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One of the characteristics of severe emphysema is hyperinflation of regions of the lungs. In this trial, valves that prevented air entry but allowed air to escape were placed in lobar airways. Patients receiving endobronchial valves had modest improvements in lung function and exercise performance. Emphysema is a leading cause of disability and death. Lung-volume–reduction surgery, in which selected areas of hyperinflated lungs are resected, improves exercise tolerance and prolongs life in selected patients. However, concern regarding the risk of perioperative death and complications contributes to underutilization. 1 – 4 Less invasive bronchoscopic techniques that are based on the presumed physiological effects of lung-volume–reduction surgery have been developed. 5 – 10 Early uncontrolled trials using unidirectional valves placed in selected lung airways to block regional inflation while allowing exhalation have reported improvements in lung function and symptoms with modest risk, including distal pneumonia or pneumothorax. 5 , 6 , 9 , 11 – . . .

The efficacy of α1 proteinase inhibitor (A1PI) augmentation treatment for α1 antitrypsin deficiency has not been substantiated by a randomised, placebo-controlled trial. CT-measured lung density is a more sensitive measure of disease progression in α1 antitrypsin deficiency emphysema than spirometry is, so we aimed to assess the efficacy of augmentation treatment with this measure. The RAPID study was a multicentre, double-blind, randomised, parallel-group, placebo-controlled trial of A1PI treatment in patients with α1 antitrypsin deficiency. We recruited eligible non-smokers (aged 18–65 years) in 28 international study centres in 13 countries if they had severe α1 antitrypsin deficiency (serum concentration <11 μM) with a forced expiratory volume in 1 s of 35–70% (predicted). We excluded patients if they had undergone, or were on the waiting list to undergo, lung transplantation, lobectomy, or lung volume-reduction surgery, or had selective IgA deficiency. We randomly assigned patients (1:1; done by Accovion) using a computerised pseudorandom number generator (block size of four) with centre stratification to receive A1PI intravenously 60 mg/kg per week or placebo for 24 months. All patients and study investigators (including those assessing outcomes) were unaware of treatment allocation throughout the study. Primary endpoints were CT lung density at total lung capacity (TLC) and functional residual capacity (FRC) combined, and the two separately, at 0, 3, 12, 21, and 24 months, analysed by modified intention to treat (patients needed at least one evaluable lung density measurement). This study is registered with ClinicalTrials.gov, number NCT00261833. A 2-year open-label extension study was also completed (NCT00670007). Between March 1, 2006, and Nov 3, 2010, we randomly allocated 93 (52%) patients A1PI and 87 (48%) placebo, analysing 92 in the A1PI group and 85 in the placebo group. The annual rate of lung density loss at TLC and FRC combined did not differ between groups (A1PI −1·50 g/L per year [SE 0·22]; placebo −2·12 g/L per year [0·24]; difference 0·62 g/L per year [95% CI −0·02 to 1·26], p=0·06). However, the annual rate of lung density loss at TLC alone was significantly less in patients in the A1PI group (−1·45 g/L per year [SE 0·23]) than in the placebo group (−2·19 g/L per year [0·25]; difference 0·74 g/L per year [95% CI 0·06–1·42], p=0·03), but was not at FRC alone (A1PI −1·54 g/L per year [0·24]; placebo −2·02 g/L per year [0·26]; difference 0·48 g/L per year [–0·22 to 1·18], p=0·18). Treatment-emergent adverse events were similar between groups, with 1298 occurring in 92 (99%) patients in the A1PI group and 1068 occuring in 86 (99%) in the placebo group. 71 severe treatment-emergent adverse events occurred in 25 (27%) patients in the A1PI group and 58 occurred in 27 (31%) in the placebo group. One treatment-emergent adverse event leading to withdrawal from the study occurred in one patient (1%) in the A1PI group and ten occurred in four (5%) in the placebo group. One death occurred in the A1PI group (respiratory failure) and three occurred in the placebo group (sepsis, pneumonia, and metastatic breast cancer). Measurement of lung density with CT at TLC alone provides evidence that purified A1PI augmentation slows progression of emphysema, a finding that could not be substantiated by lung density measurement at FRC alone or by the two measurements combined. These findings should prompt consideration of augmentation treatment to preserve lung parenchyma in individuals with emphysema secondary to severe α1 antitrypsin deficiency. CSL Behring.

