Could it happen again? the Björk-Shiley convexo-concave heart valve story.
نویسنده
چکیده
Most readers of “Twenty-Five–Year Experience With the Björk-Shiley Convexoconcave Heart Valve: A Continuing Clinical Concern” in this issue of Circulation have not heard of the valve.1 Many elements of its story parallel those of cerivastatin2,3 and rofecoxib,4 but with a twist: Recalling a heart valve may entail greater risks than leaving a possible “time bomb” in place. The Björk-Shiley story raises many questions about balancing the benefits of drugs and devices with their risks to public safety. For example:
منابع مشابه
Black holes on MR images of the brain of patients with Björk-Shiley heart valves: additional observation in three cases.
We report the cases of three patients with Björk-Shiley convexo-concave heart valves with unusual black holes shown on cerebral MR images. For two patients, these findings were associated with fracture of the Björk-Shiley convexo-concave heart valve, and for the third, with worn surfaces on the heart valve. Susceptibility changes shown by MR imaging suggest the possibility that these black hole...
متن کاملAge thresholds for prophylactic replacement of Björk-Shiley convexo-concave heart valves. A clinical and economic evaluation.
BACKGROUND Björk-Shiley convexo-concave heart valves have an increased risk of mechanical failure. One might consider prophylactic rereplacement as a preventive measure to avert the disastrous consequences of these failures. We investigated the effect that prophylactic rereplacement has on survival of individual patients and on the medical costs. METHODS AND RESULTS Quantitative estimates for...
متن کاملThe 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 ...
متن کاملProphylactic replacement of Bjŏrk-Shiley convexo-concave heart valves: an easy-to-use tool to aid decision-making in individual patients.
OBJECTIVE To develop an easy-to-use tool for decision-making on prophylactic replacement of Björk-Shiley convexo-concave heart valves. DESIGN Decision analysis comparing elective replacement with observation. SETTING Referral centres for patients with artificial heart valves. PATIENTS Quantitative estimates were obtained from a follow up study conducted in The Netherlands, including 2303 ...
متن کاملPsychological distress among recipients of Björk-Shiley convexo-concave valves: the impact of information.
OBJECTIVE To establish whether there is more psychological distress among recipients of Björk-Shiley convexo-concave (BScc) valves than among recipients of other valves not known to fracture. DESIGN Cross sectional study. PATIENTS 137 patients who received either a BScc valve or a Sorin Biomedical spherical valve during a randomised trial between 1982 and 1983 at St Antonius Hospital, Nieuw...
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ورودعنوان ژورنال:
- Circulation
دوره 111 21 شماره
صفحات -
تاریخ انتشار 2005