Bronchoscopic Evaluation of a Steerable Needle for Simulated Tumor Targets in the Lung Periphery: A Feasibility Study (Bullseye).

BACKGROUND: Peripheral bronchoscopy is often performed to biopsy peripheral pulmonary lesions. Despite technological advancements to improve reach and access to the lung periphery, the diagnostic yield of peripheral bronchoscopy has been inconsistent, and challenging, particularly for lesions that are adjacent to peripheral bronchi. Current biopsy instruments are reliant on the catheter or scope to align properly with targeted lesions. OBJECTIVES: This study evaluates the feasibility of using a steerable biopsy needle to gain access to peripheral tumor targets in a cadaveric model. METHODS: Simulated tumor targets 10-30 mm in axial diameter were placed into human cadavers. Bronchoscopy was performed using a 4.2 mm OD flexible bronchoscope, CT-anatomic correlation, and multi-planar fluoroscopy for lesion localization. Once at the targeted location, a steerable needle was deployed and the needle position was determined to be in the central zone, peripheral zone, or outside of the lesion by cone beam CT imaging. If the needle position was within the lesion, a fiducial marker was deployed to mark the needle position, and the needle was articulated and/or rotated in an attempt to place another fiducial marker into a different location within the same lesion. If the needle was outside of the lesion, the bronchoscopist was provided with two additional attempts to gain access to the lesion. RESULTS: Fifteen tumor targets were placed with a mean lesion size of 20.4 mm. The majority of lesions were located in the upper lobes. One fiducial marker was placed in 93.3% of lesions and a second fiducial marker was successfully placed in 80% of lesions. A fiducial marker was placed within the central zone in 60% of lesions. CONCLUSION: The steerable needle was successfully placed within 93% of targeted lesions 10-30 mm in diameter in a cadaveric model, with the ability steer the instrument into another portion of the lesion in 80% of cases. The ability to steer and control needle positioning toward and within peripheral lesions may complement existing catheter and scope technology during peripheral diagnostic procedures.

Accuracy of a Robotic Endoscopic System in Cadaver Models with Simulated Tumor Targets: ACCESS Study.

BACKGROUND: Bronchoscopy for the diagnosis of peripheral pulmonary lesions continues to present clinical challenges, despite increasing experience using newer guided techniques. Robotic bronchoscopic platforms have been developed to potentially improve diagnostic yields. Previous studies in cadaver models have demonstrated increased reach into the lung periphery using robotic systems compared to similarly sized conventional bronchoscopes, although the clinical impact of additional reach is unclear. OBJECTIVES: This study was performed to evaluate the performance of a robotic bronchoscopic system's ability to reach and access artificial tumor targets simulating peripheral nodules in human cadaveric lungs. METHODS: Artificial tumor targets sized 10-30 mm in axial diameter were implanted into 8 human cadavers. CT scans were performed prior to procedures and all cadavers were intubated and mechanically ventilated. Electromagnetic navigation, radial probe endobronchial ultrasound, and fluoroscopy were used for all procedures. Robotic-assisted bronchoscopy was performed on each cadaver by an individual bronchoscopist to localize and biopsy peripheral lesions. RESULTS: Sixty-seven nodules were evaluated in 8 cadavers. The mean nodule size was 20.4 mm. The overall diagnostic yield was 65/67 (97%) and there was no statistical difference in diagnostic yield for lesions <20 mm compared with lesions measuring 21-30 mm, the presence of a concentric or eccentric radial ultrasound image, or relative distance from the pleura. CONCLUSIONS: The robotic bronchoscopic system was successful at biopsying 97% of peripheral pulmonary lesions 10-30 mm in size in human cadavers. These findings support further exploration of this technology in prospective clinical trials in live human subjects.

Indwelling tunneled pleural catheters for the management of hepatic hydrothorax.

PURPOSE OF REVIEW: Hepatic hydrothorax is a complication of end-stage liver disease that may have significant associated morbidity. Sodium restriction and diuretic therapy are the mainstays of treatment, though up to a quarter of patients will become refractory to this and will require a pleural drainage procedure. Thoracentesis, transjugular intrahepatic portosystemic shunt, and chemical pleurodesis all have variable success rates and associated complications in the management of hepatic hydrothorax. Indwelling tunneled pleural catheters (ITPC) have been successfully used to manage recurrent symptomatic malignant pleural effusions, and there is growing interest regarding their use in the management of hepatic hydrothorax. RECENT FINDINGS: Evidence regarding the use of ITPC for nonmalignant pleural effusions has been limited to retrospective studies and small feasibility trials. A recent meta-analysis regarding the use of IPTC for nonmalignant pleural effusions demonstrated a rate of spontaneous pleurodesis of 51%, whereas a small, prospective study demonstrated spontaneous pleurodesis rates of 33% and an infection rate of 16.7% in 24 patients with ITPC placed for hepatic hydrothorax in patients suitable for liver transplant evaluation. SUMMARY: ITPC may be an acceptable treatment option for the management of hepatic hydrothorax which are refractory to conventional medical management. Larger, randomized controlled trials are needed to further evaluate the safety and efficacy of these catheters for the management of nonmalignant pleural effusions.

A randomised trial of lung sealant versus medical therapy for advanced emphysema.

Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy of ELS in a randomised controlled setting.Patients were randomised to ELS plus medical treatment or medical treatment alone. Despite early termination for business reasons and inability to assess the primary 12-month end-point, 95 out of 300 patients were successfully randomised, providing sufficient data for 3- and 6-month analysis.57 patients (34 treatment and 23 control) had efficacy results at 3 months; 34 (21 treatment and 13 control) at 6 months. In the treatment group, 3-month lung function, dyspnoea, and quality of life improved significantly from baseline when compared to control. Improvements persisted at 6 months with >50% of treated patients experiencing clinically important improvements, including some whose lung function improved by >100%. 44% of treated patients experienced adverse events requiring hospitalisation (2.5-fold more than control, p=0.01), with two deaths in the treated cohort. Treatment responders tended to be those experiencing respiratory adverse events.Despite early termination, results show that minimally invasive ELS may be efficacious, yet significant risks (probably inflammatory) limit its current utility.

Radial probe endobronchial ultrasound and novel navigation biopsy techniques.

Peripheral pulmonary lesions are an increasingly common finding in clinical practice. While many nodules are followed with radiographic surveillance, some may require biopsy. Conventional bronchoscopy with transbronchial lung biopsy has traditionally performed poorly for small, peripheral lesions, and transthoracic needle aspiration with computed tomographic (CT) guidance has been favored as the diagnostic test of choice. Despite the high diagnostic yield of transthoracic needle aspiration, procedural complications such as pneumothorax continue to be problematic. New technology has been developed to improve the diagnostic yield of bronchoscopy for peripheral lesions over conventional methods, while maintaining the favorable safety profile of a bronchoscopic approach. Virtual bronchoscopy and electromagnetic navigation are CT-based image guidance systems that create virtual bronchoscopic representations of the tracheobronchial tree to assist the bronchoscopist in locating peripheral lesions. Radial probe endobronchial ultrasound utilizes real-time ultrasound to confirm the location of peripheral lesions before biopsy. This article summarizes the technical platforms, procedures, and clinical evidence for these emerging technologies.

Inter- and intra-observer variability of radial-endobronchial ultrasound image interpretation for peripheral pulmonary lesions.

