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

BMC Pulmonary Medicine

Research Article

Momen M. Wahidi¹  Thomas R. Gildea²  Eric M. Toloza³  Douglas J. Minnich⁴  Erik E. Folch⁵  Mark R. Bowling⁶  Sandeep J. Khandhar⁷  Septimiu D. Murgu⁸  Kristin L. Hood⁹  Jennifer J. Wolvers⁹  Javier Flandes^1,10  Michael Pritchett^1,11  William S. Krimsky^1,12 

[1] Department of Medicine, Duke University Medical Center, Durham, NC, USA;Department of Pulmonary, Allergy, and Critical Care Medicine and Transplant Center, Cleveland Clinic, Cleveland, OH, USA;Department of Thoracic Oncology, Moffitt Cancer Center, Tampa, FL, USA;Department of Surgery and Department of Oncologic Sciences, University of South Florida Morsani College of Medicine, Tampa, FL, USA;Division of Cardiothoracic Surgery, University of Alabama at Birmingham, Birmingham, AL, USA;Present Address: Princeton Baptist Medical Center, Birmingham, AL, USA;Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Bulfinch 148, 02114, Boston, MA, USA;East Carolina University, Greenville, NC, USA;Inova Health System, Fairfax Hospital, Falls Church, VA, USA;Interventional Pulmonology Fellowship Program, The University of Chicago Medicine, Chicago, IL, USA;Medtronic, Minneapolis, MN, USA;Pulmonary Department, IIS-Fundacion Jimenez Diaz University Hospital, CIBERES, Madrid, Spain;Pulmonary Department, Pinehurst Medical Clinic and FirstHealth Moore Regional Hospital, Pinehurst, NC, USA;Pulmonary and Critical Care Associates of Baltimore, Baltimore, MD, USA;

关键词: Image-Guided Biopsy;    Lung Cancer;    Lung Neoplasms;    Neoplasm Staging;    Solitary Pulmonary Nodule;   

DOI  :  10.1186/s12890-017-0403-9

 received in 2017-01-25, accepted in 2017-03-28,  发布年份 2017

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s). 2017