Medical Policy

 

Subject: Near-Infrared Coronary Imaging and Near-Infrared Intravascular Ultrasound Coronary Imaging
Document #: RAD.00057 Publish Date:    12/27/2017
Status: Reviewed Last Review Date:    11/02/2017

Description/Scope

 

This document addresses near-infrared coronary imaging and near-infrared intravascular ultrasound coronary imaging. Near-infrared coronary imaging, also referred to as near-infrared spectroscopy (NIRS), was created for the near-infrared examination of coronary arteries to detect plaques with large lipid cores in individuals undergoing cardiac angiography. Subsequently, near-infrared intravascular ultrasound coronary imaging was developed for the near-infrared examination of coronary arteries during invasive coronary angiography in combination with intravascular ultrasound (IVUS) examination of coronary intravascular pathology.
 

Position Statement

Investigational and Not Medically Necessary:

Near-infrared coronary imaging is considered investigational and not medically necessary for all indications.

Near-infrared intravascular ultrasound coronary imaging is considered investigational and not medically necessary for all indications.

Rationale

Near-infrared coronary imaging (LipiScanCoronary Imaging System [InfraReDx, Inc., Burlington, MA]) was cleared for marketing through the U.S. Food and Drug Administration (FDA) 510(k) process in April 2008. According to the 510(k) summary, the device is intended for the near-infrared examination of coronary arteries, for the detection of lipid-core-containing plaques of interest, and for the assessment of coronary artery lipid core burden. The LipiScan Coronary Imaging System utilizes the same basic catheter design and the same operating principle as the predicate device, the InfraReDx NIR Imaging System.

Near-infrared intravascular ultrasound coronary imaging (InfraReDx LipiScan IVUS Imaging System [InfraReDx, Inc., Burlington, MA]) was cleared for marketing by the FDA 510(k) process in June 2010. The system combines both near-infrared and intravascular ultrasound technologies. According to the 510(k) summary, modifications from the LipiScan Coronary Imaging System to the LipiScan IVUS Imaging System are the inclusion of ultrasound imaging within the same dimensions of the catheter and an expanded indication for use (ultrasound examination of coronary intravascular pathology). The InfraReDx LipiScan IVUS imaging system utilizes the same basic catheter design and the same operating principle as the predicate LipiScan Coronary Imaging system, while the ultrasound capabilities are functionally equivalent to the iLab Ultrasound Imaging System (Boston Scientific Corp., Fremont, CA). The TVC Imaging System™ (Infraredx, Inc., Burlington, MA), also a dual-modality NIRS/IVUS imaging device, was cleared for marketing by the FDA 510(k) process in March 2013.

Gardner and colleagues (2008) studied the ability of NIRS to detect lipid core plaques in human coronary artery autopsy specimens by assessing the correlation between NIRS and the gold standard of histology. The NIRS measurements were obtained under conditions imitating those found in individuals undergoing cardiac catheterization. NIRS was performed on 212 coronary segments obtained from 84 autopsy hearts. For every 2 millimeters (mm) of artery, 1 histologic section was analyzed. The first 33 hearts were used to develop an algorithm and the remaining 51 hearts were used to prospectively analyze the accuracy of NIRS in the detection of lipid core plaque (LCP). LCPs were found to be present in 115 (4.3%) sections from the 51 validation hearts. The algorithm prospectively recognized LCP with a receiver-operator characteristic area of 0.80 (95% confidence interval [CI], 0.76 to 0.85). The lipid core burden index identified the presence of any fibroatheroma with an area under the curve of 0.86% (95% CI, 8.81 to 0.91). Lipid core burden index was retrospectively analyzed in extreme artery segments with either extensive or no fibroatheroma and yielded an area under the curve of 0.96% (95% CI, 0.92 to 1.00). The authors noted that study limitations included lack of use of living tissue, lack of simulation of coronary motion, and avoidance of the tortuous anatomy of the in situ coronary vasculature. An additional limitation appears to be small sample size.

Several authors, (Garcia-Garcia, 2008; Schaar, 2007) described imaging techniques (including NIRS) which were being studied to detect coronary vulnerable plaques in human coronary arteries in vivo. Both authors were in agreement that none of the techniques studied had proven value and additional clinical testing is needed. Potential problems of NIRS include acquisition time, blood scattering, and influence of pH and temperature (Schaar, 2007; Vaina, 2005). Suh and colleagues (2011) reported major limitations of NIRS as the detection of only one characteristic of vulnerable plaque and an inability to determine depth (superficial versus deep) of the lipid core.

Waxman and colleagues (2009) reported on a phase II, phase III diagnostic, non-randomized, open label, uncontrolled, multicenter clinical trial (SPECTACL: SPECTroscopic Assessment of Coronary Lipid) designed to determine whether catheter-based NIRS signals obtained with a catheter-based system from the coronary arteries of living individuals are similar to those from autopsy specimens. A secondary goal of the study was to assess initial safety of the device. A total of 106 individuals were enrolled in the study which was conducted between January 2006 and October 2007. Seventeen individuals were initially eliminated due to technical issues, leaving 89 individuals for final analysis. Spectra from 30 of the 89 individuals were unblinded to test calibration. From the remaining 59 blinded cases, 11 were excluded due to inadequate data. Final data acquired was blindly compared with autopsy NIRS signals. Spectral similarity was exhibited in 40 of 48 adequate scans. Lipid core containing plaque was demonstrated in 58% of 60 spectrally similar scans from both cohorts. The authors noted that study limitations included a high rate of failure to obtain adequate data, lack of repeatability data, and lack of perfect correlation with a given histologic feature, as is typical for an imaging device. An additional limitation appears to be small sample size.

Alsheikh-Ali and colleagues (2010) conducted a literature review regarding plaque vulnerability. A total of 120 studies were found which used imaging characteristics to predict plaque vulnerability. Different imaging methods were examined, including intravascular ultrasonography. The imaging studies were almost always limited by retrospective or cross-sectional design and none of the studies documented whether the identified lesions were responsible for the cardiovascular events. The authors noted that “the few prospective studies published to date could not measure the direct effect of imaging methods on physician decision making or patient outcomes, nor could they reliably document whether the identified lesions were responsible for future cardiovascular events.”

Two case reports (Garg, 2010; Schultz, 2010) describe the clinical use of combined NIRS and IVUS. Both authors reported on a single individual who underwent this procedure and indicated further validation or prospective studies were needed. Madder and colleagues (2011) reported on a case series of 6 individuals who underwent NIRS and IVUS and also concluded that further studies are necessary.  

In 2013, Madder and colleagues studied combined NIRS and IVUS findings of culprit lesions in ST-segment elevation myocardial infarction (STEMI). Autopsy findings indicate that most STEMI are caused by rupture of preexisting LCP. During this study, 20 individuals with acute STEMI had their culprit vessels evaluated with combined NIRS and IVUS. The STEMI culprit findings were compared to findings in nonculprit segments of the artery and also to findings in autopsy control segments. Culprit and control segments were analyzed for the maximum lipid core burden index in a 4 mm length of artery (maxLCBI4mm). MaxLCBI4mm was 5.8-fold higher in STEMI culprit segments than in 87 nonculprit segments of the STEMI culprit vessel and 87-fold higher than in 279 coronary autopsy segments free of large LCP by histology. Within the STEMI culprit artery, NIRS accurately distinguished culprit from nonculprit segments (receiver-operating characteristic analysis area under the curve 0.90). A threshold of maxLCBI4mm > 400 distinguished STEMI culprit segments from specimens free of large LCP by histology (sensitivity: 85%, specificity: 98%). The authors concluded that their data supports a long-term, large prospective study to test the hypothesis that intracoronary NIRS can provide accurate, site-specific prediction that a given plaque is likely to cause a coronary event and thereby facilitate development of more effective preventive therapies.

