<h2>Lesion Characteristics</h2>Lesion Size (diameter): 13 mmLesion Location: Lower Upper Lobe Lesion (Lingular)Bronchus Sign: YesVisible on Fluoro: YesREBUS Verification: Concentric <h2>Case Information</h2>Full Procedure Time: 55 minutesROSE: Sampling was performed with positive ROSE by cytology.Final Pathology Report: Final pathology was positive for carcinoid. <h2>Background</h2>A 61 year-old female with a history of COPD and tobacco use presented with an inferior lingular nodule. A CT chest scan in January 2021 revealed an 11 mm lingular nodule (Figure 1a). Laboratory analysis demonstrated normal white blood cell count, negative coccidioides antibodies, acid fast cultures, fungal serologies, quantiferon TB test and urine histoplasmosis antigen. Navigational bronchoscopy was initially performed in February 2021. Radial EBUS (r-EBUS) was used intra-procedure and a concentric density was identified. However, rapid on-site evaluation (ROSE) cytology was negative for malignant cells with inconclusive pathology. CT scan in April 2021 showed growth of the lingular nodule to 12 mm. Interventional radiology was consulted and TTNA was performed (Figure 1b). Pathology was again inconclusive. After further discussion with the patient about newer modalities she was still interested in a bronchoscopic method for resection rather than surgery. In October 2021, a robotic-assisted bronchoscopy procedure utilizing the Body Vision system for real-time, intraoperative 3D imaging in conjunction with the Ion by Intuitive system was scheduled.&nbsp;<img src="https://lh4.googleusercontent.com/gVv1_Xmm5VCMaA3tysm6usw-TnnqZ_sYCjF4x9WVWzR1KCHwEe0q10SoVa_VMSVbmNpvfO4CMyTuPWjsgZtHaG2xHol3LPa0hCVoe-1z-l2D4Je9ykFRxbaihEfBsDetVZ0lawB0h9pDgnZJUw" height="248" width="624">&nbsp;&nbsp;&nbsp;&nbsp;(Figures 1a and 1b) The Procedure&nbsp; PlanningA pre-operative CT is uploaded onto the Body Vision system.&nbsp;The lesion is then marked and contoured so that the Body Vision system can approximate the lesion location prior to the procedure. The Body Vision system also derives the airways from the preoperative CT so that if the user were to use the system as an end-to-end navigational bronchoscopy platform, a virtual bronch can be provided.&nbsp; CABT RegistrationRegistration of the Body Vision system consists of two C-arm spins once the patient is on the table: one around the main carina and a second iso-centered around the lesion to produce an initial C-Arm Based Computed Tomography (CABT) scan so that the bronchoscopist can view the actual lesion and lesion location prior to navigation.&nbsp; NavigationThe Ion by Intuitive robotic bronchoscopy platform was registered, the Ion catheter introduced into the airway, and the catheter navigated to the target as defined by the robotic platform’s shape-sensing technology. <img src="https://lh3.googleusercontent.com/IhO6qSf5HvFKalNQ8iPk5yngdd9e9PoexU4puxiK3xX18yqWyIuq1Ub-EloH4iFqo46C92nxO_X1H5wKf3WAVQQonaRsjn7ebFgM5Z2S7FybtwwvBzItGCpiMhyZ-3SxOdFjyb_jh1AKNLwsLQ" height="442" width="362">(Figure 1c) Once the Ion catheter was navigated to within 10mm of the target, the proximity of the bronchoscope to the pleura was enough of a concern that&nbsp;a GE OEC 9900 Elite C-arm was brought into position over the patient and a CABT scan with the Body Vision system performed to determine true lesion location. The intraoperative CT image overlayed onto the Body Vision-generated augmented fluoroscopy shows that the catheter had already been positioned roughly 10mm past the actual lesion. Ion’s shape-sensing technology indicated that the system believed that the proximal edge of the lesion was still 10mm further out, equating to an approximate 20mm (2cm) of CT-to-body divergence. (Figure 1c). Based on Body Vision’s intraoperative 3D image, the Ion bronchoscope was retracted to the actual lesion location as defined by Body Vision. Because the&nbsp;imaging is not based on