ElectromagneticNavigationalBronchoscopy.pdf

Electromagnetic Navigational Bronchoscopy Jul 14 1

National Medical Policy Subject: Electromagnetic Navigational Bronchoscopy

(ENB)

Policy Number: NMP 192

Effective Date*: July 2010

Update: July 2014

This National Medical Policy is subject to the terms in the

IMPORTANT NOTICE

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Current Policy Statement Health Net, Inc. considers electromagnetic navigational bronchoscopy, (i.e. the

SuperDimension Bronchus System, the i-Logic system, or the InReachTM System),

investigational at this time. Although electromagnetic navigation-guided

bronchoscopy is a promising minimally invasive method of reaching distant lung

lesions, additional long-term, published peer-reviewed studies with larger sample

sizes are required to define its role in the diagnostic pathway for lung cancer and

management of peripheral lung lesions.

Definitions ENB Electromagnetic navigational bronchoscopy

GPS Global positional system

TTNA Transthoracic needle aspiration

EBUS Endobronchial ultrasound

pEBUS peripheral Endobronchial Ultrasonography

SPN Single pulmonary nodule

autoIR Automatic Initial Registration

EWC Extended working channel

VB Virtual bronchoscopy

TTNA Transthoracic needle aspiration

IML Isolated mediastinal lymphadenopathy

ROSE Rapid on-site cytopathological examination

BAL Bronchoalveolar lavage

PLL Peripheral lung lesion

PET-CT Positron emission tomography-computed tomography

ROSE Rapid on-site evaluation

Codes Related To This Policy NOTE:

The codes listed in this policy are for reference purposes only. Listing of a code in

this policy does not imply that the service described by this code is a covered or non-

covered health service. Coverage is determined by the benefit documents and

medical necessity criteria. This list of codes may not be all inclusive.

On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and

inpatient procedures will be replaced by ICD-10 code sets. Health Net National

Medical Policies will now include the preliminary ICD-10 codes in preparation for this

transition. Please note that these may not be the final versions of the codes and

that will not be accepted for billing or payment purposes until the October 1, 2015

implementation date.


ICD-9 Codes 162.3 Malignant neoplasm of upper lobe bronchus or lung

162.4 Malignant neoplasm of middle lobe bronchus or lung

162.5 Malignant neoplasm of lower lobe bronchus or lung

162.8 Malignant neoplasm of other parts of bronchus or lung

162.9 Malignant neoplasm of bronchus or lung, unspecified

196.1 Secondary and unspecified malignant neoplasm of intrathoracic

lymph nodes

197.0 Secondary malignant neoplasm of lung

212.3 Benign neoplasm of bronchus and lung

518.89 Other diseases of lung not otherwise classified

785.6 Enlargement of lymph nodes

793.11-793.2 Nonspecific (Abnormal) findings on radiological and other

examination of lung field

ICD 10 CPT Codes C34.00-

C34.92

Malignant neoplasm of main bronchus

C77.0-C77.9 Secondary and unspecified malignant neoplasm of lymph nodes

J98.01-J98.9 Other respiratory disorders R59.-R59.9 Enlarged lymph nodes

R91.1-R91.8 Abnormal findings on diagnostic imaging of lung

CPT Codes 31627 Bronchoscopy, rigid or flexible, including fluoroscopic guidance,

when performed, with computer-assisted, image-guided navigation

(list separately in addition to code for primary procedure)

76377 3D rendering with interpretation and reporting of computed

tomography, magnetic resonance imaging, ultrasound, or other

tomographic modality with image postprocessing under concurrent

supervision; not requiring image postprocessing on an independent

workstation. (Code revised in 2013)

76499 Unlisted diagnostic radiographic procedure

HCPCS Codes N/A

Scientific Rationale – Update July 2014 Gex et al. (2014) completed a study to describe electromagnetic navigation

bronchoscopy’s (ENB's) yield and safety profile. The MEDLINE and EMBASE

databases were systematically searched for studies reporting ENB's yield for

peripheral lung lesions. Two independent investigators extracted data and rated each

study on a scale of methodological quality. Clearly defined performance outcomes

were reconstructed and meta-analyzed. Subgroup analysis and meta-regression

were used to identify possible sources of study heterogeneity. Results: A total of 15

trials were included (1,033 lung nodules). A positive and definitive diagnosis was

obtained after 64.9% of all ENB procedures (95% CI 59.2-70.3). Overall diagnostic

accuracy was 73.9% (95% CI 68.0-79.2). Sensitivity to detect cancer was 71.1%

(95% CI 64.6-76.8), with a negative predictive value of 52.1% (95% CI 43.5-60.6).

Pneumothorax occurred in 3.1% of patients, requiring chest tube drainage in 1.6%

of these cases. Original trials identified 6 variables associated with higher ENB yields:

nodule location in the upper or middle lobes, nodule size, lower registration error,

presence of a bronchus sign on CT imaging, combined use of an ultrasonic radial

probe, and catheter suctioning as a sampling technique. Heterogeneity exploration

revealed that studies using general anesthesia or rapid on-site cytological evaluation


reported better yields. ENB seems to be an effective and procedure, however,

additional prospective studies are needed to clarify the role of several variables

conditioning the yield of this technique.

Literature on the diagnostic yield of electromagnetic navigation bronchoscopy (ENB)

with ENB-guided fine-needle aspiration (ENB-FNA) in peripheral lung lesions (PLLs)

that measure ≤ 2 cm is scarce. Data on the diagnostic yield of ENB-FNA for PLLs

when performed in conjunction with positron emission tomography-computed

tomography (PET-CT), rapid on-site evaluation (ROSE), ENB-guided bronchial

brushing (ENB-BB), and ENB-guided transbronchial biopsy (ENB-TBx) is also limited.

Loo et al. (2013) completed a study, in which the authors evaluated their experience

with ENB-FNA performed in conjunction with all 4 modalities: PET-CT, ROSE, ENB-

BB, and ENB-TBx. ENB-FNA and other tests over a 2-year-period (from July 2011 to

July 2013) were retrospectively reviewed. There were 50 PLLs from 40 patients, and

the mean lesion size (available for 45 PLLs) was 2.6 cm: these included 24 PLLs that

measured ≤ 2 cm and 21 PLLs that measured > 2.0 cm. The ENB-FNA diagnosis was

malignant in 17 lesions, atypical in 1 lesion, benign in 31 lesions, and nondiagnostic

in 1 lesion. On the basis of lesion size, the diagnostic yield of PLLs was 87% in

lesions ≤ 2 cm and 100% in lesions > 2.0 cm (P = 0.5; not significant). Follow-up

available in 49 of 50 PLLs from 39 patients had an overall diagnostic yield of 94% for

ENB-FNA. The diagnostic yield of PET-CT (available in 31 of 50 PLLs) and of ENB-BB

and ENB-TBx (available in 40 of 50 PLLs) in conjunction with ENB-FNA was 61% and

95%, respectively. ROSE was performed in 46 of 50 PLLs: the overall sensitivity of

ROSE and ENB-FNA was 85% and 89.4%, respectively, and their specificity was

96.5% and 100%, respectively. There were no procedure-related complications. The

high overall diagnostic yield of 94% and fewer complications make ENB-FNA a useful

modality for the assessment of PLLs. In this study, ROSE was useful, whereas PET-

CT, ENB-BB, and ENB-TBx were not useful in the evaluation of PLLs.

Balbo et al. (2013) Electromagnetic navigation bronchoscopy (ENB) was reported to

increase diagnostic yield in pulmonary nodules (PNs). The aim of this study was to

assess if rapid on site evaluation (ROSE) associated with ENB could improve

diagnostic accuracy in PNs after non-diagnostic fluoroscopy-guided bronchoscopy

added to ROSE. Forty patients with PNs suspected for lung cancer underwent to ENB

+ ROSE after non-diagnostic Fluoroscopy-guided Bronchoscopy + ROSE. Each lesion

was studied with reference to size, location, presence of bronchus sign on CT. All

lesions were sampled by needle and brush; if negative, by forceps and

bronchoalveolar lavage. All patients were followed-up until achievement of definitive

diagnosis. Twenty-nine out of 41 lesions (70.7%) had a definitive diagnosis. ENB

sensitivity for malignancy was 76.5%, with higher rate in presence of bronchus sign

on CT (86.2%) and in case of lesions located in the upper and middle lobes (87.5%).

ENB is a useful tool in the evaluation of PNs. High diagnostic accuracy may be

related to sampling (transbronchial needle aspiration), ROSE, location and presence

of bronchus sign.

Rivera et al. (2013) To update previous recommendations on techniques available for

the initial diagnosis of lung cancer, a systematic search of the MEDLINE, Healthstar,

and Cochrane Library databases covering material to July 2011 and print

bibliographies was performed to identify studies comparing the results of sputum

cytology, conventional bronchoscopy, flexible bronchoscopy (FB), electromagnetic

navigation (EMN) bronchoscopy, radial endobronchial ultrasound (R-EBUS)-guided

lung biopsy, transthoracic needle aspiration (TTNA) or biopsy, pleural fluid cytology,

and pleural biopsy with histologic reference standard diagnoses among at least 50

patients with suspected lung cancer. Recommendations were developed by the

writing committee, graded by a standardized method and reviewed by all members


of the Lung Cancer Guideline Panel prior to approval by the Thoracic Oncology

NetWork, the Guidelines Oversight Committee, and the Board of Regents of the

American College of Chest Physicians. Sputum cytology is an acceptable method of

establishing the diagnosis of lung cancer, with a pooled sensitivity rate of 66% and a

specificity rate of 99%. However, the sensitivity of sputum cytology varies according

to the location of the lung cancer. For central, endobronchial lesions, the overall

sensitivity of FB for diagnosing lung cancer is 88%. The diagnostic yield of

bronchoscopy decreases for peripheral lesions. Peripheral lesions < 2 or > 2 cm in

diameter showed a sensitivity of 34% and 63%, respectively. R-EBUS and EMN are

emerging technologies for the diagnosis of peripheral lung cancer, with diagnostic

yields of 73% and 71%, respectively. The pooled sensitivity of TTNA for the

diagnosis of lung cancer was 90%. A trend toward lower sensitivity was noted for

lesions < 2 cm in diameter. TTNA is associated with a higher rate of pneumothorax

compared with bronchoscopic procedures. In a patient with a malignant pleural

effusion, pleural fluid cytology is reported to have a mean sensitivity of about 72%.

A definitive diagnosis of metastatic disease to the pleural space can be estalished

with a pleural biopsy. The diagnostic yield for closed pleural biopsy ranges from 38%

to 47% and from 75% to 88% for image-guided closed biopsy. Thoracoscopic biopsy

of the pleura carries the highest diagnostic yield, 95% to 97%. The accuracy in

differentiating between small cell and non-small cell cytology for the various

diagnostic modalities was 98%, with individual studies ranging from 94% to 100%.

The average false-positive and false-negative rates were 9% and 2%, respectively.

Although the distinction between small cell and NSCLC by cytology appears to be

accurate, NSCLCs are clinically, pathologically, and molecularly heterogeneous

tumors. In the past decade, clinical trials have shown us that NSCLCs respond to

different therapeutic agents based on histologic phenotypes and molecular

characteristics. The physician performing diagnostic procedures on a patient

suspected of having lung cancer must ensure that adequate tissue is acquired to

perform accurate histologic and molecular characterization of NSCLCs. The sensitivity

of bronchoscopy is high for endobronchial disease and poor for peripheral lesions < 2

cm in diameter. The sensitivity of TTNA is excellent for malignant disease, but TTNA

has a higher rate of pneumothorax than do bronchoscopic modalities. R-EBUS and

EMN bronchoscopy show potential for increasing the diagnostic yield of FB for

peripheral lung cancers. Thoracoscopic biopsy of the pleura has the highest

diagnostic yield for diagnosis of metastatic pleural effusion in a patient with lung

cancer. Adequate tissue acquisition for histologic and molecular characterization of

NSCLCs is paramount.

NCCN Clinical Practice Guidelines in Oncology on Non-Small Cell Lung Cancer

(NSCLC, Version 4.2014, as well as 2013 version noted in the Scientific Rationale

Update from July 2013) notes diagnostic tools that provide important additional

strategies for biopsy include:

Endobronchial Ultrasound (EBUS) guided biopsy

• Navigational bronchoscopy

NCCN (2014) also notes the least invasive biopsy with the highest yield is preferred

as the first diagnostic study. This category notes that:

Patients with suspected (outer 1/3) nodules should have navigational

bronchoscopy, radial EBUS, or transthoracic needle aspiration (TTNA).

Patients with suspected nodal disease should be biopsied by EBUS, navigational

bronchoscopy or mediastinoscopy


In summary, in order to evaluate electromagnetic navigational bronchoscopy among

other forms of diagnostic bronchoscopy techniques that are currently being used,

additional peer-reviewed, controlled and comparative studies are needed as well as

determinations of diagnostic accuracy. Lesion size and location, diagnostic accuracy,

and the impact of the use of this test alone or in addition to other tests on long-term

health outcomes including non-small cell lung cancer (NSCLC) mortality, need to be

addressed.

Scientific Rationale – Update July 2013 NCCN Clinical Practice Guidelines in Oncology on Non-Small Cell Lung Cancer

(NSCLC, 2013) notes that in cases of suspected NSCLC, diagnostic tools that provide

important additional strategies for biopsy include:

Endobronchial ultrasound (EBUS) guided biopsy

Navigational bronchoscopy

NCCN also notes that the preferred diagnostic strategy for an individual patient

depends on the size and location of the tumor, the presence of mediastinal or distant

disease, patient characteristics (such as pulmonary pathology and /or other

significant comorbidities), and local experience and expertise.

Factors to be considered in choosing the optimal diagnostic step include:

Anticipated diagnostic yield (sensitivity)

Diagnostic accuracy including specificity and particularly the reliability of a

negative diagnostic study (that is, true negative)

Adequate volume of tissue specimen for diagnosis and molecular testing

Invasiveness and risk of procedure

Efficiency of evaluation

1. Access and timeliness of procedure

2. Concomitant staging is beneficial, because it avoids additional

biopsies or procedures. It is preferable to biopsy the pathology

that would confer the highest stage (that is, to biopsy a suspected

metastasis or mediastinal lymph node rather than the pulmonary

lesion)

3. Technologies and expertise available

Decisions about the optimal diagnostic steps for suspected stage I to III lung

cancer should be made by thoracic radiologists, interventional radiologists, and

board-certified thoracic surgeons who devote a significant portion of their

practice to thoracic oncology. Multidisciplinary evaluation may also benefit from

involvement of a pulmonologist with experience in advanced bronchoscopic

techniques for diagnosis, depending on local expertise.

The least invasive biopsy with the highest yield is preferred as the first

diagnostic study. This includes:

1. Patients with central masses and suspected endobronchial

involvement should undergo bronchoscopy;

2. Patients with peripheral (outer one-third) nodules should have

navigational bronchoscopy, radial EBUS, or TTNA;

3. Patients with suspected nodal disease should be biopsied by EBUS,

navigational biopsy, or mediastinoscopy.


Esophageal ultrasound (EUS)-guided biopsy provides additional

access to station 5,7,8, and 9 lymph nodes if these are clinically

suspeicious.

TTNA and anterior mediastinotomy (that is, Chamberlain

procedure) provide additional access to anterior mediastinal

(station 5 and 6) lymph nodes if these are clinically suspicious.

NCCN recommendation is rated 2A. Per NCCN, Category 2A is based on lower-level

evidence, however, there is uniform NCCN consensus that the intervention is

appropriate.

There is a Clinical Trial which is currently recruiting participants on ' Bronchoscopy

Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary

Nodules'. The ClinicalTrials.gov Identifier is NCT01779388 and it was last verified in

January 2013. Electromagnetic navigation directed bronchoscopy (ENB) is a new

technique needing validation. The primary aim of the study is to compare ENB to

radiologically guided bronchoscopy, considered the standard comparator. The

estimated study completion date is December 2019.

Chee et al. (2013), conducted a prospective cohort study and evaluated the ability

of ENB to contribute to the diagnosis of peripheral lung lesions when EBUS failed to

localize the lesions in 60 patients (29 men, 31 women; mean age 60 years; mean

lesion size 2.7 centimeters [cm]). Four transbronchial needle aspirates, one cytology

brush, and a bronchoalveolar lavage (BAL) were obtained through the guide sheath

or a full BAL of the lung segment, in that order. Fluoroscopy was not used nor was

rapid on-site cytopathological examination (ROSE). If no additional sampling

technique was pursued, the patient’s lesion was followed for ≥ 1 year with CT to

ensure stability. Lung lesions were localized by EBUS alone in 75% (45/60) of the

patients. In the remaining 15 patients, ENB identified 11 additional lesions improving

the lesion identification rate to 56/60 (93%) (P=0.001 versus EBUS alone). Lung

lesions requiring ENB for accurate identification were smaller (mean 2.2 versus 3.0

cm; P<0.05), were less likely to have an air bronchus sign on CT (33% versus 76%;

P<0.01), and more likely to be in an upper lobe than in a middle or lower lobe

(P<0.05). Use of ENB lengthened the total procedure (mean 52.4 versus 35.9

minutes; P<0.05) and required the use of more lidocaine (mean 427 versus 379

milligrams [mg]; P<0.05). Peripheral EBUS alone led to a diagnosis in 26/45 patients

(58%) with 4/15 patients (27%) requiring ENB for a diagnosis; however, the

improvement in diagnostic yield with the addition of ENB was not statistically

significant compared with EBUS alone (43% [26/60] versus 50% [30/60]; P=0.125).

A total of 51 patients (85%) were diagnosed with a lung malignancy. There were no

differences in diagnostic yield for the different sampling techniques. The

pneumothorax rate was 8% (5/60) with a chest tube required in 2 patients (3.3%);

however, the addition of ENB did not affect this rate. While in this study, ENB

improved localization; it did not improve the overall diagnostic yield compared with

EBUS alone.

Karnak et al. (2013), completed a prospective cohort study and evaluated the

efficacy of EBN plus Rapid on-site cytopathological examination (ROSE) for the

diagnosis of peripheral lung lesions (mean size 23 mm) and enlarged mediastinal

lymph nodes (MLN) (mean size 17 mm) in 76 consecutive patients (49 men, 25

women; mean age 55.4 years). The patients were followed for ≥ 2 years (mean

2.1). Forty-one patients had enlarged MLN, 22 had peripheral lung lesions, and 13

had both lung lesions and enlarged MLN. In total, 102 MLNs and 35 lung lesions were

targeted for diagnosis. Successful sampling was achieved in 91.4% (32/35) of the


lung lesions, and in 83.3% (85/102) of the MLNs for an overall diagnostic yield of

89.5%. Lung lesions and MLNs were further grouped according to their size (lung

lesions: 93.8% < 20 mm versus 89.5% ≥ 20 mm; MLNs: 82.1% < 15 mm versus

89.4% ≥ 15 mm); the sampling yield was independent of size for both lung lesions

(P=1.00) and MLNs (P=0.38). The diagnoses obtained by EBN included 25

malignancies (20 non-small cell lung cancers and 5 small cell lung cancers) and 43

benign lung lesions. Pneumothorax occurred in 3 patients (3.9%) but none required

a chest tube.

Lamprecht et al. (2012), completed a prospective cohort study and evaluated the

diagnostic efficacy of ENB combined with fluorodeoxyglucose positron-emission

computed tomography (FDG-PET-CT) + ROSE in 112 patients (75 men, 37 women;

mean age 66.7 years; mean lesion size 27.1 mm). No additional guidance by e.g.,

fluoroscopy, was used. The final diagnosis was confirmed by histopathological

evaluation of specimens obtained by ENB, CT-guided FNA, or surgery. The mean

diagnostic yield was 80% for the first 30 procedures (mean diameter 30.4 mm) and

88% for the final 30 procedures (mean diameter 25.3 mm) (P=0.72). The diagnostic

yield of ENB in combination with FDG-PET-CT + ROSE was 84%; 15% (17/112) of

lesions were benign and 85% (95/112) were malignant. With respect to other

variables, there were no significant differences in diagnostic yields based on lesion

size (≤ 20 versus > 20 mm diameter [75.6% and 89.6%, respectively; P=0.06);

lesion site (lower versus upper lobes); or forced expiratory volume (FEV1). When

navigation to the lesion was successful (distance from the tip of the location sensor

to the center of the lesion ≤ 10 mm), sensitivity and specificity of ROSE for a

diagnosis of malignancy was 92.6% and 100%, respectively. Two patients (2%)

developed pneumothoraces within 24 hours of bronchoscopy although neither

required a chest tube.

Jensen et al. (2012) completed a retrospective cohort study, in which he evaluated

the efficacy of ENB for the diagnosis of lung lesions in 92 consecutive patients (44

men, 48 women; mean age 67 years; mean lesion size 2.61 cm; mean distance of

lesion from pleural surface 1.81 cm). The diagnosis was confirmed by bronchoscopy,

surgical biopsy, or follow-up of ≥ 6 months to assess lesion stability by x-ray. The

overall yield of ENB for lung lesions was 65% (60/92). The ENB yield for nodules ≤ 2

versus > 2 cm in size was significantly less after controlling for the distance from the

pleura (50% versus 76%, respectively; P=0.01). The distance from the pleura did

not affect the ENB diagnostic yield after controlling for nodule size (P=0.92). The

lobar location of the nodule also did not affect the diagnostic yield (P=0.59). The

overall complication rate was 4% (4/92); 3 patients (3%) had a pneumothorax and 1

(1%) had bleeding, but none required hospitalization. (Three of the authors had

financial relationships with the manufacturer).

