World Association for Bronchology and Interventional Pulmonology (WABIP) guidelines on airway stenting for malignant central airway obstruction.

Malignant Central Airway Obstruction (MCAO) encompasses significant and symptomatic narrowing of the central airways that can occur due to primary lung cancer or metastatic disease. Therapeutic bronchoscopy is associated with high technical success and symptomatic relief and includes a wide range of airway interventions including airway stents. Published literature suggests that stenting practices vary significantly across the world primarily due to lack of guidance. This document aims to address this knowledge gap by addressing relevant questions related to airway stenting in MCAO. An international group of 17 experts from 17 institutions across 11 countries with experience in using airway stenting for MCAO was convened as part of this guideline statement through the World Association for Bronchology and Interventional Pulmonology (WABIP). We performed a literature and internet search for reports addressing six clinically relevant questions. This guideline statement, consisting of recommendations addressing these six PICO questions, was formulated by a systematic and rigorous process involving the evaluation of published evidence, augmented with expert experience when necessary. Panel members participated in the development of the final recommendations using the modified Delphi technique.

Thoracic ultrasound as a predictor of pleurodesis success at the time of indwelling pleural catheter removal.

BACKGROUND AND OBJECTIVE: IPC in patients with MPE are removed within 3 months in 30-58% of cases, usually due to decreased pleural fluid output as a result of pleurodesis. Disease control can also account for the lack of fluid output, potentially explaining why 4-14% of patients undergo repeat pleural intervention for fluid re-accumulation (at the time of disease recurrence or progression). The aim of our pilot study is to determine the accuracy of thoracic ultrasound (TUS) in predicting pleurodesis success in patients with MPE at the time of IPC removal. METHODS: This is a single-centre, prospective observational cohort study that enrolled consecutive patients with confirmed MPE treated with IPC at the time of IPC removal. TUS was performed to calculate a PAS. Patients were followed up for a minimum of 3 months. Failure was defined as pleural fluid recurrence within 3 months. RESULTS: Twenty-seven patients were screened and 25 were included in the final analysis. Pleurodesis success was observed in 88% (n = 22) and failure in 12% (n = 3) of patients. The mean PAS was higher in patients with pleurodesis success (22.0 vs 9.3, P = 0.01). A PAS greater than 10 predicted pleurodesis success with a sensitivity of 100% and specificity of 86%. CONCLUSION: This pilot study suggests that TUS at the time of IPC removal accurately identifies patients who have achieved pleurodesis and therefore will not have re-accumulation of pleural effusion or require an ipsilateral pleural intervention for at least 3 months post-IPC removal.

Evaluation of Safety and Short-term Outcomes of Therapeutic Rigid Bronchoscopy Using Total Intravenous Anesthesia and Spontaneous Assisted Ventilation.

BACKGROUND: There is a paucity of published data regarding the optimal type of anesthesia and ventilation strategies during rigid bronchoscopy. OBJECTIVE: The aim of our study is to report the procedural and anesthesia-related complications with rigid bronchoscopy using total intravenous anesthesia and spontaneous assisted ventilation. METHODS: A retrospective review of patients undergoing therapeutic rigid bronchoscopy at the University of Chicago between October 2012 and December 2014 was performed. Data were recorded relating to patients' demographics, comorbidities, type of anesthesia, need for neuromuscular blockade (NMB), intraoperative hypoxemia, hypotension, perioperative adverse events, and mortality. RESULTS: Fifty-five patients underwent 79 rigid bronchoscopy procedures; 90% were performed for malignant disease and 90% of patients had an American Society of Anesthesiologists (ASA) class III or IV. The majority (76%) did not require use of NMB. The most common adverse events were intraoperative hypoxemia (67%) and hypotension (77%). Major bleeding and postoperative respiratory failure occurred in 3.8 and 5.1% of procedures, respectively. There was no intraoperative mortality or cardiac dysrhythmias. The 30-day mortality was 7.6% and was associated with older age, inpatient status, congestive heart failure, home oxygen use, and procedural duration. Intraoperative hypoxemia, hypotension, and ASA class were not associated with 30-day mortality. The majority (94%) of patients were discharged home. The use of NMB did not impact outcomes. CONCLUSIONS: This study suggests that therapeutic rigid bronchoscopy can be safely performed with total intravenous anesthesia and spontaneous assisted ventilation in patients with central airway obstruction, significant comorbidities, and a high ASA class. The only significant modifiable variable predicting the 30-day mortality was the duration of the procedure.

