A Nasal Swab Classifier to Evaluate the Probability of Lung Cancer in Patients With Pulmonary Nodules.

BACKGROUND: Accurate assessment of the probability of lung cancer (pCA) is critical in patients with pulmonary nodules (PNs) to help guide decision-making. We sought to validate a clinical-genomic classifier developed using whole-transcriptome sequencing of nasal epithelial cells from patients with a PN ≤ 30 mm who smoke or have previously smoked. RESEARCH QUESTION: Can the pCA in individuals with a PN and a history of smoking be predicted by a classifier that uses clinical factors and genomic data from nasal epithelial cells obtained by cytologic brushing? STUDY DESIGN AND METHODS: Machine learning was used to train a classifier using genomic and clinical features on 1,120 patients with PNs labeled as benign or malignant established by a final diagnosis or a minimum of 12 months of radiographic surveillance. The classifier was designed to yield low-, intermediate-, and high-risk categories. The classifier was validated in an independent set of 312 patients, including 63 patients with a prior history of cancer (other than lung cancer), comparing the classifier prediction with the known clinical outcome. RESULTS: In the primary validation set, sensitivity and specificity for low-risk classification were 96% and 42%, whereas sensitivity and specificity for high-risk classification was 58% and 90%, respectively. Sensitivity was similar across stages of non-small cell lung cancer, independent of subtype. Performance compared favorably with clinical-only risk models. Analysis of 63 patients with prior cancer showed similar performance as did subanalyses of patients with light vs heavy smoking burden and those eligible for lung cancer screening vs those who were not. INTERPRETATION: The nasal classifier provides an accurate assessment of pCA in individuals with a PN ≤ 30 mm who smoke or have previously smoked. Classifier-guided decision-making could lead to fewer diagnostic procedures in patients without cancer and more timely treatment in patients with lung cancer.

Interventional Pulmonology Productivity, Compensation, and Practice Benchmarks: The AABIP 2022 Report.

BACKGROUND: Interventional pulmonology (IP) is a growing field that has not yet been recognized by the American Board of Medical Specialties or incorporated into national benchmark organizations. As a result, there is a lack of data on IP practice patterns, physicians' compensation and productivity targets. METHODS: We sent an anonymous survey to 647 current or past physician members of the AABIP. Domains included demographics, training background, academic rank, practice settings, work relative value unit (wRVU) targets, salary, and career satisfaction. RESULTS: The response rate to the survey was 28.3%; 17.8% were female. The median salary for IP faculty in academic institutions was $320,000 for assistant professors, $338,000 for associate professors, and $350,000 for full professors. Salaries were lower for women than for men in academic practice, even after adjusting for the number of years in practice (mean salary difference after adjustment $57,175, 95% CI: $19,585-$94,764, P =0.003). The median salary for private practice was higher at $428,000. Among respondents that used wRVU targets, the median targets for academic and private practice were 5500 and 6300, respectively. The majority of IP physicians are satisfied with their career choice. CONCLUSIONS: Productivity targets in IP are used less than half the time, and when they are used, they are set in line with the lower wRVU of IP procedures. IP compensation is higher than that of general pulmonary medicine, as reported by national benchmark associations. In academic practices, gender differences in salaries were found.

Performance of a new single-use bronchoscope versus a marketed single-use comparator: a bench study.

BACKGROUND: Single-use flexible bronchoscopes eliminate cross contamination from reusable bronchoscopes and are cost-effective in a number of clinical settings. The present bench study aimed to compare the performance of a new single-use bronchoscope (Boston Scientific EXALT Model B) to a marketed single-use comparator (Ambu aScope 4), each in slim, regular and large diameters. METHODS: Three bronchoscopy tasks were performed: water suction and visualization, "mucus" mass (synthetic mucoid mixture) suctioned in 30 s, and "mucus" plug (thicker mucoid mixture) suction. Suction ability, task completion times, and subjective ratings of visualization and overall performance on a scale of one to 10 (best) were compared. All bronchoscopy tasks were completed by 15 physicians representing diversity in specialization including pulmonary, interventional pulmonary, critical care, anesthesia, and thoracic surgery. Each physician utilized the six bronchoscope versions with block randomization by bronchoscope and task. RESULTS: Aspirated mean mass of "mucus" using EXALT Model B Regular was comparable to that for an aScope 4 Large (41.8 ± 8.3 g vs. 41.5 ± 5.7 g respectively, p = 0.914). In comparisons of scopes with the same outer diameter, the aspirated mean mass by weight of water and "mucus" was significantly greater for EXALT Model B than for aScope 4 (p < 0.001 for all three diameters). Mean ratings for visualization attributes were significantly better for EXALT Model B compared to aScope 4 (p-value range 0.001-0.029). CONCLUSION: A new single-use bronchoscope provided strong suction capability and visualization compared to same-diameter marketed single-use comparators in a bench model simulation.

