Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study

Abstract

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.

Pleural dye marking of lung nodules by electromagnetic navigation bronchoscopy

“…This is especially interesting given that in the overall NAVIGATE study, 63.6% were of a limited stage, 62.6% were located in the peripheral third of the lung and 6.3% were classified as ground glass . Of the 232 biopsy subjects with Stages I‐II lung cancer in first interim analysis of NAVIGATE there were 87 who had a surgical procedure and of those, 65 (75%) had no prior ENB‐guided dye or fiducial marking. There have been 15 clinical studies (excluding single‐patient case reports) concerning ENB‐guided dye localization and only three have enrolled over 50 patients .…”

“…NAVIGATE (http://www.clinicaltrials.gov, NCT02410837) is a prospective, multicentre, global, and single‐arm cohort study evaluating ENB procedures . All ENB procedures used the superDimension navigation system version 6.0 or higher (Medtronic, Minneapolis, MN).…”

Competence in navigation and guided transbronchial biopsy for peripheral pulmonary lesions

“…43 In the largest study published to date, approximately 80% of the patients underwent the procedure under general anesthesia. 31 No head-to-head comparison of safety and yield of EBN performed under moderate or deep sedation is available in the literature. Only two studies tried to evaluate the influence of general anesthesia on the procedure, but the statistical power was not enough to allow for definitive conclusions to be drawn.…”

Lung Nodule Management: An Interventional Pulmonology Perspective

“…An interim analysis of the ongoing multicenter NAVIGATE study reported navigational success in 94.4% of the cases. 38 Unfortunately, factors like respiratory motion, 39 CT-to-body divergence, and suboptimal diagnostic tools are major factors serving as challenges to attaining high diagnostic yields. EMN trials have demonstrated a higher yield in upper and middle lobe lesions, larger target size, lower average fiducial target registration error, a bronchus sign, use of r-EBUS, and sampling using suctioning.…”