title: Performance at 10 years of the CarboMedics "Top-Hat" valve. Postclamping time is a predictor of mortality.
abstract: OBJECTIVE
  The CarboMedics "Top-Hat" supraannular prosthesis was designed to permit the implantation of a larger prosthesis. We evaluated the outcome at 10 years in patients with this prosthesis.
  
  
  METHODS
  Between June 1993 and May 2001, 269 patients (average age, 63.9 years) received a CarboMedics "Top-Hat" supraannular aortic prosthesis. Primary valve replacement was performed on 203 patients (75.5%) and repeat valve replacement on 66 (24.5%). The duration of myocardial ischemia was 70.2+/-31.4 min, cardiopulmonary bypass 96.1+/-48.3 min, and postclamping time (time between release of aortic clamp and the end of extracorporeal circulation) 22.1+/-41.3 min. The mean follow-up was 82.3+/-17.8 months. Follow-up was 97.6% complete.
  
  
  RESULTS
  The hospital mortality was 5.9%. It was 1% when the duration of postclamping time was <15 min, 2.8% between 15 and 29 min, 13.2% between 30 and 44 min, and 26.9% >44 min. In the multivariate analysis, postclamping time, urgent surgery, and body mass index were statistically significant risk factors for hospital mortality. The late mortality was 17.1%. Cardiac-related mortality showed a linearized rate of 18.1% per 1000 patients-year. The Kaplan-Meier estimates for cardiac-related mortality was 75.0% at 10 years. Postclamping time, aortic valve gradient, age over 70 years, and BMI were statistically significant risk factors for cardiac-related late mortality. The incidence of paravalvular leak in the "Top-Hat" aortic prosthesis was 1.7% per 1000 patients-year.
  
  
  CONCLUSIONS
  Using the CarboMedics supraannular prosthesis allows implantation of a larger prosthesis without increasing valve-related complications. Postclamping time appears as a strong predictor of both hospital mortality and late cardiac-related death.
authors.affiliation: Department of Cardiovascular Surgery, Hospital Universitario Valdecilla, E-39008 Santander, Spain. bernal@humv.es
authors.forename: José M
authors.initials: JM
authors.lastname: Bernal
authors.forename: Javier
authors.initials: J
authors.lastname: Lorca
authors.forename: Dolores
authors.initials: D
authors.lastname: Prieto-Salceda
authors.forename: Ivana
authors.initials: I
authors.lastname: Pulitani
authors.forename: Alejandro
authors.initials: A
authors.lastname: Pontón
authors.forename: Iván
authors.initials: I
authors.lastname: García
authors.forename: José M
authors.initials: JM
authors.lastname: Revuelta
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000473:pathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D015150:Echocardiography, Doppler; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D017052:Hospital Mortality; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011474:Prosthesis Design; D012086:Reoperation; D013997:Time Factors