Interventional Lung Solutions

Clinical Publications:

Researched and Reviewed

Our consolidation of studies and papers provides the product-specific data behind the most clinically tested platform on the market.1

Diagnostic Yield Peripheral Lesions (retrospective n=107)

Bowling MR et al: The Effect of General Anesthesia Versus Intravenous Sedation on Diagnostic Yield and Success in Electromagnetic Navigation Bronchoscopy. J Broncol Intervent Pulmonol Jan 2015, East Carolina University, Greenville, NC, USA, Independent Study

The only significant difference between general anesthesia (n=62) and IV sedation (n=58) was in procedure time with a mean of 58 vs 43 min, respectively (p=0.0005). Diagnostic yield was 74% (67/91) on a target lesion basis. Authors commented that ROSE may have improved diagnostic yield with published results of 85% to 89%.There were 3 (2.8%) pneumothoraces and 1 (0.9%) required a thoracostomy tube

Diagnostic Yield Peripheral Lesions (retrospective n=40)

Loo FL et al: The Emerging Technique of ENB-Guided FNA of Peripheral Lung Lesions: Promising Results in 50 Lesions, Cancer Cytopathology March 2014, New York-Presbyterian Hospital, Weill Cornell Medical College, New York, New York, USA, Independent Study

ENB-FNA diagnostic yield was 94% overall, 87% in Peripheral Lung Lesions (PLLs) <= 2cm and 100% in PLLs > 2cm. Results were not dependent on lesion size. PPL diagnosis by ENB-FNA had a sensitivity of 89.4% and a specificity of 100%. There were no procedure-related complications.

ENB-guided sampling method Sensitivity and Specificity (retrospective n=91)

Odronic et al: Electromagnetic Navigation Bronchoscopy-Guided Fine Needle Aspiration for the Diagnosis of Lung Lesions, Diagnostic Cytopathology Vol. 00, No. 00 2014, Cleveland Clinic, Ohio, USA, Independent Study

ENB-FNA had a sensitivity of 63% and a specificity of 100%. Sensitivity of 63% was improved to 83% during the same procedure by introducing ENB-guided transbronchial biopsy and ENB-guided bronchial brushings. ENB-FNA diagnostic yield was calculated from the article information as 85.7% (78/91).

Diagnostic Yield and Sampling Success of Lymph Nodes (prospective randomized n=94)

Diken et al: Electromagnetic navigation-guided TBNA vs conventional TBNA in the diagnosis of mediastinal lymphadenopathy, The Clinical Respiratory Journal March 2014, Ankara University School of Medicine, Turkey Independent Study

Sampling success and diagnostic yield (per histopathological results) were significantly higher with ENB-TBNA (82.7% and 72.8%, respectively) than with C-TBNA (51.6% and 42.2%, respectively) P<0.005 for both comparisons.

Diagnostic Yield Peripheral Lesions and Lymph Nodes (prospective n=76)

Karnak, et al: Rapid on-site evaluation and low registration error enhance the success of electromagnetic navigation bronchoscopy, Annals of Thoracic Medicine – Vol 8, Issue 1, January-March 2013, Ankara University, Ankara, Turkey Independent Study

Overall diagnostic yield of 89.5% for peripheral lesions and 83.3% diagnostic success in lymph nodes. (<15mm = 82.1%, >15mm = 89.4%) performed on patients who were not suitable for CT-guided needle biopsy, mediastinoscopy or thoracotomy due to high co- morbidities.

Diagnostic Yield Peripheral Lesions (retrospective n=41)

Mohanasundaram U et al: The Diagnostic Yield of Navigational Bronchoscopy Performed with Propofol Deep Sedation, ISRN Endoscopy 2013 1-5, Stanford University Medical Center, Stanford, CA, USA Independent Study

The overall diagnostic yield was 89% (42 of 47 target lesions).The diagnostic yield was greater when variance was <=4mm (91% versus 87%, p=0.003).

Diagnostic Yield Peripheral Lesions and Sensitivity (prospective n=40)

Balbo PE 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 68(6): 579-585 Dec 2013, Ospedale Maggiore della Carità Università del Piemonte Orientale, Novara, Italy, Independent Study

Definitive diagnosis was 70.7% (29/41 lesions), Overall ENB sensitivity for malignancy was 76.5% with higher rates in presence of bronchus sign on CT (86.2%) and in lesions located in the upper and middle lobes (87.5%).

