title: St. Jude Medical cardiac valves in small aortic roots: follow-up to sixteen years.
abstract: 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.
authors.affiliation: Division of Cardiothoracic Surgery, Rhode Island Hospital, Brown University Medical School, Providence, USA.
authors.forename: D
authors.initials: D
authors.lastname: Sawant
authors.forename: A K
authors.initials: AK
authors.lastname: Singh
authors.forename: W C
authors.initials: WC
authors.lastname: Feng
authors.forename: A A
authors.initials: AA
authors.lastname: Bert
authors.forename: F
authors.initials: F
authors.lastname: Rotenberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000473:pathology / Q000601:surgery; D001830:Body Surface Area; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000401:mortality; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome