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J Thorac Oncol. 2018 Nov 23. pii: S1556-0864(18)33456-7. doi: 10.1016/j.jtho.2018.11.013. [Epub ahead of print]

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

Author information

1
Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Bulfinch 148, Boston, MA 02114. Electronic address: efolch@mgh.harvard.edu.
2
Pulmonary Department, Pinehurst Medical Clinic and FirstHealth Moore Regional Hospital, 205 Page Rd, Pinehurst, NC 28374.
3
University of Rochester Medical Center, 601 Elmwood Avenue, Box 692, Rochester NY 14642.
4
Department of Internal Medicine, Division of Pulmonary Critical Care and Sleep Medicine, Brody School of Medicine, East Carolina University, 500 Moye Blvd, Greenville, NC 27834.
5
Interventional Pulmonology Program, The University of Chicago Medicine, 5841 S. Maryland Avenue, Chicago, IL 60637.
6
Pulmonary and Critical Care Associates of Baltimore, 9103 Franklin Square Drive, Suite 300, Baltimore, MD 21237.
7
Providence Health Center and Waco Lung Associates, 340 Richland West Circle, Waco, TX 76657.
8
Blount Memorial Physicians Group, 266 Joule Street, Alcoa, TN 37701.
9
Division of Cardiothoracic Surgery, University of Alabama at Birmingham, 833 Princeton Avenue, POB III Suite 200-A, Birmingham, AL 35211.
10
Penn Highlands Healthcare, 100 Hospital Avenue, PO Box 447, DuBois, PA 15801.
11
Pulmonary Associates of Mobile PC, 1700 SpringHill Ave # 100, Mobile, AL 36604.
12
Inova Health System, 2921 Telestar Court, Suite 140, Falls Church, VA 22043.
13
Department of Pulmonary, Allergy, and Critical Care Medicine and Transplant Center, Cleveland Clinic, 9500 Euclid Avenue MC M2-141, Cleveland, OH 44195.
14
Morehouse School of Medicine, and Cancer Treatment Centers of America, 600 Celebrate Life Parkway, Newnan, GA 30265.
15
Virtua Pulmonary Group, 520A Lippincott Drive, Marlton, NJ 08053.
16
Pulmonary Department, IIS-Fundacion Jimenez Diaz University Hospital, CIBERES, Avda. Reyes Católicos, 2, 28040 Madrid, Spain.
17
Department of Medicine and Thoracic Surgery, Vanderbilt University Medical Center, Ingram Cancer Center, 1301 Medical Center Drive, B824 TVC Nashville, TN, 37232.
18
University of Cincinnati Physicians Company LLC, 222 Piedmont Ave, Cincinnati, OH 45219.
19
The University of Chicago Medicine, 5841 S. Maryland Avenue, Chicago, IL 60637.
20
Divisions of Thoracic and Esophageal Surgery, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve School of Medicine, 11100 Euclid Avenue, Cleveland, OH, 44106.
21
Department of Medicine, Duke University Medical Center, 20 Duke Medicine Cir, Durham, NC 27710.
22
Gundersen Health System, 1900 South Ave, La Crosse, WI 54601.
23
Medtronic, 710 Medtronic Parkway, Minneapolis, MN, 55432.

Abstract

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. In this United States cohort analysis, 1,215 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 1,157 subjects undergoing ENB-guided biopsy, 94% (1,092/1,157) 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% (484/1,092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69%, 100%, 100%, and 56%, respectively. ENB-related CTCAE Grade ≥2 pneumothoraces (requiring admission or chest tube placement) occurred in 2.9%. The ENB-related CTCAE Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.5% and 0.7%, respectively.

CONCLUSIONS:

NAVIGATE demonstrates 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.

KEYWORDS:

Bronchoscopy; Image-Guided Biopsy; Lung Cancer; Lung Neoplasms; Lung Nodules

PMID:
30476574
DOI:
10.1016/j.jtho.2018.11.013
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