Pilot Study of an Encounter Decision Aid for Lung Cancer Screening.

The Centers for Medicare and Medicaid Services has mandated in-person shared decision-making (SDM) counseling with the use of one or more decision aids (DAs) prior to lung cancer screening. We developed a single-page, paper-based, encounter DA (EDA) to be used within a clinician-patient encounter for lung cancer screening and conducted a pre-post pilot intervention study to evaluate its feasibility and effects on patient decisional conflict. Patients referred to a pulmonary practice-based lung cancer screening program were surveyed before and after an SDM visit with a pulmonologist, who used the EDA to counsel the patient. Patient knowledge of the mortality benefit from screening and the frequency of abnormal screening test results was evaluated after the visit, while decisional conflict was measured before and after the visit using the Decisional Conflict Scale (DCS). Twenty-three patients participated (mean age = 65.8 years; 43% female; mean smoking history = 57.8 pack-years; 48% currently smoking). Following the visit, 28% of participants correctly understood the mortality benefit of lung cancer screening, while 82% understood the frequency of abnormal screening tests. The mean total DCS score decreased from 35.0 to 0.2 after the visit (p < 0.001). These data suggest that a single-page, paper-based EDA is feasible and potentially effective in reducing decision conflict when used within a SDM visit, although more research is needed to establish the independent effects of the EDA, and future efforts to promote SDM may need to devote greater attention to improving patient understanding of the mortality benefit of screening.

Clinafloxacin for Treatment of Burkholderia cenocepacia Infection in a Cystic Fibrosis Patient.

Respiratory infection with Burkholderia cenocepacia is associated with accelerated decline in lung function and increased mortality in cystic fibrosis (CF) patients (A. M. Jones, M. E. Dodd, J. R. W. Govan, V. Barcus, C. J. Doherty, J. Morris, and A. K. Webb, Thorax 59:948-951, 2004, http://dx.doi.org/10.1136/thx.2003.017210). B. cenocepacia often possesses innate resistance to multiple antimicrobial classes, making eradication uncommon in established infection (P. B. Davis, Am J Respir Crit Care Med 173:475-482, 2006, http://dx.doi.org/10.1164/rccm.200505-840OE). We report the use of clinafloxacin in a CF patient with advanced B. cenocepacia infection, present pharmacokinetic (PK) data, and discuss the potential therapeutic role of clinafloxacin in patients with this condition.

Machine Learning Model Predictors of Intrapleural tPA and DNase Failure in Pleural Infection: A Multicenter Study.

RATIONALE: Intrapleural enzyme therapy (IET) with tissue plasminogen activator (tPA) and deoxyribonuclease (DNase) has been shown to reduce the need for surgical intervention for complicated parapneumonic effusion/empyema (CPPE/empyema). Failure of IET may lead to delayed care, and increased length of stay. OBJECTIVE: The goal of this study was to identify risk factors for failure of IET. METHODS: We performed a multicenter, retrospective study of patients who received IET for the treatment of CPPE/empyema. Clinical and radiological variables at the time of diagnosis were included. We compared four different machine learning classifiers (L1-penalized logistic regression, support vector machine (SVM), XGBoost and LightGBM) by multiple bootstrap-validated metrics, including F-beta to demonstrate model performances. RESULTS: 466 participants who received IET for pleural infection were included from five institutions across the United States. Resolution of CPPE/empyema with IET was achieved in 78% (n=365). SVM performed superior with median F-beta of 56%, followed by L1-penalized logistic regression, LGBM and XGBoost. Clinical and radiological variables were graded based on their ranked variable importance. The top two significant predictors of IET failure using SVM were the presence of an abscess/necrotizing pneumonia (17%) and pleural thickening (13%). Similarly, LightGBM identified abscess/necrotizing pneumonia (35%) and pleural thickening (26%) and XGBoost indicated pleural thickening (36%) and abscess/necrotizing pneumonia (17%) as the most significant predictors of treatment failure. Predictors identified by L1-penalized logistic regression model were pleural thickening (18%) and pleural fluid LDH (9%). CONCLUSIONS: The presence of abscess/necrotizing pneumonia and pleural thickening consistently ranked among the strongest predictors of IET failure in all machine learning models. The difference in rankings between models may be a consequence of the different algorithms used by each model. These results indicate that the presence of abscess/necrotizing pneumonia, and pleural thickening may predict IET failure. These results should be confirmed in larger studies.

Long-term outcomes following alemtuzumab induction in lung transplantation.

