SHAPE-SENSING ROBOTIC ASSISTED BRONCHOSCOPY FOR THE DIAGNOSIS OF PERIPHERAL PULMONARY LESIONS

Abstract

TOPIC: Lung Cancer TYPE: Original Investigations PURPOSE: To assess the real-world performance characteristics of a shape-sensing robotic platform for the diagnosis of peripheral pulmonary nodules. METHODS: This is a retrospective, single center, single operator cohort of consecutive cases performed utilizing shape-sensing robotic assisted bronchoscopy (SSRAB) with integrated 3.5mm robotic catheter (Ion Endoluminal System, Intuitive Surgical, Sunnyvale, CA). Cases were performed between January 2020 and April 2021. A specific anesthesia protocol was used in all patients to prevent atelectasis. Radial endobronchial ultrasound (rEBUS) was used in all cases. Cone-beam CT (CBCT, Philips Allura Xper FD20 with Lung Suite, Best, Netherlands) was used at the discretion of the physician. A procedure was considered diagnostic if there was a malignant or specific benign result. Biopsies with inflammation were considered indeterminate, followed with CT imaging and considered diagnostic if there was significant improvement or resolution of the lesion. Specimens noted to be “atypical” were considered non-diagnostic. RESULTS: A total of 230 lesions, biopsied in 192 consecutive patients were included (56% female). Multiple lesions were biopsied (maximum = 3) in a single procedure in 38 patients (20%). Bilateral lesions were biopsied in 13 patients (7%). Most lesions (64%) were in the upper lobes (n= 144, 40% RUL, 24% LUL). Median lesion size was 15mm (IQR: 10, 21). A bronchus sign was present in 38% of lesions. Lesions biopsied were solid (78%), semi-solid (12%), ground glass (7%) or cavitary (3%). Diagnostic yield was 92.2% for all lesions and 89.3% for lesions 10mm or less (n=56, smallest = 5mm). CBCT was used for 75% of lesions (n=174). Malignancy was noted in 74% (n=170) of lesions. A specific benign diagnosis was noted in 16% (n=37), and 8% (n=15) of lesions were non-diagnostic. There were 8 lesions where biopsy results were indeterminate. These patients underwent serial CT scans for follow-up: 5 lesions resolved, improved significantly or were stable for 12 months. Three lesions have follow-up pending and are considered non-diagnostic in this analysis. All indeterminate lesions had tool-in-lesion confirmation on intraprocedural CBCT scan. Sensitivity for malignancy ranges from 90.4% to 91.9% considering pending follow-up of 3 lesions. Pneumothorax was noted in 2 patients (1%), 1 of which required a chest tube (0.5%). There were no episodes of respiratory failure or significant bleeding that required intervention (including removal of the robotic catheter). CONCLUSIONS: This represents the largest cohort of patients to date using any robotic bronchoscopy technology and shows that SSRAB, when combined with CBCT and rEBUS, is safe with a high diagnostic yield. CLINICAL IMPLICATIONS: The use of SSRAB may increase the diagnostic yield for peripheral pulmonary nodules. Larger, prospective multicenter trials are forthcoming. DISCLOSURES: My spouse/partner as a Employee relationship with Medtronic Please note: >$100000 by Michael Pritchett, source=Web Response, value=Salary Consultant relationship with Medtronic Please note: $5001 - $20000 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with Johnson & Johnson Please note: $5001 - $20000 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with AstraZeneca Please note: $20001 - $100000 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with Intuitive Please note: $20001 - $100000 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with BodyVision Please note: $5001 - $20000 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with Boston Scientific Please note: $1001 - $5000 by Michael Pritchett, source=Web Response, value=Consulting fee Research relationship with Philips Please note: $5001 - $20000 by Michael Pritchett, source=Web Response, value=Grant/Research Support Consultant relationship with Biodesix Please note: $5001 - $20000 by Michael Pritchett, source=Web Response, value=Consulting fee Speaker relationship with Intuitive Please note: 2 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Speaking fees Consultant relationship with Medtronic Please note: 5 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with Intuitive Please note: 2 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Consulting fee Advisory Committee Member relationship with AstraZeneca Please note: 4 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Honoraria Advisory Committee Member relationship with Pfizer Please note: 4 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Honoraria Advisory Committee Member relationship with Biodesix Please note: 4 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Honoraria Consultant relationship with BodyVision Please note: 3 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with Philips Please note: 2 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with Johnson & Johnson Please note: 3 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Consulting fee No relevant relationships by Charles Schirmer, source=Web Response