Clinical value of CT‐derived simulations of transcatheter‐aortic‐valve‐implantation in challenging anatomies the PRECISE‐TAVI trial

Author:

Hokken Thijmen W.1ORCID,Wienemann Hendrik2ORCID,Dargan James3,Ginkel Dirk‐Jan van4,Dowling Cameron56,Unbehaun Axel7,Bosmans Johan8,Bader‐Wolfe Andreas7,Gooley Robert5,Swaans Martin4,Brecker Stephen J.3,Adam Matti2,Van Mieghem Nicolas M.1ORCID

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

6. Stanford University School of Medicine, 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

Abstract

AbstractBackgroundPreprocedural 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.AimsThis 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.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 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.ResultsA 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).ConclusionFEops 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.

Publisher

Wiley

Subject

Cardiology and Cardiovascular Medicine,Radiology, Nuclear Medicine and imaging,General Medicine

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