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

NAVIGATE Study Investigators

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

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 superDimension navigation system (Medtronic, Minneapolis, Minnesota). In this United States cohort analysis, 1215 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 1157 subjects undergoing ENB-guided biopsy, 94% (1092 of 1157) 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 of 1092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69%, 100%, 100%, and 56%, respectively. ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher pneumothoraces (requiring admission or chest tube placement) occurred in 2.9%. The ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher bronchopulmonary hemorrhage and grade 4 or higher respiratory failure rates were 1.5% and 0.7%, respectively. Conclusions: NAVIGATE shows 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.

Original languageEnglish (US)
Pages (from-to)445-458
Number of pages14
JournalJournal of Thoracic Oncology
Volume14
Issue number3
DOIs
StatePublished - Mar 2019

Fingerprint

Electromagnetic Phenomena
Bronchoscopy
Multicenter Studies
Lung
Terminology
Cohort Studies
Chest Tubes
Fluoroscopy
Pneumothorax
Respiratory Rate
Respiratory Insufficiency
Neoplasms
Pathology
Hemorrhage
Technology
Biopsy
Sensitivity and Specificity

Keywords

  • Bronchoscopy
  • Image-guided biopsy
  • Lung cancer
  • Lung neoplasms
  • Lung nodules

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

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

In: Journal of Thoracic Oncology, Vol. 14, No. 3, 03.2019, p. 445-458.

Research output: Contribution to journalArticle

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title = "Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study",
abstract = "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 superDimension navigation system (Medtronic, Minneapolis, Minnesota). In this United States cohort analysis, 1215 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 1157 subjects undergoing ENB-guided biopsy, 94{\%} (1092 of 1157) 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 of 1092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69{\%}, 100{\%}, 100{\%}, and 56{\%}, respectively. ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher pneumothoraces (requiring admission or chest tube placement) occurred in 2.9{\%}. The ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher bronchopulmonary hemorrhage and grade 4 or higher respiratory failure rates were 1.5{\%} and 0.7{\%}, respectively. Conclusions: NAVIGATE shows 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.",
keywords = "Bronchoscopy, Image-guided biopsy, Lung cancer, Lung neoplasms, Lung nodules",
author = "{NAVIGATE Study Investigators} and Folch, {Erik E.} and Pritchett, {Michael A.} and Nead, {Michael A.} and Bowling, {Mark R.} and Murgu, {Septimiu D.} and Krimsky, {William S.} and Murillo, {Boris A.} and LeMense, {Gregory P.} and Minnich, {Douglas J.} and Sandeep Bansal and Ellis, {Blesilda Q.} and Mahajan, {Amit K.} and Gildea, {Thomas R.} and Bechara, {Rabih I.} and Eric Sztejman and Javier Flandes and Rickman, {Otis B.} and Sadia Benzaquen and Hogarth, {D. Kyle} and Linden, {Philip A.} and Wahidi, {Momen M.} and Mattingley, {Jennifer S.} and Hood, {Kristin L.} and Haiying Lin and Wolvers, {Jennifer J.} and Khandhar, {Sandeep J.} and Carlos Anciano and Alejandro Aragaki and Douglas Arenberg and Omar Awais and Ricardo Balestra and Emanuela Barisione and Rabih Bechara and Michela Bezzi and Krishnendu Bhadra and Julio Bird and Alessandro Blanco and Mark Bowling and Robert Cerfolio and Merete Christensen and Joseph Cicenia and Antony Courey and John Doty and Kevin Eggleston and Blesilda Ellis and Iker Fernandez and Erik Folch and Alexandre Furman and Gass, {George David} and Thomas Gildea",
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T1 - Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions

T2 - One-Year Results of the Prospective, Multicenter NAVIGATE Study

AU - NAVIGATE Study Investigators

AU - Folch, Erik E.

AU - Pritchett, Michael A.

AU - Nead, Michael A.

AU - Bowling, Mark R.

AU - Murgu, Septimiu D.

AU - Krimsky, William S.

AU - Murillo, Boris A.

AU - LeMense, Gregory P.

AU - Minnich, Douglas J.

AU - Bansal, Sandeep

AU - Ellis, Blesilda Q.

AU - Mahajan, Amit K.

AU - Gildea, Thomas R.

AU - Bechara, Rabih I.

AU - Sztejman, Eric

AU - Flandes, Javier

AU - Rickman, Otis B.

AU - Benzaquen, Sadia

AU - Hogarth, D. Kyle

AU - Linden, Philip A.

AU - Wahidi, Momen M.

AU - Mattingley, Jennifer S.

AU - Hood, Kristin L.

AU - Lin, Haiying

AU - Wolvers, Jennifer J.

AU - Khandhar, Sandeep J.

AU - Anciano, Carlos

AU - Aragaki, Alejandro

AU - Arenberg, Douglas

AU - Awais, Omar

AU - Balestra, Ricardo

AU - Barisione, Emanuela

AU - Bechara, Rabih

AU - Bezzi, Michela

AU - Bhadra, Krishnendu

AU - Bird, Julio

AU - Blanco, Alessandro

AU - Bowling, Mark

AU - Cerfolio, Robert

AU - Christensen, Merete

AU - Cicenia, Joseph

AU - Courey, Antony

AU - Doty, John

AU - Eggleston, Kevin

AU - Ellis, Blesilda

AU - Fernandez, Iker

AU - Folch, Erik

AU - Furman, Alexandre

AU - Gass, George David

AU - Gildea, Thomas

PY - 2019/3

Y1 - 2019/3

N2 - 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 superDimension navigation system (Medtronic, Minneapolis, Minnesota). In this United States cohort analysis, 1215 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 1157 subjects undergoing ENB-guided biopsy, 94% (1092 of 1157) 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 of 1092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69%, 100%, 100%, and 56%, respectively. ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher pneumothoraces (requiring admission or chest tube placement) occurred in 2.9%. The ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher bronchopulmonary hemorrhage and grade 4 or higher respiratory failure rates were 1.5% and 0.7%, respectively. Conclusions: NAVIGATE shows 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.

AB - 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 superDimension navigation system (Medtronic, Minneapolis, Minnesota). In this United States cohort analysis, 1215 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 1157 subjects undergoing ENB-guided biopsy, 94% (1092 of 1157) 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 of 1092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69%, 100%, 100%, and 56%, respectively. ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher pneumothoraces (requiring admission or chest tube placement) occurred in 2.9%. The ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher bronchopulmonary hemorrhage and grade 4 or higher respiratory failure rates were 1.5% and 0.7%, respectively. Conclusions: NAVIGATE shows 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.

KW - Bronchoscopy

KW - Image-guided biopsy

KW - Lung cancer

KW - Lung neoplasms

KW - Lung nodules

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