Molecular analysis of endobronchial ultrasound needle aspirates in patients with non-small cell lung cancer: Results from the SCOPE database.

OBJECTIVE: Molecular subtyping of non-small cell lung cancer (NSCLC) is critical in the diagnostic evaluation of patients with advanced disease. This study aimed to examine whether samples from endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) of intrathoracic lymph nodes and/or lung lesions are adequate for molecular analysis across various institutions. METHODS: We retrospectively reviewed all cases of linear EBUS-TBNA with a final bronchoscopic diagnosis of NSCLC entered in the Stather Canadian Outcomes registry for chest ProcEdures database. The primary outcome was specimen inadequacy rate for each molecular target, as defined by the local laboratory or pathologist. RESULTS: A total of 866 EBUS-TBNA procedures for NSCLC were identified. Specimen inadequacy rates were 3.8% for EGFR, 2.5% for ALK-1 and 3.5% for PD-L1. Largest target size was not different between adequate and inadequate specimens, and rapid onsite evaluation did not increase specimen adequacy rates. One centre using next-generation sequencing for EGFR had lower adequacy rates than 2 others using matrix-assisted laser desorption/ionization time-of-flight mass spectrophotometry. CONCLUSION: EBUS-TBNA specimens have a very low-specimen inadequacy rate for molecular subtyping of non-small cell lung cancer.

USPSTF2013 versus PLCOm2012 lung cancer screening eligibility criteria (International Lung Screening Trial): interim analysis of a prospective cohort study.

BACKGROUND: Lung cancer is a major health problem. CT lung screening can reduce lung cancer mortality through early diagnosis by at least 20%. Screening high-risk individuals is most effective. Retrospective analyses suggest that identifying individuals for screening by accurate prediction models is more efficient than using categorical age-smoking criteria, such as the US Preventive Services Task Force (USPSTF) criteria. This study prospectively compared the effectiveness of the USPSTF2013 and PLCOm2012 model eligibility criteria. METHODS: In this prospective cohort study, participants from the International Lung Screening Trial (ILST), aged 55-80 years, who were current or former smokers (ie, had ≥30 pack-years smoking history or ≤15 quit-years since last permanently quitting), and who met USPSTF2013 criteria or a PLCOm2012 risk threshold of at least 1·51% within 6 years of screening, were recruited from nine screening sites in Canada, Australia, Hong Kong, and the UK. After enrolment, patients were assessed with the USPSTF2013 criteria and the PLCOm2012 risk model with a threshold of at least 1·70% at 6 years. Data were collected locally and centralised. Main outcomes were the comparison of lung cancer detection rates and cumulative life expectancies in patients with lung cancer between USPSTF2013 criteria and the PLCOm2012 model. In this Article, we present data from an interim analysis. To estimate the incidence of lung cancers in individuals who were USPSTF2013-negative and had PLCOm2012 of less than 1·51% at 6 years, ever-smokers in the Prostate Lung Colorectal and Ovarian Cancer Screening Trial (PLCO) who met these criteria and their lung cancer incidence were applied to the ILST sample size for the mean follow-up occurring in the ILST. This trial is registered at ClinicalTrials.gov, NCT02871856. Study enrolment is almost complete. FINDINGS: Between June 17, 2015, and Dec 29, 2020, 5819 participants from the International Lung Screening Trial (ILST) were enrolled on the basis of meeting USPSTF2013 criteria or the PLCOm2012 risk threshold of at least 1·51% at 6 years. The same number of individuals was selected for the PLCOm2012 model as for the USPSTF2013 criteria (4540 [78%] of 5819). After a mean follow-up of 2·3 years (SD 1·0), 135 lung cancers occurred in 4540 USPSTF2013-positive participants and 162 in 4540 participants included in the PLCOm2012 of at least 1·70% at 6 years group (cancer sensitivity difference 15·8%, 95% CI 10·7-22·1%; absolute odds ratio 4·00, 95% CI 1·89-9·44; p<0·0001). Compared to USPSTF2013-positive individuals, PLCOm2012-selected participants were older (mean age 65·7 years [SD 5·9] vs 63·3 years [5·7]; p<0·0001), had more comorbidities (median 2 [IQR 1-3] vs 1 [1-2]; p<0·0001), and shorter life expectancy (13·9 years [95% CI 12·8-14·9] vs 14·8 [13·6-16·0] years). Model-based difference in cumulative life expectancies for those diagnosed with lung cancer were higher in those who had PLCOm2012 risk of at least 1·70% at 6 years than individuals who were USPSTF2013-positive (2248·6 years [95% CI 2089·6-2425·9] vs 2000·7 years [1841·2-2160·3]; difference 247·9 years, p=0·015). INTERPRETATION: PLCOm2012 appears to be more efficient than the USPSTF2013 criteria for selecting individuals to enrol into lung cancer screening programmes and should be used for identifying high-risk individuals who benefit from the inclusion in these programmes. FUNDING: Terry Fox Research Institute, The UBC-VGH Hospital Foundation and the BC Cancer Foundation, the Alberta Cancer Foundation, the Australian National Health and Medical Research Council, Cancer Research UK and a consortium of funders, and the Roy Castle Lung Cancer Foundation for the UK Lung Screen Uptake Trial.

