ABSTRACTBackground and objectiveIntratumoral administration of chemotherapeutic agents is a treatment modality that has proven efficacious in reducing the recurrence of tumours and increases specificity of treatment while minimizing systemic side effects. Direct intratumoral injection of malignant airway obstruction has potential therapeutic benefits but tissue drug concentrations and side‐effect profiles are poorly understood.MethodsBronchial wall injection of generic paclitaxel (PTX) (102 injections of 0.05, 0.5, 1.5 or 2.5 mg/mL in 10 healthy pigs), saline (14 injections in 2 healthy pigs) or Abraxane (ABX) (24 injections of 0.5 mg/mL in 4 healthy pigs) was performed with a microneedle infusion catheter. Local histopathology, plasma and tissue PTX concentrations were evaluated at 7, 20 or 28 days post‐injection.ResultsInjection of generic PTX directly into the bronchial wall at doses up to 1.5 mg/mL only caused minimal tissue injury. Dose‐limiting tissue reaction was observed at 2.5 mg/mL. Plasma PTX was detectable for up to 5 days but not at 28 days, with area under the curve (AUC)(0‐5d) 20‐ to 50‐fold lower than the AUC(0‐∞) of 6300 ng h/mL for the approved intravenous dose. At 7 and 28 days post‐injection, bronchial PTX tissue concentrations were above a 10‐nmol/L cancer therapeutic level. PTX was not found in peripheral tissues. Similar results were observed between ABX and generic PTX.ConclusionResults of these studies confirm the administration of PTX directly into the bronchial wall is safe and feasible. PTX was detectable in plasma for <7 days but tissue concentrations remained therapeutic throughout the follow‐up period.
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.
BACKGROUND:An endobronchial infusion catheter introduced through a flexible bronchoscope channel has not been previously described. The aim of this study was to evaluate the technical feasibility of a new device.METHODS:Four porcine models underwent bronchoscopy with the infusion catheter. In the first experiment, methylene blue was injected into airway in volumes of 0.1, 0.3, or 1.0 mL into 2 animals. One animal was killed at 1 hour and the other at 24 hours after the procedure and gross dye diffusion was visually assessed. In the second experiment, a mixture of 80% sterile normal saline and 20% contrast media was injected into the airway in volumes of 0.3, 1.0, and 3.0 mL into 2 animals. One animal was killed at 7 days and the other at 20 days. Histologic evaluations were performed according to a bronchial damage scoring system.RESULTS:There was no perioperative morbidity. In the first experiment, infusion volumes of 0.1, 0.3, and 1.0 mL resulted in dye surrounding 67%±29%, 55%±17%, and 80%±20% of the infusion-site circumference, and longitudinal distribution of 4.0±1.7, 8.1±4.1, and 18.0±3.0 mm each, respectively. In the second experiment, infusion of 0.3 to 3.0 mL resulted in mild injury, inflammation, and hemorrhage/fibrin/thrombus at 7 and 20 days after surgery.CONCLUSIONS:Endobronchial infusion of dye and contrast media by the endobronchial drug delivery catheter showed that the media spread in a dose-dependent manner macroscopically and histologically. Further investigation will be required to assess the catheter as a new tool for localized drug delivery into the airway.
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.
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.
BACKGROUND:The determination of competency of trainees in programs performing bronchoscopy is quite variable. Some programs provide didactic lectures with hands-on supervision, other programs incorporate advanced simulation centers, whereas others have a checklist approach. Although no single method has been proven best, the variability alone suggests that outcomes are variable. Program directors and certifying bodies need guidance to create standards for training programs. Little well-developed literature on the topic exists.METHODS:To provide credible and trustworthy guidance, rigorous methodology has been applied to create this bronchoscopy consensus training statement. All panelists were vetted and approved by the CHEST Guidelines Oversight Committee. Each topic group drafted questions in a PICO (population, intervention, comparator, outcome) format. MEDLINE data through PubMed and the Cochrane Library were systematically searched. Manual searches also supplemented the searches. All gathered references were screened for consideration based on inclusion criteria, and all statements were designated as an Ungraded Consensus-Based Statement.RESULTS:We suggest that professional societies move from a volume-based certification system to skill acquisition and knowledge-based competency assessment for trainees. Bronchoscopy training programs should incorporate multiple tools, including simulation. We suggest that ongoing quality and process improvement systems be introduced and that certifying agencies move from a volume-based certification system to skill acquisition and knowledge-based competency assessment for trainees. We also suggest that assessment of skill maintenance and improvement in practice be evaluated regularly with ongoing quality and process improvement systems after initial skill acquisition.CONCLUSIONS:The current methods used for bronchoscopy competency in training programs are variable. We suggest that professional societies and certifying agencies move from a volume- based certification system to a standardized skill acquisition and knowledge-based competency assessment for pulmonary and thoracic surgery trainees.
OBJECTIVES:Dynamic flexible bronchoscopy is the "gold standard" for assessing changes in airway luminal size associated with tracheobronchomalacia, but the procedure has not been adequately validated. The present study was designed to test the validity of diagnosing tracheobronchomalacia by dynamic flexible bronchoscopy through assessing inter- and intraobserver agreements in estimating degree of central airway collapse associated with tracheobronchomalacia.METHODS:This prospective observational pilot study enrolled consecutive patients with suspected tracheobronchomalacia scheduled for dynamic flexible bronchoscopy. Images of the airway lumen were obtained at five different sites in the tracheobronchial tree during forced inspiration and expiration and were evaluated by 23 pulmonologists (not involved in the care of study patients) with different levels of training and experience at baseline (interobserver agreement) and 8 days later (intraobserver agreement). The degree of airway collapse was visually estimated by each examiner and expressed as a percentage of narrowing. A multirater generalized kappa-type statistical method was used to calculate the correlation coefficients and to assess reliability of the measurements obtained during dynamic flexible bronchoscopy.MEASUREMENTS AND MAIN RESULTS:Between September 1 and 30, 2009, 10 patients (median age, 65 yr) underwent dynamic flexible bronchoscopy. The correlation coefficients for inter- and intraobserver agreement were favorable and ranged for the five airway sites from 0.68 to 0.92 and from 0.80 to 0.96, respectively.CONCLUSIONS:The favorable inter- and intraobserver agreements among 23 pulmonologists using dynamic flexible bronchoscopy to estimate the degree of dynamic central airway collapse provide additional evidence that dynamic flexible bronchoscopy is a reliable diagnostic tool for tracheobronchomalacia.
Medical myths die hard! Drs Farjah and Wood1Farjah F Wood DE Counterpoint: should ultrasonographic endoscopy be the preferred modality for staging lung cancer? No.Chest. 2014; 145: 449-451Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar point out deficiencies in the ultrasonographic approach that have been disproved by data or overcome by innovative solutions. These include a lack of effectiveness in sampling the radiographically normal mediastinum, an inability of endobronchial ultrasound (EBUS) and esophageal ultrasound (EUS) to collect adequate tissue for molecular analysis, and logistical difficulty in performing EBUS and EUS simultaneously. On the other hand, the authors claim an excellent track record of surgical staging in lung cancer. A survey in 2005 gathered information on the surgical care of the patient with lung cancer and illustrated the poor state of affairs in the United States: Only 27% of surgical patients underwent mediastinoscopy, and only 46% of those undergoing the procedure had documented evidence of lymph node biopsy material submitted to pathology.2Little AG Rusch VW Bonner JA et al.Patterns of surgical care of lung cancer patients.Ann Thorac Surg. 2005; 80: 2051-2056Abstract Full Text Full Text PDF PubMed Scopus (364) Google Scholar This is one of the reasons why new approaches and opportunities for staging access are desperately needed to provide patients with the best possible care.The premise that EBUS and EUS are not effective in sampling the radiographically normal mediastinum is challenged by two studies where EBUS guided-transbronchial needle aspiration (EBUS-TBNA) was used to sample mediastinal lymph nodes that are < 1 cm on chest CT scan in one study and nodes that are < 1 cm and have no fluorodeoxyglucose activity on PET scan in another study. All patients had clinical stage I lung cancer and underwent subsequent surgical staging. The sensitivity of EBUS-TBNA in detecting malignancy in these two studies was 92.3% and 89%, respectively.3Herth FJ Eberhardt R Krasnik M Ernst A Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically and positron emission tomography-normal mediastinum in patients with lung cancer.Chest. 2008; 133: 887-891Abstract Full Text Full Text PDF PubMed Scopus (306) Google Scholar, 4Herth FJ Ernst A Eberhardt R Vilmann P Dienemann H Krasnik M Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically normal mediastinum.Eur Respir J. 2006; 28: 910-914Crossref PubMed Scopus (284) Google Scholar Although we agree that these two studies were performed by EBUS experts, the same argument can be made about mediastinoscopy, which relies heavily on the experience of the surgeon.The myth of the inability of needle-based techniques to obtain enough tissue for molecular markers testing and, hence, the need for core tissue obtained by CT imaging guidance or surgical resection has been soundly refuted by robust data illustrating a success rate of EBUS in evaluating epidermal growth factor receptor status and other novel genetic mutations in ≥ 90% of specimens.5Billah S Stewart J Staerkel G Chen S Gong Y Guo M EGFR and KRAS mutations in lung carcinoma: molecular testing by using cytology specimens.Cancer Cytopathol. 