Search

Background: With complex, lengthy bronchoscopies, there is a need for safe, effective sedation. Most bronchoscopists strive for moderate sedation, though often difficult without compromising vital signs. The Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scale is a validated 6-point scale assessing responsiveness of patients coinciding with the American Society of Anesthesiologists (ASA) continuum of sedation. It is commonly used in studying bronchoscopic sedation, but depth of sedation by MOAA/S and correlation with vital signs and adverse events has not been determined., Methods: This study was a post hoc analysis of a prospective, double-blind, randomized trial evaluating the safety and efficacy of remimazolam. MOAA/S and corresponding vital signs were used to assess the effect of the level of sedation on vital signs and adverse events., Results: A total of 23,341 MOAA/S scores from 431 patients were recorded. Older and higher ASA class patients spent more time in deeper sedation (MOAA/S 0 to 1) (6% vs. 2%, P=0.01). Oxygen saturation was equal in deep sedation (MOAA/S 0 to 1) (97±3%) compared with moderate sedation (96±3%) (P=0.11). Mean systolic and diastolic blood pressures were significantly lower when comparing MOAA/S 0 to 1 to MOAA/S 5 (systolic blood pressure: 126±19 vs. 147±24 mm Hg, P<0.01; diastolic blood pressure: 68±14 vs. 84±15 mm Hg, P<0.01). There was a nonsignificant trend towards lower heart rate at deep versus moderate sedation (84±15 vs. 94±18 beats/min, P=0.07). Respiratory rate was also comparable with moderate and deep sedation (17±5 vs. 18±6 beats/min, P=0.94)., Conclusion: There was no clinically meaningful correlation between vital signs and depth of sedation assessed by MOAA/S. Older and higher ASA class patients spend more time in deeper sedation. However, when in deep sedation, there was no difference in vital signs other than a slightly increased incidence of clinically insignificant hypotension., Competing Interests: Disclosure: F.S. and W.S. disclose that at the time of the trial taking place, they were employees of PAION, and F.S. served as vice president of global clinical development during the trial. O.R. discloses that he is an employee of PAION and served as vice president of US medical affairs for PAION during the primary trial. G.A.S. received grant support and consulting fees totally <$5000 for this study from PAION Pharmaceuticals. M.I. discloses that he served as a consultant at Creative Clinical Research GmbH, a subcontractor of PAION Pharmaceuticals. For the remaining authors there is no conflict of interest or other disclosures., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

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.)

Background: Bronchoscopy is commonly used to evaluate suspicious lung lesions. The yield is likely dependent on patient, radiographic, and bronchoscopic factors. Few studies have assessed these factors simultaneously while also including the preprocedure physician-assessed probability of cancer (pCA) when assessing yield., Methods: This study is a secondary data analysis from a prospective multicenter trial. Diagnostic yield of standard bronchoscopy with biopsy ± fluoroscopy, endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA), electromagnetic navigation, and combination bronchoscopies was assessed. Definitions for diagnostic and nondiagnostic bronchoscopies were rigorously predefined. The association of diagnostic yield with individual variables was examined by using univariate and multivariate logistic regression analyses where appropriate., Results: A total of 687 patients were included from 28 sites. Overall diagnostic yield was 69%; 80% for EBUS, 55% for bronchoscopy with biopsy ± fluoroscopy, 57% for electromagnetic navigation, and 74% for combination procedures (P < .001). Patients with larger, central lesions with adenopathy were significantly more likely to undergo a diagnostic bronchoscopy. Patients with pCA < 10% and 10% to 60% had lower yields (44% and 42%, respectively), whereas pCA > 60% yielded a positive result in 77% (P < .001). In multivariate logistic regression, the use of EBUS-TBNA, larger sized lesions, and central location were significantly associated with a diagnostic bronchoscopy. Seventeen percent of those with a malignant diagnosis and 28% of those with a benign diagnosis required secondary procedures to establish a diagnosis., Conclusions: This study is the first to assess the yield of bronchoscopy according to physician-assessed pCA in a large, prospective multicenter trial. The yield of bronchoscopy varied greatly according to physician suspicion that cancer is present, the patients' clinical/radiographic features, and the type of procedure performed. Of the procedures performed, EBUS-TBNA was the most likely to provide a diagnosis., (Copyright © 2020 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

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.)

Background: While the complexity of flexible bronchoscopy has increased, standard options for moderate sedation medications have not changed in three decades. There is a need to improve moderate sedation while maintaining safety. Remimazolam was developed to address shortcomings of current sedation strategies., Methods: A prospective, double-blind, randomized, multicenter, parallel group trial was performed at 30 US sites. The efficacy and safety of remimazolam for sedation during flexible bronchoscopy were compared with placebo and open-label midazolam., Results: The success rates were 80.6% in the remimazolam arm, 4.8% in the placebo arm (P < .0001), and 32.9% in the midazolam arm. Bronchoscopy was started sooner in the remimazolam arm (mean, 6.4 ± 5.82 min) compared with placebo (17.2 ± 4.15 min; P < .0001) and midazolam (16.3 ± 8.60 min). Time to full alertness after the end of bronchoscopy was significantly shorter in patients treated with remimazolam (median, 6.0 min; 95% CI, 5.2-7.1) compared with those treated with placebo (13.6 min; 95% CI, 8.1-24.0; P = .0001) and midazolam (12.0 min; 95% CI, 5.0-15.0). Remimazolam registered superior restoration of neuropsychiatric function compared with placebo and midazolam. Safety was comparable among all three arms, and 5.6% of the patients in the remimazolam group had serious treatment-emergent adverse events as compared with 6.8% in the placebo group., Conclusions: Remimazolam administered under the supervision of a pulmonologist was effective and safe for moderate sedation during flexible bronchoscopy. In an exploratory analysis, it demonstrated a shorter onset of action and faster neuropsychiatric recovery than midazolam., (Copyright © 2018 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: New technology has resulted in bronchoscopy being increasingly used for diagnosing pulmonary lesions. Reported yield from these procedures varies widely with few randomized clinical trials. This study compares the diagnostic yield of a thin bronchoscope and radial endobronchial ultrasound (R-EBUS) with standard bronchoscopy and fluoroscopy (SB-F) in lung lesions., Methods: Patients presenting for diagnostic bronchoscopic evaluation at five centers were randomized to undergo SB-F or R-EBUS with a thin bronchoscope (TB-EBUS). If SB-F was nondiagnostic, crossover to the TB-EBUS arm was allowed. Data on patient demographics, radiographic features, and final pathologic or radiographic follow-up were collected. Statistical comparisons were made by Fisher exact test, χ 2 test, and Student t test. Bivariate and multivariate analyses were performed to determine predictors of diagnostic yield., Results: One hundred and ninety-seven patients were included in the final analyses. There was no difference in demographics, lesion size, or location between study arms. The average lesion size was 31.2 mm (SD, 10.8 mm). Bronchoscopy was diagnostic in 87 patients (44%). Although the diagnostic yield was higher in the TB-EBUS arm compared with the SB-F arm (49% vs 37%), this difference was not statistically significant (P = .11). Among those with nondiagnostic bronchoscopic findings in the standard arm, 87% (n = 46) crossed over to TB-EBUS, resulting in a diagnosis in seven additional patients (15% of 46)., Conclusions: Bronchoscopy with or without a thin scope and R-EBUS had a poor diagnostic yield for pulmonary lesions. Future work should focus on improvements in technique and technology advances that ensure a higher likelihood of obtaining a diagnosis., (Published by Elsevier Inc.)

