DEEPVESSEL FFR
- CCTA
- Myocardial Ischemia
DEEPVESSEL FFR (DVFFR) is an image analysis software developed for the quantitative and qualitative analysis of Coronary Computed Tomography Angiography (CCTA). The software utilizes image processing and artificial intelligence techniques to non-invasively calculate non-invasive fractional flow reserve (FFR) index, an index that quantifies the severity of myocardial ischemia associated with artery stenosis. The purpose is to provide additional physiological functional assessment of coronary artery disease (CAD).1
Images shown for illustrative purposes only.
72% of diagnostic Invasive Coronary Angiography studies (ICA) could have been avoided by using a DL-FFRCT value > 0.8 as a cut-off for intervention.1
Positive Predictive Value and Negative Predictive Values for ischemia above 83% at the per patient level and above 95% at the per vessel level.2
- Input coronary CTA images need to be acquired by a CT scanner with at least "4 detector rows;
- Input coronary CTA images with any of the following conditions may NOT be eligible for DVFFR analysis and should be excluded:
- Unsuitable imaging parameters:
- Slice thickness >1 mm;
- Slice spacing > 1mm;
- In-plane pixel spacing > 0.55 mm;
- kVp <70;
- Unsuitable image quality:
- Images with severe imaging artifacts, including motion artifact, misalignment calcium blooming, low contrast and high noise.
- The software generates the DVFFR analysis results in two main steps. The first step generates a 3D coronary artery tree model from the CTA image automatically using deep learning-based segmentation algorithms. Manual corrections of the segmentation results are allowed when necessary to confirm the accuracy of the 3D coronary artery tree segmentation.
- In the second step, the deep learning framework consists of a multi-layer perceptron network (MLP) and a bidirectional multi-layer recursive neural network (BRNN), which utilize the segmentation results and the CTA image, to estimate semi-continuous FFR values along the coronary artery centerlines.
- The output of the analysis is a PDF report with detailed DVFFR assessment and branch-by-branch visualizations, along with a 3D DVFFR tree model where the DVFFR values are mapped on top of the surface model.
Vendor
Keya Medical Technology
EU risk class and CE marking
DEEPVESSEL FFR has CE marking (CE0344) and risk class IIa
Reimbursement status
Not reimbursed.
Contraindications
The product itself does not cause adverse reactions. However, because this product is based on coronary artery tomography, there are strict requirements for the quality of CT image to be processed by this software. The inappropriate CT images may affect the FFR calculation results and thus affect the diagnostic evaluation. The specific tomography standards and requirements are shown in precautions. If the patient is not suitable for collecting CTA images, this product will not be used.
Target Population
- Patients with chest pain suspected to have coronary artery disease in need of confirmation
- Patients with coronary artery disease who need further assessment
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