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Malignant central airway obstruction (MCAO) is a debilitating and life-limiting complication that occurs in an unfortunately large number of individuals with advanced intrathoracic cancer. Although the management of MCAO is multimodal and interdisciplinary, the task of providing patients with prompt palliation falls increasingly on the shoulders of interventional pulmonologists. While a variety of tools and techniques are available for the management of malignant obstructive lesions, advancements and evolution in this therapeutic venue have been somewhat sluggish and limited when compared with other branches of interventional pulmonary medicine (e.g., the early diagnosis of peripheral lung nodules). Indeed, one pragmatic, albeit somewhat uncharitable, reading of this article's title might suggest a wry smile and shug of the shoulders as to imply that relatively little has changed in recent years. That said, the spectrum of interventions for MCAO continues to expand, even if at a less impressive clip. Herein, we present on MCAO and its endoscopic and nonendoscopic management-that which is old, that which is new, and that which is still on the horizon.

Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive, image-guided approach to access lung lesions for biopsy or localization for treatment. However, no studies have reported prospective 24-month follow-up from a large, multinational, generalizable cohort. This study evaluated ENB safety, diagnostic yield, and usage patterns in an unrestricted, real-world observational design.The NAVIGATE single-arm, pragmatic cohort study (NCT02410837) enrolled subjects at 37 academic and community sites in seven countries with prospective 24-month follow-up. Subjects underwent ENB using the superDimension navigation system versions 6.3 to 7.1. The prespecified primary end point was procedure-related pneumothorax requiring intervention or hospitalization.A total of 1388 subjects were enrolled for lung lesion biopsy (1329; 95.7%), fiducial marker placement (272; 19.6%), dye marking (23; 1.7%), or lymph node biopsy (36; 2.6%). Concurrent endobronchial ultrasound-guided staging occurred in 456 subjects. General anesthesia (78.2% overall, 56.6% Europe, 81.4% United States), radial endobronchial ultrasound (50.6%, 4.0%, 57.4%), fluoroscopy (85.0%, 41.7%, 91.0%), and rapid on-site evaluation use (61.7%, 17.3%, 68.5%) differed between regions. Pneumothorax and bronchopulmonary hemorrhage occurred in 4.7% and 2.7% of subjects, respectively (3.2% [primary end point] and 1.7% requiring intervention or hospitalization). Respiratory failure occurred in 0.6%. The diagnostic yield was 67.8% (range: 61.9%-70.7%; 55.2% Europe, 69.8% United States). Sensitivity for malignancy was 62.6%. Lung cancer clinical stage was I to II in 64.7% (55.3% Europe, 65.8% United States).Despite a heterogeneous cohort and regional differences in procedural techniques, ENB demonstrates low complications and a 67.8% diagnostic yield while allowing biopsy, staging, fiducial placement, and dye marking in a single procedure.

Building an efficient facility for advanced bronchoscopic procedures involves many considerations. This review places particular emphasis on anesthesiology services, based on experience at a tertiary/quaternary care referral academic medical center. Topics include equipment requirements, applicable clinical standards and multidisciplinary collaboration. Patient flow arrangements for both outpatients and inpatients, from pre-operative care to discharge/disposition are highlighted. The importance of effective business planning, personnel training, leadership, communication, teambuilding, quality of care and patient safety are also discussed.

Background Two models, the Help with the Assessment of Adenopathy in Lung cancer (HAL) and Help with Oncologic Mediastinal Evaluation for Radiation (HOMER), were recently developed to estimate the probability of nodal disease in patients with non-small cell lung cancer (NSCLC) as determined by endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA). The objective of this study was to prospectively externally validate both models at multiple centers. Research Question Are the HAL and HOMER models valid across multiple centers? Study Design and Methods This multicenter prospective observational cohort study enrolled consecutive patients with PET-CT clinical-radiographic stages T1-3, N0-3, M0 NSCLC undergoing EBUS-TBNA staging. HOMER was used to predict the probability of N0 vs N1 vs N2 or N3 (N2|3) disease, and HAL was used to predict the probability of N2|3 (vs N0 or N1) disease. Model discrimination was assessed using the area under the receiver operating characteristics curve (ROC-AUC), and calibration was assessed using the Brier score, calibration plots, and the Hosmer-Lemeshow test. Results Thirteen centers enrolled 1,799 patients. HAL and HOMER demonstrated good discrimination: HAL ROC-AUC = 0.873 (95%CI, 0.856-0.891) and HOMER ROC-AUC = 0.837 (95%CI, 0.814-0.859) for predicting N1 disease or higher (N1|2|3) and 0.876 (95%CI, 0.855-0.897) for predicting N2|3 disease. Brier scores were 0.117 and 0.349, respectively. Calibration plots demonstrated good calibration for both models. For HAL, the difference between forecast and observed probability of N2|3 disease was +0.012; for HOMER, the difference for N1|2|3 was −0.018 and for N2|3 was +0.002. The Hosmer-Lemeshow test was significant for both models (P = .034 and .002), indicating a small but statistically significant calibration error. Interpretation HAL and HOMER demonstrated good discrimination and calibration in multiple centers. Although calibration error was present, the magnitude of the error is small, such that the models are informative.

