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O.B. Rickman
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MA 20 - Recent Advances in Pulmonology/Endoscopy (ID 685)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Pulmonology/Endoscopy
- Presentations: 2
- Moderators:C. Lee, S. Sasada
- Coordinates: 10/18/2017, 14:30 - 16:15, F205 + F206 (Annex Hall)
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MA 20.02 - Pleural Dye Marking of Lung Nodules by Electromagnetic Navigation Bronchoscopy in the Prospective, Multicenter NAVIGATE Study (ID 8664)
14:30 - 16:15 | Author(s): O.B. Rickman
- Abstract
- Presentation
Background:
Pleural dye marking guided by electromagnetic navigation bronchoscopy (ENB) has been useful in identifying small peripheral lesions for sublobar resection in the management of non-small cell lung cancer and indeterminate lung nodules. We report the use of this procedure among the participants of the NAVIGATE study.
Method:
NAVIGATE (www.clinicaltrials.gov, NCT02410837) is a prospective, multicenter, global, single-arm, observational cohort study of ENB using the superDimension™ navigation system (Medtronic, Minneapolis). Enrollment of up to 1,500 subjects is planned at 37 sites in the United States and Europe. European enrollment and 2-year follow-up are in progress. This abstract presents a prespecified 1-month interim analysis of NAVIGATE subjects from the United States cohort who underwent ENB-guided pleural dye marking. Study sponsored and funded by Medtronic.
Result:
From April 2015 to August 2016 at 29 clinical sites, 1218 subjects were enrolled in the NAVIGATE United States cohort. In 7 clinical centers (7/29), 23 subjects (24 lesions) underwent pleural dye marking in preparation for surgical resection. Ten subjects underwent dye marking alone while 13 had dye marking concurrent with lung lesion biopsy and/or fiducial placement. The median nodule size was 10 mm (range 4-22) and 83.3% (20/24) were less than 20 mm in diameter. Most lesions (95.5%; 21/22) were located in the peripheral third of the lung. The median distance of the target lesion from the visceral pleura was 3.0 mm. The median total bronchoscopic procedure time was 22.0 minutes and the median ENB procedure time (first locatable guide [LG] / extended working channel [EWC] entry to last LG/EWC exit) was 11.5 minutes (range 4-38). Dye marking was considered accurate for surgical resection in 91.3% of the cases and the median time of dye marking to surgical resection was 0.5 hours (range 0.3-24). Seventy five percent of the lesions were malignant (18/24) and 50% were adenocarcinoma.
Conclusion:
Our data demonstrates that pleural dye marking with ENB guidance is useful for locating small peripheral lesions for surgical resection without adding significant additional time to the procedure. An interesting finding in our report is the underutilization of this procedure in the NAVIGATE cohort (23/1218). Given that sublobar and lung parenchymal sparing resections for non-small cell lung cancer are becoming more common, it is unclear why surgeons are not more frequently utilizing pleural dye marking. Further investigation concerning physician behavior and practice patterns in the use of lung sparing surgery needs to be explored.
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MA 20.03 - Safety of Electromagnetic Navigation Bronchoscopy in Patients with COPD: Results from the NAVIGATE Study (ID 8648)
14:30 - 16:15 | Author(s): O.B. Rickman
- 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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