title: Long-term clinical experience with the Omnicarbon prosthetic valve.
abstract: BACKGROUND
  From February 1985 to December 1994, 781 Omnicarbon valve prostheses were implanted in 647 patients. These were 357 male and 290 female patients with a mean age of 53.5+/-10.5 years (range, 4 to 78 years). Before operation, 81% of the patients were in New York Heart Association class III or IV, 16% were in class II, and only 3% were in class I.
  
  
  METHODS
  There were 227 aortic valve replacements (AVR) (35%), 286 mitral valve replacements (MVR) (44%), and 134 double-valve replacements (DVR) (21%) (AVR + MVR). Follow-up was 96.3% complete and consisted of 2,746 patient-years (mean follow-up, 4.6 years, and maximum follow-up, 10.7 years).
  
  
  RESULTS
  Hospital mortality rates were 7.0% for AVR, 8.0% for MVR, and 8.2% for DVR. The annualized rate of anticoagulant-related hemorrhage was 0.8% per patient-year, and thromboembolism occurred at a rate of 0.7% per patient-year. No structural failure was observed during 10-year follow-up. Twenty-one instances of nonstructural dysfunction (two, pannus growth, and 19, dehiscence) of the Omnicarbon valve occurred in 20 patients, an incidence of 0.8% per patient-year. Hemolytic anemia was observed only in the presence of valvular dehiscence (6 of 19). Eight patients (0.3% per patient-year) had development of prosthetic valve endocarditis (4, AVR; 2, MVR; and 2 DVR). At the end of 10 years of follow-up, 91% of the survivors were in New York Heart Association class I or II. The overall survival rate at 10 years was 82.5%+/-2.6% (85.0%+/-3.9%, AVR; 81.0%+/-4.1%, MVR; and 82.5%+/-2.6%, DVR). Considering only valve-related deaths, the survival rate at 10 years was 91.9%+/-2.4% (90.0%+/-2.7%, AVR; 93.1%+/-3.8%, MVR; and 90.0%+/-1.8%, DVR).
  
  
  CONCLUSIONS
  Clinical results over a 10-year follow-up are excellent with the Omnicarbon prosthesis.
authors.affiliation: Servicio de Cirugía Cardiovascular, Hospital Universitario La Fé, Valencia, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Torregrosa
authors.forename: J
authors.initials: J
authors.lastname: Gómez-Plana
authors.forename: F J
authors.initials: FJ
authors.lastname: Valera
authors.forename: J
authors.initials: J
authors.lastname: Caffarena
authors.forename: J M
authors.initials: JM
authors.lastname: Maroñas
authors.forename: F
authors.initials: F
authors.lastname: García-Sánchez
authors.forename: J
authors.initials: J
authors.lastname: Peris
authors.forename: R
authors.initials: R
authors.lastname: Frías
authors.forename: J M
authors.initials: JM
authors.lastname: Caffarena
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000743:Anemia, Hemolytic / Q000209:etiology; D000925:Anticoagulants / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004696:Endocarditis / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D019106:Postoperative Hemorrhage / Q000139:chemically induced; D011475:Prosthesis Failure; D012086:Reoperation; D015996:Survival Rate; D013923:Thromboembolism / Q000209:etiology
chemical_list: D000925:Anticoagulants