Prior Authorization Review Panel MCO Policy Submission

A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date:11/01/2019

Policy Number: 0029 Effective Date: Revision Date: 03/18/2019

Policy Name: Thermography

Type of Submission – Check all that apply:

New Policy Revised Policy*

Annual Review – NoRevisions Statewide PDL

*All revisions to the pol icy must be highlighted using track changes throughout the document.

Please prov ide a ny clarifying information for the p olicy below:

CPB 0029 Th ermography

Clinical content waslast revisedon 03/18/2019. No additional non-clinical updates were made by Corporate since the last PARPsubmission.

Name of Authorized Individual (Please t ype or print):

Dr. Bernard Lewin, M.D.

Signature o f Authorized Individual:

Revised July 22, 2019

Proprietary

(https://www.aetna.com/)

Thermography

Clinical Policy Bulletins Medical Clinical Policy Bulletins

Number: 0029

*Please see amendment for Pennsylvania Medicaid at the end of this CPB.

Aetna considers thermography (including digital infrared thermal imaging, magnetic resonance (MR)

thermography and temperature gradient studies) experimental and investigational for all indications including the

following (not an all-inclusive list) because available medical literature indicates thermography to be an ineffective

diagnostic technique:

Assessment of myofascial trigger points

Detection and screening for breast cancer

Detection of rupture-prone vulnerable coronary plaque

Determination of the efficacy of stroke rehabilitation

Diagnosis of complex regional pain syndrome

Diagnosis of musculoskeletal injuries

Diagnosis and management of vasculitis

Early identification of skin neoplasms

Esophageal monitoring

Evaluation of acute skin toxicity of breast radiotherapy

Evaluation of burn wounds

Evaluation of dry eye disease

Evaluation of leprosy

Evaluation and monitoring of individuals with Emery-Dreifuss muscular dystrophy

Joint assessment in individuals with inflammatory arthritis

Management of infantile hemangioma

Monitoring of diabetes mellitus

Pre- and peri-operative management of hidradenitis suppurativa

Prediction and detection of pressure ulcers

Prognosis of post-herpetic neuralgia

Screening for adolescent idiopathic scoliosis.

Last Review

03/18/2019

Effective: 07/21/1995

Next

Review: 01/09/2020

Review History

Definitions

Clinical Policy

Bulletin Notes

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Aetna considers dynamic infrared blood perfusion imaging (DIRI) for intra-operative and post-operative perfusion

assessment (e.g., assessment of skin blood perfusion in cranioplasty and flap evaluation) experimental and

investigational because of insufficient evidence regarding its clinical effectiveness.

Thermography

Thermography is the measurement of temperature variations at the body surface. The scientific evidence

suggests that thermography may only confirm the presence of a temperature difference, and that other

procedures are needed to reach a specific diagnosis. Thermography may add little to what doctors already know

based on history, physical examination, and other studies.

Thermography studies are non-invasive imaging techniques that are intended to measure the skin surface

temperature distribution of various organs and tissues. The infrared radiation from the tissues reveals

temperature variations by producing brightly colored patterns on a liquid crystal display. Interpretation of the color

pattern is thought to contribute to the diagnosis of many disorders including breast cancer, Raynaud's

phenomenon, digital artery vasospasm, impaired spermatogenesis in infertile men, deep vein thrombosis, reflex

sympathetic dystrophy/complex regional pain syndrome, vertebral subluxation, and others.

In contrast to the skin surface thermography techniques used by some chiropractors and other providers, a newer

invasive test called a temperature gradient study involves an intravenous catheter. The catheter is threaded into

the coronary arteries to directly measure temperature differences on the inner artery walls. Researchers believe

this information may be related to the presence of unstable coronary artery plaques and could be useful in

diagnosing vulnerable patients. Madjid et al (2006) have shown that inflamed atherosclerotic plaques are hot and

their surface temperature correlates with an increased number of macrophages and decreased fibrous-cap

thickness. Multiple animal and human experiments have shown that temperature heterogeneity correlates with

arterial inflammation in vivo. Several coronary temperature mapping catheters are currently being developed and

studied. These thermography methods can be used in the future to detect vulnerable plaques, potentially to

determine patients' prognosis, and to study the plaque-stabilizing effects of different medications.

A number of medical authorities have concluded that thermography has no proven medical value, including the

American Medical Association, the Office of Health Technology Assessment (OHTA), and the American Academy

of Neurology. Based on a study by the OHTA, the Health Care Financing Administration (now the Center for

Medicare and Medicaid Services) withdrew Medicare coverage of thermography.

Devices that have been used for thermography skin temperature differential analysis include the Nervoscope, the

Temp-O-Scope, and the Neurocalometer.

There is insufficient evidence for the use of thermography for detection of breast cancer. A structured evidence

review of thermography for breast cancer (Kerr, 2004) reached the following conclusions: "The evidence that is

currently available does not provide enough support for the role of infrared thermography for either population

screening or adjuvant diagnostic testing of breast cancer. The major gaps in knowledge at this time can only be

addressed by large-scale, prospective randomised trials. More robust research on the effectiveness and costs of

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technologically advanced infrared thermography devices for population screening and diagnostic testing of breast

cancer is needed, and the conclusions of this review should be revisited in the face of additional reliable

evidence".

Other reviews have also found a need for additional research on thermography. Kennedy et al (2009) noted that

thermography was first introduced as a screening tool for breast cancer in mid-1950s. However, after a 1977

study found thermography to lag behind other screening tools, the medical community lost interest in this

diagnostic approach. These researchers discussed each screening tool with a focus brought to thermography.

They stated that no single diagnostic tool provides excellent predictability; however, a combination that

incorporates thermography may boost both sensitivity as well as specificity. The authors concluded that in light of

technological advances and maturation of the thermographical industry, more research is needed to confirm the

potential of thermography in providing an effective non-invasive, low-risk adjunctive tool for the early detection of

breast cancer.

Mammography is currently the gold standard for breast cancer screening. Thus, sensitivities, specificities, as well

as positive and negative predictive values of thermography need to be compared with those of mammography in

order to ascertain if thermography is equivalent or superior to mammography. Presently, there is a lack of

scientific data comparing the 2 screening techniques. In addition, there are no published evidence-based

practice guidelines and/or position statements that recommend thermography as the appropriate method of

screening for early detection of breast cancer.

Arora et al (2008) examined the effectiveness of a non-invasive digital infrared thermal imaging (DITI) system in

the detection of breast cancer. A total of 92 patients for whom a breast biopsy was recommended based on prior

mammogram or ultrasound underwent DITI. Three scores were generated: (i) an overall risk score in the

screening mode, (ii) a clinical score based on patient i nformation, and (iii) assessment by artificial neural

network. Sixty of 94 biopsies were malignant and 34 were benign. Digital infrared thermal imaging identified 58

of 60 malignancies, with 97 % sensitivity, 44 % specificity, and 82 % negative predictive value depending on the

mode used. Compared to an overall risk score of 0, a score of 3 or greater was significantly more likely to be

associated with malignancy (30 % versus 90 %, p < 0.03). The author concluded that DITI is a valuable adjunct

to mammography and ultrasound, especially in women with dense breast parenchyma. Moreover, the authors

reported a high negative predictive value for thermography where "the location of the lesion under question based

on prior imaging was assessed to generate a positive or negative clinical assessment", i.e., where they were

unblinded to the results of the prior mammography or ultrasound. The specificity was only 11 % and the negative

predictive value of thermography was only 66 % in the blinded screening mode. Furthermore, the authors stated

that DITI is not currently recommended or approved as a substitute for screening mammography, and correlation

of findings on DITI should be made with alternative imaging techniques. They stated that further studies are

needed using a representative screening population of persons who have not been selected for biopsy based

upon prior imaging results.