Roleder and colleagues (2014) investigated the ability of a combined imaging catheter with NIRS plus IVUS to detect thin-cap fibroatheromas (TCFA) in individuals with stable coronary artery disease. Coronary segments with incomplete or poor quality NIRS, IVUS or optical coherence tomography (OCT) scans were initially removed from the investigation (16 coronary segments), resulting in a final analysis of 76 coronary segments assessed in 60 individuals. OCT and combined NIRS-IVUS assessment were performed on identical coronary segments. OCT was used as the gold-standard reference to define TCFA (fibrous cap thickness < 65 micrometers [μm]). Plaque lipid content was estimated by NIRS (lipid core burden index [LCBI]). OCT-defined TCFA was present in 18 of 76 segments. IVUS revealed that OCT-defined TCFA were positively remodeled lesions with greater plaque burden and plaque volume, smaller cross sectional area, and longer plaque length, while NIRS revealed greater LCBI per 2 mm segment (LCBI2mm) (all p<0.001). Greatest accuracy for OCT-defined TCFA detection was achieved using LCBI2mm > 315 with remodeling index (RI) > 1.046 as a combined criterion value. The authors concluded that OCT-defined TCFA are characterized by positive vessel remodeling, high plaque burden and greater lipid core burden as assessed by dual NIRS-IVUS imaging. Study limitations included a low number of subjects and the findings require validation with a larger sample size.

A single center, prospective, observational sub-study by Oemrawsing and colleagues (2014) assessed the prognostic value of coronary NIRS imaging. Between April 2009 and January 2011, a total of 203 individuals were enrolled in the study prior to coronary angiography for stable angina pectoris (SAP) or acute coronary syndrome (ACS). The pre-specified primary endpoint was the composite of all-cause mortality, nonfatal ACS, stroke, and unplanned coronary revascularization. Median follow-up was 1 year and follow-up was completed in all of the study participants. The cumulative incidence of the primary endpoint was 10.4% at 1 year. Cumulative 1 year rates in those with an LCBI at and above the median (43.0) versus those with LCBI values below the median were 16.7% versus 4.0% (adjusted hazard ratio 4.04; 95% CI, 1.33-12.29; p=0.01). Similar relationships were reported between LCBI and the primary endpoint in subjects with initial SAP and ACS. Study limitations included a small sample size and small corresponding number of events. The authors noted that their results were hypothesis generating and needed confirmation by larger trials that overcome the limitations of their study.

In 2016, Madder and colleagues evaluated NIRS and IVUS findings in pre-existing stents. A comparison was made of NIRS findings in pre-existing stents, in which an increased lipid signal possibly indicated neoatherosclerosis, to NIRS findings in a control group of newly implanted stents. In the group of pre-existing stents, at the location of lipid-rich plaque (LRP) detected by NIRS, IVUS was used to determine if neointimal tissue was present. LCBI and maximum LCBI were measured within stented segments. Of 60 pre-existing stents, NIRS detected LRP in 33%. At the location of LRP, IVUS found no neointimal tissue in 35% of cases. NIRS findings in pre-existing stents were reported as indistinguishable from those of the newly implanted stents. The authors concluded that detection of LRP in a pre-existing stent by NIRS alone is not reliable evidence of neoatherosclerosis. Further noted was that IVUS may provide insight into the potential source of the lipid signal in pre-existing stents. Study limitations included a small sample size and single-center design. Future studies are needed to determine the clinical relevance of NIRS-IVUS findings in pre-existing stents.

Currently, there is insufficient evidence available in the peer reviewed literature to determine the clinical utility of both near-infrared coronary imaging and near-infrared intravascular ultrasound imaging systems. Large, well-designed studies demonstrating the effectiveness of these technologies in improving clinical outcomes are needed.

Background/Overview

Coronary artery plaque is a deposit consisting of cholesterol-rich fat, calcium, and other substances found in the blood. As plaque accumulates on the artery wall, it reduces blood flow to the heart muscle and increases the risk of blood clots which can lead to a heart attack. Vulnerable plaque is coronary artery plaque that is unstable and at high risk of rupturing, thereby causing a clinical cardiovascular event.

The LipiScan Coronary Imaging System is a device created to detect and evaluate coronary artery plaque. It works by inserting a fiberoptic laser into the artery and measuring the wavelengths that are reflected back from the artery wall. The light reflected back at different wavelengths is analyzed to detect the chemical composition of the coronary plaque. A color-coded map is produced by the device console showing the intensity and location of lipid core within plaques of interest in the artery. A lipid core burden index is also reported, which is a measure of the total amount of lipid core containing plaques of interest in the coronary artery.

The InfraReDx LipiScan IVUS Imaging System has a similar intended use and functionality as the LipiScan Coronary Imaging System and also includes intravascular ultrasound imaging of coronary intravascular pathology. A catheter accesses the coronary vasculature and the device output is an image of the artery wall, as an adjunct to coronary angiography.

