title: Hemodynamic stability during 17 years of the Carpentier-Edwards aortic pericardial bioprosthesis.
abstract: BACKGROUND
  Long-term stability of the hemodynamic performance of commercially available Carpentier-Edwards stented bovine pericardial aortic bioprostheses (Perimount RSR) is unknown. To anticipate the fate of this bioprosthesis, we examined its hemodynamic performance up to 17 years using echocardiographic studies in a Premarket Approval cohort.
  
  
  METHODS
  Of 267 patients at four institutions in the Premarket Approval cohort, 85 had a total of 168 echocardiographic studies during a 17-year period of yearly follow-up examinations. These were reviewed and quantified in a core echocardiographic facility. Longitudinal data analysis was used to account for repeated, censored data.
  
  
  RESULTS
  Mean transvalvular gradient was inversely related to prosthesis size (p = 0.01), and possibly (p = 0.06) increased somewhat during the first 10 years of follow-up, then stabilized. Effective orifice area was larger in larger valve sizes (p = 0.01), declined somewhat during the first 10 years, and then began to increase again. Ejection fraction declined minimally (p = 0.2). In contrast to the rather stable hemodynamics, aortic regurgitation steadily increased from none to 1 to 2+ (p = 0.005), but rarely (< 10% at 17 years) progressed to 3+ or 4+.
  
  
  CONCLUSIONS
  The Carpentier-Edwards aortic pericardial bioprosthesis can be anticipated to have an acceptable long-term transvalvular gradient and effective orifice size that will change trivially up to 17 years after implantation. Mild aortic regurgitation will develop progressively. This anticipated hemodynamic resilience supports continued clinical use of the Perimount Carpentier-Edwards bovine pericardial stented bioprosthesis.
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Ohio 44195, USA. banburm@ccf.org
authors.forename: Michael K
authors.initials: MK
authors.lastname: Banbury
authors.forename: Delos M
authors.initials: DM
authors.lastname: Cosgrove
authors.forename: James D
authors.initials: JD
authors.lastname: Thomas
authors.forename: Eugene H
authors.initials: EH
authors.lastname: Blackstone
authors.forename: Jeevanantham
authors.initials: J
authors.lastname: Rajeswaran
authors.forename: J Edward
authors.initials: JE
authors.lastname: Okies
authors.forename: Robert M
authors.initials: RM
authors.lastname: Frater
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D015331:Cohort Studies; D018795:Device Approval; D004452:Echocardiography; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006439:Hemodynamics / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged