NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States

Erik E Folch; Mark R Bowling; Michael A Pritchett; Septimiu D Murgu; Michael A Nead; Javier Flandes; William S Krimsky; Amit K Mahajan; Gregory P LeMense; Boris A Murillo; Sandeep Bansal; Kelvin Lau; Thomas R Gildea; Merete Christensen; Douglas A Arenberg; Jaspal Singh; Krish Bhadra; D Kyle Hogarth; Christopher W Towe; Bernd Lamprecht; Michela Bezzi; Jennifer S Mattingley; Kristin L Hood; Haiying Lin; Jennifer J Wolvers; Sandeep J Khandhar; NAVIGATE Study Investigators

doi:10.1016/j.jtho.2021.12.008

NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States

Erik E Folch, Mark R Bowling, Michael A Pritchett, Septimiu D Murgu, Michael A Nead, Javier Flandes, William S Krimsky, Amit K Mahajan, Gregory P LeMense, Boris A Murillo, Sandeep Bansal, Kelvin Lau, Thomas R Gildea, Merete Christensen, Douglas A Arenberg, Jaspal Singh, Krish Bhadra, D Kyle Hogarth, Christopher W Towe, Bernd LamprechtMichela Bezzi, Jennifer S Mattingley, Kristin L Hood, Haiying Lin, Jennifer J Wolvers, Sandeep J Khandhar, NAVIGATE Study Investigators

Department of Cardiothoracic Surgery

95 Citations (Scopus)

Abstract

INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive, image-guided approach to access lung lesions for biopsy or localization for treatment. However, no studies have reported prospective 24-month follow-up from a large, multinational, generalizable cohort. This study evaluated ENB safety, diagnostic yield, and usage patterns in an unrestricted, real-world observational design.

METHODS: The NAVIGATE single-arm, pragmatic cohort study (NCT02410837) enrolled subjects at 37 academic and community sites in seven countries with prospective 24-month follow-up. Subjects underwent ENB using the superDimension navigation system versions 6.3 to 7.1. The prespecified primary end point was procedure-related pneumothorax requiring intervention or hospitalization.

RESULTS: A total of 1388 subjects were enrolled for lung lesion biopsy (1329; 95.7%), fiducial marker placement (272; 19.6%), dye marking (23; 1.7%), or lymph node biopsy (36; 2.6%). Concurrent endobronchial ultrasound-guided staging occurred in 456 subjects. General anesthesia (78.2% overall, 56.6% Europe, 81.4% United States), radial endobronchial ultrasound (50.6%, 4.0%, 57.4%), fluoroscopy (85.0%, 41.7%, 91.0%), and rapid on-site evaluation use (61.7%, 17.3%, 68.5%) differed between regions. Pneumothorax and bronchopulmonary hemorrhage occurred in 4.7% and 2.7% of subjects, respectively (3.2% [primary end point] and 1.7% requiring intervention or hospitalization). Respiratory failure occurred in 0.6%. The diagnostic yield was 67.8% (range: 61.9%-70.7%; 55.2% Europe, 69.8% United States). Sensitivity for malignancy was 62.6%. Lung cancer clinical stage was I to II in 64.7% (55.3% Europe, 65.8% United States).

CONCLUSIONS: Despite a heterogeneous cohort and regional differences in procedural techniques, ENB demonstrates low complications and a 67.8% diagnostic yield while allowing biopsy, staging, fiducial placement, and dye marking in a single procedure.

Original language	English
Journal	Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
Volume	17
Issue number	4
Pages (from-to)	519-531
Number of pages	13
ISSN	1556-0864
DOIs	https://doi.org/10.1016/j.jtho.2021.12.008
Publication status	Published - Apr 2022

Keywords

Electromagnetic navigation bronchoscopy
Image-guided biopsy
Interventional pulmonology
Lung cancer
Lung cancer diagnosis

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10.1016/j.jtho.2021.12.008

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Folch, E. E., Bowling, M. R., Pritchett, M. A., Murgu, S. D., Nead, M. A., Flandes, J., Krimsky, W. S., Mahajan, A. K., LeMense, G. P., Murillo, B. A., Bansal, S., Lau, K., Gildea, T. R., Christensen, M., Arenberg, D. A., Singh, J., Bhadra, K., Hogarth, D. K., Towe, C. W., ... NAVIGATE Study Investigators (2022). NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 17(4), 519-531. https://doi.org/10.1016/j.jtho.2021.12.008

NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States. / Folch, Erik E; Bowling, Mark R; Pritchett, Michael A et al.
In: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, Vol. 17, No. 4, 04.2022, p. 519-531.

