George A. Eapen

Endobronchial Ultrasound Guided Transbronchial Needle Aspiration in the Diagnosis of Lymphoma.

Background: The diagnostic accuracy of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for the diagnosis of lymphoma in patients with mediastinal lymphadenopathy is not well defined. Methods: A retrospective review was performed of all patients with mediastinal lymphadenopathy referred for EBUS-TBNA between August 2005 and December 2006 in whom lymphoma was suspected based on prior history or clinical presentation. Mediastinal biopsy specimens were taken using a linear array ultrasonic bronchoscope (Olympus XBF-UC 160F) and a 22-gauge cytology needle (NA-202C Olympus) with on-site cytopathological support. The EBUS-TBNA result was compared with a reference standard of pathological tissue diagnosis or a composite of ⩾6 months of clinical follow-up with radiographic imaging. Results: Of 236 patients who underwent EBUS-TBNA, 25 were eligible for inclusion. Indications for EBUS-TBNA were suspected mediastinal recurrence of lymphoma (n = 13) and mediastinal lymphadenopathy of unknown cause (n = 12). Adequate lymph node sampling was accomplished in 24/25 patients (96%); there were no complications. EBUS-TBNA identified lymphoma in 10 patients and benign disease in 14 patients. There was one false negative EBUS-TBNA for lymphoma (lymphoma prevalence 11/25 (44%)). Follow-up over a median of 10.5 months (range 1–19) confirmed stable or regressive lymphadenopathy in all 14 patients without a lymphoma diagnosis, consistent with a benign diagnosis. Overall, EBUS-TBNA had a sensitivity of 90.9%, specificity of 100%, positive predictive value of 100% and negative predictive value of 92.9% for the diagnosis of lymphoma. Conclusions: EBUS-TBNA is an accurate, safe and useful tool in the investigation of suspected lymphoma with isolated mediastinal adenopathy, and may diminish the need for more invasive procedures such as mediastinoscopy.

Complications, Consequences, and Practice Patterns of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: Results of the AQuIRE Registry

BACKGROUND Few studies of endobronchial ultrasound-guided transbronchial needle aspiration(EBUS-TBNA) have been large enough to identify risk factors for complications. The primary objective of this study was to quantify the incidence of and risk factors for complications in patients undergoing EBUS-TBNA. METHODS Data on prospectively enrolled patients undergoing EBUS-TBNA in the American College of Chest Physicians Quality Improvement Registry, Evaluation, and Education (AQuIRE)database were extracted and analyzed for the incidence, consequences, and predictors of complications. RESULTS We enrolled 1,317 patients at six hospitals. Complications occurred in 19 patients (1.44%;95% CI, 0.87%-2.24%). Transbronchial lung biopsy (TBBx) was the only risk factor for complications,which occurred in 3.21% of patients who underwent the procedure and in 1.15% of those who did not (OR, 2.85; 95% CI, 1.07-7.59; P 5 .04). Pneumothorax occurred in seven patients(0.53%; 95% CI, 0.21%-1.09%). Escalations in level of care occurred in 14 patients (1.06%;95% CI, 0.58%-1.78%); its risk factors were age . 70 years (OR, 4.06; 95% CI, 1.36-12.12; P 5 .012),inpatient status (OR, 4.93; 95% CI, 1.30-18.74; P 5 .019), and undergoing deep sedation or general anesthesia (OR, 4.68; 95% CI, 1.02-21.61; P 5 .048). TBBx was performed in only 12.6% of patients when rapid on site cytologic evaluation (ROSE ) was used and in 19.1% when it was not used ( P 5 .006).Interhospital variation in TBBx use when ROSE was used was significant ( P , .001). CONCLUSIONS TBBx was the only risk factor for complications during EBUS-TBNA procedures.ROSE significantly reduced the use of TBBx.

