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Background Bronchial thermoplasty is a device-based treatment for subjects ≥18 years with severe asthma poorly controlled with inhaled corticosteroids and long-acting beta-agonists. The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma (PAS2) study collected data on severe asthmatics undergoing this procedure. Research Question What are the 5-year efficacy and safety results in severe asthmatics who have undergone bronchial thermoplasty? Study Design and Methods This was a prospective, open-label, observational, multi-center study conducted in the United States and Canada. Subjects aged 18-65, taking inhaled corticosteroids ≥1000μg/day (beclomethasone or equivalent) and long-acting β-agonists ≥80μg/day (salmeterol or equivalent) were included. Severe exacerbations, hospitalization, emergency department visits, and medication usage were evaluated for the 12 months prior to and at years 1-5 post-treatment. Spirometry was evaluated at baseline and at years 1-5 post-treatment. Results 284 subjects were enrolled at 27 centers; 227 subjects (80%) completed 5 years of follow-up. By year 5 post-treatment, the proportion of subjects with severe exacerbations, emergency department visits, and hospitalizations was 42.7%, 7.9%, and 4.8%, respectively, compared to 77.8%, 29.4%, and 16.1% in the 12 months prior to treatment. The proportion of subjects on maintenance oral corticosteroids decreased from 19.4% at baseline to 9.7% at 5 years. Analyses of subgroups based on baseline clinical and biomarker characteristics revealed a statistically significant clinical improvement among all subgroups. Interpretation Five years after treatment, subjects experienced decreases in severe exacerbations, hospitalizations, emergency department visits and corticosteroid exposure. All subgroups demonstrated clinically significant improvement, suggesting that bronchial thermoplasty improves asthma control in different asthma phenotypes.

Background: Despite increased use of rigid bronchoscopy (RB) for therapeutic indications and recommendations from professional societies to use performance-based competency, an assessment tool has not been utilized to measure the competency of trainees to perform RB in clinical settings. Objectives: The aim of the study was to evaluate a previously developed assessment tool – Rigid Bronchoscopy Tool for Assessment of Skills and Competence (RIGID-TASC) – for determining the RB learning curve of interventional pulmonary (IP) trainees in the clinical setting and explore the variability of learning curve of trainees. Methods: IP fellows at 4 institutions were enrolled. After preclinical simulation training, all RBs performed in patients were scored by faculty using RIGID-TASC until competency threshold was achieved. Competency threshold was defined as unassisted RB intubation and navigation through the central airways on 3 consecutive patients at the first attempt with a minimum score of 89. A regression-based model was devised to construct and compare the learning curves. Results: Twelve IP fellows performed 178 RBs. Trainees reached the competency threshold between 5 and 24 RBs, with a median of 15 RBs (95% CI, 6–21). There were differences among trainees in learning curve parameters including starting point, slope, and inflection point, as demonstrated by the curve-fitting model. Subtasks that required the highest number of procedures (median = 10) to gain competency included ability to intubate at the first attempt and intubation time of Conclusions: Trainees acquire RB skills at a variable pace, and RIGID-TASC can be used to assess learning curve of IP trainees in clinical settings.

Background The role of tracheostomy during the coronavirus disease 2019 (COVID-19) pandemic remains unknown. The goal of this consensus statement is to examine the current evidence for performing tracheostomy in patients with respiratory failure from COVID-19 and offer guidance to physicians on the preparation, timing, and technique while minimizing the risk of infection to health care workers (HCWs). Methods A panel including intensivists and interventional pulmonologists from three professional societies representing 13 institutions with experience in managing patients with COVID-19 across a spectrum of health-care environments developed key clinical questions addressing specific topics on tracheostomy in COVID-19. A systematic review of the literature and an established modified Delphi consensus methodology were applied to provide a reliable evidence-based consensus statement and expert panel report. Results Eight key questions, corresponding to 14 decision points, were rated by the panel. The results were aggregated, resulting in eight main recommendations and five additional remarks intended to guide health-care providers in the decision-making process pertinent to tracheostomy in patients with COVID-19-related respiratory failure. Conclusion This panel suggests performing tracheostomy in patients expected to require prolonged mechanical ventilation. A specific timing of tracheostomy cannot be recommended. There is no evidence for routine repeat reverse transcription polymerase chain reaction testing in patients with confirmed COVID-19 evaluated for tracheostomy. To reduce the risk of infection in HCWs, we recommend performing the procedure using techniques that minimize aerosolization while wearing enhanced personal protective equipment. The recommendations presented in this statement may change as more experience is gained during this pandemic.