Endobronchial valves (EBVs) have been successfully used in patients with severe heterogeneous emphysema to improve lung physiology. Limited available data suggest that EBVs are also effective in homogeneous emphysema. To evaluate the efficacy and safety of EBVs in patients with homogeneous emphysema with absence of collateral ventilation assessed with the Chartis system. Prospective, multicenter, 1:1 randomized controlled trial of EBV plus standard of care (SoC) or SoC alone. Primary outcome was the percentage change in FEV (liters) at 3 months relative to baseline in the EBV group versus the SoC group. Secondary outcomes included changes in FEV , St. George's Respiratory Questionnaire (SGRQ), 6-minute-walk distance (6MWD), and target lobe volume reduction. Ninety-three subjects (age, 63.7 ± 6.1 yr [mean ± SD]; FEV , % predicted, 29.3 ± 6.5; residual volume, % predicted, 275.4 ± 59.4) were allocated to either the EBV group (n = 43) or the SoC group (n = 50). In the intention-to-treat population, at 3 months postprocedure, improvement in FEV from baseline was 13.7 ± 28.2% in the EBV group and -3.2 ± 13.0% in the SoC group (mean between-group difference, 17.0%; P = 0.0002). Other variables demonstrated statistically and clinically significant changes from baseline to 3 months (EBV vs. SoC, respectively: SGRQ, -8.63 ± 11.25 vs. 1.01 ± 9.36; and 6MWD, 22.63 ± 66.63 m vs. -17.34 ± 52.8 m). Target lobe volume reduction at 3 months was -1,195 ± 683 ml (P < 0.0001). Of the EBV subjects, 97.2% achieved volume reduction in the target lobe (P < 0.0001). Procedure-related pneumothoraces occurred in 11 subjects (25.6%). Five subjects required removal/replacement of one or more valves. One subject experienced two valve migration events requiring removal/replacement of valves. EBV in patients with homogeneous emphysema without collateral ventilation results in clinically meaningful benefits of improved lung function, exercise tolerance, and quality of life.

Lung volume reduction surgery improves survival in selected patients with emphysema, and has generated interest in bronchoscopic approaches that might achieve the same effect with less morbidity and mortality. Previous trials with endobronchial valves have yielded modest group benefits because when collateral ventilation is present it prevents lobar atelectasis. We did a single-centre, double-blind sham-controlled trial in patients with both heterogeneous emphysema and a target lobe with intact interlobar fissures on CT of the thorax. We enrolled stable outpatients with chronic obstructive pulmonary disease who had a forced expiratory volume in 1 s (FEV1) of less than 50% predicted, significant hyperinflation (total lung capacity >100% and residual volume >150%), a restricted exercise capacity (6 min walking distance <450 m), and substantial breathlessness (MRC dyspnoea score ≥3). Participants were randomised (1:1) by computer-generated sequence to receive either valves placed to achieve unilateral lobar occlusion (bronchoscopic lung volume reduction) or a bronchoscopy with sham valve placement (control). Patients and researchers were masked to treatment allocation. The study was powered to detect a 15% improvement in the primary endpoint, the FEV1 3 months after the procedure. Analysis was on an intention-to-treat basis. The trial is registered at controlled-trials.com, ISRCTN04761234. 50 patients (62% male, FEV1 [% predicted] mean 31·7% [SD 10·2]) were enrolled to receive valves (n=25) or sham valve placement (control, n=25) between March 1, 2012, and Sept 30, 2013. In the bronchoscopic lung volume reduction group, FEV1 increased by a median 8·77% (IQR 2·27–35·85) versus 2·88% (0–8·51) in the control group (Mann-Whitney p=0·0326). There were two deaths in the bronchoscopic lung volume reduction group and one control patient was unable to attend for follow-up assessment because of a prolonged pneumothorax. Unilateral lobar occlusion with endobronchial valves in patients with heterogeneous emphysema and intact interlobar fissures produces significant improvements in lung function. There is a risk of significant complications and further trials are needed that compare valve placement with lung volume reduction surgery. Efficacy and Mechanism Evaluation Programme, funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.