Diagnostic Yield Peripheral Lesions (retrospective n=55)

Brownback, K et al: Electromagnetic Navigational Bronchoscopy in the Diagnosis of Lung Lesions, J Bronchol Intervent Pulmonol Volume 19, Number 2, April 2012, University of Kansas, Kansas City, KS, USA Independent Study

Overall diagnostic yield of 74.5%. Bronchus sign, lesion size, and location did not affect the diagnostic yield. The use of fluoroscopy & general anesthesia may improve the diagnostic yield.

Diagnostic Yield Peripheral Lesions (prospective n=112)

Lamprecht B, et al: Electromagnetic navigation bronchoscopy (ENB): Increasing diagnostic yield, Respiratory Medicine (2012), doi:10.1016/j.rmed.2012.02.002, Paracelsus Medical University Hospital, Salzburg, Austria, Independent Study

Overall diagnostic yield 83.9 %. Diagnostic yield for lesions <20mm was 75.6%. Diagnostic yield for first 30 procedures was 80%. Diagnostic yield for last 30 procedures was 87.5%.

Diagnostic Yield Peripheral Lesions with Pneumothorax Rate (retrospective n=104)

Pearlstein DP et al: Electromagnetic Navigation Bronchoscopy Performed by Thoracic Surgeons: One Center’s Early Success, The Annals of Thoracic Surgery Volume 93, Issue 3, March 2012, Pages 944-950, Medical College of Wisconsin, Milwaukee, Wisconsin, USA Independent Study

Diagnostic yield of 85% utilizing rapid on-site examination of cytopathology (ROSE) with 6 pneumothoraces (5.8%). No demonstrated association between lesion size and diagnostic accuracy.

Diagnostic Yield Peripheral Lesions (retrospective n=92)

Jensen KW et al: Multicenter experience with electromagnetic navigation bronchoscopy for the diagnosis of pulmonary nodules, J Bronchology Interv Pulmonol 19(3): 195-199, 2012, National Jewish Health, Denver, CO, USA Independent Study

The overall yield for ENB-guided sampling of pulmonary nodules was 65% (60/92). Diagnostic yield is affected by nodule size but not distance from the pleura or the lobar location.

Diagnostic Yield Peripheral Lesions with Pneumothorax Rate (retrospective n=48)

Mahajan AK et al: Electromagnetic Navigation Bronchoscopy: An Effective and Safe Approach to Diagnosing Peripheral Lung Lesions Unreachable by Conventional Bronchoscopy in High Risk Patients, J Bronchol Intervent Pulmonol April 2011 – Volume 18 – Issue 2 133–137, University of Chicago, Chicago, IL, USA Independent Study

Diagnostic yield of 77% with ENB reserved for use only in lesions at the fourth order of bronchi or beyond, including subpleural lesions, in patients considered high risk for other invasive procedures. Pneumothorax rate of 10% with 2 requiring a chest tube.

Diagnostic Yield Peripheral Lesions with Pneumothorax Rate (prospective n=51)

Siejo LM et al: Diagnostic Yield of Electromagnetic Navigation Bronchoscopy Is Highly Dependent on the Presence of a Bronchus Sign on CT Imaging, CHEST December 2010 Vol. 138 No. 6: 1316-1321, Clinica Univesidad de Navarra, Pamplona, Spain Independent Study

Bronchus sign on planning CT was 74%. Overall diagnostic yield was 67%, with 79% diagnostic yield with +bronchus sign and 41% diagnostic yield with no identified bronchus sign. No reported complication.

Diagnostic Yield Peripheral Lesions (prospective n=54)

Eberhardt et al: Comparison of Suction Catheter versus Forceps Biopsy for Sampling Solitary Pulmonary Nodules Guided by Electromagnetic Navigational Bronchoscopy, Respiration 2010: 79:54-60, University of Heidelberg, Heidelberg, Germany Independent Study

75.5% overall diagnostic yield independent of lesion size, location or technical parameters. Catheter aspiration was positively correlated with success rate. Diagnostic yield = 93% when EBUS verified lesion location after ENB navigation and only 48% when lesion was not confirmed.

Diagnostic Yield Peripheral Lesions with Pneumothorax Rate (prospective n=54)

Bertoletti et al: Accuracy and Feasibility of Electromagnetic Navigated Bronchoscopy under Nitrous Oxide Sedation for Pulmonary Peripheral Opacities: An Outpatient Study, Respiration 2009, Hospital Nord, Norway Independent Study

Diagnostic success rate was 71.4%, all patients but 1 were dismissed 1-hour after procedure & tolerance of procedure was excellent. No anesthesiologist present, 4% pneumothorax; 1 requiring a chest tube.

