General Information

It is an expectation that all patients receive care/services from a licensed clinician. All appropriate supporting documentation, including recent pertinent office visit notes, laboratory data, and results of any special testing must be provided. If applicable: All prior relevant imaging results and the reason that alternative imaging cannot be performed must be included in the documentation submitted.

Where a specific clinical indication is not directly addressed in this guideline, medical necessity determination will be made based on widely accepted standard of care criteria. These criteria are supported by evidence-based or peer-reviewed sources such as medical literature, societal guidelines and state/national recommendations.

Description/Background 
Fractional flow reserve computed tomography (FFR-CT) is a relatively new technology that estimates the effect of coronary arterial narrowing on blood flow, based upon the images acquired in a coronary computed tomography angiography study. Its role is to provide information that can more appropriately select patients requiring invasive coronary angiography. 

OVERVIEW
The Development of FFR-CT as a Technology
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 decisions regarding the appropriateness of coronary revascularization.^8,9,10,11,12

Adaptation to CCTA: CCTA has shown utility in the evaluation of patients with stable chest pain, typically intermediate pretest probability, warranting non-invasive evaluation,^13,14,15,16 as well as in low-risk emergency department scenarios.¹⁷ Fractional flow reserve using CCTA 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 Theorem.¹⁸

FFR-CT Results: Quantitative estimation of coronary lesional hemodynamic severity using FFR-CT might enable deferral of invasive coronary arteriography when values are above 0.80, since such lesions would not warrant revascularization.

FFR-CT measurements appear reproducible,19 with initial data demonstrating a strong correlation to invasive FFR, resulting in a high diagnostic performance.²⁰ Invasive FFR hasexcellent reproducibility²¹ and a demonstrated track record of favorable outcomes when used in the selection of patients and vessels requiring PCI.^8,10,11,12 Evidence suggests that FFR-CT might be a better predictor of revascularization or adverse events than severe stenosis alone on CCTA22 and that a negative FFR-CT in the evaluation of chest pain results in lower revascularization rates and lower cardiovascular death and MI at 1 year follow-up.²³ The FFR-CT data to date, however, provide no evidence showing that revascularization based upon FFR-CT improves clinical outcomes over invasive angiographic assessment. As a consequence of the above considerations, current revascularization guidelines do not advocate FFR-CT as a surrogate for invasive FFR, although, those guidelines refer to FFR-CT as an “emerging technology”.²⁴

Policy 
INDICATIONS FOR FFR-CT

• Intermediate degrees of stenosis (40% – 90%) on coronary computerized tomographic angiography (CCTA) to guide decision making and help identify those patients who would benefit from revascularization¹ 
• Intermediate lesions in the above range and coronary calcification have made percentage stenosis interpretation difficult, thus could support approval of FFR-CT, in conjunction with the above criteria² 

FFR-CT — ADDITIONAL INFORMATION^3,4 
None of the following clinical scenarios below apply, since FFR-CT either: 

• Has not been adequately validated due to inapplicability of computational dynamics; OR
• Due to problematic artifacts, and/or clinical circumstances
  • When patients have artifacts (heavy calcium) or body habitus (BMI > 35) that could interfere with the examination, the suitability for FFR-CT is at the discretion of the vendor who provides the FFR-CT service
  • 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 days⁵ 
• Prior coronary artery bypass graft surgery
• Complex congenital heart disease or ventricular septal defect (VSD) with pulmonary-to-systemic flow ratio > 1.4
• Metallic stents ≤ 3.0 mm in diameter in the coronary system 
• Coronary lesions with a vessel diameter < 1.8 mm
• Severe wall motion abnormality on CCTA results
• Severe myocardial hypertrophy
• High risk indicators on stress test
• Coronary angiography within the past 90 days 
• Marginal quality of the submitted imaging data, due to motion, blooming, misalignment, arrhythmia, etc.

Abbreviations:
BMI          Body Mass Index
CCTA       Coronary Computerized Tomographic Angiography
FFR         Fractional Flow Reserve
FFR-CT    Fractional Flow Reserve derived noninvasively from CCTA
ICA          Invasive Coronary Arteriography
MI            Myocardial Infarction 
NPV         Negative Predictive Value
PCI          Percutaneous Coronary Intervention
VSD         Ventricular Septal Defect

References: 