Background: Radial probe endobronchial ultrasound (R-EBUS) is often utilized in guided bronchoscopy for the diagnosis of peripheral pulmonary lesions. R-EBUS probe positioning has been shown to correlate with diagnostic yield, but overall diagnostic yield with this technology has been inconsistent across the published literature. Currently there is no standardization for R-EBUS image interpretation, which may result in variability in grading concentricity of lesions and subsequently procedure performance. This was a survey-based study evaluating variability among practicing pulmonologists in R-EBUS image interpretation. Methods: R-EBUS images from peripheral bronchoscopy cases were sent to 10 practicing Interventional Pulmonologists at two different time points (baseline and 3 months). Participants were asked to grade the images as concentric, eccentric, or no image. Cohen's Kappa-coefficient was calculated for inter- and intra-observer variability. Results: A total of 100 R-EBUS images were included in the survey. There was 100% participation with complete survey responses from all 10 participants. Overall kappa-statistic for inter-observer variability for Survey 1 and 2 was 0.496 and 0.477 respectively. Overall kappa-statistic for intra-observer variability between the two surveys was 0.803. Conclusions: There is significant variability between pulmonologists when characterizing R-EBUS images. However, there is strong intra-rater agreement from each participant between surveys. A standardized approach and grading system for radial EBUS patterns may improve inter-observer variability in order to optimize our clinical use and research efforts in the field.

Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study (BENEFIT).

BACKGROUND: The diagnosis of peripheral pulmonary lesions (PPL) continues to present clinical challenges. Despite extensive experience with guided bronchoscopy, the diagnostic yield has not improved significantly. Robotic-assisted bronchoscopic platforms have been developed potentially to improve the diagnostic yield for PPL. Presently, limited data exist that evaluate the performance of robotic systems in live human subjects. RESEARCH QUESTION: What is the safety and feasibility of robotic-assisted bronchoscopy in patients with PPLs? STUDY DESIGN AND METHODS: This was a prospective, multicenter pilot and feasibility study that used a robotic bronchoscopic system with a mother-daughter configuration in patients with PPL 1 to 5 cm in size. The primary end points were successful lesion localization with the use of radial probe endobronchial ultrasound (R-EBUS) imaging and incidence of procedure related adverse events. Robotic bronchoscopy was performed in patients with the use of direct visualization, electromagnetic navigation, and fluoroscopy. After the use of R-EBUS imaging, transbronchial needle aspiration was performed. Rapid on-site evaluation (ROSE) was used on all cases. Transbronchial needle aspiration alone was sufficient when ROSE was diagnostic; when ROSE was not diagnostic, transbronchial biopsy was performed with the use of the robotic platform, followed by conventional guided bronchoscopic approaches at the discretion of the investigator. RESULTS: Fifty-five patients were enrolled at five centers. One patient withdrew consent, which left 54 patients for data analysis. Median lesion size was 23 mm (interquartile range, 15 to 29 mm). R-EBUS images were available in 53 of 54 cases. Lesion localization was successful in 51 of 53 patients (96.2%). Pneumothorax was reported in two of 54 of the cases (3.7%); tube thoracostomy was required in one of the cases (1.9 %). No additional adverse events occurred. INTERPRETATION: This is the first, prospective, multicenter study of robotic bronchoscopy in patients with PPLs. Successful lesion localization was achieved in 96.2% of cases, with an adverse event rate comparable with conventional bronchoscopic procedures. Additional large prospective studies are warranted to evaluate procedure characteristics, such as diagnostic yield. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT03727425; URL: www.clinicaltrials.gov.

Management of Lung Nodules and Lung Cancer Screening During the COVID-19 Pandemic: CHEST Expert Panel Report.

Background: The risks from potential exposure to coronavirus disease 2019 (COVID-19), and resource reallocation that has occurred to combat the pandemic, have altered the balance of benefits and harms that informed current (pre-COVID-19) guideline recommendations for lung cancer screening and lung nodule evaluation. Consensus statements were developed to guide clinicians managing lung cancer screening programs and patients with lung nodules during the COVID-19 pandemic. Materials and Methods: An expert panel of 24 members, including pulmonologists (n = 17), thoracic radiologists (n = 5), and thoracic surgeons (n = 2), was formed. The panel was provided with an overview of current evidence, summarized by recent guidelines related to lung cancer screening and lung nodule evaluation. The panel was convened by video teleconference to discuss and then vote on statements related to 12 common clinical scenarios. A predefined threshold of 70% of panel members voting agree or strongly agree was used to determine if there was a consensus for each statement. Items that may influence decisions were listed as notes to be considered for each scenario. Results: Twelve statements related to baseline and annual lung cancer screening (n = 2), surveillance of a previously detected lung nodule (n = 5), evaluation of intermediate and high-risk lung nodules (n = 4), and management of clinical stage I non-small cell lung cancer (n = 1) were developed and modified. All 12 statements were confirmed as consensus statements according to the voting results. The consensus statements provide guidance about situations in which it was believed to be appropriate to delay screening, defer surveillance imaging of lung nodules, and minimize nonurgent interventions during the evaluation of lung nodules and stage I non-small cell lung cancer. Conclusion: There was consensus that during the COVID-19 pandemic, it is appropriate to defer enrollment in lung cancer screening and modify the evaluation of lung nodules due to the added risks from potential exposure and the need for resource reallocation. There are multiple local, regional, and patient-related factors that should be considered when applying these statements to individual patient care.© 2020 RSNA; The American College of Chest Physicians, published by Elsevier Inc; and The American College of Radiology, published by Elsevier Inc.