2011; 119: 111-117Crossref PubMed Scopus (194) Google Scholar, 6Nakajima T Yasufuku K Nakagawara A Kimura H Yoshino I Multigene mutation analysis of metastatic lymph nodes in non-small cell lung cancer diagnosed by endobronchial ultrasound-guided transbronchial needle aspiration.Chest. 2011; 140: 1319-1324Abstract Full Text Full Text PDF PubMed Scopus (103) Google Scholar, 7Navani N Brown JM Nankivell M et al.Suitability of endobronchial ultrasound-guided transbronchial needle aspiration specimens for subtyping and genotyping of non-small cell lung cancer: a multicenter study of 774 patients.Am J Respir Crit Care Med. 2012; 185: 1316-1322Crossref PubMed Scopus (207) Google Scholar The concerns about the logistical difficulty of performing EBUS and EUS simultaneously are legitimate because getting pulmonologists and gastroenterologists to synchronize their calendars can be a significant challenge. However, thoracic surgeons have the capability of performing both procedures and should embrace them as necessary skills in their practice. The pulmonologists had to be more creative to overcome this barrier and found a solution: Why not use the same EBUS airway scope in the esophagus? Two studies did just that and evaluated the utility of a single linear EBUS bronchoscope in sampling mediastinal lymph nodes from the esophageal side (EUS fine needle aspiration) and from the bronchial side (EBUS-TBNA) in patients with suspected lung cancer.8Herth FJ Krasnik M Kahn N Eberhardt R Ernst A Combined endoscopic-endobronchial ultrasound-guided fine-needle aspiration of mediastinal lymph nodes through a single bronchoscope in 150 patients with suspected lung cancer.Chest. 2010; 138: 790-794Abstract Full Text Full Text PDF PubMed Scopus (223) Google Scholar, 9Hwangbo B Lee GK Lee HS et al.Transbronchial and transesophageal fine-needle aspiration using an ultrasound bronchoscope in mediastinal staging of potentially operable lung cancer.Chest. 2010; 138: 795-802Abstract Full Text Full Text PDF PubMed Scopus (199) Google Scholar Both studies confirmed the feasibility of this one-scope combined approach with a sensitivity of 91% to 96% in detecting mediastinal metastases. Finally, the argument about the lack of EBUS/EUS training in pulmonary and thoracic surgery fellowships should not be viewed as an obstacle but, rather, as an opportunity to optimize acquisition of knowledge and skills in ultrasonographic endoscopy among future chest physicians.This debate should not be about territorial battles among specialties but about the multidisciplinary team offering the most effective approach of mediastinal staging to the patient with lung cancer. The standard of surgical staging alone has not served the community as a whole well. For some patients, mediastinoscopy is the right procedure, but for the majority of patients, ultrasonographic endoscopy should be the first modality offered and performed by the most capable practitioner. Medical myths die hard! Drs Farjah and Wood1Farjah F Wood DE Counterpoint: should ultrasonographic endoscopy be the preferred modality for staging lung cancer? No.Chest. 2014; 145: 449-451Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar point out deficiencies in the ultrasonographic approach that have been disproved by data or overcome by innovative solutions. These include a lack of effectiveness in sampling the radiographically normal mediastinum, an inability of endobronchial ultrasound (EBUS) and esophageal ultrasound (EUS) to collect adequate tissue for molecular analysis, and logistical difficulty in performing EBUS and EUS simultaneously. On the other hand, the authors claim an excellent track record of surgical staging in lung cancer. A survey in 2005 gathered information on the surgical care of the patient with lung cancer and illustrated the poor state of affairs in the United States: Only 27% of surgical patients underwent mediastinoscopy, and only 46% of those undergoing the procedure had documented evidence of lymph node biopsy material submitted to pathology.2Little AG Rusch VW Bonner JA et al.Patterns of surgical care of lung cancer patients.Ann Thorac Surg. 2005; 80: 2051-2056Abstract Full Text Full Text PDF PubMed Scopus (364) Google Scholar This is one of the reasons why new approaches and opportunities for staging access are desperately needed to provide patients with the best