Strut fracture with Björk-Shiley 70 degrees convexo-concave valve. An international multi-institutional follow-up study.

Between 1980 and 1983, 831 Björk-Shiley 70 degrees convexo-concave prosthetic heart valves were implanted at five institutions in Sweden, Germany. The Netherlands, and Canada. As of January 1991, there were 34 outlet strut fractures occurring from 0.2 to 10.1 years (median = 4.6 years) after implantation. In addition, there were 28 sudden, unexplained deaths. The mortality after strut fracture was 84%. The mortality after emergency valve replacement for strut fracture was 50%. The 10-year actuarial fracture rate (standard error) was 10.5 (2.4)% for large (29-33 mm) valves vs. 3.3 (1.2)% for 21-27 mm valves (P less than 0.001). Within valve size groups, fracture rates for aortic and mitral valves were similar. Cox regression analysis found only valve size to be significantly associated with strut fracture. There is a further subgrouping of the valves according to the manufacturer: group I are the earlier large 29-33 mm) valves; group II are the later large valves; group III are the small size (21-27 mm) valves. The risk of strut fracture was highest in group I (12.3% at 10 years) with an approximatively constant hazard (1.4% per year). A comparison was made with a statistical model incorporating all cases reported to the manufacturer. This model estimates fracture rates approximately 63%-73% of those found in the present study. These findings lead us to recommend that group I patients should be considered for elective reoperation on an individual basis, giving careful attention to risk factors and contraindications.