An American Cancer Society report Mammograms and Other Breast Imaging Procedures (2010) stated that "

[t]hermography is a way to measure and map the heat on the surface of the breast using a special heat-sensing

camera. It is based on the idea that the temperature rises in areas with increased blood flow and metabolism,

which could be a sign of a tumor. Thermography has been around for many years, and some scientists are still

trying to improve the technology to use it in breast imaging. But no study has ever shown that it is an effective

screening tool for finding breast cancer early. It should not be used as a substitute for mammograms. Newer

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versions of this test are better able to find very small temperature differences. They may prove to be more

accurate than older versions, and are now being studied to find out if they might be useful in finding cancer".

Thermography is listed under "newer and experimental breast imaging methods" in this report.

Additionally, the United Kingdom's NHS Cancer Screening Programmes (2010) stated that "thermography is nota

replacement for mammography. It is a relatively new test and isn't reliable enough to use either to diagnose or

screen for cancer. Mammography is still the best test and is used as a world wide standard for breast screening

in women over 50".

The Food and Drug Administration (FDA, 2011) stated that breast thermography should not be used instead of

mammography, noting that thermography has not been approved as a stand-alone tool for breast cancer

screening or diagnosis. Telethermographic devices produce infrared images and do not require exposure to

radiation or breast compression, which some healthcare providers claim make them superior to mammographic

devices. However, the FDA stated that "there is simply no evidence" that breast thermography can take the place

of mammography. The agency has sent warning letters to manufacturers and practitioners who have made

misleading claims about breast thermography use.

Currently, there is insufficient evidence to support the use of thermography for the diagnosis of complex regional

pain syndrome (CRPS). The use of thermography in the diagnosis of CRPS type 1 (CRPS1) is based on the

presence of temperature asymmetries between the involved area of the extremity and the corresponding area of

the uninvolved extremity. However, the interpretation of thermographical images is subjective and not validated

for routine use. Huygen et al (2004) developed a sensitive, specific and reproducible arithmetical model as the

result of computer-assisted infra-red thermography in patients with early stage CRPS1 in one hand. Eighteen

patients with CRPS1 on one hand and 13 healthy volunteers were included in the study. The severity of the

disease was determined by means of pain questionnaires [visual analogue scale (VAS) pain and McGill Pain

Questionnaire], measurements of mobility (active range of motion) and edema volume. Asymmetry between the

involved and the uninvolved extremities was calculated by means of the asymmetry factor, the ratio and the

average temperature differences. The discrimination power of the 3 methods was determined by the receiver-

operating curve (ROC). The regression between the determined temperature distributions of both extremities

was plotted. Subsequently the correlation of the data was calculated. In normal healthy individuals the

asymmetry factor was 0.91 (0.01) (SD), whereas in CRPS1 patients this factor was 0.45 (0.07) (SD). The

performance of the arithmetic model based on the ROC curve was excellent. The area under the curve was 0.97

(p < 0.001), the sensitivity and specificity was 9 2% and 94 %, respectively. Furthermore, the temperature

asymmetry factor was correlated with the duration of the disease and VAS pain.

Gradl and colleagues (2003) stated that CRPS1 represents a frequent complication following distal radial

fractures. These investigators studied the value of clinical evaluation, radiography and thermography in the early

diagnosis of CRPS1. A total of 158 patients with distal radial fractures were followed-up for 16 weeks after

trauma. Apart from a detailed clinical examination 8 and 16 weeks after trauma, thermography and bilateral

radiographs of both hands were carried out. At the end of the observation period 18 patients (11 %) were

clinically identified as CRPS1. The severity of the preceding trauma and the chosen therapy did not influence the

process of the disease. Sixteen weeks after trauma easy differentiation between normal fracture patients and

CRPS1 patients was possible. Eight weeks after distal radial fracture clinical evaluation showed a sensitivity of

78 % and a specificity of 94 %. On the other hand, thermography (58 %) and bilateral radiography (33 %)

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revealed poor sensitivities. The specificity was high for radiography (91 %) and again poor for thermography (66

%). These authors concluded that the results of the study support the importance of clinical evaluation in the

early diagnosis of CRPS1. Plain radiographs facilitate the diagnosis as soon as bony changes develop.

Arterial wall thermography has also been used to identify rupture-prone vulnerable coronary plaque. However,

the clinical value of arterial thermography in interventional cardiology has not been established.

Schaar and colleagues (2007) noted that rupture of vulnerable plaques is the principal cause of acute coronary

syndrome and myocardial infarction. Identification of vulnerable plaques is therefore essential to enable the

development of treatment modalities to stabilize such plaques. Thermography is one of the several novel

methods being examined for detecting vulnerable plaques. It evaluates the temperature heterogeneity as an

indicator of the metabolic state of the plaque. The authors concluded that while several invasive and non­

invasive techniques are currently under development to assess vulnerable plaques, none has proven its value in

an extensive in-vivo validation and all have a lack of prospective data.

García-García and colleagues (2008) stated that thin-capped fibroatheroma is the morphology that most

resembles plaque rupture. Detection of these vulnerable plaques in-vivo is essential to being able to study their

natural history and evaluate potential treatment modalities and, therefore, may ultimately have an important

impact on the prevention of acute myocardial infarction and death. The investigators reported that, currently,

conventional grayscale intra-vascular ultrasound, virtual histology and palpography data are being collected with

the same catheter during the same pullback. A combination of this catheter with either thermography capability

or additional imaging, such as optical coherence tomography or spectroscopy, would be an exciting

development. Intra-vascular magnetic resonance imaging also holds much promise. The investigators stated

that, to date, none of the techniques described above has been sufficiently validated and, most importantly, their

predictive value for adverse cardiac events remains elusive. The investigators concluded that very rigorous and

well-designed studies are needed for defining the role of each diagnostic modality. Until researchers are able to

detect in-vivo vulnerable plaques accurately, no specific treatment is warranted.

Madjid and colleagues (2006) stated that up to 2/3 of acute myocardial infarctions develop at sites of culprit

lesions without a significant stenosis. New imaging techniques are needed to identify those lesions with an

increased risk of developing an acute complication in the near future. Inflammation is a hallmark feature of these

vulnerable/high-risk plaques. These investigators have demonstrated that inflamed atherosclerotic plaques are

hot and their surface temperature correlates with an increased number of macrophages and reduced fibrous-cap

thickness. They noted that animal and human studies have reported that temperature heterogeneity correlates

with arterial inflammation in-vivo. Several coronary temperature mapping catheters are currently being

developed. These thermographic methods can be used in the future to detect vulnerable plaques, potentially to

ascertain patients' prognosis, and to examine the plaque-stabilizing effects of various pharmacotherapies.

Sharif and Murphy (2010) noted that critical coronary stenoses have been shown to contribute to only a minority

of acute coronary syndromes and sudden cardiac death. Autopsy studies have identified a subgroup of high-risk

patients with disrupted vulnerable plaque and modest stenosis. Consequently, a clinical need exists to develop

methods to identify these plaques prospectively before disruption and clinical expression of disease. Recent

advances in invasive as well as non-invasive imaging techniques have shown the potential to identify these high-

risk plaques. The anatomical characteristics of the vulnerable plaque such as thin cap fibro-atheroma and lipid

pool can be identified with angioscopy, high frequency intra-vascular ultrasound, intra-vascular magnetic

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resonance imaging (MRI), and optical coherence tomography. Efforts have also been made to recognize active

inflammation in high-risk plaques using intra-vascular thermography. Plaque chemical composition by measuring

electro-magnetic radiation using spectroscopy is also an emerging technology to detect vulnerable plaques. Non­

invasive imaging with MRI, computed tomography, and positron emission tomography also holds the potential to

differentiate between low-risk and high-risk plaques. However, at present none of these imaging modalities is

able to detect vulnerable plaque nor have they been shown to definitively predict outcome. Nevertheless in

contrast, there has been a parallel development in the physiological assessment of advanced athero-sclerotic

coronary artery disease. Thus, recent trials using fractional flow reserve in patients with modest non flow-limiting

stenoses have shown that deferral of percutaneous coronary intervention with optimal medical therapy in these

patients is superior to coronary intervention. The authors concluded that further trials are needed to provide more

information regarding the natural history of high-risk but non flow-limiting plaque to establish patient-specific

targeted therapy and to refine plaque stabilizing strategies in the future.

There is insufficient evidence to support the use of thermography in post-herpetic neuralgia. Han and

associates (2010) examined the usefulness of infrared thermography as a predictor of post-herpetic neuralgia

(PHN). Infrared thermography was performed on the affected body regions of 110 patients who had been

diagnosed with acute herpes zoster (HZ). Demographical data collected included age, gender, time of skin

lesions onset, development of PHN, and co-morbidities. The temperature differences between the unaffected

and affected dermatome were calculated. Differences greater than 0.6 degrees C for the mean temperature

across the face and trunk were considered abnormal. The affected side was warmer in 35 patients and cooler in

33 patients than the contralateral side. A patient's age and disease duration affected treatment outcomes.

However, the temperature differences were not correlated with pain severity, disease duration, allodynia,

development of PHN, and use of anti-viral agents (p > 0.05). The authors concluded that a patient's age and

disease duration are the most important factors predicting PHN progression, irrespective of thermal findings, and

PHN can not be predicted by infrared thermal imaging.

An Agency for Healthcare Research and Quality's report on non-invasive diagnostic techniques for thedetection

of skin cancers (Parsons et al, 2011) listed thermography as one of the investigational diagnostic techniques for

the detection of skin cancers.

Kontos et al (2011) determined the sensitivity and specificity of DITI in a series of women who underwent surgical

excision or core biopsy of benign and malignant breast lesions presenting through the symptomatic clinic. Digital

infrared thermal imaging was evaluated in 63 symptomatic patients attending a 1-stop diagnostic breast clinic.

Thermography had 90 true-negative, 16 false-positive, 15 false-negative and 5 true-positive results. The

sensitivity was 25 %, specificity 85 %, positive-predictive value 24 %, and negative-predictive value 86 %. The

authors concluded that despite being non-invasive and painless, because of the low sensitivity for breast cancer,

DITI is not indicated for the primary evaluation of symptomatic patients nor should it be used on a routine basis as

a screening test for breast cancer.

The Canadian Agency for Drugs and Technologies in Health’s technology assessment on Infrared thermography

for population screening and diagnostic testing for breast cancer” (Morrison, 2012) states that “No randomized

controlled trials have been conducted that compare the effectiveness of thermography with mammography for

screening in well women, and there is no evidence regarding the cost-effectiveness of thermography used for

screening. Prospective cohort studies of symptomatic patients or patients with abnormal mammograms or

ultrasounds do not provide the type of evidence needed to justify the use of thermography for breast screening.

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Results indicate that thermography performance is worse than mammography in terms of sensitivity, specificity,

and predictive values; however, some of the studies’ authors have suggested there may be a role for

thermography as an adjunct diagnostic test in some cases”.

Kim et al (2012) evaluated the accuracy of the size and location of the ablation zone produced by volumetric MRI-

guided high-intensity focused ultrasound (HIFU) ablation of uterine fibroids on the basis of MR thermometric

analysis and assessed the effects of a feedback control technique. A total of 33 women with 38 uterine fibroids

were treated with an MR imaging-guided HIFU system capable of volumetric feedback ablation. Size (diameter

times length) and location (3-D displacements) of each ablation zone induced by 527 sonications (with [n = 471]

and without [n = 56] feedback) were analyzed according to the thermal dose obtained with MR thermometry.

Prospectively defined acceptance ranges of targeting accuracy were ± 5 mm in left-right (LR) and cranio-caudal

(CC) directions and ± 12 mm in antero-posterior (AP) direction. Effects of feedback control in 8- and 12-mm

treatment cells were evaluated by using a mixed model with repeated observations within patients. Overall mean

sizes of ablation zones produced by 4-, 8-, 12-, and 16-mm treatment cells (with and without feedback) were 4.6

mm ± 1.4 (standard deviation) × 4.4 mm ± 4.8 (n = 13), 8.9 mm ± 1.9 × 20.2 mm ± 6.5 (n = 248), 13.0 mm ± 1.2 ×

29.1 mm ± 5.6 (n = 234), and 18.1 mm ± 1.4 × 38.2 mm ± 7.6 (n = 32), respectively. Targeting accuracy values

(displacements in absolute values) were 0.9 mm ± 0.7, 1.2 mm ± 0.9, and 2.8 mm ± 2.2 in LR, CC, and AP

directions, respectively. Of 527 sonications, 99.8 % (526 of 527) were within acceptance ranges. Feedback

control had no statistically significant effect on targeting accuracy or ablation zone size. However, variations in

ablation zone size were smaller in the feedback control group. The authors concluded that sonication accuracy of

volumetric MRI-guided HIFU ablation of uterine fibroids appears clinically acceptable and may be further

improved by feedback control to produce more consistent ablation zones.

Brkljacic et al (2013) noted that breast cancer is a common malignancy causing high mortality in women

especially in developed countries. Due to the contribution of mammographic screening and improvements in

therapy, the mortality rate from breast cancer has decreased considerably. An imaging-based early detection of

breast cancer improves the treatment outcome. Mammography is generally established not only as diagnostic

but also as screening tool, while breast ultrasound plays a major role in the diagnostic setting in distinguishing

solid lesions from cysts and in guiding tissue sampling. Several indications are established for contrast-enhanced

MRI. Thermography was not validated as a screening tool and the only study performed long ago for evaluating

this technology in the screening setting demonstrated very poor results. The conclusion that thermography might

be feasible for screening cannot be derived from studies with small sample size, unclear selection of patients, and

in which mammography and thermography were not blindly compared as screening modalities. Thermography

cannot be used to aspirate, biopsy or localize lesions pre-operatively since no method so far was described to

accurately transpose the thermographic location of the lesion to the mammogram or ultrasound and to surgical

specimen. The authors concluded that thermography cannot be proclaimed as a screening method, without any

evidence whatsoever.

The Work Loss Data Institute’s guideline on “Low back -- lumbar & thoracic (acute & chronic)” (2013) listed

thermography (infrared stress thermography) as one of the interventions/procedures that was considered, but is

not recommended.

Sanchis-Sanchez et al (2014) noted that musculoskeletal injuries occur frequently. Diagnostic tests using ionizing

radiation can lead to problems for patients, and infra-red thermal imaging could be useful when diagnosing these

injuries. A systematic review was performed to determine the diagnostic accuracy of infra-red thermal imaging in

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patients with musculoskeletal injuries. A meta-analysis of 3 studies evaluating stress fractures was performed

and found a lack of support for the usefulness of infra-red thermal imaging (including thermography) in

musculoskeletal injuries diagnosis.

Dibai-Filho and Guirro (2015) reviewed recent studies published on the use of infra-red thermography (IRT) for

the assessment of myofascial trigger points (MTrPs). A search of the MEDLINE, CINAHL, PEDro, and SciELO

databases was carried out between November 2012 and January 2013 for articles published in English,

Portuguese, or Spanish from the year 2000 to 2012. Because of the nature of the included studies and the

purpose of this review, the analysis of methodological quality was assessed using the Quality Assessment of

Diagnostic Accuracy Studies tool. The search retrieved 11 articles, 2 of which were excluded based on language

(German and Chinese); 3 were duplicated in different databases, 1 did not use IRT for diagnostic purposes, and

the other did not use IRT to measure the skin temperature. Thus, the final sample was made up of 4

observational investigations: 3 comparative studies and 1 accuracy study. The authors concluded that at present,

there are few studies evaluating the accuracy and reliability of IRT for the diagnosis and assessment of MTrPs.

Of the few studies present, there is no agreement on skin temperature patterns in the presence of MTrPs.

Burke-smith et al (2015) states that currently the only evidence-based adjunct to clinical evaluation of burn depth

is laser Doppler imaging (LDI), although preliminary studies of alternative imaging modalities with instant image

acquisition are promising. These researchers investigated the accuracy of IRT and spectrophotometric

intracutaneous analysis (SIA) for burn depth assessment, and compared this to the current gold standard: LDI.

They included a comparison of the 3 modalities in terms of cost, reliability and usability. These investigators

recruited 20 patients with burns presenting to the Chelsea and Westminster Adult Burns Service. Between 48

hours and 5 days after burn, these researchers recorded imaging using (i) moorLDI2-BI-VR (LDI), (ii) FLIR E60

(IRT) and (iii) Scanoskin (SIA). Subsequent clinical management and outcome was as normal, and not affected

by the extra images taken. A total of 24 burn regions were grouped according to burn wound healing: group A

healed within 14 days, group B within 14 to 21 days, and group C took more than 21 days or underwent grafting.

Both LDI and IRT accurately determined healing potential in groups A and C, but failed to distinguish between

groups B and C (p > 0.05). Scanoskin interpretation of SIA was 100 % consistent with clinical outcome. The

authors concluded that FLIR E60 and Scanoskin both presented advantages to moorLDI2-BI-VR in terms of cost,

ease-of-use and acceptability to patients. Infra-red thermography is unlikely to challenge LDI as the gold

standard as it is subject to the systematic bias of evaporative cooling. At present, the LDI color-coded palette is

the easiest method for image interpretation, whereas Scanoskin monochrome color-palettes are more difficult to

interpret. However the additional analyses of pigment available using SIA may help more accurately indicate the

depth of burn compared with perfusion alone. The authors suggested development of Scanoskin software to

include a simplified color-palette similar to LDI and additional work to further investigate the potential of SIA as an

alternative to the current gold standard.

Evaluation of Burn Wounds

Prindeze and associates (2015) noted that despite advances in perfusion imaging, burn wound imaging

technology continues to lag behind that of other fields. Quantification of blood flow is able to predict time for

healing, but clear assessment of burn depth is still questionable. Active dynamic thermography (ADT) is a non-

contact imaging modality capable of distinguishing tissue of different thermal conductivities. Utilizing the

abnormal heat transfer properties of the burn zones, these researchers examined if ADT was useful in the

determination of burn depth in a model of early burn wound evaluation. Duroc pigs (castrated male; n = 3) were

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anesthetized, and 2 burns were created with an aluminum billet at 3 and 12 seconds. These contact times

resulted in superficial partial and deep partial thickness burn wounds, respectively. Active dynamic thermography

and laser Doppler imaging (LDI) imaging were performed every 30 minutes post-burn for a total of 5 imaging

sessions ending 150 minutes post-burn. For ADT, imaging excitation was performed for 42 to 120 seconds with

dual quartz-infrared lamps, and subsequent infrared image capture was performed for 300 seconds; MATLAB-

assisted image analysis was performed to determine burn zone region of interest thermal relaxation and

characteristic patterns. Laser Doppler imaging was performed with a moorLDI system, and biopsies were

captured for histology following the 150-minute imaging session. Both ADT and LDI imaging modalities were able

to detect different physical properties at 30, 60, 90, 120, and 150 minutes post-burn with statistical significance (p

< 0.05). Resultant ADT cooling curves characterized greater differences with greater stimulation and a potentially

more identifiable differential cooling characteristic. Histological analysis confirmed burn depth. The authors

concluded that this preliminary work confirmed that ADT can measure burn depth and is deserving of further

research either as a stand-alone imaging technology or in combination with a device to assess perfusion.

Burke-Smith and colleagues (2015) stated that the only evidence-based adjunct to clinical evaluation of burn

depth is LDI, although preliminary studies of alternative imaging modalities with instant image acquisition are

promising. These investigators examined the accuracy of IRT and spectrophotometric intracutaneous analysis

(SIA) for burn depth assessment, and compared this to the current gold standard: LDI. They included a

comparison of the 3 modalities in terms of cost, reliability and usability. These investigators recruited 20 patients

with burns presenting to the Chelsea and Westminster Adult Burns Service. Between 48 hours and 5 days post-

burn, these researchers recorded imaging using moorLDI2-BI-VR (LDI), FLIR E60 (IRT) and Scanoskin (SIA).

Subsequent clinical management and outcome was as normal, and not affected by the extra images taken. A

total of 24 burn regions were grouped according to burn wound healing: group A healed within 14 days, group B

within 14 to 21 days, and group C took more than 21 days or underwent grafting. Both LDI and IRT accurately

determined healing potential in groups A and C, but failed to distinguish between groups B and C (p > 0.05).

Scanoskin interpretation of SIA was 100 % consistent with clinical outcome. The authors concluded that FLIR

E60 and Scanoskin both presented advantages to moorLDI2-BI-VR in terms of cost, ease-of-use and

acceptability to patients. Infrared thermography is unlikely to challenge LDI as the gold standard as it is subject to

the systematic bias of evaporative cooling. At present, the LDI color-coded palette is the easiest method for

image interpretation, whereas Scanoskin monochrome color-palettes are more difficult to interpret. However the

additional analyses of pigment available using SIA may help more accurately indicate the depth of burncompared

with perfusion alone. The authors suggested development of Scanoskin software to include a simplified color-

palette similar to LDI, and additional work to further investigate the potential of SIA as an alternative to the current

gold standard.

Evaluation of Dry Eye Disease

Tan and colleagues (2016) evaluated the effectiveness of IR ocular thermography in screening for dry eye

disease (DED); IR ocular thermography was performed on 62 dry eye and 63 age- and sex-matched control

subjects. Marking of ocular surface and temperature acquisition was done using a novel “diamond” demarcation

method. A total of 30 static- and 30 dynamic-metrics were studied and receiver operating characteristic curves

were plotted. Effectiveness of the temperature metrics in detecting DED were evaluated singly and in

combination in terms of their area under the curve (AUC), Youden's index and discrimination power (DP).

Absolute temperature of the extreme nasal conjunctiva 5s and 10s after eye opening were best detectors for

DED. With threshold value for the first metric set at 34.7° C, sensitivity and specificity was 87.1 % (95 % CI: 76.2

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to 94.3 %) and 50.8 % (95 % CI: 37.9 to 63.6 %), respectively. With threshold value for the second metric set at

34.5°C, sensitivity and specificity was 77.6 % (95 % CI: 64.7 to 87.5 %) and 61.9 % (95 % CI: 48.8 to 73.9 %),

respectively. The 2 metrics had moderate accuracy and limited performances with AUC of 72 % (95 % CI: 63 to

81 %) and 73 % (95 % CI: 64 to 82 %); Youden index of about 0.4 and DP of 1.07 and 1.05, respectively. None

of the dynamic metrics was good detector for DED. Combining metrics was not able to increase the AUC. The

authors concluded that the findings of this study suggested some utility for the application of IR ocular

thermography for evaluation of patients with DED.

Evaluation of Leprosy

Cavalheiro and associates (2016) examined if IRT would be able to measure the change in temperature in the

hands of people with leprosy. The study assessed 17 leprosy patients who were under treatment at the National

Reference Center for Sanitary Dermatology and Leprosy, and 15 people without leprosy for the control group.

The infrared camera FLIR A325 and Therma CAM Researcher Professional 2.9 software were used to measure

the temperature. The room was air-conditioned, maintaining the temperature at 25° C; the distance between the

camera and the limb was 70 cm. The vasomotor reflex of patients was tested by a cold stress on the palm. The

study showed a significant interaction between the clinical form of leprosy and temperature, where the control

group and the borderline-borderline form revealed a higher initial temperature, while borderline-lepromatous and

lepromatous leprosy showed a lower temperature. Regarding vasomotor reflex, lepromatous leprosy patients

were unable to recover the initial temperature after cold stress, while those with the borderline-tuberculoid form

not only recovered but exceeded the initial temperature. The authors concluded that IRT proved a potential tool

to assist in the early detection of neuropathies, helping in the prevention of major nerve damage and the

installation of deformities and disabilities that are characteristic of leprosy.

