St. Jude Medical cardiac valves in small aortic roots: follow-up to sixteen years.

Prosthetic aortic valve replacement in the small aortic root raises concerns of its long-term effects. Between 1978 and 1994, 270 patients received only small aortic prostheses (< or = 21 mm). There were 117 men (43.3%) and 153 women (56.7%) with a mean age of 64.3 +/- 11.6 years (range 19 to 87 years). The body surface areas ranged from 1.2 to 2.26 m2 (mean 1.71 +/- 0.27 m2). Ninety-one percent of patients had New York Heart Association class III or IV symptoms and 33% underwent concomitant coronary artery bypass grafting. The operative mortality rate was 3.3% (9 deaths) and follow-up (100%) extended from 1 to 16 years (mean 6.2 +/- 3.9 years) with cumulative survival of 1676 patient-years. There were 55 late deaths (3.28% per patient-year). The linearized rates of morbidity reported as percent per patient-year were as follows: structural failure, 0%; paravalvular leak, 0.12%; prosthetic endocarditis, 0.24%; anticoagulant-related morbidity, 1.24%; and thromboembolism, 1.10%. In 89% of the survivors New York Heart Association functional performance had improved to class II or I. The actuarial survival with 95% confidence intervals at 5, 10, and 16 years was 86.9% (82.5%, 91.3%), 68.6% (60.6%, 76.6%), and 53.6% (36.6%, 70.6%), respectively. Freedom from late valve-related events (95% confidence intervals) at 10 and 16 years was as follows: thromboembolism, 91.2% (86.6%, 95.8%) and 78.3% (62.6%, 94%); anticoagulant-related morbidity, 89.1% (83.8%, 94.4%) and 81.0% (65.1%, 96.9%); and prosthetic endocarditis, 98.8% (97.5%, 100%) and 98.8% (97.5%, 100%), respectively. Multivariate analysis revealed age at operation, myocardial infarction, and endocarditis affected the long-term survival. The risk of sudden death irrespective of body surface area and valve size was not statistically different. Thus the long-term performance of the St. Jude Medical valve in small aortic roots is satisfactory.