Background: Pulmonary nodules are a common but difficult issue for physicians as most identified on imaging are benign but those identified early that are cancerous are potentially curable. Multiple diagnostic options are available, ranging from radiographic surveillance, minimally invasive biopsy (bronchoscopy or transthoracic biopsy) to more invasive surgical biopsy/resection. Each technique has differences in diagnostic yield and complication rates with no established gold standard. Currently, the safest approach is bronchoscopic but it is limited by variable diagnostic yields. Percutaneous approaches are limited by nodule location and complications. With the recent advent of electromagnetic navigation (EMN), a combined bronchoscopic and transthoracic approach is now feasible in a single, staged procedure. Here, we present the study design and rationale for a single-arm trial evaluating a staged approach for the diagnosis of pulmonary nodules., Methods: Participants with 1-3 cm, intermediate to high-risk pulmonary nodules will undergo a staged approach with endobronchial ultrasound (EBUS) followed by EMN-bronchoscopy (ENB), then EMN-transthoracic biopsy (EMN-TTNA) with the procedure terminated at any stage after a diagnosis is made via rapid onsite cytopathology. We aim to recruit 150 EMN participants from eight academic and community settings to show significant improvements over other historic bronchoscopic guided techniques. The primary outcome is overall diagnostic yield of the staged approach., Conclusion: This is the first study designed to evaluate the diagnostic yield of a staged procedure using EBUS, ENB and EMN-TTNA for the diagnosis of pulmonary nodules. If effective, the staged procedure will increase minimally invasive procedural diagnostic yield for pulmonary nodules., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Electromagnetic navigational bronchoscopy (ENB) is guided bronchoscopy to pulmonary nodules (PN) that relies on a preprocedural chest CT to create a three-dimensional (3D) virtual airway map. The CT is traditionally done at a full inspiratory breath hold (INSP), but the procedure is performed while the patient tidal breaths, when lung volumes are closer to functional residual capacity. Movement of a PN from INSP to expiration (EXP) has been shown to average 17.6 mm. Therefore, the hypothesis of this study is that preprocedural virtual maps built off a CT closer to physiological lung volumes during bronchoscopy may better represent the actual 3D location of a PN., Methods: Consecutive patients with a PN needing a histological diagnosis were enrolled. A preprocedure INSP and EXP CT scan were obtained to create two virtual maps. During the airway inspection, the system tracked the sensor probe to collect 3D points that were reconstructed into the lumen registration map. This map is thought to best represent the patient's airways during bronchoscopy. Predicted PN location on an EXP and INSP map was compared with lumen registration., Results: Twenty consecutive PN underwent ENB. The predicted PN location, compared with lumen registration, was significantly closer on EXP vs INSP (4.5 mm ± 3.3 mm vs 14.8 mm ± 9.7 mm; p < 0.0001)., Conclusions: Predicted 3D nodule location using an EXP scan for ENB is significantly closer to actual nodule location when compared with an INSP scan, but whether this leads to increased yields needs to be determined., (Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: Bronchoscopy is often the initial diagnostic procedure performed in patients with pulmonary lesions suggestive of lung cancer. A bronchial genomic classifier was previously validated to identify patients at low risk for lung cancer after an inconclusive bronchoscopy. In this study, we evaluated the potential of the classifier to reduce invasive procedure utilization in patients with suspected lung cancer., Methods: In two multicenter trials of patients undergoing bronchoscopy for suspected lung cancer, the classifier was measured in normal-appearing bronchial epithelial cells from a mainstem bronchus. Among patients with low and intermediate pretest probability of cancer (n = 222), subsequent invasive procedures after an inconclusive bronchoscopy were identified. Estimates of the ability of the classifier to reduce unnecessary procedures were calculated., Results: Of the 222 patients, 188 (85%) had an inconclusive bronchoscopy and follow-up procedure data available for analysis. Seventy-seven (41%) patients underwent an additional 99 invasive procedures, which included surgical lung biopsy in 40 (52%) patients. Benign and malignant diseases were ultimately diagnosed in 62 (81%) and 15 (19%) patients, respectively. Among those undergoing surgical biopsy, 20 (50%) were performed in patients with benign disease. If the classifier had been used to guide decision making, procedures could have been avoided in 50% (21 of 42) of patients undergoing further invasive testing. Further, among 35 patients with an inconclusive index bronchoscopy who were diagnosed with lung cancer, the sensitivity of the classifier was 89%, with 4 (11%) patients having a false-negative classifier result., Conclusions: Invasive procedures after an inconclusive bronchoscopy occur frequently, and most are performed in patients ultimately diagnosed with benign disease. Using the genomic classifier as an adjunct to bronchoscopy may reduce the frequency and associated morbidity of these invasive procedures., Trial Registry: ClinicalTrials.gov; Nos. NCT01309087 and NCT00746759; URL: www.clinicaltrials.gov., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Endobronchial ultrasound (EBUS) was introduced in the last decade, enabling real-time guidance of transbronchial needle aspiration (TBNA) of mediastinal and hilar structures and parabronchial lung masses. The many publications produced about EBUS-TBNA have led to a better understanding of the performance characteristics of this procedure. The goal of this document was to examine the current literature on the technical aspects of EBUS-TBNA as they relate to patient, technology, and proceduralist factors to provide evidence-based and expert guidance to clinicians., Methods: Rigorous methodology has been applied to provide a trustworthy evidence-based guideline and expert panel report. A group of approved panelists developed key clinical questions by using the PICO (population, intervention, comparator, and outcome) format that addressed specific topics on the technical aspects of EBUS-TBNA. MEDLINE (via PubMed) and the Cochrane Library were systematically searched for relevant literature, which was supplemented by manual searches. References were screened for inclusion, and well-recognized document evaluation tools were used to assess the quality of included studies, to extract meaningful data, and to grade the level of evidence to support each recommendation or suggestion., Results: Our systematic review and critical analysis of the literature on 15 PICO questions related to the technical aspects of EBUS-TBNA resulted in 12 statements: 7 evidence-based graded recommendations and 5 ungraded consensus-based statements. Three questions did not have sufficient evidence to generate a statement., Conclusions: Evidence on the technical aspects of EBUS-TBNA varies in strength but is satisfactory in certain areas to guide clinicians on the best conditions to perform EBUS-guided tissue sampling. Additional research is needed to enhance our knowledge regarding the optimal performance of this effective procedure., (Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Peripheral pulmonary lesions are an increasingly common finding in clinical practice. Electromagnetic navigation and radial probe endobronchial ultrasound have improved the diagnostic yield of bronchoscopy for peripheral lesions, although these techniques remain largely underutilized. One potential barrier to the adoption of these techniques may be the lack of an appropriate model to train clinicians on the various aspects of peripheral bronchoscopy. This report describes the development of a human cadaveric model with artificially implanted tumor targets designed to train physicians on aspects of peripheral bronchoscopy, including electromagnetic navigation and radial probe endobronchial ultrasound.

