From January 1, 1979 through December 1990, 456 adult patients underwent isolated aortic (AVR) (254) or mitral (MVR) (202) valve replacement with the St. Jude prosthesis at the Medical University of South Carolina. Age ranged from 21 to 84 years (mean: 54 +/- 15 years for AVR; 51 +/- 13 years for MVR). Male sex predominated in the AVR group (66%) and female sex in the MVR group (64%). Ninety-two patients (20%) had associated coronary artery bypass grafting (AVR, 25%; MVR, 14%). There were 17 deaths (3.7%) occurring during the same hospitalization or within 30 days (AVR, 10/254 [3.9%]; MVR, 7/202 [3.5%]). Follow-up is 94.5% complete and ranges from 1.0 to 131 months (mean, 55 +/- 37 months; total, 2,073 patient-years). In the AVR group, 53 late deaths have occurred and actuarial survival is 80% +/- 3% at 5 years and 47% +/- 9% at 10 years. Twenty-one patients have sustained thromboembolic episodes (1.8%/patient-year), and the probability of remaining free of thromboembolism at 10 years is 67% +/- 13%. The mean improvement in New York Heart Association functional class from preoperative to postoperative is 3.1 +/- 0.76 to 1.6 +/- 0.84 (p < 0.0001). In the MVR group, there have been 41 late deaths, and the actuarial survival was 80% +/- 3% at 5 years and 63% +/- 5% at 10 years. Twenty-eight patients have sustained thromboembolic complications (2.9%/patient-year), and the probability of remaining free of thromboembolism at 10 years is 77% +/- 5%.(ABSTRACT TRUNCATED AT 250 WORDS)