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Thomas R Gildea,1 Stacey DaCosta Byfield,2 D Kyle Hogarth,3 David S Wilson,4 Curtis C Quinn5 1Department of Pulmonary, Allergy, and Critical Care Medicine and Transplant Center, Cleveland Clinic, Cleveland, OH, 2Health Economics and Outcomes Research, Optum, Eden Prairie, MN, 3Department of Medicine, Section of Pulmonary and Critical Care, University of Chicago Medical Center, Chicago, IL, 4The Lung Institute, Columbus Regional Hospital, Columbus, IN, 5Cardiothoracic Surgery/Thoracic Surgery, Cardiothoracic Surgery of Charleston, Roper St. Francis Physician Partners Group, Charleston, SC, USA Purpose: Diagnosis of lung cancer at advanced stages can result in missed treatment opportunities, worse outcomes, and higher health care costs. This study evaluated the wait time to diagnose non-small-cell lung cancer (NSCLC) and the cost of diagnosis and treatment based on the stage at diagnosis. Patients and methods: Adult patients diagnosed with NSCLC between January 2007 and September 2011 were identified from a proprietary oncology registry and linked to health insurance claims from a large US health insurance company. Continuous enrollment in the health plan was required for at least 12 months prediagnosis (baseline) and at least 3 months postdiagnosis (follow-up). Use of diagnostic tests and time to diagnosis were examined. The rates of health care utilization and per-patient per-month (PPPM) health care costs were calculated. Results: A total of 1,210 patients with NSCLC were included in the analysis. Most patients (93.6%) had evidence of diagnostic tests beginning 5 to 6 months prior to diagnosis, and most were diagnosed at an advanced stage (23% Stage IIIb and 46% Stage IV). The PPPM total health care costs in USD pre- and postdiagnosis were $2,407±$3,364 (mean±standard deviation) and $16,577±$33,550, respectively. PPPM total health care costs and utilization after lung cancer diagnosis were significantly higher among patients diagnosed at Stage IV disease and lowest among patients diagnosed at Stage I disease ($7,239 Stage I, $9,484 Stage II, $11,193 Stage IIIa, $17,415 Stage IIIb, and $21,441 Stage IV). Conclusion: This study showed that most patients experienced long periods of delay between their first diagnostic test for lung cancer and a definitive diagnosis, and the majority were diagnosed at advanced stages of disease. Costs associated with the management of lung cancer increased substantially with higher stages at diagnosis. Procedures that diagnose lung cancer at earlier stages may allow for less resource use and costs among patients with lung cancer. Keywords: biopsy (lung), cost, health care utilization, pulmonary nodule, staging

RATIONALE: Electromagnetic navigation bronchoscopy using superDimension/Bronchus System is a novel method to increase diagnostic yield of peripheral and mediastinal lung lesions. OBJECTIVES: A prospective, open label, single-center, pilot study was conducted to determine the ability of electromagnetic navigation bronchoscopy to sample peripheral lung lesions and mediastinal lymph nodes with standard bronchoscopic instruments and demonstrate safety. METHODS: Electromagnetic navigation bronchoscopy was performed using the superDimension/Bronchus system consisting of electromagnetic board, position sensor encapsulated in the tip of a steerable probe, extended working channel, and real-time reconstruction of previously acquired multiplanar computed tomography images. The final distance of the steerable probe to lesion, expected error based on the actual and virtual markers, and procedure yield was gathered. MEASUREMENTS: 60 subjects were enrolled between December 2004 and September 2005. Mean navigation times were 7 +/- 6 min and 2 +/- 2 min for peripheral lesions and lymph nodes, respectively. The steerable probe tip was navigated to the target lung area in all cases. The mean peripheral lesions and lymph nodes size was 22.8 +/- 12.6 mm and 28.1 +/- 12.8 mm. Yield was determined by results obtained during the bronchoscopy per patient. RESULTS: The yield/procedure was 74% and 100% for peripheral lesions and lymph nodes, respectively. A diagnosis was obtained in 80.3% of bronchoscopic procedures. A definitive diagnosis of lung malignancy was made in 74.4% of subjects. Pneumothorax occurred in two subjects. CONCLUSION: Electromagnetic navigation bronchoscopy is a safe method for sampling peripheral and mediastinal lesions with high diagnostic yield independent of lesion size and location. [ABSTRACT FROM AUTHOR]

