title: Clinical evaluation of the Omniscience cardiac valve prosthesis. Follow-up of up to 6 years.
abstract: From January 1984 to June 1989, 259 Omniscience valve prostheses were implanted in 225 patients. Of the 225 patients; 143 (63.6%) received mitral, 48 (21.3%) aortic, and 34 (15.1%) double valve replacements. The early mortality rate was 8.9%; 97.6% of the patients were included in this study. These patients represent a cumulative follow-up of 407.9 patient-years, with a mean follow-up of 2.03 +/- 0.1 (standard error) years. The late mortality rate was 4.03% overall, which corresponds to 2.0% +/- 0.7%/pt-yr (SE). The annual rate of valve endocarditis was 1.0% +/- 0.5%/pt-yr (SE). The linearized rate of thromboembolism was 1.2% +/- 0.5%/pt-yr (SE). Anticoagulant-related hemorrhage occurred in 15 patients with an annual rate of 3.7% +/- 0.9%/pt-yr (SE). The linearized rate of valve thrombosis was 0.2% +/- 0.2%/pt-yr (SE). By echocardiography the mean mitral valve opening was 75.9 +/- 3.1 degrees (standard deviation) for 27 patients. During follow-up study, 136 (70.8%) patients were in New York Heart Association class I, 44 (22.9%) were in class II, and 12 (6.3%) were in class III; there were 25 (11.1%) patients in class II, 166 (73.8%) in class III, and 34 (15.1%) in class IV preoperatively. Actuarial freedom from thromboembolism was 94.5% +/- 3.6% (SE); freedom from endocarditis, 97.8% +/- 1.0% (SE); freedom from anticoagulant-related hemorrhage, 91.5% +/- 2.0% (SE); freedom from valve thrombosis 99.1% +/- 0.8% (SE); and freedom from hemolysis 98.5% +/- 1.2% (SE). Actuarial survival at 6 years is 94.0% + 2.3% (SE) overall. In conclusion, the overall rate of valve-related complications with this valve is low.
authors.affiliation: Department of Cardiovascular Surgery, Ankara University, Ibn-i Sina Hospital, Turkey.
authors.forename: H
authors.initials: H
authors.lastname: Akalin
authors.forename: E T
authors.initials: ET
authors.lastname: Corapçioğlu
authors.forename: U
authors.initials: U
authors.lastname: Ozyurda
authors.forename: K
authors.initials: K
authors.lastname: Uçanok
authors.forename: A
authors.initials: A
authors.lastname: Uysalel
authors.forename: B
authors.initials: B
authors.lastname: Kaya
authors.forename: N T
authors.initials: NT
authors.lastname: Eren
authors.forename: C
authors.initials: C
authors.lastname: Erol
mesh_terms: D000206:Actuarial Analysis; D000293:Adolescent; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects; D001021:Aortic Valve / Q000601:surgery; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000401:mortality; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery; D011183:Postoperative Complications; D011475:Prosthesis Failure; D016459:Prosthesis-Related Infections; D013923:Thromboembolism / Q000209:etiology
chemical_list: D000925:Anticoagulants