Shape-sensing robotic-assisted bronchoscopy for pulmonary nodules: initial multicenter experience using the Ion™ Endoluminal System

Abstract

Background Traditional bronchoscopy provides limited approach to peripheral nodules. Shape-sensing robotic-assisted bronchoscopy (SSRAB, Ion™ Endoluminal System) is a new tool for minimally invasive peripheral nodule biopsy. We sought to answer the research question: Does SSRAB facilitate sampling of pulmonary nodules during bronchoscopists’ initial experience? Methods The lead-in stage of a multicenter, single-arm, prospective evaluation of the Ion Endoluminal System (PRECIsE) is described. Enrolled subjects ≥ 18 years old had recent computed tomography evidence of one or more solid or semi-solid pulmonary nodules ≥ 1.0 to ≤ 3.5 cm in greatest dimension and in any part of the lung. Subjects were followed at 10- and 30-days post-procedure. This stage provided investigators and staff their first human experience with the SSRAB system; safety and procedure outcomes were analyzed descriptively. Neither diagnostic yield nor sensitivity for malignancy were assessed in this stage. Categorical variables are summarized by percentage; continuous variables are summarized by median/interquartile range (IQR). Results Sixty subjects were enrolled across 6 hospitals; 67 nodules were targeted for biopsy. Median axial, coronal and sagittal diameters were < 18 mm with a largest cardinal diameter of 20.0 mm. Most nodules were extraluminal and distance from the outer edge of the nodule to the pleura or nearest fissure was 4.0 mm (IQR: 0.0, 15.0). Median bronchial generation count to the target location was 7.0 (IQR: 6.0, 8.0). Procedure duration (catheter-in to catheter-out) was 66.5 min (IQR: 50.0, 85.5). Distance from the catheter tip to the closest edge of the virtual nodule was 7.0 mm (IQR: 2.0, 12.0). Biopsy completion was 97.0%. No pneumothorax or airway bleeding of any grade was reported. Conclusions Bronchoscopists leveraged the Ion SSRAB’s functionality to drive the catheter safely in close proximity of the virtual target and to obtain biopsies. This initial, multicenter experience is encouraging, suggesting that SSRAB may play a role in the management of pulmonary nodules. Clinical Trial Registration identifier and date NCT03893539; 28/03/2019.

Combining Shape-Sensing Robotic Bronchoscopy With Mobile Three-Dimensional Imaging to Verify Tool-in-Lesion and Overcome Divergence: A Pilot Study

“… 13 In a more recent publication reporting 67 nodules, no pneumothorax or airway bleeding of any grade was reported. 30 In a larger cohort, the safety profile was reproduced with a 3.3% pneumothorax rate. 31 …”

Lateral Decubitus Positioning for Mobile CT-guided Robotic Bronchoscopy

“…Of note, the median time from induction to the first mobile CT scan for tool-in-lesion confirmation was 52 minutes indicating that positioning the patient in lateral decubitus can be feasibly done within a reasonable time frame and is comparable to reported robotic bronchoscopy procedure times. 5 We chose to perform lateral decubitus positioning and not prone positioning assuming the former would be safer for the patient and easier for the staff in multiple obvious ways. A limitation of this technique would be the need to perform mediastinal staging before peripheral bronchoscopy since this would be slightly more challenging for bronchoscopists.…”

Contemporary Concise Review 2021: Pulmonary nodules from detection to intervention

“…In a recent human multicentre safety and feasibility study of robotic‐assisted R‐EBUS, including 54 patients with a median lesion size of 2.3 cm, lesion localization was successful in 96.2%, but with a substantially discrepant diagnostic yield of 74.1% 57 . Shape‐sensing technology is the most recent development in this field where a thin flexible fibre is embedded along the length of the navigation catheter and is capable of real‐time feedback of the shape and position of the catheter relative to the anatomy 58 . The first‐in‐human study of 30 patients with a mean lesion size of 1.2 cm reported a diagnostic yield for malignancy in 88% of cases 59 .…”