Advanced interventional pulmonary procedures of the airways, pleural space, and mediastinum continue to evolve and be refined. Health care, finance, and clinical professionals are challenged by both the indications and related coding complexities. As the scope of interventional pulmonary procedures expands with advanced technique and medical innovation, program planning and ongoing collaboration among clinicians, finance executives, and reimbursement experts are key elements for success. We describe advanced bronchoscopic procedures, appropriate Current Procedural Terminology coding, valuations, and necessary modifiers to fill the knowledge gap between basic and advanced procedural coding. Our approach is to balance the description of procedures with the associated coding in a way that is of use to the proceduralist, the coding specialist, and other nonclinical professionals.

Rationale Transbronchial cryobiopsy has been increasingly used to diagnose interstitial lung diseases. However, there is uncertainty regarding its accuracy and risks, mainly due to a paucity of prospective or randomized trials comparing cryobiopsy to surgical biopsy. Objectives To evaluate the diagnostic yield and complications of cryobiopsy in patients selected by multidisciplinary discussion. Methods This was a prospective cohort from 2017 to 2019. We included consecutive patients with suspected interstitial lung diseases being considered for lung biopsy presented at our multidisciplinary meeting. Measurements and main results Of 112 patients, we recommended no biopsy in 31, transbronchial forceps biopsy in 16, cryobiopsy in 54 and surgical biopsy in 11. By the end of the study, 34 patients had had cryobiopsy and 24 patients, surgical biopsy. Overall pathologic and multidisciplinary diagnostic yield of cryobiopsy was 47.1% and 61.8%, respectively. The yield increased over time for both pathologic (year 1: 28.6%, year 2: 54.5%, year 3: 66.7%, p = 0.161) and multidisciplinary (year 1: 50%, year 2: 63.6%, year 3: 77.8%, p = 0.412) diagnosis. Overall rate of grade 4 bleeding after cryobiopsy was 11.8%. Cryobiopsy required less chest tube placement (11.8% vs 100%, p p p = 0.004). Conclusions Diagnostic yield of cryobiopsy increased over time but the overall grade 4 bleeding rate was 11.8%.

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 .

The peripheral pulmonary nodule offers unique challenges to the clinician, especially in regards to diagnostic approach. Quite often the etiology of the nodule is spurious, though the specter of malignancy drives accurate classification of the nodule. Diagnostic approaches range in degrees of invasiveness, accuracy, and morbidity. Bronchoscopic access to these nodules had been plagued by low reported yields, especially in fluoroscopically invisible nodules. Navigational bronchoscopy, however, allowed more accurate access to peripheral nodules while maintaining a low morbidity, and thus reshaped the historic diagnostic algorithms. Though navigational bronchoscopy was initially associated with electromagnetic navigation, newer approaches to navigation and new technologies provide enthusiasm that yield can improve. In this article we will provide a historical approach to navigational bronchoscopy, from its origins to its current state, and we will discuss developing technology and its potential role in the evolving paradigm of the peripheral nodule biopsy.

Lung nodules are being identified with increasing frequency. With this growing burden of nodules comes a growing need for diagnostic technologies extending beyond the current reach of conventional bronchoscopy. One such method for diagnosing peripheral lung lesions is electromagnetic navigational bronchoscopy (ENB), which comprises a set of tools designed to aid the bronchoscopist in identifying, accessing, and sampling peripheral lung lesions under virtual guidance.Herein we present an in-depth review of ENB, including commercially available electromagnetic navigation platforms, factors influencing diagnostic yield, adjunctive imaging and biopsy tools, potential risks, cost, technical shortcomings, and competing technologies. A review of the scientific literature was conducted primarily through PubMed, ScienceDirect, and Google Scholar, and pertinent publications and abstracts from the inception of electromagnetic navigation through early 2020 were considered. We also share our perspective on the future of ENB from both a diagnostic and a therapeutic standpoint.ENB is currently a leading tool in the diagnostic evaluation of peripheral lung lesions. The future of ENB rests not only on its potential to expand into the therapeutic realm but also on its ability to keep pace with competing diagnostic and therapeutic technologies.