possible care. The premise that EBUS and EUS are not effective in sampling the radiographically normal mediastinum is challenged by two studies where EBUS guided-transbronchial needle aspiration (EBUS-TBNA) was used to sample mediastinal lymph nodes that are < 1 cm on chest CT scan in one study and nodes that are < 1 cm and have no fluorodeoxyglucose activity on PET scan in another study. All patients had clinical stage I lung cancer and underwent subsequent surgical staging. The sensitivity of EBUS-TBNA in detecting malignancy in these two studies was 92.3% and 89%, respectively.3Herth FJ Eberhardt R Krasnik M Ernst A Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically and positron emission tomography-normal mediastinum in patients with lung cancer.Chest. 2008; 133: 887-891Abstract Full Text Full Text PDF PubMed Scopus (306) Google Scholar, 4Herth FJ Ernst A Eberhardt R Vilmann P Dienemann H Krasnik M Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically normal mediastinum.Eur Respir J. 2006; 28: 910-914Crossref PubMed Scopus (284) Google Scholar Although we agree that these two studies were performed by EBUS experts, the same argument can be made about mediastinoscopy, which relies heavily on the experience of the surgeon. The myth of the inability of needle-based techniques to obtain enough tissue for molecular markers testing and, hence, the need for core tissue obtained by CT imaging guidance or surgical resection has been soundly refuted by robust data illustrating a success rate of EBUS in evaluating epidermal growth factor receptor status and other novel genetic mutations in ≥ 90% of specimens.5Billah S Stewart J Staerkel G Chen S Gong Y Guo M EGFR and KRAS mutations in lung carcinoma: molecular testing by using cytology specimens.Cancer Cytopathol. 2011; 119: 111-117Crossref PubMed Scopus (194) Google Scholar, 6Nakajima T Yasufuku K Nakagawara A Kimura H Yoshino I Multigene mutation analysis of metastatic lymph nodes in non-small cell lung cancer diagnosed by endobronchial ultrasound-guided transbronchial needle aspiration.Chest. 2011; 140: 1319-1324Abstract Full Text Full Text PDF PubMed Scopus (103) Google Scholar, 7Navani N Brown JM Nankivell M et al.Suitability of endobronchial ultrasound-guided transbronchial needle aspiration specimens for subtyping and genotyping of non-small cell lung cancer: a multicenter study of 774 patients.Am J Respir Crit Care Med. 2012; 185: 1316-1322Crossref PubMed Scopus (207) Google Scholar The concerns about the logistical difficulty of performing EBUS and EUS simultaneously are legitimate because getting pulmonologists and gastroenterologists to synchronize their calendars can be a significant challenge. However, thoracic surgeons have the capability of performing both procedures and should embrace them as necessary skills in their practice. The pulmonologists had to be more creative to overcome this barrier and found a solution: Why not use the same EBUS airway scope in the esophagus? Two studies did just that and evaluated the utility of a single linear EBUS bronchoscope in sampling mediastinal lymph nodes from the esophageal side (EUS fine needle aspiration) and from the bronchial side (EBUS-TBNA) in patients with suspected lung cancer.8Herth FJ Krasnik M Kahn N Eberhardt R Ernst A Combined endoscopic-endobronchial ultrasound-guided fine-needle aspiration of mediastinal lymph nodes through a single bronchoscope in 150 patients with suspected lung cancer.Chest. 2010; 138: 790-794Abstract Full Text Full Text PDF PubMed Scopus (223) Google Scholar, 9Hwangbo B Lee GK Lee HS et al.Transbronchial and transesophageal fine-needle aspiration using an ultrasound bronchoscope in mediastinal staging of potentially operable lung cancer.Chest. 2010; 138: 795-802Abstract Full Text Full Text PDF PubMed Scopus (199) Google Scholar Both studies confirmed the feasibility of this one-scope combined approach with a sensitivity of 91% to 96% in detecting mediastinal metastases. Finally, the argument about the lack of EBUS/EUS training in pulmonary and thoracic surgery fellowships should not be viewed as an obstacle but, rather, as an opportunity to optimize acquisition of knowledge and skills in ultrasonographic endoscopy among future chest physicians. This debate should not be about territorial battles among specialties but about the multidisciplinary team offering the most effective approach of mediastinal staging to the patient with lung cancer. The standard of surgical staging alone has not served the community as a whole well. For some patients, mediastinoscopy is the right procedure, but for the majority of patients, ultrasonographic endoscopy should be the first modality offered and performed by the most capable practitioner.