Background The coronavirus disease 2019 (COVID-19) has swept the globe and is causing significant morbidity and mortality. Given that the virus is transmitted via droplets, open airway procedures such as bronchoscopy pose a significant risk to health-care workers (HCWs). The goal of this guideline was to examine the current evidence on the role of bronchoscopy during the COVID-19 pandemic and the optimal protection of patients and HCWs. Study Design and Methods A group of approved panelists developed key clinical questions by using the Population, Intervention, Comparator, and Outcome (PICO) format that addressed specific topics on bronchoscopy related to COVID-19 infection and transmission. MEDLINE (via PubMed) was systematically searched for relevant literature and references were screened for inclusion. Validated evaluation tools were used to assess the quality of studies and to grade the level of evidence to support each recommendation. When evidence did not exist, suggestions were developed based on consensus using the modified Delphi process. Results The systematic review and critical analysis of the literature based on six PICO questions resulted in six statements: one evidence-based graded recommendation and 5 ungraded consensus-based statements. Interpretation The evidence on the role of bronchoscopy during the COVID-19 pandemic is sparse. To maximize protection of patients and HCWs, bronchoscopy should be used sparingly in the evaluation and management of patients with suspected or confirmed COVID-19 infections. In an area where community transmission of COVID-19 infection is present, bronchoscopy should be deferred for nonurgent indications, and if necessary to perform, HCWs should wear personal protective equipment while performing the procedure even on asymptomatic patients.

Current medical society guidelines recommend a procedural number for obtaining electromagnetic navigational bronchoscopy (ENB) competency and for institutional volume for training.To assess learning curves and estimate the number of ENB procedures for interventional pulmonology (IP) fellows to reach competency.We conducted a prospective multicenter study of IP fellows in the United States learning ENB. A tool previously validated in a similar population was used to assess IP fellows by their local faculty and two blinded independent reviewers using virtual recording of the procedure. Competency was determined by performing three consecutive procedures with a competency score on the assessment tool. Procedural time, faculty global rating scale, and periprocedural complications were also recorded.A total of 184 ENB procedures were available for review with assessment of 26 IP fellows at 16 medical centers. There was a high correlation between the two blinded independent observers (rho = 0.8776). There was substantial agreement for determination of procedural competency between the faculty assessment and blinded reviewers (kappa = 0.7074; confidence interval, 0.5667-0.8482). The number of procedures for reaching competency for ENB bronchoscopy was determined (median, 4; mean, 5; standard deviation, 3.83). There was a wide variation in the number of procedures to reach competency, ranging from 2 to 15 procedures. There were six periprocedural complications reported, four (one pneumomediastinum, three pneumothorax) of which occurred before reaching competence and two pneumothoraces after achieving competence.There is a wide variation in acquiring competency for ENB among IP fellows. Virtual competency assessment has a potential role but needs further studies.

Rationale: Less invasive, nonsurgical approaches are needed to treat severe emphysema. Objectives: To evaluate the effectiveness and safety of the Spiration Valve System (SVS) versus optimal medical management. Methods: In this multicenter, open-label, randomized, controlled trial, subjects aged 40 years or older with severe, heterogeneous emphysema were randomized 2:1 to SVS with medical management (treatment) or medical management alone (control). Measurements and Main Results: The primary efficacy outcome was the difference in mean FEV1 from baseline to 6 months. Secondary effectiveness outcomes included: difference in FEV1 responder rates, target lobe volume reduction, hyperinflation, health status, dyspnea, and exercise capacity. The primary safety outcome was the incidence of composite thoracic serious adverse events. All analyses were conducted by determining the 95% Bayesian credible intervals (BCIs) for the difference between treatment and control arms. Between October 2013 and May 2017, 172 participants (53.5% male; mean age, 67.4 yr) were randomized to treatment (n = 113) or control (n = 59). Mean FEV1 showed statistically significant improvements between the treatment and control groups—between-group difference at 6 and 12 months, respectively, of 0.101 L (95% BCI, 0.060–0.141) and 0.099 L (95% BCI, 0.048–0.151). At 6 months, the treatment group had statistically significant improvements in all secondary endpoints except 6-minute-walk distance. Composite thoracic serious adverse event incidence through 6 months was greater in the treatment group (31.0% vs. 11.9%), primarily due to a 12.4% incidence of serious pneumothorax. Conclusions: In patients with severe heterogeneous emphysema, the SVS shows significant improvement in multiple efficacy outcomes, with an acceptable safety profile. Clinical trial registered with www.clinicaltrials.gov (NCT01812447).