OBJECTIVES: Alemtuzumab is a commonly used induction agent for solid-organ transplantation. Its use in lung transplantation with reduced immunosuppressive regimens, however, has yet to be well characterized. METHODS: From November 2006 to March 2008, 20 consecutive lung transplantation patients received alemtuzumab induction with a reduced maintenance immunosuppression regimen. Twenty consecutive case-controls who underwent transplantation between 2005 and 2006 were treated with a standard immunosuppression regimen without induction. Outcome variables were patient survival, acute rejection, infection, and bronchiolitis obliterans syndrome. RESULTS: Mean follow-up time was 1400 days in the alemtuzumab group and 1210 days in the control group. Double lung transplantation was performed in 21 patients (12 in the alemtuzumab group and 9 in the control group). There was no difference in survival between the alemtuzumab (n = 10) and control (n = 10) groups. There was also not a significant difference in time-adjusted death based on Kaplan-Meier analysis. The mean number of any grade of rejection event per patient was not significantly different (alemtuzumab 2.3 ± 2.7 vs. control 3.2 ± 2.35; P = .22). There was a trend toward the reduced incidence of infection requiring intravenous antibiotics per patient (alemtuzumab 2.4 vs. control 3.8; P = .08). The incidence of bronchiolitis obliterans syndrome was similar in both groups (alemtuzumab 55% vs. control 70%; P = .25). CONCLUSIONS: Alemtuzumab induction with reduced immunosuppression offers a comparable 5-year survival and rejection rate compared to standard-dose immunosuppression regimen.

Aerosol Generation During Bronchoscopy.

BACKGROUND: Bronchoscopy is an aerosol-generating procedure and can place the health care providers at risk for exposure to viral pathogens. The pattern of aerosol generation during  different aspects of bronchoscopy are poorly understood. The goal of this study is to characterize the pattern of aerosol generation during flexible and rigid bronchoscopy performed under moderate sedation or general anesthesia (GA). The inhalable mass concentration of aerosol generated during the procedures was measured continuously. METHODS: The aerosol concentration in the endoscopy room at baseline and while the procedures were performed was measured. Procedures included flexible bronchoscopies with moderate sedation, flexible bronchoscopies performed through endotracheal tube under GA and rigid bronchoscopies under GA. Changes from the baseline were measured continuously during the bronchoscopy. RESULTS: Measurements obtained during the procedure were compared with the baseline reading. For flexible bronchoscopy under moderate sedation, the inhalable aerosol fraction was significantly higher (P=0.036) during atomization of lidocaine. For Flexible bronchoscopy through endotracheal tube, inhalable aerosol fraction was significantly higher (P<0.001) during intubation and extubation. For rigid bronchoscopy done under GA with jet ventilation, inhalable aerosol fraction was significantly higher during both the bronchoscopy (P=0.01) and recovery (P=0.012). CONCLUSION: Elevated levels of aerosol were generated during all aspects of bronchoscopy. However, atomization of lidocaine, intubation, extubation, and recovery generated the most aerosol.

Bleeding Risk With Combination Intrapleural Fibrinolytic and Enzyme Therapy in Pleural Infection: An International, Multicenter, Retrospective Cohort Study.

BACKGROUND: Combination intrapleural fibrinolytic and enzyme therapy (IET) has been established as a therapeutic option in pleural infection. Despite demonstrated efficacy, studies specifically designed and adequately powered to address complications are sparse. The safety profile, the effects of concurrent therapeutic anticoagulation, and the nature and extent of nonbleeding complications remain poorly defined. RESEARCH QUESTION: What is the bleeding complication risk associated with IET use in pleural infection? STUDY DESIGN AND METHODS: This was a multicenter, retrospective observational study conducted in 24 centers across the United States and the United Kingdom. Protocolized data collection for 1,851 patients treated with at least one dose of combination IET for pleural infection between January 2012 and May 2019 was undertaken. The primary outcome was the overall incidence of pleural bleeding defined using pre hoc criteria. RESULTS: Overall, pleural bleeding occurred in 76 of 1,833 patients (4.1%; 95% CI, 3.0%-5.0%). Using a half-dose regimen (tissue plasminogen activator, 5 mg) did not change this risk significantly (6/172 [3.5%]; P = .68). Therapeutic anticoagulation alongside IET was associated with increased bleeding rates (19/197 [9.6%]) compared with temporarily withholding anticoagulation before administration of IET (3/118 [2.6%]; P = .017). As well as systemic anticoagulation, increasing RAPID score, elevated serum urea, and platelets of < 100 × 109/L were associated with a significant increase in bleeding risk. However, only RAPID score and use of systemic anticoagulation were independently predictive. Apart from pain, non-bleeding complications were rare. INTERPRETATION: IET use in pleural infection confers a low overall bleeding risk. Increased rates of pleural bleeding are associated with concurrent use of anticoagulation but can be mitigated by withholding anticoagulation before IET. Concomitant administration of IET and therapeutic anticoagulation should be avoided. Parameters related to higher IET-related bleeding have been identified that may lead to altered risk thresholds for treatment.

