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Multicenter Study
. 2019 Mar;14(3):445-458.
doi: 10.1016/j.jtho.2018.11.013. Epub 2018 Nov 23.

Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study

Erik E Folch  1 , Michael A Pritchett  2 , Michael A Nead  3 , Mark R Bowling  4 , Septimiu D Murgu  5 , William S Krimsky  6 , Boris A Murillo  7 , Gregory P LeMense  8 , Douglas J Minnich  9 , Sandeep Bansal  10 , Blesilda Q Ellis  11 , Amit K Mahajan  12 , Thomas R Gildea  13 , Rabih I Bechara  14 , Eric Sztejman  15 , Javier Flandes  16 , Otis B Rickman  17 , Sadia Benzaquen  18 , D Kyle Hogarth  19 , Philip A Linden  20 , Momen M Wahidi  21 , Jennifer S Mattingley  22 , Kristin L Hood  23 , Haiying Lin  23 , Jennifer J Wolvers  23 , Sandeep J Khandhar  12 ; NAVIGATE Study Investigators
Collaborators, Affiliations
Free article
Multicenter Study

Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study

Erik E Folch et al. J Thorac Oncol. 2019 Mar.
Free article

Abstract

Introduction: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive technology that guides endoscopic tools to pulmonary lesions. ENB has been evaluated primarily in small, single-center studies; thus, the diagnostic yield in a generalizable setting is unknown.

Methods: NAVIGATE is a prospective, multicenter, cohort study that evaluated ENB using the superDimension navigation system (Medtronic, Minneapolis, Minnesota). In this United States cohort analysis, 1215 consecutive subjects were enrolled at 29 academic and community sites from April 2015 to August 2016.

Results: The median lesion size was 20.0 mm. Fluoroscopy was used in 91% of cases (lesions visible in 60%) and radial endobronchial ultrasound in 57%. The median ENB planning time was 5 minutes; the ENB-specific procedure time was 25 minutes. Among 1157 subjects undergoing ENB-guided biopsy, 94% (1092 of 1157) had navigation completed and tissue obtained. Follow-up was completed in 99% of subjects at 1 month and 80% at 12 months. The 12-month diagnostic yield was 73%. Pathology results of the ENB-aided tissue samples showed malignancy in 44% (484 of 1092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69%, 100%, 100%, and 56%, respectively. ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher pneumothoraces (requiring admission or chest tube placement) occurred in 2.9%. The ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher bronchopulmonary hemorrhage and grade 4 or higher respiratory failure rates were 1.5% and 0.7%, respectively.

Conclusions: NAVIGATE shows that an ENB-aided diagnosis can be obtained in approximately three-quarters of evaluable patients across a generalizable cohort based on prospective 12-month follow-up in a pragmatic setting with a low procedural complication rate.

Keywords: Bronchoscopy; Image-guided biopsy; Lung cancer; Lung neoplasms; Lung nodules.

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Comment in

  • Real-World Application of the NAVIGATE Trial.
    Thiboutot J, Yarmus LB, Lee HJ, Rivera MP, Ost DE, Feller-Kopman D. Thiboutot J, et al. J Thorac Oncol. 2019 Jul;14(7):e146-e147. doi: 10.1016/j.jtho.2019.02.020. J Thorac Oncol. 2019. PMID: 31235039 No abstract available.
  • Image-guided Bronchoscopy: Established and Emerging Approaches.
    Swenson KE, DuComb EA, Abia-Trujillo D, Majid A, Parikh MS. Swenson KE, et al. Am J Respir Crit Care Med. 2023 Jul 1;208(1):98-100. doi: 10.1164/rccm.202205-1008RR. Am J Respir Crit Care Med. 2023. PMID: 37129567 No abstract available.

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