Software that performs predictive simulations of transcatheter aortic valve replacement (TAVR) for specific patients based on their clinical data did not change the operators’ choice of size of transcatheter heart valve (THV), but the simulation did inform the depth that operators implanted the valve, according to a prospective, observational study released Wednesday.
Nahid El Faquir, MD, of Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands, and colleagues reported their findings from the TAVIguide (Added Value of Patient-Specific Computer Simulation in Transcatheter Aortic Valve Implantation) study in a manuscript published online in JACC: Cardiovascular Interventions.
They analyzed the added value and predictive power of the patient-specific simulation (TAVIguide, manufactured by FEops, Belgium) in patients with severe, symptomatic aortic stenosis who were treated with the self-expanding Evolut R THV (Medtronic). The study included 80 patients from five European centers; 42 underwent the simulation first, and 38 underwent TAVR without the simulation.
The operators changed their valve size in one patient because the simulation predicted paravalvular leak would occur with their original choice. The operators changed the target depth at which they implanted the valve in seven patients; five of these were because of predicted paravalvular leak and two were because of the simulation’s indicated maximum contact pressure or contact pressure index.
The study also showed no difference in valve performance between patients who underwent the simulation and those who did not.
El Faquir and colleagues wrote that as TAVR becomes more common among lower-risk patients, optimizing the procedure will become more important. An accompanying editorial by Pascal Thériault-Lauzier, MD, PHD, University of Ottawa Heart Institute, Canada, and colleagues takes issue with that, saying that TAVR must be optimized in all patients, especially in those at higher risk, as they may not be able to tolerate a procedure that is less than optimal.
“The TAVIguide workflow may find a niche in special clinical situations such as those with complex anatomic variants of the aortic root; patients with a bicuspid aortic valve or with highly calcified leaflets may benefit particularly,” Thériault-Lauzier and colleagues wrote.
El Faquir N, De Backer O, Bosmans J, et al. Patient-Specific Computer Simulation in TAVR With the Self-Expanding Evolut R Valve. JACC Cardiovasc Interv 2020 Jul 15. https://doi.org/10.1016/j.jcin.2020.04.018
Thériault-Lauzier P, Messika-Zeitoun D, Piazza N. Patient-Specific Computer Simulation in TAVR: Will the Technology Gain Widespread Adoption? JACC Cardiovasc Interv 2020 Jul 15. https://doi.org/10.1016/j.jcin.2020.05.021