Symptomatic pleural disease, specifically malignant pleural effusion, refractory benign pleural effusion, and pneumothoraces are common diseases that often require therapeutic interventions. The spectrum of management strategies often includes selection of a chemical pleurodesis agent administered in combination with an indwelling pleural catheter or chest tube.Additionally, there is a role for minimally invasive techniques which include medical thoracoscopy or more advanced video-assisted thoracoscopic approaches. Ongoing clinical trials continue to evolve best practices regarding the optimal sclerosant agents and procedural approaches in the management of these diseases.

Background The outcome of indwelling pleural catheter (IPC) use in hepatic hydrothorax (HH) is unclear. This study aimed to review the safety and feasibility of the IPC in patients with refractory HH. Methods A retrospective multicenter study of patients with HH from January 2010 to December 2016 was performed. Inclusion criteria were refractory HH treated with an IPC and an underlying diagnosis of cirrhosis. Records were reviewed for patient demographics, operative reports, and laboratory values. The Kaplan-Meier method was used to estimate catheter time to removal. The Cox proportional hazard model was used to evaluate for independent predictors of pleurodesis and death. Results Seventy-nine patients were identified from eight institutions. Indication for IPC placement was palliation in 58 patients (73%) and bridge to transplant in 21 patients (27%). The median in situ dwell time of all catheters was 156 days (range, 16-1,978 days). Eight patients (10%) were found to have pleural space infection, five of whom also had catheter-site cellulitis. Two patients (2.5%) died secondary to catheter-related sepsis. Catheter removal secondary to spontaneous pleurodesis was achieved in 22 patients (28%). Median time from catheter insertion to pleurodesis was 55 days (range, 10-370 days). Older age was an independent predictor of mortality on multivariate analysis (hazard ratio, 1.05; P = .01). Conclusions We present, to our knowledge, the first multicenter study examining outcomes related to IPC use in HH. Ten percent infection risk and 2.5% mortality were identified. IPC placement may be a reasonable clinical option for patients with refractory HH, but it is associated with significant adverse events in this morbid population.

Interventional pulmonology (IP) is a maturing subspecialty of pulmonary medicine. The robust innovation in technology demands standardization in IP training with both disease and technology driven training. Simulation based training should be considered a part of IP training as seen in other procedural and surgical subspecialties. Procedure volume is a component of training; however, this does not guarantee or translate into competency for learners. Basic competency skills can be assessed using standardized well validated assessment tools designed for various IP procedures including flexible bronchoscopy, endobronchial ultrasound guided transbronchial needle aspiration (EBUS TBNA), rigid bronchoscopy and chest tube placement; however, further work is needed to validate tools in all procedures as new technologies are introduced beyond fellowship training. Currently there are at least 39 IP fellowship programs in the United States (US) and Canada which has led to improved training by accreditation of programs who meet rigorous requirements of standardized curriculum and procedural volume. The challenge is to be innovative in how we teach globally with intention and how to best integrate new evolving technology training for those not only during fellowship training but also beyond fellowship training.

BACKGROUND: Studies have demonstrated an inverse relationship between body mass index (BMI) and the risk of developing lung cancer. We conducted a retrospective cohort study evaluating baseline quantitative computed tomography (CT) measurements of body composition, specifically muscle and fat area in a large CT lung screening cohort (CTLS). We hypothesized that quantitative measurements of baseline body composition may aid in risk stratification for lung cancer. METHODS: Patients who underwent baseline CTLS between January 1st, 2012 and September 30th, 2014 and who had an in-network primary care physician were included. All patients met NCCN Guidelines eligibility criteria for CTLS. Quantitative measurements of pectoralis muscle area (PMA) and subcutaneous fat area (SFA) were performed on a single axial slice of the CT above the aortic arch with the Chest Imaging Platform Workstation software. Cox multivariable proportional hazards model for cancer was adjusted for variables with a univariate p < 0.2. Data were dichotomized by sex and then combined to account for baseline differences between sexes. RESULTS: One thousand six hundred and ninety six patients were included in this study. A total of 79 (4.7%) patients developed lung cancer. There was an association between the 25th percentile of PMA and the development of lung cancer [HR 1.71 (1.07, 2.75), p < 0.025] after adjusting for age, BMI, qualitative emphysema, qualitative coronary artery calcification, and baseline Lung-RADS® score. CONCLUSIONS: Quantitative assessment of PMA on baseline CTLS was associated with the development of lung cancer. Quantitative PMA has the potential to be incorporated as a variable in future lung cancer risk models.

