BlueCross BlueShield of Tennessee Medical Policy Manual

Myocardial Sympathetic Innervation Imaging for Individuals with Heart Failure

DESCRIPTION

In patients with heart failure, activation of the sympathetic nervous system is an early mechanism to compensate for decreased myocardial function. The concentration of 123 Iodine meta-iodobenzylguanidine (MIBG) over several hours after injection is a potential marker of sympathetic neuronal activity and may correlate with the severity of heart failure. Once the agent is administered, planar images of the thorax are acquired at 15 minutes (early image) and then at four hours (late image), measuring the heart to mediastinum (H/M) ratio.

While the available studies vary in their patient inclusion criteria and methods for analyzing MIBG parameters, the highest quality studies demonstrate a significant association of MIBG results with adverse cardiac events, including cardiac death.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

There are studies are available that demonstrate an association between MIBG imaging results and serious adverse cardiac events. However, there is no published direct evidence regarding clinical utility of MIBG (i.e., whether findings of the test would lead to patient management changes that would improve health outcomes).

SOURCES 

ACCF/ACR/ASE/ASNC/SCCT/SCMR (2013) Appropriate Utilization of Cardiovascular Imaging in Heart Failure. Retrieved May 12, 2016 from www.acr.org.

American College of Cardiology Foundation/American Heart Association (2013) Guideline for the Management of Heart Failure. Retrieved May 12, 2016 from http://my.americanheart.org/statements.

Bax, J. J., Boogers, M. M., & Schuijf, J. D. (2009). Nuclear imaging in heart failure. Cardiology Clinics, 27 (2), 265- 276. (Level 4 evidence - Industry sponsored)

BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2016). Myocardial sympathetic innervation imaging in patients with heart failure (6.01.56). Retrieved March 2, 2017 from BlueWeb. (22 articles and/or guidelines reviewed)

Buxton, D. B., Antman, M., Danthi, N., Dilsizian, V., Fayad, Z. A., Garcia, M. J., et al. (2011). Report of the National Heart, Lung, and Blood Institute working group on the translation of cardiovascular molecular imaging. Circulation, 123 (19), 2157-2163.

Center for Medicare and Medicaid Services. CMS.gov. Local Coverage Determination (LCD): Category III CPT® Codes (L33392). Retrieved March 2, 2017 from https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33392&.

Doi, T., Nakata, T., Hashimoto, A., Yuda, S., Wakabayashi, T., Kouza, H., et al. (2012). Synergistic prognostic values of cardiac sympathetic innervation with left ventricular hypertrophy and left atrial size in heart failure patients without reduced left ventricular ejection fraction: A cohort study. BMJ Open, 2 (6), 1-11. (Level 2 evidence - Independent study)

Flotats, A., Carrió, I., Agostini, D., Le Guludec, D., Marcassa, C., Schaffers, M., et al. (2010). Proposal for standardization of 123I-metaiodobenzylguanidine (MIBG) cardiac sympathetic imaging by the EANM Cardiovascular Committee and the European Council of Nuclear Cardiology. European Journal of Nuclear Medicine and Molecular Imaging. (Level 5 evidence)

Gerson, M., Caldwell, J., Ananthasubramaniam, K., Clements, I., Henzlova, M., Amanullah, A., et al. (2011). Influence of diabetes mellitus on prognostic utility of imaging of myocardial sympathetic innervation in heart failure patients. Circulation: Cardiovascular Imaging, 2011; 4: 87-93. (Level 2 evidence)

Jacobson, A. F., Senior, R., Cerqueira, M. D., Wong, N. D., Thomas, G. S., Lopez, V. A., et al. (2010). Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study. American College of Cardiology, 55 (20), 2212-2221. (Level 1 evidence - Industry sponsored)

Leuschner, F., & Nahrendorf, M. (2011). Molecular imaging of coronary atherosclerosis and myocardial infarction: Considerations for the bench and perspectives for the clinic. Circulation Research, 108 (5), 593-606.

Nakajima, K., Nakata T., Yamada, T., Yamashina, S., Momose, M., Kasama, S., et al. (March 2014). A prediction model for 5-year cardiac mortality in patients with chronic heart failure using 123I-metaiodobenzylguanidine imaging. European Journal of Nuclear Medicine Molecular Imaging. (2014) 41:1673–1682. (Level 2 evidence - Independent study)

Nakata, T., Kakajima, K., Yamashina, S., Yamada, T., Momose, M., Kasama, S., et al. (2013). A pooled analysis of multicenter cohort studies of 123I-mIBG imaging of sympathetic innervation of assessment of long-term prognosis in heart failure. Journal of the American College of Cardiology: Cardiovascular Imaging, 6 (7), 772-784. (Level 2 evidence - Independent study)

Shah, A. M., Bourgoun, M., Narula, J., Jacobson, A. F., & Solomon, S. D. (2012). Influence of ejection fraction on the prognostic value of sympathetic innervation imaging with iodine-123 MIBG in heart failure. JACC. Cardiovascular Imaging, 5 (11), 1139-1146. (Level 2 evidence - Industry sponsored)

Technology Evaluation Center. (2013). Myocardial sympathetic innervation imaging in heart failure. (Vol. 28, No. 12) Retrieved May 18, 2015 from http://www.bcbs.com/blueresources/tec/tec-assessments.html#topics.

Travin, M. I. (2013). Cardiac autonomic imaging with SPECT tracers. Journal of Nuclear Cardiology, 20 (1), 128- 143. (Level 5 evidence)

Treglia, G., Stefanelli, A., Bruno, I., & Giordano, A. (2013). Clinical usefulness of myocardial innervations imaging using iodine-123-meta-iodobenzylguanidine scintigraphy in evaluating the effectiveness of pharmacological treatments in patients with heart failure: An overview. European Review for Medical and Pharmacological Sciences, 17 (1), 56-68. (Level 4 evidence)

U. S. Food and Drug Administration. (2013, March). Center for Drug Evaluation and Research. AdreView. Retrieved July 25, 2013 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022290s001lbl.pdf.

U. S. Food and Drug Administration. (2016, March). Center for Drug Evaluation and Research. Approved Drug Product List.  Retrieved May 12, 2016 from http://www.accessdata.fda.gov/drugsatfda.

Verschure, D., Veltman, C., Manrique, A., Somsen, A., Koutelou, M., Katsikis, A., et al., (2014). For what endpoint does myocardial 123I-MIBG scintigraphy have the greatest prognostic value in patients with chronic heart failure? Results of a pooled individual patient data meta-analysis. European Heart Journal - Cardiovascular Imaging. (2014) 15, 996–1003 (Level 4 evidence)

ORIGINAL EFFECTIVE DATE:  12/14/2013

MOST RECENT REVIEW DATE:  4/13/2017   

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.