Electromagnetic Navigation Bronchoscopy (ENB): Clinical Review

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New technology called Electromagnetic Navigation Bronchoscopy® (ENB) that uses virtual bronchoscopy and real time 3-dimensional CT images that enable me to localize these peripheral lung nodules for diagnosis and treatment. This outpatient procedure is minimally invasive and therefore has a small risk of pneumothorax (2-3%) and its published diagnostic yield rates range from 67% - 86%

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  • NOTES: A solitary pulmonary nodule is noted on 0.09 to 0.2 percent of all chest radiographs (Swensen SJ, et al. Mayo Clin Proc 1999;74:319-29. 1 of 500 chest radiographs (CXRs) demonstrates a lung nodule. More than 150,000 patients per year in US present their physicians with the diagnostic dilemma of an SPN (Bethany B. Tan et al. Chest 2003;123:89S-96S). Among the participants, 13% (4186 of 31,567) who underwent baseline CT and 5% (1460 of 27,456) who underwent annual CT had a positive result that required immediate further workup (N Engl J Med 2006;355:1763-71).
  • NOTES:
  • NOTES: A comparison of early and late stage lung cancer lesions reveals the advantages of diagnosing lung cancer lesions early. Early stage lesions have smaller size, discreet form and are easier to treat. The challenge, however, is in diagnosing distally located lesions, which are difficult to reach with conventional diagnostic tools. 1,2
  • NOTES: Not suitable for all lesion locations (central lesions) (Lawrence Shulman et al. Curr Opin Pulm Med 2007;13:271-277. ) The positive predictive value in one study involving more than 200 patients was 98.6%; the negative predictive value was 96.6%. Even for lesions that are less than 2 cm in diameter, TTNA biopsy has a sensitivity of more than 60% detecting a malignant process. For Ref 2: David Ost et al. N ENGL J MED 2003;348:2535-42. Benign lesions are harder to penetrate with a needle and the skills required are greater than for the biopsy of malignant lesions (Nagi F. Khouri et al. Chest 1987;91:128-133). Transthoracic needle aspiration has a sensitivity of 62 to 99% and a specificity of 93 to 100% but is associated with a considerable risk of pneumothorax ( Dewan NA et al. Chest 1995; 108:441–446). Pneumothorax rate is affected by: the skills of the operator, the selection of patients, and the location of the lesion (Nagi F. Khouri et al. Chest 1987;91:128-133).
  • NOTES: Major contraindications for TTNA: Pneumothorax and bleeding. Inability of the patient to cooperate during the procedure, mechanical ventilation, previous pneumonectomy, abnormal clotting function, thrombocytopenia, severe COPD and unavoidable bullae are some major concerns (Peter Mazzone et al. Lung cancer 2002;23(1):137-158).
  • NOTES: The sensitivity of bronchoscopy for detecting a malignant process in a solitary pulmonary nodule ranges from 20 to 80% depending on the size of the nodule, its proximity to the bronchial tree and the prevalence of cancer in the study population (David Ost et al. N ENGL J MED 2003;348:2535-42). For nodules that are less than 1.5 cm in diameter, the sensitivity is 10%, and for those that are 2.0 to 3.0 cm in diameter, it is 40 to 60%. When CT reveals a bronchus leading to the lesion, bronchoscopy has a 70% sensitivity. (David Ost et al. N ENGL J MED 2003;348:2535-42.)