Development and application of an electronic synoptic report for reporting and management of low-dose computed tomography lung cancer screening examination.

BACKGROUND: Interpretation of Low Dose CT scans and protocol driven management of findings is a key aspect of lung cancer screening program performance. Reliable and reproducible methods are needed to communicate radiologists' interpretation to the screening program or clinicians driving management decision. METHODS: We performed an audit of a subset of dictated reports from the PANCAN study to assess for omissions. We developed an electronic synoptic reporting tool for radiologists embedded in a clinical documentation system software. The tool was then used for reporting as part of the Alberta Lung Cancer Screening Study and McGill University Health Centre Pilot Lung Cancer Screening Program. RESULTS: Fifty reports were audited for completeness. At least one omission was noted in 30 (70%) of reports, with a major omission (missing lobe, size, type of nodule in report or actionable incidental finding in recommendation section of report) in 24 (48%). Details of the reporting template and functionality such as automated nodule cancer risk assessment, Lung-RADS category assignment, auto-generated narrative type report as well as personalize participant results letter is provided. A description of the system's performance in its application in 2815 CT reports is then summarized. CONCLUSIONS: We found that narrative type radiologist reports for lung cancer screening CT examinations frequently lacked specific discrete data elements required for management. We demonstrate the successful implementation of a radiology synoptic reporting system for use in lung cancer screening, and the use of this information to drive program management and communications.

Participant selection for lung cancer screening by risk modelling (the Pan-Canadian Early Detection of Lung Cancer [PanCan] study): a single-arm, prospective study.

BACKGROUND: Results from retrospective studies indicate that selecting individuals for low-dose CT lung cancer screening on the basis of a highly predictive risk model is superior to using criteria similar to those used in the National Lung Screening Trial (NLST; age, pack-year, and smoking quit-time). We designed the Pan-Canadian Early Detection of Lung Cancer (PanCan) study to assess the efficacy of a risk prediction model to select candidates for lung cancer screening, with the aim of determining whether this approach could better detect patients with early, potentially curable, lung cancer. METHODS: We did this single-arm, prospective study in eight centres across Canada. We recruited participants aged 50-75 years, who had smoked at some point in their life (ever-smokers), and who did not have a self-reported history of lung cancer. Participants had at least a 2% 6-year risk of lung cancer as estimated by the PanCan model, a precursor to the validated PLCOm2012 model. Risk variables in the model were age, smoking duration, pack-years, family history of lung cancer, education level, body-mass index, chest x-ray in the past 3 years, and history of chronic obstructive pulmonary disease. Individuals were screened with low-dose CT at baseline (T0), and at 1 (T1) and 4 (T4) years post-baseline. The primary outcome of the study was incidence of lung cancer. This study is registered with ClinicalTrials.gov, number NCT00751660. FINDINGS: 7059 queries came into the study coordinating centre and were screened for PanCan risk. 15 were duplicates, so 7044 participants were considered for enrolment. Between Sept 24, 2008, and Dec 17, 2010, we recruited and enrolled 2537 eligible ever-smokers. After a median follow-up of 5·5 years (IQR 3·2-6·1), 172 lung cancers were diagnosed in 164 individuals (cumulative incidence 0·065 [95% CI 0·055-0·075], incidence rate 138·1 per 10 000 person-years [117·8-160·9]). There were ten interval lung cancers (6% of lung cancers and 6% of individuals with cancer): one diagnosed between T0 and T1, and nine between T1 and T4. Cumulative incidence was significantly higher than that observed in NLST (4·0%; p<0·0001). Compared with 593 (57%) of 1040 lung cancers observed in NLST, 133 (77%) of 172 lung cancers in the PanCan Study were early stage (I or II; p<0·0001). INTERPRETATION: The PanCan model was effective in identifying individuals who were subsequently diagnosed with early, potentially curable, lung cancer. The incidence of cancers detected and the proportion of early stage cancers in the screened population was higher than observed in previous studies. This approach should be considered for adoption in lung cancer screening programmes. FUNDING: Terry Fox Research Institute and Canadian Partnership Against Cancer.