Background Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS TBNA) of mediastinal lymphadenopathy has been shown to be equivalent and possibly even superior to mediastinoscopy. Since the original dedicated 22-G aspiration needle, 21-G, 25-G, and recently 19-G needles have been introduced. Smaller needles may be more flexible and adept at accessing more difficult nodes, and may have less blood contamination compared with larger needles. Patients and methods This is a prospective observational study of 50 consecutive patients who underwent endobronchial ultrasound-guided transbronchial needle aspiration with a 21-G needle and a 25-G needle for a total of 100 biopsies. The study slides were examined by a dedicated lung cytopathologist, who was blinded to the needle size used for each slide. Demographic data, and lymph node size were recorded. Comparisons between the 2 needles with regards to sample adequacy and diagnostic yield was performed using the McNemar test for dichotomous variables and marginal homogeneity test for nondichotomous variables since samples were related. Results The majority of lymph nodes (96%) were at least >1 cm. Adequate specimens were obtained in 78% of cases with the 21-G needle and 86% of cases with 25-G needle (P-value=0.424). The overall diagnostic yield was 74% and 80% with the 21-G needle and 25-G needle, respectively (P-value=0.607). Conclusion Our study demonstrates that the there is no difference in terms of specimen adequacy and diagnostic yield when the 25-G needle is compared with the 21-G needle.

TOPIC: Education, Research, and Quality Improvement TYPE: Original Investigations PURPOSE: The unprecedented COVID 19 pandemic has contributed to an increase in patients with respiratory failure many of which are requiring tracheostomy. As a result, the need for a working knowledge of tracheostomy care by many levels of care providers has soared. There are short and long term complications associated with tracheostomies. Multi-disciplinary team training for tracheostomy care may improve the care of these patients. METHODS: Medicine residents were given a pre-survey questionnaire to test their baseline knowledge on tracheostomies, understanding of available resources and comfort levels with dealing with day to day care and emergencies. Afterwards, a pre-test was given on knowledge about tracheostomies and daily/emergency management. Subsequently, they were given an educational presentation on tracheostomy selection, special COVID considerations, daily care and emergency troubleshooting. After completion of the education portion, residents underwent simulation lab training, comprising 4 stations: basic care;bleeding tracheostomy;accidental decannulation and tracheostomy obstruction. Residents were then re-tested to assess improvement in knowledge with plans to re-test in 6 months to monitor retention. RESULTS: Pre/Post survey results showed improvement in questions related to which service to call if there is a tracheostomy issue (69.9% to 92.3%), how to find tracheostomy specifics in the electronic medical record (13% to 61.5%), usefulness of a tracheostomy chart above the head of the bed (95.6% to 100%) and if tracheostomy emergency kits in each room were useful (91% to 100%). Pre/Post testing on the didactic and hands-on curriculum were administered. The pre-test results, no one passed as scores ranged 34-68 % out of a possible score of 100%. Post-test, everyone improved their scores with 75 % of learners passing the post test exam scoring 85-100%. Average test scores prior to lecture and simulation lab was 44%, compared to post test average of 83%. CONCLUSIONS: Residents increased their knowledge and awareness about tracheostomies as seen through improvements in all categories within testing. Residents favored specific educational scenarios about tracheostomy emergencies to delineate team training, roles and algorithms for care and in person training over online modules. This curriculum on tracheostomy troubleshooting and care can be operationalized for a wide array of team based multi-disciplinary providers throughout the spectrum of care. CLINICAL IMPLICATIONS: Standardized curriculum with clear objectives coupled with hands-on team training along with pre and post knowledge assessments can be readily implemented during a global pandemic. Further follow up assessments will be needed to determine if long term knowledge retention translates to sustained bedside benefit. DISCLOSURES: No relevant relationships by Alissa Ali, source=Web Response No relevant relationships by Doreen Kane, source=Web Response No relevant relationships by Louise Kane, source=Web Response Consultant relationship with Veracyte Please note: 2019-2021 Added 06/23/2021 by Carla Lamb, source=Web Response, value=Honoraria No relevant relationships by Tania Mangahas, source=Web Response No relevant relationships by Ekaterina Yavarovich, source=Web Response

