MS16.02 Robotic Bronchoscopy: Driveless IP?

Abstract

Introduction: Robotic bronchoscopy has been developed in response to challenges which face bronchoscopists in the diagnosis of peripheral pulmonary nodules. Further, such nodules are increasingly presented to bronchoscopists because of CT screening programs, and a general increase in the performance of chest CT in the community with resultant incidental detection of small nodules. Two platforms have undergone preliminary lab evaluations followed by in-human feasibility and safety studies. These are the Auris system and the Intuitive surgical system and the results of these studies are now published (1,2). Both have since had FDA approval and are undergoing post- marketing multicentre studies, the first as the Monarch system, the second as the Ion system. The challenges facing bronchoscopists are 1. The small size of nodules, 2. The peripheral nature of the nodules requiring small calibre scopes to reach them, 3. The complex anatomic pathways to reach them, and 4. The position of the nodules in relation to the airway, with many being “extrinsic” to the bronchus, making biopsy sampling difficult. Robotic bronchoscopy seeks to answer these challenges by integrating an array of components incorporating small size of the distal scope, excellent manoeuvrability of the distal end of the scope, real time display of CT-derived navigational assistance, and biopsy channel size in the distal end of the scope to allow good quality samples. Methods: The robotic aspect of the systems means robotic arms (2 with Auris and 1 with Intuitive) drive the scope into the airway under the direction of a physician operated console, as opposed to the hands of a physician holding the scope and advancing and directing the scope. Important in this regard is the system is not “automatic”, meaning the physician is in control of the device at all times, directing the scope into pre-planned airways under direct vision provided by the system. The robotic aspect of the devices means that the driving and directing of the scope are much more precise and not prone to slipping out of airways between biopsy attempts, reducing the need to re-navigate back to a nodule. The main difference in the systems relates to the design of the catheter (Figs 1 and 2). The Auris system has a telescoping end, with a scope extending out of an outer sheath, while the Intuitive scope has a single catheter, within which a removable optic can be removed to allow deployment of biopsy instruments. Figure 1: Distal end of the Auris system incorporating a sheath (light blue) and an inner bronchoscope (dark blue). The outer sheath(6mm) is wedged in a segmental bronchus, then the inner bronchoscope (4.2mm) is advanced to the distal airways. Figure 2. The distal catheter tip of the Intuitive system (outer diameter 3.4mm), showing accompanying shape sensing image which is displayed real time, providing continuous position feedback. Results: The Auris study reported 15 patients, and the Intuitive study 29 patients, mean lesion size 26mm (1.0-6.3) and 12.2 ± 4.2 mm respectively. Bronchus was sign was absent in all cases with Auris (predefined) whereas 44% were bronchus sign absent in the Intuitive study. All patients were intubated and the procedure performed under general anaesthesia. Most patients were discharged the same day. Both systems reported no adverse events from the device itself. One SAE was reported in the Intuitive study which was an anaesthetic complication related to use of muscle relaxants from which there were no long term sequelae. Successful navigation to the nodule was made in 14 of 15 and 28 of 29 patients respectively. EBUS Guide sheath confirmation was allowed just before biopsy in the Intuitive study but not the Auris study. The devices allowed multiple samples to be taken quickly; the use of needle sampling was common in the Intuitive study because of the nature of the extrabronchial lesions. Malignancy was confirmed in 7 of 9 cases with the Auris device and 13 of 15 cases with the Intuitive device. Conclusions: Robotic bronchoscopy offers unique capability for a proceduralists in combing excellent navigation with thin scopes and stability at the biopsy tip. These early results of sampling difficult nodules need to be followed up in multicentre studies, but suggest a significant potential in dealing with small peripheral nodule biopsy. Further the large size of the biopsy channels and the stability of the tip of the instruments due to the robotics could allow further evaluation of these devices to permit endolumenal therapies for small peripheral lung cancers.