title: Clinical experience with the Carpentier-Edwards supra-annular porcine bioprosthesis implanted in the aortic position.
abstract: OBJECTIVE
  Between 1st January 1988 and 30th June 1996, a total of 165 patients (115 males, 50 females; mean age 66.8 years) underwent isolated aortic valve replacement with Carpentier-Edwards supra-annular porcine bioprostheses in our unit. Our clinical experience with this device is reported.
  
  
  METHODS
  In this retrospective study, mortality and complications observed in these patients were analyzed. Complications appearing with a non-biased time-course were expressed by means of linearized rates. Actuarial analysis was performed using the Kaplan-Meier method.
  
  
  RESULTS
  Cumulative follow up was 551.2 patient-years, with a mean follow up of 3.5 years per patient. The hospital mortality rate was 6.7%. Linearized rates (events per 100 patient-years) and actuarial probabilities of freedom from the different complications at 8.5 years follow up, respectively, were: late mortality, 4.5 and 58.6%; valve-related mortality, 1.1 and 82.6%; thromboembolism, 1.3 and 92.7%; prosthetic endocarditis, 0.5 and 97.4%; non-structural dysfunction, 0.5 and 94.7%; structural deterioration, 0.5 and 91.6%; reoperation, 0.5 and 94.2%. Actuarial freedom from any valve-related mortality or morbidity at 8.5 years was estimated at 66.3%.
  
  
  CONCLUSIONS
  The Carpentier-Edwards supra-annular bioprosthesis, when implanted in the aortic position, presents a low rate of valve-related complications at this length of follow up. However, the limited life expectancy of our patients undergoing aortic valve replacement with bioprostheses (usually elderly subjects) may overshadow the potential good performance of this device.
authors.affiliation: Department of Cardiac Surgery, Hospital General Universitario de Alicante, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Hurle
authors.forename: J
authors.initials: J
authors.lastname: Meseguer
authors.forename: P
authors.initials: P
authors.lastname: Llamas
authors.forename: J A
authors.initials: JA
authors.lastname: Casillas
mesh_terms: D000368:Aged; D000818:Animals; D001021:Aortic Valve; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis / Q000009:adverse effects / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000706:statistics & numerical data; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D015996:Survival Rate; D013552:Swine; D013997:Time Factors