BACKGROUND: The outlet struts of Björk-Shiley convexo-concave heart valves can occasionally fracture. By December 31, 1994, 564 complete strut fractures had been reported to the manufacturer, approximately two thirds of which were fatal. There are no reliable diagnostic methods to detect valves that may be at risk for strut fracture. The outlet strut has two legs, and one leg often appears to break before the other, potentially permitting detection of the single-leg separation while the valve is still functionally intact. METHODS: We used high-resolution cineradiography and defined valve profiles to evaluate 315 patients selected on the basis of their having mitral convexo-concave valves with an estimated fracture rate of 0.46 percent or higher per year. Two examinations were scheduled six months apart, with early reimaging performed when initial ratings were indeterminate. RESULTS: Three patients had unsatisfactory studies, the most recent examinations in 277 patients were rated as apparently normal, 23 had findings considered minimally suspicious, and 1 had findings termed suspicious. The number of false negative results in this study group is unknown. Eleven cineradiograms were rated as showing probable or definite single-leg separations. All five "definite" ratings and five of the six "probable" ratings were confirmed by removal of the valves. One valve with a "probable" rating was intact. Two complete outlet-strut fractures occurred three and seven months after apparently normal radiographic examinations. Unsuspected new positive findings were not found at six months among 288 patients who completed the examination cycle. CONCLUSIONS: Cineradiographic imaging can detect some single-leg separations in mitral convexo-concave valves and may help the estimated 41,000 patients with these valves worldwide and their physicians decide about elective valve removal.
BACKGROUND: The outlet struts of Björk-Shiley convexo-concave heart valves can occasionally fracture. By December 31, 1994, 564 complete strut fractures had been reported to the manufacturer, approximately two thirds of which were fatal. There are no reliable diagnostic methods to detect valves that may be at risk for strut fracture. The outlet strut has two legs, and one leg often appears to break before the other, potentially permitting detection of the single-leg separation while the valve is still functionally intact. METHODS: We used high-resolution cineradiography and defined valve profiles to evaluate 315 patients selected on the basis of their having mitral convexo-concave valves with an estimated fracture rate of 0.46 percent or higher per year. Two examinations were scheduled six months apart, with early reimaging performed when initial ratings were indeterminate. RESULTS: Three patients had unsatisfactory studies, the most recent examinations in 277 patients were rated as apparently normal, 23 had findings considered minimally suspicious, and 1 had findings termed suspicious. The number of false negative results in this study group is unknown. Eleven cineradiograms were rated as showing probable or definite single-leg separations. All five "definite" ratings and five of the six "probable" ratings were confirmed by removal of the valves. One valve with a "probable" rating was intact. Two complete outlet-strut fractures occurred three and seven months after apparently normal radiographic examinations. Unsuspected new positive findings were not found at six months among 288 patients who completed the examination cycle. CONCLUSIONS: Cineradiographic imaging can detect some single-leg separations in mitral convexo-concave valves and may help the estimated 41,000 patients with these valves worldwide and their physicians decide about elective valve removal.