Background: The determination of competency of trainees in programs performing bronchoscopy is quite variable. Some programs provide didactic lectures with hands-on supervision, other programs incorporate advanced simulation centers, whereas others have a checklist approach. Although no single method has been proven best, the variability alone suggests that outcomes are variable. Program directors and certifying bodies need guidance to create standards for training programs. Little well-developed literature on the topic exists., Methods: To provide credible and trustworthy guidance, rigorous methodology has been applied to create this bronchoscopy consensus training statement. All panelists were vetted and approved by the CHEST Guidelines Oversight Committee. Each topic group drafted questions in a PICO (population, intervention, comparator, outcome) format. MEDLINE data through PubMed and the Cochrane Library were systematically searched. Manual searches also supplemented the searches. All gathered references were screened for consideration based on inclusion criteria, and all statements were designated as an Ungraded Consensus-Based Statement., Results: We suggest that professional societies move from a volume-based certification system to skill acquisition and knowledge-based competency assessment for trainees. Bronchoscopy training programs should incorporate multiple tools, including simulation. We suggest that ongoing quality and process improvement systems be introduced and that certifying agencies move from a volume-based certification system to skill acquisition and knowledge-based competency assessment for trainees. We also suggest that assessment of skill maintenance and improvement in practice be evaluated regularly with ongoing quality and process improvement systems after initial skill acquisition., Conclusions: The current methods used for bronchoscopy competency in training programs are variable. We suggest that professional societies and certifying agencies move from a volume- based certification system to a standardized skill acquisition and knowledge-based competency assessment for pulmonary and thoracic surgery trainees.

Background: Bronchoscopy is frequently nondiagnostic in patients with pulmonary lesions suspected to be lung cancer. This often results in additional invasive testing, although many lesions are benign. We sought to validate a bronchial-airway gene-expression classifier that could improve the diagnostic performance of bronchoscopy., Methods: Current or former smokers undergoing bronchoscopy for suspected lung cancer were enrolled at 28 centers in two multicenter prospective studies (AEGIS-1 and AEGIS-2). A gene-expression classifier was measured in epithelial cells collected from the normal-appearing mainstem bronchus to assess the probability of lung cancer., Results: A total of 639 patients in AEGIS-1 (298 patients) and AEGIS-2 (341 patients) met the criteria for inclusion. A total of 43% of bronchoscopic examinations were nondiagnostic for lung cancer, and invasive procedures were performed after bronchoscopy in 35% of patients with benign lesions. In AEGIS-1, the classifier had an area under the receiver-operating-characteristic curve (AUC) of 0.78 (95% confidence interval [CI], 0.73 to 0.83), a sensitivity of 88% (95% CI, 83 to 92), and a specificity of 47% (95% CI, 37 to 58). In AEGIS-2, the classifier had an AUC of 0.74 (95% CI, 0.68 to 0.80), a sensitivity of 89% (95% CI, 84 to 92), and a specificity of 47% (95% CI, 36 to 59). The combination of the classifier plus bronchoscopy had a sensitivity of 96% (95% CI, 93 to 98) in AEGIS-1 and 98% (95% CI, 96 to 99) in AEGIS-2, independent of lesion size and location. In 101 patients with an intermediate pretest probability of cancer, the negative predictive value of the classifier was 91% (95% CI, 75 to 98) among patients with a nondiagnostic bronchoscopic examination., Conclusions: The gene-expression classifier improved the diagnostic performance of bronchoscopy for the detection of lung cancer. In intermediate-risk patients with a nondiagnostic bronchoscopic examination, a negative classifier score provides support for a more conservative diagnostic approach. (Funded by Allegro Diagnostics and others; AEGIS-1 and AEGIS-2 ClinicalTrials.gov numbers, NCT01309087 and NCT00746759.).

Background: Electromagnetic navigation has improved the diagnostic yield of peripheral bronchoscopy for pulmonary nodules. For these procedures, a thin-slice chest CT scan is performed prior to bronchoscopy at full inspiration and is used to create virtual airway reconstructions that are used as a map during bronchoscopy. Movement of the lung occurs with respiratory variation during bronchoscopy, and the location of pulmonary nodules during procedures may differ significantly from their location on the initial planning full-inspiratory chest CT scan. This study was performed to quantify pulmonary nodule movement from full inspiration to end-exhalation during tidal volume breathing in patients undergoing electromagnetic navigation procedures., Methods: A retrospective review of electromagnetic navigation procedures was performed for which two preprocedure CT scans were performed prior to bronchoscopy. One CT scan was performed at full inspiration, and a second CT scan was performed at end-exhalation during tidal volume breathing. Pulmonary lesions were identified on both CT scans, and distances between positions were recorded., Results: Eighty-five pulmonary lesions were identified in 46 patients. Average motion of all pulmonary lesions was 17.6 mm. Pulmonary lesions located in the lower lobes moved significantly more than upper lobe nodules. Size and distance from the pleura did not significantly impact movement., Conclusions: Significant movement of pulmonary lesions occurs between full inspiration and end-exhalation during tidal volume breathing. This movement from full inspiration on planning chest CT scan to tidal volume breathing during bronchoscopy may significantly affect the diagnostic yield of electromagnetic navigation bronchoscopy procedures.