Bronchoscopy is essential to the practice of pulmonary medicine. It is an important diagnostic and therapeutic tool for many disease processes. Bronchoscopy can be performed in a variety of clinical settings, from the bedside to an operating room. Although bronchoscopy has been practiced for more than a century, consensus recommendations from stakeholders have yet to be developed for the planning, implementation, and construction of a bronchoscopy suite. A wide range of procedures can be performed via bronchoscopy; therefore, the required tools and the procedure area must be aligned with the needs of the facility. Designing a bronchoscopy suite is by no means a "one size fits all" process. We present an overview of critical features to be considered in the planning for an ideal bronchoscopy suite. We use the term "ideal" because it represents a subjective conception of what is perfect and does not convey a rigid, universal blueprint.

Managing complex benign airway disease is a major challenge in interventional pulmonology. With the introduction of additive manufacturing in the medical field, patient-specific (PS) implants are an innovate prospect for airway management. Historically, stents were oversized to resist migration. However, the optimal degree and impact of stent oversizing remains unclear. The ability to design stents based on computed tomography (CT) invites opportunity to understand sizing. Here, we report a novel three-dimensional (3D) image reconstruction tool to quantify fit repeatedly over time. Analysis of CT imaging before and after successive stent implants in a single patient with different areas of stenosis and malacia was done. Nine PS airway stents over 4 years (five left mainstem and four right mainstem) were studied. The distance between the airway model and stent was calculated. The CT images were correlated to stent designs in CloudCompare software (v2.10-alpha) for novel analysis. Heat map was exported depicting the distances between the airway and the stent to the clinician’s prescribed stent model. Corresponding histograms containing distances, mean, and standard deviation were reported. It is possible to measure stent fit based on heat map quantification on patient imaging. Observation of the airway over time and stent change suggests that the airway became more open over time requiring increased stent diameters. The ability to design and measure stent fit over time can help quantify the utility and impact of PS silicone airway stent. The airway appears to display plasticity such that there is notable change in stent prescription over time.

Rationale: When stereotactic ablative radiotherapy is an option for patients with non–small cell lung cancer (NSCLC), distinguishing between N0, N1, and N2 or N3 (N2|3) disease is important.Objecti...

Background Foregut cysts account for >50% of cystic lesions in the mediastinum, of which bronchogenic cysts are most common. Surgical resection is the most definitive approach for its diagnosis and treatment. A recent systematic review, however, suggests that endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has a role in the management of bronchogenic cyst. We report our experience with EBUS-TBNA in the diagnosis and management of bronchogenic cysts. Methods Medical records of patients with evidence of mediastinal cysts who underwent EBUS-TBNA between 2008 and 2016 were reviewed.The primary aims of this study were to assess EBUS-TBNA diagnostic yield of peri-bronchial cysts and their specific type/origin and to determine its short-term and long-term drainage efficacy. Results A total of 26 patients met the inclusion criteria. The cytopathology diagnosis was compatible with bronchogenic cyst in 4 cases, pleural-pericardial cyst in 3 cases, and 19 were indeterminate cysts. Successful long-term treatment occurred in 5.5% of the subjects. One patient developed inflammatory pericarditis after EBUS-TBNA. Conclusion Diagnostic and therapeutic yield of EBUS-TBNA for mediastinal cysts is limited and surgical resection remains the treatment of choice.

BACKGROUND The Bonastent is one of the newest self-expanding metallic tracheobronchial prostheses being used in the central airways. Experience with this stent is limited; there is a gap in literature. We report herein a case series of Bonastent implantation across a variety of tracheobronchial pathologies. METHODS All adult patients who had a Bonastent implanted within the tracheobronchial tree between November 2017 through May 2018 were included in this case series. Data were derived from a combination of sources: electronic medical records and a Research Electronic Data Capture-based bronchoscopy registry. Demographic, procedural, and short-term outcome data were collected for each patient. RESULTS Thirteen Bonastents were implanted in 11 patients during the observational period. Seven patients were male (64%); the mean age was 62.2 years. The most common indication was nonmalignant airway obstruction in a transplanted lung (n=6, 56%). Over half of all stents (n=8) were implanted in the bronchus intermedius. Three patients (27%) had clinically significant obstruction from their Bonastent. CONCLUSION The Bonastent is the newest self-expanding metallic endotracheobronchial stent on the market. Like any other stent, it has its advantages and drawbacks. Interestingly, we noted 3 instances of tissue ingrowth through the covered portion of the stent. Larger studies with a longer follow-up periods are needed to assess long-term efficacy and safety of this relatively novel stent.

