Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study.
OBJECTIVE
To characterize the feasibility, accuracy, and safety of the superDimension/Bronchus system (SDBS) [superDimension, Ltd; Hertzliya, Israel] in navigating to previously unreachable peripheral lung lesions and obtaining biopsy specimens.


METHODS
Open-label, prospective, controlled clinical study.


METHODS
Pulmonary institute of a university-affiliated municipal hospital.


METHODS
Thirteen adult candidates for nonemergency bronchoscopy who gave informed consent to participate.


METHODS
The patients underwent flexible bronchoscopy using the SDBS, which is based on real-time CT-guided electromagnetic navigation and is capable of reaching peripheral lung masses beyond the reach of the bronchoscope. A position sensor was used to navigate to and sample the various target lesions for biopsy.


RESULTS
Three-dimensional chest CT was followed by SDBS methodology for marking anatomic landmarks and the target lesion on a virtual bronchoscopy screen and for sampling the lesion. The SDBS assisted in obtaining positive biopsy diagnoses in 9 of 13 cases (69%), with an average navigation accuracy of 5.7 mm. There were no SDBS-related adverse events.


CONCLUSIONS
The SDBS is safe and effective in navigating to peripheral lung lesions located beyond the optic limits of a standard flexible bronchoscope.
Schwarz
Yehuda
Y
Pulmonary Institute, Tel Aviv Sourasky Medical Center, Weizman Stt 6, Tel Aviv 64239, Israel. Schwarz@tasmc.health.gov.il
Greif
Joel
J
Becker
Heinrich D
HD
Ernst
Armin
A
Mehta
Atul
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001980:Bronchi / Q000473:pathology; D001999:Bronchoscopy; D055590:Electromagnetic Phenomena / Q000295:instrumentation*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D021621:Imaging, Three-Dimensional; D008171:Lung Diseases / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015203:Reproducibility of Results; D025321:Surgery, Computer-Assisted / Q000295:instrumentation*; D014057:Tomography, X-Ray Computed