DESCRIPTION
Coronary artery disease (CAD) is a significant cause of morbidity and mortality. Evaluation of obstructive CAD involves quantifying arterial stenoses to determine whether significant narrowing is present. Lesions with stenosis more than 50 - 70% in diameter accompanied by symptoms are generally considered significant. It has been suggested that noninvasive measurement of fractional flow reserve (FFR) after a positive coronary computed tomography angiography (CCTA) may help rule out CAD and avoid invasive coronary angiography (ICA) in individuals with a low clinical likelihood of significant CAD.
Noninvasive measurement of fractional flow reserve is being evaluated as an alternative to invasive coronary angiography. FFR is the ratio of blood flow in the presence of a stenosis to blood flow in its absence. Measuring FFR during invasive coronary angiography is accomplished by passing a pressure-sensing guidewire across a stenosis. Coronary hyperemia (increased blood flow) is then induced and pressure distal and proximal to the stenosis is used to calculate flow across it. FFR levels less than 0.75 are considered to represent significant ischemia while those 0.94 – 1.0 are considered normal. FFR can be modeled noninvasively using images obtained during coronary computed tomography angiography (CCTA). The process involves constructing a digital model of coronary anatomy and calculating FFR across the entire vascular tree using computational fluid dynamics. The analysis requires at least 64-slice CCTA and cannot be calculated when images lack sufficient quality. Only the HeartFlow™ FFR CT software has been cleared by the U.S. Food and Drug Administration.
POLICY
Noninvasive estimated coronary fractional flow reserve derived from coronary computed tomography angiography data (i.e., HeartFlow™, DeepVessel®) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Noninvasive estimated coronary fractional flow reserve derived from coronary computed tomography angiography data (i.e., HeartFlow™) for the evaluation and/or treatment of other conditions/diseases is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Noninvasive estimated coronary fractional flow reserve (i.e., HeartFlow™, DeepVessel®) is considered medically appropriate if ALL of the following are met:
Results will guide decisions about the use of invasive coronary angiography
Individual is stable
Individual is at intermediate risk of coronary artery disease
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
SOURCES
American Heart Association, American College of Cardiology, American Society of Echocardiography, American College of Chest Physicians, Society for Academic Emergency Medicine, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. (2021, November). 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR guideline for the evaluation and diagnosis of chest pain. Retrieved July 27, 2023 from https://www.jacc.org/doi/epdf/10.1016/j.jacc.2021.07.053.
Baggiano, A., Fusini, L., Del Torto, A., Vivona, P., Guglielmo, M., Muscogiuri, G., et al. (2020). Sequential strategy including FFRCT plus stress-CTP impacts on management of patients with stable chest pain: The stress-CTP RIPCORD study. Journal of Clinical Medicine, 9 (7), 2147. (Level 4 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (6:2021). Coronary computed tomography angiography with selective noninvasive fractional flow reserve (6.01.59). Retrieved July 26,2023 from https://www.evidencepositioningsystem.com/. (57 articles and/or guidelines reviewed)
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2022, August). Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease. (LCD ID L38278). Retrieved July 26, 2023 from https://www.cms.gov.
Danad, I., Szymonifka, J., Twisk, J.W.R., Norguaard, B., Zarins, C., Knaapen, P., et al. (2017). Diagnostic performance of cardiac imaging methods to diagnose ischaemia-causing coronary artery disease when directly compared with fractional flow reserve as a reference standard: a meta-analysis. European Heart Journal, 38 (13), 991–998. (Level 1 evidence)
Douglas, P., Pontone, G., Hlatky, M., Patel, M., Norgaard, B., Byrne, R., et al. (2015). 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 FFTCT: outcome and resource impacts study. European Heart Journal, 36, 3359-3367. (Level 2 evidence)
eviCore healthcare. (2023, July). Cardiac Imaging Guidelines. Retrieved July 26, 2023 from www.evicore.com. (31 articles and/or guidelines addressed).
