David E. Ost

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

BACKGROUNDnFew 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.nnnMETHODSnData 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.nnnRESULTSnWe 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).nnnCONCLUSIONSnTBBx 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

BACKGROUNDnNew 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.nnnMETHODSnWe 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.nnnRESULTSnWe 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).nnnCONCLUSIONSnTo 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.

RATIONALEnAdvanced bronchoscopy techniques such as electromagnetic navigation (EMN) have been studied in clinical trials, but there are no randomized studies comparing EMN with standard bronchoscopy.nnnOBJECTIVESnTo 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.nnnMETHODSnWe 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.nnnMEASUREMENTS AND MAIN RESULTSnFifteen 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% (Pu2009=u20090.16).nnnCONCLUSIONSnPeripheral 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.

Comparison of 21-Gauge and 22-Gauge Aspiration Needle in Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: Results of the American College of Chest Physicians Quality Improvement Registry, Education, and Evaluation Registry

BACKGROUNDnEndobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive procedure originally performed using a 22-gauge (22G) needle. A recently introduced 21-gauge (21G) needle may improve the diagnostic yield and sample adequacy of EBUS-TBNA, but prior smaller studies have shown conflicting results. To our knowledge, this is the largest study undertaken to date to determine whether the 21G needle adds diagnostic benefit.nnnMETHODSnWe retrospectively evaluated the results of 1,299 patients from the American College of Chest Physicians Quality Improvement Registry, Education, and Evaluation (AQuIRE) Diagnostic Registry who underwent EBUS-TBNA between February 2009 and September 2010 at six centers throughout the United States. Data collection included patient demographics, sample adequacy, and diagnostic yield. Analysis consisted of univariate and multivariate hierarchical logistic regression comparing diagnostic yield and sample adequacy of EBUS-TBNA specimens by needle gauge.nnnRESULTSnA total of 1,235 patients met inclusion criteria. Sample adequacy was obtained in 94.9% of the 22G needle group and in 94.6% of the 21G needle group (P = .81). A diagnosis was made in 51.4% of the 22G and 51.3% of the 21G groups (P = .98). Multivariate hierarchical logistic regression showed no statistical difference in sample adequacy or diagnostic yield between the two groups. The presence of rapid onsite cytologic evaluation was associated with significantly fewer needle passes per procedure when using the 21G needle (P < .001).nnnCONCLUSIONSnThere is no difference in specimen adequacy or diagnostic yield between the 21G and 22G needle groups. EBUS-TBNA in conjunction with rapid onsite cytologic evaluation and a 21G needle is associated with fewer needle passes compared with a 22G needle.

Randomized Clinical Trial of Endobronchial Ultrasound Needle Biopsy With and Without Aspiration

BACKGROUNDnEndobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (EBUS-TBNA) is performed with a dedicated 22- or 21-gauge needle while suction is applied. Fine-needle sampling without suction (capillary sampling) has been studied for endoscopic ultrasound and for biopsies at various body sites and has resulted in similar diagnostic yield and fewer traumatic samples. However, the role of EBUS-guided transbronchial needle capillary sampling (EBUS-TBNCS) is still to be determined.nnnMETHODSnAdults with suspicious hilar or mediastinal lymph nodes (LNs) were included in a single-blinded, prospective, randomized trial comparing EBUS-TBNA and EBUS-TBNCS. The primary end point was the concordance rate between the two techniques in terms of adequacy and diagnosis of cytologic samples. The secondary end point was the concordance rate between the two techniques in terms of quality of samples.nnnRESULTSnA total of 115 patients and 192 LNs were studied. Concordance between EBUS-TBNA and EBUS-TBNCS was high, with no significant difference in adequacy (88% vs 88%, respectively [P ± .858]; concordance rate, 83.9% [95% CI, 77.9-88.8]); diagnosis (36% vs 34%, respectively [P ± .289]; concordance rate, 95.8% [95% CI, 92-92.8]); diagnosis of malignancy (28% vs 26%, respectively [P ± .125]; concordance rate, 97.9% [95% CI, 94.8-99.4]); or sample quality (concordance rate, 83.3% [95% CI, 73.3-88.3]). Concordance between EBUS-TBNA and EBUS-TBNCS was high irrespective of LN size (≤ 1 cm vs > 1 cm).nnnCONCLUSIONSnRegardless of LN size, no differences in adequacy, diagnosis, or quality were found between samples obtained using EBUS-TBNA and those obtained using EBUS-TBNCS. There is no evidence of any benefit derived from the practice of applying suction to EBUS-guided biopsies.nnnTRIAL REGISTRYnClinicalTrials.gov; No.: NCT00886847; URL: www.clinicaltrials.gov

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

BACKGROUNDnThere is significant variation between physicians in terms of how they perform therapeutic bronchoscopy, but there are few data on whether these differences impact effectiveness.nnnMETHODSnThis 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.nnnRESULTSnFifteen 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.nnnCONCLUSIONSnTechnical 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

BACKGROUNDnEvidence-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.nnnMETHODSnWe 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.nnnRESULTSnOne 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.nnnCONCLUSIONnQuality 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.

Quality Gaps and Comparative Effectiveness in Lung Cancer Staging and Diagnosis

BACKGROUNDnGuidelines recommend mediastinal lymph node sampling as the first invasive test in patients with suspected lung cancer with mediastinal lymphadenopathy without distant metastases, but there are no comparative effectiveness studies on how test sequencing affects outcomes. The objective was to compare practice patterns and outcomes of diagnostic strategies in patients with lung cancer.nnnMETHODSnThe study included a retrospective cohort of 15,316 patients with lung cancer with regional spread without distant metastases in the Surveillance, Epidemiology, and End Results or Texas Cancer Registry Medicare-linked databases. If the first invasive test involved mediastinal sampling, patients were classified as receiving guideline-consistent care; otherwise, they were classified as receiving guideline-inconsistent care. We used propensity matching to compare the number of tests performed and multivariate logistic regression to compare the frequency of complications.nnnRESULTSnTwenty-one percent of patients had guideline-consistent diagnostic evaluations. Among patients with non-small cell lung cancer, 44% never had mediastinal sampling. Patients who had guideline-consistent care required fewer tests than those with guideline-inconsistent care (P < .0001), including thoracotomies (49% vs 80%, P < .001) and CT image-guided biopsies (9% vs 63%, P < .001), although they had more transbronchial needle aspirations (37% vs 4%, P < .001). The consequence was that patients with guideline-consistent care had fewer pneumothoraxes (4.8% vs 25.6%, P < .0001), chest tubes (0.7% vs 4.9%, P < .001), hemorrhages (5.4% vs 10.6%, P < .001), and respiratory failure events (5.3% vs 10.5%, P < .001).nnnCONCLUSIONSnGuideline-consistent care with mediastinal sampling first resulted in fewer tests and complications. We found three quality gaps: failure to sample the mediastinum first, failure to sample the mediastinum at all in patients with non-small cell lung cancer, and overuse of thoracotomy.

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

BACKGROUNDnThere 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.nnnMETHODSnWe 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.nnnRESULTSnFifteen 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.nnnCONCLUSIONSnUse 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

BACKGROUNDnThe 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.nnnMETHODSnTo 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.nnnRESULTSnOne 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).nnnCONCLUSIONSnSignificant 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.