12 YEARS EXPERIENCE WITH THE ST-JUDE MEDICAL VALVE PROSTHESIS

Since July 1978, 1,284 patients have received the St. Jude Medical pro sthesis (425 aortic, 636 mitral, and 223 double aortic-mitral), and th e results in these patients were reviewed according to guidelines of t he Society of Thoracic Surgeons. Follow-up was complete in 98%. Of 80 late deaths, 29% were valve related. The actuarial survival rate, incl uding 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 t he international normalized ratio of the prothrombin time. The lineari zed rate of complication for aortic, mitral, and double valve replacem ent, 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, a nd 0.10; and prosthetic valve endocarditis, 0.21, 0.06, and 0.20. Reop eration was performed in 16 patients. The freedom from reoperation rat e at 12 years was 99.5% and 98.0% for aortic and mitral valve replacem ent, respectively, and it was 99.1% at 11 years for double valve repla cement. Thus, during the 12-year follow-up in patients who received th e 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.