Pearlstein et al. (2012) completed a retrospective cohort study that analyzed 104

patients (64 men, 40 women; mean age 69 years; median lesion size 28 mm) who

had ENB + ROSE performed by thoracic surgeons. Follow-up imaging was performed

for up to 2 years. Three patients were excluded due to insufficient follow-up. Results

showed that 82 of 101 suspicious lesions were ultimately determined to be

malignant: 67 (82%) had a positive diagnosis on ENB. Of the 34 lesions without a

positive ENB biopsy, 19 (56%) were categorized as true-negatives: 8 had benign

surgical biopsies, 6 regressed and disappeared, and 5 were stable. The mean

diagnostic yield of ENB was 85% (86/101). The combination of ENB + ROSE had an

overall negative predictive value of 56% and an overall sensitivity of 82% for a

diagnosis of malignancy. By lesion size (< 1.5, 1.5 to 2, and > 2 cm), the

sensitivities were 75%, 69%, and 85%, respectively. Six patients (5.8%) developed

procedure-related pneumothoraces, all requiring chest tube placement and

admission. The mean hospital length of stay after chest tube placement was 3.8 days


(range 2 to 6). Although all patients were able to be extubated after the procedure,

4 (3.9%) were admitted overnight for observation secondary to tenuous respiratory

status. There were no deaths.

Navani et al. (2012) Patients with isolated mediastinal lymphadenopathy (IML) are a

common presentation to physicians, and mediastinoscopy is traditionally considered

the "gold standard" investigation when a pathological diagnosis is required.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is

established as an alternative to mediastinoscopy in patients with lung cancer. The

objective of this study was to determine the efficacy and health care costs of EBUS-

TBNA as an alternative initial investigation to mediastinoscopy in patients with

isolated IML. Prospective multicenter single-arm clinical trial of 77 consecutive

patients with IML from 5 centers between April 2009 and March 2011. All patients

underwent EBUS-TBNA. If EBUS-TBNA did not provide a diagnosis, then participants

underwent mediastinoscopy. EBUS-TBNA prevented 87% of mediastinoscopies (95%

confidence interval [CI], 77-94%; P < 0.001) but failed to provide a diagnosis in 10

patients (13%), all of whom underwent mediastinoscopy. The sensitivity and

negative predictive value of EBUS-TBNA in patients with IML were 92% (95% CI, 83-

95%) and 40% (95% CI, 12-74%), respectively. One patient developed a lower

respiratory tract infection after EBUS-TBNA, requiring inpatient admission. EBUS-

TBNA is a safe, and highly sensitive initial investigation in patients with IML. Clinical

trial registered with ClinicalTrials.gov (NCT00932854).

Ishida et al. (2011) Bronchoscopy using endobronchial ultrasound (EBUS) can help to

diagnose small peripheral pulmonary lesions. However, although biopsy sites can be

confirmed, a bronchoscope cannot be guided in EBUS. Virtual bronchoscopic

navigation (VBN) can guide a bronchoscope with virtual images, but its value has not

been confirmed. This prospective multicentre study examines the value of VBN-

assisted EBUS for diagnosing small peripheral pulmonary lesions. 199 patients with

small peripheral pulmonary lesions (diameter ≤30 mm) were randomly assigned to

VBN-assisted (VBNA) or non-VBN-assisted (NVBNA) groups. A bronchoscope was

introduced into the target bronchus of the VBNA group using the VBN system. Sites

of specimen sampling were verified using EBUS with a guide sheath under

fluoroscopy. The diagnostic yield was higher for the VBNA than for the NVBNA group

(80.4% vs 67.0%; p = 0.032). The duration of the examination and time elapsed

until the start of sample collection were reduced in the VBNA compared with the

NVBNA group (median (range), 24.0 (8.7-47.0) vs 26.2 (11.6-58.6) min, p = 0.016)

and 8.1 (2.8-39.2) vs 9.8 (2.3-42.3) min, p = 0.045, respectively). The only adverse

event was mild pneumothorax in a patient from the NVBNA group. The x`diagnostic

yield for small peripheral pulmonary lesions is increased when VBN is combined with

EBUS. Clinical trial number UMIN000000569.

The American College of Chest Physicians, in their most recent guidelines on the

evidence-based diagnosis of lung cancer published in September of 2007, noted that

a number of newer modalities such as ultrathin bronchoscopy, CT fluoroscopy,

multiplanar volume reformation, and electromagnetic navigation are being studied

for their impact on the diagnostic yield of fiberoptic bronchoscopy for lung cancer,

yet no recommendation can be made based on the preliminary results of the studies.

In 2011, the Interventional Bronchoscopy Guideline (IBG) Group of the British

Thoracic Society (BTS) developed guidelines concerning advanced diagnostic and

therapeutic flexible bronchoscopy in adult patients. The guidelines mention ENB as

one of the more recent diagnostic applications using a flexible bronchoscope. It is

considered safe and effective. Also, studies using virtual bronchoscopy alone reach

comparable diagnostic rates as ENB, according to the IBG Group.


In summary, although the 2013 NCCN guidelines for NSCLC has added navigational

bronchoscopy to their diagnostic tools, specifically for patients with peripheral (outer

1/3) nodules, additional, larger, controlled and comparative studies are necessary.

Scientific Rationale – Update July 2012 According to the NCCN 2012 guidelines on Non-small cell lung cancer, “Bronchoscopy

is used in the diagnosis and local staging of both central and peripheral lung lesions

and is recommended for pretreatment evaluation of stage I, stage II and stage IIIA

tumors. However, in patients who present with a solitary pulmonary nodule where

the suspicion of malignancy is high, surgical resection without prior invasive testing

may be reasonable.” The guidelines do not address electromagnetic navigation

bronchoscopy in the guidelines.

Scientific Rationale – Initial A solitary pulmonary nodule (SPN, also referred to as a coin lesion), is a single

abnormality in the lung that is smaller than 3 cm in diameter. Generally, a

pulmonary nodule must grow to at least 1 cm in diameter before it can be seen on a

chest x-ray. Approximately 150,000 SPNs are detected every year as incidental

findings, either on x-ray films or CT scans.

Most SPNs are benign; however, they may represent an early stage of primary lung

cancer or may indicate that cancer is metastasizing from another part of the body to

the affected lung. In lung cancer screening studies that enrolled individuals believed

to be at high risk for neoplasms of the lung, the prevalence of SPNs varied from 8 to

51 percent. To detect lung cancer, suspicious lumps and nodules that develop within

and around the lungs must be examined. The major question that follows detection

of a SPN is whether the lesion may be malignant, with management varying

accordingly. Since tuberculosis, partial lung collapse, and other conditions can cause

benign lesions that do not require surgery, minimally invasive biopsy methods have

been developed. However, lesions beyond the reach of the bronchoscope can be

inaccessible.

Flexible bronchoscopy, a minimally invasive procedure, is an established approach to

evaluating pulmonary nodules. The sensitivity of flexible bronchoscopy for

diagnosing bronchogenic carcinoma has been estimated at 88 percent for central

lesions and 78 percent for peripheral lesions. For small peripheral lesions, less than

1.5 cm in diameter, the sensitivity may be as low as 10 percent. The diagnostic

accuracy of transthoracic needle aspiration for solitary pulmonary nodules tends to

be higher than that of bronchoscopy. The sensitivity and specificity are both

approximately 94 percent. A disadvantage of transthoracic needle aspiration (TTNA)

is that a pneumothorax develops in 11-24 percent of patients and 5-14 percent

require insertion of a chest tube. PET scans are also highly sensitive for evaluating

pulmonary nodules, yet may miss small lesions less than 1 cm in size. Lung biopsy

is the gold standard for diagnosing pulmonary nodules, but is an invasive procedure.

