Medical Policies - Surgery


Electromagnetic Navigation Bronchoscopy (ENB)

Number:SUR706.013

Effective Date:10-15-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Electromagnetic navigation bronchoscopy (ENB), with or without fluoroscopic guidance, may be considered medically necessary in adult patients for the evaluation of a solitary pulmonary nodule that is highly suspicious for malignancy and meets at least one of the criteria below:

The solitary pulmonary nodule is deemed inaccessible by standard bronchoscopic methods or standard bronchoscopic methods have failed; OR

More invasive diagnostic procedures pose an unacceptable risk to the patient because of conditions such as bullous lung disease or diffuse emphysema; OR

The solitary pulmonary nodule co-exists with another cancer so that delineation of the nodule will impact staging and treatment of the primary tumor; OR

The patient requires placement of fiducial markers for radiation therapy because they are not a candidate for surgical intervention.

Use of electromagnetic navigation bronchoscopy (ENB) for any other indication is considered experimental, investigational, and/or unproven.

Description:

Electromagnetic navigation bronchoscopy (ENB) is intended to enhance standard bronchoscopy by providing a 3-dimensional roadmap of the lungs and real-time information about the position of the steerable probe during bronchoscopy. The purpose of ENB is to allow navigation to distal regions of the lungs, so that suspicious lesions can undergo biopsy and to allow for placement of fiducial markers.

Background

Pulmonary nodules are identified on plain chest radiographs or chest computed tomography (CT) scans. Although most of these nodules are benign, some are cancerous, and early diagnosis of lung cancer is desirable because of the poor prognosis when cancer is diagnosed later in the disease course. The method used to diagnose lung cancer depends on a number of factors, including lesion size and location, as well as the clinical history and status of the patient. There is generally greater diagnostic success with centrally located and larger lesions.

Peripheral lung lesions and solitary pulmonary nodules (most often defined as asymptomatic nodules <6 mm) are more difficult to evaluate than larger, centrally located lesions. There are several options for diagnosing them; none of the methods are ideal for safely and accurately diagnosing malignant disease. Sputum cytology is the least invasive approach. Reported sensitivity rates are relatively low and vary widely across studies; sensitivity is lower for peripheral lesions. Sputum cytology, however, has a high specificity; and a positive test may obviate the need for more invasive testing. 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% for central lesions and 78% for peripheral lesions. For small peripheral lesions, less than 1.5 cm in diameter, the sensitivity may be as low as 10%. 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%. A disadvantage of transthoracic needle aspiration is that a pneumothorax develops in 11% to 24% of patients, and 5% to 14% require insertion of a chest tube. Positron emission tomography scans are also highly sensitive for evaluating pulmonary nodules, yet may miss small lesions less than 1 cm in size. Lung biopsy is the criterion standard for diagnosing pulmonary nodules but is an invasive procedure. (1,2)

Recent advances in technology have led to enhancements that may increase the yield of 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%, regardless of the size and location of the lesion. (1)

Another proposed enhancement to standard bronchoscopy is ENB which is intended to enhance standard bronchoscopy by providing a 3-dimensional roadmap of the lungs and real-time information about the position of the steerable probe during bronchoscopy. The purpose of ENB is to allow navigation to distal regions of the lungs. Once the navigation catheter is in place, any endoscopic tool can be inserted through the channel in the catheter to the target. This includes insertion of transbronchial forceps to biopsy the lesion. In addition, the guide catheter can be used to place fiducial markers. Markers are loaded in the proximal end of the catheter with a guide wire inserted through the catheter.

Regulatory Status

In September 2004, the superDimension/Bronchus™ (superDimension Ltd, Herzliya, Israel) InReach™ system was cleared for marketing by the U.S. Food and Drug Administration(FDA) through the 510(k) process. The system includes planning and navigation software, a disposable extended working channel, and a disposable steerable guide. The FDA determined that this device was substantially equivalent to existing bronchoscopic devices. It is indicated for displaying images of the tracheobronchial tree that aids physicians in guiding endoscopic tools in the pulmonary tract. The device is not intended as an endoscopic tool; it does not make a diagnosis; and it is not approved for pediatric use. In May 2012, superDimension was acquired by Covidien (U.S. headquarters in Mansfield, MA). The current version of the product is called I-Logic™ Electromagnetic Navigation Bronchoscopy.

