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P.A. Linden
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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 20.01 - Fiducial Marker Placement Using Electromagnetic Navigation Bronchoscopy in the Prospective, Multicenter NAVIGATE Study (ID 7890)
14:30 - 14:35 | Author(s): P.A. Linden
- Abstract
- Presentation
Background:
Fiducial markers guide stereotactic body radiotherapy (SBRT) and can be used to localize lesions for surgical resection in the management of lung cancer. We report the safety, accuracy and common practice patterns of fiducial placement guided by electromagnetic navigation bronchoscopy (ENB).
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). This abstract presents the patient demographics, procedural characteristics, and 1-month outcomes in the subset of NAVIGATE subjects from the United States cohort who had fiducial markers placed. Continued enrollment in Europe and 2-year follow-up are ongoing. Study sponsored and funded by Medtronic.
Result:
258 subjects from 21 United States centers (29 operators) received fiducial markers during their ENB procedure. Most subjects received between 1 and 5 fiducial markers (mean 2.2±1.7). General anesthesia was used in 69.4%. Real-time confirmation by radial endobronchial ultrasound (r-EBUS) was used in 34.5% of ENB procedures. The median ENB procedure time (first locatable guide [LG] / extended working channel [EWC] entry to last LG/EWC exit) was 31.0 minutes. Among the 258 subjects undergoing ENB-guided fiducial marker placement, 213 subjects also had lung lesion biopsy. Based on subjective operator assessment, 99.2% of fiducial markers were accurately placed. Follow-up imaging an average of 4.7 days post-procedure showed that 94.3% (232/246) of markers were still in place. The ENB-related pneumothorax rate was 5.0% (13/258) overall and 3.1% were Grade ≥2 based on the Common Terminology Criteria for Adverse Events scale (i.e., requiring chest tube placement or hospitalization). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failures rates were 0.0% and 1.6%, respectively. Among the 39 subjects undergoing fiducial placement alone with no biopsy, there was 1 respiratory failure and no pneumothoraces or bronchopulmonary hemorrhages.
Conclusion:
We report the largest series to date of fiducial marker placement by ENB guidance. Our data suggest that ENB-guided fiducial marker placement is versatile and accurate, with low complication rates. Practice variations in number and type of fiducial placed between operators were noted in our data. We did not identify the type of radiotherapy system used at each institution or how many fiducial markers were useful during the therapy. In addition, not all SBRT systems require fiducial marker placement, and some fiducial markers were placed for surgical localization. Further investigation should explore these practice patterns to further hone the usefulness and accuracy of placement of fiducial markers for SBRT and surgical localization.
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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): P.A. Linden
- 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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