Strut fracture of Björk-Shiley convexo-concave valve in Japan--risk of small valve size--.

BACKGROUND The Björk-Shiley convexo-concave (BSCC) prosthetic valve was introduced in 1979. Between 1979 and 1986, approximately 86,000 BSCC valves were implanted. By December 31, 1994, 564 complete strut fractures had been reported to the manufacture. We experienced a case of an outlet strut fracture and investigated the risk of BSCC prosthetic valve fractures in Japan. METHODS AND RESULTS To investigate the risk factor of a strut fracture in Japan, we investigated published cases of strut fractures. Between 1979 and 1986, 2021 BSCC valves were implanted in Japan. By January 31, 2000, 11 complete strut fractures of 60-degree BSCC valves including our case had occurred. The patients were eight males and three females. The average age at valve replacement was 42.4+/-8.1 years, and nine of eleven (81.8%) were patients < 50 years-old. The average age of the patients when the BSCC valve fractured was 47.7+/-6.4 years, and eight of eleven (72.7%) were patients <= 50 years old. All patients were implanted in the mitral position. The sizes of the BSCC valve were 27 mm (n=5) (45.5%), 29 mm (n=3) (27.2%), and 31 mm (n=3) (27.2%). Four patients died and seven patients survived. CONCLUSIONS Although only 11 BSCC valve struts fractured and statistical analysis could not be performed, our findings suggest that the high risk group for a strut fracture in Japan is young male patients with a mitral valve, >= 27 mm in size with BSCC models manufactured before March 1982. When following-up patients with BSCC models manufactured before March 1982, the possibility of a strut fracture in all BSCC valve sizes should be kept in mind.