Management of Infantile Hemangioma

In a preliminary, prospective, observational study, Burkes et al (2016) applied a functional imaging method,

dynamic IRT, to investigate infantile hemangiomas (IH) status versus control skin and over time. A total of 25

subjects with superficial or mixed IHs (age of less than 19 months) over 59 clinic visits were included in this

study. Infrared images of IHs and control sites, standardized color images, and three-dimensional (3D) images

were obtained. Tissue responses following application and removal of a cold stress were recorded with video

IRT. Outcomes included areas under the curve during cooling (AUCcool ) and rewarming (AUCrw ) and thermal

intensity distribution maps. AUCcool and AUCrw were significantly higher and cooling rate slower for IHs versus

uninvolved tissue indicating greater heat, presumably due to greater perfusion and metabolism for the IH. Infra­

red distribution maps showed specific areas of high and low temperature. Significant changes in IH thermal

activity were reflected in the difference (AUCcool - AUCrw ), with 6.2 at 2.2 months increasing to 37.6 at 12.8

months; IH cooling rate increased with age, indicating slower recovery, and interpreted as reduced proliferation

and/or involution. The authors concluded that dynamic IRT was a well-tolerated, quantitative functional imaging

modality appropriate for the clinic, particularly when structural changes, i.e., height, volume, color, were not

readily observed. They stated that dynamic IRT may aid in monitoring progress, individualizing treatment, and

evaluating therapies.

Monitoring of Diabetes Mellitus

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Staffa et al (2016) stated that foot complications in persons with diabetes mellitus (DM) are associated with

substantial costs and loss of quality of life. Increasing evidence suggests changes in skin temperature, measured

using an IRT system, may be a predictor of foot ulcer development in patients with DM. In a case study, these

researchers described the long-term IRT findings and overall clinical outcomes of a patient with DM and

peripheral vascular disease (PVD). Foot temperature measurements using IRT were obtained slightly more than

1 year before and immediately following endovascular treatment of a 76-year old man, a non-smoker with type 2

DM, hypertension, and ischemic heart disease with cardiac arrhythmia. Although he was otherwise

asymptomatic, the infrared measurement showed an average temperature difference of 2.3˚ C between the left

and right foot until he developed a small, trauma-induced wound on the left foot, at which time left foot

temperature increased. He was diagnosed with recto-sigmoid adenocarcinoma, underwent surgery and

chemotherapy, and subsequently was evaluated for PVD. Before undergoing peripheral angiography and

percutaneous transluminal angioplasty, IRT evaluation showed a hot spot on the left heel. Immediately following

endovascular treatment, the mean temperature difference between the right and left foot was low (0.2˚ C), but a

Stage I pressure ulcer was visible on the left heel. Skin breakdown in that area was observed 2 months later, and

the wound continued to increase in size and depth. The patient died shortly thereafter due to complications of

cancer. In this case study, a series of infrared images of foot skin temperatures appeared to show a relationship

with blood circulation and wound/ulcer development and presentation. The authors concluded that IRT has the

ability to instantaneously measure the absolute temperature of the skin surface over a large area without direct

skin contact. However, they stated that these devices are very sensitive; and prospective clinical studies are

needed to determine the validity, reliability, sensitivity, and specificity of these measurements for routine use in

patients who are at risk for vascular disease and/or foot ulcers.

Predicting Pressure Ulcers

In a systematic review, Oliveira and colleagues (2017) examined the clinical significance of ultrasound (US),

thermography, photography and sub-epidermal moisture (SEM) measurement in detecting skin/tissue damage

and thus predicting the presence of pressure ulcers (PUs); determined the relative accuracy of one of these

assessment methods over another; and made recommendations for practice pertaining to assessment of early

skin/tissue damage. The following databases, Cochrane Wounds Group Specialized Register, the Cochrane

Central Register of Controlled Trials, Ovid Medline, Ovid Embase, Elsevier version, Ebsco CINAHL,

ClinicalTrials.gov , WHO International Clinical Trials Registry (ICTR) and The EU Clinical Trials Register were

searched for terms including; thermography, ultrasound, sub-epidermal moisture, photograph and pressure ulcer.

These investigators identified 4 SEM, 1 thermography and 5 ultrasound studies for inclusion in this review. Data

analysis indicated that photography was not a method that allowed for the early prediction of PU presence; SEM

values increased with increasing tissue damage, with the sacrum and the heels being the most common

anatomical locations for the development of erythema and stage I PUs. Thermography identified temperature

changes in tissues and skin that may give an indication of early PU development; however the data were not

sufficiently robust; US detected pockets of fluid/edema at different levels of the skin that were comparable with

tissue damage. Thus, SEM and US were the best methods for allowing a more accurate assessment of early

skin/tissue damage. Using the EBL Critical Appraisal Tool, the validities of the studies varied between 33.3 to

55.6 %, meaning that there is potential for bias within all the included studies. All of the studies were situated at

level IV, V and VII of the evidence pyramid. These researchers noted that although the methodological quality of

the studies warrants consideration, these studies showed the potential that SEM and US have in early PU

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detection. The authors concluded that SEM and US are promising in the detection and prediction of early tissue

damage and PU presence. However, they stated that these methods should be further studied to clarify their

potential for use more widely in PU prevention strategies.

Determining the Efficacy of Stroke Rehabilitation

Hegedus (2018) stated that maintaining good physiological circulation in the extremities requires an optimally

functioning muscle pump. Stroke symptoms indicate a change in venous circulation. In this study, these

researchers measured changes in joint function and microcirculation, and the correlation between them. A total

of 16 randomly selected post-stroke patients with hemiparesis affecting mainly the upper extremities began

undergoing rehabilitation 13 ± 4 days following stroke. Thermograms were taken with a Fluke Ti 20 (Fluke

Corporation, WA) pre-treatment and post-treatment, and a physiotherapy documentation form was completed.

Treatment comprised 15 physiotherapy, massage, and galvanic therapy sessions per patient, with the side

exhibiting no neurological symptoms as a control. Joint function showed significant improvement on the affected

side (p < 0.05). Thermographic examinations revealed microcirculatory dysfunction in the affected extremities in

100 % of the cases. Following treatment, temperature increased significantly (p ≥ 0.5°C) on the affected side. A

strong correlation (r) was observed between joint function and temperature change (p < 0.05). The authors

concluded that thermography was shown to be a reliable method for monitoring the effects of stroke rehabilitation

treatment. They stated that thermographic testing may enable clinicians to predict the course of the trauma and

the effectiveness of treatment even at the acute stage.

Thermography for Evaluating Acute Skin Toxicity of Breast Radiotherapy

Maillot and associates (2018) stated that radiotherapy is a common adjuvant treatment of breast cancer. Acute

radiation-induced dermatitis is a frequent side effect. These researchers hypothesized whether it is possible to

capture the increase of local temperature as a surrogate of the inflammatory state induced by radiotherapy. They

designed a prospective, observational, single-center study to acquire data on temperature rise in the treated

breast during the course of radiotherapy, establish a possible association with the occurrence of dermatitis and

examine the predictive value of temperature increase in future occurrences of radiation-induced dermatitis. All

patients presenting for neoadjuvant or adjuvant radiotherapy during the course of breast cancer treatment at the

university hospital of Martinique were considered for inclusion. Every week, patients were examined by 2 trained

investigators for the occurrence of radiation-induced dermatitis, graded based on Radiotherapy Oncology Group,

Common Terminology Criteria for Adverse Events v.4.0 and Wright scales. A frontal thermal image of torso was

taken in strictly controlled conditions, with a calibrated TE-Q1 camera (Thermal Expert, i3systems, Daejeon,

Korea). These investigators studied temperature differences between the irradiated breast or thoracic wall and

the contralateral area. For each thermal picture, these researchers measured the difference in maximum

temperature as well as the difference in minimum temperature and the difference in the average temperature in

the considered area. They studied the evolution of these parameters over time (week after week), measuring the

maximum recorded difference and its correlation to acute radiation dermatitis intensity. A total of 64 consecutive

patients were included. For all patients, these investigators noticed an increase of temperature during the course

of radiotherapy. Difference in maximum, minimum and average temperature was higher between the 2 breasts of

patients with a radiation-induced dermatitis grade 2 or above compared to patients with no or mild dermatitis.