Lesion heterogeneity and risk of infectious complications following peripheral endobronchial ultrasound.

BACKGROUND AND OBJECTIVE: The reported incidence of peripheral endobronchial ultrasound (pEBUS)-related infectious complications is below 1%, although studies have never focused solely on them or reported their risk factors. The goal of this study is to describe our local pEBUS infectious complication rate and characterize patient, lesion and procedural factors associated with infectious complications. METHODS: All charts, computed tomography scans and electronic records of patients who underwent a pEBUS at the Foothills Medical Center and South Health Campus Hospital in Calgary between 1 May 2014 and 1 October 2015 were reviewed. RESULTS: One hundred and ninety-nine pEBUS procedures were included in our study. The local infectious complication rate was 4.0% (8/199). Two lesion characteristics were more frequent in patients who suffered infectious complications: larger lesion diameter (P = 0.016) and lesion heterogeneity on imaging suggestive of areas of necrosis (P < 0.001). In a multivariate analysis, only the presence of lesion heterogeneity was significantly associated with infectious complications (OR = 16.74 (2.95-95.08)). The rate of infectious complications in lesions with a heterogeneous appearance was 20.7% (6/29). CONCLUSION: The rate of infectious complications after pEBUS is elevated when biopsying heterogeneous appearing lesions. This may not have previously been reported as studies of pEBUS focused on smaller and probably rarely necrotic lesions. Future studies of methods to prevent infections complications in pEBUS-guided biopsies of heterogeneous appearing lesions are warranted.

Flexible 19-Gauge Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Needle: First Experience.

BACKGROUND: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a well-established first-line invasive modality for mediastinal lymph node staging in lung cancer patients and in the diagnostic workup of patients with mediastinal adenopathy. With the current 21- and 22-gauge (G) EBUS-TBNA needles, the procedure can be limited by the degree of flexibility in the needle and the size of the lumen in tissue acquisition. OBJECTIVE: We report our initial experience with a first-generation flexible 19-G EBUS-TBNA (Flex 19G; Olympus Respiratory America, Redmond, WA, USA) needle with regards to efficacy and safety. METHODS: The Flex 19G EBUS-TBNA needle was used in 47 selected patients with enlarged hilar and/or mediastinal lymphadenopathy at 3 centers. The standard Olympus EBUS scope with a 2.2-mm working channel was used in all cases. RESULTS: The diagnostic yield of the Flex 19G needle according to clinical cytopathology reports was 89% (42/47). The diagnosis and their respective diagnostic yield with the Flex 19G EBUS-TBNA needle were malignancy 24/27 (89%), sarcoidosis 13/14 (93%), and reactive lymph node hyperplasia 5/6 (83%). The mean short axis of the sampled lymph nodes was 19 ± 9 mm. No complications occurred except for 1 instance of moderate bleeding, which did not require intervention beyond suctioning and subsequently resolved. All 13 patients diagnosed with adenocarcinoma by the 19-G needle had sufficient tissue for genetic testing. CONCLUSION: EBUS-TBNA using the first-generation Flex 19G needle is feasible and safe with promising diagnostic yield while providing a greater degree of flexion with the Olympus EBUS scope. Additional clinical evaluations are warranted.

Probability of cancer in pulmonary nodules detected on first screening CT.

BACKGROUND: Major issues in the implementation of screening for lung cancer by means of low-dose computed tomography (CT) are the definition of a positive result and the management of lung nodules detected on the scans. We conducted a population-based prospective study to determine factors predicting the probability that lung nodules detected on the first screening low-dose CT scans are malignant or will be found to be malignant on follow-up. METHODS: We analyzed data from two cohorts of participants undergoing low-dose CT screening. The development data set included participants in the Pan-Canadian Early Detection of Lung Cancer Study (PanCan). The validation data set included participants involved in chemoprevention trials at the British Columbia Cancer Agency (BCCA), sponsored by the U.S. National Cancer Institute. The final outcomes of all nodules of any size that were detected on baseline low-dose CT scans were tracked. Parsimonious and fuller multivariable logistic-regression models were prepared to estimate the probability of lung cancer. RESULTS: In the PanCan data set, 1871 persons had 7008 nodules, of which 102 were malignant, and in the BCCA data set, 1090 persons had 5021 nodules, of which 42 were malignant. Among persons with nodules, the rates of cancer in the two data sets were 5.5% and 3.7%, respectively. Predictors of cancer in the model included older age, female sex, family history of lung cancer, emphysema, larger nodule size, location of the nodule in the upper lobe, part-solid nodule type, lower nodule count, and spiculation. Our final parsimonious and full models showed excellent discrimination and calibration, with areas under the receiver-operating-characteristic curve of more than 0.90, even for nodules that were 10 mm or smaller in the validation set. CONCLUSIONS: Predictive tools based on patient and nodule characteristics can be used to accurately estimate the probability that lung nodules detected on baseline screening low-dose CT scans are malignant. (Funded by the Terry Fox Research Institute and others; ClinicalTrials.gov number, NCT00751660.).

