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Bronchoscopic lung volume reduction treatment with Zephyr one-way valves is an effective guideline-based treatment option for patients with severe emphysema and hyperinflation. However, in some cases the treatment response is less than anticipated or there might be a loss of initial treatment effect. Reasons for the lack of response can include incorrect assessment of collateral ventilation, improper valve placement, or patient related factors. Loss of initial benefit can be due to granulation tissue formation and subsequent valve dysfunction, or there may be side effects such as excessive coughing or infectious problems. Careful follow-up after treatment with valves is important and evaluation with a CT scan and/or bronchoscopy is helpful if there is no improvement after treatment or loss of initial benefit. This paper aims to describe the most important causes and provide a strategy of how to approach and manage these patients., Competing Interests: Declaration of competing interest PS declares consulting fees and educational fees. AV declares educational fees. GJC declares grants/contract, consulting fees, educational fees and participation on a DSMB. FJFH declares educational and consulting fees. DKH declares consulting fees and educational fees. AM declares consulting fees and educational fees. AC declares consulting fees and educational fees. MD declares consulting fees and support for attending meetings by GSK. JK declares consulting fees and educational fees. NS is a full-time employee of Pulmonx Corporation and declares stock options. DJS declares grants/contracts, consulting fees, educational fees and support for attending meetings. MP declares grants, consulting fees, educational fees, support for attending meetings and leadership or fiduciary roles. Regarding the consensus opinion meeting: PS, FJFH, RS, DH, RM, AM, RA, LK, AC, JK, DJS, and MP received travel and accommodation support and honoraria from Pulmonx. AV received an honorarium from Pulmonx. DEW, MD, GJC and TDK have no conflict., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Application of vapour ablation as a novel approach to lung volume reduction has positive effects in patients with severe emphysema. The BENTO study is a randomised, controlled, open, multicentre trial, to assess the effects of bronchoscopic thermal vapour ablation (BTVA) in the German healthcare system., Methods and Analysis: Patients with bilateral heterogeneous emphysema of the upper lobes in Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 3/4 will be enrolled in this trial and will receive either standard medical management alone (according to GOLD guidelines) or BTVA treatment with the InterVapor system together with standard medical management. Patients will be randomised in a 2:1 ratio (treatment group:control group). A total of 224 patients will be enrolled at 15 study sites. The primary endpoint is the change in patient-reported disease-specific quality of life, as measured by the St George's Respiratory Questionnaire for chronic obstructive pulmonary disease patients between randomisation and the 9-month follow-up visit. Secondary endpoints include adverse events, mortality, vital status, changes in lung function parameters, exercise capacity and other efficacy measures at 3, 9 and 12 months.The BENTO trial was commissioned by the German Federal Joint Committee, to demonstrate that this approach is an efficient and safe treatment option in the German healthcare system., Ethics and Dissemination: The protocol has been approved by the lead ethics committee in Germany (Ethics Committee of the Medical Faculty of Heidelberg) and until present also by the following ethics committees: Ethics Committee of the Medical Faculty of Duisburg-Essen, Ethics Committee of the Medical Faculty of Martin-Luther-University Halle-Wittenberg, Ethics Committee of the State Medical Association of Hessen, Ethics Commission of the State Office for Health and Social Affairs of the State of Berlin, Ethics Committee of the Medical Faculty of Greifswald. The results will be published in a peer-reviewed journal., Trial Registration Number: NCT05717192., Competing Interests: Competing interests: KK reports honoraria for lectures, presentations or educational events from AstraZeneca, streamed up and Berlin Chemie, lecturing honoraria with payments made to the institution from and CSL Behring and Olympus Medical and support for attending meetings and travel from Boston Scientific and AstraZeneca, all outside the submitted work. KD reports consulting fees from Bess, Lys Medical and PulmonX, honoraria or payment for lectures and presentations from bess, Boston Scientific, Böhringer I., Broncus Medical, Fujifilm, FreeFlow, Lys Medical, Morair, Medtech, Medtronic, Olympus, Storz, PulmonX and participation on a Data Safety Monitoring Board or Advisory Board for FujiFilm, bess, Lys Medical. RHH reports payment or honoraria for lectures and presentations from PulmonX. FH reports salary payments from IHF Ludwigshafen. TR reports salary payments from IHF Ludwigshafen. FJFH reports payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Pulmonx and Uptake Medical. JB reports grants or contracts from Gräfin Beatrice von Hardenberg Stiftung, consulting fees from Intuitive Surgical, Boehringer Ingelheim, Astra Zeneca and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Astra Zeneca, Boehringer Ingelheim, Berlin Chemie, Olympus and streamed up., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Patients with chronic obstructive pulmonary disease (COPD) often suffer from cachexia and malnutrition. Less is known about body composition and nutritional behaviour in patients with advanced COPD and pulmonary emphysema., Methods: We performed a single-center prospective analysis of patients with COPD GOLD III/IV. Metabolic parameters, dietary and exercise behavior, lung function, exercise capacity and body composition by bioelectrical impedance analysis (BIA) were analyzed. Patients with severe emphysema (emphysema index [EI] >20%) were compared to patients with mild emphysema (EI ≤ 20%)., Results: A total of 121 patients (45.5% female, mean age 64.8 ± 8.1 years, mean FEV 1 31.0 ± 8.6%, mean RV 234.7 ± 50.6%) were analyzed, of whom 14.1% were underweight. Only 5% of the patients substituted protein and only about 1/3 performed regular exercise training. BIA showed an unfavourable body composition: body fat ↑, ECM/BCM-index ↑, phase angle ↓ (5.0 ± 0.9°), cell percentage ↓, FFMI (fat-free mass index) ↓. The 94 patients with severe emphysema (mean EI 36.6 ± 8.5%) had lower body-mass-index (22.8 ± 4.3 vs. 31.1 ± 5.8 kg/m 2 , p < 0.001), FFMI, body weight and body fat, but did not differ significantly in the quality of body composition (e.g. phase angle). Their lipid and glucose metabolism were even better than in mild emphysema patients., Conclusion: The finding of significantly lower BMI but similar body composition and better metabolic status in severe emphysema patients needs further investigation. However, it should not distract from the necessity to implement dietary and exercise recommendations for advanced COPD patients., Competing Interests: Declaration of competing interest Christina Rott reports consultation fees outside the submitted work from Flee Flow Medical. Eldridge Limen and Katharina Kriegsmann report no conflicts of interest. Felix Herth reports no conflicts of interest regarding this work. Judith Brock has received honoraria and consultation fees from Boehringer Ingelheim, Astra Zeneca, streamed up!, Intuitive Surgical Inc, Berlin Chemie, Olympus. These activities are outside the submitted work. All authors confirm no conflicts of interest regarding this manuscript., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Patients with chronic obstructive pulmonary disease (COPD) and emphysema experience malnutrition and pulmonary cachexia. Endoscopic lung volume reduction (ELVR) with endobronchial valves has not only improved lung function, exercise capacity, and quality of life but also influenced body weight. Only a few data are available on body composition changes after ELVR., Methods: This single-center prospective study of patients with advanced COPD investigates body composition before and after endoscopic valve treatment using multifrequency bioelectrical impedance analysis (BIA). The following parameters were evaluated in addition to clinical data and routine tests: body weight, body mass index (BMI), basal metabolic rate, total body water, body fat, cell percentage, phase angle, intracellular water (ICW), extracellular water (ECW), extracellular mass (ECM), body cell mass (BCM), lean body mass (ECM + BCM), and fat-free mass index., Results: A total of 23 patients (mean emphysema index 37.2 ± 7.5%, BMI 23.4 ± 4.3 kg/m2) experienced improvements in lung function and exercise capacity with ELVR. Complete lobar atelectasis was achieved in 39.1% of participants. A non-statistically significant increase in body weight and BMI was observed after ELVR (p = 0.111 and p = 0.102). BIA measurement revealed a worsening of phase angle, cell percentage and ECM/BCM and thus of body composition, but without statistical significance. This is mainly due to a statistically significant increase in ECM, ECW, and ICW (all p &lt; 0.001)., Conclusion: ELVR demonstrated no beneficial changes in body composition, although patients tend to gain weight. A larger cohort is warranted to confirm these findings., (© 2024 S. Karger AG, Basel.)