In December 2009, the ig4™ EndoBronchial system (Veran Medical; St. Louis, MO) was cleared for marketing by FDA through the 510(k) process. The system was considered to be substantially equivalent to the InReach system and is marketed as the SPiN™ Drive system.

Several additional navigation software-only systems have been cleared for marketing by the FDA through the 510(k) process. They include:

In December 2008, the LungPoint® virtual bronchoscopic navigation (VPN) system (Broncus Technologies, Mountain View, CA).

In June 2010, the bf-NAVI VPN system (Emergo Group, Austin, TX).

FDA product codes: JAK and LLZ.

Rationale:

Electromagnetic Navigation Bronchoscopy (ENB) for the Diagnosis of Pulmonary Lesions and Mediastinal Lymph Nodes

Evaluation of ENB as a diagnostic tool involves examining the:

1. Navigation accuracy and biopsy success rate: The frequency with which the steerable navigation catheter is able to reach a peripheral nodule previously identified on computed tomography (CT) scans, and, once reached, the frequency with which biopsies are successfully obtained.

2. Diagnostic accuracy compared with other methods: The ideal study design would include a criterion standard (e.g., surgical biopsy and/or long-term follow-up) on all samples. Of particular interest is the negative predictive value (NPV), the proportion of patients with negative test results who are correctly diagnosed. If the NPV is high, we can have confidence that patients who test negative do not need additional interventions.

3. Complication rates compared with other methods of diagnosis.

Eberhardt et al. published a randomized controlled trial (RCT) to date using ENB. (3) This study consistently used surgical biopsy as a criterion standard confirmation of diagnosis. Patients were randomized to receive ENB only, endobronchial ultrasound (EBUS) only, or the combination of ENB and EBUS. Whereas ENB is designed to help navigate to the target but cannot visualize the lesion, EBUS is not able to guide navigation but enables direct visualization of the target lesion before biopsy. The study included 120 patients who had evidence of peripheral lung lesions or solitary pulmonary nodules and who were candidates for elective bronchoscopy or surgery. In all 3 arms, only forceps biopsy specimens were taken, and fluoroscopy was not used to guide the biopsies. The primary outcome was diagnostic yield, defined as the ability to yield a definitive diagnosis consistent with clinical presentation. If transbronchial lung biopsy was not able to provide a diagnosis, patients were referred for surgical biopsy. The mean size of the lesions was 26 (6) mm. Two patients who did not receive a surgical biopsy were excluded from the final analysis. Of the remaining 118 patients, 85 (72%) had a diagnostic result via bronchoscopy and 33 required a surgical biopsy. The diagnostic yield by intervention group was 59% (23/39) with ENB only, 69% (27/39) with EBUS only, and 88% (35/40) with combined ENB/EBUS; the yield was significantly higher in the combined group. The NPV for malignant disease was 44% (10/23) with ENB only, 44% (7/16) with EBUS only, and 75% (9/12) with combined ENB/EBUS. Note that the number of cases was small, and thus the NPV is an imprecise estimate. Moreover, the authors stated in the discussion that the yield in the ENB-only group is somewhat lower than in other studies and attribute this to factors such as the use of forceps for biopsy (rather than forceps and endobronchial brushes) and/or an improved diagnosis using a criterion standard. The pneumothorax rate was 6%, which did not differ significantly among the 3 groups.