Introduction: The promise of benefits from lung cancer screening is tempered by the false positive rate and the need to perform diagnostic procedures to determine the aetiology of the solitary pulmonary nodules (SPN) identified. We have developed a novel procedure which allows sampling of SPNs via a transparenchymal approach, and report the results from this as a first in human trial., Methods: This study was a prospective single-arm interventional study. We recruited patients with a SPN detected on CT imaging, which was suspicious for lung cancer, who were suitable for surgical resection. Using the subject's CT, an optimal airway wall point of entry (POE), and an avascular path through lung tissue from the POE to the SPN was calculated. A tunnel tract was created from the POE to the nodule using a set of catheter-based tools under fused fluoroscopy guidance. The patients proceeded to surgical resection immediately after the biopsy. The participants were followed-up for 6 months after the procedure. The primary endpoint of the study was to evaluate the feasibility to access and biopsy the nodule., Results: Twelve patients were recruited, and a tunnel pathway created in 10 patients. There were no adverse events during the procedures. Adequate biopsies were obtained from 10 patients (83%), which correlated with the histological findings from the surgical resection. Inspection of the resected lobes did not raise any safety concerns and indicated appropriately tunnelled pathways to the nodule., Conclusions: This first in human study demonstrates that bronchoscopic transparenchymal access of SPNs is feasible., Trial Registration Number: NCT02130115., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Bronchoscopic transparenchymal nodule access (BTPNA) is a novel approach to accessing pulmonary nodules. This real-time, image-guided approach was evaluated for safety, accuracy, and yield in the healthy canine model., Methods: A novel, inorganic model of subcentimeter pulmonary nodules was developed, consisting of 0.25-cc aliquots of calcium hydroxylapatite (Radiesse) implanted via transbronchial access in airways seven generations beyond the main bronchi to represent targets for evaluation of accuracy and yield. Thoracic CT scans were acquired for each subject, and from these CT scans LungPoint Virtual Bronchoscopic Navigation software provided guidance to the region of interest. Novel transparenchymal nodule access software algorithms automatically generated point-of-entry recommendations, registered CT images, and real-time fluoroscopic images and overlaid guidance onto live bronchoscopic and fluoroscopic video to achieve a vessel-free, straight-line path from a central airway through parenchymal tissue for access to peripheral lesions., Results: In a nine-canine cohort, the BTPNA procedure was performed to sample 31 implanted Radiesse targets, implanted to simulate pulmonary nodules, via biopsy forceps through a specially designed sheath. The mean length of the 31 tunnels was 35 mm (20.5-50.3-mm range). Mean tunnel creation time was 16:52 min, and diagnostic yield was 90.3% (28 of 31). No significant adverse events were noted in the status of any of the canine subjects post BTPNA, with no pneumothoraces and minimal bleeding (all bleeding events < 2 mL in volume)., Conclusions: These canine studies demonstrate that BTPNA has the potential to achieve the high yield of transthoracic needle aspiration with the low complication profile associated with traditional bronchoscopy. These results merit further study in humans.

Background: Although simulation-based bronchoscopy has been shown to be an effective training modality, formal assessment should still be performed as new technology emerges. We sought to validate a simulator in essential bronchoscopic tasks, and survey perceptions of bronchoscopists on simulation., Methods: A cohort study at 2 medical centers used 3 groups to assess construct validity of the Simbionix Bronchoscopy Simulator: 7 first-year fellows with <10 bronchoscopies each (novice), 6 pulmonologists with 200 to 1000 bronchoscopies each (experienced), and 7 pulmonologists with >1000 bronchoscopies each (expert). Participants were tested in 4 tasks (1: scope manipulation, 2: guided anatomic navigation, 3: airway anatomy, and 4: lymph node anatomy). Participants were scored and surveyed on their impressions of simulation. The means and Kruskal-Wallis test among groups were compared by task item (P<0.05)., Results: There were statistically significant differences in mean ranks among groups for tasks 1 and 3. For task 1, final score, time, mid-lumen time, and wall hits were discriminative (P=0.006, 0.006, 0.012, and 0.014, respectively). For task 3, time, bronchial segments identified, bronchial segments incorrectly identified, and bronchial segments skipped were discriminative (P=0.04, 0.012, 0.013, and 0.013, respectively). There was no statistically significant difference for task 2 and task 4. All participants agreed that simulation training is helpful and should be incorporated into bronchoscopic training., Conclusions: The simulator demonstrated validity in differentiating skill in scope manipulation and airway anatomy, but did not discriminate skill levels in anatomic orientation or identification of lymph nodes. Bronchoscopy simulation was viewed as helpful by all levels and should be considered before performance on patients.

Background: The current approaches for tissue diagnosis of a solitary pulmonary nodule are transthoracic needle aspiration, guided bronchoscopy, or surgical resection. The choice of procedure is driven by patient and radiographic factors, risks, and benefits. We describe a new approach to the diagnosis of a solitary pulmonary nodule, namely bronchoscopic transparenchymal nodule access (BTPNA)., Methods: In anesthetized dogs, fiducial markers were placed and thoracic CT images acquired. From the CT scan, the BTPNA software provided automatic point-of-entry prescribing of a bronchoscopic path (tunnel) through parenchymal tissue directly to the lesion. The preplanned procedure was uploaded to a virtual bronchoscopic navigation system. Bronchoscopic access was performed through the tunnels created. Proximity of the distal end of the tunnel sheath to the target was measured, and safety was recorded., Results: In four canines, 13 tunnels were created. The average length of the tunnels was 32.3 mm (range, 24.7-46.7 mm). The average proximity measure was 5.7 mm (range, 0.1-12.9 mm). The distance from the pleura to the nearest point within the target was 7.4 mm (range, 0.1-15 mm). Estimated blood loss was <2 mL per case. There were no pneumothoraces., Conclusions: We describe a new approach to accessing lesions in the lung parenchyma. BTPNA allows bronchoscopic creation of a direct path with a sheath placed in proximity to the target, creating the potential to deliver biopsy tools within a lesion to acquire tissue. The technology appears safe. Further experiments are needed to assess the diagnostic yield of this procedure in animals and, if promising, to assess this technology in humans.

Background: Linear endobronchial ultrasound (EBUS) allows real-time guidance of transbronchial needle aspiration of thoracic structures and has become an increasingly important diagnostic tool for chest physicians. Little has been published about the learning experience of operators with this technology. The purpose of this study was to define the learning experience of EBUS-guided transbronchial needle aspiration (EBUS-TBNA) among pulmonary trainees., Methods: This was a multicenter cohort study of fellows in pulmonary medicine over the first 2 years of their training. Prior to performing EBUS-TBNA, all participants had to complete 30 conventional bronchoscopies, an EBUS-specific didactic curriculum, and a simulation session with a plastic airway model. Each consecutive EBUS procedure was scored with a checklist that evaluated the ability to pass a bronchoscope through vocal cords, identify the appropriate node for sampling, acquire adequate ultrasound images, guide the bronchoscopy team through the technical steps of EBUS-TBNA, and obtain adequate tissue samples., Results: Thirteen pulmonary trainees from three training programs were enrolled in the study and were observed over a 2-year period. The majority of trainees were able to perform all essential steps of EBUS-TBNA and obtain adequate tissue after performing an average of 13 (95% CI, 7-16) procedures., Conclusions: Pulmonary trainees needed an average of 13 procedures to achieve first independent successful performance of EBUS-TBNA following a training protocol that included a didactic curriculum and simulation-based practice. Our findings could guide pulmonary fellowship directors in planning EBUS training and establishing a reasonable juncture to assess EBUS skills with validated assessment tools.

