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Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study.

Publication ,  Journal Article
Khandhar, SJ; Bowling, MR; Flandes, J; Gildea, TR; Hood, KL; Krimsky, WS; Minnich, DJ; Murgu, SD; Pritchett, M; Toloza, EM; Wahidi, MM ...
Published in: BMC Pulm Med
April 11, 2017

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.

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Published In

BMC Pulm Med

DOI

EISSN

1471-2466

Publication Date

April 11, 2017

Volume

17

Issue

1

Start / End Page

59

Location

England

Related Subject Headings

  • Young Adult
  • United States
  • Tomography, X-Ray Computed
  • Respiratory System
  • Prospective Studies
  • Pneumothorax
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Lymph Nodes
 

Citation

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Khandhar, S. J., Bowling, M. R., Flandes, J., Gildea, T. R., Hood, K. L., Krimsky, W. S., … NAVIGATE Study Investigators, . (2017). Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med, 17(1), 59. https://doi.org/10.1186/s12890-017-0403-9
Khandhar, Sandeep J., Mark R. Bowling, Javier Flandes, Thomas R. Gildea, Kristin L. Hood, William S. Krimsky, Douglas J. Minnich, et al. “Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study.BMC Pulm Med 17, no. 1 (April 11, 2017): 59. https://doi.org/10.1186/s12890-017-0403-9.
Khandhar SJ, Bowling MR, Flandes J, Gildea TR, Hood KL, Krimsky WS, et al. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med. 2017 Apr 11;17(1):59.
Khandhar, Sandeep J., et al. “Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study.BMC Pulm Med, vol. 17, no. 1, Apr. 2017, p. 59. Pubmed, doi:10.1186/s12890-017-0403-9.
Khandhar SJ, Bowling MR, Flandes J, Gildea TR, Hood KL, Krimsky WS, Minnich DJ, Murgu SD, Pritchett M, Toloza EM, Wahidi MM, Wolvers JJ, Folch EE, NAVIGATE Study Investigators. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med. 2017 Apr 11;17(1):59.
Journal cover image

Published In

BMC Pulm Med

DOI

EISSN

1471-2466

Publication Date

April 11, 2017

Volume

17

Issue

1

Start / End Page

59

Location

England

Related Subject Headings

  • Young Adult
  • United States
  • Tomography, X-Ray Computed
  • Respiratory System
  • Prospective Studies
  • Pneumothorax
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Lymph Nodes