TY - JOUR
T1 - Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects
T2 - First results of the prospective, multicenter NAVIGATE study
AU - for the NAVIGATE Study Investigators
AU - Khandhar, Sandeep J.
AU - Bowling, Mark R.
AU - Flandes, Javier
AU - Gildea, Thomas R.
AU - Hood, Kristin L.
AU - Krimsky, William S.
AU - Minnich, Douglas J.
AU - Murgu, Septimiu D.
AU - Pritchett, Michael
AU - Toloza, Eric M.
AU - Wahidi, Momen M.
AU - Wolvers, Jennifer J.
AU - Folch, Erik E.
N1 - Funding Information:
The study is sponsored and funded by Medtronic (Minneapolis, MN). Medical writing support was provided by Kristin L. Hood PhD, a full-time employee of Medtronic and coauthor on this paper. The authors wish to thank Haiying Lin (Medtronic) for biostatistics support. The authors also wish to thank the investigators and staff of all participating clinical sites (see Additional file 3).
Publisher Copyright:
© 2017 The Author(s).
PY - 2017/4/11
Y1 - 2017/4/11
N2 - Background: Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions. Methods: NAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing. Results: ENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively. Conclusions: One-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield. Trial registration: ClinicalTrials.gov NCT02410837. Registered 31 March 2015.
AB - Background: Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions. Methods: NAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing. Results: ENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively. Conclusions: One-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield. Trial registration: ClinicalTrials.gov NCT02410837. Registered 31 March 2015.
KW - Image-Guided Biopsy
KW - Lung Cancer
KW - Lung Neoplasms
KW - Neoplasm Staging
KW - Solitary Pulmonary Nodule
UR - http://www.scopus.com/inward/record.url?scp=85018507934&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85018507934&partnerID=8YFLogxK
U2 - 10.1186/s12890-017-0403-9
DO - 10.1186/s12890-017-0403-9
M3 - Article
C2 - 28399830
AN - SCOPUS:85018507934
SN - 1471-2466
VL - 17
JO - BMC Pulmonary Medicine
JF - BMC Pulmonary Medicine
IS - 1
M1 - 59
ER -