Diagnostic Yield of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: Results of the AQuIRE Bronchoscopy Registry

BACKGROUND New transbronchial needle aspiration (TBNA) technologies have been developed, but their clinical effectiveness and determinants of diagnostic yield have not been quantified. Prospective data are needed to determine risk-adjusted diagnostic yield. METHODS We prospectively enrolled patients undergoing TBNA of mediastinal lymph nodes in the American College of Chest Physicians Quality Improvement Registry, Evaluation, and Education (AQuIRE) multicenter database and recorded clinical, procedural, and provider information. All clinical decisions, including type of TBNA used (conventional vs endobronchial ultrasound-guided), were made by the attending bronchoscopist. The primary outcome was obtaining a specific diagnosis. RESULTS We enrolled 891 patients at six hospitals. Most procedures (95%) were performed with ultrasound guidance. A specific diagnosis was made in 447 cases. Unadjusted diagnostic yields were 37% to 54% for different hospitals, with significant between-hospital heterogeneity (P = .0001). Diagnostic yield was associated with annual hospital TBNA volume (OR, 1.003; 95% CI, 1.000-1.006; P = .037), smoking (OR, 1.55; 95% CI, 1.02-2.34; P = .042), biopsy of more than two sites (OR, 0.57; 95% CI, 0.38-0.85; P = .015), lymph node size (reference > 1-2 cm, ≤ 1 cm: OR, 0.51; 95% CI, 0.34-0.77; P = .003; > 2-3 cm: OR, 2.49; 95% CI, 1.61-3.85; P < .001; and > 3 cm: OR, 3.61; 95% CI, 2.17-6.00; P < .001), and positive PET scan (OR, 3.12; 95% CI, 1.39-7.01; P = .018). Biopsy was performed on more and smaller nodes at high-volume hospitals (P < .0001). CONCLUSIONS To our knowledge, this is the first bronchoscopy study of risk-adjusted diagnostic yields on a hospital-level basis. High-volume hospitals were associated with high diagnostic yields. This study also demonstrates the value of procedural registries as a quality improvement tool. A larger number and variety of participating hospitals is needed to verify these results and to further investigate other determinants of diagnostic yield.

Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry.

RATIONALE Advanced bronchoscopy techniques such as electromagnetic navigation (EMN) have been studied in clinical trials, but there are no randomized studies comparing EMN with standard bronchoscopy. OBJECTIVES To measure and identify the determinants of diagnostic yield for bronchoscopy in patients with peripheral lung lesions. Secondary outcomes included diagnostic yield of different sampling techniques, complications, and practice pattern variations. METHODS We used the AQuIRE (ACCP Quality Improvement Registry, Evaluation, and Education) registry to conduct a multicenter study of consecutive patients who underwent transbronchial biopsy (TBBx) for evaluation of peripheral lesions. MEASUREMENTS AND MAIN RESULTS Fifteen centers with 22 physicians enrolled 581 patients. Of the 581 patients, 312 (53.7%) had a diagnostic bronchoscopy. Unadjusted for other factors, the diagnostic yield was 63.7% when no radial endobronchial ultrasound (r-EBUS) and no EMN were used, 57.0% with r-EBUS alone, 38.5% with EMN alone, and 47.1% with EMN combined with r-EBUS. In multivariate analysis, peripheral transbronchial needle aspiration (TBNA), larger lesion size, nonupper lobe location, and tobacco use were associated with increased diagnostic yield, whereas EMN was associated with lower diagnostic yield. Peripheral TBNA was used in 16.4% of cases. TBNA was diagnostic, whereas TBBx was nondiagnostic in 9.5% of cases in which both were performed. Complications occurred in 13 (2.2%) patients, and pneumothorax occurred in 10 (1.7%) patients. There were significant differences between centers and physicians in terms of case selection, sampling methods, and anesthesia. Medical center diagnostic yields ranged from 33 to 73% (P = 0.16). CONCLUSIONS Peripheral TBNA improved diagnostic yield for peripheral lesions but was underused. The diagnostic yields of EMN and r-EBUS were lower than expected, even after adjustment.

