Medical Policies - Fractional Flow Reserve CT
Fractional Flow Reserve CT
Last Reviewed: October 2017
Department(s): Medical Affairs Next Review: October 2018
Original Date: October 2017
History of FFR: Fractional Flow Reserve (FFR) is the ratio of baseline coronary flow to coronary flow during maximal hyperemia. Its use in the
cardiac catheterization laboratory has successfully demonstrated utility in the quantitation of intracoronary flow dynamics secondary to lesional and
microvasculature conditions. This technology has proven helpful in evaluating individual patients, with respect to prognostication of coronary artery
disease and with decisions regarding the appropriateness of coronary revascularization. (A caveat is discussed in the Additional Information.)
Adaptation to CCTA: Fractional Flow Reserve using Coronary Computed Tomography Angiography (FFR-CT) is a new technology that seeks to
provide an estimation of FFR by non-invasive methodology. Following assessment of quality CCTA images, in the appropriate subsets of patients
with coronary stenoses, the technology makes mathematical assumptions to simulate maximal hyperemia, and calculates an estimation of FFR
(fractional flow reserve) for those coronary vessels with lesions, based upon the principles of fluid mechanics inherent to the Navier-Stokes
Effort to reduce unnecessary ICA: Since conventional FFR measurement has been performed in conjunction with invasive coronary
arteriography (ICA), FFR-CT has been developed with the intention of noninvasively adding hemodynamic information to the anatomic findings on
CCTA, with the purpose of safely reducing the frequency of unnecessary ICA procedures (defined as all ICA lesions < 50%). Such a reduction in
ICA by FFR-CT has been suggested, but not rigorously proven, by the clinical trials to date. (A caveat is discussed in the Additional Information.)
Current Methodology: The analysis requires a CCTA with at least a 64-slice capability and good-quality images. At present, the process involves
transmitting the CCTA data to an off-site location, where a digital model of coronary anatomy is constructed, and using the CCTA data, FFR is
calculated using the above described computational fluid dynamics. In this fashion, a report of estimated FFR for the vessels in question is
generated, with the intention of reporting coronary hemodynamic information to the requesting clinician.
The purpose of FFR-CT is to determine if an invasive cardiac catheterization (ICA) can be avoided. All requirements for MEDICAL NECESSITY
below must be met:
1. Prior to CCTA, the patient was stable with a pre-test probability between 20% and 80% of significant, ischemia-producing coronary artery
disease, based upon a reliable calculator (updated Diamond Forrester, ESC Consortium, University of Washington, or similar calculators,
for which links are provided in the Additional Information section).
2. The medical record documents at least one of the following scenarios:
Patient had a pretest probability of 20-50% (low-to-moderate)
prior to CCTA and was selected for evaluation with CCTA as a non-invasive test for significant coronary artery disease. The CCTA result
shows lesions of ≥ 50%.
Patient had a pretest probability of 51-80% (moderate or high moderate) prior to CCTA and was selected for evaluation with CCTA as a
non-invasive test for significant coronary artery disease. The CCTA result shows lesions of 30-50%.
3. None of the following clinical scenarios apply, since FFR-CT has not been adequately validated due to inapplicability of computational
dynamics, artifacts, and/or clinical circumstances; these indications will be considered NOT MEDICALLY NECESSARY:
or current presentation of, an acute coronary syndrome, unless the patient has unstable angina, myocardial infarction was excluded, and
ICA would not be recommended if FFR-CT were negative
Known ischemic coronary artery disease that has not been revascularized,
and there has been no change in patient status or in the CCTA images
Recent myocardial infarction within 30 days
artery bypass graft surgery
Patients who require emergency or urgent ICA or have any evidence of ongoing or active clinical
instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg,
severe congestive heart failure (New York Heart Association [NYHA] III or IV) or acute pulmonary edema
Complex congenital heart
disease or VSD with Qp/Qs > 1.4
BMI > 35
Metallic stents in the coronary system
Coronary vessels with extensive or heavy
Coronary lesions needing evaluation in which vessel diameter < 1.8 mm
Cardiac Implanted Electrical Devices
Prosthetic Heart Valves
Severe wall motion abnormality on CCTA results
Severe myocardial hypertrophy
risk indicators on stress test
ICA within the past 90 days
Marginal quality of the submitted imaging data, due to motion, blooming,
Medical Policies - Fractional Flow Reserve CT
misalignment, arrhythmia, etc.
Quantitative estimation of coronary lesional hemodynamic severity using FFR-CT may enable deferral of invasive coronary arteriography when
values are above 0.80.
A decision to follow through with coronary revascularization should not be based upon FFR-CT. Thus, justification for percutaneous coronary
intervention should usually require additional invasive FFR or other corroborative non-invasive or angiographic data. FFR-CT data to date provides
no evidence showing outcomes comparable to outcomes based upon invasive FFR determinations. By virtue of the assumption of maximal
hyperemia, the microvasculature’s true behavior is not actually measured by FFR-CT. This is important, since a coronary lesional intervention will
not improve flow if the microvasculature will not allow further increase in flow.
