Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study.

MedStar author(s):
Citation: Journal of Thoracic Oncology: Official Publication of the International Association for the Study of Lung Cancer. 2018 Nov 23PMID: 30476574Institution: MedStar Franklin Square Medical CenterDepartment: Angelos Center for Lung DiseaseForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2018Local holdings: Available online through MWHC library: 2006 - presentISSN:
  • 1556-0864
Name of journal: Journal of thoracic oncology : official publication of the International Association for the Study of Lung CancerAbstract: 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.All authors: Bansal S, Bechara RI, Benzaquen S, Bowling MR, Ellis BQ, Flandes J, Folch EE, Gildea TR, Hogarth DK, Hood KL, Khandhar SJ, Krimsky WS, LeMense GP, Lin H, Linden PA, Mahajan AK, Mattingley JS, Minnich DJ, Murgu SD, Murillo BA, NAVIGATE Study Investigators, Nead MA, Pritchett MA, Rickman OB, Sztejman E, Wahidi MM, Wolvers JJFiscal year: FY2019Digital Object Identifier: Date added to catalog: 2018-12-14
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 30476574 Available 30476574

Available online through MWHC library: 2006 - present

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.

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