Accurate balloon-expandable valve (BEV) sizing for transcatheter aortic valve implantation (TAVI) is particularly important considering the high radial force and the adverse consequences of inaccurate sizing. Under- or oversizing can lead to suboptimal results, increasing the risk of paravalvular regurgitation, higher residual gradients which may potentially impact durability, and increasing the risk of annular injury1.
Current practice suggests that the ideal annular area oversizing with BEVs is between 0% and 10%. In intermediate annular sizes, this could be effectively achieved using the current SAPIEN 3 Ultra BEV (Edwards Lifesciences) technology by adding or removing volume from the inflation balloon23.
In this analysis of the multicentre OPERA-TAVI registry, we aimed to compare outcomes of patients receiving the SAPIEN 3 Ultra BEV in optimal or intermediate sizing zones (within or outside the 0-10% area oversizing range, respectively)4.
The registry protocol was approved by the local institutional review board at each participating centre.
Excluding native bicuspid aortic valves (n=38), a total of 723 patients with available native annular area measurements received the SAPIEN 3 Ultra transcatheter heart valve (THV). Among these, 275 patients...
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