Background: Since the introduction of the flexible bronchoscope over 50 years ago, bronchoscopists have seen vast improvement in the technology available for diagnostics and therapeutics in the bronchoscopy laboratory. We set forth to evaluate the latest evolution in flexible bronchoscopes with features designed to improve imaging and airway navigation., Methods: The BF-Q190, BF-H190, and/or BF-1TH190 bronchoscopes were evaluated prospectively in 105 patients undergoing bronchoscopy from November 2010 to August 2011 at 2 tertiary care centers in the United States. Data collected from each procedure included method of insertion, airway images, and therapeutic interventions. At the completion of the study, 10 bronchoscopists were surveyed using a 7-point Likert scale to identify the perceived benefits of the design., Results: Insertion methods included nasal, oral, laryngeal mask airway or endotracheal tube, and tracheostomy. Procedures performed included bronchoalveolar lavage, endobronchial biopsy or brushing, transbronchial biopsy, transbronchial needle aspiration or injection, peripheral navigation, and large airway therapeutic interventions. Survey of bronchoscopists revealed that when compared with current bronchoscopes, the features rated as having the most significant impact on functionality are the 210-degree tip angulation (average 2.4/3) and rotational capability of the insertion tube (average 2.4/3)., Conclusions: The new-generation flexible bronchoscope offers improvement in image quality, magnification options, unique insertion tube rotation, and an increased 210-degree distal tip angulation over currently available flexible bronchoscopes. The bronchoscopes are an overall improvement to the current generation of bronchoscopes. The increased tip angulation and novel rotating insertion tube add the most to improvement in functionality.

Most interventional pulmonology studies focus on the technical success of procedures without measuring validated quality-of-life (QoL) outcomes. Studies are now incorporating end points that include QoL measurements and there are examples of interventional procedures that likely improve QoL. It is vital for the interventional pulmonary literature to incorporate cost-effectiveness when introducing new technology. While not uniformly analyzed in a rigorous manner in all studies, there are examples of interventional pulmonary studies that analyze cost-effectiveness through avoidance of more expensive procedures, cost savings per day free of emergency room visit, or cost savings per day not requiring intensive care unit care., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Endobronchial ultrasound (EBUS) has revolutionized the ability of bronchoscopists to visualize and sample structures surrounding the tracheobronchial tree. It has been shown to be safe, minimally invasive, and highly accurate in the staging and diagnosing of mediastinal diseases. A prior survey of pulmonary fellowship program directors conducted in 2004 showed that only 2% of programs offered EBUS training., Methods: Surveys were mailed to 154 pulmonary/critical care fellowship directors in the United States and Puerto Rico. Demographics of the fellowship and details of EBUS training were recorded. A comparison of EBUS volume was made between programs with and without an identifiable interventional pulmonologist (IP)., Results: The survey response rate was 71%. EBUS equipment was available at 89% of programs. Of those without EBUS, 100% expressed the goal of obtaining equipment within the year. An identifiable IP was present in 70% of programs. This was associated with more EBUS procedures performed by trainees ( P , .01). Only 30% of programs have a formal protocol in place to evaluate EBUS competency. Conventional transbronchial needle aspiration is routinely taught in 89% of fellowship programs., Conclusions: EBUS exposure has rapidly disseminated into fellowship training programs, and programs with an identifiable IP are more likely to provide fellows with more EBUS procedures. The findings of this survey point out the need to develop a standardized protocol for EBUS competency that includes current recommendations and may require training with simulation.

Over the past 15 years, patients with a myriad of pulmonary conditions have been diagnosed and treated with new technologies developed for the pulmonary community. Advanced diagnostic and therapeutic procedures once performed in an operating theater under general anesthesia are now routinely performed in a bronchoscopy suite under moderate sedation with clinically meaningful improvements in outcome. With the miniaturization of scopes and instruments, improvements in optics, and creative engineers, a host of new devices has become available for clinical testing and use. A growing community of pulmonologists is doing comparative effectiveness trials that test new technologies against the current standard of care. While more research is needed, it seems reasonable to provide an overview of pulmonary procedures that are in various stages of development, testing, and practice at this time. Five areas are covered: navigational bronchoscopy, endobronchial ultrasound, endoscopic lung volume reduction, bronchial thermoplasty, and pleural procedure. Appropriate training for clinicians who wish to provide these services will become an area of intense scrutiny as new skills will need to be acquired to ensure patient safety and a good clinical result.

Background: The detection of pulmonary nodules (PNs) is likely to increase, especially with the release of the National Lung Screen Trials. When tissue diagnosis is desired, transthoracic needle aspiration (TTNA) is recommended. Several guided-bronchoscopy technologies have been developed to improve the yield of transbronchial biopsy for PN diagnosis: electromagnetic navigation bronchoscopy (ENB), virtual bronchoscopy (VB), radial endobronchial ultrasound (R-EBUS), ultrathin bronchoscope, and guide sheath. We undertook this meta-analysis to determine the overall diagnostic yield of guided bronchoscopy using one or a combination of the modalities described here., Methods: We performed a MEDLINE search using “bronchoscopy” and “solitary pulmonary nodule.” Studies evaluating the diagnostic yield of ENB, VB, R-EBUS, ultrathin bronchoscope, and/or guide sheath for peripheral nodules were included. The overall diagnostic yield and yield based on size were extracted. Adverse events, if reported, were recorded. Meta-analysis techniques incorporating inverse variance weighting and a random-effects meta-analysis approach were used., Results: A total of 3,052 lesions from 39 studies were included. The pooled diagnostic yield was 70%, which is higher than the yield for traditional transbronchial biopsy. The yield increased as the lesion size increased. The pneumothorax rate was 1.5%, which is significantly smaller than that reported for TTNA., Conclusion: This meta-analysis shows that the diagnostic yield of guided bronchoscopic techniques is better than that of traditional transbronchial biopsy. Although the yield remains lower than that of TTNA, the procedural risk is lower. Guided bronchoscopy may be an alternative or be complementary to TTNA for tissue sampling of PN, but further study is needed to determine its role in the evaluation of peripheral pulmonary lesions.