Research output: Contribution to journal › Journal article › Research › peer-review

Folch, EE, Bowling, MR, Pritchett, MA, Murgu, SD, Nead, MA, Flandes, J, Krimsky, WS, Mahajan, AK, LeMense, GP, Murillo, BA, Bansal, S, Lau, K, Gildea, TR, Christensen, M, Arenberg, DA, Singh, J, Bhadra, K, Hogarth, DK, Towe, CW, Lamprecht, B, Bezzi, M, Mattingley, JS, Hood, KL, Lin, H, Wolvers, JJ, Khandhar, SJ & NAVIGATE Study Investigators 2022, 'NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States', Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, vol. 17, no. 4, pp. 519-531. https://doi.org/10.1016/j.jtho.2021.12.008

Folch EE, Bowling MR, Pritchett MA, Murgu SD, Nead MA, Flandes J et al. NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2022 Apr;17(4):519-531. doi: 10.1016/j.jtho.2021.12.008

@article{a6bd7d11227148928cb8dc510585d29a,

title = "NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States",

abstract = "INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive, image-guided approach to access lung lesions for biopsy or localization for treatment. However, no studies have reported prospective 24-month follow-up from a large, multinational, generalizable cohort. This study evaluated ENB safety, diagnostic yield, and usage patterns in an unrestricted, real-world observational design.METHODS: The NAVIGATE single-arm, pragmatic cohort study (NCT02410837) enrolled subjects at 37 academic and community sites in seven countries with prospective 24-month follow-up. Subjects underwent ENB using the superDimension navigation system versions 6.3 to 7.1. The prespecified primary end point was procedure-related pneumothorax requiring intervention or hospitalization.RESULTS: A total of 1388 subjects were enrolled for lung lesion biopsy (1329; 95.7\%), fiducial marker placement (272; 19.6\%), dye marking (23; 1.7\%), or lymph node biopsy (36; 2.6\%). Concurrent endobronchial ultrasound-guided staging occurred in 456 subjects. General anesthesia (78.2\% overall, 56.6\% Europe, 81.4\% United States), radial endobronchial ultrasound (50.6\%, 4.0\%, 57.4\%), fluoroscopy (85.0\%, 41.7\%, 91.0\%), and rapid on-site evaluation use (61.7\%, 17.3\%, 68.5\%) differed between regions. Pneumothorax and bronchopulmonary hemorrhage occurred in 4.7\% and 2.7\% of subjects, respectively (3.2\% [primary end point] and 1.7\% requiring intervention or hospitalization). Respiratory failure occurred in 0.6\%. The diagnostic yield was 67.8\% (range: 61.9\%-70.7\%; 55.2\% Europe, 69.8\% United States). Sensitivity for malignancy was 62.6\%. Lung cancer clinical stage was I to II in 64.7\% (55.3\% Europe, 65.8\% United States).CONCLUSIONS: Despite a heterogeneous cohort and regional differences in procedural techniques, ENB demonstrates low complications and a 67.8\% diagnostic yield while allowing biopsy, staging, fiducial placement, and dye marking in a single procedure.",

keywords = "Electromagnetic navigation bronchoscopy, Image-guided biopsy, Interventional pulmonology, Lung cancer, Lung cancer diagnosis",

author = "Folch, \{Erik E\} and Bowling, \{Mark R\} and Pritchett, \{Michael A\} and Murgu, \{Septimiu D\} and Nead, \{Michael A\} and Javier Flandes and Krimsky, \{William S\} and Mahajan, \{Amit K\} and LeMense, \{Gregory P\} and Murillo, \{Boris A\} and Sandeep Bansal and Kelvin Lau and Gildea, \{Thomas R\} and Merete Christensen and Arenberg, \{Douglas A\} and Jaspal Singh and Krish Bhadra and Hogarth, \{D Kyle\} and Towe, \{Christopher W\} and Bernd Lamprecht and Michela Bezzi and Mattingley, \{Jennifer S\} and Hood, \{Kristin L\} and Haiying Lin and Wolvers, \{Jennifer J\} and Khandhar, \{Sandeep J\} and \{NAVIGATE Study Investigators\}",

