The Björk-Shiley convexo-concave heart valve experience from the perspective of the supervisory panel.
The 20-year activities of a medical supervisory panel appointed under the terms of a settlement agreement of the Bowling v. Pfizer class action suit involving the Björk-Shiley convexo-concave (BSCC) heart valve are detailed. Of approximately 86,000 valves implanted, catastrophic failure of the valve was reported in 663 patients from 1978 to 2012. In 1994, a 7-member medical panel consisting of cardiologists, cardiovascular surgeons, epidemiologists, and a nontechnical chairman was appointed by the federal court. The panel collected clinical and manufacturing data, supported epidemiologic studies assessing risk factors for valve fracture, and developed guidelines for payment for explanting potentially defective valves in patients. Three sets of guidelines, based on comparisons of estimated risks of valve fracture versus risks of valve replacement surgery, were issued by the panel to help guide patients and their physicians in decisions about explanting valves. In addition, the panel supported research directed at identifying valves at risk for outlet strut fracture. The primary techniques evaluated included analyzing acoustic signals from the valves, imaging valves for potential cracks in the struts, and structural analyses of Björk-Shiley convexo-concave valves, but none proved applicable for large-scale surveillance of the patient population. The panel also became a patient advocate and acted as an intermediary between the manufacturer and the attorneys initiating the legal settlement. The panel's experiences may help inform future strategies for guideline development for other medical devices or procedures involving risk-benefit comparisons.
Department of Medicine, University of Cincinnati Academic Health Center, Cincinnati, Ohio. Electronic address: don@clsvc.com.
Donald C
DC
Harrison
Michel A
MA
Ibrahim
Arthur E
AE
Weyman
Lewis H
LH
Kuller
William J
WJ
Blot
David E
DE
Miller
D020878:Device Removal; D017408:Guidelines as Topic; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D011474:Prosthesis Design; D011475:Prosthesis Failure / Q000639:trends; D012086:Reoperation; D018570:Risk Assessment; D012307:Risk Factors; D013314:Stress, Mechanical