Clinical value of CT-derived simulations of transcatheter-aortic-valve-implantation in challenging anatomies the PRECISE-TAVI trial |
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| Authors: | Thijmen W. Hokken MD,Hendrik Wienemann MD,James Dargan BMBS,Dirk-Jan van Ginkel MD,Cameron Dowling MBBS,PhD,Axel Unbehaun MD,Johan Bosmans MD,PhD,Andreas Bader-Wolfe MD,PhD,Robert Gooley MBBS , PhD,MBA,Martin Swaans MD,Stephen J. Brecker MD,Matti Adam MD,Nicolas M. Van Mieghem MD,PhD |
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| Affiliation: | 1. Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands;2. Clinic III for Internal Medicine, Faculty of Medicine and University Hospital Cologne, Cologne, Germany;3. Cardiology Clinical Academic Group, St. George's University of London, London, UK;4. Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands;5. MonashHeart, Monash Health and Vascular Surgery, Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia Stanford University School of Medicine, 6. Division of Cardiovascular Medicine, Stanford, California, USA;7. Department of Cardiology, German Heart Center Berlin, Berlin, Germany;8. Department of Cardiology, Antwerp University Hospital, Antwerp, Belgium;9. MonashHeart, Monash Health and Vascular Surgery, Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia |
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| 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 HEARTguideTM 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 HEARTguideTM 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 HEARTguideTM 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 HEARTguideTM simulations may provide enhanced insights in the risk for PVL or PPI after TAVI with a self-expanding supra-annular THV in complex anatomies. |
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| Keywords: | computer simulations conduction abnormalities paravalvular leakage transcatheter aortic valve implantation |
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