BackgroundLung perfusion scan is widely undertaken as part of the assessment to select most affected lobes by emphysema prior to lung volume reduction (LVR) therapies by endo-bronchial valves, endo-bronchial coils and LVR surgery. More recently quantitative CT scans (QCT) have been introduced. QCTs quantify the degree of lung destruction by emphysema. To date there are no studies to evaluate whether lobar uptake of isotope by perfusion scan and areas of destruction on QCT’s are closely correlated.MethodsPatients referred for LVR therapies at our hospital underwent perfusion scans using single-photon emission computerised tomography (SPECT) scans. The degree of uptake of isotope in each lobe is visually scored from 0–10, 0 representing low lobar isotope uptake and 10 high uptake. The degree of lobar low attenuation area (emphysema) has been assessed by a QCT scan. This scan provided data on the proportion of each lobe with attenuation of −910 Hounsfield Units (HU) and −950 HU. Uptake on SPECT has been correlated with emphysema score on QCTs.ResultsA total 47 patients are included (20 female). Their mean age 66.2 years, and mean FEV1 30% of predicted values. Analysis by QCT and SPECT is available on 235 lung lobes. For all lung lobes, mean low attenuation at −910 HU was 53.7% and at −950 HU of 36.9%. Median Score on SPECT was 5.3 points. A weak correlation between uptake score on SPECT and QCT scores; Spearman r=-0.33, p<0.0001 for emphysema area at −910 HU and r=-0.33, p<0.001 for emphysema area at −950 HU. Significant discordance is present between the two methods (graph.1) which could lead to either treating lobes with low perfusion but preserved lung tissue or not treating lobes with high perfusion but with significant emphysema.Abstract P194 Figure 1ConclusionDespite the wide usage of perfusion scan to guide identification of lung lobes targeted for LVR, this study shows that this method needs to be interpreted with caution. QCT’s should be relied upon to choose lobes needing treatment. Longitudinal analysis is needed to evaluate the outcome of treatment when the treated lobe was selected according to low perfusion.

Patients with severe emphysema and no collateral ventilation were assigned to receive endobronchial valves or standard care. Despite valve removal in a third of the patients, an intention-to-treat analysis showed improved function and reduced symptoms in patients who received valves. Bronchoscopic lung-volume reduction with the use of one-way endobronchial valves has emerged as a potential treatment for patients with severe emphysema. This treatment was previously investigated in the randomized, controlled Endobronchial Valve for Emphysema Palliation Trial (VENT), 1 which showed significant but moderate improvements in forced expiratory volume in 1 second (FEV 1 ): an increase from baseline of 4.3% (95% confidence interval [CI], 1.4 to 7.2). Post hoc analyses of the VENT data suggested that endobronchial-valve treatment might be more effective in patients who had a complete fissure (as compared with an incomplete fissure) between the lobe that was targeted . . .

Pulmonary emphysema results from the destruction of air spaces, with a loss of elastic recoil of the lungs and alveolar capillary surface for gas exchange. In this study, lung-volume–reduction surgery was compared with medical management of emphysema. Surgery had no overall effect on mortality from emphysema. There were identifiable subgroups of patients for whom surgery had either a beneficial or an adverse effect on outcomes. Surgery had no overall effect on mortality. Lung-volume–reduction surgery has been proposed as a palliative treatment for patients with severe emphysema. 1 – 8 Uncertainty about morbidity and mortality; the occurrence, magnitude, and duration of benefit; and preoperative predictors of benefit led us to conduct a federally sponsored, multicenter, randomized clinical trial, the National Emphysema Treatment Trial (NETT). 9 The primary outcomes for the trial were mortality and maximal exercise capacity two years after randomization. Secondary outcomes included the distance walked in six minutes, pulmonary function, quality of life, and degree of dyspnea. An important goal of the trial was to identify patient-selection criteria for lung-volume–reduction surgery. Criteria for inclusion . . .

for the COPDGene Investigators Rationale: Over the last decade concerns about increased cancer risk from medical radiation exposure have motivated technological advances enabling reduced dose CT imaging. The purpose of this work is to compare quantitative measures of emphysema calculated from reduced dose CT, with and without iterative reconstruction, with those computed using an earlier, higher dose protocol.

Case Presentation: A 64-year-old man with a history of chronic obstructive pulmonary disease, and rheumatoid arthritis (RA) presented to the Emergency Department (ED) with DSE of the face, chest, abdomen, and limbs. Discussion: In our case, the formation of BPF could be due to either inappropriate chest tube positioning or originated from the cavitary lung lesion, which by itself could be caused by an abscess formation, neoplastic or an autoimmune disease such as RA.