Management of Lung Nodules and Lung Cancer Screening During the COVID-19 Pandemic: CHEST Expert Panel Report.

BACKGROUND: The risks from potential exposure to coronavirus disease 2019 (COVID-19), and resource reallocation that has occurred to combat the pandemic, have altered the balance of benefits and harms that informed current (pre-COVID-19) guideline recommendations for lung cancer screening and lung nodule evaluation. Consensus statements were developed to guide clinicians managing lung cancer screening programs and patients with lung nodules during the COVID-19 pandemic. METHODS: An expert panel of 24 members, including pulmonologists (n = 17), thoracic radiologists (n = 5), and thoracic surgeons (n = 2), was formed. The panel was provided with an overview of current evidence, summarized by recent guidelines related to lung cancer screening and lung nodule evaluation. The panel was convened by video teleconference to discuss and then vote on statements related to 12 common clinical scenarios. A predefined threshold of 70% of panel members voting agree or strongly agree was used to determine if there was a consensus for each statement. Items that may influence decisions were listed as notes to be considered for each scenario. RESULTS: Twelve statements related to baseline and annual lung cancer screening (n = 2), surveillance of a previously detected lung nodule (n = 5), evaluation of intermediate and high-risk lung nodules (n = 4), and management of clinical stage I non-small-cell lung cancer (n = 1) were developed and modified. All 12 statements were confirmed as consensus statements according to the voting results. The consensus statements provide guidance about situations in which it was believed to be appropriate to delay screening, defer surveillance imaging of lung nodules, and minimize nonurgent interventions during the evaluation of lung nodules and stage I non-small-cell lung cancer. CONCLUSIONS: There was consensus that during the COVID-19 pandemic, it is appropriate to defer enrollment in lung cancer screening and modify the evaluation of lung nodules due to the added risks from potential exposure and the need for resource reallocation. There are multiple local, regional, and patient-related factors that should be considered when applying these statements to individual patient care.

Management of Lung Nodules and Lung Cancer Screening During the COVID-19 Pandemic: CHEST Expert Panel Report.

BACKGROUND: The risks from potential exposure to coronavirus disease 2019 (COVID-19), and resource reallocation that has occurred to combat the pandemic, have altered the balance of benefits and harms that informed current (pre-COVID-19) guideline recommendations for lung cancer screening and lung nodule evaluation. Consensus statements were developed to guide clinicians managing lung cancer screening programs and patients with lung nodules during the COVID-19 pandemic. METHODS: An expert panel of 24 members, including pulmonologists (n = 17), thoracic radiologists (n = 5), and thoracic surgeons (n = 2), was formed. The panel was provided with an overview of current evidence, summarized by recent guidelines related to lung cancer screening and lung nodule evaluation. The panel was convened by video teleconference to discuss and then vote on statements related to 12 common clinical scenarios. A predefined threshold of 70% of panel members voting agree or strongly agree was used to determine if there was a consensus for each statement. Items that may influence decisions were listed as notes to be considered for each scenario. RESULTS: Twelve statements related to baseline and annual lung cancer screening (n = 2), surveillance of a previously detected lung nodule (n = 5), evaluation of intermediate and high-risk lung nodules (n = 4), and management of clinical stage I non-small cell lung cancer (n = 1) were developed and modified. All 12 statements were confirmed as consensus statements according to the voting results. The consensus statements provide guidance about situations in which it was believed to be appropriate to delay screening, defer surveillance imaging of lung nodules, and minimize nonurgent interventions during the evaluation of lung nodules and stage I non-small cell lung cancer. CONCLUSIONS: There was consensus that during the COVID-19 pandemic, it is appropriate to defer enrollment in lung cancer screening and modify the evaluation of lung nodules due to the added risks from potential exposure and the need for resource reallocation. There are multiple local, regional, and patient-related factors that should be considered when applying these statements to individual patient care.

