First European Results of Shape-Sensing Robotic-assisted bronchoscopy

Background and Objectives: Shape-Sensing robotic-assisted bronchoscopy (ssRAB) was shown to be superior in diagnosing peripheral pulmonary nodules (PPN) compared to conventional bronchoscopy. Although RAB is established in the U.S. since 2019, no European data describing the use in health care systems are published yet. Methods: The first prospective European single-center study assessed the diagnosis of PPN with ssRAB, using the ION™ Endoluminal system. Patients with suspected lung cancer or metastasis, PPN of 1-3cm and ≥3 airway generations out, were included in this study and followed for up to 6 months. The primary outcome was rate of tool-in-lesion (TIL), confirmed by mobile cone-beam computed tomography (mCBCT) or with malignant index biopsy finding. Secondary outcomes included procedural characteristics, diagnostic yield, and adverse events. Results: A total of 43 patients with a mean nodule size of 19.2x16.9x15.8 mm, a mean distance of 17.4 ± 15.5 mm to the pleura, and mean 6.6th generation of airway was analyzed in this study. TIL was achieved in 90.7% of all cases. Strict diagnostic yield was 67.4% and sensitivity for malignancy was 78.6%. No pneumothorax, and no adverse events were reported outside of 3 cases of Nashville ≤2 bleeding. Predictors for successful diagnosis were inner or middle third location (OR 4.19, p=0.039), CT bronchus sign (OR 4, p=0.044), and distance from pleural wall (OR 1.05, p=0.048). Lower lobe location (OR: 0.06, p<.001) was associated with non-diagnostic cases. Conclusion: The first European cases show ssRAB is a safe procedure with promising results for enabling diagnosis of PPN.