Background: Optimal performance of bronchoscopy requires patient's comfort, physician's ease of execution, and minimal risk. There is currently a wide variation in the use of topical anesthesia, analgesia, and sedation during bronchoscopy., Methods: A panel of experts was convened by the American College of Chest Physicians Interventional/Chest Diagnostic Network. A literature search was conducted on MEDLINE from 1969 to 2009, and consensus was reached by the panel members after a comprehensive review of the data. Randomized controlled trials and prospective studies were given highest priority in building the consensus., Results: In the absence of contraindications, topical anesthesia, analgesia, and sedation are suggested in all patients undergoing bronchoscopy because of enhanced patient tolerance and satisfaction. Robust data suggest that anticholinergic agents, when administered prebronchoscopy, do not produce a clinically meaningful effect, and their use is discouraged. Lidocaine is the preferred topical anesthetic for bronchoscopy, given its short half life and wide margin of safety. The use of a combination of benzodiazepines and opiates is suggested because of their synergistic effects on patient tolerance during the procedure and the added antitussive properties of opioids. Propofol is an effective agent for sedation in bronchoscopy and can achieve similar sedation, amnesia, and patient tolerance when compared with the combined administration of benzodiazepines and opiates., Conclusions: We suggest that all physicians performing bronchoscopy consider using topical anesthesia, analgesic and sedative agents, when feasible. The existing body of literature supports the safety and effectiveness of this approach when the proper agents are used in an appropriately selected patient population.

Background: Learning medical procedures relies predominantly on the apprenticeship model, and competency is established based on the number of performed procedures. Our study aimed to establish bronchoscopy competency metrics based on performance and enhanced learning with educational interventions., Methods: We conducted a prospective study of the acquisition of bronchoscopy skills and cognitive knowledge in two successive cohorts of new pulmonary fellows between July 5, 2006, and June 30, 2008. At prespecified milestones, validated tools were used for testing: the Bronchoscopy Skills and Tasks Assessment Tool (BSTAT), an objective evaluation of bronchoscopy skills with scores ranging from 0 to 24, and written multiple-choice questions examinations. The first cohort received training in bronchoscopy as per the standards set by each institution, whereas the second cohort received educational interventions, including training in simulation bronchoscopy and an online bronchoscopy curriculum., Results: There was significant variation among study participants in bronchoscopy skills at their 50th bronchoscopy, the minimum number previously set to achieve competency in bronchoscopy. An educational intervention of incorporating simulation bronchoscopy enhanced the speed of acquisition of bronchoscopy skills, as shown by the statistically significant improvement in mean BSTAT scores for seven of the eight milestone bronchoscopies (P < .05). The online curriculum did not improve the performance on the written tests; however, compliance of the learners with the curriculum was low., Conclusions: Performance-based competency metrics can be used to evaluate bronchoscopy skills. Educational interventions, such as simulation-based training, accelerated the acquisition of bronchoscopy skills among first-year pulmonary fellows as assessed by a validated objective assessment tool.

Background: Fospropofol disodium is a water-soluble prodrug of propofol with unique pharmacokinetic/pharmacodynamic properties. This randomized, double-blind, multicenter study evaluated the use of fospropofol in patients undergoing flexible bronchoscopy., Methods: Patients >or= 18 years of age were randomized (2:3) to receive fospropofol, 2 mg/kg or 6.5 mg/kg, after pretreatment with fentanyl, 50 microg. Supplemental doses of each were given per protocol. The primary end point was sedation success, which was defined as follows: three consecutive Modified Observer's Assessment of Alertness/Sedation scores of

Bronchoscopy is an invaluable tool utilized for the diagnosis, staging, and management of lung cancer. Advancements in computer technology and engineering have allowed for the emergence of newer modalities to evaluate endobronchial, parenchymal, and mediastinal pathology. Established techniques such as white light video bronchoscopy and its ancillary procedures (forceps biopsy, brush biopsy, bronchoalveolar lavage, bronchial washings, and transbronchial needle aspiration) are discussed here, with their accuracy described in relation to tumor location, size, and type. Newer technologies such as autofluorescence bronchoscopy, narrow band imaging, endoscopic ultrasound, endobronchial ultrasound, electromagnetic navigation, optical coherence tomography, and confocal fluorescent laser microscopy are introduced and put into perspective. Special emphasis has been placed on their role in the early detection and staging of lung cancer. Some technology requires further study to delineate its role in the disease, whereas other modalities are emerging as the new gold standard in evaluation of lung cancer. The future holds great promise with further miniaturization of equipment and improvements in computer processing power that may allow for in vivo pathological evaluation of abnormal tissue.

Background: The objectives of this study were to characterize the appearance of normal, dysplastic, and frankly malignant airway lesion appearance under narrow-band imaging (NBI), and to determine if NBI, when used in conjunction with white light (WL) bronchoscopy, could improve detection of dysplasia and malignancy., Patients and Methods: This was a prospective, partially blinded study at a university teaching hospital. Bronchoscopy was performed on 22 patients with known or suspected bronchial dysplasia or malignancy. Full airway examination was performed first under WL bronchoscopy and then under NBI. Directed endobronchial biopsies of likely dysplastic, malignant, and normal (control) areas were then performed and sent for examination by a pathologist blinded to the gross description of the lesion. Pathology interpretations were then compared to the corresponding WL and NBI images., Results: There were one malignant and four dysplastic lesions in 22 patients detected by NBI when findings by WL imaging were considered normal. In cases when the WL appearance was abnormal, NBI did not improve the diagnostic yield. The increased rate of detection of dysplasia and malignancy by NBI was statistically significant (p = 0.005)., Conclusion: NBI identified dysplasia or malignancy that was not detected by WL inspection in 23% of subjects. Further studies are needed to determine the efficacy of NBI in detection of premalignant airways lesions in an at-risk population.

Objectives: To review complications of indwelling tracheal stents and to describe a technique of stent removal using a combined open and endoscopic approach., Design: Descriptive case series., Setting: Medical University of South Carolina., Patients: Six patients were identified who had undergone combined open and endoscopic removal of indwelling tracheal stents. Coated (4 patients) and uncoated (2 patients) expandable metal stents had been present for an average time of 24 months (range, 5-60 months) before removal., Main Outcome Measures: Medical comorbidities, characteristics of the underlying airway lesion (origin, type, and length), stent characteristics (type and duration), and the presentation and management of stent-related complications., Results: All patients presented with worsening dyspnea and/or stridor, with 3 requiring intubation. Stent removal was performed in the operating room and consisted of initial exposure of the trachea for emergency airway access, removal of the indwelling stent under bronchoscopic and transtracheal guidance, and tracheotomy. Two patients experienced desaturations of more than 25% during the procedure, and 2 patients had stents that could be only partially removed. Five patients subsequently received Montgomery T-tubes without complications after a mean follow-up of 23 months (range, 6-40 months)., Conclusions: Indwelling tracheal stents are becoming increasingly common in the management of benign airway stenosis. The stents frequently occlude with granulation tissue and may require removal. A combined open and endoscopic removal maximizes airway protection and minimizes potential complications.

