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

Folch EE at al

Journal of Thoracic Oncology Vol. 14 No. 3: 445-458 ;

Abstract 

What is the key question?

  • In a prospective, multicenter pragmatic cohort study, what is the diagnostic yield and safety profile of electromagnetic bronchoscopy (ENB) in consecutively enrolled patients without strict exclusion criteria?

What is the bottom line?

  • Using the superDimension navigation platform under general anaesthesia (81.4%), the authors report on 1 year outcomes of 1,215 USA patients enrolled in the international NAVIGATE study.
  • 1,157 patients underwent ENB-aided biopsy of a lung lesion with fluoroscopic guidance (lesions visible in 60%). Adequate 24-month follow up was available in 91%.
  • Median lesion size was 20 mm (most were between 14 mm and 30 mm).
  • The 12 month diagnostic yield was 73%. Malignancy was identified in 44% (484 of 1092).
  • Sensitivity and negative predictive value for malignancy were 69% and 56%, respectively.
  • Pneumothorax, significant haemorrhage and respiratory failure rates were 2.9, 1.5 and 0.7% respectively.

Why read on?

  • This multicentre study includes sufficiently large numbers in a prospective fashion and shows that a diagnosis can be made in approximately three quarters of patients with pulmonary lesions across community and academic settings.
  • The authors further describe the usefulness of a negative EBN test in the algorithm for lung nodule work up depending on pre-test probability of cancer.
  • Information is provided with regards to the use of ENB biopsy specimens for molecular analysis.
  • Multiple traditional predictors of diagnostic yield including use of radial probe EBUS and positive bronchus sign are analysed using univariate and multivariate analysis.