Erik E Folch1, Michael A Pritchett2, Michael A Nead3, Mark R Bowling4, Septimiu D Murgu5, William S Krimsky6, Boris A Murillo7, Gregory P LeMense8, Douglas J Minnich9, Sandeep Bansal10, Blesilda Q Ellis11, Amit K Mahajan12, Thomas R Gildea13, Rabih I Bechara14, Eric Sztejman15, Javier Flandes16, Otis B Rickman17, Sadia Benzaquen18, D Kyle Hogarth19, Philip A Linden20, Momen M Wahidi21, Jennifer S Mattingley22, Kristin L Hood23, Haiying Lin23, Jennifer J Wolvers23, Sandeep J Khandhar12. 1. Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: efolch@mgh.harvard.edu. 2. Pulmonary Department, Pinehurst Medical Clinic and FirstHealth Moore Regional Hospital, Pinehurst, North Carolina. 3. University of Rochester Medical Center, Rochester New York. 4. Department of Internal Medicine, Division of Pulmonary Critical Care and Sleep Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina. 5. Interventional Pulmonology Program, The University of Chicago Medicine, Chicago, Illinois. 6. Pulmonary and Critical Care Associates of Baltimore, Baltimore, Maryland. 7. Providence Health Center and Waco Lung Associates, Waco, Texas. 8. Blount Memorial Physicians Group, Alcoa, Tennessee. 9. Division of Cardiothoracic Surgery, University of Alabama at Birmingham, Birmingham, Alabama; Princeton Baptist Medical Center, Birmingham, Alabama. 10. Penn Highlands Healthcare, DuBois, Pennsylvania. 11. Pulmonary Associates of Mobile PC, Mobile, Alabama. 12. Inova Health System, Falls Church, Virginia. 13. Department of Pulmonary, Allergy, and Critical Care Medicine and Transplant Center, Cleveland Clinic, Cleveland, Ohio. 14. Morehouse School of Medicine, and Cancer Treatment Centers of America, Newnan, Georgia. 15. Virtua Pulmonary Group, Marlton, New Jersey. 16. Pulmonary Department, IIS-Fundacion Jimenez Diaz University Hospital, CIBERES, Madrid, Spain. 17. Department of Medicine and Thoracic Surgery, Vanderbilt University Medical Center, Ingram Cancer Center, Nashville, Tennessee. 18. University of Cincinnati Physicians Company LLC, Cincinnati, Ohio. 19. The University of Chicago Medicine, Chicago, Illinois. 20. Divisions of Thoracic and Esophageal Surgery, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve School of Medicine, Cleveland, Ohio. 21. Department of Medicine, Duke University Medical Center, Durham, North Carolina. 22. Gundersen Health System, La Crosse, Wisconsin; Medtronic, Minneapolis, Minnesota. 23. Medtronic, Minneapolis, Minnesota.
Abstract
INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive technology that guides endoscopic tools to pulmonary lesions. ENB has been evaluated primarily in small, single-center studies; thus, the diagnostic yield in a generalizable setting is unknown. METHODS: NAVIGATE is a prospective, multicenter, cohort study that evaluated ENB using the superDimension navigation system (Medtronic, Minneapolis, Minnesota). In this United States cohort analysis, 1215 consecutive subjects were enrolled at 29 academic and community sites from April 2015 to August 2016. RESULTS: The median lesion size was 20.0 mm. Fluoroscopy was used in 91% of cases (lesions visible in 60%) and radial endobronchial ultrasound in 57%. The median ENB planning time was 5 minutes; the ENB-specific procedure time was 25 minutes. Among 1157 subjects undergoing ENB-guided biopsy, 94% (1092 of 1157) had navigation completed and tissue obtained. Follow-up was completed in 99% of subjects at 1 month and 80% at 12 months. The 12-month diagnostic yield was 73%. Pathology results of the ENB-aided tissue samples showed malignancy in 44% (484 of 1092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69%, 100%, 100%, and 56%, respectively. ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher pneumothoraces (requiring admission or chest tube placement) occurred in 2.9%. The ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher bronchopulmonary hemorrhage and grade 4 or higher respiratory failure rates were 1.5% and 0.7%, respectively. CONCLUSIONS: NAVIGATE shows that an ENB-aided diagnosis can be obtained in approximately three-quarters of evaluable patients across a generalizable cohort based on prospective 12-month follow-up in a pragmatic setting with a low procedural complication rate.
INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive technology that guides endoscopic tools to pulmonary lesions. ENB has been evaluated primarily in small, single-center studies; thus, the diagnostic yield in a generalizable setting is unknown. METHODS: NAVIGATE is a prospective, multicenter, cohort study that evaluated ENB using the superDimension navigation system (Medtronic, Minneapolis, Minnesota). In this United States cohort analysis, 1215 consecutive subjects were enrolled at 29 academic and community sites from April 2015 to August 2016. RESULTS: The median lesion size was 20.0 mm. Fluoroscopy was used in 91% of cases (lesions visible in 60%) and radial endobronchial ultrasound in 57%. The median ENB planning time was 5 minutes; the ENB-specific procedure time was 25 minutes. Among 1157 subjects undergoing ENB-guided biopsy, 94% (1092 of 1157) had navigation completed and tissue obtained. Follow-up was completed in 99% of subjects at 1 month and 80% at 12 months. The 12-month diagnostic yield was 73%. Pathology results of the ENB-aided tissue samples showed malignancy in 44% (484 of 1092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69%, 100%, 100%, and 56%, respectively. ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher pneumothoraces (requiring admission or chest tube placement) occurred in 2.9%. The ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher bronchopulmonary hemorrhage and grade 4 or higher respiratory failure rates were 1.5% and 0.7%, respectively. CONCLUSIONS: NAVIGATE shows that an ENB-aided diagnosis can be obtained in approximately three-quarters of evaluable patients across a generalizable cohort based on prospective 12-month follow-up in a pragmatic setting with a low procedural complication rate.
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Authors: Thomas R Gildea; Erik E Folch; Sandeep J Khandhar; Michael A Pritchett; Gregory P LeMense; Philip A Linden; Douglas A Arenberg; Otis B Rickman; Amit K Mahajan; Jaspal Singh; Joseph Cicenia; Atul C Mehta; Haiying Lin; Jennifer S Mattingley Journal: J Bronchology Interv Pulmonol Date: 2021-07-01