preoperative CT scans and is captured in real-time intraoperatively, no CT-to-body divergence exists with Body Vision’s imaging technology. r-EBUS Confirmation<img src="https://lh5.googleusercontent.com/wcHduPNcth4EiYcidlQRNJtLgy-aSUkTCLKxRtcqlWIL1E26Vf1qdLuEg-Z7Fd3Hr_DZYAoloATSGR731dsn_EmTPFFzuBhk1dfB8JyrkKOsB0iWjKv3ZVA3zpEhC0g-l440QoeQQ1CGkfD-Dw" height="242" width="340">(Figure 1d) Once the Ion catheter was repositioned to where Body Vision’s intraoperative imaging showed the lesion to be, the Ion vision probe was retracted from the bronchoscope and replaced with a radial endobronchial ultrasound (r-EBUS) probe.&nbsp;The r-EBUS probe illustrated a concentric echo-density (Figure 1d), verifying that the lesion location as defined by Body Vision was correct and that the repositioned catheter was now at the lesion.&nbsp; Biopsy<img src="/assets/quill-image-1655145121689.jpg" width="405">﻿The r-EBUS probe was retracted from the working channel of the Ion system and replaced by biopsy tools.&nbsp;Under augmented fluoroscopy which showed both lesion boundaries and biopsy tool location in real-time, Dr. Nobari was able to acquire biopsy samples and ensure that those samples were from within the lesion. Rapid On-Site Evaluation (ROSE) assessed that samples collected via needle biopsy were adequate and consistent with a carcinoid (Figure 1e).&nbsp;This was later confirmed by cytology on the final pathology report. <img src="https://lh6.googleusercontent.com/YTK4x-asztIvPF2KVmDlp3cMDf06M7PN-FbSjubqpwliterQSx5kvkGCs2ekN4sgob_Y9IYpaxIN_zmY-YELaOaCAk0f2-Y-Fy9cM8Wivlw7gE0_Nleej3065eeTKLTy_9WrwCvGqPqGAFF3UA" height="230" width="396">(Figure 1e) ConclusionThis case demonstrates the value of Body Vision’s real-time, intraoperative 3D imaging when used in conjunction with the Ion by Intuitive platform during robotic-assisted bronchoscopy. While the benefits of Ion’s robotic catheter – namely stability and articulation – provide very real tangible benefits during navigation bronchoscopy, its reliance on pre-operative CTs for establishing a virtual navigation target makes it susceptible to CT-to-body divergence and does not provide the ability to visually confirm that biopsy samples are acquired from within the lesion.&nbsp;Thus, Body Vision’s intraoperative imaging proved&nbsp;crucial for navigating to the actual lesion location and enabled image-guided sampling of this peripheral pulmonary nodule.&nbsp; About Dr. Nobari<img src="/assets/quill-image-1655144307233.jpg" width="133">Matthew M. Nobari MDPulmonary and Critical CareAssistant Clinical Professor&nbsp;University of California San Diego

Overcoming CT-to-Body Divergence in a 13mm Left Upper Lobe Lesion

<h1>Case Details</h1><h2> </h2><h2>Lesion Characteristics</h2>Lesion Size (diameter): 25 mmLesion Location: Right Upper LobeBronchus Sign: YesVisible on Fluoro: YesREBUS Verification: Concentric <h2>Case Information</h2>Full Procedure Time: 75 minutes (this included biopsy of 25mm nodule in right upper lobe (RUL) as well as a biopsy of a right lower lobe (RLL) nodule and staging of lymph nodes)ROSE: Adenocarcinoma from needle biopsy and touch preps from transbronchial lung biopsy (TBBx)Final Pathology Report: Well-differentiated adenocarcinoma of the lung from needle biopsies and transbronchial lung biopsies <h2>Background</h2>An 88-year-old woman with no smoking history but with a remote history of breast cancer was referred with a solitary pulmonary nodule in the right upper lobe (RUL).&nbsp;The patient had two previous attempts to biopsy from the RUL lesion prior to the referral but both attempts proved non-diagnostic.&nbsp;A Fluorodeoxyglucose (FDG) PET scan of the RUL lesion exhibited a standardized uptake value (SUV) of 4.9.&nbsp;At this point, the patient was referred to Dr. D. Kyle Hogarth at the University of Chicago Medical Center for a second opinion.&nbsp;The patient returned a normal pulmonary function test (PFT).