Because of the lack of long-term outcomes data and flaws in the design of multiple trials, and given the controversy evidenced by numerous
editorials in peer-reviewed journals, there is a lack of formal guidelines from professional societies at this time. Based upon findings in the
PLATFORM trial, patients who are evaluated initially by CCTA with contingent FFR-CT, could be perceived as actually having a higher rate of
unnecessary ICA. This has necessitated numerous considerations based upon multiple published trials and meta-analyses in formulating this de
Calculations of pre- and post-test probability:
Prior to each non-invasive test, there is a pretest probability of finding significant coronary artery disease. The result of a non-invasive test yields a
post-test probability, which then becomes the pretest probability for a subsequent non-invasive test. This is helpful when a patient who had a prior
stress test is being considered for FFR-CT.
1. University of Washington pretest and post-test probability table (preferred), to determine a pretest probability for patients
undergoing FFR-CT subsequent to a prior non-invasive test. The University of Washington Calculator for Pre- and Post-test
2. Updated Diamond Forrester Pretest Probability Table, based upon symptoms prior to initial non-invasive testing:
3. European Society of Cardiology CAD Consortium Pretest Probability, based upon clinical information (CAC optional) prior to non-invasive
testing for coronary artery disease. The ESC CAD Consortium Pretest Probability Calculator can be found at this address:
CCTA = Coronary Computerized Tomographic Angiography
CIED = Cardiac Implanted Electrical Devices
ESC = European Society of Cardiology
FFR = Fractional Flow Reserve
ICA= Invasive Coronary Arteriography
MACE= Major Adverse Coronary Events
NPV= Negative Predictive Value
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Test Probability of Coronary Artery Disease and Severity of Coronary Arterial Calcification: The CorE-64 International, Multicenter Study.
2. BL Norgaard, J Hjort, S Gaur, et al. Clinical Use of Coronary CTA-Derived FFR for Decision-Making in Stable CAD. JACC Cardiovascular
3. BL Nørgaard, J Leipsic, S Gaur, et al. 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:
4. BL Nørgaard, S Gaur, J Leipsic, et al. Influence of coronary calcification on the diagnostic performance of CT angiography derived FFR in
coronary artery disease: a substudy of the NXT Trial. JACC Cardiovasc Imaging. Sep 2015; 8(9):1045-1055. http://ac.els-
Medical Policies - Fractional Flow Reserve CT
CA Taylor, TA Fonte, JK Min. Computational fluid dynamics applied to cardiac computed tomography for noninvasive quantification of
fractional flow reserve: scientific basis. J Am Coll Cardiol. Jun 4 2013; 61(22):2233- 2241. doi: 10.1016/j.jacc.2012.11.083
D Newby, M Williams, A Hunter, (SCOT-Heart Investigators) et al. CT coronary angiography in patients with suspected angina due to
coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial. The Lancet Volume 385, No. 9985, p2383-2391,
De Bruyne B, Fearon WF, Pijls NH. et al. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. Sep 25
2014; 371(13):1208-1217. DOI: 10.1056/NEJMoa1408758
DT Linker. Decision-Support Tool to Calculate Pre- and Post-Test Probabilities of Coronary Artery Disease with Cardiac Functional Tests.
E Hulten, C Pickett, MS Bittencourt, et al. Outcomes after Coronary Computed Tomography Angiography in the Emergency Department.
Systematic Review and Meta-Analysis of Randomized, Controlled Trials. JACC Vol. 61, No. 8, 2013 p 880-892
E Hulten, MF Di Carli. FFRCT: Solid PLATFORM or thin ice? J Am Coll Cardiol. Dec 1 2015; 66(21):2324-2328. PMID 26475206.
IM Graham. Diagnosing coronary artery disease—the Diamond and Forrester model revisited. Eur Heart J. 2011 Jun;32(11):1311-2. doi:
JK Min, J Leipsic, MJ Pencina, et al. Diagnostic Accuracy of Fractional Flow Reserve From Anatomic CT Angiography. JAMA. Sep 26
JK. Min. Look Backwards But Live Forwards JACC Cardiovasc Imaging. 2017 May;10(5):551-553. doi: 10.1016/j.jcmg.2015.12.014
M Dewey, M Rief, P Martus, et al. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for
MA Hlatky, DeBruyne, G Pontone, et al. Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve with Computed
Tomography Angiography: PLATFORM J Am Coll Cardiol. 2015 Dec 1;66(21):2315-23. doi: 10.1016/j.jacc.2015.09.051. Epub 2015 Oct
MR Patel, JH Calhoon, GJ Dehmer, et al. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate Use Criteria for coronary
revascularization in patients with stable ischemic heart disease: a report of the American College of Cardiology Appropriate Use Criteria
Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American
Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed
Tomography, and Society of Thoracic Surgeons. J Am Coll Cardiol. May 02 2017; 69(17):2212-2241. DOI: 10.1016/j.jacc.2017.02.001
MS Bittencourt, E Hulten, TS Polonsky, et al. European Society of Cardiology Recommended CAD Consortium Pre-Test Probability
Scores More Accurately Predict Obstructive Coronary Disease and Cardiovascular Events Than the Diamond and Forrester Score: The
Partners Registry. Circulation. 2016 Jul 19;134(3):201-11. doi: 10.1161/CIRCULATIONAHA.116.023396. Epub 2016 Jul 13.
