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Kelvin Lau

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    Proffered Paper session I (ID 57)

    • Event: ELCC 2019
    • Type: Proffered Paper session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/10/2019, 16:30 - 18:15, Room C
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      68O - Electromagnetic navigation bronchoscopy in the European cohort of the prospective, multicenter NAVIGATE study (ID 154)

      16:30 - 18:15  |  Presenting Author(s): Kelvin Lau

      • Abstract
      • Presentation
      • Slides


      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.

      a9ded1e5ce5d75814730bb4caaf49419 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.

      20c51b5f4e9aeb5334c90ff072e6f928 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.

      fd69c5cf902969e6fb71d043085ddee6 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.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT02410837. First posted April 8, 2015.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

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

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study


      213f68309caaa4ccc14d5f99789640ad Funding


      682889d0a1d3b50267a69346a750433d 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.


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