True external diameter better predicts hemodynamic performance of bioprosthetic aortic valves than the manufacturers' stated size.

BACKGROUND AND AIM OF THE STUDY: Currently, there is no universal standard for sizing bioprosthetic aortic valves. Hence, a standardized comparison was performed to clarify this issue.

METHODS: Every size of four commercially available bioprosthetic aortic valves marketed in the United States (Biocor Supra; Mosaic Ultra; Magna Ease; Mitroflow) was obtained. Subsequently, custom sizers were created that were accurate to 0.0025 mm to represent aortic roots 18 mm through 32 mm, and these were used to measure the external diameter of each valve. Using the effective orifice area (EOA) and transvalvular pressure gradient (TPG) data submitted to the FDA, a comparison was made between the hemodynamic properties of valves with equivalent manufacturer stated sizes and valves with equivalent measured external diameters.

RESULTS: Based on manufacturer size alone, the valves at first seemed to be hemodynamically different from each other, with Mitroflow valves appearing to be hemodynamically superior, having a large EOA and equivalent or superior TPG (p < 0.05). However, Mitroflow valves had a larger measured external diameter than the other valves of a given numerical manufacturer size. Valves with equivalent external diameters were then compared, regardless of the stated manufacturer sizes. For truly equivalently sized valves (i.e., by measured external diameter) there was no clear hemodynamic difference. There was no statistical difference in the EOAs between the Biocor Supra, Mosaic Ultra, and Mitroflow valves, and the Magna Ease valve had a statistically smaller EOA (p < 0.05). On comparing the mean TPG, the Biocor Supra and Mitroflow valves had statistically equivalent gradients to each other, as did the Mosaic Ultra and Magna Ease valves.

CONCLUSION: When comparing valves of the same numerical manufacturer size, there appears to be a difference in hemodynamic performance across different manufacturers' valves according to FDA data. However, comparing equivalently measured valves eliminates the differences between valves produced by different manufacturers.