Diagnostic Yield Peripheral Lesions with Pneumothorax Rate (prospective n=13)

Lamprecht et al: Electromagnetic Navigation Bronchoscopy in Combination with PET·CT and Rapid On-site Cytopathologic Examination for Diagnosis of Peripheral Lung Lesions, LUNG 2009, Paracelsus Medical University Hospital, Salzburg, Austria Independent Study

76.9% yield with no adverse events.

Diagnostic Yield Peripheral Lesions and Lymph Nodes (retrospective n=9)

Weiser TS et al: Electromagnetic Navigational Bronchoscopy: A Surgeon’s Perspective, Ann Thorac Surg 2008, Department of Cardiothoracic Surgery, Mount Sinai Medical Center, New York, New York, USA Independent Study

In 6 out of 9 (66. 7%) ENB was successful, in 4 out of 5 (80%) of all lymph nodes biopsied were diagnostic and in 2 out of 4 (50%) of the lesions biopsied were diagnostic.

Diagnostic Yield Peripheral Lesions (prospective n=40)

Makris D et al: Electromagnetic navigation diagnostic bronchoscopy for small peripheral lung lesions, Eur. Respir. J., Jun 2007; 29: 1187 – 1192, University of Lille, France Independent Study

Diagnostic Yield = 62.5% in patients unsuitable for surgery or CT guided needle biopsy, 77.2% when divergence < 4 mm.

Diagnostic Yield Peripheral Lesions with Pneumothorax Rate (prospective n=13)

Schwarz Y et al: Real-Time Electromagnetic Navigation Bronchoscopy to Peripheral Lung Lesions Using Overlaid CT Images: The First Human Study, Chest, Apr 2006; 129: 988 – 994, TASMC, Israel Independent Study

Diagnostic Yield = 69% with no complications.

Diagnostic Yield Peripheral Lesions and Lymph Nodes (prospective n=60)

Gildea T et al: Electromagnetic Navigation Diagnostic Bronchoscopy: A Prospective Study, Am J. of Respiratory Critical Care Medicine 2006 174: 982-989, Cleveland Clinic, Cleveland OH, USA Independent Study

Diagnostic Yield = 74% for Peripheral Lesions and 100% for Lymph Nodes, 57% of lesions were <2cm in diameter.

Diagnostic Yield Peripheral Lesions (retrospective n=30)

Becker H et al: Bronchoscopic Biopsy of Peripheral Lung Lesions under Electromagnetic Guidance, J of Bronchology; January 2005, Heidelberg, Germany Independent Study

Registration accuracy (AFTRE) 3 mm. Diagnostic Yield = 69%. No serious complications related to the use of the device.

ENB Localization of Non-Palpable Lesions (retrospective n=6)

Tay JH et al: Electromagnetic Navigation Bronchoscopy-directed Pleural Tattoo to Aid Surgical Resection of Peripheral Pulmonary Lesions, Journal of Bronchology Interventional Pulmonology Oct 2015, Departments of Respiratory & Sleep Medicine; Cardiothoracic Surgery, Royal Melbourne Hospital, Parkville; and Department of Pathology, St. Vincent’s Hospital, Fitzroy, Victoria, Australia Independent Study

ENB-directed staining of the pleura by dye was successful in all attempted patients. There were no conversions from VATS to open and no pneumothorax or bleeding complications.

ENB Localization of Non-Palpable Lesions (retrospective n=19)

Bolton WD et al: The Utility of Electromagnetic Navigational Bronchoscopy as a Localization Tool for Robotic Resection of Small Pulmonary Nodules, Ann Thorac Surg April 2014, Univ of South Carolina School of Medicine, Greenville, South Carolina, USA Independent Study

ENB localization of non-palpable lesions with blue dye was successful in all attempted patients. No conversions to VATS or an open procedure were necessary with no associated adverse events.

ENB Localization of Non-Palpable Lesions (retrospective n=22)

Krimsky W et al: Thoracoscopic detection of occult indeterminate pulmonary nodules using bronchoscopic pleural dye marking, J Community Hosp Intern Med Perspect Feb 2014, Franklin Square Hospital Center, Maryland, USA Independent Study

Dye marker was visible in 81% of patients at the time of resection and outlined the area of biopsy. No complications reported.

