Medtronic. Dr. Nead has received personal fees from Medtronic. Dr. Bowling has received personal fees from Medtronic. Dr. Murgu has received personal fees from Medtronic, Boston Scientific, Pinnacle Biologics, Olympus, Cook, Auris Robotics, and Elsevier; and has stock ownership in Concordia, Boston Scientific, and Merck. Dr. Krimsky has received personal fees from Medtronic, Innovital Systems, Gala Therapeutic, SOC, and Peytant; has stock ownership with Innovital Systems and CSA Medical; and has patents pending with Medtronic and Merit. Dr. Murillo has received support from Medtronic. Dr. LeMense has received personal fees from Medtronic. Dr. Minnich has received personal fees from Medtronic. Dr. Bansal has received personal fees from Medtronic, Pinnacle Biologics, Sunovion, and Veran Medical. Dr. Ellis has received support from Medtronic. Dr. Mahajan has received personal fees from Medtronic. Dr. Gildea has received personal fees from Medtronic. Dr. Bechara has received support from Medtronic. Dr. Sztejman has received support from Medtronic. Dr. Flandes has received grants from BTG-PneumRx and Ambu; and personal fees from Medtronic, BTG-PneumRx, Olympus, Ambu, PulmonX, and Boston Scientific. Dr. Rickman has received personal fees from Medtronic, Veran Medical, BD, Olympus, and Abbvie. Dr. Benzaquen has received support from Medtronic. Dr. Hogarth has received personal fees from Medtronic, Auris Surgical Robotics, Boston Scientific, Grifols, Shire, and CSL; and has stock ownership with Auris Surgical Robotics. Dr. Linden has received support from Medtronic. Dr. Wahidi has received personal fees from Medtronic and Veran Medical. Dr. Mattingley has received personal fees from Medtronic and is current employee of Medtronic (employment began after completion of enrollment). Dr. Hood is an employee with stock ownership at Medtronic; and has stock ownership with Boston Scientific. Ms. Lin and Ms. Wolvers are employees with stock ownership at Medtronic. Dr. Khandar has received personal fees from Medtronic.

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Guided bronchoscopy offers a minimally invasive and safe method for accessing indeterminate pulmonary nodules. However, all current guided bronchoscopy systems rely on a preprocedural computed tomography (CT) scan to create a virtual map of the patient's airways. Changes in lung anatomy between the preprocedural CT scan and the bronchoscopy procedure can lead to a divergence between the expected and actual location of the target lesion. Termed "CT-to-body divergence", this effect reduces diagnostic yield, adds time to the procedure, and can be challenging for the operator. The objective of this paper is to describe the concept of CT-to-body divergence, its contributing factors, and methods and technologies that might minimize its deleterious effects on diagnostic yield.

BackgroundElectromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions.MethodsNAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing.ResultsENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively.ConclusionsOne-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield.Trial registrationClinicalTrials.gov NCT02410837. Registered 31 March 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12890-017-0403-9) contains supplementary material, which is available to authorized users.