BlueCross BlueShield of Tennessee Medical Policy Manual

Noninvasive Fractional Flow Reserve Measurement

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

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2017). Coronary computed tomography angiography with selective noninvasive fractional flow reserve (6.01.59). Retrieved November 14, 2017 from BlueWeb. (55 articles and/or guidelines reviewed)

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., 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.

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.

U.S. Food and Drug Administration. (2016, January). Center for Devices and Radiiological 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 July 2017). 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:  1/12/2018  

ID_BA

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.