Therapeutic Bronchoscopy for Malignant Central Airway Obstruction: Success Rates and Impact on Dyspnea and Quality of Life

BACKGROUND There is significant variation between physicians in terms of how they perform therapeutic bronchoscopy, but there are few data on whether these differences impact effectiveness. METHODS This was a multicenter registry study of patients undergoing therapeutic bronchoscopy for malignant central airway obstruction. The primary outcome was technical success, defined as reopening the airway lumen to > 50% of normal. Secondary outcomes were dyspnea as measured by the Borg score and health-related quality of life (HRQOL) as measured by the SF-6D. RESULTS Fifteen centers performed 1,115 procedures on 947 patients. Technical success was achieved in 93% of procedures. Center success rates ranged from 90% to 98% (P = .02). Endobronchial obstruction and stent placement were associated with success, whereas American Society of Anesthesiology (ASA) score > 3, renal failure, primary lung cancer, left mainstem disease, and tracheoesophageal fistula were associated with failure. Clinically significant improvements in dyspnea occurred in 90 of 187 patients measured (48%). Greater baseline dyspnea was associated with greater improvements in dyspnea, whereas smoking, having multiple cancers, and lobar obstruction were associated with smaller improvements. Clinically significant improvements in HRQOL occurred in 76 of 183 patients measured (42%). Greater baseline dyspnea was associated with greater improvements in HRQOL, and lobar obstruction was associated with smaller improvements. CONCLUSIONS Technical success rates were high overall, with the highest success rates associated with stent placement and endobronchial obstruction. Therapeutic bronchoscopy should not be withheld from patients based solely on an assessment of risk, since patients with the most dyspnea and lowest functional status benefitted the most.

Quality gaps and comparative effectiveness in lung cancer staging: The impact of test sequencing on outcomes

BACKGROUND Evidence-based guidelines recommend mediastinal sampling as the first invasive test in patients with suspected lung cancer and mediastinal adenopathy. The goal of this study was to assess practice patterns and outcomes of diagnostic strategies in this patient population. METHODS We conducted a retrospective analysis of all patients in 2009 who had mediastinal adenopathy without distant metastatic disease to determine whether guideline-consistent care was delivered. Guideline-consistent care was defined as mediastinal lymph node sampling being performed as part of the first invasive procedure. RESULTS One hundred thirty-seven patients were included. Guideline-consistent care was provided in 30 cases (22%). Patients receiving guideline-consistent care had fewer invasive tests than patients with guideline-inconsistent care (1.3 ± 0.5 tests/patient vs 2.3 ± 0.5 tests/patient, respectively; P < .0001) and fewer complications (0 of 30, 0% vs 18 of 108, 17%; P = .01). Most of the complications (16 of 18) were related to CT image-guided needle biopsy. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was sufficient to guide treatment decisions without any other invasive tests in 88 patients (64%). Although not all the complications and costs due to CT image-guided biopsies could have been avoided, roughly two-thirds could have been eliminated by just changing the testing sequence. CONCLUSION Quality gaps in lung cancer staging in patients with mediastinal adenopathy are common and lead to unnecessary testing and increased complications. In patients with suspected lung cancer without distant metastatic disease with mediastinal adenopathy, EBUS-TBNA should be the first test.

Interventional Pulmonology Fellowship Accreditation Standards: Executive Summary of the Multisociety Interventional Pulmonology Fellowship Accreditation Committee

&NA; 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.

Complications following therapeutic bronchoscopy for malignant central airway obstruction: Results of the AQuIRE registry