A number of prospective and retrospective case series using ENB have been published. A 2011 meta-analysis by Wang Memoli et al. evaluated the diagnostic yield of guided bronchoscopy techniques for evaluating pulmonary nodules (including ENB and EBUS, among others). (4) Studies evaluating the diagnostic yield of ENB, virtual bronchoscopy (VB), radial endobronchial ultrasound (R-EBUS), ultrathin bronchoscope, and guide sheath. VB, R-EBUS, ultrathin bronchoscope, and/or guide sheath for peripheral nodules were included. The overall diagnostic yield and yield based on size were extracted. Adverse events, if reported, were recorded. Meta-analysis techniques incorporating inverse variance weighting and a random-effects meta-analysis approach were used. A total of 3,052 lesions from 39 studies were included. The pooled diagnostic yield was 70%, which is higher than the yield for traditional transbronchial biopsy. The yield increased as the lesion size increased. The pneumothorax rate was 1.5%, which is significantly smaller than that reported for transthoracic needle aspiration (TTNA). This meta-analysis shows that the diagnostic yield of guided bronchoscopic techniques is better than that of traditional transbronchial biopsy. Although the yield remains lower than that of TTNA, the procedural risk is lower. Guided bronchoscopy may be an alternative or be complementary to TTNA for tissue sampling of pulmonary nodules, but further study is needed to determine its role in the evaluation of peripheral pulmonary lesions

In 2012, Brownback et al. retrospectively reported on 55 individuals older than 18 years who underwent ENB at their institution between 2008 and 2011. (5) Reasons for undergoing ENB included a solitary pulmonary nodule, pulmonary infiltrate, or hilar lymphadenopathy that was not considered to be accessible by conventional bronchoscopy. ENB was considered successful if the ENB-directed biopsy resulted in a plausible histologic diagnosis, or if additional procedures following a determination by ENB that the lesion was negative for malignancy confirmed the initial ENB diagnosis. Additional procedures for patients with negative or nondiagnostic ENBs included CT-guided transthoracic needle aspiration, surgical biopsy, or serial CT scans. Forty-one of the 55 ENB procedures performed led to a diagnosis and were considered successful (diagnostic yield, 74.5%). Twenty-five ENBs identified a carcinoma, 13 found no evidence of malignancy, and this was confirmed by other tests, and 3 revealed infection. Among the nondiagnostic studies, 11 were found to be malignant after additional procedures. Thus, the sensitivity of ENB for malignancy was 25 of 36 (sensitivity, 69.4%). The positive predictive value (PPV) for malignancy was 100% and the NPV for malignancy was 63.3%. When ENB failed to result in a diagnosis, the NPV was 54.2%. No postprocedure pneumothoraxes were identified in patients undergoing ENB. There were 2 cases of postprocedural hypoxemic respiratory failure; 1 patient required a chest tube.

In a large series published in 2007, Wilson et al. reviewed the records of 248 consecutive patients who were referred for evaluation of suspicious peripheral lung lesions, enlarged mediastinal lymph nodes, or both. (6) There was no consistent protocol for confirming diagnosis, although the authors stated that most patients were followed up for confirmation of diagnosis. ENB was used to locate, register, and navigate to lung lesions. Once navigation was completed, fluoroscopic guidance was used to verify its accuracy and to aid in the biopsy or transbronchial needle aspiration. Forceps were used to sample lung lesions. The mean size of the targeted peripheral lung lesions was 21 (14) mm. A total of 266 of 279 (95%) of the targeted peripheral lung lesions and 67 of 71 (94%) of the lymph nodes were successfully reached, and tissue samples for biopsy were obtained from all of these. The primary study outcome was diagnostic yield on the day of the procedure; this was obtained for 151 of 279 (54%) of the peripheral lung lesions that were reached and 64 of 67 of the lymph nodes that were reached. Ninety of the lung lesions were malignant, and 61 were benign. Another 16 peripheral lung lesions were followed-up and later confirmed as true negatives. The final status of 89 lesions (approximately 30% of the targeted lesions) was inconclusive. There were 8 complications: 3 cases of moderate bleeding (none required transfusion), 3 cases of pneumothorax (none required treatment), 1 case of hematoma (did not require treatment), and 1 case of pneumonia/chronic obstructive pulmonary disease exacerbation (treated on outpatient basis).