A pilot study of cystic fibrosis exacerbation response phenotypes reveals contrasting serum and sputum iron trends.

The cystic fibrosis (CF) community seeks to explain heterogeneous outcomes of pulmonary exacerbation (PEX) treatment. Serum and sputum inflammatory mediators may identify people with CF (PwCF) at risk for suboptimal responses. However, lack of an established association between response phenotypes and these mediators limits clinical application. In this pilot study, we prospectively characterized treatment response phenotypes by assessing health-related quality-of-life (HRQoL) during PEX. We also measured lung function and iron-related biochemical parameters in serum and sputum. We classified subjects as sustained symptom-responders (SRs) or non-sustained symptom-responders (NSRs) based on the absence or presence, respectively, of worsened symptom scores after initial improvement. We used linear mixed models (LMMs) to determine whether trends in lung function, hematologic, serum, and sputum indices of inflammation differed between response cohorts. In 20 PwCF, we identified 10 SRs and 10 NSRs with no significant differences in lung function at PEX onset and treatment durations. SRs had better model-predicted trends in lung function than NSRs during PEX. Non-linear trends in serum and sputum iron levels significantly differed between SRs and NSRs. In adults with cystic fibrosis, PEX treatment response phenotypes may be correlated with distinctive trends in serum and sputum iron concentrations.

Core needle biopsy with endobronchial ultrasonography: single center experience with 100 cases.

INTRODUCTION: Adequate sampling by endobronchial ultrasound (EBUS)-transbronchial needle aspiration to meet the demands of precision medicine or histologic evaluation is challenging. There is increasing demand for core biopsy specimens with advances in therapy. Franseen enodoscopic ultrasound needles have shown promising results in gastroenterology application for obtaining core biopsies and same design has recently been extended for pulmonary use. We evaluated Franseen needles with EBUS to assess its utility, safety and ability to provide core biopsy specimens. MATERIALS AND METHODS: Retrospective analysis of our database at the University of Utah of patients undergoing EBUS with a Franseen needle was performed to ascertain the performance characteristics of this needle in the first 100 patients after its implementation. Medical records were also reviewed to identify any immediate procedure-related complications. RESULTS: One hundred seventy locations were sampled in 100 patients. A total of 152 lymph nodes and 18 masses were sampled. Core biopsies, as per pathology report, were seen in 87% of patients. A clinically concordant pathological diagnosis was established in 97% of patients. Diagnostic yield for granulomatous lymphadenopathy was 95.6% (22 of 23). No patient-related adverse events were noted. CONCLUSION: The Franseen needle evaluated in this study can safely procure core tissue samples during EBUS bronchoscopy that are adequate for histopathological diagnosis in benign and malignant lesions. Its ability to provide adequate tissue in patients with granulomatous inflammation is encouraging.

Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Using 19-G Needle for Sarcoidosis.

BACKGROUND: Flexible bronchoscopy with endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) is increasingly being used to obtain pathology specimens for diagnosis of sarcoidosis. There is wide variation in reported diagnostic yield in literature. New TBNA needles are available in the market but data are lacking about their diagnostic yield especially for sarcoidosis. This study reports the diagnostic yield of bronchoscopy with EBUS-TBNA using ViziShot FLEX 19-G needle in a series of patients with suspected sarcoidosis. METHODS: This is a retrospective chart review for diagnostic yield of the 19-G EBUS-TBNA needle for suspected sarcoidosis. RESULTS: Eighty-six EBUS bronchoscopies were performed, 15 were done with clinical suspicion of sarcoidosis. The 19-G needle was used for all cases of suspected sarcoidosis. The procedure was diagnostic of sarcoidosis in 14 (93.3%) patients by TBNA with 1 nondiagnostic bronchoscopy. Procedural diagnostic yield was 93.3%. Eighty-five percent (28/33) of sampled lymph nodes were positive for noncaseating granulomas. The yield of transbronchial lung biopsy (TBLB) and endobronchial lung biopsy was 38% (5/13) and 43% (6/14), respectively. TBLB and endobronchial lung biopsy did not add to the diagnostic yield of the procedure. No significant adverse events were noted. CONCLUSION: This series reports a higher diagnostic yield than most other published studies and opens platform for direct comparison of each available needle. It also adds to the safety data for this larger needle. In addition, it raises doubt into utility of TBLB for diagnosis of sarcoidosis, which can increase the procedural complications.