Fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFR-CT) offers a non-invasive alternative to invasive FFR measurement, the clinical gold standard for assessing the functional significance of coronary stenosis. This study presents and validates the Cardiolens FFR-CT Pro®method that integrates coronary computed tomography angiography (CCTA) images, medical interview data, and continuous non-invasive blood pressure (CNBP) waveform signals to provide patient-specific boundary conditions for computational fluid dynamics (CFD) simulations. The aim of this study is to investigate how pressure morphology affects FFR-CT calculations by comparing the use of patient-specific pressure waveforms versus using systolic and diastolic blood pressure values only, obtained from population based formulas. In this study, 132 patients (167 vessels) were included prospectively across 11 centers between 2020 and 2022 and analyzed retrospectively. Cardiolens FFR-CT Pro®using patient-specific pressure waveform boundary conditions, and an FFR-CT population based model. Diagnostic performance metrics (accuracy, specificity, sensitivity) were calculated and compared between methods. The Cardiolens FFR-CT Pro®demonstrated higher accuracy (88.6%), specificity (87.4%) and sensitivity (92.5%) than population based pressure input FFR-CT accuracy (87.3%), specificity (87.3%) and sensitivity (87.5%). Incorporating patient-specific pressure waveform morphology into boundary conditions improves diagnostic performance compared with population-based formulas alone. These findings underscore the clinical utility of non-invasive FFR-CT, particularly when patient-specific physiological data are available, and highlight the potential for broader adoption of this technique in routine practice.
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