Introduction Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive technology that guides endoscopic tools to pulmonary lesions. ENB has been evaluated primarily in small, single-center studies; thus, the diagnostic yield in a generalizable setting is unknown. Methods NAVIGATE is a prospective, multicenter, cohort study that evaluated ENB using the superDimension navigation system (Medtronic, Minneapolis, Minnesota). In this United States cohort analysis, 1215 consecutive subjects were enrolled at 29 academic and community sites from April 2015 to August 2016. Results The median lesion size was 20.0 mm. Fluoroscopy was used in 91% of cases (lesions visible in 60%) and radial endobronchial ultrasound in 57%. The median ENB planning time was 5 minutes; the ENB-specific procedure time was 25 minutes. Among 1157 subjects undergoing ENB-guided biopsy, 94% (1092 of 1157) had navigation completed and tissue obtained. Follow-up was completed in 99% of subjects at 1 month and 80% at 12 months. The 12-month diagnostic yield was 73%. Pathology results of the ENB-aided tissue samples showed malignancy in 44% (484 of 1092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69%, 100%, 100%, and 56%, respectively. ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher pneumothoraces (requiring admission or chest tube placement) occurred in 2.9%. The ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher bronchopulmonary hemorrhage and grade 4 or higher respiratory failure rates were 1.5% and 0.7%, respectively. Conclusions NAVIGATE shows that an ENB-aided diagnosis can be obtained in approximately three-quarters of evaluable patients across a generalizable cohort based on prospective 12-month follow-up in a pragmatic setting with a low procedural complication rate.

Tracheobronchial injury is a rare but a potentially high-impact event with significant morbidity and mortality. Common etiologies include blunt or penetrating trauma and iatrogenic injury that might occur during surgery, endotracheal intubation, or bronchoscopy. Early recognition of clinical signs and symptoms can help risk-stratify patients and guide management. In recent years, there has been a paradigm shift in the management of tracheal injury towards minimally invasive modalities, such as endobronchial stent placement. Although there are still some definitive indications for surgery, selected patients who meet traditional surgical criteria as well as those patients who were deemed to be poor surgical candidates can now be managed successfully using minimally invasive techniques. This paradigm shift from surgical to nonsurgical management is promising and should be considered prior to making final management decisions.

Background The diagnostic yield of electromagnetic navigation bronchoscopy (ENB) is impacted by biopsy tool strategy and rapid on-site evaluation (ROSE) use. This analysis evaluates usage patterns, accuracy, and safety of tool strategy and ROSE in a multicenter study. Methods NAVIGATE (NCT02410837) evaluates ENB using the superDimension navigation system (versions 6.3 to 7.1). The 1-year analysis included 1215 prospectively enrolled subjects at 29 United States sites. Included herein are 416 subjects who underwent ENB-aided biopsy of a single lung lesion positive for malignancy at 1 year. Use of a restricted number of tools (only biopsy forceps, standard cytology brush, and/or bronchoalveolar lavage) was compared with an extensive multimodal strategy (biopsy forceps, cytology brush, aspirating needle, triple needle cytology brush, needle-tipped cytology brush, core biopsy system, and bronchoalveolar lavage). Results Of malignant cases, 86.8% (361/416) of true positive diagnoses were obtained using extensive multimodal strategies. ROSE was used in 300/416 cases. The finding of malignancy by ROSE reduced the total number of tools used. A malignant ROSE call was obtained in 71% (212/300), most (88.7%; 188/212) by the first tool used (49.5% with aspirating needle, 20.2% with cytology brush, 17.0% with forceps). True positive rates were highest for the biopsy forceps (86.9%) and aspirating needle (86.6%). Use of extensive tool strategies did not increase the rates of pneumothorax (5.5% restricted, 2.8% extensive) or bronchopulmonary hemorrhage (3.6% restricted, 1.1% extensive). Conclusion These results suggest that extensive biopsy tool strategies, including the aspirating needle, may provide higher true positive rates for detecting lung cancer without increasing complications.