&nbsp;A robotic-assisted navigation bronchoscopy procedure utilizing the Body Vision system for real-time, intraoperative 3D imaging in conjunction with the Auris MONARCH® platform was scheduled. <h1>The Procedure</h1> <h2>Planning</h2><img src="/assets/quill-image-1634652634728.jpg">The Body Vision system derives the airways from the pre-operative CT as well as uses the physician’s marking of the lesion and lesion boundaries to approximate lesion location prior to the procedure.&nbsp;During the procedure, lesion location and positioning of the bronchoscope and tools relative to the lesion is provided by real-time, intraoperative 3D imaging. <h2>CABT™ Registration</h2><img src="/assets/quill-image-1634613070980.jpg">Using any conventional C-arm, Body Vision's C-arm-based computational tomography (CABT) technology provides intraoperative 3D images. Registration of the Body Vision system entails a CABT scan of the main carina and a second CABT scan iso-centered around the lesion which provides visualization of the actual lesion and lesion location, even of radiolucent lesions which are typically not fluoro visible.&nbsp; <h2>Navigation </h2><img src="/assets/quill-image-1649441007414.jpg">The MONARCH® platform was initialized and used to navigate to within close proximity of the virtual target using the robotic platform’s electromagnetic navigation. The C-arm was then brought into position over the patient and a CABT scan with the Body Vision was performed to determine true lesion location (A).&nbsp;The robotic bronchoscope was repositioned based on the new information provided by Body Vision’s intraoperative 3D imaging and lesion’s presence at the location as imaged by Body Vision was confirmed with Radial Endobronchial Ultrasound (REBUS).&nbsp;REBUS returned a concentric view (B).&nbsp;Because Body Vision’s intraoperative 3D imaging is captured in real-time when the patient is on the table and is not reliant on pre-operative CT images, CT-to-body divergence is eliminated and, as in this case, accurate navigation to the actual lesion was enabled. <h2>Tool-In-Lesion Confirmation</h2><img src="/assets/quill-image-1649097333487.jpg">Under Body Vision’s augmented fluoroscopy where the C-arm fluoro image is augmented with actual lesion location provided by the most recent CABT scan, Dr. Hogarth was able to see in real-time as he introduced a Body Vision stylet (no longer needed for robotic bronchoscopy cases) with radiopaque markers down the working channel of the MONARCH and guides it to the lesion. <img src="/assets/quill-image-1649268717249.jpg">With the Body Vision stylet in place, a CABT was performed to provide visual confirmation of tool-in-lesion in multiple 3D planes.&nbsp; <h2>Biopsy</h2><img src="/assets/quill-image-1634652769276.jpg">With tool-in-lesion confirmed under Body Vision’s intraoperative 3D imaging, the Body Vision stylet was retracted and a biopsy needle was introduced down the working channel of the MONARCH.&nbsp;Under augmented fluoroscopy which showed both lesion boundaries and biopsy tool location in real-time, Dr. Hogarth was able to acquire biopsy samples and ensure that those samples were from within the lesion. Rapid On-Site Evaluation (ROSE) assessed that samples collected via needle biopsy and touch preps from transbronchial lung biopsy (TBBx) were adequate and consistent with adenocarcinoma.&nbsp;Endobronchial Ultrasound (EBUS) staging of the mediastinal (station 1) and hilar (station 10) nodes radiographically showed the lymph nodes were of normal size. The diagnosis of well-defined adenocarcinoma was confirmed via the final pathology report.&nbsp;&nbsp;&nbsp; <h2>Conclusion</h2>This use case demonstrates the value of&nbsp;Body Vision’s intraoperative 3D imaging regardless of bronchoscopy platform.&nbsp;The stability and articulation provided by robotic bronchoscopy platforms provide a clear clinical value during navigation bronchoscopy.