title: Early and late-phase events after valve replacement with the St. Jude Medical prosthesis in 1200 patients.
abstract: From May 1982 to August 1991, 1200 patients underwent valve replacement with the St. Jude Medical (St. Jude Medical, Inc., St. Paul, Minn.) valve: 615 men (51%) and 585 women, mean age 58 years. Preoperatively, 830 patients (69%) were in functional class III or IV. A total of 611 patients (51%) had the aortic valve replaced, 490 (41%) the mitral valve, 2 (0.2%) the tricuspid valve, and 97 (8%) multiple valves. There were 81 hospital deaths (6.8%). Risk factors included older age (p = 0.0001), female gender (p = 0.02), higher preoperative left ventricular end-diastolic pressure (p = 0.05), previous cardiac operation (p = 0.003), longer aortic crossclamp time (p = 0.0001), and longer cardiopulmonary bypass time (p = 0.0001). Follow-up was 98% complete (3153 patient-years). There were 152 late deaths; 32 (21%) were considered valve-related: six thromboembolism, four valve thrombosis, five anticoagulant-related hemorrhage, eight prosthetic valve endocarditis, one paravalvular leak, and seven sudden death. The 5-year actuarial survival was 75%. Risk factors for late death included older age (p = 0.03), lower preoperative ejection fraction (p = 0.005), longer aortic crossclamp time (p = 0.001), longer cardiopulmonary bypass time (p = 0.0001), previous cardiac operation (p = 0.02), and higher preoperative functional class (p = 0.0001). Actuarial freedom at 5 years from major thromboembolic events and anticoagulant-related hemorrhage was 97% and 95%, respectively. This value for valve thrombosis was 99%, for reoperation 96%, for prosthetic valve endocarditis 98%, and for paravalvular leak 96%. Actuarial freedom from all valve-related events and valve-related death at 5 years was 74% and 94%, respectively. We conclude that the low incidence of valve-related events and low mortality supports the continued use of the St. Jude Medical valve.
authors.affiliation: Deborah Heart and Lung Center, Department of Thoracic and Cardiovascular Surgery, Browns Mills, NJ 08015.
authors.forename: J
authors.initials: J
authors.lastname: Fernandez
authors.forename: G W
authors.initials: GW
authors.lastname: Laub
authors.forename: M S
authors.initials: MS
authors.lastname: Adkins
authors.forename: W A
authors.initials: WA
authors.lastname: Anderson
authors.forename: C
authors.initials: C
authors.lastname: Chen
authors.forename: B M
authors.initials: BM
authors.lastname: Bailey
authors.forename: L M
authors.initials: LM
authors.lastname: Nealon
authors.forename: L B
authors.initials: LB
authors.lastname: McGrath
mesh_terms: D000206:Actuarial Analysis; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000009:adverse effects* / Q000401:mortality / Q000706:statistics & numerical data; D006470:Hemorrhage / Q000209:etiology; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation / Q000706:statistics & numerical data; D012307:Risk Factors; D016019:Survival Analysis; D013923:Thromboembolism / Q000209:etiology*
chemical_list: D000925:Anticoagulants