A retrospective review of the performance of the St Jude Medical valve prosthesis over a 12-year period was undertaken.Methods and Results.
Between 1978 and 1990, 696 St Jude Medical valve prostheses (351 isolated aortic, 191 isolated mitral, 64 double aortic/mitral) were implanted into 616 patients (mean age, 55 years). Concomitant coronary artery graft surgery was performed in 18%. During mid-1991, follow-up was conducted, yielding a 97% completion (16 lost), for a total of 3075 cumulative patient-years (mean, 5.0 years). Early (30-day) mortality rates were 3.1%, 5.2%, and 6.4% after aortic, mitral, and double valve replacements, respectively. The 5-year actuarial survival rates were 94.1±1.3%, 85.8±2.7%, and 86.3±4.6% and those for 10 years were 89.6±1.9%, 72.9±6.1%, and 83.0±5.4%, respectively. There were no structural valve failures. Anticoagulant-related hemorrhage was the most common valve-related complication (28 events, 0.9% per patient-year), with three being fatal. Thromboembolism (13 events) occurred at a rate of 0.5% per patient-year (0.6% aortic, 0.3% mitral, 0.3% double). All of the nonstructural deteriorations (10 events, 0.3% per patient-year) were paravalvular leaks, including 3 aortic valve replacements in patients who developed hemolytic anemia. There was 1 valve thrombosis (0.03% per patient-year). Patients undergoing coronary artery graft surgery had lower survival and higher complication rates than patients without coronary artery graft surgery. There was a significant improvement (P<.001) in New York Heart Association functional class for the entire patient population.Conclusions.
The St Jude Medical valve prosthesis has performed well in all positions over a 12-year period, with an acceptably low incidence of valve-related complications. (Circulation.1993;88[part 2]:49–54.)