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

BackgroundPre-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. MethodsThis 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 teams 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. ResultsA 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). ConclusionFEops 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.