  • Electromagnetic Navigation Bronchoscopy (ENB): Clinical Review

    1. 1. Bassel Ericsoussi, MDPulmonary & Critical Care SpecialistElectromagnetic Navigation Bronchoscopy®(ENB™)
    2. 2. Solitary Pulmonary Nodule (SPN)A Common Problem• > 150,000 patients / year in the U.S. present toPCP with SPN• 1 in 500 CXR demonstrate a lung nodule2• The prevalence is higher in CT-scans (13%prevalence in ELCAP)3• Prevalence of SPNs in screening trials of populations athigh risk for lung neoplasm– 8-51%• Prevalence of malignancy in patients with SPNs:– 1.1-12% in screening trials– 46-82% in PET trialsSources:1.Swensen SJ, et al. Mayo Clin Proc 1999; 74:319-292.Tan, B, et al. Chest 2003;123:89S-96S3.Henscke, C, et al. NEJM 2006; 355:1763-714.Wahidi, MM. Chest 2007; 132:94s-107s
    3. 3. Lung Cancer – A Growing Problem in the U.S.• 2012 estimates in U.S.:– >226,000 new cases1– >160,000 deaths1• #1 cause of cancer-related death2:Kills morepeople every year than breast, prostate, colon andpancreatic cancers combined3• Lung cancer is recognized late– It has only been until recently that we have seen some keyturning points in the early detection of lung cancer and this willimprove survival.Sources:1.American Cancer Society, 20122.Jemal, et al, CA Cancer J Clin 2007;57:43-663.American Cancer Society, 2009
    4. 4. Lung Cancer Relative Survival RatesSource:1.SEER Cancer Statistics Review, 2002-2008Stage of Diagnosis5-Year RelativeSurvival RatesLocalized (confined to primary site) 52%Regional (spread to regional lymph nodes) 25%Distant (metastasized) 4%Unknown (unstaged) 8%Early Detection is Key to Improving Survival Rates
    5. 5. The Diagnostic Dilemma• Malignant SPN can represent a potentiallycurable form of lung cancer– 5 yrs survival > 60%• The flip side is unnecessary procedures andsurgeries with resultant morbidities• Cost implications
    6. 6. Clinical Factors Influence Pre-TestClinical Probability of Malignancy• Size• Calcification• Margins• Morphology
    7. 7. SPN SizeDiameter Risk of Malignancy< 5 mm 0-1%5-10 mm 6-28%> 20 mm 64-82%Wahidi, MM. Chest 2007; 132:94s-107s
    8. 8. Calcification Patterns of SPN• SPNs that are calcified in aclearly benign pattern do notwarrant additional diagnosticevaluation• Benign calcification patterns:– Diffuse– Central– Popcorn– Laminated• Potentially malignantcalcification patterns:– Stippled– Eccentric
    9. 9. “Popcorn” CalcificationHamartoma
    10. 10. Benign CalcificationsDiffuse: Benign granuloma Central: Benign diseaseLaminated
    11. 11. Malignant CalcificationsAdenocarcinomaEccentricCarcinoid tumorAdenocarcinomaSpeckled
    12. 12. Margins• Risk of malignancy is 20-30% in nodules withsmooth edges• Risk of malignancy is 33-100% in nodules withirregular, lobulated, or spiculated bordersWahidi, MM. Chest 2007; 132:94s-107s
    13. 13. MarginsLobulatedSCCCavitarySCCSpiculatedBACSmoothGranuloma
    14. 14. Diagnostic and ManagementDilemma• Low clinical pre-test probability of malignancy (<5%):serial chest CT at 3, 6, 12 and 24 months• High clinical pre-test probability of malignancy(>60%): proceed to surgical resection• Indeterminate clinical pre-test probability ofmalignancy (5-60%): careful consideration of optionsin conjunction with patient’s preferences
    15. 15. Current Diagnostic AlternativesLeast Invasive Most Invasive
    16. 16. Talk to Your Patient• Discuss the risks and benefits of alternativemanagement strategies and elicit patientpreferences
    17. 17. Pre-Test Probability• In every patient with SPN, the clinical pre-testprobability of malignancy should be estimatedeither:– Qualitatively by clinical judgment– Quantitatively by using validated quantitative model• The SPN calculator:http://www.chestx-ray.com/spn/spnprob.html• This facilitates the selection and interpretation ofsubsequent diagnostic tests
    18. 18. Limitations to Current Approaches to DiagnosisTransthoracic Needle Aspiration (TTNA)Limitations:•Cannot be used in all cases due to co-morbidities•Not suitable for all lesion locations1•Sensitivity rate = 80-95%2•Specificity rate = 50-88%2•False negative rate = 3-29%2Sources:1.Shulman, L, et al. Curr Opin Pulm Med 2007; 13:271-2772.Ost, et al, NEJM 2003; 348:2535-42