Managing complex benign airway disease is a major challenge in interventional pulmonology. Airway stent placement can result in complications due to a variety of factors, including poor fit of the stent in the airway. We report the 1-year outcome of 2 patients with airway disease caused by granulomatosis with polyangiitis (Wegener’s) affecting the left main bronchus and secondary carina. These patients had not responded to systemic therapy or standard bronchoscopic techniques and had complications with commercially available airway stents. We describe a first-in-human, clinical experience to address these issues. Using computed tomography (CT) imaging and 3D printing technology, we generated and implanted patient-specific silicone airway stents to address airway disease. 3D patient-specific stent prescription was created using a CT scan of the patient’s chest and a proprietary software package originally developed for orthopedic surgical planning. Silicone stents were manufactured and implanted. Observation for > 1 year after implantation compared to the 6 months prior to patient-specific stent implant were compared for the number, clinically required stent changes, procedure time, and general clinical improvement per usual standard of care after airway stenting. Patients showed improved durability, a shorter procedure time, and improvement of patient-reported symptoms leading to a reduced need for stent changes and modifications. The use of 3D printing technology to make patient-specific silicone stents is feasible with early clinical proof of concept noting a durable improvement over 1 year of follow-up.

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

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 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.

Endobronchial ultrasonography (EBUS) has become an invaluable tool in the diagnosis of patients with a variety of thoracic abnormalities. The majority of EBUS procedures are used to diagnose and stage mediastinal and hilar abnormalities, as well as peripheral pulmonary targets, with a probe-based technology. Nearly 1,000 articles have been written about its use and utility. New Current Procedural Terminology (CPT) codes have been introduced in 2016 to better capture the work and clinical use associated with the various types of EBUS procedures. The existing 31620 code has been deleted and replaced by three new codes: 31652, 31653, and 31654. These new codes have been through the valuation process, and the new rule for reimbursement has been active since January 1, 2016 with National Correct Coding Initiative correction as of April 1, 2016. The impact of these new codes will result in a net reduction in professional and technical reimbursement. This article describes the current use of EBUS and explains the current codes and professional reimbursement.

The value of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in the mediastinal staging of lung cancer has been well established. However, data regarding its utility in the diagnosis of intrapulmonary lesions has been sparse. This study assesses the sampling utility of convex probe EBUS-visible intrapulmonary lesions not visualized by the white-light bronchoscopy.A retrospective analysis of EBUS-TBNA of EBUS-visible intrapulmonary lesions was performed between January 2010 and March 2015. Patients with visible endobronchial lesions by white-light bronchoscopy were excluded from analysis.Among 108 procedures, the diagnostic yield of EBUS-TBNA for EBUS-visible intrapulmonary lesions was 87%. Following diagnoses were established: lung cancer (73/67.6%), lung metastases (10/9.2%), infection (5/4.6%), lymphoma (1/1%), sarcoma/spindle cell sarcoma or neoplasm (3/2.8%), unspecified malignancy (11%), and hamartoma (1/1%). EBUS-TBNA was nondiagnostic in 14 (13%); among these, 9 turned out to have benign disease based on additional bronchoscopy samples or other testing and/or follow-up imaging. Five were ultimately diagnosed with a malignant condition: lymphoma (1), epithelioid hemangioendothelioma (1), and non-small cell lung cancer (3). The sensitivity and the negative predicted value of EBUS-TBNA for differentiating malignancy from benign disease was 94.7% and 75%, respectively, while the accuracy for diagnosing the neoplastic disease was 95.3%. There was one major bleeding requiring bronchial artery embolization and 1 pneumothorax requiring chest tube drainage.EBUS-TBNA is safe and effective in the diagnosis of EBUS-visible intrapulmonary lesions. It should be considered as the diagnostic test of choice in patients with these lesions undergoing EBUS-TBNA for the staging of suspected lung cancer.

BACKGROUND The use of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for diagnosis and staging of benign and malignant thoracic disease has rapidly evolved into the standard of care. The lymph node stations that can be reached by EBUS and EUS are substantially more than those that can be accessed by mediastinoscopy. In rare cases, the clinician is faced with extraordinary circumstances in which a minimally invasive approach to the lymph nodes in station 5 is required. We present our findings in 10 cases, at 7 different institutions, where EBUS was instrumental in reaching a diagnosis. METHODS We retrospectively collected 10 cases where EBUS-TBNA was performed through the pulmonary artery in an attempt to reach the territory of lymph node station 5. All cases were performed by experienced interventional pulmonologists at 7 tertiary care centers in the United States and Canada. We describe the patients' demographics, comorbidities, complications, and cytopathology. RESULTS A definitive diagnosis was reached in 9 of the 10 patients. One case showed atypical cells and required a confirmatory Chamberlain procedure. No complications occurred as a result of careful transpulmonary artery needle aspiration. CONCLUSIONS This multicenter case series suggests that transpulmonary artery needle aspiration guided by EBUS is possible and safe in the hands of experienced interventional pulmonologists. It is important to recognize that this is not an alternative to left VATS or Chamberlain procedure, but a last resort procedure.

