Efficacy and safety of virtual bronchoscopic navigation with fused fluoroscopy and vessel mapping for access of pulmonary lesions

Background and objective: Virtual bronchoscopic navigation (VBN) with fused fluoroscopy and vessel mapping provides a point of entry (POE) for puncturing airway wall to biopsy lesions. The study was designed to evaluate the safety and efficacy of this technology to diagnose peripheral pulmonary lesions. Methods: It was a prospective, single-arm, multicentre study. Patients underwent lesions biopsy with the Archimedes® VBN System via a POE using one of the two techniques: (1) bronchoscopic transparenchymal nodule access (BTPNA) and (2) guided transbronchial needle aspiration (TBNA). Biopsy yield, sampling yield and diagnostic yield were mainly determined in lesions biopsy attempted. Results: One hundred and thirty patients underwent anaesthesia and constituted the intention-to-treat population. One hundred and four patients with 114 lesions had biopsy attempted. Mean lesion size was 2.4 ± 1.13 cm. Sufficient tissue samples were obtained from 86 lesions with a biopsy yield of 75.4%. Nevertheless, sufficient samples for diagnosis based on histology ± cytology were obtained from 107 lesions with a sampling yield of 93.9%. Follow-up was conducted for more than 1 year, with a diagnostic yield of 75.4% and 72.8%, respectively, on high and low estimate with consideration of three lesions without follow-up. Two (1.9%) pneumothoraxes and one (1.0%) mild bleeding occurred. Conclusion: BTPNA and guided TBNA contribute to safe and effective sampling of peripheral pulmonary lesions. A relatively high biopsy yield was obtained independent of the presence or absence of a bronchus sign (BS), and high sampling yield and diagnostic yield were obtained independent of location, lesion size and presence or absence of a BS.