Recent advances in technology have led to enhancements in established diagnostic

methods. CT scanning equipment can be used to guide bronchoscopy and

bronchoscopic transbronchial needle biopsy, but have the disadvantage of exposing

the patient and staff to radiation. Endobronchial ultrasound (EBUS) by radial probes,

previously used in the perioperative staging of lung cancer, can also be used to

locate and guide sampling of peripheral lesions. EBUS is reported to increase the

diagnostic yield of flexible bronchoscopy to at least 82 percent, regardless of the size

and location of the lesion.

Another proposed enhancement to standard bronchoscopy is “Electromagnetic

Navigation Bronchoscopy” (ENB). ENB is a minimally invasive procedure, which


includes the use of virtual bronchoscopy (VB). Information obtained during this

procedure is super-imposed on previously acquired, preoperative, computed

tomography (CT) data. Three-dimensional virtual images of the patient’s lungs are

generated. The system was designed to solve the clinical problem of reaching small

suspected lesions in the peripheral lung airways and mediastinal lymph nodes. ENB is

being proposed as an alternative to open surgical biopsy of distant lung lesions. With

the 3D roadmap of the lungs, the physician is able to maneuver catheters through

multiple branches of the bronchial tree, and introduce endobronchial accessories

(e.g., forceps, brushes, needles, etc.), for performing biopsies of these lesions.

ENB consists of several parts: a guide catheter, a steerable navigation catheter, and

planning and navigation software and hardware (i.e. computer and monitor). This

procedure is facilitated by an electromagnetic tracking system that detects a position

sensor incorporated into a flexible catheter advanced through the bronchoscope.

During ENB, the patient is positioned over an electromagnetic board and a

microsensor probe is inserted through the extended working channel (EWC) of the

bronchoscope into the airways. Through the low frequency electromagnetic waves

emitted from this board, the monitor picks up the signal sent out by the sensor. The

sensor’s movements and position are overlaid in real time onto the virtual 3D image

of the lungs, guiding the physician to areas of the lungs that were previously

inaccessible. If the targeted lesions are determined to be cancerous, ENB is

proposed to be used to transbronchially place radiosurgical markers in and around

lung tumors, to assist treatment with external beam radiation.

The ENB system consists of the following four essential components noted above,

which are described below in greater depth:

Computer software that creates a three-dimensional (3D), reconstruction from

CT images;

An electromagnetic location board that emits a low-dose electromagnetic field;

A sensor probe that has an 8-way steering mechanism and is located within the

electromagnetic field;

An extended working channel (EWC) that when secured enables the placement

of the bronchoscopic tools to the lung periphery.

The following are the three phases of the ENB procedure:

Planning phase: This consists of loading previously taken CT scans onto a

laptop computer and using software to construct a 3-D image of the patient's

lungs with anatomical landmarks identified. The file containing this information

is transferred to a computer on the console for use during the procedure;

Registration phase: A steerable navigational catheter is placed through the

extended working channel of a standard bronchoscope. The anatomical

landmarks identified in the planning phase are viewed on the 3-D image from

phase one, and these virtual images are correlated with the actual image from

the video-bronchoscope. The steerable navigation catheter is placed at the

same site as the virtual markers, and the position of each is marked;

Navigation phase: The steerable navigation catheter is moved towards the

target and the real-time location of the catheter's tip is displayed on the CT

images. When the navigation catheter reaches the target, it is locked in place

and the working guide is retracted. Once this occurs, any endoscopic tool can be

inserted through the channel in the catheter to the target. This includes

insertion of a transbronchial forceps to biopsy the lesion.

Examples of electromagnetic navigational bronchoscopy systems include but may not

be limited to:


SuperDimension Bronchus System (also known as the i-Logic system, or the

InReachTM System).

Ig4 EndoBronchial (SPiN Drive).

Professional Societies

(2005) National Institute for Health and Clinical Excellence (NICE):

Guidelines concerning the diagnosis of lung cancer were developed by NICE, a

component of the UK National Health Service. Although these guidelines do not

mention the superDimension i-Logic System or image-guided bronchoscopic biopsy,

NICE has made the following recommendations concerning biopsies for diagnosis of

lung cancer:

CT of the chest should be performed before fiberoptic bronchoscopy or any other

biopsy procedure.

Patients with peripheral lesions should undergo percutaneous transthoracic

needle biopsy.

When minimally invasive biopsy is not successful or feasible, surgical biopsy

should be performed. In addition, for solitary pulmonary nodules, a PET scan

should be performed depending on nodule position, size, and characterization by

CT.

If a distant metastasis seems to be present, it should undergo biopsy rather than

the primary site if the primary site is less readily accessible.

(2007) Major recommendations for the evaluation of patients with

pulmonary nodules by the American College of Chest Physicians Health

(ACCP), the Science Policy Committee (ACCP HSP) Committee, and the

Thoracic Oncology Network of the college, were noted with a Grade of

recommendation, 1C or 1B, which is a strong recommendation. None of these

professional societies advocate electromagnetic navigation-guided bronchoscopy as a

technique to be used to visualize or biopsy pulmonary nodules.

(2010) National Cancer Comprehensive Network [NCCN] Presentation as a

solitary peripheral nodule without central adenopathy is uncommon, and in this

situation, fine-needle aspiration may not adequately differentiate small cell

carcinoma from low-grade (typical carcinoid), intermediate-grade (atypical

carcinoid), or high-grade (large-cell) neuroendocrine carcinoma. If a new pulmonary

nodule appears after 2 years, it should be evaluated as a new primary tumor

because second primary tumors are a frequent occurrence in patients who are cured

of SCLC. NCCN does not mention electromagnetic navigational bronchoscopy in their

literature on lung cancer; it is not a designated technique to reach small suspected

nodules in the peripheral lung airways, per NCCN.

FDA Approvals

Electromagnetic navigation during bronchoscopy is a procedure and, therefore, not

subject to FDA regulation. However, medical devices, tests, and/or drugs used for

this procedure may be subject to FDA regulation. It should be noted that from 1992

to 2010 there were 155 adverse events recorded.

The superDimension System received initial 510(k) approval on November 8, 2004

(K042438) for use in conjunction with bronchoscopy. This device is a minimally

invasive image-guidance localization and navigation system that uses

electromagnetic guidance for the management of peripheral lung lesions. According

to the device manufacturer, the superDimension System received CE Marking for

marketing in the European Union in June 2002.


The superDimension System has had many additions and modifications throughout

the years, which have all received FDA 510(k) approval. This includes all of the

following:

K052260: Approval of the superDimension/Bronchus 4.1 System on September

8, 2005.

K052852: Approval of the superDimension/Bronchus Premium System on

November 14, 2005.

K062315: Approval of the superDimension/Bronchus Premium 2 System on

September 8, 2006.

K071473: Modification of superDimension System disposable components and

labeling on July 12, 2007.

K080271: Approval of the superDimension inReach System on March 31, 2008.

K081379: Modification of the inReach System instructions for use on June 11,

2008.

K082386: Approval of the inReach System Planning Laptop on September 16,

2008.

K092365: Modification of the inReach System software and applicable

instructions for use on September 4, 2009.

An additional device, Veran’s SpiN Drive System, received clearance (K091934) from

the U.S. Food and Drug Administration (FDA) on January 8, 2010. Veran's SPiN Drive

System acts as a GPS-like system to enable pulmonologists and surgeons to access

peripheral SPN's to immediately diagnose malignancy.