Robotic assisted-bronchoscopy: technical tips and lessons learned from the initial experience with sampling peripheral lung lesions.

BACKGROUND: Peripheral pulmonary nodules are increasingly detected in patients screened for lung cancer or during disease progression of thoracic or extrathoracic malignancies. Sampling these lesions requires surgery, computed tomography (CT)-guided biopsy or bronchoscopic interventions. Bronchoscopic interventions are preferable because they have lower complications and often patients may not be ideal candidates for surgical or CT-guided biopsy. In addition, guidelines recommend diagnosis and staging in one single procedure. The diagnostic yield of existing advanced bronchoscopic techniques including electromagnetic navigation, radial probe ultrasonography, ultrathin bronchoscopy or virtual bronchoscopy remains suboptimal. The purpose of this paper is to codify the technique whereby a diagnostic bronchoscopy is performed using the new robotic platform. METHODS: In the present report, I describe the technique for performing robotic-assisted bronchoscopy (RAB) using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). RESULTS: Appropriate team training, patient selection, anesthesia settings, optimal tissue acquisition and processing, and prevention of complications are described and illustrated. CONCLUSIONS: RAB may be beneficial for patients with peripheral lung lesions that require biopsy prior to surgical resection, stereotactic radiation, targeted or immunotherapy.

Robot-assisted bronchoscopy for pulmonary lesion diagnosis: results from the initial multicenter experience.

BACKGROUND: The Robotic Endoscopic System (Auris Health, Inc., Redwood City, CA) has the potential to overcome several limitations of contemporary guided-bronchoscopic technologies for the diagnosis of lung lesions. Our objective is to report on the initial post-marketing feasibility, safety and diagnostic yield of this technology. METHODS: We retrospectively reviewed data on consecutive cases in which robot-assisted bronchoscopy was used to sample lung lesions at four centers in the US (academic and community) from June 15th, 2018 to December 15th, 2018. RESULTS: One hundred and sixty-seven lesions in 165 patients were included in the analysis, with an average follow-up of 185 ± 55 days. The average size of target lesions was 25.0 ± 15.0 mm. Seventy-one percent were located in the peripheral third of the lung. Pneumothorax and airway bleeding occurred in 3.6 and 2.4% cases, respectively. Navigation was successful in 88.6% of cases. Tissue samples were successfully obtained in 98.8%. The diagnostic yield estimates ranged from 69.1 to 77% assuming the cases of biopsy-proven inflammation without any follow-up information (N = 13) were non-diagnostic and diagnostic, respectively. The yield was 81.5, 71.7 and 26.9% for concentric, eccentric and absent r-EBUS views, respectively. Diagnostic yield was not affected by lesion size, density, lobar location or centrality. CONCLUSIONS: RAB implementation in community and academic centers is safe and feasible, with an initial diagnostic yield of 69.1-77% in patients with lung lesions that require diagnostic bronchoscopy. Comparative trials with the existing bronchoscopic technologies are needed to determine cost-effectiveness of this technology.

Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study.

BACKGROUND: Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions. METHODS: NAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing. RESULTS: ENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively. CONCLUSIONS: One-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield. TRIAL REGISTRATION: ClinicalTrials.gov NCT02410837 . Registered 31 March 2015.

Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy.

BACKGROUND: Electromagnetic navigation bronchoscopy (ENB) procedures allow physicians to access peripheral lung lesions beyond the reach of conventional bronchoscopy. However, published research is primarily limited to small, single-center studies using previous-generation ENB software. The impact of user experience, patient factors, and lesion/procedural characteristics remains largely unexplored in a large, multicenter study. METHODS/DESIGN: NAVIGATE (Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy) is a prospective, multicenter, global, cohort study. The study aims to enroll up to 2,500 consecutive subjects presenting for evaluation of lung lesions utilizing the ENB procedure at up to 75 clinical sites in the United States, Europe, and Asia. Subjects will be assessed at baseline, at the time of procedure, and at 1, 12, and 24 months post-procedure. The pre-test probability of malignancy will be determined for peripheral lung nodules. Endpoints include procedure-related adverse events, including pneumothorax, bronchopulmonary hemorrhage, and respiratory failure, as well as quality of life, and subject satisfaction. Diagnostic yield and accuracy, repeat biopsy rate, tissue adequacy for genetic testing, and stage at diagnosis will be reported for biopsy procedures. Complementary technologies, such as fluoroscopy and endobronchial ultrasound, will be explored. Success rates of fiducial marker placement, dye marking, and lymph node biopsies will be captured when applicable. Subgroup analyses based on geography, demographics, investigator experience, and lesion and procedure characteristics are planned. DISCUSSION: Study enrollment began in April 2015. As of February 19, 2016, 500 subjects had been enrolled at 23 clinical sites with enrollment ongoing. NAVIGATE will be the largest prospective, multicenter clinical study on ENB procedures to date and will provide real-world experience data on the utility of the ENB procedure in a broad range of clinical scenarios. TRIAL REGISTRATION: ClinicalTrials.gov NCT02410837 . Registered 31 March 2015.

