LONG-TERM RESULTS OF VALVE-REPLACEMENT WITH THE ST-JUDE MEDICAL PROSTHESIS

To assess with truly long follow-up the long-term results of valve rep lacement with the St. Jude Medical prosthesis (St. Jude Medical, Inc., St. Paul, Minn.), we reviewed the case histories of the first 1112 pa tients undergoing 1244 valve replacements with this valve between June 12, 1978, and June 12, 1987: 62% male (62%) and 422 female patients, mean age 56 years. A total of 773 patients (69%) had the aortic valve replaced, 207 (19%) the mitral valve, and 132 (12%) the aortic and mit ral valves. There were 42 hospital deaths (3.8%). Follow-up was 97.5% complete (8988 patient-years). There were 213 late deaths. Ninety-one (43%) were considered valve-related: sudden death, n = 27; anticoagula nt-related hemorrhage, n = 22; thromboembolism, n = 19; prosthetic val ve endocarditis, n = 13; valve thrombosis, n = 9; and noninfectious pe rivalvular leak, n = 1. Overall actuarial survival, including hospital mortality, was 68% +/- 6% (95% confidence limits) 14 years after the operation. Linearized rates of late valve-related events were as follo ws: thromboembolism, 1.09% per patient-year; anticoagulant-related hem orrhage, 0.94% per patient-year; prosthetic valve endocarditis, 0.32% per patient-year; valve thrombosis, 0.33% per patient-year; and periva lvular leak, 0.19% per patient-year. Actuarial freedom, at 13 years, f rom thromboembolism was 89% +/- 3%, anticoagulant-related hemorrhage 8 3% +/- 8%, valve thrombosis 97% +/- 1%, and reoperation 95% +/- 3%. Ac tuarial freedom from all valve-related deaths and valve-related morbid ity and mortality, at 14 years, was 84% +/- 6% and 61% +/- 8%, respect ively. We conclude that, because of its low: thrombogenicity, low inci dence of valve-related events, and low valve-related mortality, the St , Jude Medical valve is one of the best performing mechanical prosthes is currently available. Nevertheless, the late valve-related complicat ions and deaths illustrate that the quest for a ''perfect'' prosthesis remains unfulfilled.