&nbsp;However, without real-time intraoperative imaging like that provided by Body Vision, the current generation of robotic bronchoscopy platforms cannot account for CT-to-body divergence. Utilizing the Body Vision intraoperative 3D imaging system in concert with the Auris MONARCH robotic bronchoscopy platform, Dr. Hogarth was able to definitively diagnose a peripheral 2.5cm RUL lesion. <h2>About Dr. Hogarth</h2><img src="/assets/quill-image-1634613173893.jpg" width="116">Kyle Hogarth, MD, FCCPProfessor of MedicineDirector of Bronchoscopy, Co-Director of Lung Cancer Screening ProgramUniversity of Chicago Medical Center

Biopsy and Diagnosis of 25mm Right Upper Lobe Lesion

<h1>Case Details</h1><h2> </h2><h2>Lesion Characteristics</h2>Lesion Size (diameter): 9 mmLesion Location: Right Middle LobeBronchus Sign: YesVisible on Fluoro: NoREBUS Verification: Concentric Rebus Confirmation <h2>Case Information</h2>Time to First Biopsy: 13 minutesFull Procedure Time: 30 minutesROSE: No ROSE on-siteDefinitive Diagnosis: Adenocarcinoma <h2>Background</h2>A 67-year-old woman,&nbsp;non-smoker. CT completed due to unexplained weight loss. <h2>Planning</h2><img src="/assets/quill-image-1637006035939.jpg">In Planning, the pre-operative CT was uploaded and the lesion and lesion boundaries were marked. The Body Vision System proposed different pathway options to reach the lesion and Dr. Abramovich chose the appropriate one. <h2>Virtual Navigation</h2><img src="/assets/quill-image-1637005712731.jpg">Dr. Abramovich viewed and verified the virtual pathway via Body Vision's virtual bronchoscopy.<h2> </h2><h2>CABT Registration</h2><img src="/assets/quill-image-1637003491596.jpg">Using only a conventional C-arm, Body Vision produced a tomographic reconstruction of the lesion in 3D, thus enabling Dr. Ambramovich to see the real-time, accurate lesion location and overcome any concerns with CT-to-body divergence. <h2>Tool-in-Lesion CABT</h2><img src="/assets/quill-image-1641926528551.jpg">﻿Here, Dr. Abramovich was able to confirm the tool was inside the lesion using Body Vision's real-time, CABT technology. <h2>Biopsy</h2><h1><img src="/assets/quill-image-1637003920840.jpg"></h1>Dr. Abramovich successfully takes a biopsy sample from within the lesion using forceps. <h2>Conclusion</h2>Small nodules should be diagnosed even if the patient does not have risk factors. The Body Vision system is capable of assisting a definitive diagnosis by creating a reliable augmented fluoroscopy image and providing real-time, CABT tool-in-lesion confirmation in nodules as small as only a few millimeters. <h2>About Dr. Amir Abramovich</h2><img src="/assets/quill-image-1637004139156.jpg" width="200">Director, Interventional PulmonologyCarmel Medical Center

Biopsy and Diagnosis of 9mm Nodule in Right Middle Lobe

<h1>Case Details</h1><h2> </h2><h2>Lesion Characteristics</h2>Lesion Size (diameter): 11 mmLesion Location: Left Upper Lobe, outer 1/3 of the lungBronchus Sign: YesVisible on Fluoro: NoREBUS Verification: Eccentric <h2>Case Information</h2>Time to First Biopsy: 6 minutesFull Procedure Time: 75 minutesROSE: Positive (3 samples)Definitive Diagnosis: Yes, invasive mucinous adenocarcinoma (pT1bN0) <h2>Background</h2>A 59-year-old male with no smoking history underwent a CT scan in January 2021 for evaluation of mid-back pain that revealed an incidental finding of a solitary pulmonary nodule in the left upper lobe (LUL). The patient had previously had a CT chest in August 2012 for the evaluation of dyspnea and chest pain which disclosed a 13mm non-calcified speculated pulmonary nodule at the left upper lobe. Subsequent PET/CT in September 2012 demonstrated no FDG uptake at the LUL nodule. The patient underwent bronchoscopy in December 2012 with endobronchial forceps biopsies that were inconclusive, showing benign respiratory epithelium and scant alveolar parenchyma. The patient had an additional CT chest in October 