ENB-guided Fiducial Marker Placement (retrospective n=64)

Bolton WD et al: Electromagnetic Navigational Bronchoscopy: A Safe and Effective Method for Fiducial Marker Placement in Lung Cancer Patients. The American Surgeon July 2015, Univ of South Carolina School of Medicine, Greenville, South Carolina, USA Independent Study

The placement of an average of 3 markers per lesion led to an adequate retention rate for all patients to successfully complete their stereotactic radiation treatment. Two patients (3%) suffered from respiratory failure and two patients (3%) developed a pneumothorax (both upper lobes

ENB-guided Fiducial Marker Placement (retrospective n=15)

Rong Y et al: Minimal Inter-Fractional Fiducial Migration during Image-Guided Lung Stereotactic Body Radiotherapy Using SuperLock Nitinol Coil Fiducial Markers. PloS One July 2015, University of California Davis, Sacramento, CA Independent Study

Retention rate was 100% (55/55) comparing planning CT versus cone beam CT. Mean individual migration distance was 1.87 mm (range 0.63 – 5.25 mm).

ENB-guided Fiducial Marker Placement (retrospective n=48)

Minnich DJ et al: Retention Rate of Electromagnetic Navigation Bronchoscopic Placed Fiducial Markers for Lung Radiosurgery, Annals of Thoracic Surgery Oct 2015, Division of Cardiothoracic Surgery, Univ of Alabama at Birmingham, Alabama, USA Independent Study

After standard ENB marker placement all patients received a chest x-ray and no pneumothoraces were observed. Coil fiducial markers had a better retention rate than linear two band and gold seeds.

ENB-guided Fiducial Marker Placement (retrospective n=31)

Nabavizadeh N et al: ENB-guided Fiducial Markers for Lung Stereotactic Body Radiation Therapy Analysis of Safety, Feasibility, and Interaction Stability, J Bronchol Intervent Pulmonol Volume 21, Number 2 April 2014, Oregon Health and Science University, Portland, OR, USA Independent Study

Of the 105 fiducially placed (mean number placed per patient was 3.09), 103 were identified on simulation CT with a retention rate of 98.1%. Two (6%) patients had asymptomatic pneumothoraces identified on chest radiography.

ENB Biopsy with Fiducial Marker Placement (Case Report)

Quinn CC: Diagnostic Approach to Pulmonary Nodules in the post pneumonectomy Patient, Seminars in Thoracic and Cardiovascular Surgery Volume 22, Number 4, Waukesha Memorial Hospital, Aurora Advanced Healthcare, Milwaukee, WI, USA Independent Study

ENB is used for diagnostic biopsy and concomitant placement of gold fiducials for stereotactic radiosurgery in a post pneumonectomy patient.

ENB-guided Fiducial Marker Placement (Case Report)

Andrade et al: Electromagnetic Navigation Bronchoscopy-Guided Thoracoscopic Wedge Resection of Small Pulmonary Nodules, Seminars in Thoracic and Cardiovascular Surgery Volume 22, Number 3, Department of Surgery, University of Minnesota, Minnesota, USA Independent Study

2 cases performed successfully and without hematoma formation. ENB-guided fiducial placement can be accomplished within 30 minutes, and the entire procedure can be completed in 90 minutes, including reintubation and repositioning.

ENB-guided Fiducial Marker Placement (prospective n=52)

Schroeder C et al: Coil spring fiducial markers placed safely using navigation bronchoscopy in inoperable patients allows accurate delivery of CyberKnife stereotactic radiosurgery, J Thorac Cardiovasc Surg 2010; 140:1137-42, Case Medical Center University Hospitals, Cleveland OH, USA Independent Study

234 fiducial markers placed in 52 patients (60 tumors) with ENB under moderate sedation in an outpatient bronchoscopy suite. At Cyberknife planning, 8 (47%) of 17 linear markers and 215 (99%) of 217 coil spring markers were in place. 3 Pnemothoraces (5.8%) reported.

ENB-guided Fiducial Marker Placement (prospective n=43)

Harley D et al: Fiducial Marker Placement Using Endobronchial Ultrasound and Navigational Bronchoscopy for Stereotactic Radiosurgery: An Alternative Strategy, Ann Thorac Surg Feb 2010; 89(2):368-74, Franklin Square Hospital, Baltimore MD, USA Independent Study

Average of 3.7 Fiducial Markers (FMs) per patient were deployed, 86.7% FM identified radiologically at SRS planning. At CT 2 weeks after deployment, no clinically significant hemoptysis and 1 small pneumothorax.

