Affiliations: Delft University of Technology, Delft, the Netherlands | Villanova University, Villanova, PA, USA
Note: [] Address for correspondence: B.A.J.M. de Mol, MD, PhD, JD, Academic Medical Center of the University of Amsterdam, Department of Cardiopulmonary Surgery, P.O. Box 22700, 1100 DE Amsterdam, the Netherlands. Tel.: +31 20 566 6088; Fax: +31 20 696 2289 (business); E-mail: [email protected].
Abstract: The Björk-Shiley convexo-concave artificial heart valve has a significant risk of failure which is often fatal. Elective explantation has a mortality of approximately 5%. Follow-up studies provide the basis for clinical decision making whether or not to explant the valve. So far, the contribution of technical, organizational, ethical, and professional considerations to success or failure of any risk control strategy have hardly been considered. A string of six consecutive deaths due to valve failure initiated a systemic rather than an epidemiological analysis of the problem. Systemic failure analysis not only yields sound explanations, but also warrants acceptable solutions on the basis of assembling multidisciplinary knowledge and experience.