Higher temperatures were also significantly associated with an increased sensation of discomfort, as recorded by

questionnaire (p < 0.05). The authors concluded that as expected from the inflammatory phenomena involved in

radiation-induced dermatitis, a noticeable increase in temperature during the course of radiotherapy was

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observed in all patients. Furthermore, high-grade radiation-induced dermatitis was strongly associated with an

additional increase in local temperature, which was probably linked to the intense inflammatory reaction. Lastly,

with a 1.4°C threshold set beforehand, it was possible to anticipate the occurrence of radiation-induced

dermatitis, with interesting positive and negative predictive values (PPV and NPV) of 70 % and 77 %, respectively

in this population. Moreover, these researchers stated that these findings need to be confirmed in a dedicated

study.

Thermography for Evaluating and Monitoring of Individuals Emery-Dreifuss Muscular Dystrophy

Cabizosu and colleagues (2018) noted that Emery-Dreifuss muscular dystrophy (EDMD) is a clinical condition

characterized by neuro-skeletal and cardiac impairments. By means of thermography, new insights could be

obtained regarding the evaluation and follow-up of this disease. Actually, musculoskeletal disorders are a major

cause of counseling and access to rehabilitation services and are some of the most important problems that

affect the quality of life of many people. There are urgent clinical and research needs for the assessment and

follow-up of patients with EDMD. These researchers offered a new possible hypothesis of validating

thermographic techniques that support the evaluation and clinical follow-up of the EDMD. They relied on

evidence of existing bibliography. These investigators performed a systematic review; and after the application of

an automatic and manual filter, inclusion and exclusion criteria, no study was obtained. There is a lack of

evidence on the use of thermography in EDMD. Due to a lack of information, these researchers expanded the

search to studies concerning the use of thermography in relation to alterations of the musculoskeletal system

compatible with those of EDMD, genetic diseases related to the X chromosome and more generally muscular

atrophy. Based on other studies performed in diseases that showed signs and symptoms similar to EDMD, the

authors believed that a new line of translational research could be opened with novel findings and they thought

thermography could be an optimal tool for the clinical monitoring of this pathology. These researchers believed

that it would be of a great importance to carry out an observational study, to lay the foundations for future work,

that relate thermography to EDMD.

Thermography for Joint Assessment in Individuals with Inflammatory Arthritis

Jones and associates (2018) noted that rheumatoid arthritis (RA) is a common inflammatory disease that causes

destruction of joints. Accurate recognition of active disease has significant implications in determining

appropriate treatment; however, there is significant inter-rater variability in clinical joint assessment. In a cross-

sectional study, these researchers evaluated the use of thermographic imaging in the evaluation of inflammatory

arthritis activity as an adjunct to clinical assessment. This trial included 79 subjects recruited from the University

of Alberta out-patient rheumatology clinic. These investigators compared the hand joints of 49 patients with RA

diagnosed by American College of Rheumatology (ACR) criteria to 30 healthy volunteers. Convenience sampling

of consecutive RA patients was undertaken. The effect of clinical assessment (HAQ and DAS-28) on joint

temperature was evaluated using a linear mixed effect model. A thermography camera, FLIR T300 model, 30­

Hz, was used to obtain both thermographic and digital images on subjects. Pearson's correlation coefficient was

used to assess the correlation of clinical assessments and average joint temperature averaged over all joints.

Thermographic analysis did not associate with clinical measures of disease activity. In RA patients, there was no

statistically significant relationship between joint temperature and clinical assessment of disease activity including

Health Assessment Questionnaire (coefficient estimate - 0.54, p = 0.056), swollen joints (coefficient estimate - 0.09,

p = 0.238), or serologic markers of inflammation such as C-reactive protein (CRP; coefficient estimate - 0.006,

p = 0.602) and erythrocyte sedimentation rate (ESR; coefficient estimate - 0.01, p = 0.503). The authors

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concluded that evaluation of disease activity requires a multi-faceted approach that includes clinical assessment

and appropriate imaging. They stated that there may be a role for thermography in assessment of larger joints;

however, it does not appear to be an effective modality for the small joints of the hand.

Thermography for Pre- and Peri-Operative Management of Hidradenitis Suppurativa

Derruau and co-workers (2018) stated that hidradenitis suppurativa (HS) is a chronic, inflammatory, and recurrent

skin disease. Surgical excision of wounds appears to be the only curative treatment for the prevention of

recurrence of moderate-to-severe stages; MRI is a standard reference examination for the detection of HS peri­

anal inflammatory fistula. In this case study, the use of real-time medical infrared thermography (MIT), in

combination with MRI as appropriate imaging, was proposed. The objective was to assist surgeons in the pre­

and peri-surgical management of severe perianal HS with the intent to ensure that all diseased lesions were

removed during surgery and therefore to limit recurrence. The results showed that MIT, combined with MRI,

could be a highly effective strategy to address thermally distinguished health tissues and inflammatory sites

during excision, as characterized by differential increases in temperature. Medical infrared thermography could

be used to check the total excision of inflammatory lesions as a non-invasive method that is not painful, not

radiant, and is easily transportable during surgery. The authors concluded that this method could be

complementary with MRI in providing clinicians with objective data on the status of tissues below the perianal skin

surface in the pre- and peri-operating management of severe HS. This was a single-case study; its findings need

to be validated by well-designed studies.

Infrared Thermography for Diagnosis and Management of Vasculitis, Early Identification of Skin Neoplasms, Esophageal Monitoring, and Screening for Adolescent Idiopathic Scoliosis

Lin and colleagues (2018) noted that vasculitis is a clinical condition with associated diagnostic challenges due to

non-specific symptoms and lack of a confirmatory imaging modality. These investigators reported a case of a 39­

year old woman who developed generalized malaise, lethargy, and headache. Laboratory evaluation showed

elevated inflammatory markers. Conventional imaging studies including computed tomography (CT) and carotid

duplex ultrasound (US) were unremarkable. Infrared thermography revealed enhanced thermographic signals in

the left carotid artery and aortic arch. Corticosteroid therapy was commenced, and the patient responded well.

Follow-up infrared thermography at 6 months showed complete resolution of the thermographic pattern, and the

patient remained symptom-free. The authors concluded that this case highlighted the potential clinical utility of

using infrared thermography in patients with vasculitis. The enhanced thermal signals in the aortic arch and

carotid artery provided valuable information in the diagnosis and treatment of arteritis in this patient. This

technology was similarly beneficial in subsequent surveillance evaluation once the patient completed the

prescribed treatment. Moreover, they stated that further studies are needed to determine the clinical sensitivity

and diagnostic accuracy of this imaging modality in vasculitis.

Magalhaes and associates (2018) stated that infrared thermal imaging captures the infrared radiation emitted by

the skin surface. The thermograms contain valuable information, since the temperature distribution can be used

to characterize physiological anomalies. Thus, the use of infrared thermal imaging (IRT) has been studied as a

possible tool to aid in the diagnosis of skin oncological lesions. These researchers evaluated the current state of

the applications of IRT in skin neoplasm identification and characterization. They carried out a literature survey

using the reference bibliographic databases: Scopus, PubMed and ISI Web of Science. Keywords

(thermography, infrared imaging, thermal imaging and skin cancer) were combined and its presence was verified

at the title and abstract of the article or as a main topic. Only articles published after 2013 were considered

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during this search. A total of 55 articles were encountered, resulting in 14 publications for revision after applying

the exclusion criteria. It was denoted that IRT have been used to characterize and distinguish between malignant

and benign neoplasms and different skin cancer types; IRT has also been successfully applied in the treatment

evaluation of these types of lesions. The authors concluded that trends and future challenges have been

established to improve the application of IRT in this field, disclosing that dynamic infrared thermography is a

promising tool for early identification of oncological skin conditions.

