NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States

• Published in: Journal of thoracic oncology Vol. 17; no. 4; pp. 519 - 531
• Main Authors: Folch, Erik E., Bowling, Mark R., Pritchett, Michael A., Murgu, Septimiu D., Nead, Michael A., Flandes, Javier, Krimsky, William S., Mahajan, Amit K., LeMense, Gregory P., Murillo, Boris A., Bansal, Sandeep, Lau, Kelvin, Gildea, Thomas R., Christensen, Merete, Arenberg, Douglas A., Singh, Jaspal, Bhadra, Krish, Hogarth, D. Kyle, Towe, Christopher W., Lamprecht, Bernd, Bezzi, Michela, Mattingley, Jennifer S., Hood, Kristin L., Lin, Haiying, Wolvers, Jennifer J., Khandhar, Sandeep J.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.04.2022
• Subjects: Bronchoscopy - methods; Cohort Studies; Electromagnetic navigation bronchoscopy; Electromagnetic Phenomena; Humans; Image-guided biopsy; Interventional pulmonology; Lung - pathology; Lung cancer; Lung cancer diagnosis; Lung Neoplasms - complications; Lung Neoplasms - diagnosis; Lung Neoplasms - surgery; Pneumothorax - epidemiology; Pneumothorax - etiology; Pneumothorax - pathology; Prospective Studies; United States; United States; Electromagnetic navigation bronchoscopy; Image-guided biopsy; Lung cancer diagnosis; Interventional pulmonology; Lung cancer
• ISSN: 1556-0864; 1556-1380; 1556-1380
• DOI: 10.1016/j.jtho.2021.12.008

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. 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. 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). 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.