BACKGROUND Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is well established for the staging and diagnosis of lung cancer and mediastinal lymphadenopathy. Central mediastinal vascular structures may preclude EBUS-TBNA access to lymph nodes in the aortopulmonary window and certain centrally located parenchymal lesions. Thus, a transvascular approach is necessitated. Few such reports exist in the literature. METHODS We retrospectively analyzed the results of endobronchial ultrasound-guided transvascular needle aspiration (EBUS-TVNA) performed over 1 year to sample mediastinal lymph nodes (stations: 5) and lung lesions inaccessible by standard bronchoscopy or EBUS-TBNA. Data regarding the indication, location, size, and relationship to adjacent blood vessels, the number of transvascular passes, EBUS-TVNA diagnosis, the final diagnosis, procedural images, and complications were collected. Patients' charts were reviewed for 6 months after the procedure for evidence of late complications, including mediastinitis or mediastinal hemorrhage. RESULTS Of 865 EBUS-TBNA procedures, 10 were performed by traversing the pulmonary artery or its branches. Nine were for left-sided lesions, 3 for hilar parenchymal nodules, 6 for hilar or mediastinal LN, and the remainder for a right-sided mass. Rapid-onsite evaluation was either diagnostic or positive for lymphoid cells in 9 patients and the final cytopathology was diagnostic in 9 patients: 5 non-small cell lung cancer, 1 small cell cancer, 1 metastatic colon cancer, and 2 normal lymphoid tissue. One patient had necrosis and required video assisted thoracoscopic surgery to diagnose histoplasmosis. Bleeding was insignificant, with no short-term/long-term complications. CONCLUSIONS From our single-center experience, we conclude that in experienced hands, EBUS-TVNA is feasible, with a high yield, but without complications. Larger prospective trials are warranted to explore its diagnostic potential.

Based on its clinical effectiveness, bronchial thermoplasty (BT) was approved by the Food and Drug Administration in 2010 for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well-controlled with inhaled corticosteroids and long-acting beta-agonist medicines.Assess the 10 year cost-effectiveness of BT for individuals with severe uncontrolled asthma.Using a Markov decision analytic model, the cost-effectiveness of BT was estimated. The patient population involved a hypothetical cohort of 41-year-old patients comparing BT to usual care over a 10-year time frame. The main outcome measure was cost in 2013 dollars per additional quality adjusted life year (QALY).Treatment with BT resulted in 6.40 QALYs and $7512 in cost compared to 6.21 QALYs and $2054 for usual care. The incremental cost-effectiveness ratio for BT at 10 years was $29,821/QALY. At a willingness to pay per QALY of $50,000, BT continues to be cost effective unless the probability of severe asthma exacerbation drops below 0.63 exacerbation per year or the cost of BT rises above $10,384 total for all three bronchoscopic procedures needed to perform thermoplasty and to cover the entire bronchial tree (baseline = $6690).BT is a cost-effective treatment for asthmatics at high risk of exacerbations. Continuing to follow asthmatics treated with BT beyond 5 years will help inform longer efficacy and support its cost-effectiveness.

BACKGROUND There are significant variations in how therapeutic bronchoscopy for malignant airway obstruction is performed. Relatively few studies have compared how these approaches affect the incidence of complications. METHODS We used the American College of Chest Physicians (CHEST) Quality Improvement Registry, Evaluation, and Education (AQuIRE) program registry to conduct a multicenter study of patients undergoing therapeutic bronchoscopy for malignant central airway obstruction. The primary outcome was the incidence of complications. Secondary outcomes were incidence of bleeding, hypoxemia, respiratory failure, adverse events, escalation in level of care, and 30-day mortality. RESULTS Fifteen centers performed 1,115 procedures on 947 patients. There were significant differences among centers in the type of anesthesia (moderate vs deep or general anesthesia, P .001), use of rigid bronchoscopy ( P .001), type of ventilation (jet vs volume cycled, P .001), and frequency of stent use (P P = .002). Risk factors for complications were urgent and emergent procedures, American Society of Anesthesiologists (ASA) score > 3, redo therapeutic bronchoscopy, and moderate sedation. The 30-day mortality was 14.8%; mortality varied among centers (range, 7.7%-20.2%, P = .02). Risk factors for 30-day mortality included Zubrod score > 1, ASA score > 3, intrinsic or mixed obstruction, and stent placement. CONCLUSIONS Use of moderate sedation and stents varies significantly among centers. These factors are associated with increased complications and 30-day mortality, respectively.