In a similar manner to the InfraReDx Lipiscan IVUS, the TVC Imaging System uses integrated near-infrared and intravascular ultrasound technology to identify lipid-core plaque and intravascular pathology.

Definitions

Coronary arteries: Blood vessels supplying blood to the heart.

Fibroatheroma: Lipid rich plaque suspected to be a type of vulnerable plaque.

Lipid: A fatty substance in the blood.

Neoatherosclerosis: A phenomenon in which lipid-rich plaques develop within pre-existing stents.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:

CPT

 

0205T

Intravascular catheter-based coronary vessel or graft spectroscopy (eg, infrared) during diagnostic evaluation and/or therapeutic intervention including imaging supervision, interpretation and report, each vessel (add-on)

 

 

ICD-10 Procedure

 

8E023DZ

Near infrared spectroscopy of circulatory system, percutaneous approach

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Alsheikh-Ali AA, Kitsios GD, Balk EM, et al. The vulnerable atherosclerotic plaque: scope of the literature. Ann Intern Med. 2010; 153(6):387-395.
  2. Caplan JD, Waxman S, Nesto RW, Muller JE. Near-infrared spectroscopy for the detection of vulnerable coronary artery plaques. J Am Coll Cardiol. 2006; 47(8 Suppl):C92-96.
  3. de Boer SP, Brugaletta S, Garcia-Garcia HM, et al. Determinants of high cardiovascular risk in relation to plaque-composition of a non-culprit coronary segment visualized by near-infrared spectroscopy in patients undergoing percutaneous coronary intervention. Eur Heart J. 2014; 35(5):282-289.
  4. García-García HM, Gonzalo N, Granada JF, et al. Diagnosis and treatment of coronary vulnerable plaques. Expert Rev Cardiovasc Ther. 2008; 6(2):209-222.
  5. Gardner CM, Tan H, Hull EL, et al. Detection of lipid core coronary plaques in autopsy specimens with a novel catheter-based near-infrared spectroscopy system. JACC Cardiovasc Imaging. 2008; 1(5):638-648.
  6. Garg S, Serruys PW, van der Ent M, et al. First use in patients of a combined near infra-red spectroscopy and intra-vascular ultrasound catheter to identify composition and structure of coronary plaque. EuroIntervention. 2010; 5(6):755-756.
  7. Kang SJ, Mintz GS, Pu J, et al. Combined IVUS and NIRS detection of fibroatheromas: histopathological validation in human coronary arteries. JACC Cardiovasc Imaging. 2015; 8(2):184-194.
  8. Madder RD, Goldstein JA, Madden SP, et al. Detection by near-infrared spectroscopy of large lipid core plaques at culprit sites in patients with acute ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2013; 6(8):838-846.
  9. Madder RD, Khan M, Husaini M, et al. Combined near-infrared spectroscopy and intravascular ultrasound imaging of pre-existing coronary artery stents: can near-infrared spectroscopy reliably detect neoatherosclerosis? Circ Cardiovasc Imaging. 2016; 9(1). pii: e003576.
  10. Madder RD, Steinberg DH, Anderson RD. Multimodality direct coronary imaging with combined near-infrared spectroscopy and intravascular ultrasound: initial US experience. Catheter Cardiovasc Interv. 2013; 81(3):551-557.
  11. Moreno PR, Lodder RA, Purushothaman KR, et al. Detection of lipid pool, thin fibrous cap, and inflammatory cells in human aortic atherosclerotic plaques by near-infrared spectroscopy. Circulation. 2002; 105(8):923-927.
  12. Oemrawsingh RM, Cheng JM, García-García HM, et al; ATHEROREMO-NIRS Investigators. Near-infrared spectroscopy predicts cardiovascular outcome in patients with coronary artery disease. J Am Coll Cardiol. 2014; 64(23):2510-2518.
  13. Puri R, Madder RD, Madden SP, et al. Near-infrared spectroscopy enhances intravascular ultrasound assessment of vulnerable coronary plaque: A combined pathological and in vivo study. Arterioscler Thromb Vasc Biol. 2015; 35(11):2423-2431.
  14. Roleder T, Kovacic JC, Ali Z, et al. Combined NIRS and IVUS imaging detects vulnerable plaque using a single catheter system: a head-to-head comparison with OCT. EuroIntervention. 2014; 10(3):303-311.
  15. Schaar JA, Mastik F, Regar E, et al. Current diagnostic modalities for vulnerable plaque detection. Curr Pharm Des. 2007; 13(10):995-1001.
  16. Schultz CJ, Serruys PW, van der Ent M, et al. First-in-man clinical use of combined near-infrared spectroscopy and intravascular ultrasound: a potential key to predict distal embolization and no-reflow? J Am Coll Cardiol. 2010; 56(4):314.
  17. Suh WM, Seto AH, Margey RJ, et al. Intravascular detection of the vulnerable plaque. Circ Cardiovasc Imaging. 2011; 4(2):169-178.
  18. Tan KT, Lip GY. Imaging of the unstable plaque. Int J Cardiol. 2008; 127(2):157-165.
  19. Vaina S, Stefanadis C. Detection of the vulnerable coronary atheromatous plaque. Where are we now? Int J Cardiovasc Intervent. 2005; 7(2):75-87.
  20. Wang J, Geng YJ, Guo B, et al. Near-infrared spectroscopic characterization of human advanced atherosclerotic plaques. J Am Coll Cardiol. 2002; 39(8):1305-1313.
  21. Waxman S, Dixon SR, L'Allier P, et al. In vivo validation of a catheter-based near-infrared spectroscopy system for detection of lipid core coronary plaques: initial results of the SPECTACL study. JACC Cardiovasc Imaging. 2009; 2(7):858-868.
  22. Waxman S, Ishibashi F, Caplan JD. Rationale and use of near-infrared spectroscopy for detection of lipid-rich and vulnerable plaques. J Nucl Cardiol. 2007; 14(5):719-728.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. U.S. Food and Drug Administration 510(k) Premarket Notification Database. iLab Ultrasound Imaging System. No. K051679. Rockville, MD: FDA. July 14, 2005. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051679.pdf. Accessed on August 29, 2017.
  2. U.S. Food and Drug Administration 510(k) Premarket Notification Database. LipiScan Coronary Imaging System. No. K072932. Rockville, MD: FDA. April 25, 2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072932.pdf. Accessed on August 29, 2017.
  3. U.S. Food and Drug Administration 510(k) Premarket Notification Database. InfraReDx LipiScan IVUS Imaging System. K093993. Rockville, MD: FDA. June 30, 2010. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093993.pdf. Accessed on August 29, 2017.
  4. U.S. Food and Drug Administration 510(k) Premarket Notification Database. TVC Imaging System. K123108. Rockville, MD: FDA. March 15, 2013. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf12/K123108.pdf. Accessed on August 29, 2017.
Index