Robotic Endoscopic Airway Challenge: REACH Assessment.

PURPOSE: Bronchoscopy for peripheral pulmonary lesions continues to present challenges to clinicians. One potential limitation may be the inability to advance conventional bronchoscopes into close proximity of peripheral lesions before biopsy. This study was performed to assess the reach of a robotic endoscopic system within human cadaveric lungs compared with conventional thin bronchoscopes. DESCRIPTION: All segmental bronchi (RB1 to 10, LB1 to 10) were accessed in two human cadavers using a conventional thin bronchoscope and robotic endoscope of identical outer diameter. Bronchus generation count and insertion depth measured by electromagnetic navigation and external fluoroscopy were recorded. EVALUATION: The robotic endoscope was advanced beyond the conventional thin bronchoscope in all segments, particularly in bronchi with increased angulation such as RB1 (mean generation count 8 versus 3.5, respectively) and LB1+2 (mean generation count 8 versus 4.5). CONCLUSIONS: The robotic endoscopic system was advanced beyond a conventional thin bronchoscope with identical outer diameter into the periphery of human cadaveric lungs. Improved reach within the lung periphery may address some limitations with contemporary bronchoscopic approaches for peripheral lesion biopsy.

Localization of Peripheral Pulmonary Lesions Using a Method of Computed Tomography-Anatomic Correlation and Radial Probe Endobronchial Ultrasound Confirmation.

RATIONALE: Peripheral pulmonary lesions requiring a diagnosis continue to present challenges to clinicians. One significant barrier is the inability to reliably locate peripheral lesions by bronchoscopic approaches. Multiplanar computed tomographic (CT) scan reconstruction is available to most physicians and provides axial, coronal, and sagittal images that may be used to estimate target lesion location and guide bronchoscopists during procedures. OBJECTIVES: This study was performed to evaluate a systematic method of CT-anatomic correlation based on multiplanar reconstruction CT scanning with monoplanar fluoroscopy during bronchoscopy to locate peripheral pulmonary lesions and confirm lesion location, using radial probe endobronchial ultrasound. METHODS: A retrospective review of peripheral bronchoscopy cases in which radial probe endobronchial ultrasound for peripheral lesions was performed at a tertiary care, university hospital. All cases involved a systematic approach of reviewing axial, coronal, and sagittal CT reconstructions, coupled with monoplanar fluoroscopy during procedures to assist with locating peripheral lesions. MEASUREMENTS AND MAIN RESULTS: Using the method of CT-anatomic correlation, 332 of 348 (95.4%) of all lesions were successfully localized and confirmed, using radial probe endobronchial ultrasound. Lesions 1-2 cm in size accounted for 45% of all lesions, and the ability to locate lesions was not significantly different based on lesion size. Mean time to lesion localization was 6.8 minutes. Larger lesions and lesions demonstrating an air bronchus sign on CT scan were located in less time. The overall diagnostic yield was 58.9%. CONCLUSIONS: A systematic approach applying CT-anatomic correlation with multiplanar CT scan reconstruction and monoplanar fluoroscopy during procedures can result in an efficient, and successful process for locating peripheral pulmonary lesions.

Adult wilms' tumor metastatic to the lung: endobronchial ultrasound-guided fine needle aspiration biopsy.