MT Lu, M Ferencik, RS Roberts, et al. Noninvasive FFR Derived From Coronary CT Angiography: Management and Outcomes in the
PROMISE Trial. JACC Cardiovasc Imaging. 2017 Apr 7. pii: S1936-878X(17)30262-0. doi: 10.1016/j.jcmg.2016.11.024
National Institute for Health and Care Excellence. HeartFlow FFRCT for estimating fractional flow reserve from coronary CT angiography
NP Johnson, DT Johnson, RL Kirkeeide, et al. Repeatability of fractional flow reserve despite variations in systemic and coronary
hemodynamics. JACC Cardiovasc Interv. Jul 2015; 8(8):1018-1027. PMID 26205441 doi: 10.1016/j.jcin.2015.01.039
PS Douglas, B DeBruyne, G Pontone, et al. 1-Year Outcomes of FFRCT-Guided Care in Patients with Suspected Coronary Disease: The
PLATFORM Study. J Am Coll Cardiol. 2016 Aug 2;68(5):435-45. doi: 10.1016/j.jacc.2016.05.057
PS Douglas, G Pontone, MA Hlatky, et al. Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided
diagnostic strategies vs. usual card in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR (CT):
outcome and resource impacts study. Eur Heart J. 2015 Dec 14;36(47):3359-67. doi: 10.1093/eurheartj/ehv444. Epub 2015 Sep 1.
R Detrano, J Yiannikas, EE Salcedo. Et al. Bayesian probability analysis: a prospective demonstration of its clinical utility in diagnosing
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RK Munnur, JD Cameron, BS Ko. et al. Cardiac CT: atherosclerosis to acute coronary syndrome. Cardiovascular Diagnosis and Therapy,
Dec, 2014, 4(5):430-448. doi: 10.3978/j.issn.2223-3652.2014.11.03
S Gaur, CA Taylor, JM Jensen, et al. FFR Derived From Coronary CT Angiography in Nonculprit Lesions of Patients With Recent ST-
segment elevation myocardial infarction. JACC VOL. 10, NO. 4, 2017 p 424-433 DOI: 10.1016/j.jcmg.2016.05.019.
S Gaur, HG Bezerra, JF Lassen, et al. Fractional flow reserve derived from coronary CT angiography: variation of repeated analyses. J
Medical Policies - Fractional Flow Reserve CT
Cardiovasc Comput Tomogr. Jul-Aug 2014; 8(4):307-314. PMID 25151923 DOI: 10.1016/j.jcct.2014.07.002
27. S Packard, RP. Karlsberg. Integrating FFRCT into Routine Clinical Practice: A Solid PLATFORM or Slippery Slope? J Am Coll Cardiol.
28. SD Fihn, JM Gardin, J Abrams, et al. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of
patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task
Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive
Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am
Coll Cardiol. Dec 18 2012; 60(24):e44-e164. DOI: 10.1016/j.jacc.2012.07.013
29. TM Labounty, BK Nallamothu. FFR (CT): a new technology in search of a clinical application. Eur Heart J. 2015 Dec 14;36(47):3368-9.
doi: 10.1093/eurheartj/ehv534. Epub 2015 Oct 7.
30. TSS Genders, EW Steyerberg, MGM Hunink, et al. Prediction model to estimate presence of coronary artery disease: retrospective
31. Van Nunen LX, Zimmermann FM, Tonino PA. et al. Fractional flow reserve versus angiography for guidance of PCI in patients with
multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial. Lancet. Nov 7 2015; 386(10006):1853-
0501T Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data
using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary
artery disease; data preparation and transmission, analysis of fluid dynamics and simulated maximal coronary hyperemia,
generation of estimated FFR model, with anatomical data review in comparison with estimated FFR model to reconcile discordant
data, interpretation and report
0502T Data preparation and transmission
0503T Analysis of fluid dynamics and simulated maximal coronary hyperemia, and generation of estimated FFR model
0504T Anatomical data review in comparison with estimated FFR model to reconcile discordant data, interpretation and report
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This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical
community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this
community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers,
reference to federal regulations, other plan medical policies, and accredited national guidelines.
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