Endobronchial ultrasound learning curve in interventional pulmonary fellows.

BACKGROUND AND OBJECTIVE: Little published data exist regarding the learning curve for endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA). We sought to assess the improvement in skill as trainees learned EBUS-TBNA in a clinical setting. METHODS: This is a multicentre cohort study of EBUS-TBNA technical skill of interventional pulmonology (IP) fellows as assessed with EBUS-TBNA computer simulator testing every 25 clinical cases throughout IP fellowship training. RESULTS: Nine fellows from three academic centres in the United States and Canada were enrolled in the study. Ongoing improvements were seen for EBUS-TBNA efficiency score and percentage of lymph nodes correctly identified on ultrasound exam, even after 200 clinical cases. Expert-level technical skill was obtained for EBUS efficiency score and for percentage of lymph nodes correctly identified on ultrasound exam at a median of 212 and 164 procedures, respectively; however, 33% of fellows did not achieve expert-level technical skill for either metric during their fellowship training. Significant variation in learning curves of the fellows was observed. CONCLUSIONS: Significant variation is seen in the EBUS-TBNA learning curves of individual IP fellows and for individual procedure components, with ongoing improvement in EBUS-TBNA skill even after 200 clinical cases. These results highlight the need for validated, objective measures of individual competence, and can assist training programmes in ensuring adequate procedure volumes required for a majority of trainees to successfully complete these assessments.

Combined medical-interventional approaches for the management of complex fungal balls: a case series as a viable alternative in non-surgical patients.

Intracavitary pulmonary aspergilloma is a persistent and life-threatening infection that carries a mortality rate of up to 15%. It occurs when Aspergillus species gain entry to an existing lung cavity. In the absence of definitive treatment, patients may succumb to severe complications such as massive hemoptysis, cachexia, or secondary infections. Aspergillomas often show limited response to antifungal medications, mainly due to insufficient drug concentrations within the cavities. Surgery is frequently the preferred treatment option, but it poses significant risks, and many individuals are ineligible due to underlying health issues. We present the most extensive non-surgical fungal ball cohort to date, managed using an innovative multimodal strategy that combines antifungal therapy before and after bronchoscopic debulking. This was a cross-sectional observational study. For those who cannot undergo surgery, our medical center has pioneered a multimodal approach to aspergilloma resection. This approach combines bronchoscopic endoscopy with antifungal therapy and has been applied successfully to more than 18 patients that are presented in this series. The median age of the cohort was 58 years (range: 32-73), with an equal sex distribution. The mean percent predicted FEV1 was 65.3%. The mean follow-up duration was 3.6 years (range: 0.5-10 years). The cohort receiving antifungals systematically prior to debridement showed a reduction of the pre-existing cavity (40.38 mm versus 34.02 mm, p = 0.021). Across the 18 patients during the follow-up period, 94% remained recurrence-free (defined by symptoms and radiology). Our study fills a critical knowledge gap regarding the significance of initiating antifungal treatment before bronchoscopic debulking and presents a viable approach in these cases for which there is a current unmet therapeutic need.

The use of both medical and interventional methods to treat difficult fungal masses: A collection of cases showing efficacy for patients who can't undergo surgeryIntracavitary pulmonary aspergilloma is a serious and potentially deadly infection with a death rate of up to 15%. It happens when certain types of fungi invade existing lung cavities. Without proper treatment, patients may experience severe complications like heavy bleeding from the lungs, weight loss, or other infections. Traditional antifungal medications often don't work well because they can't reach high enough concentrations in the cavities. Surgery is usually the best option, but it's risky and not possible for many due to other health problems. Our study introduces a new way to treat aspergilloma without surgery. We've treated a significant number of patients using a combination of antifungal drugs and a procedure called bronchoscopic debulking. This involves removing the fungal growth using a thin tube inserted through the airways. Our research involved observing 18 patients treated this way. They were mostly middle-aged, with equal numbers of men and women. Their lung function was moderately impaired, and we followed them for an average of 3.6 years. We found that giving antifungal drugs before the debulking procedure helped reduce the size of the cavities. After treatment, almost all patients remained free of symptoms and signs of recurrence. This study highlights the importance of starting antifungal therapy before bronchoscopic debulking and offers a promising option for patients who can't have surgery.