Interventional pulmonology for asthma and emphysema: bronchial thermoplasty and bronchoscopic lung volume reduction.

Emphysema and asthma are responsible for economic and social burden. Altering the natural course of these diseases is a field of intense research. The National Emphysema Treatment Trial showed that lung volume reduction surgery (LVRS) could significantly reduce both morbidity and mortality in properly selected patients. LVRS is seldom performed, however, due to the high morbidity associated with the surgery. Numerous bronchoscopic interventions have been introduced with the goal of providing the clinical benefits of LVRS without the surgical complications. Thus far, these modalities have not produced the results once hoped. However, through active modification of both technique and patient selection, the role of minimally invasive modalities in the treatment of emphysema continues to evolve. Bronchial thermoplasty (BT) is a method of delivering controlled heat to airway mucosa with the goal of reducing airway smooth muscle mass and hence bronchoconstriction. In patients suffering from asthma who cannot achieve control with standard medical care, BT has been shown to be safe and improves symptoms, with long lasting benefit. BT does not seem to affect traditional markers of asthma severity such as forced expiratory volume in 1 second and questions remain regarding proper patient selection for this therapy and its true physiologic effects. This article is a review of bronchoscopic modalities for emphysema and asthma.

Achieving competency in bronchoscopy: challenges and opportunities.

Bronchoscopy education is undergoing significant changes in step with other medical and surgical specialties that seek to incorporate simulation-based training and objective measurement of procedural skills into training programmes. Low- and high-fidelity simulators are now available and allow learners to gain fundamental bronchoscopy skills in a zero-risk environment. Testing trainees on simulators is currently possible by using validated assessment tools for both essential bronchoscopy and endobronchial ultrasound skills, and more tools are under development for other bronchoscopic techniques. Educational concepts including the 'flipped classroom' model and problem-based learning exercises are increasingly used in bronchoscopy training programmes. These learner-centric teaching modalities require well-trained educators, which is possible thorough the expansion of existing faculty development programmes.

Combined optical coherence tomography and endobronchial ultrasonography for laser-assisted treatment of postintubation laryngotracheal stenosis.

OBJECTIVES: We describe the use of combined optical coherence tomography (OCT) and endobronchial ultrasonography (EBUS) to identify the residual hypertrophic tissues and persistent inflammation that are known contributors to stricture recurrence after laser-assisted mechanical dilation (LAMD) oflaryngotracheal stenosis (LTS). METHODS: Commercially available high-frequency EBUS (approximately 100-microm resolution) and time-domain OCT (approximately 10- to 20-microm resolution) systems were used to visualize airway wall microstructures in the area of hypertrophic tissue formation before and after LAMD in 2 patients with complex circumferential postintubation LTS. RESULTS: Before LAMD, EBUS revealed a homogeneous layer consistent with hypertrophic tissue overlying a hyperechogenic layer corresponding to tracheal cartilage. OCT revealed a homogeneous light backscattering layer and an absence of layered microstructures within hypertrophic tissue. Immediately after LAMD, OCT of the laser-charred tissue showed high backscattering and shadowing artifacts; OCT of noncharred tissue showed bright light backscattering regions that suggested acute inflammation. EBUS revealed thinner but persistent hypertrophic tissue overlying the cartilage. Stenosis recurred in both patients. CONCLUSIONS: Intraoperative use of EBUS and OCT could potentially identify residual hypertrophic tissues and persistent inflammation during or after LAMD. It might help physicians predict stricture recurrence, prompting alternative therapeutic strategies and avoidance of repeated endoscopic treatments for LTS.

Robotic bronchoscopy in diagnosing lung cancer-the evidence, tips and tricks: a clinical practice review.