Background: Advanced diagnostic bronchoscopy targeting the lung periphery has developed at an accelerated pace over the last two decades, whereas evidence to support introduction of innovative technologies has been variable and deficient. A major gap relates to variable reporting of diagnostic yield, in addition to limited comparative studies. Objectives: To develop a research framework to standardize the evaluation of advanced diagnostic bronchoscopy techniques for peripheral lung lesions. Specifically, we aimed for consensus on a robust definition of diagnostic yield, and we propose potential study designs at various stages of technology development. Methods: Panel members were selected for their diverse expertise. Workgroup meetings were conducted in virtual or hybrid format. The cochairs subsequently developed summary statements, with voting proceeding according to a modified Delphi process. The statement was cosponsored by the American Thoracic Society and the American College of Chest Physicians. Results: Consensus was reached on 15 statements on the definition of diagnostic outcomes and study designs. A strict definition of diagnostic yield should be used, and studies should be reported according to the STARD (Standards for Reporting Diagnostic Accuracy Studies) guidelines. Clinical or radiographic follow-up may be incorporated into the reference standard definition but should not be used to calculate diagnostic yield from the procedural encounter. Methodologically robust comparative studies, with incorporation of patient-reported outcomes, are needed to adequately assess and validate minimally invasive diagnostic technologies targeting the lung periphery. Conclusions: This American Thoracic Society/American College of Chest Physicians statement aims to provide a research framework that allows greater standardization of device validation efforts through clearly defined diagnostic outcomes and robust study designs. High-quality studies, both industry and publicly funded, can support subsequent health economic analyses and guide implementation decisions in various healthcare settings. [ABSTRACT FROM AUTHOR]

Rationale: Strict adherence to procedural protocols and diagnostic definitions is critical to understand the efficacy of new technologies. Electromagnetic navigational bronchoscopy (ENB) for lung nodule biopsy has been used for decades without a solid understanding of its efficacy, but offers the opportunity for simultaneous tissue acquisition via electromagnetic navigational transthoracic biopsy (EMN-TTNA) and staging via endobronchial ultrasound (EBUS). Objective: To evaluate the diagnostic yield of EBUS, ENB, and EMN-TTNA during a single procedure using a strict a priori definition of diagnostic yield with central pathology adjudication. Methods: A prospective, single-arm trial was conducted at eight centers enrolling participants with pulmonary nodules (,3 cm; without computed tomography [CT]- and/or positron emission tomography-positive mediastinal lymph nodes) who underwent a staged procedure with same-day CT, EBUS, ENB, and EMNTTNA. The procedure was staged such that, when a diagnosis had been achieved via rapid on-site pathologic evaluation, the procedure was ended and subsequent biopsy modalities were not attempted. A study finding was diagnostic if an independent pathology core laboratory confirmed malignancy or a definitive benign finding. The primary endpoint was the diagnostic yield of the combination of CT, EBUS, ENB, and EMN-TTNA. Measurements and Main Results: A total of 160 participants at 8 centers with a mean nodule size of 1866mm were enrolled. The diagnostic yield of the combined procedure was 59% (94 of 160; 95% confidence interval [CI], 51-66%). Nodule regression was found on same-day CT in 2.5% of cases (4 of 160; 95% CI, 0.69-6.3%), and EBUS confirmed malignancy in 7.1% of cases (11 of 156; 95% CI, 3.6-12%). The yield of ENB alone was 49% (74 of 150; 95% CI, 41-58%), that of EMN-TTNA alone was 27% (8 of 30; 95% CI, 12-46%), and that of ENB plus EMN-TTNA was 53% (79 of 150; 95% CI, 44-61%). Complications included a pneumothorax rate of 10% and a 2% bleeding rate. When EMN-TTNA was performed, the pneumothorax rate was 30%. Conclusions: The diagnostic yield for ENB is 49%, which increases to 59% with the addition of same-day CT, EBUS, and EMN-TTNA, lower than in prior reports in the literature. The high complication rate and low diagnostic yield of EMN-TTNA does not support its routine use. Clinical trial registered with www.clinicaltrials.gov (NCT 03338049). [ABSTRACT FROM AUTHOR]

Guided bronchoscopy is increasingly used to diagnose peripheral pulmonary lesions (PPLs). A meta-analysis published in 2012 demonstrated a pooled diagnostic yield of 70%; however, recent publications have documented yields as low as 40% and as high as 90%. Has the diagnostic yield of guided bronchoscopy in patients with PPLs improved over the past decade? A comprehensive search was performed of studies evaluating the diagnostic yield of differing bronchoscopic technologies used to reach PPLs. Study quality was assessed using the Quality assessment of diagnostic accuracy of studies (QUADAS-2) assessment tool. Number of lesions, type of technology used, overall diagnostic yield, and yield by size were extracted. Adverse events were recorded. Meta-analytic techniques were used to summarize findings across all studies. A total of 16,389 lesions from 126 studies were included. There was no significant difference in diagnostic yield prior to 2012 (39 studies; 3,052 lesions; yield 70.5%) vs after 2012 (87 studies; 13,535 lesions; yield 69.2%) (P >.05). Additionally, there was no significant difference in yield when comparing different technologies. Studies with low risk of overall bias had a lower diagnostic yield than those with high risk of bias (66% vs 71%, respectively; P =.018). Lesion size > 2 cm, presence of bronchus sign, and reports with a high prevalence of malignancy in the study population were associated with significantly higher diagnostic yield. Significant (P <.0001) between-study heterogeneity was also noted. Despite the reported advances in bronchoscopic technology to diagnose PPLs, the diagnostic yield of guided bronchoscopy has not improved. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Bronchoscopic lung biopsy is typically performed using transbronchial forceps. However, this method is limited by small sample size and presence of crush artifact. Cryobiopsy offers the potential to overcome these limitations with larger artifact-free samples but has not been widely adopted due to concerns over increased rates of bleeding and pneumothorax. A new, smaller 1.1-mm cryoprobe has been developed that operates in a similar fashion to forceps, though the safety profile of this cryoprobe has not yet been prospectively studied. Objective: The aim of this study was to investigate the safety of transbronchial biopsy using a novel 1.1-mm cryoprobe. Methods: This prospective, single-arm study enrolled patients referred for transbronchial biopsy. All procedures were performed using the 1.1-mm cryoprobe with oversheath. The primary outcome was the composite of significant complications related to the cryobiopsy procedure (bleeding Grade ≥3, pneumothorax Grade ≥2, and respiratory failure). Bleeding and pneumothorax were graded according to previously published scales. Results: Fifty participants from two academic medical centers underwent transbronchial cryobiopsy. Indications for biopsy included evaluation of lung transplant allograft (50%), diffuse lung disease (44%), and pulmonary parenchymal lesion (6%). There were two pneumothoraces (4%), neither of which required aspiration or chest tube placement. There were no Grade 3 or 4 bleeding events. Mild bleeding (Grade ≤2) was observed in 25 cases (50%). No complications occurred that met the a priori primary outcome of bleeding Grade ≥3, pneumothorax Grade ≥2, and respiratory failure. Conclusions: Transbronchial cryobiopsy using a 1.1-mm cryoprobe is feasible with an acceptable safety profile. [ABSTRACT FROM AUTHOR]