Background and Objective: Exacerbations drive the progression of chronic obstructive pulmonary disease (COPD). Endoscopic lung volume reduction (ELVR) with valves is an established treatment option for patients with severe emphysema. Post-interventional exacerbations are observed in 8-17% of cases. Whether the exacerbation rate changes in the medium term after ELVR, is not known., Methods: This is a single-center retrospective analysis of severe emphysema patients with endobronchial valve implantation. The number of exacerbations before and after ELVR was compared, including lung function parameters, exercise capacity and degree of lung volume reduction. The primary endpoint of the study was the number of exacerbations one year after ELVR compared to one year before ELVR., Results: 129 patients (mean age 64.1 ± 7.7 years, 57% female, mean FEV 1 0.8 ± 0.2 l, mean RV 243.4 ± 54.9 %) with ELVR in the years 2016-2019 and complete exacerbation history were analyzed. Patients experienced a mean of 2.5 ± 2.2 moderate and severe exacerbations in the year before ELVR. The number of exacerbations decreased significantly to 1.8 ± 2.2 exacerbations in the first year after ELVR (p = 0.009). The decrease in exacerbation rate was associated with the development of complete lobar atelectasis (r = 0.228. p = 0.009). Accordingly, in 41 patients with complete lobar atelectasis, the decrease in exacerbation rate was higher from 2.8 ± 2.0 to 1.4 ± 1.8 exacerbations (p < 0.001)., Conclusions: ELVR with valves appears promising to reduce the exacerbation rate in COPD patients, especially when the full treatment benefit of complete lobar atelectasis is achieved., Competing Interests: Declaration of competing interest There is no conflict of interest., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Purpose: Up to 41% of patients with endobronchial valve implantation need revision bronchoscopies and valve replacements most likely due to valve dysfunction or lack of benefit. So far, no data is available whether valve replacements lead to the desired lobar volume reduction and therapy benefit., Patients and Methods: We conducted a single-center retrospective analysis of patients with endobronchial valve implantation and at least one valve replacement. Indications and number of revision bronchoscopies and valve replacements were evaluated. Therapy benefit regarding lung function and exercise capacity as well as development of complete lobar atelectasis was investigated and possible predictors identified., Results: We identified 73 patients with 1-12 revision bronchoscopies and 1-5 valve replacements. The main indication for revision bronchoscopy in this group was lack of therapy benefit (44.2%). Lung function and exercise capacity showed improvements in about one-third of patients even years after the initial implantation. A total of 26% of all patients showed a complete lobar atelectasis at the end of the observation period, 56.2% had developed lung volume reduction. The logistic regression revealed the development of a previous complete lobar atelectasis as predictor for a complete lobar atelectasis at final follow-up. Oral cortisone long-term therapy was also shown as predictive factor. The probability for a final complete lobar atelectasis was 69.2% if a lobar atelectasis had developed before., Conclusion: Valve replacements are more likely to be beneficial in patients who develop a re-aeration of a previous lobar atelectasis following valve implantation. Every decision for revision bronchoscopy must be taken carefully., Competing Interests: Judith Brock has received honoraria and consultation fees from Boehringer Ingelheim, Astra Zeneca, streamed up!, Intuitive Surgical Inc, Berlin Chemie, outside the submitted work. Paul Ulrich Schuster, Felix Böhmker, and Nicola Benjamin have no conflicts of interest to report for this work. Prof. Dr. Ralf Eberhardt reports honoraria or payment for lectures and presentations from Broncus, Olympus, Pentax, Pulmonx, Astra Zeneca. He joins the data safety monitoring board for Intuitive Surgical Inc, outside the submitted work. Prof. Dr. Daniela Gompelmann reports fees for lectures and travel from Pulmonx, Chiesi, Boehringer Ingelheim, Astra Zeneca, Berlin Chemie, Erbe, Novartis, Olympus, outside the submitted work. Konstantina Kontogianni has received honoraria for lectures from Berlin-Chemie, Astra Zeneca and Boston Scientific, outside the submitted work. Franziska Trudzinski has received honoraria for lectures from Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Novartis, CSL Behring. She participates in an Advisory Board for CSL Behring, GlaxoSmithKline and Boehringer Ingelheim, outside the submitted work. Felix Herth reports Research Support from Olympus Medical, Pulmonx, Broncus, Uptake Medical, Roche Diagnostics, BMBF, DFG, EU, Klaus-Tschira Stiftung, BMG; Lecturing honoraria from Pulmonx, Uptake Medical, Roche Diagnostics, Astra Zeneca, Boehringer Ingelheim, Novartis, Berlin Chemie, Chiesi, Medupdate, Erbe, GSK and consulting activities for Olympus Medical, Pulmonx, Broncus – Uptake Medical, Roche Diagnostics, Astra Zeneca, J&J, Karger, LÄK, Boston Scientific, Dinova, Nanovation, Free Flow Medical, Erbe, outside the submitted work., (© 2023 Brock et al.)

Endoscopic lung volume reduction procedure with valves is a well-studied treatment option for advanced lung emphysema to target lung hyperinflation in carefully selected patients with COPD. Before valve implantation, collateral ventilation (CV) of the target lobe needs to be assessed to obtain an optimal treatment effect. The analysis of CV according to current standards occurs via an in vivo assessment with the Chartis®system (PulmonX Inc., Redwood City, CA, USA) and a computed tomography (CT) scan of the thorax with interlobar fissure analysis. The focus of this review is to provide detailed information about the Chartis®procedure and interpretation of Chartis® phenotypes. As a main tool in the assessment of CV and being a safe procedure, the Chartis® assessment should be performed by default to confirm interlobar fissure analysis in most emphysema patients. Based on the obtained results, lung volume reduction therapy options should be discussed in an interdisciplinary emphysema conference., (© 2023 S. Karger AG, Basel.)

Introduction: Treatment with AeriSeal is an alternate treatment option to achieve lung volume reduction in patients with severe COPD and emphysema who are not eligible for valve treatment. This study aimed to assess the safety and mode of action of a modified staged treatment algorithm with a staged treatment with lower dose of AeriSeal., Methods: We performed a prospective, multicenter feasibility study. AeriSeal was administered during two sequential bronchoscopies: 2 subsegments of a lobe treated with two 5 mL doses, followed by two 10 mL doses in a contralateral lobe after 6 weeks., Results: A total of 14 patients (36% male, mean FEV 1 28.4% ± 6.7% of predicted) were enrolled. Ten patients completed both treatments, four were treated unilaterally. AeriSeal treatment resulted in significant TLVR (median 220.5 mL) at 3 months follow up. There were no significant changes from baseline at 12 months in lung function, exercise capacity and quality of life. During the 3-month post-treatment period, respiratory SAEs included 5 COPD exacerbations in 4 (28.6%) subjects, post-treatment acute inflammatory response (PAIR) in 2 (14.3%) subjects, and 1 respiratory failure event in 1 (7.1%) subject., Conclusion: The staged and lower dosed administration of AeriSeal does not impact the overall safety profile in terms of reducing the type and frequency of respiratory SAEs previously reported for a single-stage treatment. A larger volume of AeriSeal than used in this study may be necessary to provide meaningful clinical benefits., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Aims and Objectives: Many patients with chronic obstructive lung disease suffer from emphysema. Valve implantation may be a reasonable method in patients presenting advanced emphysema and absent interlobar collateral ventilation (CV). However, other clinical parameters influencing the effectiveness of endoscopic lung volume reduction (ELVR) are not well known., Methods: COPD patients with advanced emphysema who received valve implantation in 2016 were retrospectively analyzed. The following characteristics were collected prior to valve implantation: age, sex, body mass index, presence of allergies, use of inhaled corticosteroids (ICS), lung function parameters, diffusion capacity, 6-minute walk distance (6-MWD), blood gases, COHb, smoking history, and emphysema index (quantitative multi-detector computed tomography). Three months following valve implantation, lung function parameters, diffusion capacity, 6-MWD and blood gases were measured. In this analysis, we evaluated the impact of these variables on an increase in FEV 1 and 6-MWT as well as a decrease in RV three months after valve implantation., Results: Overall, 77 COPD patients (57% male, mean age 66, mean FEV 1 32%, mean RV 259%) who underwent valve therapy were enrolled. At 3-month follow-up, patients experienced a mean FEV 1 increase of 0.09 ± 0.21 L, a mean RV decrease of 0.42 ± 1.80 L and a mean improvement of 8.3 ± 57 m in the 6-MWT. Overall, ICS, sex and emphysema index had an impact on the outcome following ELVR: ICS medication was associated with inferior FEV 1 outcome. The higher the emphysema index, the less the RV reduction. Sex was a predictor for change of FEV 1 (%), RV (L), and 6-MWT: male patients seem to benefit less than female patients from valve implantation., Conclusion: These findings suggest that ICS, emphysema index and sex are clinical parameters that may be associated with inferior outcome following ELVR. Further studies have to confirm these results to improve patient selection and clinical outcome of ELVR., Competing Interests: Prof. Dr. Ralf Eberhardt reports personal fees from Olympus and Pulmonx, outside the submitted work. Prof. Dr. Daniela Gompelmann reports personal fees from Pulmonx, Olympus, Böhringer Ingelheim, Novartis, Chiesi, Astra Zeneca, Berlin Chemie, and Grifols, outside the submitted work. The authors report no other conflicts of interest in this work., (© 2022 Polke et al.)