In a 2007 prospective study, Eberhardt et al. reported on 89 patients who underwent ENB. (7) All patients had evidence of peripheral lung lesions or solitary pulmonary nodules without evidence of endobronchial pathology. The mean size of the targeted lesions was 24 (8) mm. ENB yielded a definitive diagnosis in 52 lesions, and another 10 lesions that were followed up for a mean of 16 months appear to have been true negatives. The authors reported a specificity of 100% and an NPV for malignant disease of 44%. Complications included 2 asymptomatic cases of pneumothorax that were identified; no treatment was necessary.

A 2013 prospective study by Chee et al. in Canada investigated the use of ENB in cases where peripheral EBUS alone was unable to obtain a diagnosis. (8) The study included 60 patients with peripheral pulmonary lesions. Patients either had a previous negative CT-guided biopsy or did not have a CT-guided biopsy due to technical difficulties. An attempt was first made to identify the lesion using peripheral EBUS and, if the lesion was not identified, then an ENB system was used. Nodules were identified on ultrasound image by EBUS alone in 45 of 60 cases (75%). ENB was used in 15 cases (25%), and in 11 of these cases (73%), the lesion was identified. Peripheral EBUS led to a diagnosis in 26 cases and ENB in an additional 4 cases, for a total diagnostic yield of 30 of 60 cases (50%). The extent of improved diagnosis with ENB over EBUS alone was not statistically significant (p=0.125). The rate of pneumothorax was 8% (5 of 60 patients); the addition of ENB did not alter the pneumothorax rate.

Several series sought to identify factors that increase the likelihood of successfully obtaining a diagnosis using ENB. Diagnostic yield with ENB was found to be higher for larger lesions, i.e., greater than 2 cm in size, compared with smaller lesions in several series, including a retrospective study by Jenson et al. (n=92) and a prospective study by Lamprecht et al. (n=112). (9, 10) Diagnostic yield has also been found to be significantly higher in patients with a bronchus sign compared with the absence of a bronchus sign. In a study by Seijo et al. overall diagnostic yield using ENB was 67% (34/51 procedures). (11) A diagnosis was obtained in 30 of 38 lesions (79%) with a bronchus sign and 4 of 13 (31%) without a bronchus sign. In a study by Balbo et al., ENB was diagnostic in 25 of 32 patients (78%) with a bronchus sign and 4 of 9 (44%) without a bronchus sign. (12) The overall diagnostic yield of ENB was 70.7% (29/41 cases).

ENB for the Placement of Fiducial Markers

Evaluation of ENB as an aid to placement of fiducial markers involves searching for evidence that there are better clinical outcomes when ENB is used to place markers than either when fiducials are placed using another method or when no fiducial markers are used. This policy only evaluates the use of ENB to place fiducial markers; it does not evaluate the role of fiducial markers in radiation therapy.

Three studies were identified; there were no RCTs. Only one of the trials compared fiducial marker placement with ENB to another method of fiducial marker placement. This study, by Kupelian et al. included 28 patients scheduled for radiation therapy for early-stage lung cancer. (13) Follow-up data were available for 23 (82%) patients; 15 had markers placed transcutaneously under CT or fluoroscopic guidance, and 8 patients had markers placed transbronchially using the SuperDimension system. At least 1 marker was placed successfully within or near a lung tumor in all patients. The fiducial markers did not show substantial migration during the course of treatment with either method of marker placement. The only clinical outcome reported was rate of pneumothorax; 8 of 15 patients with transcutaneous placement developed pneumothorax, 6 of which required chest tubes. In contrast, none of the 8 patients with transbronchial placement developed pneumothorax.

A study by Anantham et al. included 9 patients with peripheral lung tumors who were considered nonsurgical candidates and were scheduled to undergo treatment with robotic stereotactic radiosurgery (Cyberknife). (14) Using the SuperDimension InReach system, 39 fiducial markers were successfully placed in 8 of the 9 patients. A total of 35 of the 39 markers (90%) were still in place at radiosurgery planning 7 to 10 days later. No complications were observed.