ENB-guided Fiducial Marker Placement (prospective n=9)

Anantham D et al: Electromagnetic navigation bronchoscopy guided fiducial placement for robotic stereotactic radiosurgery of lung tumors — a feasibility study, CHEST 2007; 132:930–935, Beth Israel Deaconess, Boston, MA, USA Independent Study

Feasibility of EMN placement of fiducial markers, 89% successful deployment (8 of 9 patients) and 7 of 8 with fiducial within tumor (88%).

ENB-guided Radiotherapy Monitoring Device Implantation (Case Report)

McGuire F et al: Radiotherapy Monitoring Device Implantation into Peripheral Lung Cancers: A Therapeutic Utility of Electromagnetic Navigational Bronchoscopy, Journal of Bronchology, July 2007; 14(3):173-176, University of South Carolina, South Carolina, USA Independent Study

Successful case.

ENB-guided versus Transcutaneous Fiducial Marker Placement (prospective n=23)

Kupelian P et al: Implantation and Stability of Metallic Fiducials within Pulmonary Lesions, Int. J. Radiation Oncology Biol. Phys. 2007; 69 (3): 777–785, M. D. Anderson Cancer Center Orlando, Orlando, FL, USA Independent Study

Transbronchial marker placement is less invasive than transcutaneous placement. Fiducial markers were stable and ENB placement had lower pneumothorax rates.

ENB-guided Brachytherapy Placement (Case Report)

Harms W et al: Electromagnetically Navigated Brachytherapy as a New Treatment Option for Peripheral Pulmonary Tumors, Strahlentherapie und Onkologie 2006, 182:108–11, Heidelberg, Germany Independent Study

Patient tolerated well the ENB catheter and Brachytherapy over 5 days. 12 month follow up showed complete remission by histology, partial remission by CT and ultrasound.

ENB-Procedure (Review Article with mention of author experience)

Mungal V, Bowling MR et al: The Utility of Bronchoscopy for the Placement of Fiducial Markers for Stereotactic Body Radiotherapy, Clinical Pulmonary Medicine Nov 2015, Brody School of Medicine, East Carolina University, Greenville, NC, USA Independent Study

This article reviews fiducial marker (FM) studies and concludes that coiled FMs have lower migration rates and thus shortened times from FM placement to treatment than linear FM. ENB enables a biopsy of lesion and FM placement in the same procedure.

ENB-Procedure (Review Article)

Zhang W et al: Meta-analysis of the diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules, Journal of Thoracic Disease 2015;7(5):799-809, Tianjin Medical University General Hospital, Tianjin, China, Independent Study

The meta-analysis included 17 studies (1,106 patients with peripheral lung lesions) with an ENB pooled sensitivity of 82% and a pool specificity of 100%.

ENB-Procedure (Review Article)

Reynisson PJ et al: Navigated Bronchoscopy A Technical Review, J Bronchol Intervent Pulmonol Volume 21, Number 3, July 2014, St. Olavs Hospital, Trondheim, Norway, Independent Study

This paper presents an overview of the components necessary for performing navigated bronchoscopy. The literature review showed that the peripheral diagnostic accuracy has improved using navigated bronchoscopy compared with traditional bronchoscopy.

ENB-Procedure (Review Article)

Gex G et al: Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis, Respiration 87(2): 165-176 Jan 2014, Geneva University Hospitals, Geneva, Switzerland, Independent Study

The meta-analysis included 15 studies (1,033 lung nodules in 971 patients) with successful navigation to peripheral lung nodules reported in 97.4% of cases (range 90.2- 100%). Pooled diagnostic yield was 64.9% (range 55.7% to 87.5%). Pneumothoraces occurred in 32 patients (3.1%) but only 17 (1.6%) required chest tube drainage.

ENB-Procedure (Review Article)

Leong S et al: Electromagnetic navigation bronchoscopy: A descriptive analysis, J Thorac Dis 2012;4(2):173-185, The Prince Charles Hospital, Brisbane, Australia, Independent Study

This article describes electromagnetic navigation bronchoscopy (ENB) as similar to a car global positioning system (GPS). It also explores potential uses of ENB such as the biopsy of peripheral lung lesions pleural dye marking of nodules for surgical resection, placement of fiducial markers for stereotactic radiotherapy, and the therapeutic insertion of brachytherapy.

