Erik E Folch1, Mark R Bowling2, Michael A Pritchett3, Septimiu D Murgu4, Michael A Nead5, Javier Flandes6, William S Krimsky7, Amit K Mahajan8, Gregory P LeMense9, Boris A Murillo10, Sandeep Bansal11, Kelvin Lau12, Thomas R Gildea13, Merete Christensen14, Douglas A Arenberg15, Jaspal Singh16, Krish Bhadra17, D Kyle Hogarth18, Christopher W Towe19, Bernd Lamprecht20, Michela Bezzi21, Jennifer S Mattingley22, Kristin L Hood23, Haiying Lin23, Jennifer J Wolvers23, Sandeep J Khandhar24. 1. Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: efolch@mgh.harvard.edu. 2. Division of Pulmonary Critical Care and Sleep Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina. 3. Pulmonary and Critical Care Medicine, FirstHealth of the Carolinas and Pinehurst Medical Clinic, Pinehurst, North Carolina. 4. Section of Pulmonary and Critical Care Medicine/Interventional Pulmonology, University of Chicago Medicine, Chicago, Illinois. 5. Pulmonary and Critical Care Medicine, University of Rochester Medical Center, Rochester, New York. 6. Bronchoscopy and Interventional Unit, Hospital Fundación Jiménez Díaz IIS-FJD Ciberes, Madrid, Spain. 7. Gala Therapeutics, San Carlos, CA. 8. Interventional Pulmonology and Complex Airways Disease Program, Division of Thoracic Surgery, Virginia Cancer Specialists, Inova Health System, Falls Church, Virginia. 9. Pulmonary and Sleep Medicine, Blount Memorial Physicians Group, Alcoa, Tennessee; Present Address: Pulmonary Medicine, Bozeman Health, Bozeman, Montana. 10. Ascension Medical Group Providence Lung Clinic, Providence Health Center and Waco Lung Associates, Waco, Texas. 11. Interventional Pulmonology, Penn Highlands Healthcare, DuBois, Pennsylvania. 12. Cardiothoracic Surgery, St. Bartholomew's Hospital, West Smithfield, London, United Kingdom. 13. Department of Pulmonary, Allergy, and Critical Care Medicine and Transplant Center, Cleveland Clinic, Cleveland, Ohio. 14. Department of Cardiothoracic Surgery, Rigshospitalet, Thoraxkirurgisk klin, Copenhagen, Denmark. 15. Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Michigan. 16. Pulmonary, Critical Care, and Sleep Medicine, Carolinas Medical Center, Atrium Health and Levine Cancer Institute, Charlotte, North Carolina. 17. Interventional Pulmonology, CHI Memorial Rees Skillern Cancer Institute, Chattanooga, Tennessee. 18. Section of Pulmonary and Critical Care Medicine/Interventional Pulmonology, The University of Chicago Medicine, Chicago, Illinois. 19. Division of Thoracic and Esophageal Surgery, Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio. 20. Klinik für Lungenheilkunde, Kepler Universitätsklinikum GmbH, Linz, Austria. 21. Azienda Ospedaliero Universitaria Careggi, Florence, Italy. 22. Pulmonary and Critical Care, Gundersen Health System, La Crosse, Wisconsin; Present Address: Clinical Research and Medical Science, Medtronic, Plymouth, Minnesota. 23. Clinical Research and Medical Science, Medtronic, Plymouth, Minnesota. 24. Division of Thoracic Surgery, Virginia Cancer Specialists, Inova Health System, Fairfax, Virginia.
Abstract
INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive, image-guided approach to access lung lesions for biopsy or localization for treatment. However, no studies have reported prospective 24-month follow-up from a large, multinational, generalizable cohort. This study evaluated ENB safety, diagnostic yield, and usage patterns in an unrestricted, real-world observational design. METHODS: The NAVIGATE single-arm, pragmatic cohort study (NCT02410837) enrolled subjects at 37 academic and community sites in seven countries with prospective 24-month follow-up. Subjects underwent ENB using the superDimension navigation system versions 6.3 to 7.1. The prespecified primary end point was procedure-related pneumothorax requiring intervention or hospitalization. RESULTS: A total of 1388 subjects were enrolled for lung lesion biopsy (1329; 95.7%), fiducial marker placement (272; 19.6%), dye marking (23; 1.7%), or lymph node biopsy (36; 2.6%). Concurrent endobronchial ultrasound-guided staging occurred in 456 subjects. General anesthesia (78.2% overall, 56.6% Europe, 81.4% United States), radial endobronchial ultrasound (50.6%, 4.0%, 57.4%), fluoroscopy (85.0%, 41.7%, 91.0%), and rapid on-site evaluation use (61.7%, 17.3%, 68.5%) differed between regions. Pneumothorax and bronchopulmonary hemorrhage occurred in 4.7% and 2.7% of subjects, respectively (3.2% [primary end point] and 1.7% requiring intervention or hospitalization). Respiratory failure occurred in 0.6%. The diagnostic yield was 67.8% (range: 61.9%-70.7%; 55.2% Europe, 69.8% United States). Sensitivity for malignancy was 62.6%. Lung cancer clinical stage was I to II in 64.7% (55.3% Europe, 65.8% United States). CONCLUSIONS: Despite a heterogeneous cohort and regional differences in procedural techniques, ENB demonstrates low complications and a 67.8% diagnostic yield while allowing biopsy, staging, fiducial placement, and dye marking in a single procedure.
INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive, image-guided approach to access lung lesions for biopsy or localization for treatment. However, no studies have reported prospective 24-month follow-up from a large, multinational, generalizable cohort. This study evaluated ENB safety, diagnostic yield, and usage patterns in an unrestricted, real-world observational design. METHODS: The NAVIGATE single-arm, pragmatic cohort study (NCT02410837) enrolled subjects at 37 academic and community sites in seven countries with prospective 24-month follow-up. Subjects underwent ENB using the superDimension navigation system versions 6.3 to 7.1. The prespecified primary end point was procedure-related pneumothorax requiring intervention or hospitalization. RESULTS: A total of 1388 subjects were enrolled for lung lesion biopsy (1329; 95.7%), fiducial marker placement (272; 19.6%), dye marking (23; 1.7%), or lymph node biopsy (36; 2.6%). Concurrent endobronchial ultrasound-guided staging occurred in 456 subjects. General anesthesia (78.2% overall, 56.6% Europe, 81.4% United States), radial endobronchial ultrasound (50.6%, 4.0%, 57.4%), fluoroscopy (85.0%, 41.7%, 91.0%), and rapid on-site evaluation use (61.7%, 17.3%, 68.5%) differed between regions. Pneumothorax and bronchopulmonary hemorrhage occurred in 4.7% and 2.7% of subjects, respectively (3.2% [primary end point] and 1.7% requiring intervention or hospitalization). Respiratory failure occurred in 0.6%. The diagnostic yield was 67.8% (range: 61.9%-70.7%; 55.2% Europe, 69.8% United States). Sensitivity for malignancy was 62.6%. Lung cancer clinical stage was I to II in 64.7% (55.3% Europe, 65.8% United States). CONCLUSIONS: Despite a heterogeneous cohort and regional differences in procedural techniques, ENB demonstrates low complications and a 67.8% diagnostic yield while allowing biopsy, staging, fiducial placement, and dye marking in a single procedure.