Clinical Value Of CT-Derived Simulations Of Transcatheter-Aortic-Valve-Replacement In Challenging Anatomies The PRECISE-TAVR Trial

Background Pre-procedural computed tomography planning improves procedural safety and efficacy of transcatheter aortic valve replacement(TAVR). However, contemporary imaging modalities do not account for device-host interactions. This study evaluates the value of pre-procedural computer simulation with FEops HEARTguide™ on overall device success in patients with challenging anatomies undergoing TAVR with a contemporary self-expanding supra-annular transcatheter heart valve. Methods This prospective multicenter observational study included patients with a challenging anatomy defined as bicuspid aortic valve, small annulus or severely calcified aortic valve. We compared the heart team’s transcatheter heart valve(THV) planning decision based on 1) conventional multislice computed tomography(MSCT) and 2) MSCT imaging with FEops HEARTguide™ simulations. Clinical outcomes and THV performance were followed up to 30 days. Results A total of 77 patients were included(Median age 79.9 years (IQR 74.2-83.8), 42% male). In 35% of the patients, pre-procedural planning changed after FEops HEARTguide™ simulations(change in valve size selection(12%) or target implantation height(23%)). A new permanent pacemaker implantation(PPI) was implanted in 13% and >trace paravalvular leakage (PVL) occurred in 28.5%. The contact pressure index(i.e. simulation output indicating the risk of conduction abnormalities) was significantly higher in patients with a new PPI, compared to those without(16.0%(25th-75th percentile 12.0-21.0) vs. 3.5%(25th-75th percentile 0−11.3), p<0.01) The predicted PVL was 5.7mL/s(25th-75th percentile 1.3-11.1) in patients with none-trace PVL, 12.7(25th-75th percentile 5.5-19.1) in mild PVL and 17.7(25th-75th percentile 3.6-19.4) in moderate PVL(p=0.04). Conclusion FEops HEARTguide™ simulations may provide enhanced insights in the risk for PVL or PPI after TAVR with a self-expanding supra-annular THV in complex anatomies. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04473443 ### Funding Statement PRECISE-TAVR is part of a project that has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No. 945698. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was conducted in accordance with the declaration of Helsinki and did not fall under the scope of the Medical Research Involving Human Subjects Act per review of the Daily Board of the Medical Ethics Committee Erasmus MC, Rotterdam, the Netherlands(MEC-2020-0486) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Data is available by request to the corresponding author * BAV : Bicuspid Aortic Valve ECG : Electrocardiogram LVOT : Left Ventricular Outflow Tract MSCT : Multislice Computed Tomography PPI : Permanent pacemaker Implantation PVL : Paravalvular Leakage TAVR : Transcatheter Aortic Valve Replacement TTE : Transthoracacic Echocardiography