Background: Endoscopic valve therapy has been established as a therapeutic option for patients with severe emphysema. Several randomized controlled trials confirmed the efficacy of this therapeutic approach in COPD patients without significant collateral ventilation. However, patients with clinical relevant hypercapnia were excluded from these trials., Aims and Objectives: Patients with hypercapnia who underwent endoscopic valve treatment were enrolled in this retrospective analysis. The efficacy of valve treatment and its impact on blood gases were analysed., Methods: COPD patients with mild to severe hypercapnia (pCO2 ≥45 mm Hg) who were treated by endoscopic valve placement at the Thoraxklinik, University of Heidelberg, were enrolled in this retrospective trial. Lung function test (vital capacity [VC], forced expiratory volume in 1 s [FEV1], residual volume [RV]), blood gases (pO2, pCO2), and 6-minute-walk test (6-MWT) were assessed prior to intervention and at 3 and 6 months following valve implantation., Results: 129 patients (mean age 64 ± 7 years) with severe COPD (mean FEV1 26 ± 12% of predicted, mean RV 285 ± 22% of predicted) with hypercapnia (pCO2 ≥45 mm Hg, mean pCO2 50 ± 5 mm Hg) underwent endoscopic valve treatment. 3 and 6 months following intervention, statistical significant improvement was observed in VC, FEV1, RV, and 6-MWT (all p < 0.001). Blood gas analysis revealed a significant improvement of mean pCO2 at 3- and 6-month follow-up (both p < 0.001). 40% of the patients had normal pCO2 values 3 and 6 months following intervention., Conclusion: COPD patients with hypercapnia should not be excluded from valve treatment, as the hyperinflation reduction improves the respiratory mechanics and thus leading to improvement of hypercapnia., (© 2022 S. Karger AG, Basel.)

Background: Patients with chronic obstructive pulmonary disease (COPD) commonly have comorbidities which may impact both symptoms and prognosis. Endoscopic lung volume reduction (ELVR) with endobronchial valves (EBV) is an innovative, effective and safe treatment for patients with severe emphysema who remain symptomatic despite optimal medical therapy., Objectives: To evaluate medical comorbidities associated with increased risk of complications after EBV procedure., Method: This was a retrospective cohort review of patients with severe, heterogeneous emphysema who underwent Zephyr® EBV installation for ELVR. Demographics, baseline comorbidities, dyspnea scores, data regarding procedure, pulmonary function test, minimal clinically important difference and post-EBV complications were recorded., Results: Of a total 82 participants, 24 were identified as having a post procedure complication. There was a significant difference in the incidence of type 2 diabetes mellitus (T2DM) at baseline (25%) in complication group compared with non-complication group (5.1%) (p value = 0.01). There was also a significant difference between baseline coronary artery disease (CAD) in those with (58.3%) or without (29.3%) complication (p = 0.01). Multivariate analysis of other covariables, identified associations of both CAD and T2DM with a heightened risk of complication (adjusted OR 4.19 CI: 1.23-14.2, p value = 0.02 and adjusted OR of 6.1 CI: 1.3-26.1, p value = 0.02 respectively)., Conclusions: Our study found that patients with severe, heterogeneous emphysema who undergo ELVR utilizing Zephyr® EBV and suffer complications during post-procedure period are more likely to have CAD or T2DM as baseline comorbidity. These data suggest that baseline CAD and T2DM might be predictive of increased risk of complications following ELVR with EBV., (© 2021 John Wiley & Sons Ltd.)

Background: Bronchoscopic valve placement constitutes an effective endoscopic lung volume reduction (ELVR) therapy in patients with severe emphysema and low collateral ventilation. After the most destroyed lobe is occluded with valves, significant target lobe volume reduction leads to improvements in lung function, exercise capacity, and quality of life. The effects are not consistent in some patients, leading to long-term therapy failure. We hypothesized that surgical lung volume reduction (LVRS) would reestablish ELVR short-term clinical improvements after ELVR long-term failure., Methods: This retrospective single-center analysis included all patients who underwent consolidating LVRS by lobectomy after long-term failure of valve therapy between 2010 and 2015. Changes in forced expiratory volume in 1 second, residual volume, 6-minute walking distance, and Modified Medical Research Council dyspnea score 90 days after ELVR and LVRS were analyzed, and the outcomes of both procedures were compared., Results: LVRS was performed in 20 patients after ELVR failure. A lower lobectomy was performed in 90%. The 30-day mortality of the cohort was 0% and 90-day mortality was 5% (1 of 20). The remaining 19 patients showed a significant increase in forced expiratory volume in 1 second (+27.5% ± 19.4%) and a reduction in residual volume (-21.0% ± 17.4%) and total lung capacity (-11.1% ± 11.1%). This resulted in significant improvements in exercise tolerance (6-minute walking distance: +56 ± 60 m) and relief of dyspnea (ΔModified Medical Research Council: -1.8 ± 1.4 points.)., Conclusions: Consolidating LVRS by lobectomy after failure of a previously successful ELVR is feasible and results in significant symptom relief and improvement of lung function., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Rationale: The long-term safety and effectiveness of bronchoscopic lung volume reduction with Zephyr endobronchial valves in subjects with severe homogeneous emphysema with little to no collateral ventilation beyond 3 months have yet to be established., Methods: Ninety-three subjects were randomized to either bronchoscopic lung volume reduction with Zephyr valves or standard of care (SoC) (1:1). Zephyr valve subjects were assessed at 3, 6, and 12 months. SoC subjects were assessed at 3 and 6 months; they were then offered crossover to Zephyr valve treatment., Results: The mean group difference (Zephyr valve - SoC) for change in FEV1 from baseline to 6 months was 16.3 ± 22.1% (mean ± SD; p < 0.001). Secondary outcomes showed the mean between-group difference for the six-minute walk distance of +28.3 ± 55.3 m (p = 0.016); St. George's Respiratory Questionnaire, -7.51 ± 9.56 points (p < 0.001); modified Medical Research Council, -0.42 ± 0.81 points (p = 0.019); BODE index, -0.85 ± 1.39 points (p = 0.006); and residual volume of -430 ± 830 mL (p = 0.011) in favor of the Zephyr valve group. At 6 months, there were significantly more responders based on the minimal clinically important difference for these same measures in the Zephyr valve versus the SoC group. The clinical benefits were persistent at 12 months. The percentage of subjects with respiratory serious adverse events was higher in the Zephyr valve group compared to SoC during the first 30 days post-procedure but not statistically different for the Zephyr valve and SoC groups from 31 days to 6 months, and stable in the Zephyr valve group out to 12 months. There were 2 deaths in the SoC group in the 31-day to 6-month period and none in the Zephyr valve group out to 12 months., Conclusions: Bronchoscopic lung volume reduction with Zephyr valves in subjects with severe homogeneous emphysema and little to no collateral ventilation provides clinically meaningful change from baseline in lung function, quality of life, exercise capacity, dyspnea, and the BODE index at 6 months, with benefits maintained out to 12 months., (© 2021 The Author(s) Published by S. Karger AG, Basel.)

