failures. Embolism (28 events, 2.1%/patient-year) was less common with warfarin treatment (1.5%/patient-year; n = 492) than with antiplatelet (3.2%/patient-year; n = 19) or no drug therapy (18.9%/patient-year; n = 16) (p less than 0.01). One embolic event was fatal (3.6%). Warfarin-treated patients remained 91% +/- 1% free of emboli after 8 years. Valve thrombosis (six events; 0.4%/patient-year) occurred exclusively in patients not treated with effective warfarin therapy; one (17%) died. The most common complication was hemorrhage (39 events; 2.9%/patient-year); nine (23%) were fatal, and these constituted 82% of 11 valve-related late deaths. In warfarin-treated patients (target prothrombin time ratio 1.5 to 2.5), hemorrhage was twice as frequent (2.9%/patient-year) as embolism (1.5%/patient-year).(ABSTRACT TRUNCATED AT 250 WORDS)