Medical Policy

 

Subject: Near-Infrared Spectroscopy Brain Screening for Hematoma Detection
Document #: MED.00116 Publish Date:    03/29/2018
Status: Reviewed Last Review Date:    02/27/2018

Description/Scope

 

This document addresses the use of near-infrared spectroscopy (NIRS) for the screening and detection of brain hematomas and intracranial bleeding. The InfraScanner2000 (InfraScan, Inc., Philadelphia, PA) system, a noninvasive handheld device, uses NIRS for the detection of possible development of intracranial hematomas in high-risk individuals, such as those with head trauma.

 

Position Statement

Investigational and Not Medically Necessary:

Near-infrared spectroscopy scanning for brain hematoma screening (that is, InfraScanner 2000) is considered investigational and not medically necessary for all indications.

Rationale

A near-infrared brain hematoma detector (that is, InfraScanner 2000) was cleared for marketing through the U.S. Food and Drug Administration (FDA) 510(k) process in January 2013. According to the 510(k) summary, the device is intended for the detection of traumatic supratentorial hematomas of greater than 3.5 mL in volume that are less than 2.5 cm from the brain surface, and as an adjunctive device to the clinical evaluation in the acute hospital setting of adults with suspected traumatic supratentorial intracranial hematomas. The device is indicated to assess individuals for head computerized tomography (CT) use but does not serve as a substitute for CT scanning. The InfraScanner 2000 has the same intended uses and similar indications as the predicate device, the InfraScanner 1000 (InfraScan, Inc., Philadelphia, PA).

Near-infrared (NIR) light can be transmitted through hair, scalp, bone, dura and brain for several centimeters. By knowing how the light is differentially absorbed by hemoglobin through the tissues and by calculating a differential between the right and left sides of the brain, a unilateral hematoma can be detected. Preliminary studies using portable NIRS technology found NIRS as a screening tool for intracranial hemorrhage (ICH) promising, although the studies were limited by small sample sizes (Francis, 2005; Kahraman, 2007; Kessel, 2007).

In 2007, Kessel and colleagues concluded that while infrared spectroscopy allowed early recognition of epidural and subdural hematomas in trauma cases, “further studies are needed to evaluate whether immediate confirmation or exclusion of epidural and subdural haematomas with portable near-infrared spectroscopy devices improves the decision-making process in the treatment of severely injured people.”

An industry-supported, multicenter, observational study by Robertson and colleagues (2010) evaluated the performance of non-invasive NIR-based screening for traumatic intracranial hematomas by comparing the findings of NIR screenings to participant admission CT scans (imaging within 12 hours of blunt or penetrating head injury). The study enrolled 365 participants; 96 were found to have intracranial hemorrhage with CT imaging. NIR demonstrated a sensitivity of 88% (95% confidence interval [CI], 74.9% to 95.0%) and a specificity of 90.7% (95% CI, 86.4% to 93.7%) in detecting the 50 intracranial hematomas that were large enough to be clinically important (larger than 3.5 mL in volume) and that were less than 2.5 cm from the surface of the brain. Considering all 96 study subjects, the sensitivity was 68.7% (95% CI, 58.3% to 77.6%), and the specificity was 90.7% (95% CI, 86.4% to 93.7%). The authors concluded that:

The high specificity and high negative predictive value (NPV) of the NIR examination suggest that the device might be useful to supplement clinical information, such as the neurological status, the mechanism of injury, and hemodynamic stability, which are used in the field to triage patients to a Level 1 trauma center, and in the emergency department to determine the urgency and/or the need to subsequent imaging studies. The portability of the NIR device might be particularly useful in military applications and other austere conditions. The NIR technology cannot replace CT scanning when it is readily available, but the finding of a positive NIR examination might suggest a higher priority for imaging, even in an otherwise low-risk patient. Future studies will be needed to confirm the role of this IR technology in the screening and treatment of traumatic brain injury (TBI).

The Department of Veterans Affairs (VA) published guidelines on the management of concussion or mild traumatic brain injury (mTBI) in 2009 (updated in 2016); these guidelines do not discuss a role for NIR brain hematoma detection using NIRS.

Bressan and colleagues (2014) reported results from a prospective, observational pilot study assessing the use of the InfraScanner in children with mild head injury. The authors concluded:

Larger multicenter studies are needed to appropriately assess InfraScanner accuracy for the management of children with minor head injury (MHI) in the emergency department (ED), as data on false negative results should be carefully analysed in order to minimize the risk of missing ciTBI while optimizing the selection of patients who need a CT scan. In addition, it would be interesting to assess the possible impact of negative NIRS results on the duration of observation in the ED or in the ED based observation unit, following a MHI.

