The Björk-Shiley Delrin tilting disc heart valve: historical perspective, design and need for scientific analyses after 25 years.

The Björk-Shiley Delrin (BSD) tilting disc heart valve was first used clinically in 1969. It is estimated that up to 24,000 BSD heart valves were implanted between 1969 and 1981, of which 7,000 may still be implanted in patients. The BSD valve provided a low-profile, quiet prosthesis with excellent hemodynamics. There have been only two reports of mechanical failure due to inlet strut fracture. Recent reports of wear of the Delrin disc combined with wear as observed on explanted BSD valves after 17-20 years in patients stimulated the formation of a Scientific Advisory Panel by Shiley to review the status of the BSD heart valve and make recommendations regarding patients living with BSD heart valves. The studies presented in this Supplement of The Journal of Heart Valve Disease summarize some of the scientific investigations conducted by Shiley and those recommended by this Panel. The material reviewed by the Panel included: (i) clinical publications on BSD heart valves; (ii) seventy-three explanted BSD heart valves returned to Shiley over the past 25 years; (iii) BSD valves subjected to accelerated wear tests; (iv) unimplanted BSD heart valves in Shiley's inventory; (v) in vitro studies of static leakage and pulsatile regurgitation of explanted and unimplanted "control' BSD heart valves; (vi) two Christiansen hip prostheses explanted from patients after five and 13 years; (vii) implant data for the BSD heart valve from the Karolinska Hospital, Stockholm, Sweden; and (viii) test reports for studies and analyses conducted by Shiley for the BSD heart valve. This article gives an overview of and introduction to the studies of the BSD heart valve presented in the following papers.