Background Patients at high-risk for lung cancer and qualified for CT lung cancer screening (CTLS) are at risk for numerous cardio-pulmonary comorbidities. We sought to examine if qualitatively assessed coronary artery calcifications (CAC) on CTLS exams could identify patients at increased risk for non-cardiovascular events such as all cause, COPD and pneumonia related hospitalization and to verify previously reported associations between CAC and mortality and cardiovascular events. Study design and methods Patients (n = 4673) from Lahey Hospital and Medical Center who underwent CTLS from January 12, 2012 through September 30, 2017 were included with clinical follow-up through September 30, 2019. CTLS exams were qualitatively scored for the presence and severity of CAC at the time of exam interpretation using a four point scale: none, mild, moderate, and marked. Multivariable Cox regression models were used to evaluate the association between CT qualitative CAC and all-cause, COPD-related, and pneumonia-related hospital admissions. Results 3631 (78%) of individuals undergoing CTLS had some degree of CAC on their baseline exam: 1308 (28.0%), 1128 (24.1%), and 1195 (25.6%) had mild, moderate and marked coronary calcification, respectively. Marked CAC was associated with all-cause hospital admission and pneumonia related admissions HR 1.48; 95% CI 1.23–1.78 and HR 2.19; 95% 1.30–3.71, respectively. Mild, moderate and marked CAC were associated with COPD-related admission HR 2.30; 95% CI 1.31–4.03, HR 2.17; 95% CI 1.20–3.91 and HR 2.27; 95% CI 1.24–4.15. Conclusion Qualitative CAC on CTLS exams identifies individuals at elevated risk for all cause, pneumonia and COPD-related hospital admissions.

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.

BACKGROUND Interventional pulmonary (IP) fellows spend ≥6 years of postgraduate medical education before IP training. Given the high employment attrition rates of early medical professionals, we investigated the IP fellows' self-assessed readiness for employment and the role of an intense preemployment educational intervention on improving the same. MATERIALS AND METHODS Over 2 consecutive academic years, IP fellows nationally were invited to a mid-year career development symposium focusing on employment search strategy and early career development. Attendees were anonymously surveyed presymposium/postsymposium and 6 months later at graduation. Both quantitative and qualitative data were collected. Attendees' knowledge and skills were rated on a 5-point Likert scale. A control group of IP fellows that did not attend the symposium were also surveyed at graduation. RESULTS In total, 53 of 55 attendees (96% response rate) completed the presymposium survey and 50 of 55 (91%) completed the final survey at graduation. Overall, 16 of 18 (89%) nonattendees also completed the final survey at graduation. IP Fellows reported low baseline self-assessment scores on all question domains. Scores increased significantly postsymposium and were sustained at graduation (P

8551 Background: The goal of lung nodule management is to make an early diagnosis in patients with lung cancer while avoiding unnecessary, costly and potentially harmful procedures in patients with benign lesions. Increased implementation of low dose CT screening will lead to increased numbers of both benign and malignant nodules that will require effective management. We have previously described the feasibility of detecting gene expression changes associated with lung cancer (“field of injury”) in nasal epithelium utilizing whole transcriptome RNA sequencing from non-invasive nasal brush samples. Using this approach, we now report the performance of candidate nasal classifiers that combine both genomic and clinical features to risk stratify lung nodules from ever-smokers to aid in the diagnosis of lung cancer. Methods: Patients from several clinical cohorts who were ever-smokers with a lung nodule < 30 mm and without a history of prior cancer underwent nasal epithelium sampling. All patients had at least one year of follow up or until a final diagnosis of benign or malignant nodule was made. Candidate classifiers were developed using whole-transcriptome RNA sequencing and machine learning. Training of these classifiers included genomic and clinical information (age, sex, pack-years, years-since-quit, nodule size and nodule spiculation). Two decision boundaries were chosen to maximize sensitivity and specificity for low and high-risk nodules, respectively. The performance of these classifiers was evaluated using cross-validation (CV). Results: All candidate nasal classifiers underwent CV assessment on over 700 patients with lung nodules. All candidate classifiers achieved CV performance of > 40% specificity at 95% sensitivity in low- risk nodules and all candidate classifiers achieved CV performance of > 60% sensitivity at 90% specificity in high-risk nodules. The classifiers stratified benign nodules as low- risk with > 95% negative predictive value (NPV), intermediate risk nodules were stratified as 5-65% risk and malignant nodules were stratified as high- risk with > 65% positive predictive value (PPV) in a population with estimated 25% prevalence. This performance was robust across subgroups of age ( < 65 year vs. >65 year), sex, and current versus former smokers. Conclusions: The nasal genomic-clinical candidate classifiers have a high NPV effectively identifying benign nodules when calling them low- risk, thereby, informing decisions to more safely avoid a diagnostic workup. Additionally, the high PPV of these classifiers identifies malignant nodules when calling them high- risk and informs decisions regarding the urgency of a further diagnostic work-up. A nasal genomic-clinical classifier has the potential to serve as a non-invasive tool for lung cancer risk-stratification to help inform decision making in patients with lung nodules.

