title: The CarboMedics valve: midterm follow-up with analysis of risk factors.
abstract: BACKGROUND
  This study examined the midterm results with the CarboMedics prosthetic valve.
  
  
  METHODS
  From 1987 through 1991 a total of 569 patients received the CarboMedics prosthesis.
  
  
  RESULTS
  Early mortality was 4.9% and related to emergency operation, presence of diabetes mellitus, coronary artery disease, preoperative New York Heart Association class, duration of cardiopulmonary bypass, and aortic cross-clamp time. Midterm follow-up with respect to mortality was 100% complete. All patients were followed up in the hospital after 1 year. In addition 86% of the patients responded to a questionnaire. Mean follow-up was 3 years (range, 0 to 5.6 years). Cumulative survival at 1 and 4 years was 91.2% +/- 1.2% and 83.7% +/- 1.8%, respectively. Five patients experienced obstructive valve thrombosis (0.3%/patient-year), 16 patients had major thromboembolic events (0.9%/patient-year), and 10 patients had major warfarin-related bleeding (0.6%/patient-year) requiring hospitalization or blood transfusions. Eight patients were reoperated on for paraprosthetic leak (0.4%/patient-year). Prosthetic valve endocarditis developed in 4 patients (0.2%/patient-year). No structural valve failure was observed.
  
  
  CONCLUSIONS
  Midterm follow-up demonstrates that the CarboMedics mechanical prosthesis is reliable and has an acceptable rate of valve-related complications.
authors.affiliation: Department of Cardiothoracic Surgery, Rikshospitalet, University of Oslo, Norway.
authors.forename: A E
authors.initials: AE
authors.lastname: Fiane
authors.forename: K
authors.initials: K
authors.lastname: Saatvedt
authors.forename: J L
authors.initials: JL
authors.lastname: Svennevig
authors.forename: O
authors.initials: O
authors.lastname: Geiran
authors.forename: K
authors.initials: K
authors.lastname: Nordstrand
authors.forename: T
authors.initials: T
authors.lastname: Frøysaker
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D002648:Child; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000503:physiopathology / Q000601:surgery; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery; D012307:Risk Factors; D014261:Tricuspid Valve / Q000601:surgery