Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial.

BACKGROUND: Robotic-assisted bronchoscopy has recently emerged as an alternative to electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions. While robotic-assisted bronchoscopy is proposed to have several advantages, such as an easier learning curve, it is unclear if it has comparable diagnostic utility as electromagnetic navigational bronchoscopy. METHODS: Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT (RELIANT) is an investigator-initiated, single-center, open label, noninferiority, cluster randomized controlled trial conducted in two operating rooms at Vanderbilt University Medical Center. Each operating room (OR) is assigned to either robotic-assisted or electromagnetic navigational bronchoscopy each morning, with each OR day considered one cluster. All patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion in one of the two operating rooms are eligible. Schedulers, patients, and proceduralists are blinded to daily group allocations until randomization is revealed for each operating room each morning. The primary endpoint is the diagnostic yield defined as the proportion of cases yielding lesional tissue. Secondary and safety endpoints include procedure duration and procedural complications. Enrolment began on March 6, 2023, and will continue until 202 clusters have been accrued, with expected enrolment of approximately 400 patients by the time of completion in March of 2024. DISCUSSION: RELIANT is a pragmatic randomized controlled trial that will compare the diagnostic yield of the two most commonly used bronchoscopic approaches for sampling peripheral pulmonary lesions. This will be the first known cluster randomized pragmatic trial in the interventional pulmonology field and the first randomized controlled trial of robotic-assisted bronchoscopy. TRIAL REGISTRATION: ClinicalTrials.gov registration (NCT05705544) on January 30, 2023.

Navigational Bronchoscopy versus Computed Tomography-guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung Nodules: protocol and rationale for the VERITAS multicenter randomized trial.

Background: Lung nodule incidence is increasing. Many nodules require biopsy to discriminate between benign and malignant etiologies. The gold-standard for minimally invasive biopsy, computed tomography-guided transthoracic needle biopsy (CT-TTNB), has never been directly compared to navigational bronchoscopy, a modality which has recently seen rapid technological innovation and is associated with improving diagnostic yield and lower complication rate. Current estimates of the diagnostic utility of both modalities are based largely on non-comparative data with significant risk for selection, referral, and publication biases. Methods: The VERITAS trial (na V igation E ndoscopy to R each Indeterminate lung nodules versus T ransthoracic needle A spiration, a randomized controlled S tudy) is a multicenter, 1:1 randomized, parallel-group trial designed to ascertain whether electromagnetic navigational bronchoscopy with integrated digital tomosynthesis is noninferior to CT-TTNB for the diagnosis of peripheral lung nodules 10-30 mm in diameter with pre-test probability of malignancy of at least 10%. The primary endpoint is diagnostic accuracy through 12 months follow-up. Secondary endpoints include diagnostic yield, complication rate, procedure duration, need for additional invasive diagnostic procedures, and radiation exposure. Discussion: The results of this rigorously designed trial will provide high-quality data regarding the management of lung nodules, a common clinical entity which often represents the earliest and most treatable stage of lung cancer. Several design challenges are described. Notably, all nodules are centrally reviewed by an independent interventional pulmonology and radiology adjudication panel relying on pre-specified exclusions to ensure enrolled nodules are amenable to sampling by both modalities while simultaneously protecting against selection bias favoring either modality. Conservative diagnostic yield and accuracy definitions with pre-specified criteria for what non-malignant findings may be considered diagnostic were chosen to avoid inflation of estimates of diagnostic utility. Trial registration: ClinicalTrials.gov NCT04250194.

Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial.

Background: Robotic assisted bronchoscopy has recently emerged as an alternative to electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions. While robotic assisted bronchoscopy is proposed to have several advantages, such as an easier learning curve, it is unclear if it has comparable diagnostic utility as electromagnetic navigational bronchoscopy. Methods: Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT (RELIANT) is an investigator-initiated, single-center, open label, noninferiority, cluster randomized controlled trial conducted in two operating rooms at Vanderbilt University Medical Center. Each operating room is assigned to either robotic assisted or electromagnetic navigational bronchoscopy each morning, with each OR day considered one cluster. All patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion in one of the two operating rooms are eligible. Schedulers, patients and proceduralists are blinded to daily group allocations until randomization is revealed for each operating room each morning. The primary endpoint is the diagnostic yield defined as the proportion of cases yielding lesional tissue. Secondary and safety endpoints include procedure duration and procedural complications. Enrolment began on March 6, 2023, and will continue until 202 clusters have been accrued, with expected enrolment of approximately 400 patients by the time of completion in March of 2024. Discussion: RELIANT is a pragmatic randomized controlled trial that will compare the diagnostic yield of the two most commonly used bronchoscopic approaches for sampling peripheral pulmonary lesions. This will be the first known cluster randomized pragmatic trial in the interventional pulmonology field and the first randomized controlled trial of robotic assisted bronchoscopy. Trial registration: ClinicalTrials.gov registration (NCT05705544) on January 30, 2023.