Hydroxychloroquine has been widely prescribed to treat patients with COVID-19 pneumonia. A 73-year-0ld woman with COVID-19 pneumonia was treated with dexamethasone and hydroxychloroquine. Her home medications, citalopram and donepezil, were continued. The ECG prior to starting hydroxychloroquine showed normal sinus rhythm with prolonged corrected QT (QTc) of 497 ms, due to citalopram and donepezil therapy. Repeat ECG on days 3 and 4 of hydroxychloroquine therapy showed significantly prolonged QTc of 557 ms and 538 ms, respectively, despite normal serum electrolytes. All QT-prolonging medications including hydroxychloroquine were discontinued on day 4; however, she suffered a transient torsades de pointes lasting for about 15 s, which resolved before any intervention. QTc improved to 477 ms, after discontinuation of QT-prolonging medications. The patient had QTc prolongation and torsades de pointes due to therapy with multiple QT-prolonging medications. Medicine reconciliation and careful monitoring of QTc may help prevent cardiac complications in patients with COVID-19 treated with hydroxychloroquine.

BACKGROUND: In the United States, 9 to 10 million Americans are estimated to be eligible for computed tomographic lung cancer screening (CTLS). Those meeting criteria for CTLS are at high-risk for numerous cardio-pulmonary co-morbidities. The objective of this study was to determine the association between qualitative emphysema identified on screening CTs and risk for hospital admission. STUDY DESIGN AND METHODS: We conducted a retrospective multicenter study from two CTLS cohorts: Lahey Hospital and Medical Center (LHMC) CTLS program, Burlington, MA and Mount Auburn Hospital CTLS program (MAH), Cambridge, MA. CT scans were qualitatively scored by radiologists at time of screening for presence of emphysema. Multivariable Cox regression models were used to evaluate the association between CT qualitative emphysema and all-cause, COPD-related, and pneumonia-related hospital admission RESULTS: We included 4675 participants from the LHMC cohort and 915 from the MAH cohort. 57% and 51.9% of the LHMC and MAH cohorts had presence of CT emphysema, respectively. In the LHMC cohort, the presence of emphysema was associated with all-cause hospital admission (HR 1.15, CI 1.03–1.31; p = 0.014) and COPD-related admission (HR 1.64; 95% CI 1.14–2.36; p = 0.007), but not with pneumonia-related admission (HR 1.33; 95% CI 0.96–1.85; p = 0.088). In the MAH cohort, the presence of emphysema was only associated with COPD-related admission (HR 2.05; 95% CI 1.07–3.95; p = 0.031). CONCLUSION: Qualitative CT assessment of emphysema is associated with COPD-related hospital admission. Identification of CT emphysema may provide an opportunity for prevention and early intervention to reduce admission risk.

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.

Annual low-radiation-dose computed tomography (LDCT) screening for lung cancer has been shown to reduce lung cancer mortality among high-risk individuals and is now recommended by multiple organizations. However, LDCT screening is complex, and implementation requires careful planning to ensure benefits outweigh harms. Little guidance has been provided for sites wishing to develop and implement lung cancer screening programs.To promote successful implementation of comprehensive LDCT screening programs that are safe, effective, and sustainable.The American Thoracic Society (ATS) and American College of Chest Physicians (ACCP) convened a committee with expertise in lung cancer screening, pulmonary nodule evaluation, and implementation science. The committee reviewed the evidence from systematic reviews, clinical practice guidelines, surveys, and the experience of early-adopting LDCT screening programs and summarized potential strategies to implement LDCT screening programs successfully.We address steps that sites should consider during the main three phases of developing an LDCT screening program: planning, implementation, and maintenance. We present multiple strategies to implement the nine core elements of comprehensive lung cancer screening programs enumerated in a recent ACCP/ATS statement, which will allow sites to select the strategy that best fits with their local context and workflow patterns. Although we do not comment on cost-effectiveness of LDCT screening, we outline the necessary costs associated with starting and sustaining a high-quality LDCT screening program.Following the strategies delineated in this policy statement may help sites to develop comprehensive LDCT screening programs that are safe and effective.

