Table 1

Relative risk of outlet strut fracture (OSF) in Björk-Shiley convexo concave heart valves for demographic and manufacturing characteristics based on univariate Cox models

Variable n OSF/n at risk Relative risk 95% CI p Value
Age at implantation (years)
 < 50 (baseline)30/10271.0< 0.001
 50–5921/11070.70.4 to 1.2
 ⩾ 605/11600.20.1 to 0.4
Sex0.27
 Male (baseline)27/14111.0
 Female29/18820.70.4 to 1.3
 Missing data0/1
Valve characteristics
 Valve size (mm)< 0.001
 ⩽ 21 (baseline)1/3561.0
 237/4525.30.6 to 42.9
 251/4680.80.1 to 12.0
 276/5064.10.5 to 34.4
 2914/7007.31.0 to 55.3
 3122/69712.31.7 to 91.4
 335/11220.22.4 to 173.1
 Missing data0/3
Valve position0.001
 Aortic (baseline)13/14611.0
 Mitral43/18272.81.5 to 5.3
 Tricuspid0/6
Manufacturing period1-150 < 0.001
 Before 1981 (baseline)4/7571.0
 1981–198452/23654.81.7 to 14.3
 Missing data0/72
Welder group1-150 < 0.001
 Low risk (baseline)11/10851.0
 Intermediate risk16/5182.91.4 to 6.4
 High risk22/7512.91.4 to 5.9
 Missing data7/8400.80.3 to 2.0
Shop order fracture rate1-150 1-151 56/31941.51.4 to 1.7< 0.001
  • 1-150 Based on 3194 valves with complete serial numbers;

  • 1-151 For continuous variable, the number listed is the number of strut fractures among patients for whom the value of the variable is known.