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MULTICENTER, PROSPECTIVE PILOT AND FEASIBILITY STUDY OF ROBOTIC-ASSISTED BRONCHOSCOPY FOR PERIPHERAL PULMONARY LESIONS

2019; Elsevier BV; Volume: 156; Issue: 4 Linguagem: Inglês

10.1016/j.chest.2019.08.313

1931-3543

Alexander Chen, Nicholas J. Pastis, Amit Mahajan, Sandeep J. Khandhar, Michael Simoff, Michael Machuzak, Joseph Cicenia, Thomas R. Gildea, Gerard A. Silvestri,

Tracheal and airway disorders

SESSION TITLE: Late Breaking Bronchoscopy SESSION TYPE: Original Investigations PRESENTED ON: 10/23/2019 08:45 AM - 09:45 AM PURPOSE: Robotic assisted bronchoscopic (RAB) platforms have been developed to potentially improve the diagnostic yield for peripheral pulmonary lesions. Cadaveric studies using an RAB platform have demonstrated increased peripheral reach compared to conventional bronchoscopes of similar caliber, as well as the ability to successfully biopsy simulated tumor targets 1-3cm in size. Presently, limited data exists evaluating the performance of robotic systems in live human subjects. This study was performed to evaluate the safety and feasibility of robotic assisted bronchoscopic biopsy in patients with peripheral pulmonary lesions utilizing the current generation RAB platform. METHODS: This was a prospective, multicenter pilot and feasibility study using a robotic bronchoscopic system (Monarch, Auris Health, Redwood City, CA) to diagnose peripheral pulmonary lesions 1-5cm in size. Following flexible bronchoscopic airway inspection, the robotic system was advanced to the targeted lobe where the outer sheath was left in position. The inner scope was subsequently advanced using a combination of direct visualization, electromagnetic navigational bronchoscopic (ENB) guidance and fluoroscopy. Once in position, a radial endobronchial ultrasound probe (UM-S20-17S, Olympus, Tokyo, Japan) was used to confirm lesion localization. If localization was confirmed, transbronchial needle aspiration (TBNA) was performed. Rapid on-site evaluation (ROSE) was utilized on all cases. TBNA was sufficient when ROSE was diagnostic, and for cases in which ROSE was non-diagnostic, transbronchial biopsy was performed using the RAB platform followed by conventional bronchoscopy utilizing ENB and/or R-EBUS at the discretion of the bronchoscopist. Primary endpoints were lesion localization using R-EBUS as well as incidence of procedure related complications. RESULTS: Forty-six patients were enrolled across 5 study sites. Mean lesion size was 22.9mm (SD 10.9mm). Lesion localization was confirmed using R-EBUS in 43/45 (95.6%) of cases, with R-EBUS not available for 1 case. Concentric R-EBUS views were obtained in 23/46 (50%) of cases. Pneumothorax occurred in 2/46 (4.3%) of cases and required tube thoracostomy in 1/46 (2.17%) case. No additional serious adverse events were reported. Diagnostic yield will be reported once the appropriate follow up period has elapsed. CONCLUSIONS: In this study, RAB procedures demonstrated feasibility and a safety profile comparable to conventional transbronchial biopsy. The RAB system successfully localized 95.6% of lesions using R-EBUS. CLINICAL IMPLICATIONS: This is the first, prospective, multicenter study of robotic bronchoscopy in patients with peripheral pulmonary lesions. These findings suggest that RAB may improve the bronchoscopists' ability to localize peripheral lesions in a safe and effective manner. Additional studies are warranted to further validate these findings. DISCLOSURES: Consultant relationship with Olympus Please note: $5001 - $20000 Added 11/25/2018 by Alexander Chen, source=Web Response, value=Consulting fee Consultant relationship with Auris Please note: $1001 - $5000 Added 11/25/2018 by Alexander Chen, source=Web Response, value=Consulting fee Consultant relationship with Intuitive Surgical Please note: $1001 - $5000 Added 11/25/2018 by Alexander Chen, source=Web Response, value=Consulting fee Consultant relationship with Boston Scientific Please note: $1001 - $5000 Added 11/25/2018 by Alexander Chen, source=Web Response, value=Consulting fee Research relationship with Veran Medical Please note: $5001 - $20000 Added 03/14/2019 by Alexander Chen, source=Web Response, value=Grant/Research No relevant relationships by Joseph Cicenia, source=Web Response Advisory Committee Member relationship with Intuitive Please note: $5001 - $20000 Added 11/30/2018 by Thomas Gildea, source=Web Response, value=Travel Advisory Committee Member relationship with J&J Ethicon Please note: $5001 - $20000 Added 11/30/2018 by Thomas Gildea, source=Web Response, value=Consulting fee Inventor relationship with NewCOD Please note: $1-$1000 Added 03/15/2019 by Thomas Gildea, source=Web Response, value=Non-yet Investigator relationship with Auris Please note: $5001 - $20000 Added 06/21/2019 by Thomas Gildea, source=Web Response, value=Research funding for trial Consultant relationship with Medtronic Please note: $20001 - $100000 Added 03/14/2019 by Sandeep Khandhar, source=Web Response, value=Consulting fee Consultant relationship with Auris Robotics Please note: $5001 - $20000 Added 03/14/2019 by Sandeep Khandhar, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Boston Scientific Please note: $1001 - $5000 Added 03/14/2019 by Sandeep Khandhar, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Bard Please note: $1001 - $5000 Added 03/14/2019 by Sandeep Khandhar, source=Web Response, value=Consulting fee Stock Holder relationship with Transenterix Please note: $5001 - $20000 Added 03/14/2019 by Sandeep Khandhar, source=Web Response, value=Stock Consultant relationship with Medtronic Please note: $1001 - $5000 Added 03/14/2019 by Sandeep Khandhar, source=Web Response, value=Travel Board Member relationship with bh Please note: $1-$1000 Added 03/14/2019 by Sandeep Khandhar, source=Web Response, value=Consulting fee Removed 03/14/2019 by Sandeep Khandhar, source=Web Response No relevant relationships by Michael Machuzak, source=Web Response No relevant relationships by Amit Mahajan, source=Web Response Consultant relationship with Cook Please note: $1001 - $5000 Added 11/27/2018 by Nicholas Pastis, source=Web Response, value=Honoraria Consultant relationship with Olympus Please note: $5001 - $20000 Added 11/27/2018 by Nicholas Pastis, source=Web Response, value=Honoraria Consultant relationship with Auris Please note: $1001 - $5000 Added 11/27/2018 by Nicholas Pastis, source=Web Response, value=Honoraria No relevant relationships by Gerard Silvestri, source=Web Response Consultant relationship with Auris Health Please note: $1001 - $5000 Added 03/15/2019 by Michael Simoff, source=Web Response, value=Consulting fee Board Member relationship with Intuitive Surgical Please note: $1001 - $5000 Added 03/15/2019 by Michael Simoff, source=Web Response, value=Consulting fee Principle Investigator relationship with Gongwin Biopharm Please note: $5001 - $20000 Added 03/15/2019 by Michael Simoff, source=Web Response, value=Grant/Research Support