ENB-Procedure (Review Article)

Krimsky W et al: Bronchoscopy and the peripheral nodule in the age of lung cancer screening and targeted therapies, Current Respiratory Care Reports Curr Respir Care Rep (2012) 1:67-71 DOI 10.1007/s13665-011-0002-9, Franklin Square Hospital, Baltimore MD, USA Independent Study

The discovery of pulmonary nodules in screening that require further management will generate a growing need for tissue given the recent inroads in the pursuit of individualized therapies for lung cancer. This review highlights advances in navigational bronchoscopy and tissue processing which may help the bronchoscopist of the 21st century meet these and other challenges.

ENB-Procedure (Review Article)

Bechara R et al: Electromagnetic Navigation Bronchoscopy, Future Oncology (2011) 7(1), 31–36, Emory University, School of Medicine, Atlanta, GA, USA Independent Study

Describes ENB-procedure for biopsying, dye marking prior to surgery, and fiducial marker placement prior to radiation therapy.

ENB-Procedure (Review Article)

Khan I et al: Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Lung Lesions, Clin Pulm Med 2011;18:42–45, Wake Forest University, Baptist Medical Center, Winston Salem, NC., USA Independent Study

Pooling the data of all the studies, the diagnostic yield of ENB is 70% with a pneumothorax rate of 2.75%. This is highly desirable, considering the high risk of pneumothorax seen with traditional CT-guided transthoracic needle biopsies.

ENB-Procedure (Review Article)

Edell E et al: Navigational Bronchoscopy Overview of Technology and Practical Considerations- New Current Procedural Terminology Codes Effective 2010, CHEST February 2010;137(2):450-454, Mayo Clinic, Rochester MN, USA Independent Study

This article overviews this technology and the procedural terminology codes that have been created for its use.

ENB Sensitivity (Review Article)

Shulman L et al: Advances in Bronchoscopic Diagnosis of Lung, Cancer; Curr Opin Pulm Med 13:271-277, New York University School of Medicine, NYC, NY, USA Independent Study

Sensitivity summarized from 3 articles 69% to 100%.

ENB-Procedure (Review Article)

Herth F et al: Innovative Bronchoscopic Diagnostic Techniques: Endobronchial Ultrasound and Electromagnetic Navigation, Current Opinion in Pulmonary Medicine 2005 11:278-281, Thoraxklink University of Heidelberg, Heidelberg, Germany, Independent Study

Referenced studies from Dr Yehuda Schwarz and Dr. Heinrich Becker.

ENB-guided Fiducial Marker Placement and Lung Cancer Stage Shift (retrospective chart review of early & late NSCLC diagnosed before (2010 & 2011)and after (2012 & 2013) introduction of ENB

Brown C, Bowling M et al: The Impact of Electromagnetic Navigation Bronchoscopy on a Multidisciplinary Thoracic Oncology Program, Journal of the National Comprehensive Cancer Network Feb 2016, East Carolina University, Greenville, NC, USA Independent Study

Post-ENB the overall volume of fiducial marker placement increased by 36% (86 to 117) with 105 placed by bronchoscopy and only 12 by interventional radiology Authors attribute this increase because after ENB, non-operable patients with presumed Stage I or II lung cancers had an option to be safely diagnosed and fiducials placed within one procedure. Post-ENB there was a 73% increase in Stage I/II lung cancer diagnosis and a 20.5% decrease in Stage III/IV diagnosis. This shift occurred prior to the introduction of lung cancer screening at this institution.

Respiratory Cytology Survey asking which respiratory specimen types were performed in each laboratory, including ENB (Survey)

Sturgis CD et al: Respiratory Cytology-Current Trends Including Endobronchial Ultrasound-Guided Biopsy and Electromagnetic Navigational Bronchoscopy: Analysis of Data From a 2013 Supplemental Survey of Participants in the College of American Pathologists Interlaboratory Comparison Program in Nongynecologic Cytology, Arch Pathol Lab Med, Jan 2016, 140(1):22-8, Cleveland Clinic, Cleveland, Ohio, USA Independent Study

In early 2013, the Cytopathology Committee of the College of American Pathologists developed a questionnaire to investigate practice patterns regarding utilization and reporting of bronchopulmonary cytology. Results are based upon 788 respondent laboratories Molecular testing for newly diagnosed non-small cell lung carcinomas was offered by 76% (532/702) of laboratories with 86% (455/527) outsourcing this service to a reference laboratory.