For selected patients with advanced emphysema, bronchoscopic lung volume reduction with one-way valves can lead to clinically relevant improvements of airflow obstruction, hyperinflation, exercise capacity, and quality of life. The most common complication of this procedure is pneumothorax with a prevalence of up to ±34% of the treated patients. Patients who develop a pneumothorax also experience meaningful clinical benefits once the pneumothorax is resolved. Timely resolution of a post-valve treatment pneumothorax requires skilled and adequate pneumothorax management. This expert panel statement is an updated recommendation of the 2014 statement developed to help guide pneumothorax management after valve placement. Additionally, mechanisms for pneumothorax development, risk assessment, prevention of pneumothorax, and outcomes after pneumothorax are addressed. This recommendation is based on a combination of the current scientific literature and expert opinion, which was obtained through a modified Delphi method., (© 2021 The Author(s) Published by S. Karger AG, Basel.)

Background and Objective: The RENEW trial demonstrated that bronchoscopic lung volume reduction using endobronchial coils improves quality of life, pulmonary function and exercise performance. In this post hoc analysis of RENEW, we examine the mechanism of action of endobronchial coils that drives improvement in clinical outcomes., Methods: A total of 78 patients from the RENEW coil-treated group who were treated in one or both lobes that were deemed as the most destroyed were included in this retrospective analysis. Expiratory and inspiratory HRCT scans were used to assess lobar volume change from baseline to 12 months post coil treatment in treated and untreated lobes., Results: Reduction in lobar RV in treated lobes was significantly associated with favourable clinical improvement. Independent predictor of the change in RV and FEV 1 was the change in lobar RV reduction in the treated lobes and for change in 6MWD the absence of cardiac disease and the change in SGRQ, while the independent predictor of change in SGRQ was the change in 6MWD., Conclusion: Our results suggest that residual lobar volume reduction in treated lobes measured by QCT is the driving mechanism of action of endobronchial coils leading to positive clinical outcomes. However, the improvement in exercise capacity and quality of life seems to be affected by the presence of cardiac disease., (© 2020 The Authors. Respirology published by John Wiley & Sons Australia, Ltd on behalf of Asian Pacific Society of Respirology.)

Background: Endoscopic valve therapy aims at lung volume reduction that is associated with improved lung function, exercise tolerance and quality of life in emphysema patients. The size of intrabronchial valves of the Spiration® Valve System (SVS) selected to achieve lobar occlusion may have an influence on treatment outcomes., Methods: 49 severe emphysema patients (M/F: 24/25, age: 64 ± 7 years), with complete interlobar fissures on the side intended to be treated, underwent treatment with at least one 9-mm intrabronchial valve implantation at 3 centers and were followed up at 30, 90 and 180 days after intervention. Changes in pulmonary function tests (PFT), 6-min walk test (6MWT), modified Medical Research Council (mMRC) dyspnea scale and chronic obstructive pulmonary disease assessment test scores as well as possible complications were recorded., Results: Forced expiratory volume in 1 s (FEV1) improved significantly over the 6-month period of the study, and the proportion of patients achieving a minimal clinically important difference (MCID) for FEV1 was 46.4% at 6 months. Regarding the remaining PFT values, the changes were not statistically significant at 6 months, but when looking at the MCIDs, 44.4% of the patients achieved the MCID decrease for residual volume. The 6MWT distance also improved statistically significantly, and an MCID increase of ≥26 m was reached by 41.7% of the patients. Furthermore, there was a statistically significant improvement in the mMRC score. The incidence of pneumothoraxes requiring drainage was 26.5% while a valve dislocation rate of 24% was observed but only in the lower lobes., Conclusions: Endoscopic lung volume reduction with the 9-mm SVS valves was associated with statistically significant but modest improvement of FEV1, mMRC and 6MWT up to 6 months after intervention. These results were accompanied by an anticipated and acceptable risk profile. The relative increased incidence of device dislocation observed needs to be further elucidated., (© 2020 S. Karger AG, Basel.)

Background: The Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) trial reported improvements in quality of life, pulmonary function, and exercise performance following endobronchial coil treatment., Objectives: The purpose of this post hoc analysis was to identify baseline predictors, including quantitative CT measures, that identify patients most likely to significantly benefit from endobronchial coil therapy., Methods: Quantitative CT analysis by an independent radiology laboratory and a qualitative evaluation by five blinded experts of the baseline thoracic CT imaging were performed. Univariate and multivariate logistic regression analyses were performed to elucidate characteristics associated with clinical response., Results: In total, 125 patients underwent coil treatment and had evaluable 12-month follow-up results. Of these, 78 patients received treatment of lobes with the highest emphysematous destruction determined by quantitative CT analysis (quantitative visual match [QVM]+), and 47 received treatment in at least one lobe that was not the most destroyed (QVM-). From the 78 patients with QVM+ treatment, a subgroup of 50 patients (64%) was identified with baseline residual volume > 200% predicted, emphysema score > 20% low attenuation area, and absence of airway disease. In this subgroup, greater lobar residual volume reduction in the treated lobes was achieved, which was associated with significant mean ± SE improvement in FEV 1 (15.2 ± 3.1%), St. George's Respiratory Questionnaire (-12 ± 2 points), and residual volume (-0.57 ± 0.13 L)., Discussion: This post hoc analysis found that both significant hyperinflation (residual volume ≥ 200% predicted) and CT analysis are critical for patient selection and treatment planning for endobronchial coil therapy. Quantitative CT analysis is important to identify optimal lobar treatment and to exclude patients with insufficient emphysema (< 20% low attenuation area), whereas visual assessment identifies patients with signs of airway disease associated with worse outcomes., Trial Registry: ClinicalTrials.gov; No.: NCT01608490; URL: www.clinicaltrials.gov., (Copyright © 2019 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: Severe emphysema is a debilitating condition with few treatment options. Lung volume reduction procedures in the treatment of severe emphysema have shown excellent results in selected patients but their exact role remains unclear with studies reporting a wide variation in outcomes. We therefore aimed to evaluate the effects of volume reduction., Methods: We did a systematic review and meta-analysis. We searched MEDLINE on Sept 29, 2016, for trials of lung volume reduction in patients with emphysema, and we did an updated search on Embase and PubMed on June 18, 2018. We only included randomised controlled studies published in English evaluating the intervention with either sham or standard of care. Inclusion was limited to trials of techniques in which there was sustainable volume reduction. Primary outcomes were residual volume, FEV 1 , St George's Respiratory Questionnaire (SGRQ), and 6-min walk distance (6MWT). Secondary outcomes were severe adverse events (including mortality), short-term mortality, and overall mortality. We extracted summary level data from the trial publications and where necessary we obtained unpublished data. A random-effects model with the I 2 statistic was used to determine heterogeneity and trial weight in each analysis. The study is registered with the PROSPERO database, number CRD42016045705., Findings: We identified 4747 references in the search, and included 20 randomised controlled trials of lung volume reduction involving 2794 participants with emphysema. Following lung volume reduction from any of the interventions in pooled analyses (ie, surgery, endobronchial valve, endobronchial coil, or sclerosing agents), the mean differences compared with the control were reduction in residual volume of 0·58 L (95% CI -0·80 to -0·37), increase in FEV 1 of 15·87% (95% CI 12·27 to 19·47), improvement in 6MWT of 43·28 m (31·36 to 55·21), and reduction in the SGRQ of 9·39 points (-10·92 to -7·86). The odds ratio for a severe adverse event, which included mortality, was 6·21 (95% CI 4·02 to 9·58) following intervention. Regression analysis showed improvements relative to the degree of volume reduction: FEV 1 (r 2 =0·86; p<0·0001), 6MWT (r 2 =0·77; p<0·0001), and SGRQ (r 2 =0·70; p<0·0001). Most studies were at high risk of bias for lack of blinding, and heterogeneity was high for some outcomes when pooled across all interventions, but was generally lower in the subgroups by intervention type., Interpretation: Despite limitations of high risk of bias and heterogeneity for some analyses, our results provide support that lung volume reduction in patients with severe emphysema on maximal medical treatment has clinically meaningful benefits. These benefits should be considered alongside potential adverse events., Funding: None., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background and Objective: Endoscopic valve therapy is a treatment modality in patients with advanced emphysema and absent interlobar collateral ventilation (CV). So far, long-term outcome following valve implantation has been insufficiently evaluated. The aim of this study was to investigate the real-world efficacy of this interventional therapy over 3 years., Methods: From 2006 to 2013, 256 patients with severe emphysema in whom absent CV was confirmed underwent valve therapy. The 3-year effectiveness was evaluated by pulmonary function testing (VC, FEV 1 , RV, TLC), 6-minute-walk test (6-MWT) and dyspnea questionnaire (mMRC). Long-term outcome was also assessed according to the radiological outcome following valve placement., Results: Of 256 patients treated with valves, 220, 200, 187, 100 and 66 patients completed the 3-month, 6-month, 1-year, 2-year and 3-year follow-up (FU) visit, respectively. All lung function parameters, 6-MWT and mMRC were significantly improved at 3- and 6-month FU. At 1-year FU, patients still experienced a significant improvement of all outcome parameters expect VC (L) and TLC (%). At 2 years, RV (L and %) and TLC (L and %) remained significantly improved compared to baseline. Three years after valve therapy, sustained significant improvement in mMRC was observed and the proportion of patients achieving a minimal clinically important difference from baseline in RV and 6-MWT was still 71% and 46%, respectively. Overall, patients with complete lobar atelectasis exhibited superior treatment outcome with 3-year responder rates to FEV 1 , RV and 6-MWT of 10%, 79% and 53%, respectively., Conclusions: Patients treated by valves experienced clinical improvement over 1 year following valve therapy. Afterwards, clinical benefit gradually declines more likely due to COPD progression.