In 2010, Schroeder et al. reported on findings from a single-center prospective study with 52 patients who underwent placement of fiducial markers using ENB with the InReach system. (15) Patients all had peripheral lung tumors; 47 patients had inoperable tumors and 5 patients refused surgery. Patients were scheduled to receive tumor ablation using the CyberKnife stereotactic radiosurgery, which involves fiducial marker placement. The procedures were considered successful if the markers remained in place without migration during the timeframe required for radiosurgery. A total of 234 fiducial markers were deployed; 17 linear fiducial markers in 4 patients and 217 coil spring fiducial markers in 49 patients. CyberKnife planning CT scans were performed between 7 and 14 days after fiducial marker placement. The planning CT scans showed that 215 of 217 coil spring markers (99%) and 8 of 17 linear markers (47%) markers remained in place, indicating a high success rate for coil spring markers. Three patients developed pneumothorax; 2 were treated with chest tubes, and 1 received observation-only.

2014 update

This policy was updated through July 31, 2014. Following is a summary of key literature to date.

In 2014, Odronic et al. (16) investigated the sensitivity and specificity of ENB-guided fine needle aspiration (FNA) in the diagnosis of lung lesions. All ENB-guided FNAs performed at one institution were included in the study. The superDimension I-Logic System™ was used in all cases. Pathologic reports of the ENB-guided FNAs, as well as all other pulmonary sampling performed simultaneously with the FNA and within 1 year of the ENB-guided FNA were reviewed. Patients with a positive ENB-guided FNA or malignancy within the same lobe within the follow-up period were considered positive for malignancy. Patients with an atypical diagnosis but no definitive malignancy were considered negative for malignancy for statistical purposes. Ninety-one patients underwent 95 ENB-guided FNAs over a 3-year period. Thirty-five patients (38%) were positive for malignancy. ENB-guided FNA had a sensitivity of 63% for the detection of malignancy. The sensitivity for the detection of malignancy using all ENB-guided sampling methods, including FNA, bronchoscopic biopsy, and bronchial brushing was 83%. Odronic concluded, Pathologists and cytotechnologists should be aware of ENB-guided FNA as an emerging technology with a relatively high sensitivity for the diagnosis of peripheral lung lesions.

Studies that measure the diagnostic yield of ENB with ENB-guided fine-needle aspiration (ENB-FNA) in peripheral lung lesions that measure ≤ 2 cm is limited. 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. In 2014, Loo et al. (17) evaluated their experience with ENB-FNA performed in conjunction with all 4 modalities: PET-CT, ROSE, ENB-BB, and ENB-TBx. 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 peripheral lung lesions 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 peripheral lung lesions) in conjunction with ENB-FNA was 61% and 95%, respectively. ROSE was performed in 46 of 50 peripheral lung lesions: 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. Loo et al. concluded that the high overall diagnostic yield of 94% and fewer complications make ENB-FNA a useful modality for the assessment of peripheral lung lesions. In this study, ROSE was useful, whereas PET-CT, ENB-BB, and ENB-TBx were not useful in the evaluation of peripheral lung lesions.

In 2014, Gex et al. (18) completed a systematic review that included 15 trials that included 1,033 lung nodules. Overall there was a positive and definitive diagnosis of 64.9% (95% confidence interval [CI] 59.2-70.3). Diagnostic accuracy was 73.9% (95% CI 68.0-79.2) and sensitivity to detect cancer was 71.1% (95% CI 64.6-76.8) Pneumothorax occurred in 3.1% of patients; chest tube drainage occurred in 1.6% of these patients. Factors associated with higher ENB yields: nodule location in the upper or middle lobes, nodule size, lower registration error, presence of a bronchus sign on computed tomography (CT) imaging, combined use of an ultrasonic radial probe, and catheter suctioning as a sampling technique. Uses of general anesthesia or rapid on-site cytologic evaluation were associated with better yields. “ENB is effective and particularly safe. Prospective studies are needed to clarify the role of several variables conditioning the yield of this technique.”

In April 2014, ECRI (19) published a product brief on I-Logic ENB for aiding in the diagnosis of peripheral lung lesions. The review of results presented in abstracts included 1 systematic review of 15 trials and 1 meta-analysis of 39 studies, plus review of results presented in 4 individual clinical studies. These studies indicate that I-Logic is safe and effective for sampling peripheral lung lesions. The authors of the ECRI brief stated that I-Logic resulted in a high diagnostic yield and low complication rates. Factors associated with higher ENB yields were 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.

