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
at the end of this document

For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for
coverage guidelines prior to applying Health Net Medical Policies
The Centers for Medicare & Medicaid Services (CMS)
For Medicare Advantage members please refer to the following for coverage
guidelines first:
Use

Source

National Coverage Determination

(NCD)
National Coverage Manual Citation
Local Coverage Determination (LCD)*
Article (Local)*

Other

None

Reference/Website Link

Electromagnetic Navigation Bronchoscopy:

http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx
Palmetto GBA. Jurisdiction 1 Part B
Electromagnetic Navigational Bronchoscopy. 12/1/11:
http://www.palmettogba.com/dev/newhome.nsf/docs
Cat/Providers~Jurisdiction%201%20Part%20B~Articl
es~General~Electromagnetic%20Navigational%20Bro
nchoscopy?open
Use Health Net Policy

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Electromagnetic Navigational Bronchoscopy Jul 14

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contained in the NCD or National Coverage Manual.
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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
GPS
TTNA
EBUS
pEBUS
SPN
autoIR
EWC
VB
TTNA
IML
ROSE
BAL
PLL
PET-CT
ROSE

Electromagnetic navigational bronchoscopy

Global positional system
Transthoracic needle aspiration
Endobronchial ultrasound
peripheral Endobronchial Ultrasonography
Single pulmonary nodule
Automatic Initial Registration
Extended working channel
Virtual bronchoscopy
Transthoracic needle aspiration
Isolated mediastinal lymphadenopathy
Rapid on-site cytopathological examination
Bronchoalveolar lavage
Peripheral lung lesion
Positron emission tomography-computed tomography
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 noncovered 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.

Electromagnetic Navigational Bronchoscopy Jul 14

ICD-9 Codes
162.3
162.4
162.5
162.8
162.9
196.1
197.0
212.3
518.89
785.6
793.11-793.2

Malignant neoplasm of upper lobe bronchus or lung

Malignant neoplasm of middle lobe bronchus or lung
Malignant neoplasm of lower lobe bronchus or lung
Malignant neoplasm of other parts of bronchus or lung
Malignant neoplasm of bronchus or lung, unspecified
Secondary and unspecified malignant neoplasm of intrathoracic
lymph nodes
Secondary malignant neoplasm of lung
Benign neoplasm of bronchus and lung
Other diseases of lung not otherwise classified
Enlargement of lymph nodes
Nonspecific (Abnormal) findings on radiological and other
examination of lung field

ICD 10 CPT Codes

C34.00C34.92
C77.0-C77.9
J98.01-J98.9
R59.-R59.9

R91.1-R91.8

Malignant neoplasm of main bronchus

Secondary and unspecified malignant neoplasm of lymph nodes
Other respiratory disorders
Enlarged lymph nodes
Abnormal findings on diagnostic imaging of lung

CPT Codes
31627
76377

76499

Bronchoscopy, rigid or flexible, including fluoroscopic guidance,

when performed, with computer-assisted, image-guided navigation
(list separately in addition to code for primary procedure)
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)
Unlisted diagnostic radiographic procedure

HCPCS Codes
N/A

Scientific Rationale Update July 2014

Gex et al. (2014) completed a study to describe electromagnetic navigation
bronchoscopys (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
Electromagnetic Navigational Bronchoscopy Jul 14

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, ENBBB, 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 PETCT, 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
Electromagnetic Navigational Bronchoscopy Jul 14

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

Electromagnetic Navigational Bronchoscopy Jul 14

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.
2.

3.

Access and timeliness of procedure

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)
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.

Electromagnetic Navigational Bronchoscopy Jul 14

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 patients 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
Electromagnetic Navigational Bronchoscopy Jul 14

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
Electromagnetic Navigational Bronchoscopy Jul 14

(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 EBUSTBNA 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, 8395%) and 40% (95% CI, 12-74%), respectively. One patient developed a lower
respiratory tract infection after EBUS-TBNA, requiring inpatient admission. EBUSTBNA 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 VBNassisted 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.

