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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Electromagnetic Navigation Bronchoscopy (ENB): Clinical Review
- 1. Bassel Ericsoussi, MD Pulmonary & Critical Care Specialist Electromagnetic Navigation Bronchoscopy® (ENB™ )
- 2. Solitary Pulmonary Nodule (SPN) A Common Problem • > 150,000 patients / year in the U.S. present to PCP 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 at high risk for lung neoplasm – 8-51% • Prevalence of malignancy in patients with SPNs: – 1.1-12% in screening trials – 46-82% in PET trials Sources: 1.Swensen SJ, et al. Mayo Clin Proc 1999; 74:319-29 2.Tan, B, et al. Chest 2003;123:89S-96S 3.Henscke, C, et al. NEJM 2006; 355:1763-71 4.Wahidi, MM. Chest 2007; 132:94s-107s
- 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 more people every year than breast, prostate, colon and pancreatic cancers combined3 • Lung cancer is recognized late – It has only been until recently that we have seen some key turning points in the early detection of lung cancer and this will improve survival. Sources: 1.American Cancer Society, 2012 2.Jemal, et al, CA Cancer J Clin 2007;57:43-66 3.American Cancer Society, 2009
- 4. Lung Cancer Relative Survival Rates Source: 1.SEER Cancer Statistics Review, 2002-2008 Stage of Diagnosis 5-Year Relative Survival Rates Localized (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. The Diagnostic Dilemma • Malignant SPN can represent a potentially curable form of lung cancer – 5 yrs survival > 60% • The flip side is unnecessary procedures and surgeries with resultant morbidities • Cost implications
- 6. Clinical Factors Influence Pre-Test Clinical Probability of Malignancy • Size • Calcification • Margins • Morphology
- 7. SPN Size Diameter Risk of Malignancy < 5 mm 0-1% 5-10 mm 6-28% > 20 mm 64-82% Wahidi, MM. Chest 2007; 132:94s-107s
- 8. Calcification Patterns of SPN • SPNs that are calcified in a clearly benign pattern do not warrant additional diagnostic evaluation • Benign calcification patterns: – Diffuse – Central – Popcorn – Laminated • Potentially malignant calcification patterns: – Stippled – Eccentric
- 10. Benign Calcifications Diffuse: Benign granuloma Central: Benign diseaseLaminated
- 12. Margins • Risk of malignancy is 20-30% in nodules with smooth edges • Risk of malignancy is 33-100% in nodules with irregular, lobulated, or spiculated borders Wahidi, MM. Chest 2007; 132:94s-107s
- 14. Diagnostic and Management Dilemma • 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 of malignancy (5-60%): careful consideration of options in conjunction with patient’s preferences
- 15. Current Diagnostic Alternatives Least Invasive Most Invasive
- 16. Talk to Your Patient • Discuss the risks and benefits of alternative management strategies and elicit patient preferences
- 17. Pre-Test Probability • In every patient with SPN, the clinical pre-test probability of malignancy should be estimated either: – 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 of subsequent diagnostic tests
- 18. Limitations to Current Approaches to Diagnosis Transthoracic 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%2 Sources: 1.Shulman, L, et al. Curr Opin Pulm Med 2007; 13:271-277 2.Ost, et al, NEJM 2003; 348:2535-42
- 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. Surgical Resection Limitations •Highly invasive procedure •Higher cost, higher risk •Associated with higher morbidity and mortality rates •Not always suitable for patients with advanced disease or significant co-morbidities1 •Non-therapeutic thoracotomy in 20-45%2-5 Sources: 1.Shulman et al. Curr Opin Pulm Med 2007;13:271-277 2.Bernard, et al. Ann Thorac Surg 1996; 61: 202-204 3.MJ Mack, et al. Ann Thorac Surg. 1993; 56: 825-830 4.Hoffmann H, et al. 2000; 97:A-1067-1071 5.Cardillo G, Ann Thorac Surg. 2003; 75(5):1607-11; Discussion 1611-2. Limitations to Current Approaches to Diagnosis
- 21. Limitations to Current Approaches to Diagnosis Standard Bronchoscopy Limitations: • Generally cannot reach effectively beyond~5th airway generation • Use of fluoroscopy – generally lesions smaller than 1 cm are not detectable • Localization does not guarantee sampling success • Essentially a blind procedure Source: David Ost, et al, NEJM 2003;348:2535-42 Source: David Ost, et al, NEJM 2003;348:2535-42
- 22. Standard Bronchoscopy Yield for Lung Lesions: Size and Location matter • The yield is 20% - 80% (size, proximity to bronchial tree, prevalence of cancer in the study 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- 1054 2.Schreiber et al, Chest 2003; 123:115S-118S 3.Baaklini, WA, et al, Chest 2000; 117:1049- 1052
- 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 diagnostic procedures – Transthoracic Needle Aspiration (TTNA) – Surgical Biopsy Sources: 1. Ernst et al., Chest 123: 1693-1717, 2003 2. Schwarz Y et al., Chest Apr 2006; 129:988-994
- 24. Electromagnetic Navigation Bronchoscopy (ENB)
- 25. The Clinical Opportunity for your Patients Electromagnetic 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 nodes4 Source: 1.Brownback, K, et al, J Bronchol Intervent Pulmon, April 2012 2.Pearlstein, D, et al, Annals of Thoracic Surgery, March 2012; 944-950 3.Eberhardt, R, et al, CHEST June 2007; 1800-1805 4.Gildea, T, et al, AJRCCM 2006; 174: 982-989
- 27. Lymph Node Needle Aspiration Using ENB
- 28. Electromagnetic Navigation Bronchoscopy (ENB) Allows You To: Stage Stage lymph nodes Navigate Navigate to distal lesions for biopsy Deliver Guide high dose radiation catheters Locate Place markers to facilitate VATS Place Place fiducial markers for radiation treatment
- 29. Other Applications of ENB • Transbronchial placement of fiducial markers directly into and/or around a lung tumor to aid respiratory motion management when delivering Stereotactic Radiosurgery (SRT) • Transbronchial Dye Localization Technique Using ENB to help CT surgeons localizing impalpable nodules – ≤10 mm in size – ≥5 mm from pleural surface
- 30. Electromagnetic Navigation Bronchoscopy (ENB) Procedure Overview CT-Scan DICOM CD Planning Software Planned Pathway File Navigation Biopsy Treatment
- 31. ENB – Procedure Animation
- 34. If you had the capability to gain access to all areas of the lung in a simple, safe and reliable manner, what would you do? Thank you! How will this impact: •Our patients? •Our practices? •Our specialty?
Editor's Notes
- 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.)