Prospective Analysis of a Novel Endobronchial Augmented Fluoroscopic Navigation System for Diagnosis of Peripheral Pulmonary Lesions

BACKGROUND: Navigational bronchoscopy has improved upon traditional bronchoscopy to identify suspicious pulmonary lesions, but wide variability exists in the diagnostic yield of various modalities. The aim of this study was to measure localization accuracy and diagnostic yield of a novel endobronchial augmented fluoroscopic navigation system (first-generation LungVision system) for peripheral pulmonary lesions (PPLs). METHODS: This prospective single-center study included adults undergoing guided bronchoscopy to evaluate PPLs. Preprocedure computed tomography (CT) images were obtained, and planning software calculated a pathway to the lesion. A flexible bronchoscope was used to navigate along the pathway overlaid on the intraprocedural fluoroscopic image. When real-time display indicated the catheter tip had reached the lesion, cone-beam computed tomography (CBCT) was used to measure the actual location of the tip. Biopsy and rapid on-site cytopathologic evaluation were performed. RESULTS: Fifty-one patients were included in the analysis. The median lesion diameter was 18.0 mm (range: 7.0 to 48.0 mm). Localization success was 96.1%. The average distance between lesion location as shown by LungVision augmented fluoroscopy and actual location measured by CBCT was 5.9 mm (range: 2.1 to 10.0 mm). Diagnostic yield at the index procedure was 78.4%. Diagnostic accuracy assessed at 12 months follow-up was 88.2%. Average CT-to-body divergence was 14.5 mm (range: 2.6 to 33.0 mm) from preprocedure CT to intraprocedural CBCT images. CONCLUSION: Augmented fluoroscopy for navigation and biopsy of PPLs with the LungVision system showed a high localization success rate and corresponding high diagnostic yield. Navigation and biopsy with real-time visualization can improve diagnostic yield for PPLs.