Fairbairn, T. A., Nieman, K., Akasaka, T., Nørgaard, B. L., Berman, D. S., Raff, G., et al. (2018). Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: Lessons from the ADVANCE Registry. European heart journal, 39 (41), 3701–3711. (Level 4 evidence)
Graham, I. (2011). Diagnosing coronary artery disease – the Diamond and Forrester model revisited. European Heart Journal, 32, 1311-1312. (Level 3 evidence)
Liu, X., Mo, X., Zhang, H., Yang, G., Shi, C., & Hau, W. K. (2021). A 2-year investigation of the impact of the computed tomography-derived fractional flow reserve calculated using a deep learning algorithm on routine decision-making for coronary artery disease management. European radiology, 31 (9), 7039–7046. Abstract retrieved May 6, 2022 from PubMed database.
National Institute for Health and Care Excellence. (2017, February; last update search May 2021). HeartFlow FFRCT for estimating fractional flow reserve from coronary CT angiography. Retrieved July 26, 2023 from www.nice.org.uk/guidance/mtg32.
Nørgaard, B.L., Hjort, J., Gaur, S., Hansson, N., Bøtker, H.E., Leipsic, J., et al. (2017). Clinical use of coronary CTA-derived FFR for decision-making in stable CAD. JACC Cardiovascular Imaging, 10 (5), 541-550. Abstract retrieved November 16, 2017 from PubMed database.
Nørgaard, B.L., Leipsic, J., Gaur, S., Seneviratne, S., Ko, B.S., Ito, H. et al. (2014). 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). Journal of American College of Cardiology, 63 (12), 1145-1155. Abstract retrieved November 16, 2017 from PubMed database.
Nous, F., Budde, R., Lubbers, M. M., Yamasaki, Y., Kardys, I., Bruning, T. A., et al. (2020). Impact of machine-learning CT-derived fractional flow reserve for the diagnosis and management of coronary artery disease in the randomized CRESCENT trials. European radiology, 30 (7), 3692–3701. (Level 2 evidence)
Patel, M. R., Nørgaard, B. L., Fairbairn, T. A., Nieman, K., Akasaka, T., Berman, D. S., et al. (2020) 1-Year impact on medical practice and clinical outcomes of FFRCT: The ADVANCE registry. JACC. Cardiovascular imaging, 13 (1 Pt 1), 97–105. (Level 4 evidence)
Pontone, G., Guaricci, A. I., Palmer, S. C., Andreini, D., Verdecchia, M., Fusini, L., et al. (2020). Diagnostic performance of non-invasive imaging for stable coronary artery disease: A meta-analysis. International Journal of Cardiology, 300, 276–281. Abstract retrieved May 6, 2022 from PubMed database.
Qiao, H. Y., Tang, C. X., Schoepf, U. J., Tesche, C., Bayer, R. R., 2nd, Giovagnoli, D. A., et al. (2020). Impact of machine learning-based coronary computed tomography angiography fractional flow reserve on treatment decisions and clinical outcomes in patients with suspected coronary artery disease. European Radiology, 30 (11), 5841–5851. Abstract retrieved May 6, 2022 from PubMed database.
U.S. Food and Drug Administration. (2016, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K152733. Retrieved November 15, 2017 from https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152733.pdf.
U.S. Food and Drug Administration. (2022, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K213657. Retrieved July 27, 2023 from https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213657.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2020, December; last update search January 2023). Noninvasive computed fractional flow reserve from computed tomography (FFRCT) for coronary artery disease. Retrieved July 26, 2023 from www.Hayesinc.com/subscribers. (114 articles and/or guidelines reviewed)
Yang, L., Xu, P. P., Schoepf, U. J., Tesche, C., Pillai, B., Savage, R. H., et al. (2021). Serial coronary CT angiography-derived fractional flow reserve and plaque progression can predict long-term outcomes of coronary artery disease. European radiology, 31 (9), 7110–7120. Abstract retrieved May 6, 2022 from PubMed database.
ORIGINAL EFFECTIVE DATE: 1/12/2018
MOST RECENT REVIEW DATE: 9/14/2023
ID_BA
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