BACKGROUND:Patients who achieve significant target lobe volume reduction (TLVR) following endobronchial valve (EBV) treatment may experience substantial improvements in clinical outcome measures. However, in cases of rapid TLVR, the risk of pneumothorax increases due to parenchymal rupture of the adjacent untreated lobe. Target lobe collapse may be more likely in EBV-treated patients who have low collateral ventilation.OBJECTIVES:The aim of this study was to evaluate the impact of pneumothorax on outcome following EBV treatment.METHODS:Data from three prospective clinical trials (the US and European cohorts of VENT and the Multicenter Chartis study) were retrieved for the analysis. All patients had undergone chest X-ray within 24 h of EBV implantation to explore the presence of pneumothorax. TLVR was assessed at either 30 (Chartis study) or 180 days (VENT), and clinical outcome measures (forced expiratory volume in 1 s (FEV1), St. George's Respiratory Questionnaire (SGRQ) and 6-min-walk distance (6-MWD)) were assessed 180 days after implantation.RESULTS:The overall rate of pneumothorax following valve therapy was 5.9% (25/421). Among these patients, 68% had a prolonged air leak for >7 days. However, patients who experienced a pneumothorax benefitted from EBV therapy, with a mean TLVR of 65% (n = 20). The mean percent change in FEV1 was 15 ± 15%, and the mean change in SGRQ was -7 ± 12 points.CONCLUSIONS:Although pneumothorax is a complication of EBV placement, it does not appear to have a negative impact on clinical outcome in terms of FEV1 and health-related quality of life.
Lung cancer remains the leading cause of cancer deaths in the United States, accounting for an estimated 29% and 26% of deaths in 2012 in men and women, respectively.1Siegel R Naishadham D Jemal A Cancer statistics, 2012.CA Cancer J Clin. 2012; 62: 10-29Crossref PubMed Scopus (10476) Google Scholar Outcomes of patients with lung cancer vary dramatically on the basis of stage, with a 5-year survival ranging from 73% for stage IA to 13% for stage IV.2Shepherd FA Crowley J Van Houtte P et al.The International Association for the Study of Lung Cancer lung cancer staging project: proposals regarding the clinical staging of small cell lung cancer in the forthcoming (seventh) edition of the tumor, node, metastasis classification for lung cancer.J Thorac Oncol. 2007; 2 (International Association for the Study of Lung Cancer International Staging Committee and Participating Institutions): 1067-1077Abstract Full Text Full Text PDF PubMed Scopus (458) Google Scholar Therefore, accurate staging of lung cancer plays an essential role in patient management, dictating the optimal treatment or combination of treatments with surgery, chemotherapy, or radiation therapy. Of particular interest for precise staging is the determination of metastatic involvement in mediastinal lymph nodes. Although radiographic imaging can be helpful, it suffers from low sensitivity (chest CT scan) or low specificity (PET scan).3Silvestri GA Gonzalez AV Jantz MA et al.Methods for staging non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines.Chest. 2013; 143: e211S-e250SAbstract Full Text Full Text PDF PubMed Scopus (1057) Google Scholar Tissue sampling remains the most accurate method to make this determination, following the cliché “tissue is the issue.” Mediastinoscopy has been the standard approach to mediastinal tissue biopsy for decades, but more recently, newer ultrasonographic endoscopic technology has emerged as a sensitive and less invasive mediastinal sampling approach. This technology includes endobronchial ultrasound (EBUS) and esophageal ultrasound (EUS) used separately or in combination. In this point editorial, we argue that EBUS- and EUS-guided transbronchial needle aspiration of the mediastinum should be the preferred first approach to mediastinal staging in lung cancer over cervical mediastinoscopy (CM) because of their high sensitivity, low morbidity, and reduced cost. A number of prospective trials have been performed with the primary goal of comparing the efficacy of CM and endoscopic ultrasonography in mediastinal staging. A study of patients with suspected non-small cell lung cancer and enlarged mediastinal lymph nodes (≥ 10 mm on chest CT scan) found EBUS-guided transbronchial needle aspiration (EBUS-TBNA) to have a higher sensitivity and negative predictive value than CM (87% and 78% vs 68% and 59%, respectively)4Ernst A Anantham D Eberhardt R Krasnik M Herth FJ Diagnosis of mediastinal adenopathy-real-time endobronchial ultrasound guided needle aspiration versus mediastinoscopy.J Thorac Oncol. 