Endobronchial valves that allow air to escape from a pulmonary lobe but not enter it can induce a reduction in lobar volume that may thereby improve lung function and exercise tolerance in patients ...with pulmonary hyperinflation related to advanced emphysema.
We compared the safety and efficacy of endobronchial-valve therapy in patients with heterogeneous emphysema versus standard medical care. Efficacy end points were percent changes in the forced expiratory volume in 1 second (FEV1) and the 6-minute walk test on intention-to-treat analysis. We assessed safety on the basis of the rate of a composite of six major complications.
Of 321 enrolled patients, 220 were randomly assigned to receive endobronchial valves (EBV group) and 101 to receive standard medical care (control group). At 6 months, there was an increase of 4.3% in the FEV1 in the EBV group (an increase of 1.0 percentage point in the percent of the predicted value), as compared with a decrease of 2.5% in the control group (a decrease of 0.9 percentage point in the percent of the predicted value). Thus, there was a mean between-group difference of 6.8% in the FEV1 (P=0.005). Roughly similar between-group differences were observed for the 6-minute walk test. At 12 months, the rate of the complications composite was 10.3% in the EBV group versus 4.6% in the control group (P=0.17). At 90 days, in the EBV group, as compared with the control group, there were increased rates of exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization (7.9% vs. 1.1%, P=0.03) and hemoptysis (6.1% vs. 0%, P=0.01). The rate of pneumonia in the target lobe in the EBV group was 4.2% at 12 months. Greater radiographic evidence of emphysema heterogeneity and fissure completeness was associated with an enhanced response to treatment.
Endobronchial-valve treatment for advanced heterogeneous emphysema induced modest improvements in lung function, exercise tolerance, and symptoms at the cost of more frequent exacerbations of COPD, pneumonia, and hemoptysis after implantation. (Funded by Pulmonx; ClinicalTrials.gov number, NCT00129584.)
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) can reliably sample enlarged mediastinal lymph nodes in patients with non-small cell lung cancer (NSCLC), and in practice ...is mostly used to sample nodes visible on CT or positron emission tomography (PET). Few data are available on the use of endoscopic procedures to stage the mediastinum in clinical stage 1 lung cancer. The aim of the present study was to determine the results of EBUS-TBNA in sampling mediastinal lymph nodes in patients with lung cancer and a radiographically normal mediastinum and no PET activity.
From January 2004 to May 2007, patients highly suspicious for NSCLC with CT scans showing no enlarged lymph nodes (no node > 1 cm) and a negative PET finding of the mediastinum underwent EBUS-TBNA. Identifiable lymph nodes at locations 2r, 2L, 4r, 4L, 7, 10r, 10L, 11r, and 11L were aspirated. All patients underwent subsequent surgical staging. Diagnoses based on aspiration results were compared with those based on surgical results.
One hundred patients (mean age, 52.4 years; 59 men) were included. After surgery, 97 patients (mean age, 52.9 years; 57 men) had NSCLC confirmed and were included in the analysis. In this group, 156 lymph nodes ranging 5 to 10 mm in size were detected and sampled. Malignancy was detected in nine patients but missed in one patient. Mean diameter of the punctured lymph nodes was 7.9 mm. The sensitivity of EBUS-TBNA for detecting malignancy was 89%, specificity was 100%, and the negative predictive value was 98.9%. No complications occurred.
In conclusion, EBUS-TBNA can be used to accurately sample and stage patients with clinical stage 1 lung cancer and no evidence of mediastinal involvement on CT and PET. Potentially operable patients with no signs of mediastinal involvement may benefit from presurgical staging with EBUS-TBNA.
Electromagnetic navigation bronchoscopy (ENB) with biopsy under fluoroscopic guidance has enhanced the yield of flexible bronchoscopy in the diagnosis of peripheral lung lesions. However, the ...accuracy of ENB navigation suggests that the addition of fluoroscopy is redundant.
Data were prospectively collected to determine the yield of ENB without fluoroscopy in the diagnosis of peripheral lung lesions.
ENB was performed via flexible bronchoscopy (superDimension/Bronchus system; superDimension Inc; Plymouth, MN). Biopsy specimens were obtained through the extended working channel after navigation. Fluoroscopy was not utilized, but post-transbronchial biopsy chest radiographs were obtained to exclude pneumothorax. The primary end point was diagnostic yield, and the secondary end points were navigation accuracy, procedure duration, and safety. Analysis by lobar distribution was also performed to assess performance in different lobes of the lung.
