Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study.

Autor:	Folch EE; Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: efolch@mgh.harvard.edu., Pritchett MA; Pulmonary Department, Pinehurst Medical Clinic and FirstHealth Moore Regional Hospital, Pinehurst, North Carolina., Nead MA; University of Rochester Medical Center, Rochester New York., Bowling MR; Department of Internal Medicine, Division of Pulmonary Critical Care and Sleep Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina., Murgu SD; Interventional Pulmonology Program, The University of Chicago Medicine, Chicago, Illinois., Krimsky WS; Pulmonary and Critical Care Associates of Baltimore, Baltimore, Maryland., Murillo BA; Providence Health Center and Waco Lung Associates, Waco, Texas., LeMense GP; Blount Memorial Physicians Group, Alcoa, Tennessee., Minnich DJ; Division of Cardiothoracic Surgery, University of Alabama at Birmingham, Birmingham, Alabama; Princeton Baptist Medical Center, Birmingham, Alabama., Bansal S; Penn Highlands Healthcare, DuBois, Pennsylvania., Ellis BQ; Pulmonary Associates of Mobile PC, Mobile, Alabama., Mahajan AK; Inova Health System, Falls Church, Virginia., Gildea TR; Department of Pulmonary, Allergy, and Critical Care Medicine and Transplant Center, Cleveland Clinic, Cleveland, Ohio., Bechara RI; Morehouse School of Medicine, and Cancer Treatment Centers of America, Newnan, Georgia., Sztejman E; Virtua Pulmonary Group, Marlton, New Jersey., Flandes J; Pulmonary Department, IIS-Fundacion Jimenez Diaz University Hospital, CIBERES, Madrid, Spain., Rickman OB; Department of Medicine and Thoracic Surgery, Vanderbilt University Medical Center, Ingram Cancer Center, Nashville, Tennessee., Benzaquen S; University of Cincinnati Physicians Company LLC, Cincinnati, Ohio., Hogarth DK; The University of Chicago Medicine, Chicago, Illinois., Linden PA; Divisions of Thoracic and Esophageal Surgery, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve School of Medicine, Cleveland, Ohio., Wahidi MM; Department of Medicine, Duke University Medical Center, Durham, North Carolina., Mattingley JS; Gundersen Health System, La Crosse, Wisconsin; Medtronic, Minneapolis, Minnesota., Hood KL; Medtronic, Minneapolis, Minnesota., Lin H; Medtronic, Minneapolis, Minnesota., Wolvers JJ; Medtronic, Minneapolis, Minnesota., Khandhar SJ; Inova Health System, Falls Church, Virginia.
Jazyk:	angličtina
Zdroj:	Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer [J Thorac Oncol] 2019 Mar; Vol. 14 (3), pp. 445-458. Date of Electronic Publication: 2018 Nov 23.
DOI:	10.1016/j.jtho.2018.11.013
Abstrakt:	Introduction: 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. Methods: 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. Results: 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. Conclusions: 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. (Copyright © 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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