Long-term performance of the St. Jude Medical valve: low incidence of thromboembolism and hemorrhagic complications with modest doses of warfarin.
Between January 1980 and April 1986, 204 patients were hospital survivors after aortic, mitral, or double valve replacement with the St. Jude Medical valve. One hundred ninety patients underwent anticoagulation with modest doses of warfarin (Coumadin), with prothrombin times in the range of 1.3 to 1.5 times control. Fourteen patients received aspirin and dipyridamole only. Follow-up ranged from 0.5 to 6.6 years (mean 3.1) and was 99.5% complete. The group was analyzed for occurrence of thromboembolism, hemorrhage, valve thrombosis, endocarditis, perivalvular leak, valve failure, late cardiac death, and all morbidity and mortality combined in linear and actuarial terms over the 7 year period. With this anticoagulation regimen, the linear rate for thromboembolism and hemorrhage was 0.67% and 1.3% patient-year, respectively, and the actuarial event-free incidence at 5 years was 97.4% and 94.4%, respectively. There were no instances of structural valve failure and one instance of valve thrombosis in the mitral position. Eighty-seven percent of patients were alive at 5 years and 76.7% of patients were alive and free of all complications at 5 years. We conclude that the St. Jude Medical valve has a low incidence of thromboembolism, hemorrhagic complications, and valve thrombosis in patients receiving modest doses of warfarin.
D000206:Actuarial Analysis; D000328:Adult; D000368:Aged; D001021:Aortic Valve; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000601:surgery*; D006350:Heart Valve Prosthesis; D006470:Hemorrhage / Q000453:epidemiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve; D011183:Postoperative Complications / Q000453:epidemiology*; D011474:Prosthesis Design; D013923:Thromboembolism / Q000453:epidemiology*; D013997:Time Factors; D014859:Warfarin / Q000627:therapeutic use*
D014859:Warfarin