TY  - BOOK
AU  - Krimsky, William S
TI  - Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study
SN  - 1556-0864
PY  - 2018///
KW  - IN PROCESS -- NOT YET INDEXED
KW  - MedStar Franklin Square Medical Center
KW  - Angelos Center for Lung Disease
KW  - Journal Article
N1  - Available online through MWHC library: 2006 - present
N2  - CONCLUSIONS: NAVIGATE demonstrates that an ENB-aided diagnosis can be obtained in approximately three quarters of evaluable patients across a generalizable cohort based on prospective 12-month follow-up in a pragmatic setting, with a low procedural complication rate; Copyright (c) 2018. Published by Elsevier Inc; INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive technology that guides endoscopic tools to pulmonary lesions. ENB has been evaluated primarily in small, single-center studies; thus, the diagnostic yield in a generalizable setting is unknown; METHODS: NAVIGATE is a prospective, multicenter, cohort study that evaluated ENB using the superDimensionTM navigation system. In this United States cohort analysis, 1,215 consecutive subjects were enrolled at 29 academic and community sites from April 2015 to August 2016; RESULTS: The median lesion size was 20.0 mm. Fluoroscopy was used in 91% of cases (lesions visible in 60%) and radial endobronchial ultrasound in 57%. The median ENB planning time was 5 minutes; the ENB-specific procedure time was 25 minutes. Among 1,157 subjects undergoing ENB-guided biopsy, 94% (1,092/1,157) had navigation completed and tissue obtained. Follow-up was completed in 99% of subjects at 1 month and 80% at 12 months. The 12-month diagnostic yield was 73%. Pathology results of the ENB-aided tissue samples showed malignancy in 44% (484/1,092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69%, 100%, 100%, and 56%, respectively. ENB-related CTCAE Grade >=2 pneumothoraces (requiring admission or chest tube placement) occurred in 2.9%. The ENB-related CTCAE Grade >=2 bronchopulmonary hemorrhage and Grade >=4 respiratory failure rates were 1.5% and 0.7%, respectively
UR  - https://dx.doi.org/10.1016/j.jtho.2018.11.013
ER  -