Bronchial dehiscence after lung transplantation is difficult to treat and associated with high mortality. We describe our experience using self-expanding metallic stents to treat post-lung transplant bronchial dehiscence. From January 1995 to June 2004, 189 single and 118 double lung transplants were performed in our institution, totaling 425 at-risk bronchial anastomoses. Seven (1.6%) incidents of life-threatening bronchial dehiscence were treated with self-expanding metallic stents. The interval between transplant and diagnosis of dehiscence was 29.1 +/- 18.5 days. All patients presented with respiratory distress, and three required mechanical ventilation. Self-expanding metallic stent placement resulted in complete bronchial healing. All three patients with respiratory failure requiring mechanical ventilation were successfully weaned after stent placement. In two later cases, the stents were electively removed after adequate healing of the dehiscence. Complications included stent migration (one patient) and in-stent stenosis (three patients). Two of these patients required repeat stent insertion after removal, due to bronchomalacia. In patients with life-threatening bronchial dehiscence, self-expanding metallic stents offer prospects for a successful outcome. Self-expanding metallic stents are known to be associated with significant granulation tissue formation, and this property provides a platform for healing of dehiscence and, in time, peribronchial soft tissue grows in to cover the defect, allowing stent removal. [ABSTRACT FROM AUTHOR]

CONTEXT: The long-term survival of patients with cirrhosis of the liver admitted to the ICU has not been described. OBJECTIVE: The main objectives were to determine the 1-year and 5-year mortality rates of a cohort of patients admitted to a medical ICU (MICU), and to identify the risk factors that may predict long-term outcomes. DESIGN: This is a cohort study. We used a model-building (MB) and model validation (MV) procedure that has previously been described to determine the risk factors for overall mortality.Settings: An MICU in a major referral medical center. PATIENTS: Four hundred twenty consecutive patients admitted to the ICU from January 1, 1993, through October 31, 1998, met the inclusion criteria of diagnosis of liver failure, cirrhosis, chronic liver disease, variceal bleeding, hepatic encephalopathy, or hepatorenal syndrome. Patients with acute liver failure who had undergone liver transplantation, or candidates for orthotopic liver transplantation were excluded. INTERVENTION: None. RESULTS: The 1-year mortality rate was 69%, and the 5-year mortality rate was 77%. The median survival time was 1 month. The independent predictors of mortality in patients in the MB group who retained their significance in the MV group were as follows: an acute physiology, age, and chronic health evaluation (APACHE) III score of >/= 90 (hazard ratio [HR], 2.2; 95% confidence interval [CI], 1.6 to 2.8; p < 0.0001), the use of pressors (HR, 2.5; 95% CI, 1.9 to 3.2; p < 0.0001), and jaundice (HR, 1.7; 95% CI, 1.4 to 2.2; p < 0.0001). Patients with all three risk factors (ie, APACHE III score >/= 90, use of pressors, and jaundice) had a 92% 1-month mortality rate compared to 11.2% for patients with no risk factors. CONCLUSIONS: Patients admitted to an MICU with underlying cirrhosis who are not eligible for liver transplantation have a poor long-term prognosis, even if they survive the ICU admission, particularly as the number of risk factors increases. [ABSTRACT FROM AUTHOR]

Glomus tumors are derived from the normal glomus body, which is an arteriovenous confluence involved with thermoregulation. These true glomus tumors are different from the "glomus tumors" derived from the paraganglion system often encountered by the otolaryngologist. Glomus tumors have been reported in a variety of locations including the pancreas, perineum, nasal cavity, and torso; however, most are found in the extremities. We present the first case of a laryngeal glomangiomyoma. Furthermore, this lesion was successfully excised endoscopically with a CO2 laser. [ABSTRACT FROM AUTHOR]