Forbearance with endobronchial stenting: cognisance before conviction.

Endobronchial stenting is an important aspect of the practice of interventional pulmonology. The most common indication for stenting is the management of clinically significant airway stenosis. The list of endobronchial stents available on the market continues to grow. More recently, patient-specific 3D-printed airway stents have been approved for use. Airway stenting should be considered only when all other options have been exhausted. Due to the environment of the airways and the stent-airway wall interactions, stent-related complications are common. Although stents can be placed in various clinical scenarios, they should only be placed in scenarios with proven clinical benefit. The unwarranted placement of a stent can expose the patient to complications with little or no clinical benefit. This article reviews and outlines the key principles of endobronchial stenting and important clinical scenarios in which stenting should be avoided.

Rapid On-site Evaluation Practice Variability Appraisal (ROSE PETAL) survey.

BACKGROUND: Rapid on-site evaluation (ROSE) is frequently used during diagnostic procedures in patients with or suspected to have lung cancer. There is variation in ROSE use among bronchoscopists, and discussion of ROSE results can have significant consequences for patients. This study was performed to define ROSE practice and result disclosure patterns among bronchoscopists. METHODS: This cross-sectional study was performed using an electronic survey disseminated to the members of the American Association for Bronchology and Interventional Pulmonology and the Society for Advanced Bronchoscopy. The questions centered around ROSE availability, utilization, barriers, and discussion of results with patients. RESULTS: There were 137 respondents. Most identified themselves as interventional pulmonologists (109, 80%); most respondents worked in an academic setting (71, 52%). Availability of ROSE was reported by 121 (88%) respondents. Time constraints (28%), availability of cytology (22%), and scheduling conflicts (20%) were the most reported barriers to ROSE use. Endobronchial ultrasound transbronchial needle aspiration (85%) and nonrobotic peripheral bronchoscopy (65%) were the most reported procedures that used ROSE. There was heterogeneity regarding discussion of ROSE results with the patient or their caregiver in the immediate postprocedure setting: yes - always (40, 33%), yes - sometimes (32, 26%), yes - rarely (18, 15%), or no (31, 26%). Thirty-eight respondents reported they believed ROSE was ≥90% concordant with final cytology results. CONCLUSIONS: The results confirmed the heterogeneity of practice patterns. Estimates of ROSE-final cytology concordance were lower than previously published concordance results. Notably, the discussion of ROSE results varied significantly.

Association between terminal pleural elastance and radiographic lung re-expansion after therapeutic thoracentesis in patients with symptomatic pleural effusion: a post-hoc analysis of a randomised trial.

OBJECTIVES: Recurrent symptomatic effusions can be durably managed with pleurodesis or placement of indwelling pleural catheters. Recent pleurodesis trials have largely relied on lung re-expansion on post-thoracentesis radiograph as an inclusion criterion rather than pleural elastance as determined by manometry, which is an important predictor of successful pleurodesis. We investigated the association between lung re-expansion on post-pleural drainage chest imaging and pleural physiology, with particular attention to pleural elastance over the final 200 mL aspirated. DESIGN: Post-hoc analysis of a recent randomised trial. SETTING AND PARTICIPANTS: Post-results analysis of 61 subjects at least 18 years old with symptomatic pleural effusions estimated to be at least of 0.5 L in volume allocated to manometry-guided therapeutic thoracentesis in a recent randomised trial conducted at two major university hospitals in the USA. PRIMARY OUTCOME MEASURES: The primary outcome was concordance of radiographic with normal terminal pleural elastance over the final 200 mL aspirated. We label this terminal elastance 'visceral pleural recoil', or the tendency of the maximally expanded lung to withdraw from the chest wall. RESULTS: Post-thoracentesis chest radiograph and thoracic ultrasound indicated successful lung re-expansion in 69% and 56% of cases, respectively. Despite successful radiographic lung re-expansion, visceral pleural recoil was abnormal in 71% of subjects expandable by radiograph and 77% expandable by ultrasound. The sensitivity and positive predictive value of radiographic lung re-expansion for normal visceral pleural recoil were 44% and 24%, respectively. CONCLUSION: Radiographic lung re-expansion by post-thoracentesis chest radiograph or thoracic ultrasound is a poor surrogate for normal terminal pleural elastance. Clinical management of patients with recurrent symptomatic pleural effusions guided by manometry rather than post-thoracentesis imaging might produce better outcomes, which should be investigated by future clinical trials. TRIAL REGISTRATION NUMBER: NCT02677883; Post-results.

