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Folch, Erik E.; Bowling, Mark R.; Pritchett, Michael A.; Murgu, Septimiu D.; Nead, Michael A.; Flandes, Javier; Krimsky, William S.; Mahajan, Amit K.; LeMense, Gregory P.; Murillo, Boris A.; Bansal, Sandeep; Lau, Kelvin; Gildea, Thomas R.; Christensen, Merete; Arenberg, Douglas A.; Singh, Jaspal; Bhadra, Krish; Hogarth, D. Kyle; Towe, Christopher W.; Lamprecht, Bernd; Bezzi, Michela; Mattingley, Jennifer S.; Hood, Kristin L.; Lin, Haiying; Wolvers, Jennifer J.; Khandhar, Sandeep J.
Journal of thoracic oncology, April 2022, 2022-04-00, 20220401, Letnik: 17, Številka: 4Journal Article
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. 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. 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). 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.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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