Trainee impact on advanced diagnostic bronchoscopy: an analysis of 607 consecutive procedures in an interventional pulmonary practice.

BACKGROUND AND OBJECTIVE: Complications during advanced diagnostic bronchoscopy are rare and include: pneumothorax, bleeding, mediastinitis and lymphadenitis. Increased complications have been demonstrated in patients undergoing routine bronchoscopy procedures performed by trainees. This study aimed to determine the impact of trainees during advanced diagnostic bronchoscopy on procedure time, sedation use and complications. METHODS: A retrospective review of a quality improvement database including consecutive pulmonary procedures performed by an interventional pulmonologist (D.R.S.) at the University of Calgary, from 1 July 2007 to 1 April 2011. RESULTS: Six hundred seven (55.2%) of the 1100 procedures involved an advanced diagnostic procedure defined as: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), electromagnetic navigation bronchoscopy (ENB) and/or peripheral EBUS. A trainee participated in 512 (84.3%) procedures. A complication occurred in 25 patients (4.1%), with a trend towards increased complication rates in the trainee group (4.7% vs 1.1%, difference 3.6%, P = 0.076). Significant differences were seen when a trainee participated versus when no trainee participated for procedure length (58.32 min vs 37.69 min, difference 20.63 min (95% confidence interval: 19.07-22.19), P = 0.001) and for the dose of propofol (178.3 mg vs 137.1 mg, difference 41.2 mg (95% confidence interval: 19.81-63.38), P = 0.002). CONCLUSIONS: In an academic interventional pulmonology practice utilizing the apprenticeship model, trainee participation in advanced diagnostic bronchoscopy increased procedure time, increased the amount of sedation used and resulted in a trend to increased complications. Attempts to modify trainee procedural training to reduce the burden of procedural learning for patients are warranted.

Diagnostic utility of peripheral endobronchial ultrasound with electromagnetic navigation bronchoscopy in peripheral lung nodules.

BACKGROUND AND OBJECTIVE: This study aimed to investigate the diagnostic utility of peripheral endobronchial ultrasound (pEBUS) followed by as-needed electromagnetic navigation bronchoscopy (ENB) for sampling peripheral lung nodules. METHODS: The study was a single-arm, prospective cohort study of patients with peripheral lung nodules. Peripheral lung lesion localization was initially performed using a pEBUS probe with guide sheath. If localization failed with pEBUS alone, ENB was used to help identify the lesion. Transbronchial biopsy, bronchial brush, transbronchial needle aspiration and bronchial washings were performed. RESULTS: Sixty patients were enrolled with average lesion size of 27 mm and mean pleural distance of 20 mm. Lesions were found with pEBUS alone in 75% of cases. The addition of ENB improved lesion localization to 93%. However, diagnostic yield for pEBUS alone and pEBUS with ENB were 43% and 50%, respectively. Factors predicting need for ENB use included smaller lesion size and absence of an air bronchus sign on computed tomography. CONCLUSIONS: ENB improves localization of lung lesions after unsuccessful pEBUS but is often not sufficient to ensure confirmation of a specific diagnosis. Technical improvements in sampling methods could improve the diagnostic yield.

Trainee impact on procedural complications: an analysis of 967 consecutive flexible bronchoscopy procedures in an interventional pulmonology practice.

BACKGROUND: Increased complications have been demonstrated in patients undergoing some medical procedures performed by trainees. Flexible bronchoscopy is generally considered a safe procedure; however, complications can include pneumothorax, bleeding and even death. OBJECTIVES: This study aimed to determine the impact of trainees during interventional pulmonology procedures on procedure time, sedation use and complications. METHODS: A retrospective review of a quality improvement database from all consecutive medical procedures performed by an interventional pulmonologist (D.R.S.) at the University of Calgary, from July 1, 2007, to April 1, 2011. RESULTS: Of 1,100 consecutive procedures during the study period, 967 were flexible bronchoscopies. A trainee participated in 82.2% of the procedures. Complications occurred in 38 patients (3.9%). No death occurred. Significant differences were seen when a trainee participated in the procedure versus when no trainee participated for procedure length [50.81 vs. 32.49 min, difference 18.32 min (95% CI 16.04-20.60), p = 0.001], dose of midazolam used [6.34 vs. 5.73 mg, difference 0.61 mg (95% CI 0.15-1.08), p = 0.01], dose of propofol used [153.08 vs. 111.60 mg, difference 41.48 mg (95% CI 21.81-61.15), p = 0.001], as well as the number of complications [4.5 vs. 1.2%, difference 3.3%, p = 0.048]. CONCLUSIONS: In an academic interventional pulmonology practice utilizing the apprenticeship model for procedural education, trainee participation in procedures can increase procedure time and the amount of sedation required, and result in increased complications. Medical procedural training methods that do not involve practicing on patients warrant further investigation in order to reduce the burden of procedural learning for patients.