InfraReDx LipiScan NIR Catheter Imaging System
InfraReDx LipiScan IVUS Imaging System
LipiScan Coronary Imaging System
Near-Infrared Imaging (NIR) as an Aid for the Evaluation of Coronary Artery Plaques
Near Infrared IVUS Imaging System
Near-Infrared Intravascular Ultrasound Coronary Imaging
NIR Spectroscopy
Near-Infrared Spectroscopy (NIRS)
TVC Imaging System

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review. Description/Scope, Rationale, Background/Overview and References sections updated. The document header wording updated from “Current Effective Date” to “Publish Date.”

Reviewed

11/03/2016

MPTAC review. Rationale, Definition and References sections updated.

Reviewed

11/05/2015

MPTAC review. Rationale and Reference sections updated. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review. Description, Rationale and Reference sections updated.

Reviewed

11/14/2013

MPTAC review. Rationale and Reference sections updated.

Reviewed

11/08/2012

MPTAC review. Rationale, References and Index sections updated.

Reviewed

11/17/2011

MPTAC review. Description, Rationale, Background, and References updated.

Revised

11/18/2010

MPTAC review. Title, Description, Rationale, Background, References, and Index updated. Clarified existing position statement and added a position statement addressing near-infrared intravascular ultrasound coronary imaging.

Reviewed

11/19/2009

MPTAC review. Description, rationale, background, references, and definitions updated. Updated Coding section with 01/01/2010 CPT changes.

New

11/20/2008

MPTAC review. Initial document development.