The St. Jude Medical bileaflet valve prosthesis. A 5 year experience.

A 5 year experience with the bileaflet St. Jude Medical valve is reported. Between March, 1978, and June, 1982, 198 patients received 233 such valves (90 mitral, 73 aortic, and 35 double mitral-aortic valve replacements). Total follow-up was 4,896 patient-months; survivors were followed up for 1 to 5 years (mean 35 months). Early (30 day) mortality was 6.6% overall and 11.1% after mitral, 2.7% after aortic, and 2.9% after double valve replacement. Total late mortality was 15.2%; the actuarial survival rate at 4 years was 67% after mitral, 79% after aortic, and 79% after double valve replacement. Ischemic mitral valve disease was associated with an early mortality of 26.7% and a 4 year survival rate of 34%; without this high-risk subset, early mortality was 3.3% and the 4 year survival rate was 77% after mitral valve replacement. A multivariate logistic regression model identified three preoperative patient characteristics associated with increased postoperative mortality: ischemic mitral valve disease (p less than 0.001), a depressed left ventricular ejection fraction (less than 55%; p less than 0.05), and advanced New York Heart Association class (IV; p less than 0.05). Valve-related complications occurred in 14 patients (3.4% per patient-year). There were no instances of primary structural failure or hemolysis. Thromboembolism (nine patients, 2.2% per patient-year) occurred more frequently after double (3.7% per patient-year) or mitral valve replacement (2.3% per patient-year) than after aortic valve replacement (1.3% per patient-year) and more frequently in 12 patients receiving aspirin and dipyridamole (6.5% per patient-year) than in 173 patients receiving warfarin (1.9% per patient-year). No thromboembolic event was fatal. Reoperation was necessary because of one valve thrombosis, one valve erosion, and two perivalvular leaks due to endocarditis; three of the four patients survived reoperation (one valve-related death, 0.5%). Of 154 patients alive at latest follow-up, 85% were in New York Heart Association Class I or II, and 90% had improved by at least one class. This intermediate experience with the St. Jude Medical valve indicates that, in addition to its previously demonstrated excellent hemodynamic performance, there have been no instances of primary structural failure or hemolysis. Warfarin anticoagulation is recommended in all patients.