    19. 19. Pneumothorax Risk of TTNA:Very Common Complication• Increases with number of passes– 37% one pass– 57% five passes• Increases with distance from pleura– 15% 0 cm (pleura based)– 50% 0-5 cm• Decreases with lesion size– 0-2 cm = 50%– 2-4 cm = 35%– >4 cm = 15%• Increases with presence of emphysema– With emphysema = 50% (chest tube 27%)– Without emphysema = 35% (chest tube 9%)Sources:Cox et al. Radiology July 1999;212:165-168
    20. 20. Surgical Resection Limitations•Highly invasive procedure•Higher cost, higher risk•Associated with higher morbidity and mortalityrates•Not always suitable for patients with advanceddisease or significantco-morbidities1•Non-therapeutic thoracotomy in 20-45%2-5Sources:1.Shulman et al. Curr Opin Pulm Med 2007;13:271-2772.Bernard, et al. Ann Thorac Surg 1996; 61: 202-2043.MJ Mack, et al. Ann Thorac Surg. 1993; 56: 825-8304.Hoffmann H, et al. 2000; 97:A-1067-10715.Cardillo G, Ann Thorac Surg. 2003; 75(5):1607-11; Discussion 1611-2.Limitations to Current Approaches to Diagnosis
    21. 21. Limitations to Current Approaches to DiagnosisStandard Bronchoscopy Limitations:• Generally cannot reach effectively beyond~5thairway generation• Use of fluoroscopy – generally lesions smaller than1 cm are not detectable• Localization does not guarantee sampling success• Essentially a blind procedureSource:David Ost, et al, NEJM 2003;348:2535-42Source:David Ost, et al, NEJM 2003;348:2535-42
    22. 22. Standard Bronchoscopy Yield for Lung Lesions:Size and Location matter• The yield is 20% - 80% (size, proximity tobronchial tree, prevalence of cancer in thestudy population)1• Location and size matter• <2 cm peripheral lesions: 14%• <2 cm central lesions: 31%• Airway leading to the lesion: 60%Source:1.Baaklini, WA, et al. Chest 2000;117:1049-10542.Schreiber et al, Chest 2003; 123:115S-118S3.Baaklini, WA, et al, Chest 2000; 117:1049-1052
    23. 23. Failure of Standard Conventional Bronchoscopy• 500,000 bronchoscopies performed annually in the U.S.1• 65% of bronchoscopies fail to reach peripheral lesions2• Failure of bronchoscopy often leads to more invasive diagnosticprocedures– Transthoracic Needle Aspiration (TTNA)– Surgical BiopsySources:1. Ernst et al., Chest 123: 1693-1717, 20032. Schwarz Y et al., Chest Apr 2006; 129:988-994
    24. 24. Electromagnetic Navigation Bronchoscopy (ENB)
    25. 25. The Clinical Opportunity for your PatientsElectromagnetic Navigation Bronchoscopy®(ENB™)• Out-patient procedure• Safety profile– Carries a 3% or less risk of pneumothorax3• Ability to reach peripheral nodules• Navigate with real-time guidance• Less invasive than TTNA• High diagnostic rate and the ability to stage in one procedure– Current diagnostic yield rate 74.5% - 85%1-2– Diagnostic yield 100% for lymph nodes4Source:1.Brownback, K, et al, J Bronchol Intervent Pulmon, April 20122.Pearlstein, D, et al, Annals of Thoracic Surgery, March 2012; 944-9503.Eberhardt, R, et al, CHEST June 2007; 1800-18054.Gildea, T, et al, AJRCCM 2006; 174: 982-989
    26. 26. Lymph Node Needle Aspiration Using ENB
    27. 27. Electromagnetic Navigation Bronchoscopy (ENB)Allows You To:StageStage lymph nodesNavigateNavigate to distal lesions for biopsyDeliverGuide high dose radiation cathetersLocatePlace markers to facilitate VATSPlacePlace fiducial markers for radiation treatment
    28. 28. Other Applications of ENB• Transbronchial placement of fiducialmarkers directly into and/or around a lungtumor to aid respiratory motion managementwhen delivering Stereotactic Radiosurgery(SRT)• Transbronchial Dye LocalizationTechnique Using ENB to help CT surgeonslocalizing impalpable nodules– ≤10 mm in size– ≥5 mm from pleural surface
    29. 29. Electromagnetic Navigation Bronchoscopy (ENB)Procedure OverviewCT-Scan DICOM CD Planning Software Planned Pathway File Navigation Biopsy Treatment
    30. 30. ENB – Procedure Animation
    31. 31. Procedure Overview
    32. 32. Edge Catheter Animation
    33. 33. If you had the capability to gain access to all areas ofthe lung in a simple, safe and reliable manner, whatwould you do?Thank you!How will this impact:•Our patients?•Our practices?•Our specialty?

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