In a systematic review and meta-analysis, Brogan and colleagues (2017) evaluated NIRS for detecting traumatic intracranial hematomas. After evaluating 192 studies from 1990-2015, the researchers included 8 in the meta-analysis. NIRS devices included the Infrascanner 1000, CrainScan (India), “smartscan,” and a researcher-developed device. In a broad adult population (n=783), the cross-study sensitivity was 78% (95% CI, 72% to 83%), the specificity 90% (95% CI, 87% to 92%), the negative predictive value (NPV) 90% (95% CI, 88% to 93%) and the positive predictive value (PPV) 77% (95% CI, 71% to 82%). The researchers concluded that NIRS technology for hematoma detection does not meet their requirements for diagnosing and triaging individuals and should not replace CT scans. They state that “larger and more heterogeneous studies are required that specifically evaluate NIRS performance in detecting intracranial lesions requiring emergency evacuation in the emergency department and prehospital setting.”

Peters and colleagues (2017) conducted a small feasibility study that compared the NIRS InfraScanner 2000 to CT scans in 25 individuals. Subjects were evaluated for TBI with the InfraScanner device before or during emergency helicopter transport to the hospital. Physicians were unable to complete a full scan for 10 individuals due to inaccessibility. Compared to the CT scan, the InfraScanner had three false positives and one false negative. The sensitivity was 93.3% and the specificity was 78.6%. Limitations of the study included a small sample size, potential selection bias, and lack of long-term follow-up. The authors concluded that further research is needed.

In a 2017 single-center, observational study, Xu and colleagues compared CT scan results with the NIRS InfraScanner 2000 for the detection of traumatic hematomas occurring within 12 hours of a blunt or penetrating head injury. A total of 85 subjects were categorized as either having intracranial hemorrhage (n=45), having a Glascow Coma Scale (GCS) score of 15 (indicating no intracranial hemorrhage; n=20), or healthy volunteers (n=20). Results included a specificity of 92.5% (95% CI, 78.5% to 98%), a sensitivity of 95.6% (95% CI, 83.6% to 99.2%), an NPV of 94.9% (95% CI, 81.4% to 99.1%), and a PPV of 93.5% (95% CI, 81.1% to 98.3%). Limitations of the study included methodological design; the healthy volunteers received MRI scans instead of CT scans. The authors noted concerns that the InfraScanner could miss bilateral hematomas, deep bleeds, and small contusions. Certain characteristics can create false positives such as scalp injuries, high-neck clothes, thick and dark hair, and scalp displacement. Additionally, it is not certain how different skin colors affect results. The researchers concluded that the InfraScanner has potential as a portable device, but future studies are needed.

Although NIR-based technology has been used to screen for brain hematoma at the site of injury, there have been limited published clinical studies and its clinical utility is unproven. Further well-designed studies of portable NIR brain imaging are needed to evaluate the effectiveness of this technology in improving the diagnosis of intracranial bleeds and in improving individual outcomes.

Background/Overview

 

According to the Centers for Disease Control and Prevention (CDC), in 2013 there were nearly 2.8 million Americans who suffered TBI, resulting in more than 50,000 deaths. According to the CDC, a TBI “is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the normal function of the brain." These injuries are principally the result of motor vehicle accidents, violence, sports injuries, and falls. Individuals who have suffered a TBI often experience residual impairments affecting motor control, communication skills, social behavior and cognition. These deficits may result in a variety of alterations in the individual, including but not limited to changes in memory, language, attention and concentration, visual processing, reasoning, and problem-solving, as well as emotional and behavioral control.

 

The InfraScanner 2000 brain imaging system is a device created to portably detect and evaluate traumatic supratentorial hematomas. The technology compares regional differences in absorbance of NIR light. The application of NIRS to hematoma evaluation is based on the principle that intracranial hemoglobin concentration will differ where a hematoma is present, compared to hemoglobin concentrations in normal intracranial regions.

 

Definitions

Hematoma: Localized swelling filled with blood, resulting from a ruptured blood vessel.

Traumatic brain injury: Occurs when an external mechanical force causes brain dysfunction, often associated with a diminished or altered state of consciousness, and potentially leads to permanent or temporary impairment of cognitive, physical, and psychosocial functions. TBI usually results from a violent blow or jolt to the head or body, but can also be caused by an object penetrating the skull.