2008; 3: 577-582Abstract Full Text Full Text PDF PubMed Scopus (287) Google Scholar; this study has been criticized for selecting patients with radiographically enlarged lymph nodes (size > 1 cm). A second trial found similar results for both EBUS-TBNA and CM in sensitivity and negative predictive values (81% and 93% vs 79% and 93%, respectively) and no significant difference in determining the true pathologic N stage.5Yasufuku K Pierre A Darling G et al.A prospective controlled trial of endobronchial ultrasound-guided transbronchial needle aspiration compared with mediastinoscopy for mediastinal lymph node staging of lung cancer.J Thorac Cardiovasc Surg. 2011; 142: 1393-1400Abstract Full Text Full Text PDF PubMed Scopus (425) Google Scholar The most robust data come from a study by Annema et al,6Annema JT van Meerbeeck JP Rintoul RC et al.Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial.JAMA. 2010; 304: 2245-2252Crossref PubMed Scopus (502) Google Scholar which randomized patients to either CM or endosonography (EBUS-TBNA and EUS-guided fine needle aspiration) followed by CM in case no nodal metastases were found on endosonography. When lymph nodes were found to be normal by either approach, thoracotomy with lymph node dissection was performed. The study found a diagnostic sensitivity of 79% for endosonography, 85% for CM, and 94% for endosonography followed by CM and recommended the latter combined strategy as the best staging approach. In line with the findings of these studies, the American College of Chest Physicians lung cancer guidelines3Silvestri GA Gonzalez AV Jantz MA et al.Methods for staging non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines.Chest. 2013; 143: e211S-e250SAbstract Full Text Full Text PDF PubMed Scopus (1057) Google Scholar recommends ultrasound-guided needle techniques as the best first test over surgical staging in patients with a high suspicion of mediastinal involvement (grade 1B). Although the rates of morbidity and mortality for mediastinoscopy are low (2% and 0.08%, respectively), the complications can be significant, particularly injury to vascular and mediastinal structures.3Silvestri GA Gonzalez AV Jantz MA et al.Methods for staging non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines.Chest. 2013; 143: e211S-e250SAbstract Full Text Full Text PDF PubMed Scopus (1057) Google Scholar, 7Hammoud ZT Anderson RC Meyers BF et al.The current role of mediastinoscopy in the evaluation of thoracic disease.J Thorac Cardiovasc Surg. 1999; 118: 894-899Abstract Full Text Full Text PDF PubMed Scopus (270) Google Scholar On the other hand, complications from EBUS-TBNA are extremely rare. A meta-analysis of 11 studies involving 1,299 patients undergoing EBUS-TBNA revealed a complication rate of 0.15% (occurring in two patients: one with a pneumothorax and the other with self-limited hypoxemia).8Gu P Zhao YZ Jiang LY Zhang W Xin Y Han BH Endobronchial ultrasound-guided transbronchial needle aspiration for staging of lung cancer: a systematic review and meta-analysis.Eur J Cancer. 