Background: Endoscopic lung volume reduction using Zephyr® valves has been recently adopted as a treatment option for patients with severe emphysema without collateral ventilation (CV)., Objectives: To assess the efficacy and safety of Zephyr valves in such a population., Methods: Studies were identified from MEDLINE and EMBASE databases. All searches were current until June 2018. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating the efficacy and safety of Zephyr. We defined as outcome: change in forced expiratory volume in 1 s (FEV1), in the 6-min walking test (6MWT), in the St George's Respiratory Questionnaire (SGRQ), and in residual volume (RV). Safety analysis included relative risk (RR) of pneumothorax. We assessed the quality of the evidence using GRADE., Results: 7 RCTs reported on Zephyr valves and 5 RCTs included only patients without CV. Zephyr improved FEV1 with a mean difference (MD) of 17.36% (CI, 9.28-25.45, I2 = 78%). Subgroup analysis showed significant FEV1 improvement following Zephyr placement in patients with heterogeneous distribution: MD = 21.78% (CI, 8.70-34.86, I2 = 89%) and 16.27% (CI, 8.78-23.76, I2 = 0%) in patients with homogeneous emphysema. Studies with a follow-up of 3 months reported FEV1 MD = 17.19% (CI, 3.16-31.22, I2 = 89%) compared to studies with a follow-up of 6-12 months, which showed a consistent improvement of FEV1 MD = 17.90% (CI, 11.47-24.33, I2 = 0%). Zephyr also showed improvement of SGRQ, 6MWT, and RV. RR of pneumothorax was 6.32 (CI, 3.74-10.67, I2 = 0%)., Conclusion: In this population, Zephyr valves provided significant and clinically meaningful short-term improvements in either homogeneous or heterogeneous emphysema without CV but with an increase in adverse events., (© 2019 S. Karger AG, Basel.)

Background: Endoscopic valve therapy leads to an improvement of lung function, exercise tolerance, and quality of life in a selected cohort of patients with advanced emphysema. So far, only few data exist on the long-term outcome., Objectives: This analysis evaluated the impact of valve therapy on the survival of emphysema patients., Methods: Survival rates of emphysema patients who underwent valve therapy were assessed according to their radiological outcome following valve placement., Results: From 2005 to 2013, 449 emphysema patients (mean age 64 ± 7 years) underwent valve therapy and were followed for a mean time of 37.3 ± 21.3 months. A total of 128 patients (29%) developed complete lobar atelectasis, 34 out of these also experienced a pneumothorax; 50 patients (11%) developed pneumothorax without lobar atelectasis, and 261 patients (58%) target lobe volume reduction or no volume change. Patients with atelectasis showed significantly better baseline forced expiratory volume in 1 second (%), residual volume (L), total lung capacity (L), and transfer factor for carbon monoxide (%; all p < 0.05), but there was no significant difference in the BODE score (p = 0.195). Patients with valve-induced lobar atelectasis had a significant survival benefit compared to patients without atelectasis (p = 0.009; 5-year survival rate 65.3 vs. 43.9%). The advent of pneumothorax in 84 patients did not influence survival (p = 0.52)., Conclusions: Lobar atelectasis following endoscopic valve therapy is associated with a survival benefit., (© 2018 S. Karger AG, Basel.)

Background: Bronchoscopic lung volume reduction (BLVR) using valves and coils has been approved for use since 2003 and 2010, respectively., Objective(s): To study adoption patterns of BLVR in an early-adopting country, and to estimate potential treatment volumes in other European countries., Methods: Therapy- and age-specific volumes for endobronchial valve and coil procedures were obtained from German federal statistics for 2007-2016. Therapy-specific and total BLVR procedure volumes and growth were computed, and patterns in treatment age and device utilization analyzed. Patient volumes for other European countries were predicted using mean German patient volumes of the last 3 data years and age-specific population and emphysema incidences., Results: Over the study period, annual BLVR procedure volumes grew from 91 to 2,053 (+2,256%), reaching a peak of 2,556 procedures in 2013. Coil procedures constituted 36% of the total volume in 2016. Treatment age was stable over time, with highest procedure counts in age group 60-64 years for valves and 65-69 years for coils. A limited increase in device use per procedure was observed. For -Germany, 1,655 newly treated BLVR patients were estimated per year, approximating about 5% of the annual newly diagnosed severe emphysema cases. Predicted volume estimates for other European countries ranged from 1 for Liechtenstein to 1,226 for France., Conclusions: Analysis of -German procedure data show pronounced BLVR therapy uptake in the early years of adoption, with the more recently introduced coil therapy used in about one-third of patients. Estimated patient volumes to date constitute only a small fraction of the severe emphysema population., (© 2018 S. Karger AG, Basel.)

Background: Endoscopic and surgical interventions may be beneficial for selected patients with emphysema. Rates of treatment failure decrease when the predictors for successful therapy are known. The aim of the study was to evaluate the number of patients with severe emphysema who were not eligible for any intervention, and the reasons for their exclusion., Methods: The study was a retrospective analysis of 231 consecutive patients with advanced emphysema who were considered for interventional therapy in 2016 at the Thoraxklinik, Heidelberg, Germany. The reasons for not receiving valve or coil therapy were assessed for all patients who did not receive any therapy., Results: Of the 231 patients, 50% received an interventional therapy for lung volume reduction (LVR) (82% valve therapy, 6% coil therapy, 4.3% polymeric LVR or bronchial thermal vapour ablation, 4.3% total lung denervation, and 3.4% lung volume reduction surgery [LVRS]). A total of 115 patients did not undergo LVR. Out of these, valve or coil therapy was not performed due to one or more of the following reasons: incomplete fissure in 37% and 0%; missing target lobe in 31% and 30%; personal decision in 18% and 28%; pulmonary function test results in 8% and 15%; ventilatory failure in 4% and 4%; missing optimal standard medical care and/or continued nicotine abuse in 4% and 3%; general condition too good in less than 1% and 3%; cardiovascular comorbidities in 0% and 3%; age of patient in 0% and less than 1%. Both techniques were not performed due to one or more of the following reasons: solitary pulmonary nodule(s)/consolidation in 27%; bronchopathy in 7%; neoplasia in 2%; destroyed lung in 2%; prior LVRS in less than 1%., Conclusions: The main reason for not placing valves was an incomplete fissure and for coils a missing target lobe. Numerous additional contraindications that may exclude a patient from interventional emphysema therapy should be respected.