Daly and co-workers (2018) noted that catheter ablation for atrial fibrillation (AF) has potential to cause

esophageal thermal injury. Esophageal temperature monitoring during ablation is commonly used; however, it

has not eliminated thermal injuries, possibly because conventional sensors have poor spatial sampling and

response characteristics. To enhance understanding of temperature dynamics that may underlie esophageal

injury, these researchers tested a high-resolution, intra-body, infrared thermography catheter to continuously

image esophageal temperatures during ablation. Patients undergoing AF ablation were instrumented with a

flexible, 9F infrared temperature catheter inserted nasally (n = 8) or orally (n = 8) into the esophagus adjacent to

the left atrium. Ablation was performed while the infrared catheter continuously recorded surface temperatures

from 7,680 points/sec circumferentially over a 6-cm length of esophagus. Physicians were blinded to temperature

data. Endoscopy was performed within 24 hours to document esophageal injury. Thermal imaging showed that

most patients (10/16) experienced greater than or equal to 1 events where peak esophageal temperature was

over 40° C; 3 patients experienced temperatures over 50° C; and 1 experienced over 60 °C. Analysis of

temperature data for each subject's maximum thermal event revealed high gradients (2.3 ± 1.4° C/mm) and rates

of change (1.5 ± 1.3° C/sec) with an average length of esophageal involvement of 11.0 ± 5.4 mm. Endoscopy

identified 3 distinct thermal lesions, all in patients with temperatures over 50° C; all resolved within 2 weeks. The

authors concluded that infrared thermography provided dynamic, high-resolution mapping of esophageal

temperatures during cardiac ablation. Esophageal thermal injury occurred with temperatures of over 50° C and

was associated with large spatiotemporal gradients. Moreover ,they stated that additional studies are needed to

determine the relationships between thermal parameters and esophageal injury.

In an editorial that accompanied the afore-mentioned study by Daly et al (2018), Borne and Nguyen (2018) stated

that “it is important to note the multiple limitations of esophageal temperature monitoring. First, to be effective,

esophageal monitoring must accurately reflect the esophageal temperature. The esophagus is a broad and

patulous structure, and the position of a temperature probe might not align with the ablation catheter such that

monitoring might provide a false sense of security. In a prior investigation in which 2 commercially available

probes (9F esophageal probe and an 18F esophageal stethoscope) were used among patients undergoing

ablation, there were significant differences in the peak temperature and rise in temperature between the probes,

suggesting that significant temperature variation exists among frequently used temperature probes. Second,

there is evidence to suggest that the use of a temperature probe can be potentially harmful. In an ex vivo model,

ablation near a non-insulated multi-sensor esophageal probe significantly increased temperatures in the tissues

adjacent to the ablation lesion compared with lesions without a nearby temperature probe. This was echoed in

clinical work in which patients undergoing AF ablation were enrolled prospectively to receive an esophageal

temperature probe-guided ablation strategy versus no temperature monitoring … The study has some notable

limitations. First, there is limited validation of this technology for esophageal temperature monitoring. A previous

report described the use of infrared probes to monitor esophageal temperatures in a swine model, which were

significantly higher than conventional probes. The current authors reported their experience with the first-in­

human use of the IRTC in a patient undergoing PVI. Rigorous ex vivo and in vivo experiments need to be

performed, establishing best practices and limitations of this technology, including how distance and location of

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the IRTC and ablation catheter affect temperature readings, if interactions between radiofrequency ablation and

the probe exist and correlations to multiple different conventional temperature probes. Second, lesions identified

on endoscopy were not correlated to specific ablation lesions and their characteristics (i.e., contact force, force-

time integral). To best define risk for esophageal injury and thereby allow for risk modification, ablation

characteristics and IRTC esophageal temperatures need to be analyzed. For instance, is the risk of esophageal

injury related to a time-temperature phenomenon, is it a structural/anatomic phenomenon, or is it related other

factors that result in visible injury in some but not other ablation lesions causing temperatures >50° C? If lesions

identified on endoscopy did not correlate to higher esophageal temperatures, it is hard to know how temperature

monitoring would guide ablation … Although further work needs to be performed in establishing the use of

infrared thermography, the authors should be commended on their work for developing a system that has the

potential to provide useful temperature monitoring data to improve the safety of AF catheter ablation. Although

the question remains as to what the optimal approach to avoid esophageal injury is, this study provides evidence

to suggest that more accurate esophageal temperature monitoring is possible. Until then, we should remain on

red alert for risks of esophageal injury, in order to keep catheter ablation safe”.

Kwok and colleagues (2017) stated that adolescent idiopathic scoliosis (AIS) is a multi-factorial, 3-D deformity of

the spine and trunk. School scoliosis screening (SSS) is recommended by researchers as a means of early

detection of AIS to prevent its progression in school-aged children. The traditional screening technique for AIS is

the forward-bending test because it is simple, non-invasive and inexpensive. Other tests, such as the use of

Moiré topography, have reduced the high false referral rates. These researchers examined the use of infrared

(IR) thermography for screening purposes based on the findings of previous studies on the asymmetrical para­

spinal muscle activity of scoliotic patients compared with non-scoliotic subjects; IR thermography was performed

with an IR camera to determine the temperature differences in para-spinal muscle activity. A statistical analysis

showed that scoliotic subjects demonstrated a statistically significant difference between the left and right sides of

the regions of interest. This difference could be due to the higher IR emission of the convex side of the observed

area, thereby creating a higher temperature distribution. The authors concluded that the findings of this study

suggested the feasibility of incorporating IR thermography as part of SSS. Moreover, they stated that future

studies could also consider a larger sample of both non-scoliotic and scoliotic subjects to further validate the

findings.

Intraoperative Infra-Red Thermography in Surgery of Glioblastoma Multiforme

Naydenov and colleagues (2017) noted that IRT is a real-time non-contact diagnostic tool with a broad potential

for neurosurgical applications. These researchers described the intraoperative use of this technique in a single

patient with newly diagnosed glioblastoma multiforme (GBM). An 86-year old woman was admitted in the clinic

with a 2-month history of slowly progressing left-sided paresis. Neuroimaging studies demonstrated an irregular

space-occupying process consistent with a malignant glioma in the right fronto-temporo-insular region. An

elective surgical intervention was performed by using 5-aminolevulinic acid fluorescence (BLUE 400, OPMI) and

intraoperative IRT brain mapping (LWIR, 1.25 mRad IFOV, 0.05°C NETD). After dura opening, the cerebral

surface appeared inconspicuous. However, IRT revealed a significantly colder area (Δt° 1.01°C), well

corresponding to the cortical epicenter of the lesion. The underlying tumor was partially excised and the

histological result was GBM. The authors concluded that intraoperative IRT appeared to be a useful technique

for subcortical convexity brain tumor localization. Moreover, they stated that further studies with a large number

of patients are needed to prove the reliability of this method in GBM surgery.

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Dynamic Infrared Blood Perfusion Imaging

Dynamic infrared blood perfusion imaging (DIRI) is a new infrared imaging technique that is intended to detect

changes in blood flow in tissue and organs by sensing passively emitted infrared radiation from tissues. Potential

clinical applications of DIRI include: use as an adjunctive screening tool for breast cancer and other cancers;

evaluation of response to cancer chemotherapy; monitoring response to therapy in diabetic peripheral vascular

disease; identifying perforator vessels during pre-surgical planning; assessing post-operative perfusion of pedicle

flaps following reconstructive surgery (i.e., of the breast); mapping of functional cortex in patients undergoing

tumor surgery; and determining cardiac bypass graft patency and perfusion of the myocardium in cardiac

surgery. Agostini and colleagues (2009) stated that dynamic infrared imaging is a promising technique in breast

oncology. Currently available evidence, however, is limited to evaluations of DIRI's technical feasibility. There is

an absence of evidence of the impact of DIRI on health outcomes. The BioScanIR System (OmniCorder

Technologies, Inc., Bohemia, NY) is an example of a DIRI device that is commercially available.

