Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study
Authors: Erik E. Folch, Michael A. Pritchett, Michael A. Nead, Mark R. Bowling, Septimiu D. Murgu, William S. Krimsky, Boris A. Murillo, Gregory P. LeMense, Douglas J. Minnich, Sandeep Bansal, Blesilda Q. Ellis, Amit K. Mahajan, Thomas R. Gildea, Rabih I. Bechara, Eric Sztejman, Javier Flandes, Otis B. Rickman, Sadia Benzaquen, D. Kyle Hogarth, Philip A. Linden, Momen M. Wahidi, Jennifer S. Mattingley, Kristin L. Hood, Haiying Lin, Jennifer J. Wolvers, Sandeep J. Khandhar, Carlos Anciano, Alejandro Aragaki, Douglas Arenberg, Omar Awais, Ricardo Balestra, Sandeep Bansal, Emanuela Barisione, Rabih Bechara, Sadia Benzaquen, Michela Bezzi, Krishnendu Bhadra, Julio Bird, Alessandro Blanco, Mark Bowling, Robert Cerfolio, Merete Christensen, Joseph Cicenia, Antony Courey, John Doty, Kevin Eggleston, Blesilda Ellis, Iker Fernandez, Javier Flandes, Erik Folch, Alexandre Furman, George David Gass, Thomas Gildea, Anil Gogineni, Musija Fikreta Grabcanovic, John David Hinze, David Kyle Hogarth, Raj Karunakara, Jordan Kazakov, Sandeep Khandhar, Sandhya Khurana, William Krimsky, Ganesh Krishna, Roman Krol, Roland Kropfmüller, Bernd Lamprecht, Kelvin Lau, Andrew Lee, Gregory LeMense, Philip Linden, Peter Lutz, Amit Mahajan, Kamran Mahmood, Fabien Maldonado, Rafael Martinez, Jennifer Mattingley, Douglas Minnich, Septimiu Murgu, Boris Murillo, Katie Nason, Michael Nead, Christopher Parks, Kenneth Perret, Peter Porsch, Michael Pritchett, Otis Rickman, Maydee Rosario, Mario Salio, Saiyad Sarkar, Andrew Seevaratnam, Sonali Sethi, Jaspal Singh, Michael Studnicka, Eric Sztejman, Tamejiro Takubo, Catalina Teba, Christopher Towe, Marco Trigiani, JeanRichel Vergnon, Niels-Erik Viby, Momen Wahidi, Ernest Waller, Benjamin Wei, Dragos Zanchi, Michael Zgoda
Journal: Journal of Thoracic Oncology (2018)

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.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.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.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.