BACKGROUND AND AIMS OF THE STUDY: The Björk-Shiley Delrin (BSD) disc heart valve was first used clinically in 1969. We estimate that as of January 1996, no more than 7,000 patients may be alive with the BSD valve. METHODS: We reviewed the published reports of clinical experience with the BSD valve in addition to the records regarding BSD valves returned to Shiley Incorporated. Measurements of the maximum radial gap, static leak flow rate and inspection of the Delrin disc for wear were obtained. RESULTS AND CONCLUSIONS: We concluded that clinically important regurgitation, due to disc wear, was rare but may occur. Larger prostheses, in general, showed greater disc wear than smaller sized valves. There were no reports of fracture of the Delrin disc. Two cases of inlet strut fracture were reported. Late disc embolization, in the absence of inlet strut fracture, occurred in two patients following surgical manipulation. Disc wear did not cause abnormal valve opening or closing although increased regurgitation may occur.
BACKGROUND AND AIMS OF THE STUDY: The Björk-Shiley Delrin (BSD) disc heart valve was first used clinically in 1969. We estimate that as of January 1996, no more than 7,000 patients may be alive with the BSD valve. METHODS: We reviewed the published reports of clinical experience with the BSD valve in addition to the records regarding BSD valves returned to Shiley Incorporated. Measurements of the maximum radial gap, static leak flow rate and inspection of the Delrin disc for wear were obtained. RESULTS AND CONCLUSIONS: We concluded that clinically important regurgitation, due to disc wear, was rare but may occur. Larger prostheses, in general, showed greater disc wear than smaller sized valves. There were no reports of fracture of the Delrin disc. Two cases of inlet strut fracture were reported. Late disc embolization, in the absence of inlet strut fracture, occurred in two patients following surgical manipulation. Disc wear did not cause abnormal valve opening or closing although increased regurgitation may occur.