First 50 Cases with the ION Robotic-Assisted Navigational Bronchoscopy System in Routine Clinical Use in Germany: The...

Background: The diagnostic work-up of small peripheral pulmonary nodules (PPNs) is becoming increasingly important, especially in light of the upcoming lung cancer screening programs and recommendations in practice. The systematic clinical introduction of the ION robotic-assisted navigational bronchoscopy (RNB) system represents a significant innovation in Germany, whereas clinical experience in the United States has already yielded promising results. The objective of this study is to present the outcomes of the first 50 patients examined with the ION system at our institutions. Materials and Methods: This is a retrospective, single-center analysis. We included the first 50 consecutive patients who underwent diagnostic evaluation of pulmonary nodules using the ION-RNB system, either in the Department of Thoracic Surgery or the Department of Pulmonology. Results: A total of 50 patients were evaluated, including 24 from the Department of Thoracic Surgery and 26 from the Department of Pulmonology. The pulmonary nodules were found in the peripheral third of the lung in 74% of cases, in the middle third in 18% of cases, and in the central third in 8% of cases. The mean lesion size was 1.64 cm (±0.91 cm). In all, 84% of the nodules were solid, 4% were subsolid, and 12% presented as ground-glass opacities (GGOs). Cone beam computed tomography (CBCT) was used to confirm tool-in-lesion position in 68% of cases compared to C-arm fluoroscopy in 32%. Additionally, radial endobronchial ultrasound (rEBUS) was applied in 30% of procedures. The overall diagnostic yield, independent of imaging modality or histological processing method, was 78%. When CBCT and formalin-fixed paraffin-embedded (FFPE) histological analysis were utilized, the diagnostic yield exceeded 90%. Conclusions: Initial clinical experience with the ION-RNB system in Germany shows encouraging results. The high diagnostic accuracy underlines the system's potential for evaluating peripheral pulmonary lesions precisely. The use of advanced imaging techniques, particularly CBCT, and the choice of histopathological processing methods are critical variables in optimizing patient-centered diagnostic pathways. Further prospective studies are warranted to assess the long-term clinical utility of robotic-assisted bronchoscopy in diverse clinical settings.