Summary

While the overall evidence base consists largely of case series, there is some evidence that ENB provides a minimally invasive option for a select subset of patients where a tissue diagnosis is not feasible by conventional bronchoscopy methods. Diagnostic rates appear comparable with a reduced risk for pneumothorax compared to transthoracic needle biopsy (TTNA).

Practice Guidelines and Position Statements

National Comprehensive Cancer Network (NCCN)

The 2014 NCCN clinical practice guideline on non-small-cell lung cancer states that the strategy for diagnosing lung cancer should be individualized, and the least invasive biopsy with the highest diagnostic yield is preferred as the initial diagnostic study. (20)

For patients with central masses and suspected endobronchial involvement, bronchoscopy is preferred.

For patients with peripheral (outer one-third) nodules, either navigation bronchoscopy, radial EBUS or TTNA is preferred.

For patients with suspected nodal disease, EBUS, navigation biopsy or mediastinoscopy is preferred.

American College of Chest Physicians (ACCP)

In 2013, the ACCP issued updated guidelines on the diagnosis of lung cancer. (21) Regarding ENB, the guideline stated: “In patients with peripheral lung lesions difficult to reach with conventional bronchoscopy, electromagnetic navigation guidance is recommended if the equipment and the expertise are available”. The authors noted that the procedure can be performed with or without fluoroscopic guidance and has been found to complement radial probe ultrasound. The strength of evidence for this recommendation as Grade 1C, defined as “Strong recommendation, low- or very-low-quality evidence.”

British Thoracic Society

In 2011, the British Thoracic Society published a guideline on advanced diagnostic and therapeutic flexible bronchoscopy in adults. (22) The guideline included the following recommendation: “Electromagnetic bronchoscopy may be considered for the biopsy of peripheral lesions or to guide TBNA for sampling mediastinal lymph nodes.” This was a “Grade D” recommendation, meaning that it is based on nonanalytic studies, e.g., case series or expert opinion, or based on extrapolated data from observational studies.

2016 Update

This policy was updated through September 31, 2016. Following is a summary of key literature to date.

In 2015, Diken et al. (23) compared the use of ENB with transbronchial needle aspiration (ENB-TBNA) to conventional transbronchial needle aspiration (C-TBNA) in the evaluation of patients with mediastinal lymphadenopathy (MLN). This prospective study randomized patients into two groups: C-TBNA and ENB-TBNA using a computer-based number shuffling system to avoid recruitment bias. Ninety-four cases (M/F: 45/49) with a total of 145 stations of MLN were enrolled in the study. In 44 patients, 81 stations were sampled by ENB-TBNA, and in 50 patients were sampled in 64 stations by C-TBNA. The mean size of MLN was 17.56 ± 6.25 mm. The sampling success was significantly higher in ENB-TBNA group (82.7%) compared to the C-TBNA group (51.6%) (P < 0.005). Defined by histopathological result, the diagnostic yield in ENB-TBNA was 72.8%, and 42.2% with C-TBNA (P < 0.005). For subcarinal localization, sampling or diagnostic success was higher in ENB-TBNA than that of C-TBNA (P < 0.05). Based on the size of the MLN ≤15 mm or >15 mm, the sampling success of ENB-TBNA was also significantly higher than C-TBNA in both subgroups (P < 0.005 and P < 0.005, respectively). No serious complication was noted. The study concluded that the sampling and diagnostic success of ENB-TBNA was superior while dealing with MLN, in all categories studied.

