12 YEARS EXPERIENCE WITH THE ST-JUDE MEDICAL VALVE PROSTHESIS

Since July 1978, 1,284 patients have received the St. Jude Medical prosthesis (425 aortic, 636 mitral, and 223 double aortic-mitral), and the results in these patients were reviewed according to guidelines of the Society of Thoracic Surgeons. Follow-up was complete in 98%. Of 80 late deaths, 29% were valve related. The actuarial survival rate, including operative deaths, at 12 yeats was 81.7% and 87.1%, respectively, for aortic and mitral valve replacement, and it was 82.6% at 11 years after double valve replacement. All patients were anticoagulated with warfarin to maintain the thrombotest value between 10% and 25%, which is equivalent to between 2.8 and 1.6 times the control according to the international normalized ratio of the prothrombin time. The linearized rate of complication for aortic, mitral, and double valve replacement, respectively (expressed as the percent per patient-year), was as follows: structural deterioration, 0; nonstructural dysfunction, 0.16, 0.30, and 0.20; valve thrombosis, 0.05, 0.09, and 0; thromboembolism, 1.35, 1.63, and 0.79; anticoagulant-related hemorrhage, 0.10, 0.18, and 0.10; and prosthetic valve endocarditis, 0.21, 0.06, and 0.20. Reoperation was performed in 16 patients. The freedom from reoperation rate at 12 years was 99.5% and 98.0% for aortic and mitral valve replacement, respectively, and it was 99.1% at 11 years for double valve replacement. Thus, during the 12-year follow-up in patients who received the St. Jude Medical prosthesis, the valve performed satisfactorily and with an acceptable risk of late complication even though patients were anticoagulated using a lower dose of warfarin.