Preprocedural computer simulation with FEops HEARTguide changed the transcatheter heart valve planning decision in 35% of patients with challenging anatomies.
Observational (n=77)
Yes
Does preprocedural computer simulation with FEops HEARTguide TM change planning decisions and predict complications in patients with challenging anatomies undergoing TAVI?
Preprocedural computer simulation with FEops HEARTguide TM alters TAVI planning in 35% of patients with complex anatomies and its outputs correlate with the risk of paravalvular leak and permanent pacemaker implantation.
Abstract Background Preprocedural computed tomography planning improves procedural safety and efficacy of transcatheter aortic valve implantation (TAVI). However, contemporary imaging modalities do not account for device‐host interactions. Aims This study evaluates the value of preprocedural computer simulation with FEops HEARTguide TM on overall device success in patients with challenging anatomies undergoing TAVI 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 TM 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, preprocedural planning changed after FEops HEARTguide TM 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 5.7 mL/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 TM simulations may provide enhanced insights in the risk for PVL or PPI after TAVI with a self‐expanding supra‐annular THV in complex anatomies.
Hokken et al. (Tue,) conducted a observational in Challenging anatomies undergoing TAVI (n=77). FEops HEARTguide computer simulation vs. Conventional multislice computed tomography (MSCT) was evaluated on Change in preprocedural planning. Preprocedural computer simulation with FEops HEARTguide changed the transcatheter heart valve planning decision in 35% of patients with challenging anatomies.
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