Safety of Electromagnetic Navigation Bronchoscopy in Patients With COPD: Results From the NAVIGATE Study

BACKGROUND: Electromagnetic navigation bronchoscopy (ENB) aids in the localization of lung lesions for biopsy and/or to guide fiducial or dye marking for stereotactic radiation or surgical localization. This study assessed ENB safety in patients with chronic obstructive pulmonary disease (COPD) and/or poor lung function. METHODS: NAVIGATE is a prospective, multicenter, observational study of ENB. This substudy analyzed the 1-month follow-up of the first 1000 enrolled subjects. COPD was determined by medical history. Pulmonary function testing (PFT) results were collected if available within 30 days of the procedure. Procedure-related complications were captured. RESULTS: The analysis included 448 subjects with COPD and 541 without COPD (COPD data missing in 11). One-month follow-up was completed in 93.3%. Subjects with COPD tended to be older, male, and have history of tobacco exposure, asthma, and recent pneumonia. Nodule size, location, and procedure time were similar between groups. There was no statistically significant difference in the procedure-related composite complication rate between groups (7.4% with COPD, 7.8% without COPD, P=0.90). Common Terminology Criteria for Adverse Events scale grade ≥2 pneumothorax was not different between groups (2.7% with COPD, 3.7% without COPD, P=0.47). COPD was not a significant multivariate predictor of complications. Severity of forced expiratory volume in 1 second (FEV1) or diffusing capacity of the lung for carbon monoxide impairment was not associated with increased composite procedure-related complications (ppFEV1 P=0.66, ppDLCO P=0.36). CONCLUSION: In this analysis, complication rates following ENB procedures were not increased in patients with COPD or poor pulmonary function. Because pneumothorax risk is not elevated, ENB may be the preferred method to biopsy peripheral lung lesions in patients with COPD and/or poor pulmonary function testing.