St. Jude Medical valve replacement. An evaluation of valve performance.

St. Jude Medical cardiac valve replacement was performed in 791 patients: 335 had aortic, 330 mitral, and 126 had multiple valve replacements. Follow-up extended from 4 to 64 months (mean 34 months) with a cumulative postoperative survival of 2,111 patient-years. The overall actuarial survival rate at 5 years was 76% +/- 3%. Late valve-related mortality occurred in 28 patients (1.33%/pt-yr) and was most often caused by anticoagulant-related hemorrhage. The linearized incidences of valve failure, thromboembolism, thrombotic obstruction, prosthetic valve endocarditis, periprosthetic leak, and all valve-related complications were as follows: 1.80% /pt-yr, 2.45% /pt-yr, 0.52% /pt-yr, 0.33% /pt-yr, 0.14% /pt-yr, and 4.0% /pt-yr, respectively. Actuarially, 94% +/- 2% of patients were free of valve-related mortality at 5 years; the corresponding figures for valve failure, thromboembolism, thrombotic obstruction, and all valve-related complications were 91% +/- 2%, 89% +/- 2%, 96% +/- 1%, and 83% +/- 3%, respectively. Prosthetic valve endocarditis was uniformly fatal, and 45% of patients with thrombotic obstruction died. The greater incidence of thrombotic obstruction after mitral valve replacement was statistically significant. The performance of the St. Jude Medical valve compares most favorably with other substitute valves. Nevertheless, it retains all the imperfections and hazards of other mechanical valves, most notably, thromboembolism and thrombotic obstruction.