First European Experience of Shape-Sensing Robotic-assisted bronchoscopy: Learning Curve Analysis

<bold>Background:</bold> Shape-sensing robotic-assisted bronchoscopy (SSRAB) is an emerging approach in Europe for sampling peripheral lung nodules. With new technology, learning curves should be understood along with early results. <bold>Aims and Objectives:</bold> This analysis reports learning curves in the first cases of SSRAB combined with cone-beam computed tomography (CBCT) from two experienced interventional pulmonologists. <bold>Methods:</bold> A retrospective analysis of prospective data from a single centre was conducted. 45 subjects were enrolled with 6-month follow-up currently ongoing. Tool-in-lesion (TIL) was confirmed with CBCT or diagnostic sampling. A cumulative sum (CUSUM) quantified learning curves for procedure duration and diagnostic procedure (failure rates set at 0.25 and 0.5). <bold>Results:</bold> Biopsies were attempted in 40 subjects with a median (IQR) nodule size of 20 (17.5,24.5) mm. TIL rate was 97.5%. Procedure time improved for Investigator 1 (I1) after case 5 with a significantly decreased duration before and after case 5 (70 ± 33 vs 25 ± 8 min, p=0.037); procedure time for Investigator 2 (I2) improved after case 7 with a 22 min decrease between phases (p=ns). Both investigators were immediately capable in achieving TIL. CUSUM for diagnostic procedures showed capability immediately with proficiency demonstrated at case 8 (I1) and 11 (I2). No study related serious adverse events or pneumothorax occurred. <bold>Conclusion:</bold> Learning curves for SSRAB demonstrate capability is achieved with a low number of cases with a strong safety profile.