The development of robotic-assisted bronchoscopy has empowered bronchoscopists to access the periphery of the lung with more confidence and promising accuracy. This is due in large to the superior maneuverability, further reach, and stability of these technologies. Despite the advantages of robotic bronchoscopy, there are some drawbacks to using these technologies, such as the loss of tactile feedback, the need to overcome computed tomography (CT)-to-body divergence, and the potential for overreliance on the navigation software. There are currently two robotic bronchoscopy platforms on the US market, the MonarchTM Platform by Auris Health© (Redwood City, CA, USA) and the IonTM endoluminal robotic bronchoscopy platform by Intuitive Surgical© (Sunnyvale, CA, USA). In this clinical practice review, we highlight the evidence and strategies for successful clinical use of both robotic bronchoscopy platforms for pulmonary lesion sampling. Specifically, we will review pre-procedural considerations, such as procedural mapping, room set-up and anesthesia considerations. We will also review the technical aspects of using the robotic bronchoscopy platforms, such as how to compensate for the loss of tactile feedback, optimize visualization, use of ancillary technology to accommodate for CT-to-body divergence, employ best practices for sampling techniques, and utilize information from rapid on-site evaluation (ROSE) to aid in improving diagnostic yield.

The role of bronchoscopy in the multidisciplinary approach to benign tracheal stenosis.

Benign tracheal stenosis can cause dyspnea, wheezing, and cough mimicking other obstructive lung diseases which often leads to a delay in the diagnosis. Risk factors and etiologies for tracheal strictures include autoimmune diseases, infection, gastro-esophageal reflux disease (GERD), radiation injury and iatrogenic factors such as post-intubation and post-tracheostomy. Once suspected, tracheal strictures are diagnosed by performing a thorough evaluation involving clinical exam, laboratory workup, pulmonary function test, chest imaging and bronchoscopy. Bronchoscopy plays a pivotal role in the diagnosis of stenosis and along with the imaging and physiologic assessments leads to a proper description of the stenosis based on all parameters that matters for management. Surgical resection provides a definitive management in most patients with idiopathic or post intubation/tracheostomy stenosis, however, factors such as severe co-morbidities, length and location of the stricture can preclude patients from undergoing curative surgery. Several bronchoscopic interventions including mechanical or laser assisted dilation, electrosurgery (ES), airway stenting and pharmacological treatment with mitomycin C (MMC) and intralesional steroid have been reported in the literature for management of patients who are not surgical candidates. Herein, we review the role of bronchoscopy and illustrate the importance of a multi-disciplinary team (MDT) approach comprising of interventional pulmonologists, thoracic surgeons and otorhinolaryngologists in the diagnosis and management of patients with benign tracheal stenosis.

Advanced Imaging for Robotic Bronchoscopy: A Review.

Recent advances in navigational platforms have led bronchoscopists to make major strides in diagnostic interventions for pulmonary parenchymal lesions. Over the last decade, multiple platforms including electromagnetic navigation and robotic bronchoscopy have allowed bronchoscopists to safely navigate farther into the lung parenchyma with increased stability and accuracy. Limitations persist, even with these newer technologies, in achieving a similar or higher diagnostic yield when compared to the transthoracic computed tomography (CT) guided needle approach. One of the major limitations to this effect is due to CT-to-body divergence. Real-time feedback that better defines the tool-lesion relationship is vital and can be obtained with additional imaging using radial endobronchial ultrasound, C-arm based tomosynthesis, cone-beam CT (fixed or mobile), and O-arm CT. Herein, we describe the role of this adjunct imaging with robotic bronchoscopy for diagnostic purposes, describe potential strategies to counteract the CT-to-body divergence phenomenon, and address the potential role of advanced imaging for lung tumor ablation.

Factors Associated With Diagnostic Accuracy of Robotic Bronchoscopy With 12-Month Follow-up.

BACKGROUND: Robotic bronchoscopy (RB) aims to increase the diagnostic yield of guided bronchoscopy by providing improved navigation, farther reach, and stability during lesion sampling. METHODS: We reviewed data on consecutive cases in which RB was used to diagnose lung lesions from June 15, 2018, to December 15, 2019, at the University of Chicago Medical Center. RESULTS: The median lesion size was 20.5 mm. All patients had at least 12 months of follow-up. The overall diagnostic accuracy was 77% (95 of 124). The diagnostic accuracy was 85%, 84%, and 38% for concentric, eccentric, and absent radial endobronchial ultrasound (r-EBUS) views, respectively (P < .001). A positive r-EBUS view and lesions size of 20 to 30 mm had higher odds of achieving a diagnosis on multivariate analysis. The 12-month diagnostic accuracy, sensitivity, specificity, and positive and negative predictive value for malignancy were 77%, 69%, 100%, 100%, and 58%, respectively. Pneumothorax was noted in 1.6% (n = 2) patients with bleeding reported in 3.2% (n = 4). No postprocedure respiratory failure was noted. CONCLUSIONS: The overall diagnostic accuracy using RB for pulmonary lesion sampling in our cohort with 12-month follow-up compared favorably with established guided bronchoscopy technologies. Lesion size ≥20 mm and confirmation by r-EBUS predicted higher accuracy independent of concentric or eccentric r-EBUS patterns.