Management of Pulmonary Nodules by Community Pulmonologists (retrospective n=377)

Tanner NT et al: Management of Pulmonary Nodules by Community Pulmonologists, CHEST, Dec 2015;148(6):1405-1414, Univ of South Carolina, Charleston, SC, USA Independent Study

Multicenter, community-based, retrospective observational study of consecutive patients with pulmonary nodules (PNs) ranging in size from 8 to 20 mm in diameter. Eighteen sites were chosen and 2,579 patients were screened for eligibility. Based on the inclusion criteria of lesion size, complete clinical records and 2 year follow-up, 377 patients were included. Of the 377 patients, 283 (75%) had a benign nodule and 94 (25%) had a malignant nodule. The validated models predicted a cancer rate of 33% for all patients, which was close to the actual incidence of 25%. The rate of surgical resection was similar among the low (17%), intermediate (21%), and high risk (17%) groups, P=.69.

Hybrid DynaCT-guided ENB (Case Report)

Ng CSH et al: Hybrid DynaCT-guided electromagnetic navigational bronchoscopic biopsy, Eur J Cardiothorac Surg Nov 2015, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China Independent Study

This Case Report describes the use of ENB (superDimension™ navigation system Version 7) with an Edge 90° (superDimension) catheter to biopsy an 8mm right middle lobe lesion. The lesion was too small to confirm correct catheter placement with Fluoroscopy, so an intraoperative DynaCT scan was performed resulting in slight catheter adjustment by a few millimeters prior to a successful biopsy being obtained.

Importance of Rebiopsy in Advanced Non-small Cell Lung Cancer (Summary of Literature)

Jekunen AP et al: Role of rebiopsy in relapsed non-small cell lung cancer for directing oncology treatments, J Oncol Oct 2015, Clinical Cancer Research Center, Vaasa Oncology Clinic, Turku Univ, Finland Independent Study

When rebiopsy should be performed: 1) If the prior specimen is too small for adequate tumor characterization, including genetic testing for predictive alterations, 2) If relapse happens six months after CR treatment result, 3) If the new tumor behaves in a different way than expected from the primary tumor, 4) If new molecules entering clinical trials in the near future is foreseeable. Nearly all clinical study protocols in relapsed adenocancer NSCLC now require a rebiopsy option to gather histological samples.

Biomarker Testing & Time to Treatment in Advanced Lung Cancer Patients (Retrospective n=300)

Lim C et al: Biomarker testing and time to treatment decision in patients with advanced non-small cell lung cancer, Annals of Oncology Aug 2015;26:1415-1421, Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, Canada Independent Study

Guidelines published in 2013 recommend testing all patients with nonsquamous advanced NSCLC for EGFR and ALK. Of 300 patients, 202 had a consultation with a medical oncologist and 175 were nonsquamous NSCLC. Within this group, 72% (126/175) of patients had biomarker testing carried out. Of the 126 nonsquamous patients with biomarker testing, 20 (16%) had inadequate tissue for biomarker analysis. Only 21% (27/126) of nonsquamous NSCLC patients undergoing biomarker testing had test results available to the oncologist at the time of initial consultation.

Lung Cancer Screening of High Risk Medicare Patients (Actuarial Analysis)

Pyenson BS, Yankelevitz DF et al: Offering lung cancer screening to high-risk Medicare beneficiaries saves lives and is cost-effective: an actuarial analysis, Am Health Drug Benefits Aug 2014;7(5):272-82, Milliman Inc. Actuary and Mount Sinai, NY, USA Independent Study

Approximately 4.9 million high-risk Medicare beneficiaries (~10% of Medicare beneficiaries) would meet the criteria for lung cancer screening for 2014. Screening would add 4 years of additional life expectancy versus no screening, and would be highly cost-effective at an estimated $18,452 per life-year saved.

ENB-guided Diagnostic Biopsy Cost-Effectiveness (Decision Analysis Model)

Deppen SA et al: Cost-Effectiveness of Initial Diagnostic Strategies for Pulmonary Nodules Presenting to Thoracic Surgeons, Annals of Thoracic Surgery May 2014, Tennessee Valley Health System Veterans Affairs, and Vanderbilt University Medical Center, Nashville TN, USA Independent Study

If the likelihood of cancer approaches 85%, VATS would be the most cost-effective choice. If the likelihood of cancer is 50% to 85%, then tissue acquisition is best. ENB should be used when expected diagnostic yield is greater than 65% and CT-FNA is chosen if its expected yield is greater than 85%.