Background: Chronic obstructive pulmonary disease (COPD) has become a leading cause of morbidity and mortality in China, with tobacco smoke, air pollution, and occupational biohazards being the major risk factors., Objectives: The REACH trial is a multicenter, prospective, randomized controlled trial undertaken in China to assess the safety and effectiveness of the Spiration® Valve System (SVS) compared to standard medical care in COPD patients with severe emphysema., Methods: Patients with severe airflow obstruction, hyperinflation, and severe dyspnea with interlobar fissure integrity were evaluated for enrollment. A total of 107 subjects were randomized in a 2: 1 allocation ratio to either the treatment group (SVS valves and medical management) or the control group (medical management alone)., Results: The 3-month primary endpoint showed statistically significant improvement in forced expiratory volume in 1 s in the treatment group compared to the control group (0.104 ± 0.18 vs. 0.003 ± 0.15 L, p = 0.001), with the difference being durable through 6 months. Statistically significant target lobe volume reduction was achieved at 3 months (mean change 684.4 ± 686.7 mL) and through 6 months (757.0 ± 665.3 mL). Exercise function and quality of life measures improved in the treatment group, but showed a deterioration in the control group. The serious adverse event (SAE) rate was 33% in the treatment group and 24.2% in the control group. The predominance of SAEs were acute exacerbations of COPD in both groups. There was 1 death in the control group and no deaths in the treatment group., Conclusion: The SVS represents a novel approach for the treatment of severe emphysema with a clinically acceptable risk-benefit profile., (© 2018 The Author(s) Published by S. Karger AG, Basel.)

Bronchoscopic lung volume reduction (BLVR) is a minimally invasive procedure for patients with symptomatic severe emphysema who may not be candidates for surgical lung volume reduction. BLVR has been shown to improve both functional and clinical outcomes with a relatively low risk of severe complications. Any potential candidate to BLVR should be on optimal pharmacological and nonpharmacological treatment. Radiographic and pulmonary function testing provide key data to help identify potential BLVR candidates. A variety of BLVR techniques have been published with different associated benefits and risks. Current strategies include either blocking procedures such as endobronchial valves and intrabronchial valves or nonblocking procedures such as endobronchial coils and bronchoscopic thermal vapor ablation. The aim of this review is to describe current options of BLVR including their efficacy and safety based on available data., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objectives: Bronchoscopic lung volume reduction using coils (LVRC) is a well-known treatment option for severe emphysema. The purpose of this study was to identify quantitative computed tomography (QCT) and clinical parameters associated with positive treatment outcome., Patients and Methods: The CT scans, pulmonary function tests (PFT), and 6-minute walk test (6-MWT) data were collected from 72 patients with advanced emphysema prior to and at 3 months after LVRC treatment. The procedure involved placing 10 coils unilaterally. Various QCT parameters were derived using Apollo imaging software (VIDA). Independent predictors of clinically relevant outcome (Δ6-MWT ≥ 26 m, ΔFEV 1 ≥ 12%, ΔRV ≥ 10%) were identified through stepwise linear regression analysis., Results: The response outcome for Δ6-MWT, for ΔFEV 1 and for ΔRV was met by 55%, 32% and 42%, respectively. For Δ6-MWT ≥ 26 m a lower baseline 6-MWT ( p = 0.0003) and a larger standard deviation (SD) of low attenuation cluster (LAC) sizes in peripheral regions of treated lung ( p = 0.0037) were significantly associated with positive outcome. For ΔFEV 1 ≥ 12%, lower baseline FEV 1 ( p = 0.02) and larger median LAC sizes in the central regions of treated lobe ( p = 0.0018) were significant predictors of good response. For ΔRV ≥ 10% a greater baseline TLC ( p = 0.0014) and a larger SD of LAC sizes in peripheral regions of treated lung ( p = 0.007) tended to respond better., Conclusion: Patients with lower FEV 1 and 6-MWT, with higher TLC and specific QCT characteristics responded more positively to LVRC treatment, suggesting a more targeted CT-based approach to patient selection could lead to greater efficacy in treatment response., Competing Interests: Disclosure KK, KR and SW report no conflicts of interest in this work. RE: Lecture and travel fees from Olympus, Pulmonx and Uptake Medical/Broncus outside the submitted work. MS: Fees for lectures and advisory boards from the following companies: Olympus, Pulmonx, Astra Zeneca, Novartis, Teva, GSK, PneumRx and Boston Scientific outside the submitted work. CH: Stock ownership in medical industry, Stada, GSK; Patents Method and Device for Representing the Microstructure of the Lungs. IPC8 Class: AA61B5055FI, PAN: 20080208038, Inventors: W Schreiber, U Wolf, AW Scholz, CP Heussel; personal fees from Schering-Plough, personal fees from Pfizer, personal fees from Basilea, personal fees from Boehringer Ingelheim, personal fees from Novartis, personal fees from Roche, personal fees from Astellas, personal fees from Gilead, personal fees from MSD, personal fees from Lilly, personal fees from Intermune, personal fees from Fresenius, personal fees from Olympus, personal fees from Siemens, personal fees from MeVis, personal fees from Essex, personal fees from AstraZeneca, personal fees from Bracco, personal fees from MEDA Pharma, personal fees from Intermune, personal fees from Chiesi, personal fees from Covidien, personal fees from Pierre Fabre, personal fees from Grifols, personal fees from Bayer, other from Stada, other from GSK, outside the submitted work. FH: Fees for lectures and advisory boards from Astra, Allmirall, Berlin Chemie, Boehringer, Roche, GSK, Pulmonx, BTG, Olympus, PneumRx, Boston Scientific, Medupdate, Grifols, CSL Behring, Omniamed, Lilly, Novartis, Teva, Uptake and Vital Air, outside the submitted work. DG: Personal fees from Olympus, personal fees from Pulmonx, personal fees from Chiesi, personal fees from Berlin Chemie, personal fees from Astra Zeneca, personal fees from Boehringer Ingelheim, personal fees from Novartis, personal fees from Mundipharma, personal fees from Grifols, outside the submitted work.

Background: Bronchoscopic valve implantation is an established treatment in selected patients with severe lung emphysema. There is evidence in literature of increased bacterial colonization of various implants. So far, it is unclear if an increased bacterial colonization can also be observed after endoscopic valve therapy., Methods: Retrospective analysis of patients with examination of the bronchial secretions for presence or change of bacterial growth before and after valve implantation., Results: Overall, 144 patients who underwent bronchoscopic follow-up after valve implantation were included in this analysis. Prior to valve placement, only 7 out of 144 consecutive emphysema patients (5%) presented with evidence of bacterial colonization, whereas 137 patients (95%) showed no bacterial growth prior to valve placement. One hundred seven out of the 137 patients (78%) showed new bacterial growth after valve implantation. Almost 38% of the patients who presented with a new bacterial growth had evidence of Viridans streptococci , Rothia mucilaginousa and Neisseria species simultaneously, as bacterial colonization. Pathogenic bacterial growth was recorded for Staphylococcus aureus (18%), Pseudomonas aeruginosa (13%) and Stenotrophomonas maltophilia (9%) microorganisms. There was also a significant bacterial growth by Moraxella catarrhalis (26%) and anaerobic bacteria (23%), especially in patients with complete atelectasis after successful endoscopic lung volume reduction. For all of the 7 patients, the presented initial bacterial colonization showed a change in the flora after bronchoscopy valve implantation., Conclusion: In this study we observed an increased bacterial colonization in the long term after valve implantation. This finding needs further evaluation regarding its possible clinical relevance but should be taken into consideration in the follow-up of these patients., Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Background: Valve implantation provides a reversible effective therapy in a selected group of emphysema patients. Knowing predictors for successful therapy, the rate of treatment failure has decreased. Some patients, however, do not benefit, so that the valves may have to be removed., Objectives: To assess implant-related events, complications during valve removal, and clinical outcome after endoscopic procedure., Methods: The data of 76 consecutive emphysema patients who underwent valve removal > 6 months since implantation were collected., Results: Seventy-six patients (mean age 62 years, 54% male) underwent removal of all valves after a mean time of 624 days (193-3,043 days) since implantation. Granulation tissue was observed in 39.5% (30/76) and significant secretion in 34.2% (26/76). In 5.3% (4/76), valve removal was complicated requiring another bronchoscopy in 2 of them. In 5.3% (4/76) of the patients, one valve could not be removed and remained in situ. Bleeding requiring intervention occurred in 3.9% (3/76) during valve removal. Following bronchoscopy, there was a need for antibiotics in 34.2% (26/76), glucocorticosteroids in 1.3% (1/76), and both in 6.6% (5/76) due to productive cough or chronic obstructive pulmonary disease (COPD) exacerbation. Due to respiratory failure, invasive ventilation or noninvasive ventilation was necessary in 2.6% (2/76) and 6.6% (5/76), respectively, following procedure. No statistical significant change in lung function was observed following valve removal., Conclusions: Valve removal after > 6 months since implantation is feasible and associated with an acceptable safety profile. However, close monitoring of these patients with limited pulmonary reserve is recommended with particular attention to COPD exacerbations and respiratory failure., (© 2018 S. Karger AG, Basel.)