Purpose The aim of this study was to compare results of National Comprehensive Cancer Network (NCCN) high-risk group 2 with those of NCCN high-risk group 1 in a clinical CT lung screening program. Methods The results of consecutive clinical CT lung screening examinations performed from January 2012 through December 2013 were retrospectively reviewed. All examinations were interpreted by radiologists credentialed in structured CT lung screening reporting, following the NCCN Clinical Practice Guidelines in Oncology: Lung Cancer Screening (version 1.2012). Positive results required a solid nodule ≥4 mm, a ground-glass nodule ≥5 mm, or a mediastinal or hilar lymph node >1 cm, not stable for >2 years. Significant incidental findings and findings suspicious for pulmonary infection were also recorded. Results A total of 1,760 examinations were performed (464 in group 2, 1,296 in group 1); no clinical follow-up was available in 432 patients (28%). Positive results, clinically significant incidental findings, and suspected pulmonary infection were present in 25%, 6%, and 6% in group 2 and 28.2%, 6.2%, and 6.6% in group 1, respectively. Twenty-three cases of lung cancer were diagnosed (6 in group 2, 17 in group 1), for annualized rates of malignancy of 1.8% in group 2 and 1.6% in group 1. Conclusion NCCN group 2 results were substantively similar to those for group 1 and closely resemble those reported in the National Lung Screening Trial. Similar rates of positivity and lung cancer diagnosis in both groups suggest that thousands of additional lives may be saved each year if screening eligibility is expanded to include this particular high-risk group.

Ample evidence supports genetic and functional heterogeneity in primary tumors, but it remains unclear whether circulating tumor cells (CTCs) also exhibit the same hierarchical organization. We examined the functional diversity of viable, single CTCs using an array of subnanoliter wells (nanowells). The compartmentalization of single cells by nanowells allowed clonal comparison and mapping of heterogeneity of single cells or preformed clusters of cells. By measuring the short-term viability, invasiveness and secretory profiles of individual CTCs, it was evident that only a rare subset of CTCs possessed malignant traits indicative of metastatic potential in late-stage, progressing metastatic castration-resistant prostate cancer (mCRPC) patients. These CTCs were resistant to anoikis after being in the circulation, were invasive in their epithelial state, or secreted proteases capable of cleaving peptide substrates. Every CTC observed, however, did not exhibit such metastatic potential, suggesting that enumeration of CTCs alone may be insufficient to understand metastasis or stratify patients.

Background Indwelling pleural catheters (IPCs) offer effective control of malignant pleural effusions (MPEs). IPC-related infection is uncommon but remains a major concern. Individual IPC centers see few infections, and previous reports lack sufficient numbers and detail. This study combined the experience of 11 centers from North America, Europe, and Australia to describe the incidence, microbiology, management, and clinical outcomes of IPC-related pleural infection. Methods This was a multicenter retrospective review of 1,021 patients with IPCs. All had confirmed MPE. Results Only 50 patients (4.9%) developed an IPC-related pleural infection; most (94%) were successfully controlled with antibiotics (62% IV). One death (2%) directly resulted from the infection, whereas two patients (4%) had ongoing infectious symptoms when they died of cancer progression. Staphylococcus aureus was the causative organism in 48% of cases. Infections from gram-negative organisms were associated with an increased need for continuous antibiotics or death (60% vs 15% in gram-positive and 25% mixed infections, P = .02). The infections in the majority (54%) of cases were managed successfully without removing the IPC. Postinfection pleurodesis developed in 31 patients (62%), especially those infected with staphylococci (79% vs 45% with nonstaphylococcal infections, P = .04). Conclusions The incidence of IPC-related pleural infection was low. The overall mortality risk from pleural infection in patients treated with IPC was only 0.29%. Antibiotics should cover S aureus and gram-negative organisms until microbiology is confirmed. Postinfection pleurodesis is common and often allows removal of IPC. Heterogeneity in management is common, and future studies to define the optimal treatment strategies are needed.

The National Lung Screening Trial demonstrated a significant mortality benefit for patients at high risk for lung cancer undergoing serial low-dose CT. Currently, the National Comprehensive Cancer Network and several United States-based professional associations recommend CT Lung screening for high-risk patients. In the absence of established reimbursement, the authors modeled and implemented a free low-dose CT lung cancer screening program to provide equitable access to all eligible patients. Elements of the program reported in this article include a decentralized referral network, centralized program coordination, structured reporting, and a patient data management system. The experience and initial results observed in this clinical setting closely match the performance metrics of the National Lung Screening Trial with regard to cancer detection and incidental findings rates. To eliminate health care disparities a vigorous lobbying effort will be needed to expedite reimbursement and make CT lung screening equally available to all patients at high-risk.