Endobronchial Therapies for Diagnosis, Staging, and Treatment of Lung Cancer.

Lung cancer is the leading cause of cancer-related death worldwide and within the United States. Although evidence-based screening has been shown to reduce cancer-related mortality, the late-stage presentation remains common. Bronchoscopy has been proven to be an essential tool in the diagnosis and management of lung cancer. Basic and advanced diagnostic bronchoscopic techniques offer a minimally invasive modality for diagnosing and staging patients with lung cancer. In patients with malignant endotracheobronchial disease, therapeutic bronchoscopy (flexible or rigid) is a safe procedure that palliates symptoms such as dyspnea and hemoptysis. In this article, we review the various endobronchial tools and strategies essential for the management of lung cancer.

Sight Unseen: Diagnostic Yield and Safety Outcomes of a Novel Multimodality Navigation Bronchoscopy Platform with Real-Time Target Acquisition.

BACKGROUND: Several advanced bronchoscopy platforms are currently available, but the clinical data supporting their use vary. Electromagnetic navigation bronchoscopy (ENB) remains the dominant technology; it is limited by its reliance on preoperative computed tomography, which only approximates patient anatomy during the procedure. Recently, ENB was enhanced with the (1) addition of digital tomosynthesis-based navigation correction, (2) improvements in planning algorithms, and (3) continuous real-time guidance (Illumisite™; Medtronic, Minneapolis, MN, USA). There are currently no clinical data on the diagnostic yield and safety profile of this system. OBJECTIVES: The primary objective of this study is to describe the diagnostic yield of the first 100 pulmonary parenchymal lesions sampled using the multimodality navigation bronchoscopy (MNB) platform. The secondary objective is to describe safety. METHODS: In this single-center prospective observational study, a database was maintained to track patient, procedural, and outcome data for the first 100 consecutive lesions sampled using the MNB platform at an academic quaternary referral center. Descriptive statistics and univariate and multivariate analyses are reported. RESULTS: The overall diagnostic yield of samples acquired was 79% (79/100). In the cohort where digital tomosynthesis was used, the diagnostic yield was 83% (69/83). Sensitivity for malignancy was 71% (52/73). Overall complication rates were low: pneumothorax (n = 3, 3%) and bleeding requiring intervention (n = 2, 2%). There were no procedural-related hospital admissions. CONCLUSIONS: The MNB system performed favorably. Platform superiority cannot be established without future prospective and comparative studies.

Medical Thoracoscopy.

Medical thoracoscopy is an effective and safe modality to visualize and sample contents of the pleural cavity. It is an outpatient procedure that can be performed while the patient is spontaneously breathing, with the use of local anesthesia and intravenous medications for sedation and analgesia. Medical thoracoscopy has indications in the management of a variety of pleural diseases. It is most commonly performed as a diagnostic procedure but has therapeutic applications as well. Although it has its advantages, management strategies of certain pleural diseases should take place within a multidisciplinary environment including general pulmonologists, interventional pulmonologists, and thoracic surgeons.

Sans Standardization: Effective Endoscope Reprocessing.