Bronchial Thermoplasty in Patients With Severe Asthma at 5 Years: The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma Study.

BACKGROUND: Bronchial thermoplasty is a device-based treatment for subjects ≥ 18 years of age 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 patients with severe asthma undergoing this procedure. RESEARCH QUESTION: What are the 5-year efficacy and safety results in patients with severe asthma who have undergone bronchial thermoplasty? STUDY DESIGN AND METHODS: This was a prospective, open-label, observational, multicenter study conducted in the United States and Canada. Subjects 18 to 65 years of age who were taking inhaled corticosteroids ≥ 1,000 µg/d (beclomethasone or equivalent) and long-acting beta-agonists ≥ 80 µg/d (salmeterol or equivalent) were included. Severe exacerbations, hospitalization, ED visits, and medication usage were evaluated for the 12 months prior to and at years 1 through 5 posttreatment. Spirometry was evaluated at baseline and at years 1 through 5 posttreatment. RESULTS: A total of 284 subjects were enrolled at 27 centers; 227 subjects (80%) completed 5 years of follow-up. By year 5 posttreatment, the proportion of subjects with severe exacerbations, ED visits, and hospitalizations was 42.7%, 7.9%, and 4.8%, respectively, compared with 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, ED visits, and corticosteroid exposure. All subgroups demonstrated clinically significant improvement, suggesting that bronchial thermoplasty improves asthma control in different asthma phenotypes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT01350336; URL: www. CLINICALTRIALS: gov.

Comparison of Sample Adequacy and Diagnostic Yield of the 21-G and 25-G EBUS TBNA Needles.

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.

Variable Learning Curve of Basic Rigid Bronchoscopy in Trainees.

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 <60 s. 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.

Torsades de pointes in SARS-CoV-2 (COVID-19) pneumonia: medicine reconciliation and careful monitoring of QTc interval may help prevent cardiac complications.

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.

Standardizing education in interventional pulmonology in the midst of technological change.

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.

Use of Tracheostomy During the COVID-19 Pandemic: American College of Chest Physicians/American Association for Bronchology and Interventional Pulmonology/Association of Interventional Pulmonology Program Directors Expert Panel Report.

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.

The Use of Bronchoscopy During the Coronavirus Disease 2019 Pandemic: CHEST/AABIP Guideline and Expert Panel Report.

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.

Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial.

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).

Experience With a CT Screening Program for Individuals at High Risk for Developing Lung Cancer.

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.

An official American Thoracic Society/American College of Chest Physicians policy statement: implementation of low-dose computed tomography lung cancer screening programs in clinical practice.

RATIONALE: 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. OBJECTIVES: To promote successful implementation of comprehensive LDCT screening programs that are safe, effective, and sustainable. METHODS: 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. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSIONS: Following the strategies delineated in this policy statement may help sites to develop comprehensive LDCT screening programs that are safe and effective.

Surgical Outcomes in a Large, Clinical, Low-Dose Computed Tomographic Lung Cancer Screening Program.

BACKGROUND: Lung cancer screening with low-dose computed tomography is proven to reduce lung cancer mortality among high-risk patients. However, critics raise concern over the potential for unnecessary surgical procedures performed for benign disease as a result of screening. We reviewed our outcomes in a large clinical lung cancer screening program to assess the number of surgical procedures done for benign disease, as we believe this is an important quality metric. METHODS: We retrospectively reviewed our surgical outcomes of consecutive patients who underwent low-dose computed tomography lung cancer screening from January 2012 through June 2014 using a prospectively collected database. All patients met the National Comprehensive Cancer Network lung cancer screening guidelines high-risk criteria. RESULTS: There were 1,654 screened patients during the study interval with clinical follow-up at Lahey Hospital & Medical Center. Twenty-five of the 1,654 (1.5%) had surgery. Five of 25 had non-lung cancer diagnoses: 2 hamartomas, 2 necrotizing granulomas, and 1 breast cancer metastasis. The incidence of surgery for non-lung cancer diagnosis was 0.30% (5 of 1,654), and the incidence of surgery for benign disease was 0.24% (4 of 1,654). Twenty of 25 had lung cancer, 18 early stage and 2 late stage. There were no surgery-related deaths, and there was 1 major surgical complication (4%) at 30 days. CONCLUSIONS: The incidence of surgical intervention for non-lung cancer diagnosis was low (0.30%) and is comparable to the rate reported in the National Lung Screening Trial (0.62%). Surgical intervention for benign disease was rare (0.24%) in our experience.

Experience with a CT screening program for individuals at high risk for developing lung cancer.

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.