In September 2016, UpToDate (24) provided a summary recommendation on image-guided bronchoscopy for biopsy of peripheral pulmonary lesions which states:

“Electromagnetic navigation bronchoscopy is the most common image guided biopsy technique. It incorporates VB (virtual bronchoscopy) imaging with an electromagnetic field, an additional navigational tool, to guide biopsy equipment (e.g., forceps, brush, guide sheath) to the target lesion. ENB can be used alone or in combination with radial probe endobronchial ultrasonography (RP-EBUS) to biopsy peripheral lung lesions.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT02410837a

NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

2500

July 2018

NCT01779388

Bronchoscopy Assisted by Electromagnetic Navigation in the Diagnosis of Small Pulmonary Nodules

120

December 2019

Table Key: NCT: national clinical trial; a Denotes industry-sponsored or cosponsored trial.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network (NCCN)

The NCCN clinical practice guideline (v1.2017) on non-small-cell lung cancer states that the strategy for diagnosing lung cancer should be individualized, and the least invasive biopsy with the highest diagnostic yield is preferred as the initial diagnostic study. (25)

For patients with central masses and suspected endobronchial involvement, bronchoscopy is preferred.

For patients with peripheral (outer one-third) nodules, either navigation bronchoscopy, radial EBUS or TTNA is preferred.

For patients with suspected nodal disease, EBUS, navigation biopsy or mediastinoscopy is preferred.

This clinical practice guideline has not changed since the 2014 recommendation.

Summary of Evidence

One new randomized controlled clinical trial publication was noted. Current evidence primarily consists of case series, although there is some evidence that electromagnetic navigation bronchoscopy (ENB) provides a minimally invasive option for a select subset of patients where a tissue diagnosis is not feasible by conventional bronchoscopy methods. Diagnostic rates appear comparable with a reduced risk for pneumothorax compared to transthoracic needle biopsy. Based on available studies and current society guidelines, no evidence was noted that would prompt reconsideration of the coverage statement, which remains unchanged.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

31626, 31627

HCPCS Codes

A4648, C9751

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Rivera MP, Mehta AC, American College of Chest P. Initial diagnosis of lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition). Chest 2007; 132(3 Suppl):131S-48S. PMID: 17873165

2. Tape TG. Solitary pulmonary nodule. In Black ER et al. eds. Diagnostic strategies for common medical problems, 2nd edition. Philadelphia, PA: American College of Physicians; 1999.

3. Eberhardt R, Anantham D, Ernst A et al. Multimodality bronchoscopic diagnosis of peripheral lung lesions: a randomized controlled trial. Am J Respir Crit Care Med 2007; 176(1):36-41. PMID 17379850

4. Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest 2012; 142(2):385-93. PMID 21980059

5. Brownback KR, Quijano F, Latham HE et al. Electromagnetic navigational bronchoscopy in the diagnosis of lung lesions. J Bronchology Interv Pulmonol 2012; 19(2):91-7. PMID 23207349

6. Wilson DS, Bartlett BJ. Improved diagnostic yield of bronchoscopy in a community practice: combination of electromagnetic navigation system and rapid on-site evaluation. J Bronchology Interv Pulmonol 2007; 14(4):227-32.

7. Eberhardt R, Anantham D, Herth F et al. Electromagnetic navigation diagnostic bronchoscopy in peripheral lung lesions. Chest 2007; 131(6):1800-5. PMID 17400670

8. Chee A, Stather DR, Maceachern P et al. Diagnostic utility of peripheral endobronchial ultrasound with electromagnetic navigation bronchoscopy in peripheral lung nodules. Respirology 2013; 18(5):784-9. PMID 23521707

9. Jensen KW, Hsia DW, Seijo LM et al. Multicenter experience with electromagnetic navigation bronchoscopy for the diagnosis of pulmonary nodules. J Bronchology Interv Pulmonol 2012; 19(3):195-9. PMID 23207460

10. Lamprecht B, Porsch P, Wegleitner B et al. Electromagnetic navigation bronchoscopy (ENB): Increasing diagnostic yield. Respir Med 2012; 106(5):710-5. PMID 22391437

11. Seijo LM, de Torres JP, Lozano MD et al. Diagnostic yield of electromagnetic navigation bronchoscopy is highly dependent on the presence of a Bronchus sign on CT imaging: results from a prospective study. Chest 2010; 138(6):1316-21. PMID 20435658

12. 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; 68(6):579-85. PMID 24193290