The impact of tunneled pleural catheters on the quality of life of patients with malignant pleural effusions.

BACKGROUND: Tunneled pleural catheters (TPC) are used in the management of malignant pleural effusions (MPE), but the impact of this palliative procedure on patient quality of life (QoL) has not been well described. OBJECTIVES: To ascertain the impact of TPCs on symptoms and QoL of patients with recurrent MPE. METHODS: Patients with recurrent MPE completed the EORTC QLQ-C30 and LC13 QoL questionnaires at baseline, 2 and 14 weeks; FACIT-TS-G© treatment satisfaction surveys were completed at 14 weeks. RESULTS: A total of 82 patients were recruited. Thirty-seven patients (37/82, 45%) died prior to their 14-week follow-up appointment. Significant improvements in dyspnea at 2 weeks were demonstrated with both dyspnea scores (LC13 baseline score 64.1, 2-week score 43.7, mean change -20.4, n = 56, p < 0.001; C30 baseline score 78.9, 2-week score 46.6, mean change -32.4, n = 68, p < 0.001), as well as with the MRC score (baseline median score 4, 2-week score 3, n = 70, p < 0.001). Global health status/QoL was also significantly improved at 2 weeks (baseline score 34.1, 2-week score 46.3, mean change 12.3, n = 68, p < 0.001). Improvements in cough, fatigue and all functional scales were noted at 2 weeks. The improvements in dyspnea and global health status/QoL were maintained to 14 weeks in surviving subjects and there was further improvement in the MRC score at 14 weeks. Patients who completed the FACIT-TS-G survey demonstrated overall satisfaction with TPC treatment. CONCLUSIONS: TPCs are associated with a significant improvement in global health status, QoL and dyspnea at the 2-week time point in patients with recurrent MPE.

Probability of lung cancer in a population excluded from screening due to low PLCOM2012 risk.

BACKGROUND: Several randomized trials demonstrated have reduced lung cancer mortality with screening using computed tomography. However, there remains debate about the optimal approach for determining screening eligibility, and no evidence yet exists reporting lung cancer rates in those excluded from screening due to too low of a personalized risk. METHODS: This study was based on the Alberta Lung Cancer Screening Study, which received 1737 applicants and enrolled 850 based on the NLST criteria or a PLCOM2012 risk ≥ 1.5%. We excluded 887 applicants who were interested in screening but deemed ineligible. We report lung cancer rates in the screened and unscreened cohorts. RESULTS: We observed 30 and 8 lung cancers in the screened and unscreened groups, respectively. Only 1 of 8 lung cancers were among those considered too low risk (0.14%), while the remaining 7 were among those excluded for other reasons, including symptoms requiring more immediate workup. No NLST eligible but PLCO risk < 1.5% screened individual had a lung cancer detected as part of the study, so that of all applicants contacting the program with risk estimates less than 1.5%, only 1/857 (0.12%) developed lung cancer. CONCLUSION: Our findings indicate that a risk-based approach for screening eligibility is unlikely to miss many lung cancers.

Health Care Utilization and Costs in Lung Cancer Screening Participants-A Propensity-Matched Economic Analysis.

Introduction: Lung cancer screening (LCS) for high-risk populations has been firmly established to reduce lung cancer mortality, but concerns exist regarding unintended downstream costs. Methods: Mean health care utilization and costs were compared in the Alberta Lung Cancer Screening Study in a cohort undergoing LCS versus a propensity-matched control group who did not. Results: A cohort of 651 LCS participants was matched to 336 unscreened controls. Over the study period (mean 3.6 y), a modest increase in the number of claims (22.4 versus 21.9 per person-year [PY]; Δ 0.50 [95% confidence interval: 0.15-0.86], p = 0.006) and outpatient visits (4.01 versus 3.50 per PY; Δ 0.51 [0.37-0.65], p <0.0001), but not in inpatient admissions, was noted in the screened cohort. Claims payments, inpatient costs, and cancer care costs were similar in the screening arm versus the unscreened. Outpatient encounter costs per participant were higher in the screened group ($2662.18 versus $2040.67 per PY; Δ -$621.51 [-1118.05 to -124.97], p = 0.014). Removing the additional computed tomography screening examinations rendered differences not significant. Mean total costs were not significantly different at $6461.10 per PY in the screening group and $6125.31 in the unscreened group (Δ -$335.79 [-2009.65 to 1338.07], p = 0.69). Conclusions: Modest increases in outpatient costs are noted in individuals undergoing LCS, in part attributable to the screening examinations, without differences in overall health care costs. Health care costs and utilization seem otherwise similar in individuals participating in LCS and those who do not.