Studies

Schwarz et al. (2006) completed an uncontrolled study that was done to propose

that ENB was safe and added only an average of 15 minutes to the time of a

conventional bronchoscopy. Successful diagnostic biopsies were obtained in 69% of

patients. A follow-up study of 60 patients, published in 2006, successfully reached

the target lesion in 100% of cases. Bronchoscopy with electromagnetic navigation

diagnosed 80.3% of the lesions, 74% of the peripheral lesions, and 100% of the

lymph nodes. Of the lesions, 57% were less than 2 cm in size. Diagnostic yield did

not differ significantly based on the size of the lesion. Nevertheless, all preceding

diagnostic studies using ENB also used fluoroscopy to guide biopsies. Therefore, the

role of ENB as a stand-alone technology is still unproven and concerns remain that

biopsy instruments may dislodge an accurately positioned extended working channel

(EWC) when replacing the sensor probe.

Gould et al. (2007) Guidelines from the American College of Chest Physicians on

evaluation of patients with pulmonary nodules commented on electromagnetic

navigation bronchoscopy, but made no specific recommendations for its use: "A

newer technique, electromagnetic navigation, combines simultaneous CT virtual

bronchoscopy with real-time fiberoptic bronchoscopy and shows promise as another

tool for guiding biopsy of peripheral nodules. Although these new methods seem to

improve diagnostic yields over fluoroscopic guidance, results still do not compare

favorably with those from a recent series that evaluated transthoracic needle

aspiration (TTNA) in patients with small peripheral nodules."

Eberhardt et al. (2007) completed a prospective study in which ENB was performed

via flexible bronchoscopy (i.e. superDimension). Biopsy specimens were obtained

through the extended working channel (EWC) after navigation. Fluoroscopy was not

used, but post-transbronchial biopsy chest radiographs were obtained to exclude

pneumothorax. The primary end point was diagnostic yield, and the secondary end

points were navigation accuracy, procedure duration, and safety. Analysis by lobar

distribution was also performed to assess performance in different lobes of the lung.


Ninety-two peripheral lung lesions were biopsied in the 89 subjects. The diagnostic

yield of ENB was 67%, which was independent of lesion size. Total procedure time

ranged from 16.3 to 45.0 min (mean [+/- SD] procedure time, 26.9 +/- 6.5 min).

The mean navigation error was 9 +/- 6 mm (range, 1 to 31 mm). There were two

incidences of pneumothorax for which no intervention was required. When analyzed

by lobar distribution, there was a trend toward a higher ENB yield in diagnosing

lesions in the right middle lobe (88%). ENB can be used as a stand-alone

bronchoscopic technique without compromising diagnostic yield or increasing the risk

of pneumothorax. This may result in sizable timesaving and avoids radiation

exposure. However, the upper lobes tend to have sharper angles in the bronchial

tree that may be challenging to navigate even with a steerable sensor probe. The

EWC ends are close to the tip of the sensor probe and therefore make it less flexible.

This reduces the range of deflection and, consequently, the ability to navigate. It can

also make the probe flip into a different position when negotiating some tight angles

in the bronchi. Furthermore, these tight angles may result in the EWC being more

easily dislodged when stiffer biopsy devices like forceps are passed through them.

Navigation in the lower lobes is more affected by diaphragmatic movement during

breathing and could result in larger errors than recorded. This is because the

planning data are based on CT scan images acquired in a single breathhold. The size

of the lesion did not prove to be a determinant in diagnostic yield. The improved

yield of ENB compared to conventional transbronchial lung biopsy in small lesions

(i.e. those < 20 mm in diameter) can be attributed to the improved precision in

navigation. The lack of additional gains in the yield with larger lesions may be due to

the fact that these larger lesions tend to distort and occlude the airways leading up

to them. This could result in the sensor probe ending up adjacent to the lesion rather

than within the lesion. Navigation to the margin of the lesion rather than to the

center and the utilization of biopsy tools like transbronchial needle aspiration biopsy

may be able to overcome this. The design of this study did not allow direct

comparisons with other techniques. A randomized controlled trial using ENB with or

without fluoroscopy is needed to make definitive conclusions about the comparative

yield. The future of ENB may see improved means of specimen collection with

dedicated instruments. Multimodality diagnosis by combining ENB with other

bronchoscopic and imaging techniques may further enhance the diagnostic yield.

Eberhardt et al. (2007) completed another prospective study which was the only

randomized controlled trial on the superDimension System. The study included 120

patients who underwent transbronchial forceps biopsy of peripheral lung lesions

guided by the superDimension System (SD) alone (SD Group: 20 men, 19 women;

mean age 55 ± 15 years; mean lesion size 28 ± 8 mm), endobronchial ultrasound

alone (EBUS Group, 23 men, 16 women; mean age 54 ± 12 years; mean lesion size

25 ± 5 mm), or both methods combined (SD+EBUS Group, 25 men, 15 women;

mean age 51 ± 12 years; mean lesion size 24 ± 5 mm). No fluoroscopic guidance

was used. If the biopsy procedure did not give a definitive diagnosis, patients were

referred to open surgical biopsy. Two patients, one in the SD Group and one in the

EBUS Group, refused open biopsy and were excluded from the study. At baseline,

there were no statistically significant differences between the three groups in

demographics except for lesion size (P<0.05). The final diagnosis indicated that 26

(22%) lesions were benign and 92 (78%) were malignant. There were no statistically

significant differences between the groups in the incidence of benign versus

malignant lesions. A definitive diagnosis was obtained by the minimally invasive

biopsy technique in 27 (69%) SD Group patients, 23 (59%) EBUS Group patients,

and in 35 (88%) SD+EBUS Group. Differences between the SD+EBUS Group and

other groups in diagnostic yield were statistically significant (P<0.05) and the

smaller mean lesion size in the SD+EBUS Group may have caused an

underestimation of diagnostic yield in this group. There was no statistically

significant difference between the SD Group and the EBUS Group in diagnostic yield.


Although pneumothorax occurred in 7 (6%) patients, there were no statistically

significant differences between the groups in the incidence of this complication and

no other complications occurred that required therapeutic interventions. Additional

controlled studies are needed to confirm that a combination of the superDimension

System and endobronchial ultrasonography improves diagnostic yield, to verify that

use of the superDimension System does not increase complications, and to explore

whether the superDimension System alone improves diagnostic yield compared with

endobronchial ultrasonography alone.

Krishna et al. (2008) stated that newer minimally invasive techniques should be

rigorously evaluated for their role in the diagnostic algorithm of peripheral lung

lesions. Electromagnetic navigation-guided bronchoscopy is a promising minimally

invasive method of reaching distant lung lesions, however, long-term studies with

larger sample sizes are required to define its role in the diagnostic pathway for lung

cancer and management of peripheral lung lesions.

A technology assessment on electromagnetic navigation bronchoscopy by the VA

Boston Healthcare System (2008) concluded that the data are insufficient to

determine whether the use of electromagnetic navigation bronchoscopy will avoid

surgical biopsy procedures in surgical candidates because of its low negative

predictive value. An earlier evaluation by CEDIT (2006) concluded that

electromagnetic navigation bronchoscopy is promising but as yet insufficiently

validated.