Current Practices Supporting Rigid Bronchoscopy-An International Survey.

BACKGROUND: There are no guidelines for anesthesia or staff support needed during rigid bronchoscopy (RB). Identifying current practice patterns for RB pertinent to anesthesia, multidisciplinary teams, and algorithms of intra and post-procedural care may inform best practice recommendations. METHODS: Thirty-three-question survey created obtaining practice patterns for RB, disseminated via email to the members of the American Association of Bronchology and Interventional Pulmonology and the American College of Chest Physicians Interventional Chest Diagnostic Procedures Network. RESULTS: One hundred seventy-five clinicians participated. Presence of a dedicated interventional pulmonology (IP) suite correlated with having a dedicated multidisciplinary RB team ( P =0.0001) and predicted higher likelihood of implementing team-based algorithms for managing complications (39.4% vs. 23.5%, P =0.024). A dedicated anesthesiology team was associated with the increased use of high-frequency jet ventilation ( P =0.0033), higher likelihood of laryngeal mask airway use post-RB extubation ( P =0.0249), and perceived lower rates of postprocedural anesthesia adverse effects ( P =0.0170). Although total intravenous anesthesia was the most used technique during RB (94.29%), significant variability in the modes of ventilation and administration of muscle relaxants was reported. Higher comfort levels in performing RB are reported for both anesthesiologists ( P =0.0074) and interventional pulmonologists ( P =0.05) with the presence of dedicated anesthesia and RB supportive teams, respectively. CONCLUSION: Interventional bronchoscopists value dedicated services supporting RB. Multidisciplinary dedicated RB teams are more likely to implement protocols guiding management of intraprocedural complications. There are no preferred modes of ventilation during RB. These findings may guide future research on RB practices.

The Effect of Definitions and Cancer Prevalence on Diagnostic Yield Estimates of Bronchoscopy: A Simulation-based Analysis.

Rationale: Studies of bronchoscopy have reported diagnostic yield (DY) using different calculation methods, which has hindered comparisons across studies. Objectives: To quantify the effect of the variability of four methods on DY estimates of bronchoscopy. Methods: We performed a simulation-based analysis of patients undergoing bronchoscopy using variations around base case assumptions for cancer prevalence (60%), distribution of nonmalignant findings, and degree of follow-up information at a fixed sensitivity of bronchoscopy for malignancy (80%). We calculated DY, the rate of true positives and true negatives (TNs), using four methods. Method 1 considered malignant and specific benign findings at index bronchoscopy as true positives and TNs, respectively. Method 2 included nonspecific benign findings as TNs. Method 3 considered nonspecific benign findings cases as TNs only if follow-up confirmed benign disease. Method 4 counted all cases with a nonmalignant diagnosis as TNs if follow-up confirmed benign disease. A scenario analysis and probabilistic sensitivity analysis were conducted to demonstrate the effect of parameter estimates on DY. A change in DY of >10% was considered clinically meaningful. Results: Across all pairwise comparisons of the four methods, a DY difference of >10% was observed in 76.7% of cases (45,992 of 60,000 comparisons). Method 4 resulted in DY estimates that were >10% higher than estimates made with other methods in >90% of scenarios. Variation in cancer prevalence had a large effect on DY. Conclusions: Across a wide range of clinical scenarios, the categorization of nonmalignant findings at index bronchoscopy and cancer prevalence had the largest impact on DY. The large variability in DY estimates across the four methods limits the interpretation of bronchoscopy studies and warrants standardization.

Interventional Pulmonary Fellowship Training: End of the Beginning.

Interventional pulmonology (IP) fellowship training has undergone increased popularity and growth. The Accreditation Council of Graduate Medical Education recently recognized IP medicine as a new subspecialty, which leads to new challenges and opportunities for a young subspecialty. Although the specialty-specific requirements are in progress, IP fellowship programs must plan ahead for the known common program requirements and anticipated accreditation process. The educational leadership in IP must identify and execute solutions to sustain continued excellence. This includes transitioning to a new regulatory environment with issues of funding new fellowships, keeping up to date with training/assessment of new procedures, and shaping the future through recruitment of talent to lead the young subspecialty.