The Björk-Shiley 70 degree convexo-concave prosthesis strut fracture problem (present state of information)

Between June 1980 and June 1983 4028 Björk-Shiley 70 degree convexo-concave prosthetic heart valves were distributed and implanted in Australia, Canada, Europe and South Africa. As of March 1986, a total of 52 outlet strut fractures (1.29%; 70% CL: 1.1%-1.5%) have been reported from 29 implant institutions in 12 countries. The majority (82.7%) occurred in Europe. Intervals between implantation and fracture were 13 days to 45.3 months (mean: 18.4 months; 70% CL: 16.6 months-20.1 months). The mortality rate after strut fracture was 78.7% (70% CL: 72.5%-84.9%). Upon stratification of the fracture by valve sizes and types it becomes evident that 75% (70% CL: 68.8%-81.2%) of all fractures are related to the sizes 29 mm to 33 mm (which virtually represent the same valve size) and predominantly to mitral valves (p less than 0.01). The large valves again have been stratified into two subsets, namely those fabricated from flanges originally machined as Björk-Shiley 60 degree convexo-concave valves (group I) and later produced valves machined initially to 70 degree specifications (group II). In group I the fracture rate was 5.2% (70% CL: 4.2%-6.2%) versus 1.6% (70% CL: 1.1%-2.1%) in group II (p less than 0.01), which identifies the group I 29 mm-33 mm Björk-Shiley 70 degree convexo-concave valves as the highest risk group for strut fracture. The rates are based upon all available information as of March 16, 1986.(ABSTRACT TRUNCATED AT 250 WORDS)