HeartFlow FFRCT Analysis

HeartFlow
The HeartFlow Analysis is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides the calculations of FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The HeartFlow Analysis is intended to support the functional evaluation of coronary artery disease.
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Information source: Vendor
Last updated: June 9, 2024

General Information

General
Product name HeartFlow FFRCT Analysis
Company HeartFlow
Subspeciality Cardiac
Modality CT
Disease targeted Coronary artery stenosis, coronary artery disease
Key-features FFRCT values along coronary vessels
Suggested use During: interactive decision support (shows abnormalities/results only on demand)
After: diagnosis verification

Technical Specifications

Data characteristics
Population People with suspected coronary artery disease
Input Coronary CT (following SCCT and ACC guidelines), 64-slice or higher
Input format DICOM
Output 3D model of coronary tree with FFRCT values
Output format 3D model, PDF
Technology
Integration Integration in standard reading environment (PACS), Stand-alone webbased, Integration with HL7
Deployment Cloud-based
Trigger for analysis On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time

Regulatory

Certification
CE
Certified, Class IIa , MDD
FDA 510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE) The HeartFlow Analysis is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides the calculations of FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The HeartFlow Analysis is intended to support the functional evaluation of coronary artery disease. The HeartFlow Analysis is provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The HeartFlow Analysis is intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment. It is for prescription use only.

Market

Market presence
On market since 01-2016
Distribution channels
Countries present (clinical, non-research use)
Paying clinical customers (institutes) >500
Research/test users (institutes)
Pricing
Pricing model Pay-per-use
Based on Number of analyses

Evidence

Evidence
Peer reviewed papers on performance

  • Diagnosis and treatment of ischemia-producing coronary stenoses improves 5-year survival of patients undergoing major vascular surgery (read)

  • Long-term prognostic implications of CT angiography-derived fractional flow reserve: Results from the DISCOVER-FLOW study (read)

  • Computed tomography-derived fractional flow reserve (FFRCT) has no additional clinical impact over the anatomical Coronary Artery Disease - Reporting and Data System (CAD-RADS) in real-world elective healthcare of coronary artery disease (read)

  • Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps)(read)

  • Comparison of Coronary Computed Tomography Angiography, Fractional Flow Reserve, and Perfusion Imaging for Ischemia Diagnosis(read)

  • Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFRCT: outcome and resource impacts study(read)

  • Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM.(read)

  • 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study.(read)

  • Clinical Outcomes Using Coronary CT Angiography and FFRCT-Guided Management of Stable Chest Pain Patients(read)

  • Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE Registry,(read)

  • 1-Year Impact on Medical Practice and Clinical Outcomes of FFRCT: The ADVANCE Registry(read)

  • Impact of Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography on Heart Team Treatment Decision- Making in Patients With Multivessel Coronary Artery Disease: Insights From the SYNTAX III REVOLUTION Trial,(read)

  • Computed Tomography Derived Fractional Flow Reserve Testing in Stable Patients with Typical Angina Pectoris: Influence on Downstream Rate of Invasive Coronary Angiography(read)

  • Identification of High-Risk Plaques Destined to Cause Acute Coronary Syndrome Using Coronary Computed Tomographic Angiography and Computational Fluid Dynamics(read)

  • Effect of the Ratio of Coronary Arterial Lumen Volume to Left Ventricle Myocardial Mass Derived from Coronary Ct Angiography on Fractional Flow Reserve(read)
Non-peer reviewed papers on performance

  • White paper: CCTA and FFRCT - The Diagnostic Approach to CAD Has Been Disrupted (read)
Other relevant papers