Lohman et al (2015) stated that over the last decade, microsurgeons have used a greater variety of more

complex flaps. At the same time, microsurgeons have also become more interested in technology, such as indo­

cyanine green (ICG) angiography, dynamic infra-red thermography (DIRT), and photo-spectrometry, for pre­

operative planning and post-operative monitoring. These technologies are now migrating into the operating room,

and are used to optimize flap design and to identify areas of hypo-perfusion or problems with the anastomoses.

Although relatively more has been published about ICG angiography, information is generally lacking about the

intra-operative role of these techniques. A systematic analysis of articles discussing intra-operative ICG

angiography, DIRT, and photo-spectrometry was performed to better define the sensitivity, specificity, expected

outcomes, and potential complications associated with these techniques. For intra-operative ICG angiography,

the sensitivity was 90.9 % (95 % confidence interval [CI]: 77.5 to 100) and the accuracy was 98.6 % (95 % CI:

97.6 to 99.7). The sensitivity of DIRT was 33 % (95 % CI: 11.3 to 64.6), the specificity was 100 % (95 % CI: 84.9

to 100), and the accuracy was 80 % (95 % CI: 71.2 to 89.7). The sensitivity of intra-operative photo-spectrometry

was 92 % (95 % CI: 72.4 to 98.6), the specificity was 100 % (95 % CI: 98.8 to 100), and the accuracy was also

100 % (95 % CI: 98.7 to 100). The authors concluded that these technologies for intra-operative perfusion

assessment have the potential to provide objective data that may improve decisions about flap design and the

quality of microvascular anastomoses. However, more work is needed to clearly document their value.

Just and colleagues (2016) investigated static IRT and DIRT for intra- and post-operative free-flap monitoring

following oropharyngeal reconstruction. A total of 16 patients with oropharyngeal reconstruction by free radial

forearm flap were included in this prospective, clinical study. Prior ("intraop_pre") and following ("intraop_post")

completion of the microvascular anastomoses, IRT was performed for intra-operative flap monitoring. Further IR

images were acquired 1 day ("postop_1") and 10 days ("postop_10") after surgery for post-operative flap

monitoring. Of the 16, 15 transferred free radial forearm flaps did not show any perfusion failure. A significant

decreasing mean temperature difference (∆T: temperature difference between the flap surface and the

surrounding tissue in Kelvin) was measured at all investigation points in comparison with the temperature

difference at "intraop_pre" (mean values on all patients: ∆T intraop_pre = -2.64 K; ∆T intraop_post = -1.22 K, p <

0.0015; ∆T postop_1 = -0.54 K, p < 0.0001; ∆T postop_10 = -0.58 K, p < 0.0001). Intra-operative DIRT showed

typical pattern of non-pathological rewarming due to re-established flap perfusion after completion of the

microvascular anastomoses. The authors concluded that static and dynamic IRT is a promising, objective method

for intra-operative and post-operative monitoring of free-flap reconstructions in head and neck surgery and to

detect perfusion failure, before macroscopic changes in the tissue surface are obvious. They noted that a lack of

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significant decrease of the temperature difference compared to surrounding tissue following completion of

microvascular anastomoses and an atypical re-warming following a thermal challenge are suggestive of flap

perfusion failure.

Dynamic Infrared Blood Perfusion Imaging (DIRI) for Assessment of Skin Blood Perfusion in Cranioplasty

Rathmann and colleagues (2018) noted that complications in wound healing after neurosurgical operations occur

often due to scarred dehiscence with skin blood perfusion disturbance. The standard imaging method for intra-

operative skin perfusion assessment is the invasive indocyanine green video angiography (ICGA). The non­

invasive dynamic infrared thermography (DIRT) is a promising alternative modality that was evaluated by

comparison with ICGA. These researchers performed a proof-of-concept study for qualitative comparison of

DIRT with the standard ICGA. This trial was carried out in 2 parts: investigation of technical conditions for intra-

operative use of DIRT for its comparison with ICGA, and visual and quantitative comparison of both modalities in

9 patients. Time-temperature curves in DIRT and time-intensity curves in ICGA for defined regions of interest

were analyzed. New perfusion parameters were defined in DIRT and compared with the usual perfusion

parameters in ICGA. The visual observation of the image data in DIRT and ICGA showed that operation material,

anatomical structures and skin perfusion were represented similarly in both modalities. Although the analysis of

the curves and perfusion parameter values showed differences between patients, no complications were

observed clinically. These differences were represented in DIRT and ICGA equivalently. The authors concluded

that DIRT has shown a great potential for intra-operative use, with several advantages over ICGA. The technique

is passive, contactless and non-invasive. The practicability of the intra-operative recording of the same operation

field section with ICGA and DIRT has been demonstrated. These researchers stated that the promising results of

this proof-of-concept provided a basis for a trial with a larger number of patients.

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

Code Code Description

CPT codes not covered for indications listed in the CPB:

93740 Temperature gradient studies

ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):

A30.0 - A30.9 Leprosy [Hansen's disease]

B02.22 Postherpetic trigeminal neuralgia

B02.29 Other postherpetic nervous system involvement

C00.0 - C96.9 Malignant neoplasms

D18.00 - D18.09 Hemangioma and lymphangioma, any site

E08.3211 - E13.37x9 Diabetes mellitus

E10.51 - E10.59

E11.51 - E11.59

Diabetes mellitus with circulatory complications [Type 1 or 2]

www.aetna.com/cpb/medical/data/1_99/0029.html Proprietary 18/24

Code Code Description

G71.09 Other specified muscular dystrophies

G90.50 - G90.59 Complex regional pain syndrome

H04.121 - H04.129 Dry eye syndrome

I25.10 - I25.9 Coronary atherosclerosis

I73.9 Peripheral vascular disease, unspecified

I77.6 Arteritis, unspecified

L73.2 Hidradenitis suppurativa

L89.000 - L89.95 Pressure ulcer

M06.4 Inflammatory polyarthropathy

M79.601 -M79.609 Pain in limb

M84.421S - M84.429S

M84.431S - M84.439S

S42.209S - S42.496S

S49.001S - S49.199S

S52.001S - S52.92xS

S59.001S - S59.299S

S62.90xS - S62.92xS

Fracture of upper extremity, sequela

S52.501+ - S52.509+

S52.531+ - S52.539+

Fracture of radius [open or closed]

T20.00xA - T32.99 Burns

Y84.2 Radiological procedure and radiotherapy as the cause of abnormal reaction of the patient, or of

later complication, without mention of misadventure at the time of the procedure

Z01.810 Encounter for preprocedural cardiovascular examination

Z01.818 Encounter for other preprocedural examination

Z01.89 Encounter for other specified special examinations [not covered for intra-operative and

post-operative perfusion assessment]

Z12.0 - Z12.9 Encounter for screening for malignant neoplasms

Z13.89 Encounter for screening for other disorder

Z51.11 - Z51.12 Encounter for antineoplastic chemotherapy or immunotherapy

Z95.1 Presence of aortocoronary bypass graft

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28. Gradl G, Steinborn M, Wizgall I, et al. Acute CRPS I (morbus sudeck) following distal radialfractures-­

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29. Madjid M, Willerson JT, Casscells SW. Intracoronary thermography for detection of high-riskvulnerable

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31. García-García HM, Gonzalo N, Granada JF, et al. Diagnosis and treatment of coronaryvulnerable

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56. Childs C, Siraj MR, Fair FJ, et al. Thermal territories of the abdomen after caesarean section birth:

Infrared thermography and analysis. J Wound Care. 2016;25(9):499-512.

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57. Cavalheiro AL, Costa DT, Menezes AL, et al. Thermographic analysis and autonomic response in the

hands of patients with leprosy. An Bras Dermatol. 2016;91(3):274-283.

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2018;118:103-106.

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of

coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a

contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent

contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and

treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

Copyright © 2001-2019 Aetna Inc.

www.aetna.com/cpb/medical/data/1_99/0029.html Proprietary 24/24

AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical PolicyBulletin Number: 0029

Thermography

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania annual 11/01/2019

Proprietary