Background: The ability to successfully perform a biopsy on pulmonary lesions by means of bronchoscopy varies widely due to anatomic and technological limitations. One major limitation is the lack of the ability to utilize real-time guidance during tissue sampling in the periphery. A novel system has been developed that enables real-time visualization and sampling of peripheral lesions by displaying an ultrasound image of the lesion and needle simultaneously. Methods: We performed a multicenter, prospective pilot in patients with peripheral pulmonary lesions undergoing a clinically indicated bronchoscopy. The purpose of this study was to demonstrate the feasibility of visualizing, accessing, and obtaining specimens adequate for the cytology of lung lesions when using a novel hybrid real-time ultrasound-guided fine-needle aspiration system for peripheral pulmonary lesions. Results: Twenty-three patients underwent bronchoscopic sampling of a peripheral pulmonary lesion with the study device. Mean lesion size was 3.6 (range 1.7–5.7) cm. Targeted lesions were located in all lobes of the lung. All lesions were successfully visualized and sampled under real-time visualization with specimens adequate for cytological evaluation. The needle was visualized in all lesions throughout targeting and sampling. There were no incidents of pneumothorax or moderate-to-severe bleeding. Conclusion: In this feasibility study, we report the first-in-human use of a continuous real-time endobronchial ultrasound guidance system to sample peripheral pulmonary lesions. Future generations of this device may improve usability and further studies are needed to determine the true diagnostic capabilities of this novel technique. [ABSTRACT FROM AUTHOR]

The article discusses the development and significant complications of endobronchial ultrasound (EBUS). Topics discussed include minimally invasive procedural and quality of life improvements and outcomes in the interventional pulmonary, emergence of drug-resistant pathogens (DRP), and prognostic biomarkers of community-acquired pneumonia (CAP).

Interventional pulmonology (IP) is a rapidly evolving subspecialty of pulmonary medicine. In the last 10 years, formal IP fellowships have increased substantially in number from five to now > 30. The vast majority of IP fellowship trainees are selected through the National Resident Matching Program, and validated in-service and certification examinations for IP exist. Practice standards and training guidelines for IP fellowship programs have been published; however, considerable variability in the environment, curriculum, and experience offered by the various fellowship programs remains, and there is currently no formal accreditation process in place to standardize IP fellowship training. Recognizing the need for more uniform training across the various fellowship programs, a multisociety accreditation committee was formed with the intent to establish common accreditation standards for all IP fellowship programs in the United States. This article provides a summary of those standards and can serve as an accreditation template for training programs and their offices of graduate medical education as they move through the accreditation process. [ABSTRACT FROM AUTHOR]

The article discusses a study to determine the competency of trainees in programs performing bronchoscopy. Topics cited include information on the current methods used for bronchoscopy competency and a call on professional societies and certifying agencies to shift from a volume-based certification system to skill acquisition and knowledge-based competency assessment for trainees.

Background: The gene expression profile of cytologically-normal bronchial airway epithelial cells has previously been shown to be altered in patients with lung cancer. Although bronchoscopy is often used for the diagnosis of lung cancer, its sensitivity is imperfect, especially for small and peripheral suspicious lesions. In this study, we derived a gene expression classifier from airway epithelial cells that detects the presence of cancer in current and former smokers undergoing bronchoscopy for suspect lung cancer and evaluated its sensitivity to detect lung cancer among patients from an independent cohort. Methods: We collected bronchial epithelial cells (BECs) from the mainstem bronchus of 299 current or former smokers (223 cancer-positive and 76 cancer-free subjects) undergoing bronchoscopy for suspected lung cancer in a prospective, multi-center study. RNA from these samples was run on gene expression microarrays for training a gene-expression classifier. A logistic regression model was built to predict cancer status, and the finalized classifier was validated in an independent cohort from a previous study. Results: We found 232 genes whose expression levels in the bronchial airway are associated with lung cancer. We then built a classifier based on the combination of 17 cancer genes, gene expression predictors of smoking status, smoking history, and gender, plus patient age. This classifier had a ROC curve AUC of 0.78 (95% CI, 0.70-0.86) in patients whose bronchoscopy did not lead to a diagnosis of lung cancer (n = 134). In the validation cohort, the classifier had a similar AUC of 0.81 (95% CI, 0.73-0.88) in this same subgroup (n = 118). The classifier performed similarly across a range of mass sizes, cancer histologies and stages. The negative predictive value was 94% (95% CI, 83-99%) in subjects with a non-diagnostic bronchoscopy. Conclusion: We developed a gene expression classifier measured in bronchial airway epithelial cells that is able to detect lung cancer in current and former smokers who have undergone bronchoscopy for suspicion of lung cancer. Due to the high NPV of the classifier, it could potentially inform clinical decisions regarding the need for further invasive testing in patients whose bronchoscopy is non diagnostic. [ABSTRACT FROM AUTHOR]

The article presents a meta-analysis which examines the total diagnostic yield of guided-bronchoscopy technologies to improve the diagnosis of pulmonary nodules (PNs). Findings reveal that the overall diagnostic yield was 70%. It indicates that the increase of lesion size can also increase the yield's percentage.

The article focuses on the study which assesses the utility of endobronchial ultrasound (EBUS) with transbronchial needle aspiration (TBNA) for pulmonary sarcoidosis. To test, patients with suspected pulmonary sarcoidosis were made as subjects who underwent EBUS-TBNA. They have also undergone histologic biopsy or clinical follow-up to determine the final diagnosis. The results conclude that EBUS-TBNA is an effective tool for the primary diagnosis of pulmonary sarcoidosis.

The article discusses the invasive procedures for confirmatory staging of the mediastinum in patients with lung cancer. Particular focus is on patients in whom there is a strong suspicion of lung cancer. Such presumptive clinical diagnosis is generally possible by an experienced clinician after an assessment of risk factors, and a review of the clinical presentation and the radiographic appearance on a computed tomography (CT) scan.

B PURPOSE: b Robotic assisted bronchoscopic (RAB) platforms have been developed to potentially improve the diagnostic yield for peripheral pulmonary lesions. This study was performed to evaluate the safety and feasibility of robotic assisted bronchoscopic biopsy in patients with peripheral pulmonary lesions utilizing the current generation RAB platform. Primary endpoints were lesion localization using R-EBUS as well as incidence of procedure related complications. [Extracted from the article]