Electromagnetic Navigational Bronchoscopy Jul 14

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
Electromagnetic Navigational Bronchoscopy Jul 14

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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 patients 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
sensors 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:
Electromagnetic Navigational Bronchoscopy Jul 14

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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.

Electromagnetic Navigational Bronchoscopy Jul 14

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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, Verans 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.
Electromagnetic Navigational Bronchoscopy Jul 14

13

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.
Electromagnetic Navigational Bronchoscopy Jul 14

14

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%
Electromagnetic Navigational Bronchoscopy Jul 14

15

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
July
July
July
July

2010
2011
2012
2013
2014

Medical Advisory Council Initial Approval

Update. Added Revised Medicare Table. No revisions.
Update no revisions
Update no revisions. Updated codes.
Update no revisions. Updated Codes.

This policy is based on the following evidence-based guidelines:

1.
2.
3.
4.

5.

Hayes Search & Summary. Electromagnetic Navigation During Bronchoscopy.

April 2, 2010.
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.
National Cancer Comprehensive Network (NCCN). NCCN Clinical Practice
Guidelines in Oncology. Small Cell Lung Cancer. V.1.2010. Updated Version
2.2014.
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.
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.

Electromagnetic Navigational Bronchoscopy Jul 14

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6.
7.

8.
9.

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.
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
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.
Hayes. Endobronchial Ultrasound (EBUS) for the Diagnosis of Peripheral
Pulmonary Lesions. Updated April 3, 2012. Archived April 28, 2013.

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Balbo PE, Bodini BD, Patrucco F, et al. Electromagnetic navigation bronchoscopy

and rapid on site evaluation added to fluoroscopy-guided assisted bronchoscopy
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Chee A, Stather DR, Maceachern P, et al. Diagnostic utility of peripheral
endobronchial ultrasound with electromagnetic navigation bronchoscopy in
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Epub 2014 Jan 3.
Karnak D, Cileda A, Ceyhan K, et al. Rapid on-site evaluation and low
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Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer:
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Brownback KR, et al. Electromagnetic navigational bronchoscopy in the diagnosis

of lung lesions. J Bronchology Interv Pulmonol. 2012 Apr;19(2):91-7.
Clinicaltrials.gov. Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in
the Diagnosis of Small Pulmonary Nodules. ClinicalTrials.gov Identifier:
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ted+by+Electromagnetic+Navigation&rank=1
Du Rand IA, Barber PV, Goldring J, et al. BTS Interventional Bronchoscopy
Guideline Group. British Thoracic Society guideline for advanced diagnostic and
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%20Bronchoscopy%20guideline%20November%202011.pdf
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.

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5.

Jensen KW, et al. Multicenter experience with electromagnetic navigation

bronchoscopy for the diagnosis of pulmonary nodules. J Bronchology Interv
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6. Lamprecht B, et al. Electromagnetic navigation bronchoscopy (ENB): Increasing
diagnostic yield. Respir Med 2012 May;106(5):710-5.
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References Update July 2012

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Ernst A, Anantham D. Update on interventional bronchoscopy for the thoracic

radiologist. J Thorac Imaging. 2011 Nov;26(4):263-77.
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Eberhardt R, Kahn N, Herth FJ. 'Heat and destroy': Bronchoscopic-guided

therapy of peripheral lung lesions. Respiration. 2010;79(4):265-273.
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Diagnostic Bronchoscopy.
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(Northern California). Contractor Number 01102. MAC Part B. Revision History
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Bronchoscopy Effective 01/01/2010.
CMS. Centers for Medicare & Medicaid Services (CMS). Article for
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(Southern California). Contractor Number 01192. MAC Part B. Revision History
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GBA. (South Carolina). Contractor Number 00880. Original Determination

Effective Date, For services performed on or after 03/02/2010.
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.
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Navigation for BRONCHOSCOPY (L30171). National Government Services, Inc.
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or after 06/01/2010.
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Navigation for BRONCHOSCOPY (L30171). National Government Services, Inc.
(Connecticut). Contractor Number 13102. MAC Part B. For services performed on
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Navigation for BRONCHOSCOPY (L30171). National Government Services, Inc.
(Entire state of New York). Contractor Number 13201. MAC Part A. Originally
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