Chest
Volume 129, Issue 4, April 2006, Pages 988-994
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Original Research
Real-Time Electromagnetic Navigation Bronchoscopy to Peripheral Lung Lesions Using Overlaid CT Images: The First Human Study

https://doi.org/10.1378/chest.129.4.988Get rights and content

Study objectives

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.

Design

Open-label, prospective, controlled clinical study.

Setting

Pulmonary institute of a university-affiliated municipal hospital.

Patients

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

Interventions

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.

Measurements and 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.

Section snippets

Materials and Methods

Fifteen subjects (7 men and 8 women; age range, 26 to 81 years) were originally enrolled into an open-label, prospective, single-group, controlled clinical study from June 2003 to May 2004. The study was approved by the Tel Aviv Sourasky Medical Center Helsinki Committee, and informed consent was obtained from all the subjects prior to bronchoscopy. Bronchoscopy was performed on an outpatient basis under conscious sedation with midazolam or propofol. Patient selection was based on

Results

The SDBS navigation procedure was performed in 13 of the 15 originally enrolled subjects. One subject was dropped after severe bronchoconstriction developed as a result of propofol sedation, and the other subject was dropped for poor virtual bronchoscopy findings due to excessive mucopurulent secretions in the bronchial airways. Data from both subjects were excluded from the analyses.

The size of lesions was from 1.5 to 5 cm (average, 3.35 ± 1.1 cm) [Table 1]. The location of the lesions was as

Discussion

In the present study, we were able to show a high diagnostic yield using SDBS navigation for diagnosing peripheral pulmonary lesions. The diagnostic sensitivity of this procedure was as high as 69% in peripheral pulmonary lesions beyond the optical reach of the bronchoscope compared to the diagnostic sensitivity of flexible fiberoptic bronchoscopy (FFB) for small peripheral pulmonary lesions under radiographic fluoroscopic guidance, which has been < 35% in our institute. Moreover, the

References (35)

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Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).

Grant support was provided by superDimension, Ltd, Hertzliya, Israel.

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