BACKGROUND There are significant variations in how therapeutic bronchoscopy for malignant airway obstruction is performed. Relatively few studies have compared how these approaches affect the incidence of complications. METHODS We used the American College of Chest Physicians (CHEST) Quality Improvement Registry, Evaluation, and Education (AQuIRE) program registry to conduct a multicenter study of patients undergoing therapeutic bronchoscopy for malignant central airway obstruction. The primary outcome was the incidence of complications. Secondary outcomes were incidence of bleeding, hypoxemia, respiratory failure, adverse events, escalation in level of care, and 30-day mortality. RESULTS Fifteen centers performed 1,115 procedures on 947 patients. There were significant differences among centers in the type of anesthesia (moderate vs deep or general anesthesia, P < .001), use of rigid bronchoscopy (P < .001), type of ventilation (jet vs volume cycled, P < .001), and frequency of stent use (P < .001). The overall complication rate was 3.9%, but significant variation was found among centers (range, 0.9%-11.7%; P = .002). Risk factors for complications were urgent and emergent procedures, American Society of Anesthesiologists (ASA) score > 3, redo therapeutic bronchoscopy, and moderate sedation. The 30-day mortality was 14.8%; mortality varied among centers (range, 7.7%-20.2%, P = .02). Risk factors for 30-day mortality included Zubrod score > 1, ASA score > 3, intrinsic or mixed obstruction, and stent placement. CONCLUSIONS Use of moderate sedation and stents varies significantly among centers. These factors are associated with increased complications and 30-day mortality, respectively.

Respiratory Infections Increase the Risk of Granulation Tissue Formation Following Airway Stenting in Patients With Malignant Airway Obstruction

BACKGROUND The most serious complications of airway stenting are long term, including infection and granulation tissue formation. However, to our knowledge, no studies have quantified the incidence rate of long-term complications for different stents. METHODS To compare the incidence of complications of different airway stents, we conducted a retrospective cohort study of all patients at our institution who had airway stenting for malignant airway obstruction from January 2005 to August 2010. Patients were excluded if more than one type of stent was in place at the same time. Complications recorded were lower respiratory tract infections, stent migration, granulation tissue, mucus plugging requiring intervention, tumor overgrowth, and stent fracture. RESULTS One hundred seventy-two patients with 195 stent procedures were included. Aero stents were associated with an increased risk of infection (hazard ratio [HR] = 1.98; 95% CI, 1.03-3.81; P = .041). Dumon silicone tube stents had an increased risk of migration (HR = 3.52; 95% CI, 1.41-8.82; P = .007). Silicone stents (HR = 3.32; 95% CI, 1.59-6.93; P = .001) and lower respiratory tract infections (HR = 5.69; 95% CI, 2.60-12.42; P < .001) increased the risk of granulation tissue. Lower respiratory tract infections were associated with decreased survival (HR = 1.57; 95% CI, 1.11-2.21; P = .011). CONCLUSIONS Significant differences exist among airway stents in terms of infection, migration, and granulation tissue formation. These complications, in turn, are associated with significant morbidity and mortality. Granulation tissue formation develops because of repetitive motion trauma and infection.

Quality-Adjusted Survival Following Treatment of Malignant Pleural Effusions With Indwelling Pleural Catheters

BACKGROUND Malignant pleural effusions (MPEs) are a frequent cause of dyspnea in patients with cancer. Although indwelling pleural catheters (IPCs) have been used since 1997, there are no studies of quality-adjusted survival following IPC placement. METHODS With a standardized algorithm, this prospective observational cohort study of patients with MPE treated with IPCs assessed global health-related quality of life using the SF-6D to calculate utilities. Quality-adjusted life days (QALDs) were calculated by integrating utilities over time. RESULTS A total of 266 patients were enrolled. Median quality-adjusted survival was 95.1 QALDs. Dyspnea improved significantly following IPC placement (P < .001), but utility increased only modestly. Patients who had chemotherapy or radiation after IPC placement (P < .001) and those who were more short of breath at baseline (P = .005) had greater improvements in utility. In a competing risk model, the 1-year cumulative incidence of events was death with IPC in place, 35.7%; IPC removal due to decreased drainage, 51.9%; and IPC removal due to complications, 7.3%. Recurrent MPE requiring repeat intervention occurred in 14% of patients whose IPC was removed. Recurrence was more common when IPC removal was due to complications (P = .04) or malfunction (P < .001) rather than to decreased drainage. CONCLUSIONS IPC placement has significant beneficial effects in selected patient populations. The determinants of quality-adjusted survival in patients with MPE are complex. Although dyspnea is one of them, receiving treatment after IPC placement is also important. Future research should use patient-centered outcomes in addition to time-to-event analysis. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT01117740; URL: www.clinicaltrials.gov.