Data for the European cohort of the NAVIGATE study confirm electromagnetic navigation bronchoscopy as a safe platform to aid in lung lesion biopsy with a high success rate and a median time of 40 minutes for the procedure.
Why this matters
Electromagnetic navigation bronchoscopy (ENB) is a relatively novel approach to access peripheral pulmonary lesions. Although the results of a global, prospective, multicenter study of ENB with the superDimension™ navigation system have been published (BMC Pulm Med 2017;17:59), practice patterns and safety specifically in the full European cohort have not yet been presented.
Prespecified 1-month interim analysis of the European cohort of the NAVIGATE study, including 175 subjects enrolled at 8 sites.
- ENB was used primarily for lung biopsies (99.4%), but also for fiducial marking (8%).
- A bronchus sign was present in 66.8% of cases (versus 49% in US population); the success rate for biopsies was 96.6%.
- General anesthesia was used in 57% (US: 81%), radial EBUS in 4.0% (US: 57%), cone-beam CT in 9.7%, fluoroscopy in 41.7%, and rapid on-site evaluation (ROSE) in 17.9%.
- Planning time for the procedure was 12.5 minutes, the procedure itself lasted 43.5 minutes (median values).
- The pneumothorax rate of all grades was 7.4 %; 5.1% required intervention or hospitalisation.
- There were 0.6% respiratory failures of grade 4 or worse.
“The diagnostic yield of ENB is very high, when you have a bronchus sign. [It’s a very safe procedure, but] CT-guided percutaneous transthoracic biopsies using 10G large-core needles are successful most of the time, and the pneumothorax rate in our hands is rather low. In stage I lung cancer, tissue is the issue.” Prof. Anne-Marie Dingemans, Maastricht UMC, Netherlands