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.
Noninvasive estimated coronary fractional flow reserve derived from coronary computed tomography angiography data (i.e. Heartflow) 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.
Noninvasive estimated coronary fractional flow reserve (i.e. Heartflow) 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
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BlueCross BlueShield Association. Evidence Positioning System. (6:2019). Coronary computed tomography angiography with selective noninvasive fractional flow reserve (6.01.59). Retrieved April 3, 2020 from https://www.evidencepositioningsystem.com/. (52 articles and/or guidelines reviewed)
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)
Graham, I. (2011). Diagnosing coronary artery disease - the Diamond and Forrester model revisited. European Heart Journal, 32, 1311-1312. (Level 3 evidence)
National Institute for Health and Care Excellence. (2017). HeartFlow FFRCT for estimating fractional flow reserve from coronary CT angiography. Retrieved November 15, 2017 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.
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.
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, August; last update search September 2019). Noninvasive computed fractional flow reserve from computed tomography (FFRCT) for coronary artery disease. Retrieved December 11, 2017 from www.Hayesinc.com/subscribers. (48 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 1/12/2018
MOST RECENT REVIEW DATE: 6/25/2020
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