BACKGROUND There is significant variation between physicians in terms of how they perform therapeutic bronchoscopy, but there are few data on whether these differences impact effectiveness. METHODS This was a multicenter registry study of patients undergoing therapeutic bronchoscopy for malignant central airway obstruction. The primary outcome was technical success, defined as reopening the airway lumen to > 50% of normal. Secondary outcomes were dyspnea as measured by the Borg score and health-related quality of life (HRQOL) as measured by the SF-6D. RESULTS Fifteen centers performed 1,115 procedures on 947 patients. Technical success was achieved in 93% of procedures. Center success rates ranged from 90% to 98% ( P = .02). Endobronchial obstruction and stent placement were associated with success, whereas American Society of Anesthesiology (ASA) score > 3, renal failure, primary lung cancer, left mainstem disease, and tracheoesophageal fistula were associated with failure. Clinically significant improvements in dyspnea occurred in 90 of 187 patients measured (48%). Greater baseline dyspnea was associated with greater improvements in dyspnea, whereas smoking, having multiple cancers, and lobar obstruction were associated with smaller improvements. Clinically significant improvements in HRQOL occurred in 76 of 183 patients measured (42%). Greater baseline dyspnea was associated with greater improvements in HRQOL, and lobar obstruction was associated with smaller improvements. CONCLUSIONS Technical success rates were high overall, with the highest success rates associated with stent placement and endobronchial obstruction. Therapeutic bronchoscopy should not be withheld from patients based solely on an assessment of risk, since patients with the most dyspnea and lowest functional status benefitted the most.

Lung nodules are being increasingly detected, particularly with lung cancer screening with low-dose computed tomography. Although the vast majority of lung nodules are benign, many often require tissue diagnosis. Several modalities to obtain diagnostic tissue from peripheral lung nodules are available. Bronchoscopic modalities such as radial ultrasound and electromagnetic navigational bronchoscopy are becoming increasingly used because of their superior safety profile and improving diagnostic yield. Although these modalities continue to become more advanced, newer and complementary technologies appear promising.

Tracheal or bronchial-mediastinal fistulas are a rare entity associated to high mortality. We report a case of a 58-year-old man with an unresectable non-small cell carcinoma of the lung, treated with chemoradiation followed by bevacizumab. Approximately, 6 weeks after starting bevacizumab he developed a severe cough with copious secretions He could not lie supine due to the feeling of drowning. Investigations revealed a large tracheo-mediastinal-parenchymal-pleural fistula. Palliative management was offered with interventional bronchoscopic techniques. He was found to have a large central airway defect that obliterated almost 40% of the trachea. Under general anesthesia and positive pressure ventilation, a unique approach was used to rebuild an eroded tracheal and right main stem bronchial wall. A self-expanding metallic stent (SEMS) was placed to provide a scaffold of support, whereas a Dumon Y-stent was placed inside the SEMS. This combination allowed for a patent, stable airway; recreating the normal anatomy in a minimally invasive manner walling off the fistula. The patient was discharged 2 days after the bronchoscopic intervention, with significant palliation of his symptomatology. Eighteen months later, the upper lobe cavity persists with a stable airway and stents perfectly positioned with clinically insignificant evidence of stent related granulation in the upper trachea.

Background Airway stents are traditionally used in central airway obstructions to maintain airway patency. Historically, distal bronchial stenting within lobar and segmental bronchi has not been amenable to stenting. In addition, there are questionable benefits to stenting small airways. The Atrium iCast stent is a polytetrafluoroethylene covered stainless steel balloon deployed stent which can be deployed through a flexible bronchoscope under direct visualization. The purpose of this study was to assess the feasibility, complications, and long-term impact of using this stent in patients with lobar bronchial stenosis either secondary to malignancy or benign etiologies. Methods All records of patients who had the placement of an iCast stent were reviewed over 3.5 years. For each patient the age, sex, location, histology, stent size, duration of stent placement, radiographic improvement, and complications were collected. Results A total of 122 iCast stents were deployed in 38 patients with lobar bronchial stenosis. The average age was 58 years with 50% male. The etiology included 45% malignant and 55% due to benign conditions. In total, 18.5% patients had stents placed in >1 segment. There was an average of 4 procedures per patient with a mean time to stent revision or removal of 85 days. All patients had symptomatic or radiographic improvement. Common complications included migration (10%), granulation tissue formation (5%), deployment malfunction (2%), stent dislodgement immediately after deployment (2%), mucous plugging (1%), and tumor occlusion (1%). Conclusion Stenting small airways with lobar salvage is feasible and improves symptoms and radiographic outcomes.