2013 that demonstrated stability in the size and character of the LUL nodule. There were no further surveillance images. As described above, the patient obtained CT imaging of the c- and t-spine in January 2021 to evaluate back pain. The LUL nodule was re-identified and a dedicated CT chest disclosed that the nodule was 1.6 x 1.6 cm in the axial dimension and 1.6 x 1.1 cm in the coronal plane, increased from the 2012 imaging when it measured 1.5 x 1 cm in axial dimension and 1.1 x 0.9 cm in the coronal plane. There were additional sub-centimeter nodules in the LUL and right upper lobe. The patient was referred to Dr. George Cheng and underwent diagnostic bronchoscopy using LungVision’s advanced imaging navigation technology in March 2021. Dr. Cheng was able to navigate to the lesion in the left upper lobe, confirm the tool was in the lesion using CABTTM, obtain multiple biopsies, and arrive at a successful diagnosis of mucinous adenocarcinoma. The patient was staged as IA2 (T1b, N0, M0) and subsequently referred to Cardiothoracic Surgery where he underwent robotic left upper lobectomy and the diagnosis was confirmed as invasive mucinous adenocarcinoma (pT1bN0).&nbsp; <h1>The Procedure</h1> <h2>Planning</h2><img src="/assets/quill-image-1619707028074.jpg">In this phase, the pre-operative CT was loaded, the lesion and lesion boundaries were marked and the LungVision™ System learned the anatomical structure of the lung and identified potential pathways to the lesion. <h2>CABT™ Registration</h2><img src="/assets/quill-image-1619707317583.jpg">Using a conventional C-arm, a non-fluoro visible lesion became visible to the user, by producing a tomographic reconstruction of the lesion in 3D. This enabled the physician to understand the real-time, accurate location of the lesion and overcome any CT-to-body divergence.&nbsp; <h2>Navigation </h2><img src="/assets/quill-image-1619707528042.jpg">Guided by advanced real-time imaging, the distal tip of the LungVision™&nbsp;sheath, part of the disposable procedural kit, was navigated to the lesion. <h2>CABT™ Tool-In-Lesion Confirmation</h2><img src="/assets/quill-image-1623129732544.jpg">Confirmation that the LungVision tool was inside the lesion occurred here with Body Vision's CABT™ technology. <h2>Biopsy</h2><img src="/assets/quill-image-1619707725644.jpg">Here, biopsy samples were successfully taken from within the lesion. <h2>Conclusion</h2>A peripheral 11mm lesion in the left upper lobe was evaluated via traditional bronchoscopy including endobronchial forceps biopsies. This approach led to inconclusive results. LungVisionTM System enabled true real-time visualization during navigation and tool-in-lesion confirmation, resulting in a definitive cancer diagnosis and treatment.&nbsp; <img src="/assets/quill-image-1629386591370.jpg">Figure 1. A) CT chest of the LUL nodule from August 2012. B) PET imaging from September 2012 with no FDG uptake at the LUL nodule. C, D) Intraoperative radial ultrasound images from bronchoscopy in December 2012.&nbsp; <img src="/assets/quill-image-1629386658342.jpg">Figure 2. A) CT imaging demonstrating LUL nodule in January 2021. B) Dedicated CT chest characterizing the nodule as 1.6 x 1.6 cm in the axial dimension and 1.6 x 1.1 cm in the coronal plane. C, D) Histological slides from navigation bronchoscopy demonstrating samples which were hypercellular with single and sheets of glandular appearing cells with no cilia, abundant intracytoplasmic mucin, increased nuclear to cytoplasmic ratios, prominent nucleoli, and cleared but bland appearing chromatin; findings compatible with mucinous adenocarcinoma of lung origin.&nbsp; <h2>About Dr. Cheng and Dr. Tran</h2> <img src="/assets/quill-image-1626269696304.jpg" width="116">George Z. Cheng, MD, PhDInterventional PulmonologistSan Diego, CA <img src="/assets/quill-image-1632341731007.jpg" width="116">Dr. Brian TranPulmonary Critical Care FellowSan Diego, CA