Purpose of Review: This review provides an overview of the evolving field of airway stenting (AS), highlighting its relevance in the management of central airway obstruction (CAO). It discusses recent advancements, including 3D-printed silicone stents (3DPSS), metallic stents, biodegradable stents (BS), and drug-eluting stents (DES), which are transforming clinical practice. The review underscores the ongoing challenges in patient selection, stent choice, and long-term management in the context of an evolving landscape., Recent Findings: Innovations, particularly 3DPSS, have shown promise in providing patient-specific solutions. These stents offer improved symptom relief, enhanced quality of life, and lower complication rates, especially for complex airway diseases. The use of BS and DES is explored, raising prospects for future applications., Summary: The evolution of AS reflects a deepening understanding of airway obstructions. Recent innovations, such as 3DPSS, BS, and DES, show considerable promise in addressing the limitations of conventional stents. However, challenges related to complications, patient selection, and long-term management persist, demanding further research. Wide practice variations in the management of AS highlight the need for more clinical data and standardized guidelines. The search for the ideal stent continues, driven by the pursuit of better outcomes for patients with CAO., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Interventional pulmonologists require a unique set of skills including precise motor abilities and physical endurance, but surprisingly the application of ergonomic principles in the field of bronchoscopy remains limited. This is particularly intriguing when considering the significant impact that poor ergonomics can have on diagnostic aptitude, income potential and overall health. It is therefore imperative to provide comprehensive education to physicians regarding the significance of ergonomics in their work, especially considering the introduction of advanced diagnostic and therapeutic procedures. By implementing simple yet effective measures ( e.g. maintaining neutral positions of the wrist, neck and shoulder; adjusting the height of tables and monitors; incorporating scheduled breaks; and engaging in regular exercises), the risk of injuries can be substantially reduced. Moreover, objective tools are readily available to assess ergonomic postures and estimate the likelihood of work-related musculoskeletal injuries. This review aims to evaluate the current literature on the impact of procedure-related musculoskeletal pain on practising pulmonologists and identify modifiable factors for future research., Competing Interests: Conflict of interest: All authors have nothing to disclose., (Copyright ©The authors 2023.)

The primary function of an airway stent is to reestablish patency, impeding restenosis, supporting the tracheobronchial wall, or occluding fistulas. But stent-related complications are prevalent and can have devastating consequences. For this reason, stents are considered a last resort when there are no alternatives in treatment. Additionally, commercially available airway stents often poorly fit patients with complex airways, and they can cause various complications. At the end of the 20th century, three-dimensional (3D) printing technology was created. It has been transformative in healthcare and has been used in several applications. One of its first utilizations was the anatomical modeling of body structures that helps preoperative planning. In respiratory medicine, this technology has been essentially used in central airway diseases to produce 3D airway models and to create airway splints and prostheses. In the last decade, it has led to a transformation and allowed progress in personalized medicine, making patient-specific stents for individuals with complex airway problems. A patient-specific stent using 3D printing may minimize complications, improve quality of life, and reduce the need for repeated procedures. This review describes the recent advances in 3D printing technology, its use for developing airway prostheses to treat complex airway diseases, and the current evidence that supports its use., Competing Interests: Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at https://atm.amegroups.com/article/view/10.21037/atm-22-2878/coif). The series “Lung Cancer Management—The Next Decade” was commissioned by the editorial office without any funding or sponsorship. TRG reports that Cleveland Clinic and Cleveland Clinic Institutional Officials/Leaders have an equity interest in Visionair and are entitled to royalty payments from the company for technology developed at Cleveland Clinic. Visionair is the manufacturer of the stents. TRG is the inventor and may be entitled to royalty payments from the company in accordance with Cleveland Clinic policy. The authors have no other conflicts of interest to declare., (2023 Annals of Translational Medicine. All rights reserved.)

German laryngologist Gustav Killian performed the first "Direkte Bronchoskopie" using a rigid bronchoscope to extract a foreign airway body from the right main bronchus over a hundred years ago, transforming the practice of respiratory medicine. The procedure instantaneously became popular throughout the world. Chevalier Jackson Sr from the United States further advanced the instrument, technique, safety, and application. In the 1960s, Professors Harold H. Hopkins and N.S. Kapany introduced optical rods as well as fiberoptics that led Karl Storz to develop the cold light system improving endoluminal illumination, achievements that ushered in the modern era of flexible endoscopy. Several diagnostic and therapeutic procedures became possible such as transbronchial needle biopsy, transbronchial lung biopsy, airway electrosurgery, or cryotherapy. Dr. Jean-François Dumon from France advanced the use of Nd-YAG laser in the endobronchial tree and created the dedicated Dumon silicone stent introducing the whole new field of interventional pulmonology (IP). This major milestone revitalized interest in rigid bronchoscopy (RB). Now, advancements are being made in stenting, instrumentation, and education. RB robotic technology advancements are currently anticipated and can potentially revolutionize the practice of pulmonary medicine. In this review, we describe some of the most substantial advances related to RB from its beginning to the modern era., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-22-779/coif). Cleveland Clinic and Cleveland Clinic Institutional Officials/Leaders have an equity interest in Visionair and are entitled to royalty payments from the company for technology developed at Cleveland Clinic. Visionair is the manufacturer of the stents mentioned in this review. TRG is the inventor and may be entitled to royalty payments from the company in accordance with Cleveland Clinic policy. The other authors have no conflicts of interest to declare., (2023 Journal of Thoracic Disease. All rights reserved.)

