From January 1, 1980, through December 31, 1985, 473 patients underwent valve replacement with an Ionescu-Shiley valve. Overall hospital mortality was 7.8%. Major associated procedures and preoperative New York Heart Association (NYHA) Classes IV and V influenced hospital mortality significantly. The mean follow-up was 2.6 +/- 1.3 years. Late mortality was 5.9%. Overall actuarial survival was 81% at 5 years. A chief cause of reoperation was cusp rupture of a mitral prosthesis in 5 patients (all after aortic and mitral valve replacement). The overall actuarial reoperation-free incidence was 93% at 5 years. Thromboembolic (TB) phenomena occurred at a linear incidence of 1.4 +/- 0.3% per patient-year or an actuarial thromboembolism-free incidence of 92% at 5 years. Univariate and multivariate analyses showed that postoperative NYHA Class, rhythm at follow-up, and anticoagulant therapy significantly influenced the incidence of TE phenomena.