Discrepancies Between Labeled and Actual Dimensions of Prosthetic Valves and Sizers

A bstract Background and aims : The hemodynamic performance of a mechanical or stented bioprosthetic valve is primarily determined by the diameter of its orifice. Thus, in aortic or mitral valve replacement, assessment of the native annular size and selection of the correspondingly sized prosthetic valve is necessary to achieve maximum hemodynamic performance. The purpose of this study was to determine the actual dimensions of aortic and mitral valve sizers and their corresponding prostheses, and to determine whether they differed from their marked dimensions. Methods : Mechanical and stented bioprosthetic valves and sizers were obtained from the manufacturers (CarboMedics, St. Jude, Medtronic-Hall, Starr-Edwards, Carpentier-Edwards, and Medtronic-Hancock), and the diameters were measured. Results : For the mechanical models, both aortic and mitral sizers were larger than their marked size by 0.5 mm to 1.0 mm. The aortic valves were all smaller than their corresponding sizers, but the relationship of the mitral valves to corresponding sizers varied with the manufacturer. For the bioprosthetic models the aortic and mitral sizers were true to marked size, the aortic valves were close to marked size and the mitral valves were smaller than marked size. Conclusions : These differences make optimal sizing difficult at best, particularly if more than one manufacturers' product is used in an institution. These differences may or may not impact valve performance in an individual surgeon's hands. However, the wide range of variations across prosthetic type and manufacturer obligate the surgeon to be aware of these variances to achieve maximum hemodynamic performance for each patient.