2009; 45: 1389-1396Abstract Full Text Full Text PDF PubMed Scopus (516) Google Scholar A few case reports highlighted the potential for infectious complications after EBUS-TBNA, including mediastinal abscess and mediastinitis.9Gochi F Chen F Aoyama A Date H Mediastinal infectious complication after endobronchial ultrasound-guided transbronchial needle aspiration.Interact Cardiovasc Thorac Surg. 2013; 17: 751-752Crossref PubMed Scopus (23) Google Scholar, 10Moffatt-Bruce SD Ross Jr, P Mediastinal abscess after endobronchial ultrasound with transbronchial needle aspiration: a case report.J Cardiothorac Surg. 2010; 5: 33Crossref PubMed Scopus (48) Google Scholar, 11Parker KL Bizekis CS Zervos MD Severe mediastinal infection with abscess formation after endobronchial ultrasound-guided transbrochial needle aspiration.Ann Thorac Surg. 2010; 89: 1271-1272Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar Only one case of death following EBUS-TBNA was reported in a patient with thrombocytopenia, prolonged coagulation tests, and renal and hepatic dysfunction; hemoptysis developed after the procedure, and the patient was not resuscitated due to family wishes.12Miller DR Mydin HH Marshall AD Devereux GS Currie GP Fatal haemorrhage following endobronchial ultrasound-transbronchial needle aspiration: an unfortunate first.QJM. 2013; 106: 295-296Crossref PubMed Scopus (19) Google Scholar Several economic analyses have found EBUS alone or EBUS/EUS to be more cost-effective than mediastinoscopy in the diagnosis and staging of lung cancer.13Ang SY Tan RW Koh MS Lim J Economic analysis of endobronchial ultrasound (EBUS) as a tool in the diagnosis and staging of lung cancer in Singapore.Int J Technol Assess Health Care. 2010; 26: 170-174Crossref PubMed Scopus (17) Google Scholar, 14Harewood GC Pascual J Raimondo M et al.Economic analysis of combined endoscopic and endobronchial ultrasound in the evaluation of patients with suspected non-small cell lung cancer.Lung Cancer. 2010; 67: 366-371Abstract Full Text Full Text PDF PubMed Scopus (58) Google Scholar, 15Sharples LD Jackson C Wheaton E et al.Clinical effectiveness and cost-effectiveness of endobronchial and endoscopic ultrasound relative to surgical staging in potentially resectable lung cancer: results from the ASTER randomised controlled trial.Health Technol Assess. 2012; 16: 1-75Crossref PubMed Scopus (104) Google Scholar, 16Steinfort DP Liew D Conron M Hutchinson AF Irving LB Cost-benefit of minimally invasive staging of non-small cell lung cancer: a decision tree sensitivity analysis.J Thorac Oncol. 2010; 5: 1564-1570Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar Earlier criticism of the data pointed to the lack of inclusion of the cost of mediastinoscopies performed to confirm the normal results of ultrasound-based sampling. Researchers listened and included the cost in two subsequent studies. An Australian study compared real costs derived from actual patient data at a major teaching hospital and demonstrated that EBUS-TBNA (with normal results being surgically confirmed) to be the most cost-beneficial approach (AU$2,961) compared with EBUS-TBNA alone (normal results not being surgically confirmed, AU$3,344) and mediastinoscopy (AU$8,859).16Steinfort DP Liew D Conron M Hutchinson AF Irving LB Cost-benefit of minimally invasive staging of non-small cell lung cancer: a decision tree sensitivity analysis.J Thorac Oncol. 2010; 5: 1564-1570Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar A UK cost-effectiveness study showed that the 6-month cost of the endosonography strategy (followed by CM if results were normal) was £9,713 vs £10,459 for the surgical approach, with savings related primarily to the reduction of the number of unnecessary thoracotomies.15Sharples LD Jackson C Wheaton E et al.Clinical effectiveness and cost-effectiveness of endobronchial and endoscopic ultrasound relative to surgical staging in potentially resectable lung cancer: results from the ASTER randomised controlled trial.Health Technol Assess. 2012; 16: 1-75Crossref PubMed Scopus (104) Google Scholar In an era of ever-changing health-care delivery models and the advent of high-value care and bundled payments, these findings cannot be overlooked. In summary, ultrasonographic endoscopy has emerged as the preferred modality for the staging of lung cancer because it is equally sensitive to mediastinoscopy yet is safer and cheaper. This statement should be qualified by emphasizing that a normal result from EBUS or EUS should not be presumed to be truly normal, and surgical sampling should ensue in these situations. Following this approach, the majority of patients with suspected lung cancer would be adequately staged, and only a handful would need