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.

Background: Endoscopic therapies are firmly established in the management algorithm of benign subglottic and tracheal stenosis (SGTS). The optimal dilation strategy, however, has yet to be elucidated. The objective of this study was to compare the efficacy and safety of balloon versus rigid bronchoplasty in the treatment of benign SGTS., Methods: De novo cases of benign SGTS at our institution over a 9-year period were retrospectively identified. Patients were divided into 2 groups based on the initial dilation strategy of balloon or rigid bronchoplasty. Demographics, clinical findings, concurrent interventions, lesion characteristics, and complications were analyzed. Two reviewers independently assigned an index and follow-up endoscopic stenosis grade for each case. The mean stenosis grade at follow-up in both groups was then calculated and compared., Results: Sixty-three patients with benign SGTS were included. Most stenoses in the rigid (80%) and balloon (63%) bronchoplasty groups were complex ( P =0.174). In addition, 94% (59/63) of index stenoses were classified as Cotton Myer Grade 3. At follow-up, no significant difference was found in the mean stenosis grade between dilation strategies (1.97 vs. 2.2, P =0.287). Furthermore, no procedural-related complications were observed in either group., Conclusion: Balloon and rigid bronchoplasty are safe and effective endoscopic tools in the early management of benign SGTS. A multimodality approach centered around mucosal sparing techniques remains vitally important to the overall and likely long-term success of treating this challenging disease entity., Competing Interests: Disclosure: M.M. is a consultant for Olympus and Serpex Medical. The remaining authors there is no conflict of interest or other disclosures., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

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., Competing Interests: None declared., (Thieme. All rights reserved.)

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 < 0.001) and less hospitalizations compared to surgical biopsy (26.5% vs 95.7%, p < 0.001), but hospitalized patients had a longer median hospital stay (2 days vs 1 day, p = 0.004)., Conclusions: Diagnostic yield of cryobiopsy increased over time but the overall grade 4 bleeding rate was 11.8%., (© 2022. The Author(s).)

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 preoperative care to discharge/disposition, are highlighted. The importance of effective business planning, personnel training, leadership, communication, team building, quality of care, and patient safety are also discussed., (Copyright © 2021 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Introduction: 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., Methods: 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., Results: 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)., Conclusions: 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., (Copyright © 2021. Published by Elsevier Inc.)

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., (Copyright © 2021. Published by Elsevier Inc.)

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., Competing Interests: Disclosure: Dr E.E.F. reports consultant fees from Medtronic and Boston Scientific, and a research grant from Intuitive Surgical. Dr T.R.G. reports travel funds from Medtronic. Dr S.J.K. reports consultant fees from Medtronic. Dr G.P.L. reports consultant fees from Medtronic. H.L. and Dr J.S.M. are full-time employees of Medtronic. Dr A.K.M. reports consultant fees from Medtronic. Dr M.A.P. reports speaking, consulting, or research payments from Medtronic, Auris Health, BodyVision, Intuitive Surgical, Philips, Biodesix, AstraZeneca, Johnson and Johnson, Boehringer Ingelheim, United Therapeutics, Actelion, Inivata, and Boston Scientific. Dr O.B.R. reports consultant fees from Medtronic. Dr J.S. reports consultant fees from Somnoware Sleep Solutions. For the remaining authors there is no conflict of interest or other disclosures., (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.)

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., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Bronchoscopy is an aerosol-generating procedure that creates unique challenges for healthcare providers to reduce the potential spread of the COVID-19 respiratory pathogen. As part of the initial response, Cleveland Clinic postponed elective surgeries including bronchoscopy. We established a 5-tier system for prioritizing the urgency of bronchoscopy procedures. When elective bronchoscopies were resumed, we established protocols to reduce aerosolization and potential virus transmission risks such as using an airborne infection-isolation room and changing to total intravenous anesthesia. Also, we established guidelines for periprocedural care and use of personal protective equipment including requirements for wearing N95 masks for all bronchoscopy procedures., (Copyright © 2020 The Cleveland Clinic Foundation. All Rights Reserved.)

