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J Thorac Cardiovasc Surg 1999;117:766-775
© 1999 Mosby, Inc.

SURGERY FOR ADULT CARDIOVASCULAR DISEASE

WHICH MANUFACTURING CHARACTERISTICS ARE PREDICTORS OF OUTLET STRUT FRACTURE IN LARGE SIXTY-DEGREE BJÖRK-SHILEY CONVEXO-CONCAVE MITRAL VALVES?

Marjon Kallewaard, PhDa, Ale Algra, MD, PhDa, Jo Defauw, MDb, Yolanda van der Graaf, MD, PhDa, for the Björk-Shiley Study Group

From the Julius Center for Patient Oriented Research, Clinical Epidemiology Unit,a Utrecht University Medical School, Utrecht, and Department of Cardiothoracic Surgery, the St Antonius Hospital,b Nieuwegein, The Netherlands.

Members of the Netherlands Björk-Shiley Study Group are listed in the appendix.

Received for publication Feb 24, 1998. Revisions requested May 14, 1998. Revisions received Sept 30, 1998. Accepted for publication Oct 16, 1998. Address for reprints: Yolanda van der Graaf, MD, PhD, Julius Center for Patient Oriented Research, Utrecht University, Medical School, PO Box 85500, 3508 GA Utrecht, The Netherlands.

Background: Identification of predictors of outlet strut fracture is important for recipients of large (>=29 mm) 60-degree Björk-Shiley convexo-concave mitral valves when it comes to decision making on prophylactic explantation. An association between the manufacturing process of Björk-Shiley convexo-concave valves and the risk of fracture has been suggested. Objective: The aim of this study was to determine which items from the manufacturing records, in addition to known risk factors, were predictive of fracture of large 60-degree Björk-Shiley convexo-concave mitral valves.
Methods: All Dutch recipients (n = 2264) of Björk-Shiley convexo-concave valves were followed up until fracture, death, reoperation, or end of the study (July 1, 1996). Information was abstracted from the manufacturing records of large 60-degree Björk-Shiley convexo- concave mitral valves (n = 655) in Dutch recipients and included items that described the manufacturing process and items for which an association with strut fracture had been suggested. Manufacturing records were available for 637 valves (97%), including 25 fractured valves.
Results: Multivariate analysis identified age at implantation (hazard ratio 0.95, 95% confidence interval 0.93-0.97), lot size (<175 valves versus >=175 valves; hazard ratio 6.6, 95% confidence interval 2.2-20.1), number of hook deflection tests performed (0 or 1 versus >=2; hazard ratio 4.7, 95% confidence interval 1.4-16.2), number of disks that were used (1 versus >=2; hazard ratio 5.9, 95% confidence interval 1.9-18.5), and lot fracture percentage (hazard ratio 1.6, 95% confidence interval 1.4-1.8) as independent predictors of fracture. Although the added predictive value of a model with these 5 variables was sizable compared with a model containing age only, it was only slightly better than a model with age, lot size, and lot fracture percentage.
Conclusion: If the serial number of a large 60-degree Björk-Shiley convexo-concave mitral valve is known, manufacturing information can add significantly to the prediction of fracture. Information on lot size and lot fracture percentage should be made available to clinicians for risk assessment of prophylactic explantation.




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