(2009) There is a Clinical Trial on ‘Bronchoscopic Approach to the Peripheral Lung

Nodule - An Alternative Approach’ that is currently recruiting participants. This

nonrandomized uncontrolled study design has the ClinicalTrials.gov Identifier of

NCT00925210. Patients presenting with solitary or multiple lung nodules often

require tissue confirmation in order to guide further management and determine if

the lesion is benign or malignant. Several bronchoscopic techniques have emerged

which have significantly improved the diagnostic yield of bronchoscopy in this

setting, and in particular the combination of peripheral Endobronchial

Ultrasonography (pEBUS) and Electromagnetic Navigation Bronchoscopy (ENB) has

resulted in diagnostic yields of nearly 90%. In an attempt to reduce the significant

cost of this combined approach, the sequential use of pEBUS followed by the more

costly ENB technique only if a lesion is not identified on the ultrasound image could

be as accurate. This study aims to determine the diagnostic yield of this sequential

approach in patients with lung nodule(s). The estimated primary completion date is

December 2010. This would be the final data collection date for primary outcome

measure.

Seijo et al. (2010) conducted a prospective single center study of ENB in 51

consecutive patients with pulmonary nodules. ENB was chosen as the least invasive

diagnostic technique in patients with a high surgical risk, suspected metastatic

disease, advanced stage disease, or those who demanded a pre-operative diagnosis

prior to undergoing curative resection. The authors studied patient and technical

variables which might condition diagnostic yield including; size, etiology, location,

distance to the pleural surface, and FDG uptake of a given nodule, the presence of a

bronchus sign on CT, registration point divergence, and the minimum distance from

the tip of the locatable guide to the nodule measured during the procedure. The

diagnostic yield of ENB was 67% (34/51). The sensitivity and specificity of ENB for

malignancy in this study were 71 and 100% respectively. ENB was diagnostic in

30/38 (79%) patients with a bronchus sign on CT, but only in 4/13 (31%) with no

discernible bronchus sign. Univariate analysis identified the bronchus sign (p=0.005)

and nodule size (p=0.04) as statistically significant variables conditioning yield, but

on multivariate analysis only the bronchus sign remained significant (OR: 7.6; 95%


CI: 1.8-31.7). No procedure related complications were observed. ENB diagnostic

yield is highly dependent on the presence of a bronchus sign on CT.

Additional studies that have been done regarding electromagnetic navigational

bronchoscopy with the superDimension System include the largest available

uncontrolled study done by Wilson et al. (2007); other uncontrolled studies have

been performed by Gildea et al. (2006); Makris et al. (2007); Bertoletti et al.

(2009); and Eberhardt et al. (2010).

Per Herth et al (2010 MD Consult), There are still some major limitations to the

technique used in ENB. For planning, a CT scan is necessary with a special protocol

(1-mm cuts and tight overlay). For the planning of the procedure, use of the

electromagnetic navigation bronchoscopy (ENB) software is required. The planning

can be done even on the system or on a special dedicated laptop before the

procedure; the planning needs some time, up to 10 minutes even in trained hands.

The whole procedure time is prolonged compared with a traditional diagnostic

bronchoscopy with fluoroscopy; but equal to that required by the CT-guided

percutaneous needle aspiration.

In summary, although electromagnetic navigation-guided bronchoscopy is a

promising minimally invasive method of reaching distant lung lesions, additional

long-term, published peer-reviewed studies with larger sample sizes are required to

define its role in the diagnostic pathway for lung cancer and management of

peripheral lung lesions. There is a paucity of outcome studies to demonstrate the

diagnostic accuracy of ENB compared to currently available biopsy techniques,

including transthoracic needle aspiration (TTNA) or flexible bronchoscopy combined

with multiplanar computed tomography (CT) or endobronchial ultrasound. Additional

randomized controlled studies are needed to confirm that a combination of the

electromagnetic navigational bronchoscopy (ENB) system and endobronchial

ultrasonography improves diagnostic yield, to verify that the use of the ENB system

does not increase complications, and to explore whether the ENB alone improves

diagnostic yield compared with endobronchial ultrasonography alone.

Review History July 2010 Medical Advisory Council Initial Approval

July 2011 Update. Added Revised Medicare Table. No revisions.

July 2012 Update – no revisions

July 2013 Update –no revisions. Updated codes.

July 2014 Update – no revisions. Updated Codes.

This policy is based on the following evidence-based guidelines: 1. Hayes Search & Summary. Electromagnetic Navigation During Bronchoscopy.

April 2, 2010.

2. Hayes Health Technology Brief. Computed Tomography (CT)-Guided Lung Biopsy

with the superDimension i-Logic System (superDimension Inc.). June 11, 2010.

Updated April 24, 2013. Updated March 5, 2014.

3. National Cancer Comprehensive Network (NCCN). NCCN Clinical Practice

Guidelines in Oncology. Small Cell Lung Cancer. V.1.2010. Updated Version

2.2014.

4. Gould MK, Fletcher J, Iannettoni MD, et al. American College of Chest Physicians

(ACCP). Evaluation of patients with pulmonary nodules: When is it lung cancer?

ACCP Evidence-Based Clinical Prctice Guidelines (2nd Edition). Chest.

2007;132(3 Suppl):108S-130S.

5. National Institute for Clinical Excellence (NICE). Lung cancer: the diagnosis and

treatment of lung cancer. NICE Clinical Guideline No. 24. London, UK: National

Institute for Health and Clinical Excellence; 2005.


6. National Cancer Comprehensive Network (NCCN). NCCN Clinical Practice

Guidelines in Oncology. Non-Small Cell lung Cancer. Version 3.2012. Updated

Version 2. 2013. Updated Version 4. 2014.

7. Rivera MP, Mehta AC; American College of Chest Physicians. Initial diagnosis of

lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition).

Chest. 2007;132(3 Suppl):131S-148S. Available at:

http://journal.publications.chestnet.org/article.aspx?articleid=1211610

8. Hayes. Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

(EBUS-TBNA) of Mediastinal Lymph Nodes in Patients with Lung Cancer. Updated

December 17, 2012. Updated December 17, 2012. Archived January 2, 2014.

9. Hayes. Endobronchial Ultrasound (EBUS) for the Diagnosis of Peripheral

Pulmonary Lesions. Updated April 3, 2012. Archived April 28, 2013.

References – Update July 2014 1. Balbo PE, Bodini BD, Patrucco F, et al. Electromagnetic navigation bronchoscopy

and rapid on site evaluation added to fluoroscopy-guided assisted bronchoscopy

and rapid on site evaluation: improved yield in pulmonary nodules. Minerva

Chir. 2013 Dec;68(6):579-85.

2. Chee A, Stather DR, Maceachern P, et al. Diagnostic utility of peripheral

endobronchial ultrasound with electromagnetic navigation bronchoscopy in

peripheral lung nodules. Respirology. March 22, 2013. [Epub ahead of print].

3. Gex G, Pralong JA, Combescure C, et al. Diagnostic yield and safety of

electromagnetic navigation bronchoscopy for lung nodules: a systematic review

and meta-analysis. Respiration. 2014;87(2):165-76. doi: 10.1159/000355710.

Epub 2014 Jan 3. 4. Karnak D, Ciledağ A, Ceyhan K, et al. Rapid on-site evaluation and low

registration error enhance the success of electromagnetic navigation

bronchoscopy. Ann Thorac Med. 2013;8(1):28-32. Available at:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3573554 5. Loo FL, Halligan AM, Port JL, et al. The emerging technique of electromagnetic

navigation bronchoscopy-guided fine-needle aspiration of peripheral lung

lesions: Promising results in 50 lesions. Cancer Cytopathol. 2013 Dec 5. doi:

10.1002/cncy.21373. [Epub ahead of print.

6. Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer:

Diagnosis and management of lung cancer, 3rd ed: American College of Chest

Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5

Suppl):e142S-65S. doi: 10.1378/chest.12-2353.