Introduction: 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., Areas Covered: 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., Expert Opinion: 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.

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., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/jtd-2019-ndt-11). The series “Novel Diagnostic Techniques for Lung Cancer” was commissioned by the editorial office without any funding or sponsorship. JC reports other from Medtronic, other from BodyVision LTD, outside the submitted work. TRG reports other from Medtronic, other from Intuitive surgical, grants and other from J&J/Ethicon/Auris robotics, outside the submitted work. SKA has no other conflicts of interest to declare., (2020 Journal of Thoracic Disease. All rights reserved.)

Traditional therapies for emphysema such as bronchodilators and anti-inflammatory drugs have limited value due to permanent structural changes in the emphysematous lung that result in hyperinflation. Surgical lung volume reduction partially corrects hyperinflation by removing emphysematous lung and is an option in selected patients, but it carries a risk of morbidity and death. Valve therapy is a less-invasive option that involves bronchoscopic implantation of 1-way valves in emphysematous lung segments to allow air flow and mucus clearance in the direction of central airways. The authors review the rationale, evidence, and applications of valve therapy., (Copyright © 2020 The Cleveland Clinic Foundation. All Rights Reserved.)

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., (Copyright © 2019. Published by Elsevier Inc.)

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., (© 2019 S. Karger AG, Basel.)

Molecular determinants governing the evolution of tumor subclones toward phylogenetic branches or fixation remain unknown. Using sequencing data, we model the propagation and selection of clones expressing distinct categories of BRAF mutations to estimate their evolutionary trajectories. We show that strongly activating BRAF mutations demonstrate hard sweep dynamics, whereas mutations with less pronounced activation of the BRAF signaling pathway confer soft sweeps or are subclonal. We use clonal reconstructions to estimate the strength of "driver" selection in individual tumors. Using tumors cells and human-derived murine xenografts, we show that tumor sweep dynamics can significantly affect responses to targeted inhibitors of BRAF/MEK or DNA damaging agents. Our study uncovers patterns of distinct BRAF clonal evolutionary dynamics and nominates therapeutic strategies based on the identity of the BRAF mutation and its clonal composition.

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., (Copyright © 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)

It has been 30 years since the first commercial three-dimensional (3D) printer was available on market. The technological advancement of 3D printing has far exceeded its implementation in medicine. The application of 3D printing technology has the potential of playing a major role within interventional pulmonology; specifically, in the management of complex airway disease. Tailoring management to the patient-specific anatomical malformation caused by benign or malignant disease is a major challenge faced by interventional pulmonologists. Such cases often require adjunctive therapeutic procedures with thermal therapies followed by dilation and airway stenting to maintain the patency of the airway. Airway-stent size matching is one key to reducing stent-related complications. A major barrier to matching is the expansion of the stent in two dimensions (fixed sizes in length and diameter) within the deformed airway. Additional challenges are created by the subjective oversizing of the stent to reduce the likelihood of migration. Improper sizing adversely affects the stability of the stent. The stent-airway mismatch can be complicated by airway erosion, perforation, or the formation of granulation tissue. Stents can migrate, fracture, obstruct, or become infected. The use of patient-specific 3D printed airway stents may be able to reduce the stent airway mismatch. These stents allow more precise stent-airway sizing and minimizes high-pressure points on distorted airway anatomy. In theory, this should reduce the incidence of the well-known complications of factory manufactured stents. In this article, the authors present the brief history of 3D printed stents, their consideration in select patients, processing steps for development, and future direction., Competing Interests: Conflicts of Interest: Cleveland Clinic and Cleveland Clinic Institutional Officials/Leaders have an equity interest in Custom Orthopaedic Solutions and are entitled to royalty payments from the company for technology developed at Cleveland Clinic. Custom Orthopaedic Solutions is the manufacturer the stent referrenced in the text. Dr. Gildea has Intellectual Property filed but no existing conflict as there is no commercial product at the time of this submission.

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., (Copyright © 2017 Elsevier Inc. All rights reserved.)

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., (© 2018 S. Karger AG, Basel.)

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.

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.

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., (Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2016 Elsevier Inc. All rights reserved.)

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.

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.

Rationale: 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., Objective: Assess the 10 year cost-effectiveness of BT for individuals with severe uncontrolled asthma., Methods: 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)., Results: 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)., Conclusions: 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.