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Y. Perry
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MA 20 - Recent Advances in Pulmonology/Endoscopy (ID 685)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Pulmonology/Endoscopy
- Presentations: 1
- Moderators:C. Lee, S. Sasada
- Coordinates: 10/18/2017, 14:30 - 16:15, F205 + F206 (Annex Hall)
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MA 20.03 - Safety of Electromagnetic Navigation Bronchoscopy in Patients with COPD: Results from the NAVIGATE Study (ID 8648)
14:40 - 14:45 | Author(s): Y. Perry
- Abstract
- Presentation
Background:
Electromagnetic navigation bronchoscopy (ENB) is used to access lung lesions or lymph nodes for biopsy and/or to guide fiducial or dye marking for stereotactic radiation or surgical localization. CT-guided lung biopsy can be complicated by pneumothorax, particularly in patients with emphysema. We examined the safety of ENB in patients with COPD and/or poor lung function.
Method:
NAVIGATE (www.clinicaltrials.gov, NCT02410837) is a prospective, multicenter, global, single-arm, observational study of ENB using the superDimension™ system (Medtronic, Minneapolis). This NAVIGATE substudy analyzes the 1-month follow-up of the first 1,000 subjects enrolled in the United States and Europe. Subjects were determined to have COPD by medical history. Pulmonary function test results (PFTs) were collected if available. Procedure-related pneumothorax, bronchopulmonary hemorrhage, respiratory failure, and composite complications were prospectively captured. Study sponsored and funded by Medtronic.
Result:
1,000 subjects were enrolled at 29 clinical sites, including 448 with COPD and 541 without COPD (COPD data missing in 11). One-month follow-up was completed in 933 subjects (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, 9.1% in subjects missing COPD data, P=0.81). CTCAE Grade ≥2 pneumothorax was not different between groups (2.7%, 3.7%, 0.0%, respectively, P=0.63). Severity of FEV1 or DLCO impairment was not associated with increased composite procedure-related complications (ppFEV1 P=0.66, ppDLCO P=0.37). Figure 1
Conclusion:
Patients with a clinical diagnosis of COPD or with poor PFTs can undergo ENB without an increase in complication rates. Because the risk of pneumothorax is not elevated, in patients undergoing ENB in this analysis, ENB may be the preferred method to biopsy peripheral lung lesions in patients with COPD and/or poor PFTs.
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