References – Update July 2013 1. Brownback KR, et al. Electromagnetic navigational bronchoscopy in the diagnosis

of lung lesions. J Bronchology Interv Pulmonol. 2012 Apr;19(2):91-7.

2. Clinicaltrials.gov. Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in

the Diagnosis of Small Pulmonary Nodules. ClinicalTrials.gov Identifier:

NCT01779388. January 2013. Available at:

http://www.clinicaltrials.gov/ct2/show/NCT01779388?term=Bronchoscopy+Assis

ted+by+Electromagnetic+Navigation&rank=1

3. Du Rand IA, Barber PV, Goldring J, et al. BTS Interventional Bronchoscopy

Guideline Group. British Thoracic Society guideline for advanced diagnostic and

therapeutic flexible bronchoscopy in adults. Thorax. 2011;66(3)::iii1-iii21.

Available at: http://www.brit-

thoracic.org.uk/Portals/0/Guidelines/BronchoscopyGuidelines/BTS%20Advanced

%20Bronchoscopy%20guideline%20November%202011.pdf

4. Ishida T, Asano F, Yamazaki K, et al. Virtual bronchoscopic navigation combined

with endobronchial ultrasound to diagnose small peripheral pulmonary lesions: a

randomised trial. Thorax. 2011 Dec;66(12):1072-7. Epub 2011 Jul 11.

http://journal.publications.chestnet.org/article.aspx?articleid=1211610%20

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3573554

http://www.clinicaltrials.gov/ct2/show/NCT01779388?term=Bronchoscopy+Assisted+by+Electromagnetic+Navigation&rank=1

http://www.clinicaltrials.gov/ct2/show/NCT01779388?term=Bronchoscopy+Assisted+by+Electromagnetic+Navigation&rank=1

http://www.brit-thoracic.org.uk/Portals/0/Guidelines/BronchoscopyGuidelines/BTS%20Advanced%20Bronchoscopy%20guideline%20November%202011.pdf




5. Jensen KW, et al. Multicenter experience with electromagnetic navigation

bronchoscopy for the diagnosis of pulmonary nodules. J Bronchology Interv

Pulmonol 2012 Jul;19(3):195-9.

6. Lamprecht B, et al. Electromagnetic navigation bronchoscopy (ENB): Increasing

diagnostic yield. Respir Med 2012 May;106(5):710-5.

7. Leong S. Electromagnetic navigation bronchoscopy: A descriptive analysis. J

Thorac Dis 2012 Apr 1;4(2):173-85. 8. Navani N, Lawrence DR, Kolvekar S, et al. Endobronchial ultrasound-guided

transbronchial needle aspiration prevents mediastinoscopies in the diagnosis of

isolated mediastinal lymphadenopathy: a prospective trial. Am J Respir Crit Care

Med. 2012 Aug 1;186(3):255-60. Epub 2012 May 31.

9. Pearlstein DP, Quinn CC, Burtis CC, et al. Electromagnetic navigation

bronchoscopy performed by thoracic surgeons: one center's early success. Ann

Thorac Surg. 2012 Mar;93(3):944-9; discussion 949-50. Epub 2012 Jan 23.

10. Wang Memoli JS, et al. Meta-analysis of guided bronchoscopy for the evaluation

of the pulmonary nodule. Chest 2012 Aug;142(2):385-393.

References – Update July 2012 1. Ernst A, Anantham D. Update on interventional bronchoscopy for the thoracic

radiologist. J Thorac Imaging. 2011 Nov;26(4):263-77.

2. Gex G, Montet X, Rochat T, Gasche-Soccal PM. Electromagnetic navigation

bronchoscopy for the assessment of peripheral lung nodules. Rev Med Suisse.

2010 Nov 24;6(272):2252-6.

3. Muehling B, Wehrmann C, Oberhuber A, et al. Comparison of clinical and

surgical-pathological staging in IIIA non-small cell lung cancer patients. Ann

Surg Oncol. 2012 Jan;19(1):89-93

References Update – July 2011 1. Eberhardt R, Kahn N, Herth FJ. 'Heat and destroy': Bronchoscopic-guided

therapy of peripheral lung lesions. Respiration. 2010;79(4):265-273.

2. Eberhardt R, Morgan RK, Ernst A, et al. Comparison of suction catheter versus

forceps biopsy for sampling of solitary pulmonary nodules guided by

electromagnetic navigational bronchoscopy. Respiration. 2010;79(1):54-60.

References Initial 1. Seijo L, de Torres J, Lozano M, et al. Diagnostic yield of electromagnetic

navigation bronchoscopy is highly dependent on the presence of a bronchus sign

on CT: results from a prospective study. Chest. 2010 Apr 30

2. Herth FJF, Eberhardt R. Flexible Bronchoscopy and its Role in the Staging of

Non-Small Cell Lung Cancer. Clinics in Chest Medicine Volume 31, Issue 1

(March 2010).

3. Mason: Murray and Nadel's Textbook of Respiratory Medicine, 5th ed. 2010.

Diagnostic Bronchoscopy.

4. CMS Centers for Medicare & Medicaid Services (CMS). Article for

ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (A49392). Palmetta GBA.

(Northern California). Contractor Number 01102. MAC Part B. Revision History

Explanation, 12/15/2009 - New CPT code for Electromagnetic Navigational

Bronchoscopy Effective 01/01/2010.

5. CMS. Centers for Medicare & Medicaid Services (CMS). Article for

ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (A49392). Palmetta GBA.

(Southern California). Contractor Number 01192. MAC Part B. Revision History

Explanation. 12/15/2009 - New CPT code for Electromagnetic Navigational

Bronchoscopy Effective 01/01/2010.

6. CMS. Centers for Medicare & Medicaid Services (CMS). LCD for

ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) (L30679). Palmetto


GBA. (South Carolina). Contractor Number 00880. Original Determination

Effective Date, For services performed on or after 03/02/2010.

7. CMS. Centers for Medicare & Medicaid Services. LCD for ELECTROMAGNETIC

Navigation BRONCHOSCOPY (ENB) (L30510). Wisconsin Physicians Service

Insurance Corporation. Contractor Number 52280. (Coverage for Arizona,

Connecticut, New Jersey, Oregon). For services performed on or after

2/15/2010.


Navigation for BRONCHOSCOPY (L30171). National Government Services, Inc.

(Connecticut). Contractor Number 13101. MAC Part A. For services performed on

or after 06/01/2010.



(Connecticut). Contractor Number 13102. MAC Part B. For services performed on

or after 12/01/2009.



(Entire state of New York). Contractor Number 13201. MAC Part A. Originally

effective For services performed on or after 12/01/2009, Revisions effective on

or after 06/01/2010.



(Entire state of New York). Contractor Number 13102. MAC Part B. Originally


or after 06/01/2010.



(Upstate New York). Contractor Number 13282. MAC Part B. Originally effective

For services performed on or after 12/01/2009, Revisions effective on or after

06/01/2010.



(New York - Queens) Contractor Number 13292. MAC Part B. Originally


or after 06/01/2010.

14. Weinberger SE. Diagnostic evaluation and initial management of the solitary

pulmonary nodule. UpToDate 2010.

15. Edell E, Krier-Morrow D. Navigational bronchoscopy: overview of technology and

practical considerations--new Current Procedural Terminology codes effective

2010. Chest. 2010 Feb;137(2):450-4. Epub 2009 Dec 4.

16. Eberhardt R, Morgan RK, Ernst A, Beyer T, Herth FJ. Comparison of suction

catheter versus forceps biopsy for sampling of solitary pulmonary nodules guided

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