Patients with malignant pleural effusions have significant dyspnea and shortened life expectancy. Indwelling pleural catheters allow patients to drain pleural fluid at home and can lead to autopleurodesis. The optimal drainage frequency to achieve autopleurodesis and freedom from catheter has not been determined.To determine whether an aggressive daily drainage strategy is superior to the current standard every other day drainage of pleural fluid in achieving autopleurodesis.Patients were randomized to either an aggressive drainage (daily drainage; n = 73) or standard drainage (every other day drainage; n = 76) of pleural fluid via a tunneled pleural catheter.The primary outcome was the incidence of autopleurodesis following the placement of the indwelling pleural catheters. The rate of autopleurodesis, defined as complete or partial response based on symptomatic and radiographic changes, was greater in the aggressive drainage arm than the standard drainage arm (47% vs. 24%, respectively; P = 0.003). Median time to autopleurodesis was shorter in the aggressive arm (54 d; 95% confidence interval, 34-83) as compared with the standard arm (90 d; 95% confidence interval, 70 to nonestimable). Rate of adverse events, quality of life, and patient satisfaction were not significantly different between the two arms.Among patients with malignant pleural effusion, daily drainage of pleural fluid via an indwelling pleural catheter led to a higher rate of autopleurodesis and faster time to liberty from catheter. Clinical trial registered with www.clinicaltrials.gov (NCT 00978939).

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 now30. 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.

Rationale: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is becoming standard of care for the sampling of mediastinal adenopathy. The need for a safe, effective, accurate procedure makes EBUS-TBNA ideal for mastery training and testing. Objectives: The Endobronchial Ultrasound Skills and Tasks Assessment Tool (EBUS-STAT) was created as an objective competencyoriented assessment tool of EBUS-TBNA skills and knowledge. This study demonstrates the reliability and validity evidence of this tool. Methods: The EBUS-STAT objectively scores the EBUS-TBNA operator’sskills,includingatraumaticairwayintroductionandnavigation, ultrasoundimageacquisitionandoptimization,identificationofmediastinal nodal and vascular structures, EBUS-TBNA sampling, and recognition of EBUS/computed tomography images of mediastinal structures. It can be administered at the bedside or using combination of low- and high-fidelity simulation platforms. Two independent testers administered the EBUS-STAT to 24 operators at three levels of EBUS-TBNA experience (8 beginners, 8 intermediates, and 8 experienced) at three institutions; operators were also asked to self-assess their skills. Scores were analyzed for intertester reliability, correlation with prior EBUS-TBNA experience, and association with self-assessments. Measurements and Main Results: Intertester reliability between testerswasveryhigh(r¼0.9991,P,0.00005).MeanEBUS-STATscores for beginner, intermediate, and experienced groups, respectively, were 31.1, 74.9, and 93.6 out of 100 (F2,21 ¼ 118.6, P , 0.0001). Groups were nonoverlapping: post hoc tests showed each group differed significantly from the others (P , 0.001). Self-assessments corresponded closely to actual EBUS-STAT scores (r 2 ¼ 0.81, P , 0.001). Conclusions: The EBUS-STAT can be used to reliably and objectively score and classify EBUS-TBNA operators from novice to expert. Its use to assess and document the acquisition of knowledge and skill is a step toward the goal of mastery training in EBUS-TBNA.

Background Malignant pleural effusions (MPEs) affect > 150,000 people each year in the United States. Current palliative options include pleurodesis and placement of an indwelling catheter, each with its own associated benefits. This study was conducted to determine the safety, efficacy, and feasibility of a rapid pleurodesis protocol by combining medical thoracoscopy with talc pleurodesis and simultaneous placement of a tunneled pleural catheter (TPC) in patients with symptomatic MPE. Methods Patients with recurrent, symptomatic MPEs underwent medical thoracoscopy with placement of a TPC and talc poudrage. The TPC was drained per protocol until the output was Results Between October 2005 and September 2009, 30 patients underwent the procedure. The median duration of hospitalization following the procedure was 1.79 days. All patients showed an improvement in dyspnea and quality of life. Pleurodesis was successful in 92% of patients, and the TPC was removed at a median of 7.54 days. Complications included fever (two patients), the need for TPC replacement (one patient), and empyema (one patient). Conclusion Rapid pleurodesis can be achieved safely by combining medical thoracoscopy and talc poudrage with simultaneous TPC placement. Both hospital length of stay and duration of TPC use can be reduced significantly as compared with historical controls of either procedure alone. Future randomized trials are needed to confirm these results.