mediastinoscopy. The data are robust and now endorsed by rigorously performed evidence-based societal guidelines, such as the American College of Chest Physicians lung cancer guidelines. It is time to embrace this approach and to overcome the comfort of our old ways. Learning and mastering ultrasonographic endoscopy for staging lung cancer should be part of the armamentarium of pulmonologists and thoracic surgeons who participate in the multidisciplinary care of patients with lung cancer. Our tools should conform to patient needs and not vice versa. John F. Kennedy once said, “Change is the law of life. And those who look only to the past or present are certain to miss the future.”17http://www.jfklibrary.org/Research/Research-Aids/Ready-Reference/JFK-Quotations.aspx#CGoogle Scholar
Endobronchial valve (EBV) therapy may be associated with improvements in chronic obstructive pulmonary disease-related outcomes and may therefore be linked to improvements in the body mass index, airflow obstruction, dyspnoea, exercise capacity (BODE) index.Data from 416 patients with advanced emphysema and hyperinflation across Europe and USA, who were randomised to EBV (n=284) or conservative therapy (n=132) were analysed. Quantitative image analysis was used to compare the volume of the targeted lobe at baseline and at 6 months to determine target lobe volume reduction (TLVR).44% of patients receiving EBV therapy (versus24.7% of controls) had clinically significant improvements in the BODE index (p<0.001). BODE index was significantly reduced by mean±sd1.4±1.8, 0.2±1.3 and 0.1±1.3 points in patients with TLVR >50%, 20%–50% and <20%, respectively (intergroup differences p<0.001), but increased by 0.3±1.2 points in controls. Changes in BODE were predicted by baseline BODE and correlated significantly with lobar exclusion and lung volumes at 6 months.A greater proportion of patients in the treatment group than in the control group achieved a clinically meaningful improvement in BODE index; however, the likelihood of benefit was less than half in both groups. Patients in whom TLVR was obtained had greater improvements in clinical outcomes.
BACKGROUND Prior to the 1980s, permanent feeding tube placement was limited to an open surgical procedure until Gauderer and colleagues described the safe placement of percutaneous endoscopic gastrostomy (PEG) tubes. This procedure has since expanded beyond the realm of surgeons to include gastroenterologists, thoracic surgeons, and interventional radiologists. In some academic centers, interventional pulmonologists (IPs) also perform this procedure. We describe the safety and feasibility of PEG tube placement by IPs in a critically ill population. METHODS Prospectively collected data of patients in a medical ICU undergoing PEG tube placement from 2003 to 2007 at a tertiary-care center were reviewed. Inclusion criteria included all PEG tube insertions performed or attempted by the IP team. Data were collected on mortality, PEG tube removal rate, total number of days with PEG tube, and complication rates. Follow-up included hospital length of stay and phone contact after discharge. Procedural and long-term PEG-related complications were recorded. RESULTS Seventy-two patients were studied. PEG tube insertion was completed successfully in 70 (97.2%), with follow-up data in 69 of these 70. Thirty-day mortality was 11.7%. No deaths or immediate complications were attributed to PEG tube placement. PEG tube removal occurred in 27 patients, with a median time to removal of 76 days. CONCLUSIONS Bedside PEG tube placement can be performed safely and effectively by trained IPs. Because percutaneous tracheostomy is currently performed by IPs, the ability to place both PEG and tracheostomy tubes at the same time has the potential for decreased costs, anesthesia exposure, procedural times, ventilator times, and ICU days.
BackgroundEndobronchial 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.MethodsWe 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.ResultsA 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).ConclusionsThere 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.