Fifteen-year experience with the Medtronic-Hall valve prosthesis - A follow-up study of 1104 consecutive patients

Background The Medtronic-Hall valvular prosthesis was used for the first time in Oslo, Norway, in June 1977. During the 10-year period from 1977 through 1987, the valve was the valve of choice in Oslo and was implanted in a total of 1104 consecutive patients with mean age of 56 years. There were 816 aortic (AVR), 187 mitral (MVR), and 101 combined mitral and aortic (DVR) valve replacements. Methods and Results We report our 15-year experience with this prosthesis in a total of 1090 patients (98.7% complete followup). The observation time ranged from 7 to 17.8 years (mean, 9.2 years), with cumulative follow-up representing 10 016 patient-years. Actuarial survival, including both early and late deaths, was 46% after AVR, 42% after MVR, and 28% after DVR. Thromboembolism occurred at linearized rates of 1.8%, 1.9%, and 1.9% per patient-year after AVR, MVR, and DVR, respec tively. There were eight cases of valvular thrombosis, one fatal, resulting in linearized rates of 0.05%, 0.19%, and 0.13% per patient-year after AVR, MVR, and DVR, respectively. There were no instances of structural valve failure. Morbidity from anticoagulant-related hemorrhage was 1.19% per patient-year, with seven fatal events, all of cerebral origin. Conclusions Excellent long-term outcomes were confirmed for patients, with 80% of survivors in New York Heart Association class I or II.