Endoscopic lung volume reduction is a minimally invasive procedure performed to reduce the space occupied by the emphysemas' lobes. This procedure has been demonstrated to be beneficial for patients with advanced chronic obstructive pulmonary disease and severe hyperinflation. The use of endobronchial valves is increasing, as well as the number of reports of adverse events. The most common complications after the procedure are a pneumothorax, bleeding, infections, the need for valve removal, and valve expulsion. We have recently treated a patient who achieved immediate left upper lobe atelectasis but developed a pneumothorax on the 6th day and near-fatal kinking of the left lower lobe bronchus. This patient had asphyctic episodes probably due to a functional left pneumonectomy. We should consider this unusual complication in patients undergoing endoscopic lung volume reduction whose condition worsens after achieving complete lobar atelectasis., (© 2018 S. Karger AG, Basel.)

Endobronchial coils are an additional treatment option for lung volume reduction in patients with severe emphysema. Patient selection should be focused on patients with severe emphysema on optimal medical therapy and with evidence of severe hyperinflation. The technique is suitable in a broad range of patients with emphysema; however, patients with paraseptal emphysema, large focal (giant) bullae, significant co-morbidity and airway-predominant disease should be avoided. Treatment involves placing between 10 and 14 coils by bronchoscopy in the selected treatment lobe, with 2 lobes being treated sequentially. Lobe selection for treatment should be based on quantitative computed tomography, and the lobes with the greatest destruction should be targeted (excluding the right middle lobe). The treatment results in an improvement in pulmonary function, exercise performance and quality of life, particularly in patients with severe hyperinflation (residual volume > 200% predicted) and upper-lobe heterogeneous emphysema, but will also be of benefit in lower-lobe predominant and homogeneous emphysema. Finally, it has an acceptable safety profile, although special attention has to be paid to coil-associated opacity which is an inflammatory response that occurs in some patients treated with endobronchial coils., (© 2018 S. Karger AG, Basel.)

Rationale: Single-center randomized controlled trials of the Zephyr endobronchial valve (EBV) treatment have demonstrated benefit in severe heterogeneous emphysema. This is the first multicenter study evaluating this treatment approach., Objectives: To evaluate the efficacy and safety of Zephyr EBVs in patients with heterogeneous emphysema and absence of collateral ventilation., Methods: This was a prospective, multicenter 2:1 randomized controlled trial of EBVs plus standard of care or standard of care alone (SoC). Primary outcome at 3 months post-procedure was the percentage of subjects with FEV 1 improvement from baseline of 12% or greater. Changes in FEV 1 , residual volume, 6-minute-walk distance, St. George's Respiratory Questionnaire score, and modified Medical Research Council score were assessed at 3 and 6 months, and target lobe volume reduction on chest computed tomography at 3 months., Measurements and Main Results: Ninety seven subjects were randomized to EBV (n = 65) or SoC (n = 32). At 3 months, 55.4% of EBV and 6.5% of SoC subjects had an FEV 1 improvement of 12% or more (P < 0.001). Improvements were maintained at 6 months: EBV 56.3% versus SoC 3.2% (P < 0.001), with a mean ± SD change in FEV 1 at 6 months of 20.7 ± 29.6% and -8.6 ± 13.0%, respectively. A total of 89.8% of EBV subjects had target lobe volume reduction greater than or equal to 350 ml, mean 1.09 ± 0.62 L (P < 0.001). Between-group differences for changes at 6 months were statistically and clinically significant: ΔEBV-SoC for residual volume, -700 ml; 6-minute-walk distance, +78.7 m; St. George's Respiratory Questionnaire score, -6.5 points; modified Medical Research Council dyspnea score, -0.6 points; and BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index, -1.8 points (all P < 0.05). Pneumothorax was the most common adverse event, occurring in 19 of 65 (29.2%) of EBV subjects., Conclusions: EBV treatment in hyperinflated patients with heterogeneous emphysema without collateral ventilation resulted in clinically meaningful benefits in lung function, dyspnea, exercise tolerance, and quality of life, with an acceptable safety profile. Clinical trial registered with www.clinicaltrials.gov (NCT02022683).

Advanced emphysema is a lung disease in which alveolar capillary units are destroyed and supporting tissue is lost. The combined effect of reduced gas exchange and changes in airway dynamics impairs expiratory airflow and leads to progressive air trapping. Pharmacological therapies have limited effects. Surgical resection of the most destroyed sections of the lung can improve pulmonary function and exercise capacity but its benefit is tempered by significant morbidity. This issue stimulated a search for novel approaches to lung volume reduction. Alternative minimally invasive approaches using bronchoscopic techniques including valves, coils, vapour thermal ablation, and sclerosant agents have been at the forefront of these developments. Insertion of endobronchial valves in selected patients could have benefits that are comparable with lung volume reduction surgery. Endobronchial coils might have a role in the treatment of patients with emphysema with severe hyperinflation and less parenchymal destruction. Use of vapour thermal energy or a sclerosant might allow focal treatment but the unpredictability of the inflammatory response limits their current use. In this Review, we aim to summarise clinical trial evidence on lung volume reduction and provide guidance on patient selection for available therapies., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Background: Lung volume reduction coil (LVRC) treatment is established in daily endoscopic lung volume reduction routine. The aim of this study was to evaluate the safety and efficacy of LVRC treatment., Patients and Methods: This was a retrospective analysis of 86 patients (male/female: 40/46, mean age: 64±7 years) with severe COPD and bilateral incomplete fissures. A total of 10 coils were unilaterally implanted in a single lobe, and 28 out of 86 patients were treated bilaterally. At 90-, 180-, and 365-day follow-up, changes in pulmonary function test (PFT), 6-minute walk test (6MWT) and modified Medical Research Council (mMRC) dyspnea scale, as well as possible complications, were recorded., Results: At 90 days, the forced expiratory volume in 1 second did improve ( P <0.001), but the improvement was not sustained at the 180- and 365-day follow-up (baseline: 0.71±0.21 vs 0.77±0.23 vs 0.73±0.22 vs 0.70±0.18 L). Both vital capacity and residual volume improved significantly ( P <0.001) at the 90- and 180-day follow-up, but the improvement was lost after 365 days. Total lung capacity decreased at the 90-day follow-up but returned to baseline values at the 180- and 365-day follow-up. 6MWT ( P =0.01) and mMRC ( P =0.007) also improved at 90 and 180 days (Δ6MWT of 31±54 and 20±60 m, respectively), but the improvement was also lost at the 365-day follow-up. No significant further improvement was evident at any point in the follow-up after the second procedure. A total of 4 out of 86 patients passed away due to complications. Significant complications in the first 3 months and then at 12 months included the following: severe hemoptysis in 4 (3.5%) and 4 (3.5%) patients, pneumonia requiring hospitalization in 32 (28.1%) and 9 (7.9%) patients and pneumothorax in 7 (6.1%) and 2 (1.7%) patients, respectively. Milder adverse events included self-limited hemoptysis, pneumonias, or COPD exacerbations treated orally., Conclusion: LVRC improved PFT, 6MWT and mMRC initially, but the improvement was lost after 365 days. Furthermore, we observed 4 deaths and significant severe complications, which need to be further elucidated., Competing Interests: DG received lecture and travel fees from Pulmonx, Novartis, Astra Zeneca, Mundipharma, Berlin Chemie and Grifols. MS received travel subsistence or speaker fees from Olympus, PneumRx, Pulmonx, Boston Scientific, AstraZeneca, GlaxoSmithKline, Novartis, Boehringer, and Teva. CPH has stock ownership in medical industry, Stada, and GSK, and patents, method, and device for representing the microstructure of the lungs; IPC8 Class: AA61B5055FI, PAN: 20080208038, Inventors: W Schreiber, U Wolf, AW Scholz, CP Heussel; Consultation or other fees Schering-Plough 2009, 2010, Pfizer 2008-2014, Basilea 2008, 2009, 2010, Boehringer Ingelheim 2010-2014, Novartis 2010, 2012, Roche 2010, Astellas 2011, 2012, Gilead 2011–2014, MSD 2011–2013, Lilly 2011, Intermune 2013–2014, Fresenius 2013, 2014; Expert testimony no; Research funding Siemens 2012–2014, Pfizer 2012–2014, MeVis 2012, 2013, Boehringer Ingelheim 2015; Lecture fees Gilead 2008–2014, Essex 2008, 2009, 2010, Schering-Plough 2008, 2009, 2010, AstraZeneca 2008–2012, Lilly 2008, 2009, 2012, Roche 2008, 2009, MSD 2009–2014, Pfizer 2010–2014, Bracco 2010, 2011, MEDA Pharma 2011, Intermune 2011–2014, Chiesi 2012, Siemens 2012, Covidien 2012, Pierre Fabre 2012, Boehringer Ingelheim 2012, 2013, 2014, Grifols 2012, Novartis 2013, 2014; and had no relationship with tobacco industry. FJFH received consultant and lecture fees from Astra, Allmirall, Berlin Chemie, Boehringer, Roche, GSK, Pulmonx, PneumRx, Boston Scientific, Medupdate, Grifols, CSL Behring, Omniamed, Lilly, Novartis, Teva, Uptake, and Vital Air. RE received lecture and travel fees from Pulmonx and Olympus. KK, VG, and HH report no conflicts of interest in this work.

