TY - JOUR
T1 - NAVIGATE 24-Month Results
T2 - Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States
AU - Folch, Erik E
AU - Bowling, Mark R
AU - Pritchett, Michael A
AU - Murgu, Septimiu D
AU - Nead, Michael A
AU - Flandes, Javier
AU - Krimsky, William S
AU - Mahajan, Amit K
AU - LeMense, Gregory P
AU - Murillo, Boris A
AU - Bansal, Sandeep
AU - Lau, Kelvin
AU - Gildea, Thomas R
AU - Christensen, Merete
AU - Arenberg, Douglas A
AU - Singh, Jaspal
AU - Bhadra, Krish
AU - Hogarth, D Kyle
AU - Towe, Christopher W
AU - Lamprecht, Bernd
AU - Bezzi, Michela
AU - Mattingley, Jennifer S
AU - Hood, Kristin L
AU - Lin, Haiying
AU - Wolvers, Jennifer J
AU - Khandhar, Sandeep J
AU - NAVIGATE Study Investigators
N1 - Copyright © 2021. Published by Elsevier Inc.
PY - 2022/4
Y1 - 2022/4
N2 - 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.
AB - 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.
KW - Electromagnetic navigation bronchoscopy
KW - Image-guided biopsy
KW - Interventional pulmonology
KW - Lung cancer
KW - Lung cancer diagnosis
UR - http://www.scopus.com/inward/record.url?scp=85123204261&partnerID=8YFLogxK
U2 - 10.1016/j.jtho.2021.12.008
DO - 10.1016/j.jtho.2021.12.008
M3 - Journal article
C2 - 34973418
SN - 1556-0864
VL - 17
SP - 519
EP - 531
JO - Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
JF - Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
IS - 4
ER -