68O - Electromagnetic navigation bronchoscopy in the European cohort of the prospective, multicenter NAVIGATE study

Date 10 April 2019
Event European Lung Cancer Congress 2019
Session Proffered Paper session I
Topics Imaging
Non-Small Cell Lung Cancer
Presenter Kelvin Lau
Citation Annals of Oncology (2019) 30 (suppl_2): ii26-ii30. 10.1093/annonc/mdz064
Authors K. Lau1, J. Flandes2, M. Christensen3, M. Bezzi4, B. Lamprecht5, M. Salio6, J.M. Vergnon7, M. Studnicka8, M. Trigiani4, I. Fernandez2, R. Kropfmüller5, E. Barisione6, N. Viby3, S. Khandhar9, E. Folch10
  • 1Cardiothoracic Surgery, St. Bartholomew's Hospital, EC1A 7BE - London/GB
  • 2University Hospital "Fundacion Jimenez Diaz", Madrid/ES
  • 3Rigshospitalet, Copenhagen University Hospital, Copenhagen/DK
  • 4Azienda Ospedaliera Universitaria Careggi, Firenze/IT
  • 5Department Of Pulmonology, Kepler University Hospital, 4020 - Linz/AT
  • 6IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, Genova/IT
  • 7CHU University hospital of St Etienne, 42055 - St. Etienne/FR
  • 8Paracelsus University Hospital Salzburg, Salzburg/AT
  • 9Inova Health System, Fairfax Hospital, Falls Church/US
  • 10Massachusetts General Hospital, Boston/US

Abstract

Background

Electromagnetic navigation bronchoscopy (ENB) is an image-guided approach to access peripheral pulmonary lesions. ENB has been evaluated in a prospective global study (NAVIGATE, NCT02410837, Khandhar, BMC Pulm Med 2017;17:59). Practice patterns and safety specifically in the full European cohort have not yet been presented. The objective of this study is to evaluate ENB safety and usage in the NAVIGATE European sites.

Methods

NAVIGATE is a global, prospective, multicenter study of ENB (superDimension™ navigation system) use in community and academic settings. A prespecified 1-month interim analysis was conducted of the European cohort.

Results

Subjects (n = 175) were enrolled at 8 European sites, with complete 1-month follow-up in 99.4%. ENB was used to aid in lung biopsy in 99.4% (174/175) and fiducial marking in 8.0% (14/175). Lymph node sampling was attempted in 12 procedures (9 using linear EBUS). General anesthesia was used in 57%, radial EBUS in 4.0%, cone-beam CT in 9.7%, fluoroscopy in 41.7%, and rapid on-site evaluation (ROSE) in 17.9%. The median lesion size was 18.0 mm. Lesions were in the peripheral third of the lung in 72.7% and the upper lobe in 62.6%. A bronchus sign was present in 66.8%. Navigation was successful in 96.6% of biopsy cases. The median ENB planning time was 12.5 minutes. The median total procedure time (bronchoscope in to bronchoscope out) was 43.5 minutes, which included 32.9 minutes of ENB-specific navigation/sampling time (first entry to last exit of the locatable guide or extended working channel). The ENB-related pneumothorax rate was 7.4% (13/175), 5.1% requiring intervention or hospitalization. The ENB-related Common Terminology Criteria for Adverse Events Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failures rates were 2.3% and 0.6%, respectively. Longer follow-up is required to assess diagnostic yield.

Conclusions

The results from the European cohort of the NAVIGATE study suggest that ENB provides a safe platform to aid in lung lesion biopsy. ENB also allows multidimensional lung lesion biopsy, fiducial placement, and concurrent lymph node sampling during a single anesthetic event.

Clinical trial identification

NCT02410837. First posted April 8, 2015.

Editorial acknowledgement

Medical writing support was provided by Kristin L. Hood PhD of Medtronic, in accordance with Good Publication Practice (GPP3) guidelines.

Legal entity responsible for the study

Medtronic.

Funding

Medtronic.

Disclosure

K. Lau, M. Christensen, M. Bezzi, B. Lamprecht, M. Salio, J.M. Vergnon, M. Studnicka, M. Trigiani, I. Fernandez, R. Kropfmüller, E. Barisione, N-E. Viby: Research funding to institution for participating in the Medtronic-sponsored NAVIGATE study. J. Flandes: Consulting fees, research funding to institution: Medtronic (Steering Committee, study principal investigator); Consulting fees: BTG-PneumRx, Olympus, Ambu, PulmonX, Boston Scientific; Research grant support: BTG-PneumRx. S. Khandhar: Consulting fees: Medtronic (study principal investigator and Steering Committee, clinical advisory board); Advisory board: Boston Scientific; Research funding to institution: Medtronic-sponsored NAVIGATE study; Stock ownership: TransEnterix. E. Folch: Consulting fees: Medtronic (study principal investigator, Steering Committee, clinical advisory board); Scientific advisory board: Boston Scientific.