note = "Copyright {\textcopyright} 2021. Published by Elsevier Inc.",

year = "2022",

month = apr,

doi = "10.1016/j.jtho.2021.12.008",

language = "English",

volume = "17",

pages = "519--531",

journal = "Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer",

issn = "1556-0864",

publisher = "Elsevier Inc.",

number = "4",

}

TY - JOUR

T1 - NAVIGATE 24-Month Results

T2 - Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States

AU - Folch, Erik E

AU - Bowling, Mark R

AU - Pritchett, Michael A

AU - Murgu, Septimiu D

AU - Nead, Michael A

AU - Flandes, Javier

AU - Krimsky, William S

AU - Mahajan, Amit K

AU - LeMense, Gregory P

AU - Murillo, Boris A

AU - Bansal, Sandeep

AU - Lau, Kelvin

AU - Gildea, Thomas R

AU - Christensen, Merete

AU - Arenberg, Douglas A

AU - Singh, Jaspal

AU - Bhadra, Krish

AU - Hogarth, D Kyle

AU - Towe, Christopher W

AU - Lamprecht, Bernd

AU - Bezzi, Michela

AU - Mattingley, Jennifer S

AU - Hood, Kristin L

AU - Lin, Haiying

AU - Wolvers, Jennifer J

AU - Khandhar, Sandeep J

AU - NAVIGATE Study Investigators

PY - 2022/4

Y1 - 2022/4

N2 - INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive, image-guided approach to access lung lesions for biopsy or localization for treatment. However, no studies have reported prospective 24-month follow-up from a large, multinational, generalizable cohort. This study evaluated ENB safety, diagnostic yield, and usage patterns in an unrestricted, real-world observational design.METHODS: The NAVIGATE single-arm, pragmatic cohort study (NCT02410837) enrolled subjects at 37 academic and community sites in seven countries with prospective 24-month follow-up. Subjects underwent ENB using the superDimension navigation system versions 6.3 to 7.1. The prespecified primary end point was procedure-related pneumothorax requiring intervention or hospitalization.RESULTS: A total of 1388 subjects were enrolled for lung lesion biopsy (1329; 95.7%), fiducial marker placement (272; 19.6%), dye marking (23; 1.7%), or lymph node biopsy (36; 2.6%). Concurrent endobronchial ultrasound-guided staging occurred in 456 subjects. General anesthesia (78.2% overall, 56.6% Europe, 81.4% United States), radial endobronchial ultrasound (50.6%, 4.0%, 57.4%), fluoroscopy (85.0%, 41.7%, 91.0%), and rapid on-site evaluation use (61.7%, 17.3%, 68.5%) differed between regions. Pneumothorax and bronchopulmonary hemorrhage occurred in 4.7% and 2.7% of subjects, respectively (3.2% [primary end point] and 1.7% requiring intervention or hospitalization). Respiratory failure occurred in 0.6%. The diagnostic yield was 67.8% (range: 61.9%-70.7%; 55.2% Europe, 69.8% United States). Sensitivity for malignancy was 62.6%. Lung cancer clinical stage was I to II in 64.7% (55.3% Europe, 65.8% United States).CONCLUSIONS: Despite a heterogeneous cohort and regional differences in procedural techniques, ENB demonstrates low complications and a 67.8% diagnostic yield while allowing biopsy, staging, fiducial placement, and dye marking in a single procedure.

AB - INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive, image-guided approach to access lung lesions for biopsy or localization for treatment. However, no studies have reported prospective 24-month follow-up from a large, multinational, generalizable cohort. This study evaluated ENB safety, diagnostic yield, and usage patterns in an unrestricted, real-world observational design.METHODS: The NAVIGATE single-arm, pragmatic cohort study (NCT02410837) enrolled subjects at 37 academic and community sites in seven countries with prospective 24-month follow-up. Subjects underwent ENB using the superDimension navigation system versions 6.3 to 7.1. The prespecified primary end point was procedure-related pneumothorax requiring intervention or hospitalization.RESULTS: A total of 1388 subjects were enrolled for lung lesion biopsy (1329; 95.7%), fiducial marker placement (272; 19.6%), dye marking (23; 1.7%), or lymph node biopsy (36; 2.6%). Concurrent endobronchial ultrasound-guided staging occurred in 456 subjects. General anesthesia (78.2% overall, 56.6% Europe, 81.4% United States), radial endobronchial ultrasound (50.6%, 4.0%, 57.4%), fluoroscopy (85.0%, 41.7%, 91.0%), and rapid on-site evaluation use (61.7%, 17.3%, 68.5%) differed between regions. Pneumothorax and bronchopulmonary hemorrhage occurred in 4.7% and 2.7% of subjects, respectively (3.2% [primary end point] and 1.7% requiring intervention or hospitalization). Respiratory failure occurred in 0.6%. The diagnostic yield was 67.8% (range: 61.9%-70.7%; 55.2% Europe, 69.8% United States). Sensitivity for malignancy was 62.6%. Lung cancer clinical stage was I to II in 64.7% (55.3% Europe, 65.8% United States).CONCLUSIONS: Despite a heterogeneous cohort and regional differences in procedural techniques, ENB demonstrates low complications and a 67.8% diagnostic yield while allowing biopsy, staging, fiducial placement, and dye marking in a single procedure.

KW - Electromagnetic navigation bronchoscopy

KW - Image-guided biopsy

KW - Interventional pulmonology

KW - Lung cancer

KW - Lung cancer diagnosis

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U2 - 10.1016/j.jtho.2021.12.008

DO - 10.1016/j.jtho.2021.12.008

M3 - Journal article

C2 - 34973418

SN - 1556-0864

VL - 17

SP - 519

EP - 531

JO - Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

JF - Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

IS - 4

ER -

NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States

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