First-in-Human Experience With Patient-Specific Computer Simulation of TAVR in Bicuspid Aortic Valve Morphology

Abstract

ObjectivesThe aim of this study was to prospectively evaluate the clinical use of patient-specific computer simulation of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) morphology. BackgroundPatient-specific computer simulation of TAVR in BAV may predict important clinical outcomes, such as paravalvular regurgitation and conduction disturbance. MethodsBetween May 2018 and April 2019, all patients who were referred for TAVR who had BAV identified on work-up cardiac multidetector computed tomographic imaging prospectively underwent patient-specific computer simulation with a self-expanding transcatheter heart valve (THV) using TAVIguide technology. ResultsNine patients were included in the study. Sievers classification was type 0 in 2 patients and type 1 in 7 patients. The simulations altered the treatment strategy in 8 patients (89%). The simulations suggested moderate to severe paravalvular regurgitation in 3 patients, who were referred for consideration of surgery. The remaining 6 patients underwent TAVR with a self-expanding THV. In 5 of these patients (83%), THV size and/or implantation depth was altered to minimize paravalvular regurgitation and/or conduction disturbance. In 1 patient, simulations suggested significant conduction disturbance after TAVR, and a permanent pacemaker was implanted before the procedure. Following treatment, all 9 patients had no to mild paravalvular regurgitation. The patient who had a pre-procedure permanent pacemaker implanted became pacing dependent, with underlying third-degree atrioventricular block. ConclusionsPatient-specific computer simulation of TAVR in BAV can be used to identify those patients where TAVR may be associated with unfavorable clinical outcomes. Patient-specific computer simulation may be useful to guide THV sizing and positioning for potential favorable clinical outcomes.