INIITIAL EXPERIENCE WITH STEERABLE INSTRUMENTATION IN HUMAN CADAVERIC MODELS WITH SIMULATED TUMOR TARGETS

Abstract

TOPIC: Procedures TYPE: Original Investigations PURPOSE: Despite growing experience using advanced guided techniques, the diagnostic yield of bronchoscopy for peripheral pulmonary lesions remains suboptimal, particularly for lesions which are adjacent to peripheral bronchi. While recent publications have focused on improving bronchoscopic reach, access and precision in the lung periphery, few have addressed significant modifications to the instrumentation used to obtain biopsies. This exercise was performed to evaluate two novel, steerable instruments within human cadaveric lungs with simulated tumor targets. Instrument assessment included the ability of both instruments to access simulated tumor targets in all lobes of the lung, as well as to reposition instruments within tumor targets. METHODS: Artificial tumor targets were placed in all lobes of the lungs of two human cadaver torsos which were intubated, ventilated and underwent CT scanning. Bronchoscopists utilized a large caliber bronchoscope (BF-1TH190, Olympus, Tokyo, Japan) and steerable guide sheath (2.7mm OD)(SerpeX Medical, Santa Clara, CA) by advancing, rotating and articulating the distal end of the guide sheath towards the targeted lesion using fluoroscopic guidance and a reference CT scan. Radial probe endobronchial ultrasound (UM S20-17S, Olympus Tokyo, Japan) was used to confirm lesion localization prior to performing transbronchial needle aspiration (Periview Flex, Olympus, Tokyo, Japan) and transbronchial biopsy (Precisor Broncho Forceps, ConMed, Utica, NY). Following this, a standard diagnostic bronchoscope (BF-H190, Olympus, Tokyo, Japan) was used to advance a steerable needle (1.8mm OD)(SerpeX Medical, Santa Clara, CA) towards the same targeted lesions using insertion, rotation and articulation of the distal tip. RESULTS: Both the steerable sheath and steerable needle were successfully placed within simulated tumor targets in all lobes of two cadaveric lungs with diagnostic biopsy material obtained from all lobes. Additionally, manipulation of the distal end of the steerable sheath and steerable needle was successfully used to reposition each tool within different locations of the same lesion. CONCLUSIONS: This is an initial reporting of two fully articulating, steerable instruments designed to assist with bronchoscopic biopsy of peripheral lung lesions. In this exercise both instruments were successfully positioned within tumor targets in all lobes of two human cadaveric lungs. Additionally, articulation and rotation of the distal end of each of these instruments successfully repositioned biopsy instruments within different locations of targeted lesions. CLINICAL IMPLICATIONS: Steerable instrumentation may improve the bronchoscopist's ability to place biopsy tools within targeted peripheral lesions, thereby potentially improving diagnostic yield, particularly for lesions that are positioned adjacent to peripheral bronchi. DISCLOSURES: Consultant relationship with Serpex Please note: 2020-2021 Added 04/24/2021 by Alexander Chen, source=Web Response, value=Consulting fee Removed 04/27/2021 by Alexander Chen, source=Web Response Investigator relationship with Olympus Please note: 2020-2021 Added 04/27/2021 by Alexander Chen, source=Web Response, value=Grant/Research Support Consultant relationship with Boston Scientific Please note: 2020-2021 Added 05/10/2021 by Alexander Chen, source=Web Response, value=Consulting fee Consultant relationship with Olympus America, Inc Please note: 1/2019 to current Added 04/28/2021 by Andrew Haas, source=Web Response, value=Consulting fee Consultant relationship with Serpex Medical Please note: 1/2020 to current Added 04/28/2021 by Andrew Haas, source=Web Response, value=Consulting fee DSMB, consultant relationship with Novocure, Inc Please note: 1/2019 to current Added 04/28/2021 by Andrew Haas, source=Web Response, value=Consulting fee Consultant relationship with Olympus America Please note: 1/2019 to current Added 04/28/2021 by Andrew Haas, source=Web Response, value=Consulting fee No relevant relationships by Michael Machuzak, source=Web Response