Ninety-two peripheral lung lesions were biopsied in the 89 subjects. The diagnostic yield of ENB was 67%, which was independent of lesion size. Total procedure time ranged from 16.3 to 45.0 min (mean ± SD procedure time, 26.9 ± 6.5 min). The mean navigation error was 9 ± 6 mm (range, 1 to 31 mm). There were two incidences of pneumothorax for which no intervention was required. When analyzed by lobar distribution, there was a trend toward a higher ENB yield in diagnosing lesions in the right middle lobe (88%).
ENB can be used as a stand-alone bronchoscopic technique without compromising diagnostic yield or increasing the risk of pneumothorax. This may result in sizable timesaving and avoids radiation exposure.
Background The lung volume reduction coil (LVR-coil), a new experimental device to achieve lung volume reduction by bronchoscopy in patients with severe emphysema, works in a manner unaffected by ...collateral airflow. We investigated the safety and efficacy of LVR-coil treatment in patients with heterogeneous emphysema. Methods In this prospective cohort pilot study, patients were treated bronchoscopically with Nitinol LVR-coils under fluoroscopic guidance in either one procedure or two sequential procedures. Follow-up tests included the St. George Respiratory Questionnaire (SGRQ), pulmonary function testing, and the 6-min walk test (6MWT). Results Twenty-eight LVR-coil procedures were performed in 16 patients (baseline FEV1 , 28% ± 7.6% predicted). Four patients were treated in one lung, and 12 patients were treated in both lungs. A median of 10 (5–12) coils was placed per lung in 36.5 (20–60) min. Adverse events (AEs) rated as possibly related to either the device or the procedure < 30 days after treatment were pneumothorax (n = 1), pneumonia (n = 2), COPD exacerbation (n = 6), chest pain (n = 4), and mild (< 5 mL) hemoptysis (n = 21). From 30 days to 6 months, the AEs that occurred were pneumonia (n = 3) and COPD exacerbation (n = 14). All events resolved with standard care. Six months after LVR-coil treatment, there were significant improvements in SGRQ (−14.9 points ± 12.1 points, with 11 patients improving by > 4 points), FEV1 (+14.9% ± 17.0%), FVC (+13.4% ± 12.9%), residual volume (−11.4% ± 9.0%), and 6MWT (+84.4 ± 73.4 m), all P < .005. Conclusions LVR-coil treatment is a promising technique for the treatment of patients with severe heterogeneous emphysema. The treatment is technically feasible and results in significant improvements in pulmonary function, exercise capacity, and quality of life, with an acceptable safety profile. Trial registry ClinicalTrials.gov ; No.: NCT01220908 ; URL: www.clinicaltrials.gov
Pulmonary alveolar proteinosis (PAP) is a disease characterized by the deposition of amorphous lipoproteinaceous material
in the alveoli secondary to abnormal processing of surfactant by macrophages. ...Whole-lung lavage often is performed as the
first line of treatment for this disease because it is a means to wash out the proteinaceous material from the alveoli and
reestablish effective oxygenation and ventilation. Whole-lung lavage is a large-volume BAL that is performed mainly in the
treatment of PAP. In brief, it involves the induction of general anesthesia followed by isolation of the two lungs with a
double-lumen endotracheal tube and performance of single-lung ventilation while large-volume lavages are performed on the
nonventilated lung. Warmed normal saline solution in 1-L aliquots (total volumes up to 20 L) is instilled into the lung, chest
physiotherapy is performed, then the proteinaceous effluent is drained with the aid of postural positioning. The sequence
of events is repeated until such time as the effluent, which is initially milky and opaque, becomes clear. This procedure
results in significant clinical and radiographic improvement secondary to the washing out of the proteinaceous material from
the alveoli. The whole-lung lavage video details all aspects of the procedure, including case selection, patient preparation
and equipment, a step-by-step review of the procedure, and postoperative considerations.
To avoid reexpansion pulmonary edema (RPE), thoracenteses are often limited to draining no more than 1 L. There are, however, significant clinical benefits to removing more than 1 L of fluid. The ...purpose of this study was to define the incidence of RPE among patients undergoing large-volume (> or = 1 L) thoracentesis.