Use of a drug eluting pleural catheter for pleurodesis.

PURPOSE: Repeated administration of low-dose silver nitrate (SN) has been shown to be effective in creating pleurodesis. This study aimed to determine the effectiveness of a SN-eluting pleural catheter for pleurodesis. METHODS: Catheters with a chitosan-SN-hyaluronic acid hydrogel coating designed to release SN over 14 days, or placebo uncoated catheters, were inserted in rabbit and lamb pleurodesis models. Pleurodesis was assessed at 28 days according to a 1-8 point scoring system and pleural fibrosis and inflammation assessed histologically on a 0-4 point scale. RESULTS: In the rabbit model, pleurodesis scores were significantly increased in both the 24 mg and 50 mg SN catheters versus control animals as well as compared to the contralateral untreated pleural space (median-treated side scores were 5, 8, and 1, respectively, median score for contralateral side was 1 in all groups). In the lamb model, pleurodesis scores were significantly increased in both the 750 mg and 1000 mg catheter groups versus control animals as well as compared to the contralateral untreated pleural space (median-treated side scores were 7, 7, and 1, respectively, median score for contralateral pleural space was 1 in all groups). Catheters appeared well tolerated, although higher than expected mortality was seen in the 50 mg catheter rabbit group. CONCLUSIONS: A catheter designed to deliver SN to the pleural space over 14 days appears to be effective in creating pleurodesis. Further investigations to determine in-vivo catheter pharmacokinetics, toxicity, dose and optimal coating methods are warranted.

Evaluation of clinical endobronchial ultrasound skills following clinical versus simulation training.

BACKGROUND AND OBJECTIVE: Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) is a pulmonary procedure that can be challenging to learn. This study aims to compare trainee EBUS-TBNA performance during clinical procedures, following training with a computer EBUS-TBNA simulator versus conventional clinical EBUS-TBNA training. METHODS: A prospective study of pulmonary trainees performing EBUS-TBNA procedures on patients with suspected lung cancer and mediastinal adenopathy. Two cohorts of trainees were each evaluated while performing EBUS-TBNA on two patients. Group 1 received training by performing 15 cases on an EBUS-TBNA simulator (n = 4) and had never performed a clinical EBUS-TBNA procedure. Group 2 received training by doing 15-25 EBUS-TBNA procedures on patients (n = 4). RESULTS: There was no significant difference in the primary outcome measure of total EBUS-TBNA procedure time/number of successful aspirates between Groups 1 and 2 (3.95 (±0.93) vs 3.64 (±0.89), P = 0.51). Total learner EBUS-TBNA procedure time in minutes (23.67 (±5.58) vs 21.81 (±5.36), P = 0.17) and percentage of successful aspirates (93.3% (±5.8%) vs 86.3% (±6.7%), P = 0.12) were not significantly different between Group 1 and Group 2. The only significant difference found between Group 1 and Group 2 was time to intubation in minutes (0.99 (±0.46) vs 0.50 (±0.42), P = 0.04). CONCLUSIONS: EBUS-TBNA simulator use leads to rapid acquisition of clinical EBUS-TBNA skills comparable with that obtained with conventional training methods using practice on patients, suggesting that skills learned using an EBUS-TBNA simulator are transferable to clinical EBUS-TBNA performance. EBUS-TBNA simulators show promise for training, potentially minimizing the burden of procedural learning on patients.

Safety of endobronchial ultrasound-guided transbronchial needle aspiration for patients taking clopidogrel: a report of 12 consecutive cases.

