title: CarboMedics and Monostrut valves: clinical and hemodynamic outcomes in a randomized study.
abstract: OBJECTIVE
  Our aim was to compare the CarboMedics (CM) and Monostrut (M) mechanical heart valve prostheses in the aortic position. These prostheses have been studied extensively in the past, both have well-defined characteristics, and have not been modified for many years.
  
  
  METHODS
  This randomized, prospective study included 200 consecutive patients; 100 received the CM prosthesis and 100 the M prosthesis. Both groups were statistically similar in terms of age, aortic valve lesion, and preoperative clinical and surgical characteristics. Mean follow up was 5.58 years (range: 2 months to 11 years); total follow up was 1095 patient-years (pt-yr) (CM 5.33 years, 528 pt-yr; M 5.85 years, 567 pt-yr).
  
  
  RESULTS
  Early mortality rates were 1% in the CM group and 3% in the M group. Late mortality rates were 7% and 9%, respectively. Mean (+/- SD) survival rates at 11 years were 80.51 +/- 7.36% for the CM group and 79.62 +/- 5.59% for the M group. There were no cases of mechanical valve failure in either group. The linearized rates of major thromboembolism were 1.03% and 0.20% per pt-yr for the CM and M groups, respectively; the rates of major bleeding-events were 0.71% and 0.61% per pt-yr, respectively. The rate of paravalvular leak was 0.35% and 0% per pt-yr in the CM and M groups, respectively. Postoperative NYHA class was I-II in 95.83% of CM patients, and in 94.37% of M patients.
  
  
  CONCLUSIONS
  Clinical results with CarboMedics and Monostrut prostheses are highly satisfactory, but no superiority of one valve over the other can be identified.
authors.affiliation: Department of Cardiac Surgery, Hospital de Navarra, Pamplona, Spain.
authors.forename: A
authors.initials: A
authors.lastname: de la Fuente
authors.forename: R
authors.initials: R
authors.lastname: Sanchez
authors.forename: J
authors.initials: J
authors.lastname: Romero
authors.forename: J
authors.initials: J
authors.lastname: Berjon
authors.forename: M A
authors.initials: MA
authors.lastname: Imizcoz
authors.forename: J L
authors.initials: JL
authors.lastname: Fernandez
authors.forename: I
authors.initials: I
authors.lastname: Moriones
mesh_terms: D000328:Adult; D000368:Aged; D001022:Aortic Valve Insufficiency / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006439:Hemodynamics / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000401:mortality / Q000503:physiopathology* / Q000601:surgery; D011446:Prospective Studies; D011474:Prosthesis Design; D012086:Reoperation; D015996:Survival Rate; D016896:Treatment Outcome