Follow-up of Incidental Pulmonary Nodules (retrospective n=1000)

Blagev DP et al: Follow-up of incidental pulmonary nodules and the radiology report April 2014;11(4):378-83, Department of Medicine, Intermountain Medical Center, Murray, Utah, USA Independent Study

2,562 patients were identified to whom the Fleischer Society guidelines apply and a random sample of 1000 patients was selected for retrospective manual chart review. Of the 96 patients with incidental pulmonary nodules requiring follow-up according to Fleischer Society guidelines, only 28 (29%) had appropriate follow-up.

EGFR mutation heterogeneity between tumor and lymph node (prospective n=70)

Shimizu K et al: Heterogeneity of the EGFR mutation status between the primary tumor and metastatic lymph node and the sensitivity to EGFR tyrosine kinase inhibitor in non-small cell lung cancer, Target Oncol Dec 2013;8(4):237-42, Department of General Thoracic Surgery, Kawasaki Medical School, Okayama, Japan Independent Study

EGFR gene mutations were found in the primary tumor (PT) of 21 (31.5%) patients and metastatic lymph node (MLN) of 11 (15.1%) patients. All patients with EGFR mutations in the MLN also had EGFR mutations in the PT. However, of 21 patients with EGFR mutations in the PT, 48% (10/21) showed no EGFR mutations in the MLN.

EGFR mutation (retrospective n=65)

Duc Ha et al: Histologic and Molecular Characterization of Lung Cancer With Tissue Obtained by Electromagnetic Navigation Bronchoscopy, J Bronchol Intervent Pulmonol 2013;20:10–15, Cleveland Clinic, Cleveland OH, USA Independent Study

ENB-obtained samples from 15 patients with adenocarcinoma were sent for EGFR mutation analysis, of which 14 (93.3%) were adequate.

Safety with implantable cardiac devices (prospective n=24)

Khan, et al: Safety of Pacemakers and Defibrillators in Electromagnetic Navigation Bronchoscopy, CHEST 2013; 143(1):75–81, Emory University, Atlanta GA, USA Independent Study

In 24 patients “None of the patients suffered any arrhythmias or disruption to their pacemakers’ function either during the procedure or afterward”.

Establishing a Community-Based Lung Cancer Multidisciplinary Clinic (retrospective)

Bjegovich-Weidman M et al: Establishing a Community-Based Lung Cancer Multidisciplinary Clinic As Part of a Large Integrated Health Care System: Aurora Health Care, Journal of Oncology Practice Nov 2010; Vol 6, Issue 6, Aurora Health Care, Milwaukee, WI, USA Independent Study

After initiating the multidisciplinary clinic (MDC), time from diagnosis to treatment was reduced from a mean of 24 days down to 18 days, the community cancer clinic experienced a 28% increase in lung cancer patient care and a 9.1% increase in gross revenue. In addition, the MDC affiliated thoracic surgeon experienced a 75% increase in referrals from the MDC geographic area over the previous year.

ENB Location Success of Peripheral Lesions and Lymph Nodes (retrospective n=248)

Wilson, D: Improved Diagnostic Yield of Bronchoscopy in a Community Practice:Combination of Electromagnetic Navigation System and Rapid on-Site Evaluation, J Bronchol Intervent Pulmonol, Oct. 2007;14 (4);227-232, Columbus Regional Hospital, Columbus, Ohio, USA Independent Study

ENB success of 95% peripheral lesions; 94.3% lymph nodes. On the day of the procedure, 65% of patients received a definitive malignant or plausible non-malignant diagnosis.

ENB Positive Biopsy Rates (prospective n=89)

Eberhardt R et al: Electromagnetic Navigation Diagnostic Bronchoscopy in Peripheral Lung Lesions, CHEST Jun 2007:131: 1800–1805, Thoraxklink University of Heidelberg, Heidelberg, Germany, Independent Study

Positive biopsies obtained for 62 of 92 (67%) lung lesions, 88% of positive biopsies obtained for lesions at RML location. Procedure Time 16 to 45 min.

ENB Positive Biopsy Rates (prospective randomized n=120)

Eberhardt R et al: Multimodality Bronchoscopic Diagnosis of Peripheral Lung Lesions: A randomized controlled trial, Am. J. Respir. Crit. Care Med. 176: 36-41, July 2007 Thoraxklink University of Heidelberg, Heidelberg, Germany Independent Study
Positive biopsies obtained from 23/39 (59%) in ENB group and 35/40 (88%) in EBUS+ENB group.

1 Zhang W. et al. J. Thorac. Dis. 7;(5):799–809. 2015.