Bronchoscopy is a commonly performed procedure within thoracic and critical care medicine. Modern bronchoscopes are technologically advanced tools made of fragile electronic components. Their design is catered to allow maximum maneuverability within the semi-rigid tracheobronchial tree. Effective cleaning and reprocessing of these tools can be a challenge. Although highly functional, the design poses several challenges when it comes to reprocessing. It is a very important step, and lapses in the procedure have been tied to nosocomial infections. The process lacks universal standardization; several organizations have developed their own recommendations. Data have shown that key stakeholders are not fully versed in the essentials of endoscope reprocessing. A significant knowledge gap exists between those performing bronchoscopy and those who are stewards of effective endoscope reprocessing. To service as a resource for bronchoscopists, this study summarizes the steps of effective reprocessing, details the important elements within a health-care facility that houses this process, and reviews some of the current data regarding the use of disposable endoscopes.

Venovenous extracorporeal membrane oxygenation during high-risk airway interventions.

OBJECTIVES: Practice patterns for the use of extracorporeal membrane oxygenation (ECMO) during high-risk airway interventions vary, and data are limited. We aim to characterize our recent experience using ECMO for procedural support during whole-lung lavage (WLL) and high-risk bronchoscopy for central airway obstruction (CAO). METHODS: We performed a retrospective cohort study of adults who received ECMO during WLL and high-risk bronchoscopy from 1 July 2018 to 30 March 2020. Our primary end point was successful completion of the intervention. Secondary end points included ECMO-associated complications and hospital survival. RESULTS: Eight patients received venovenous ECMO for respiratory support during 9 interventions; 3 WLLs for pulmonary alveolar proteinosis were performed in 2 patients, and 6 patients underwent 6 bronchoscopic interventions for CAO. We initiated ECMO prior to the intervention in 8 cases and during the intervention in 1 case for respiratory decompensation. All 9 interventions were successfully completed. Median ECMO duration was 17.8 h (interquartile range, 15.9-26.6) for the pulmonary alveolar proteinosis group and 1.9 h (interquartile range, 1.4-8.1) for the CAO group. There was 1 cannula-associated deep vein thrombosis; there were no other ECMO complications. Seven patients (87.5%) and 4 (50.0%) patients survived to discharge and 1 year postintervention, respectively. CONCLUSIONS: Use of venovenous ECMO to facilitate high-risk airway interventions is safe and feasible. Planned preprocedural ECMO initiation may prevent avoidable respiratory emergencies and extend therapeutic airway interventions to patients otherwise considered too high-risk to treat. Guidelines are needed to inform the utilization of ECMO during high-risk bronchoscopy and other airway interventions.

Transbronchial Cryobiopsy in Interstitial Lung Diseases: State-of-the-Art Review for the Interventional Pulmonologist.

Interstitial lung diseases are a heterogenous group of disorders that are often difficult to diagnose precisely. Clinical, laboratory, radiographic, and histologic information may be needed to arrive at the correct diagnosis. The multidisciplinary discussion has been proven to be useful in this patient group. Transbronchial cryobiopsy has become a popular method for obtaining tissue samples. Over the course of the last decade, there has been a significant amount of research assessing the feasibility, safety, and diagnostic endpoints of transbronchial cryobiopsy in patients with interstitial lung disease. Data continues to mount to support its use, which has been reflected in guidelines and expert panel reports. Patient selection, procedural performance, and appropriate specimen handling are critical factors for success. A coordinated approach by pulmonologists with expertise in interstitial lung diseases, interventional pulmonologists, and thoracic pathologists is essential. In this evidence-based narrative review, we address transbronchial cryobiopsies from these three distinct perspectives. In addition, the current literature was used to address nine common procedural questions.

Navigational bronchoscopy: a guide through history, current use, and developing technology.

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.

Convex probe endobronchial ultrasound: historical, contemporary, and cutting-edge applications.

The use of convex-probe endobronchial ultrasound (CP-EBUS) has revolutionized bronchoscopy. It has provided the option of a relatively safe, minimally invasive approach for the assessment of various intrathoracic diseases. In current practice, its most dramatic impact has been on the diagnosing and staging of lung cancer. It has served as an invaluable tool that has replaced mediastinoscopy in a variety of clinical scenarios. Many pulmonologists and thoracic surgeons consider CP-EBUS the most significant milestone in bronchoscopy after the development of the flexible bronchoscope itself. In this review, we summarize the historical aspects, current indications, technical approach, and future direction of CP-EBUS.

A Blueprint for Success: Design and Implementation of an Ideal Bronchoscopy Suite.

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.