1. Gulati M, Levy PD, Mukherjee D, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. Nov 30 2021;78(22):e187-e285. doi:10.1016/j.jacc.2021.07.053
2. Nørgaard BL, Gaur S, Leipsic J, 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. doi:10.1016/j.jcmg.2015.06.003
3. Douglas PS, De Bruyne B, Pontone G, et al. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study. J Am Coll Cardiol. Aug 2 2016;68(5):435-445. doi:10.1016/j.jacc.2016.05.057
4. Pontone G, Patel MR, Hlatky MA, et al. Rationale and design of the Prospective LongitudinAl Trial of FFRCT: Outcome and Resource IMpacts study. Am Heart J. Sep 2015;170(3):438-46.e44. doi:10.1016/j.ahj.2015.06.002
5. Gaur S, Taylor CA, Jensen JM, et al. FFR Derived From Coronary CT Angiography in Nonculprit Lesions of Patients With Recent STEMI. JACC Cardiovasc Imaging. Apr 2017;10(4):424-433. doi:10.1016/j.jcmg.2016.05.019
6. Hulten EA. Does FFR(CT) have proven utility as a gatekeeper prior to invasive angiography? J Nucl Cardiol. Oct 2017;24(5):1619-1625. doi:10.1007/s12350-017-0974-0
7. Maroules C, Cury R. CT Perfusion and FFRCT are Ready for Clinical Use. American College of Cardiology. Updated February 6, 2017. Accessed January 27, 2023. https://www.acc.org/latest-in-cardiology/articles/2017/02/06/11/11/ct-perfusion-and-ffrct-are-ready-for-clinical-use
8. 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):1208-17. doi:10.1056/NEJMoa1408758
9. Pijls NH, van Schaardenburgh P, Manoharan G, et al. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. May 29 2007;49(21):2105-11. doi:10.1016/j.jacc.2007.01.087
10. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. Jan 15 2009;360(3):213-24. doi:10.1056/NEJMoa0807611
11. 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):1853-60. doi:10.1016/s0140-6736(15)00057-4
12. Xaplanteris P, Fournier S, Pijls NHJ, et al. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. Jul 19 2018;379(3):250-259. doi:10.1056/NEJMoa1803538
13. Douglas PS, Hoffmann U, Patel MR, et al. Outcomes of anatomical versus functional testing for coronary artery disease. N Engl J Med. Apr 2 2015;372(14):1291-300. doi:10.1056/NEJMoa1415516
14. Newby D, Williams M, Hunter A, et al. CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial. Lancet. Jun 13 2015;385(9985):2383-91. doi:10.1016/s0140-6736(15)60291-4
15. Oberweis BS, Taylor AJ. The PROMISE Trial: The CTA Perspective. American College of Cardiology. Updated July 28, 2015. Accessed January 27, 2023. https://www.acc.org/latest-in-cardiology/articles/2015/07/27/10/58/the-promise-trial-the-cta-perspective
16. Williams MC, Hunter A, Shah ASV, et al. Use of Coronary Computed Tomographic Angiography to Guide Management of Patients With Coronary Disease. J Am Coll Cardiol. Apr 19 2016;67(15):1759-1768. doi:10.1016/j.jacc.2016.02.026
17. Hulten E, Pickett C, Bittencourt MS, et al. Outcomes after coronary computed tomography angiography in the emergency department: a systematic review and meta-analysis of randomized, controlled trials. J Am Coll Cardiol. Feb 26 2013;61(8):880-92. doi:10.1016/j.jacc.2012.11.061
18. Taylor CA, Fonte TA, Min JK. 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):2233-41. doi:10.1016/j.jacc.2012.11.083
19. Gaur S, Bezerra HG, Lassen JF, et al. Fractional flow reserve derived from coronary CT angiography: variation of repeated analyses. J Cardiovasc Comput Tomogr. Jul-Aug 2014;8(4):307-14. doi:10.1016/j.jcct.2014.07.002
20. Driessen RS, Danad I, Stuijfzand WJ, et al. Comparison of Coronary Computed Tomography Angiography, Fractional Flow Reserve, and Perfusion Imaging for Ischemia Diagnosis. J Am Coll Cardiol. Jan 22 2019;73(2):161-173. doi:10.1016/j.jacc.2018.10.056
21. Johnson NP, Johnson DT, Kirkeeide RL, et al. Repeatability of Fractional Flow Reserve Despite Variations in Systemic and Coronary Hemodynamics. JACC Cardiovasc Interv. Jul 2015;8(8):1018-1027. doi:10.1016/j.jcin.2015.01.039
22. Lu MT, Ferencik M, Roberts RS, et al. Noninvasive FFR Derived From Coronary CT Angiography: Management and Outcomes in the PROMISE Trial. JACC Cardiovasc Imaging. Nov 2017;10(11):1350-1358. doi:10.1016/j.jcmg.2016.11.024
23. Patel MR, Nørgaard BL, Fairbairn TA, et al. 1-Year Impact on Medical Practice and Clinical Outcomes of FFR(CT): The ADVANCE Registry. JACC Cardiovasc Imaging. Jan 2020;13(1 Pt 1):97-105. doi:10.1016/j.jcmg.2019.03.003
24. Patel MR, Calhoon JH, Dehmer GJ, 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 2 2017;69(17):2212-2241. doi:10.1016/j.jacc.2017.02.001

Coding Section 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

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,  and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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