BACKGROUND: Clopidogrel is an oral agent commonly used for primary or secondary prevention of cardiovascular disease. It is associated with an increased risk of bleeding during some medical and surgical procedures. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a new bronchoscopic technique used to accurately biopsy intrathoracic structures during flexible bronchoscopy. It is currently unknown whether clopidogrel increases bleeding complications during EBUS-TBNA procedures. OBJECTIVES: To evaluate the safety of clopidogrel use in EBUS-TBNA by identifying consecutive cases of EBUS-TBNA procedures performed on patients taking clopidogrel. METHODS: A retrospective review of a prospectively collected quality improvement database from 1,100 consecutive pulmonary procedures performed by an interventional pulmonologist (D.R.S.) at the University of Calgary from July 1st, 2007 to April 1st, 2011 was performed. RESULTS: Twelve cases of EBUS-TBNA procedures performed on patients taking clopidogrel were identified. Mean age was 74 years (range 61-85). Seven patients (66.7%) were taking aspirin in addition to clopidogrel. There was no significant bleeding seen in any cases at the time of bronchoscopy and no additional complications were identified during follow-up (at least 4 weeks; median follow-up 3 months). CONCLUSIONS: This series of 12 cases suggests that EBUS-TBNA can be performed safely by experienced operators in patients taking clopidogrel. Nevertheless, until larger prospective studies confirm this hypothesis, proceeding to EBUS-TBNA without first withdrawing clopidogrel should only be performed in situations where the risk of short-term thrombosis is believed to outweigh the (theoretical) risk of bleeding.

Endobronchial Ultrasound Transbronchial Needle Aspiration With a 19-Gauge Needle vs 21- and 22-Gauge Needles for Mediastinal Lymphadenopathy.

BACKGROUND: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is commonly used to evaluate mediastinal lymphadenopathy. Studies focusing on malignant lymphadenopathy have compared 21- and 22-gauge (21G and 22G, respectively) needles and have not identified an advantage of one needle size over the other in terms of diagnostic yield. RESEARCH QUESTION: Does the 19-gauge (19G) EBUS needle offer greater diagnostic yield and sensitivity vs the 21G and 22G EBUS needles for a diagnosis of sarcoidosis, lymphoma, or mediastinal lymphadenopathy not yet diagnosed? STUDY DESIGN AND METHODS: This study retrospectively examined records of 730 patients from the Stather Canadian Outcomes Registry for Chest Procedures (SCOPE) database who underwent EBUS-TBNA for a diagnosis of suspected sarcoidosis, lymphoma, or mediastinal lymphadenopathy not yet diagnosed. A propensity score analysis of two groups was performed. One group comprised patients undergoing EBUS-TBNA with a 19G needle, the other with a 21G or 22G needle. Cases for analysis were selected with a 1:2 ratio of 19G vs 21/22G using logistic regression and random matching with all eligible 19G cases included. RESULTS: There were 137 patients (312 targets) in the 19G group and 274 patients (631 targets) in the 21/22G group in the propensity score analysis. The diagnostic yield was 107 of 137 (78.1%) in the 19G group vs 194 of 274 (70.8%) in the 21/22G group (difference, 7.3%; 95% CI, -1.9 to 15.6; P = .116). The sensitivity of EBUS-TBNA for sarcoidosis was 80 of 83 (96.4%) in the 19G group vs 150 of 156 (96.2%) in the 21/22G group (difference, 0.24%; 95% CI, -6.6 to 85.1; P = .93). In patients with a final diagnosis of lymphoma, EBUS was diagnostic in 10 of 13 (76.9%) in the 19G group vs 12 of 12 (100%) in the 21/22G group (difference, 23.1%; 95% CI, -5.4 to 50.3; P = .08). INTERPRETATION: The study did not identify an advantage of the 19G EBUS needle over the 21/22G EBUS needles for diagnostic yield nor sensitivity for sarcoidosis or lymphoma.

Pleural controversy: pleurodesis versus indwelling pleural catheters for malignant effusions.

Malignant pleural effusions (MPE) are a common complication of advanced malignancy. The treatment of MPE should be focused on palliation of associated symptoms. The traditional approach to MPE has been to attempt pleurodesis by introducing a sclerosant into the pleural space. A more recent development in the treatment of MPE has been the use of indwelling pleural catheters (IPC) for ongoing drainage of the pleural space. Controversy exists as to which approach is superior. Pleurodesis approaches will have the advantage of a time-limited course of treatment and high pleurodesis rate at the cost of a more invasive procedure requiring a general anaesthetic or conscious sedation (for thoracoscopic approaches) and an inpatient hospital stay. Use of IPC will allow the patient to be treated on an outpatient basis with a minimally invasive procedure, at the cost of long-term need for catheter drainage and care. Symptom control appears similar between techniques. Complication rates between the two approaches cannot be easily compared, but studies suggest more frequent severe complications such as respiratory failure, arrhythmias and even mortality following pleurodesis, with infection rates similar between the two approaches. IPC will likely see increasing utilization in the future but patient preference and local resources and expertise will continue to play a significant part in treatment decisions. Randomized trials directly comparing the two approaches are needed and some are underway. Novel combination approaches utilizing both IPC and pleurodesis agents have the potential to further improve the care of these patients.