title: Assessing the benefit of biological valve prostheses: cumulative incidence (actual) vs. Kaplan-Meier (actuarial) analysis.
abstract: OBJECTIVE
  The standard method of analysing structural valve degeneration (SVD) of biological prostheses is the Kaplan-Meier method. In order to assess SVD with regard to competing risks (e.g. death particularly in elderly patients) cumulative incidence (actual analysis) was compared to Kaplan-Meier (actuarial analysis).
  
  
  METHODS
  We retrospectively analysed 257 patients older than 60 years, who underwent mitral valve replacement with different biological prostheses between 1974 and 2000. Reoperation-free survival was determined, both according to Kaplan-Meier and cumulative incidence analysis.
  
  
  RESULTS
  For the total group of patients older than 60 years, the 10- and 15-year freedom from reoperation was 79+/-5 and 55+/-8%, respectively, according to Kaplan-Meier and 90+/-2 and 83+/-3% according to cumulative incidence analysis. For patients older than 65 years of age (n=170), Kaplan-Meier analysis revealed 85+/-7% freedom from reoperation at 10 years vs. 94+/-3% according to cumulative incidence analysis. For those between 60 and 65 years of age (n=87), Kaplan-Meier freedom from reoperation was 76+/-7% at 10 years and 48+/-9% at 15 years vs. 86+/-4 and 75+/-5% according to cumulative incidence analysis.
  
  
  CONCLUSIONS
  Kaplan-Meier analysis overestimates the 10- and 15-year risk of SVD compared to cumulative incidence analysis, thus underestimating the benefit of biological valve replacement. Cumulative incidence analysis may lead to a more complete evaluation of risk and benefit and thus better patient management.
authors.affiliation: German Heart Center Munich, Technical University of Munich, Germany. stefkaempchen@web.de
authors.forename: S
authors.initials: S
authors.lastname: Kaempchen
authors.forename: T
authors.initials: T
authors.lastname: Guenther
authors.forename: M
authors.initials: M
authors.lastname: Toschke
authors.forename: G L
authors.initials: GL
authors.lastname: Grunkemeier
authors.forename: M
authors.initials: M
authors.lastname: Wottke
authors.forename: R
authors.initials: R
authors.lastname: Lange
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001705:Bioprosthesis / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000401:mortality / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000592:standards*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve; D011475:Prosthesis Failure; D012086:Reoperation; D012189:Retrospective Studies; D018570:Risk Assessment; D016019:Survival Analysis