13. Kupelian PA, Forbes A, Willoughby TR et al. Implantation and stability of metallic fiducials within pulmonary lesions. Int J Radiat Oncol Biol Phys 2007; 69(3):777-85. PMID 17606334

14. Anantham D, Feller-Kopman D, Shanmugham LN et al. Electromagnetic navigation bronchoscopy-guided fiducial placement for robotic stereotactic radiosurgery of lung tumors: a feasibility study. Chest 2007; 132(3):930-5. PMID 17646225

15. Schroeder C, Hejal R, Linden PA. Coil spring fiducial markers placed safely using navigation bronchoscopy in inoperable patients allows accurate delivery of CyberKnife stereotactic radiosurgery. J Thorac Cardiovasc Surg 2010; 140(5):1137-42. PMID 20850809

16. Odronic, SI et al. Electromagnetic navigation bronchoscopy-guided fine needle aspiration for the diagnosis of lung lesions. Diagn Cytopathol. 2014. PMID 24692403

17. Loo et al. The emerging technique of electromagnetic navigation bronchoscopy-guided fine-needle aspiration of peripheral lung lesions: promising results in 50 lesions. Cancer Cytopathol. 2014 Mar; 122(3):191-9. PMID 24323803

18. 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- 176. PMID 24401166

19. ECRI Institute. i-Logic Electromagnetic Navigation Bronchoscopy (Covidien, Inc.) for Aiding Diagnosis of Peripheral Lung Lesions; 2014 April (Hotline Response).

20. National Comprehensive Cancer Network (NCCN). Non-small cell lung cancer, 2.2014. Available online at: <www.nccn.org> (Accessed October 25, 2016).

21. 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; 143(5 Suppl): e142S-65S.

22. Du Rand IA, Barber PV, Goldring J et al. British Thoracic Society guideline for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax 2011; 66 Suppl 3: iii1-21.

23. Diken ÖE et al. Electromagnetic navigation-guided TBNA vs conventional TBNA in the diagnosis of mediastinal lymphadenopathy. Clin Respir J. 2015 Apr; 9(2):214-20. PMID 25849298

24. Shepherd, Wes et al. Image-guided bronchoscopy for biopsy of peripheral pulmonary lesions. In: UpToDate Post TW (Ed), UpToDate, Waltham, MA. Topic last updated: September 22, 2016. Available at: <http://www.uptodate.com> (Accessed on October 27, 2016).

25. National Comprehensive Cancer Network (NCCN). Non-small cell lung cancer, 1.2017. Available online at: <www.nccn.org> (Accessed October 25, 2016).

26. Electromagnetic Navigational Bronchoscopy. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (June 2016). Surgery 7.01.122.

Policy History:

Date Reason
10/15/2017 Reviewed. No changes.
1/1/2017 Document updated with literature review. Coverage unchanged.
7/15/2015 Reviewed. No changes.
10/15/2014 Document updated with literature review. The following coverage change was made: Electromagnetic navigation bronchoscopy (ENB) with or without fluoroscopic guidance may be considered medically necessary in adult patients for the evaluation of a solitary pulmonary nodule that is highly suspicious for malignancy and meets one of the criteria below: 1.) The solitary pulmonary nodule is deemed inaccessible by standard bronchoscopic methods or standard bronchoscopic methods have failed; 2.) More invasive diagnostic procedures pose an unacceptable risk to the patient (e.g., bullous lung disease, diffuse emphysema); 3.) Patients with an identified lung lesion(s) and a co-existing cancer in whom further determination of the lung lesion will impact staging of the primary tumor and thus impact the treatment plan; 4.) Placement of fiducial markers in patients who are not candidates for surgical intervention and who have elected to undergo radiation therapy. Use of electromagnetic navigation bronchoscopy (ENB) for any other indication is considered experimental, investigational, and/or unproven.
7/15/2011 Document updated with literature review. The following language change was made to the coverage statement: Electromagnetic navigation bronchoscopy is considered experimental, investigational and unproven for all indications.
1/1/2010 New medical document originating from SUR716.013bu. Bulletin converted to Medical policy new CPT codes added.
1/1/2009 New medical document

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