One hundred eighty-five patients undergoing large-volume thoracentesis were included in this study. The volume of fluid removed, absolute pleural pressure, pleural elastance, and symptoms during thoracentesis were compared in patients who did and did not experience RPE.
Of the 185 patients, 98 (53%) had between 1 L and 1.5 L withdrawn, 40 (22%) had between 1.5 L and 2 L withdrawn, 38 (20%) had between 2 L and 3 L withdrawn, and 9 (5%) had more than 3 L withdrawn. Only 1 patient (0.5%, 95% confidence interval: 0.01% to 3%) experienced clinical RPE. Four patients (2.2%, 95% confidence interval: 0.06% to 5.4%) had radiographic RPE (diagnosed only on postprocedure imaging without clinical symptoms). The incidence of RPE was not associated with the absolute change in pleural pressure, pleural elastance, or symptoms during thoracentesis.
Clinical and radiographic RPE after large-volume thoracentesis is rare and independent of the volume of fluid removed, pleural pressures, and pleural elastance. The recommendation to terminate thoracentesis after removing 1 L of fluid needs to be reconsidered: large effusions can, and should, be drained completely as long as chest discomfort or end-expiratory pleural pressure less than -20 cm H2O does not develop.
To investigate the sensitivity and accuracy of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for restaging the mediastinum after induction chemotherapy in patients with ...non-small-cell lung cancer (NSCLC).
One hundred twenty-four consecutive patients with tissue-proven stage IIIA-N2 disease who were treated with induction chemotherapy and who had undergone mediastinal restaging by EBUS-TBNA were reviewed. On the basis of computed tomography, 58 patients were classified as having stable disease and 66 were judged to have had a partial response. All patients subsequently underwent thoracotomy with attempted curative resection and a lymph node dissection regardless of EBUS-TBNA findings.
Persistent nodal metastases were detected by using EBUS-TBNA in 89 patients (72%). Of the 35 patients in whom no metastases were assessed by EBUS-TBNA, 28 were found to have residual stage IIIA-N2 disease at thoracotomy. The majority (91%) of these false negative results were due to nodal sampling error rather than detection error. Overall sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of EBUS-TBNA for mediastinal restaging after induction chemotherapy were 76%, 100%, 100%, 20%, and 77%, respectively.
EBUS-TBNA is a sensitive, specific, accurate, and minimally invasive test for mediastinal restaging of patients with NSCLC. However, because of the low negative predictive value, tumor-negative findings should be confirmed by surgical staging before thoracotomy.
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.
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.
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.
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.
Background Intrabronchial valve placement for endoscopic lung volume reduction is used for patients with severe lung emphysema. Different treatment approaches are unilateral valve placement with the ...goal of complete occlusion and subsequent atelectasis leading to true volume reduction vs bilateral partial closure aiming for redistribution of ventilation but avoiding atelectasis. In this prospective pilot trial, we compared the efficacy of these treatment approaches. Methods Patients with severe bilateral heterogeneous emphysema were randomized to two groups. In the first group, patients received unilateral valves aiming for total occlusion of one lobe. In the other group, valves were placed in two contralateral lobes with incomplete closure. In all cases, one-way valves were placed via a flexible bronchoscope. Patients were followed at 30 and 90 days, end points being change in pulmonary function tests (PFTs), 6-min walk distance (6MWD), and dyspnea score as measured by the modified Medical Research Council (mMRC) dyspnea score, as well as quality of life as measured by the St. George Respiratory Questionnaire (SGRQ). Results Twenty-two patients were treated in this study, 11 patients in each arm. At 30 days and 90 days, significant differences were seen in PFT and 6MWD, as well as in mMRC and SGRQ scores, in favor of unilateral treatment. At 90 days, FEV1 was improved by 21.4% ± 10.7% in this group, but not in the bilateral group (−0.03% ± 13.9%, P = .002). One patient in the unilateral group experienced a pneumothorax, and two patients in the bilateral group were treated for transient respiratory failure. Conclusions Unilateral intrabronchial valve placement with complete occlusion appears superior to bilateral partial occlusion. Trial registry ClinicalTrials.gov ; No.: NCT00995852; URL: www.clinicaltrials.gov