A 68-year-old man with chronic myelogenous leukemia presents for evaluation of 2 months of dyspnea with exertion. He denies cough, fever, chest pain, weight gain, orthopnea, and edema. Since diagnosis of chronic myelogenous leukemia 5 years ago, he has been treated with dasatinib, with recent BCR-ABL1 assay showing no detectable disease in the peripheral blood. Medical history also includes hyperlipidemia, prostate enlargement, and hypothyroidism, but no prior heart or lung disease. Born in the Middle East, he immigrated to the United States 30 years ago and is working as a physician. He received the Bacillus Calmette-Guérin vaccine as a child. Quantiferon Gold test 1 year ago was positive (TB antigen response 0.91, reference range in 0.35), but he has not received treatment for this. He is a lifelong nonsmoker and rarely drinks alcohol. Medications include dasatinib, rosuvastatin, levothyroxine, tamsulosin, and dutasteride.

To highlight a potentially fatal complication of broncho-vascular fistula arising from the self expanding metallic stent (SEMS) placement. We retrospectively analyzed five patients with benign and malignant airway diseases, who developed tracheo/broncho-vascular fistulas following SEMS placement in our tertiary care setting. All patients received either Wallstent or Ultraflex ® stent (Boston Scientific, Natick, MA) between 1999 and 2007. All patients had received adjunct therapy such as balloon bronchoplasty, laser therapy or electrocautery. Most patients presented with massive hemoptysis. A total of 483 SEMS were placed during this period. SEMS placement can be complicated by Broncho-vascular fistula formation. True incidence and precise time interval between the insertion of stent and onset of this complication is unknown. Additional therapeutic modalities to maintain stent patency may enhance the risk of fistula formation. SEMS should only be used in a select sub-group of patients, after exhaustive evaluation of other treatment options. These cases provide evidence that broncho-vascular fistulas can develop at any time following SEMS placement, suggesting the need for a more cautious approach, especially while using them for a long term management. In benign airway disease, the stent should be removed as soon as healing has taken place.

Estimating the probability of finding N2 or N3 (prN2/3) malignant nodal disease on endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in patients with non-small cell lung cancer (NSCLC) can facilitate the selection of subsequent management strategies.To develop a clinical prediction model for estimating the prN2/3.We used the AQuIRE (American College of Chest Physicians Quality Improvement Registry, Evaluation, and Education) registry to identify patients with NSCLC with clinical radiographic stage T1-3, N0-3, M0 disease that had EBUS-TBNA for staging. The dependent variable was the presence of N2 or N3 disease (vs. N0 or N1) as assessed by EBUS-TBNA. Univariate followed by multivariable logistic regression analysis was used to develop a parsimonious clinical prediction model to estimate prN2/3. External validation was performed using data from three other hospitals.The model derivation cohort (n = 633) had a 25% prevalence of malignant N2 or N3 disease. Younger age, central location, adenocarcinoma histology, and higher positron emission tomography-computed tomography N stage were associated with a higher prN2/3. Area under the receiver operating characteristic curve was 0.85 (95% confidence interval, 0.82-0.89), model fit was acceptable (Hosmer-Lemeshow, P = 0.62; Brier score, 0.125). We externally validated the model in 722 patients. Area under the receiver operating characteristic curve was 0.88 (95% confidence interval, 0.85-0.90). Calibration using the general calibration model method resulted in acceptable goodness of fit (Hosmer-Lemeshow test, P = 0.54; Brier score, 0.132).Our prediction rule can be used to estimate prN2/3 in patients with NSCLC. The model has the potential to facilitate clinical decision making in the staging of NSCLC.

Electromagnetic navigational bronchoscopy is a useful addition to the array of modalities available to sample peripheral lung lesions. Its utility in diagnosing peripheral lesions has been steadily increasing since the Food and Drug Administration first approved it in 2004. The improvement can be attributed to continuous refinement in technology, increasing training and experience with the procedure, perhaps widespread availability of rapid onsite cytologic evaluation, and better patient selection. It may also be attributable to improvements of the technology and more available tools to perform biopsy of the peripheral lung.

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. Electronic supplementary material The online version of this article (doi:10.1186/s12890-016-0228-y) contains supplementary material, which is available to authorized users.