Radiographic detection of single strut leg separations as a putative basis for prophylactic explantation of Björk-Shiley convexo-concave heart valves.

Cineradiography, using higher kVp and two or more specified profiles for each outlet strut leg, was used to evaluate Björk-Shiley convexo-concave (C/C) heart valves with epidemiologically defined > 0.1% per year estimated fracture rates. Among 828 mitral valves, eight radiographs were assessed as definite single leg separations (SLS) and 23 were read as probable SLS. Explantation confirmed SLS in 24 valves; 4 probables were false positives, and 3 patients with probable SLS ratings decided against explantation. Four patients with SLS died, an operative mortality of 14%. Only 23 mitral and 6 aortic valves receiving ratings ranging from apparently normal to suspicious have become available for verification; 1 rated apparently normal was found to have a SLS. Two patients experienced fatal fractures and 1 SLS valve was explanted 3 to 15 months after apparently normal x-ray studies; it cannot be known if a SLS was or was not present at the time of these examinations. As 97% of negatively rated valves remain in situ, the sensitivity of the test is similarly not known. Only 1 SLS has been detected among 136 aortic valves. Uncertainty about test accuracy and SLS progression condition the clinical utility of radiographic SLS detection, particularly with respect to assurance from apparently normal readings. However, radiographic identification of an SLS substantially enhances epidemiologically derived risk categorization as a basis for consideration of prophylactic replacement for the approximately 12,000 valves with a > 0.1% estimated annual fracture risk, currently thought to be implanted in living patients.