Single-leg strut fractures in explanted Björk-Shiley valves. 1994

B A de Mol, and M Kallewaard, and R B McLellan, and L A van Herwerden, and J J Defauw, and Y van der Graaf
Safety Science Group, Delft University of Technology and Cardiopulmonary Surgical Center of Amsterdam, Netherlands.

A retrospective follow-up study in the Netherlands on the risk of fracture of Björk-Shiley convexo-concave valves concluded that prophylactic replacement is advisable for certain groups of patients. We have examined valves explanted from twenty-two patients because they met epidemiological criteria for reoperation, with or without the presence of moderate cardiac impairment, or because there were other cardiac complaints not related to the valve. No information was available before explanation to suggest a valve defect. All patients survived their operations. Of the twenty-four valves, seven (29% [95% CI 13-52]) had fracture of one of the legs of the outlet strut (single-leg strut fracture [SLF]). Two other valves had features that suggested fatigue defects. As in the previous study, 70 degrees valves had the highest risk of SLF (five of sixteen, two aortic and three mitral). However, two of eight 60 degrees valves (both aortic) also had SLF. Current hazard calculations and explanation recommendations may need to be revised. Since several of the defective valves were welded by the same person, knowledge of manufacturing details may help in estimation of fracture risk for an individual patient.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D004867 Equipment Design Methods and patterns of fabricating machines and related hardware. Design, Equipment,Device Design,Medical Device Design,Design, Medical Device,Designs, Medical Device,Device Design, Medical,Device Designs, Medical,Medical Device Designs,Design, Device,Designs, Device,Designs, Equipment,Device Designs,Equipment Designs
D004868 Equipment Failure Failure of equipment to perform to standard. The failure may be due to defects or improper use. Defects, Equipment,Device Failure,Failure, Equipment,Malfunction, Equipment,Medical Device Failure,Misuse, Equipment,Device Failure, Medical,Device Failures, Medical,Failure, Medical Device,Failures, Medical Device,Defect, Equipment,Device Failures,Equipment Defect,Equipment Defects,Equipment Failures,Equipment Malfunction,Equipment Malfunctions,Equipment Misuse,Equipment Misuses,Failure, Device,Failures, Device,Failures, Equipment,Malfunctions, Equipment,Misuses, Equipment
D005260 Female Females
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006350 Heart Valve Prosthesis A device that substitutes for a heart valve. It may be composed of biological material (BIOPROSTHESIS) and/or synthetic material. Prosthesis, Heart Valve,Cardiac Valve Prosthesis,Cardiac Valve Prostheses,Heart Valve Prostheses,Prostheses, Cardiac Valve,Prostheses, Heart Valve,Prosthesis, Cardiac Valve,Valve Prostheses, Cardiac,Valve Prostheses, Heart,Valve Prosthesis, Cardiac,Valve Prosthesis, Heart
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly

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