Adult Wilms' tumor (WT) is a rare entity with less than 300 cases reported to date in the medical literature. Histologic and cytologic features of adult WT of the kidney are similar to findings in pediatric WT. While the lungs are noted to be the most frequent site of metastatic disease in the pediatric population, the incidence of lung metastases remains unknown for adult WT. A search revealed 38 cases of adult WT with lung metastases published to date in the English literature. Amongst these cases only two have utilized cytology of the lung lesions as a means to arrive at a final diagnosis. We report a case of adult WT metastatic to the lung that was initially diagnosed using endobronchial ultrasound-guided fine needle aspiration biopsy. The aim is to compare the current cytologic and immunohistochemical findings with those cases previously published, to outline the cytologic features of adult WT metastatic to the lung, and to emphasize the significance of cytologic diagnosis in the work-up of adult WT.

Telecytology for EBUS-FNA immediate adequacy assessment: implementation experience at a large academic medical center.

INTRODUCTION: Performing immediate assessment (IA) has become the standard of care for endobronchial ultrasound-guided fine-needle aspiration (EBUS-FNA) specimens. Despite the benefits of aiding interventional pulmonologists to achieve higher adequacy rates and fewer unnecessary passes, the time required by attending cytopathologists to be present for on-site assessments is significant and affects other clinical responsibilities. Telepathology, as implemented here, consists of a cytotechnologist-driven or trainee-driven microscope attached to a Nikon DS-Fi1 Camera and DS-L2 controller that displays dynamic microscopic images in real time on the attending pathologist's office computer. MATERIALS AND METHODS: Preliminary assessment results, final diagnoses, and corresponding surgical pathology diagnoses, when available, were compared between consecutive EBUS-FNA specimens acquired before and after implementation of telepathology-assisted IA. Cases were divided into 3 categories: satisfactory for evaluation, indeterminate for evaluation, and unsatisfactory for evaluation. RESULTS: During the first half of 2012, immediate assessments for adequacy were performed in person by attending pathologists for all cases in the EBUS-FNA suite. There were 209 adequacy assessments performed without the use of telepathology and 289 with telepathology. There were no differences in the relative distribution of satisfactory, indeterminate, and unsatisfactory for evaluation cases, the percentages of diagnostic samples relative to the adequacy category or in the histologic concordance between pretelepathology and post-telepathology cases. CONCLUSIONS: Telepathology-assisted IA of EBUS-FNA allowed for the same diagnostic accuracy as traditional on-site IA and is saves time for pathologists.

Improved laboratory resource utilization and patient care with the use of rapid on-site evaluation for endobronchial ultrasound fine-needle aspiration biopsy.

BACKGROUND: Endobronchial ultrasound guided (EBUS) fine-needle aspiration (FNA) biopsy has become widely used to evaluate patients with thoracic abnormalities. Rapid on-site evaluation (ROSE) can provide the bronchoscopist with immediate evaluation findings during the procedure. This study examines EBUS FNA biopsy procedures with and without ROSE, and investigates the impact of ROSE service on the EBUS procedure and laboratory resource utilization. METHODS: The cytopathology database at Washington University Medical Center, St. Louis, Missouri, was searched for EBUS FNA biopsy cases before and after introduction of ROSE service, and a matched cohort was collected. Reports were reviewed and pertinent data was collected, such as sites biopsied, ROSE performance, slide smears, cell blocks, and diagnostic categories. Statistical analysis of the results was performed. RESULTS: A matched case-controlled EBUS FNA cohort of 340 patients (680 total) for each category of non-ROSE and ROSE service were identified. There was a 33% reduction in the number of sites biopsied with ROSE. A total of 68% of patients with ROSE had just one biopsy site compared to only 36% of non-ROSE patients. There was a 30% decrease in total slides (mean, 5.27 slides) after the introduction of ROSE. All of these improvements were statistically significant. CONCLUSIONS: EBUS FNA biopsy ROSE service benefits patients by contributing to significantly fewer biopsies and improved utilization of health care resources. ROSE service results in substantially fewer total slides, which has a significant impact on the cytopathology laboratory work effort. The use of ROSE for EBUS FNA biopsy provides significant improvements in patient care and laboratory resource utilization.