title: Carpentier-Edwards porcine bioprostheses: clinical performance assessed by actual analysis.
abstract: OBJECTIVE
  The clinical performance of porcine bioprostheses for valve replacement has been evaluated for over three decades by actuarial analysis as the standard for reporting time-related results. Actual or cumulative incidence analysis provides a complementary method to determine the manifestations of valve-related complications due primarily to structural valve deterioration. Valve-related mortality and reoperation of porcine bioprostheses for aortic and mitral valve replacement was compared by actuarial and actual methodology.
  
  
  METHODS
  The Carpentier-Edwards porcine bioprostheses were implanted between 1975 and 1995 as 2,237 aortic valve replacements (AVR) and 1,582 mitral valve replacements (MVR). Coronary artery bypass was performed in 36.4% of AVR, and 30.6% of MVR. Fatal valve-related complications occurred in 7.6% of AVR and 11.3% of MVR. The cumulative follow up was 14,810 patient-years (mean 6.6 years) for AVR and 9,718 patient-years (mean 6.1 years) for MVR.
  
  
  RESULTS
  Patient survival, and actuarial and actual freedom from valve-related mortality and valve-related reoperation was reported at 15 years. For AVR, survival in the 61-70 years age group was 30.9%, freedom from valve-related mortality was 79.3% and 86.9% respectively, and freedom from valve-related reoperation 79.0% and 88.1% respectively. For AVR, survival in the >70 years age group was 18.1%, freedom from valve-related mortality 72.8% and 84.9% respectively, and freedom from reoperation 86.3% and 96.1% respectively. For MVR, survival in the 61-70 years age group was 16.1% at 15 years, freedom from valve-related mortality was 59.5% and 79.5% respectively, and freedom from valve-related reoperation 32.6% and 71.0% respectively. For MVR, survival in the >70 years age group was 2.8% at 15 years, valve-related mortality was 26.1% and 82.0% respectively, and freedom from valve-related reoperation 83.4% and 93.3% respectively.
  
  
  CONCLUSIONS
  The actual freedom from valve-related mortality and valve-related reoperation (primarily from structural valve deterioration), provides further evidence to consider porcine bioprostheses for AVR in patients aged >60 years, and for MVR in patients aged >70 years. The freedom from valve-related mortality supports the use of porcine bioprostheses for MVR in patients aged 61-70 years. Patient survival is influenced to the greatest extent by factors other than valve-related mortality.
authors.affiliation: University of British Columbia, Vancouver, Canada.
authors.forename: W R
authors.initials: WR
authors.lastname: Jamieson
authors.forename: R T
authors.initials: RT
authors.lastname: Miyagishima
authors.forename: L H
authors.initials: LH
authors.lastname: Burr
authors.forename: S V
authors.initials: SV
authors.lastname: Lichtenstein
authors.forename: G J
authors.initials: GJ
authors.lastname: Fradet
authors.forename: M T
authors.initials: MT
authors.lastname: Janusz
mesh_terms: D000206:Actuarial Analysis; D000328:Adult; D000367:Age Factors; D000368:Aged; D000818:Animals; D001021:Aortic Valve; D001705:Bioprosthesis; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000401:mortality*; D006801:Humans; D008875:Middle Aged; D008943:Mitral Valve; D012086:Reoperation / Q000706:statistics & numerical data; D016019:Survival Analysis; D013552:Swine; D013997:Time Factors