title: Long term follow up of 292 patients after valve replacement with the Omnicarbon prosthetic valve.
abstract: In a prospective study, 292 consecutive patients received 336 Omnicarbon cardiac valves from September 1984 through September 1992 at the Montpellier University Hospital. There were 153 aortic (52%), 95 mitral (33%) and 44 double (15%) mitral and aortic replacements. Mean age was 58 years; 57% were male. Total follow up was 1,383 patient-years, with a maximum of nine and a mean of 4.87 years. Early mortality was 2.75% overall. Late mortality occurred at a rate of 1.9%/patient-year. Nine-year probability of freedom from mortality (including early mortality) was 85.0% +/- 2.6% overall. There were no cases of structural failure. Thromboembolic events occurred in nine patients, producing a linearized rate of 0.7%/patient-year. Hemorrhage associated with anticoagulant therapy occurred at a rate of 0.8%/patient-year. Therefore, the combined rate of thromboembolic/hemorrhagic events was 1.5%/patient-year. Cumulative overall freedom from thromboembolism and hemorrhage was 91.5% +/- 1.9% at nine years; it was 86.2% +/- 4.3% after mitral and 95.1% +/- 2.0% after aortic valve replacement. Hemolytic anemia was not observed. Endocarditis occurred eight times (0.6%/patient-year), and there were seven cases of perivalvular lead (0.5%/patient-year). At the end of the follow up, 86% of the patients were in NYHA class I. It is concluded that clinical results over a nine-year period are excellent with the Omnicarbon prosthesis.
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, University Hospital, Montpellier, France.
authors.forename: A
authors.initials: A
authors.lastname: Thevenet
authors.forename: B
authors.initials: B
authors.lastname: Albat
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000401:mortality / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000295:instrumentation*; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control; D012086:Reoperation; D012189:Retrospective Studies; D015996:Survival Rate; D013923:Thromboembolism / Q000517:prevention & control
chemical_list: D000925:Anticoagulants