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:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

93998

Unlisted noninvasive vascular diagnostic study [when specified as NIR imaging of the brain for hematoma screening]

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Bressan S, Daverio M, Martinolli F, et al. The use of handheld near-infrared device (InfraScanner) for detecting intracranial haemorrhages in children with minor head injury. Childs Nerv Syst. 2014; 30(3):477-484.
  2. Brogan RJ, Kontojannis V, Garara B, et al. Near-infrared spectroscopy (NIRS) to detect traumatic intracranial haematoma: a systematic review and meta-analysis. Brain Inj. 2017; 31(5):581-588.
  3. Fox WC, Park MS, Belverud S, et al. Contemporary imaging of mild TBI: the journey toward diffusion tensor imaging to assess neuronal damage. Neurol Res. 2013; 35(3):223-232.
  4. Francis SV, Ravindran G, Visvanathan K, Ganapathy K. Screening for unilateral intracranial abnormalities using near infrared spectroscopy: a preliminary report. J Clin Neurosci. 2005; 12(3):291-295.
  5. Kahraman S, Kayali H, Atabey C, et al. The accuracy of near-infrared spectroscopy in detection of subdural and epidural hematomas. J Trauma. 2006; 61(6):1480-1483.
  6. Kessel B, Jeroukhimov I, Ashkenazi I, et al. Early detection of life-threatening intracranial haemorrhage using a portable near-infrared spectroscopy device. Injury. 2007; 38(9):1065-1068.
  7. Leon-Carrion J, Dominguez-Rolan JM, Leon-Dominguez U, Murillo-Cabezas. The InfraScanner, a hand held device for screening in situ for the presence of brain haematomas. Brain Injury. 2010; 24(10)10:1193-1201.
  8. Peters J, Van Wageningen B, Hoogerwerf N, Tan E. Near-infrared spectroscopy: a promising prehospital tool for management of traumatic brain injury. Prehosp Disaster Med. 2017; 32(4):414-418.
  9. Robertson CS, Zager EL, Narayan RK, et al. Clinical evaluation of a portable near-infrared device for detection of traumatic intracranial hematomas. J Neurotrauma. 2010; 27(9):1597-1604.
  10. Xu L, Tao X, Liu W, et al. Portable near-infrared rapid detection of intracranial hemorrhage in Chinese population. J Clin Neurosci. 2017; 40:136-146.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American College of Emergency Physicians. Clinical policy: Neuroimaging and decision making in adult mild traumatic brain injury in the acute setting. Updated August 2008. Available at: http://www.acep.org/clinicalpolicies/. Accessed on October 31, 2017.
  2. Centers for Disease Control and Prevention (CDC). Injury prevention & control: traumatic brain injury. Updated March 27, 2015. Available at: https://www.cdc.gov/traumaticbraininjury/pdf/tbi_clinicians_factsheet-a.pdf. Accessed on October 31, 2017.
  3. Centers for Disease Control and Prevention (CDC). Updated mild traumatic brain injury guideline for adults. Available at: http://www.cdc.gov/traumaticbraininjury/pdf/fact_sheet_concusstbi-a.pdf. Accessed on October 31, 2017.
  4. Department of Veteran Affairs Department of Defense. VA/DoD clinical practice guideline for management of concussion/mild traumatic brain injury. Washington (DC): Department of Veteran Affairs, Department of Defense; 2016. Available at: https://www.healthquality.va.gov/guidelines/Rehab/mtbi/‌mTBICPGFullCPG50821816.pdf. Accessed on October 31, 2017.
  5. Giza CC, Kutcher JS, Ashwal S, et al. Summary of evidence-based update: evaluation and management of concussion in sports: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2013; 80(24):2250-2257. Available at:   http://n.neurology.org/content/80/24/2250 Accessed on October 31, 2017.
  6. National Institute of Neurological Disorders and Stroke (NINDS). NINDS Traumatic brain injury information page. Available at: https://www.ninds.nih.gov/Disorders/All-Disorders/Traumatic-Brain-Injury-Information-Page. Accessed October 31, 2017.
  7. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. InfraScan, Inc.’s InfraScanner Model 2000. Rockville, MD: FDA. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf12/k120949.pdf. Accessed on October 31, 2017.
Index

InfraScanner 2000
Near-Infrared Spectroscopy
Traumatic Brain Injury

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

02/27/2018

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

Reviewed

02/02/2017

MPTAC review.

Reviewed

02/04/2016

MPTAC review. Updated Description and References section. Removed ICD-9 codes from Coding section.

New

02/05/2015

MPTAC review. Initial document development.