Pre-procedural fit-testing of TAVR valves using parametric modeling and 3D printing

Successful transcatheter aortic valve replacement (TAVR) requires an understanding of how a prosthetic valve will interact with a patient's anatomy in advance of surgical deployment. To improve this understanding, we developed a benchtop workflow that allows for testing of physical interactions between prosthetic valves and patient-specific aortic root anatomy, including calcified leaflets, prior to actual prosthetic valve placement. This was a retrospective study of 30 patients who underwent TAVR at a single high volume center. By design, the dataset contained 15 patients with a successful annular seal (defined by an absence of paravalvular leaks) and 15 patients with a sub-optimal seal (presence of paravalvular leaks) on post-procedure transthoracic echocardiogram (TTE). Patients received either a balloon-expandable (Edwards Sapien or Sapien XT, n = 15), or a self-expanding (Medtronic CoreValve or Core Evolut, n = 14, St. Jude Portico, n = 1) valve. Pre-procedural computed tomography (CT) angiograms, parametric geometry modeling, and multi-material 3D printing were utilized to create flexible aortic root physical models, including displaceable calcified valve leaflets. A 3D printed adjustable sizing device was then positioned in the aortic root models and sequentially opened to larger valve sizes, progressively flattening the calcified leaflets against the aortic wall. Optimal valve size and fit were determined by visual inspection and quantitative pressure mapping of interactions between the sizer and models. Benchtop-predicted “best fit” valve size showed a statistically significant correlation with gold standard CT measurements of the average annulus diameter (n = 30, p