Endoscopic lung volume reduction (ELVR) is being adopted as a treatment option for carefully selected patients suffering from severe emphysema. ELVR with the one-way endobronchial Zephyr valves (EBV) has been demonstrated to improve pulmonary function, exercise capacity, and quality of life in patients with both heterogeneous and homogenous emphysema without collateral ventilation. In this "expert best practices" review, we will highlight the practical aspects of this therapy. Key selection criteria for ELVR are hyperinflation with a residual volume >175% of predicted, forced expiratory volume <50% of predicted, and a 6-min walking distance >100 m. Patients with repeated infectious complications, severe bronchiectasis, and those with unstable cardiovascular comorbidities should be excluded from EBV treatment. The procedure may be performed with either conscious sedation or general anesthesia and positive pressure mechanical ventilation using a flexible endotracheal tube or a rigid bronchoscope. Chartis and EBV placement should be performed in 1 procedure when possible. The sequence of valve placement should be orchestrated to avoid obstruction and delivery of subsequent valves. If atelectasis has not occurred by 1 month after procedure, evaluate valve position on CT and consider replacing the valves that are not optimally positioned. Pneumothorax is a common complication and typically occurs in the first 2 days following treatment. A management algorithm for pneumothorax has been previously published. Long-term sequelae from EBV therapy do occur but are easily manageable., (© 2016 The Author(s) Published by S. Karger AG, Basel.)

Rationale: 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., Objectives: To evaluate the efficacy and safety of EBVs in patients with homogeneous emphysema with absence of collateral ventilation assessed with the Chartis system., Methods: 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 1 (liters) at 3 months relative to baseline in the EBV group versus the SoC group. Secondary outcomes included changes in FEV 1 , St. George's Respiratory Questionnaire (SGRQ), 6-minute-walk distance (6MWD), and target lobe volume reduction., Measurements and Main Results: Ninety-three subjects (age, 63.7 ± 6.1 yr [mean ± SD]; FEV 1 , % 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 1 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., Conclusions: EBV in patients with homogeneous emphysema without collateral ventilation results in clinically meaningful benefits of improved lung function, exercise tolerance, and quality of life.

Background and Objective: The aim of endoscopic valve therapy in patients with emphysema is complete lobar atelectasis of the most emphysematous lobe. However, even after the radiological advent of atelectasis, great variability in clinical outcomes can be observed., Methods: The baseline clinical measures (vital capacity (VC), forced expiratory flow in 1 s (FEV1 ), residual volume (RV) and 6-min walk test (6-MWT)) and computed tomography variables (low attenuation volume (LAV) of the target lobe, LAV% of the target and the ipsilateral untreated lobe and LAV of the target lobe to LAV of the target lung and to LAV of the total lung) of 77 patients with complete atelectasis following valve therapy were retrospectively examined to determine their impact on patient´s outcome (changes in VC, FEV1 , RV and 6-MWT from baseline to the time of atelectasis)., Results: Low attenuation volume of the target lobe to LAV of the target lung predicts a significant FEV1 improvement in patients with complete lobar atelectasis following valve therapy. A 10% difference in that computed tomography predictor was associated with a 82-mL improvement in FEV1 (P = 0.006). Lower 6-MWT scores, low VC and high RV at baseline were significantly associated with greater improvement in the respective parameter (all P < 0.001)., Conclusion: Low attenuation volume of the target lobe to LAV of the target lung and baseline clinical measures seem to significantly predict clinical outcomes in patients with complete lobar atelectasis following valve treatment., (© 2016 Asian Pacific Society of Respirology.)

Background: Endoscopic valve implantation is an effective treatment for patients with advanced emphysema. Despite the minimally invasive procedure, valve placement is associated with risks, the most common of which is pneumothorax. This study was designed to identify predictors of pneumothorax following endoscopic valve implantation., Methods: Preinterventional clinical measures (vital capacity, forced expiratory volume in 1 second, residual volume, total lung capacity, 6-minute walk test), qualitative computed tomography (CT) parameters (fissure integrity, blebs/bulla, subpleural nodules, pleural adhesions, partial atelectasis, fibrotic bands, emphysema type) and quantitative CT parameters (volume and low attenuation volume of the target lobe and the ipsilateral untreated lobe, target air trapping, ipsilateral lobe volume/hemithorax volume, collapsibility of the target lobe and the ipsilateral untreated lobe) were retrospectively evaluated in patients who underwent endoscopic valve placement (n=129). Regression analysis was performed to compare those who developed pneumothorax following valve therapy (n=46) with those who developed target lobe volume reduction without pneumothorax (n=83)., Finding: Low attenuation volume% of ipsilateral untreated lobe (odds ratio [OR] =1.08, P=0.001), ipsilateral untreated lobe volume/hemithorax volume (OR =0.93, P=0.017), emphysema type (OR =0.26, P=0.018), pleural adhesions (OR =0.33, P=0.012) and residual volume (OR =1.58, P=0.012) were found to be significant predictors of pneumothorax. Fissure integrity (OR =1.16, P=0.075) and 6-minute walk test (OR =1.05, P=0.077) were also indicative of pneumothorax. The model including the aforementioned parameters predicted whether a patient would experience a pneumothorax 84% of the time (area under the curve =0.84)., Interpretation: Clinical and CT parameters provide a promising tool to effectively identify patients at high risk of pneumothorax following endoscopic valve therapy.

Importance: Preliminary clinical trials have demonstrated that endobronchial coils compress emphysematous lung tissue and may improve lung function, exercise tolerance, and symptoms in patients with emphysema and severe lung hyperinflation., Objective: To determine the effectiveness and safety of endobronchial coil treatment., Design, Setting, and Participants: Randomized clinical trial conducted among 315 patients with emphysema and severe air trapping recruited from 21 North American and 5 European sites from December 2012 through November 2015., Interventions: Participants were randomly assigned to continue usual care alone (guideline based, including pulmonary rehabilitation and bronchodilators; n = 157) vs usual care plus bilateral coil treatment (n = 158) involving 2 sequential procedures 4 months apart in which 10 to 14 coils were bronchoscopically placed in a single lobe of each lung., Main Outcomes and Measures: The primary effectiveness outcome was difference in absolute change in 6-minute-walk distance between baseline and 12 months (minimal clinically important difference [MCID], 25 m). Secondary end points included the difference between groups in 6-minute walk distance responder rate, absolute change in quality of life using the St George's Respiratory Questionnaire (MCID, 4) and change in forced expiratory volume in the first second (FEV1; MCID, 10%). The primary safety analysis compared the proportion of participants experiencing at least 1 of 7 prespecified major complications., Results: Among 315 participants (mean age, 64 years; 52% women), 90% completed the 12-month follow-up. Median change in 6-minute walk distance at 12 months was 10.3 m with coil treatment vs -7.6 m with usual care, with a between-group difference of 14.6 m (Hodges-Lehmann 97.5% CI, 0.4 m to ∞; 1-sided P = .02). Improvement of at least 25 m occurred in 40.0% of patients in the coil group vs 26.9% with usual care (odds ratio, 1.8 [97.5% CI, 1.1 to ∞]; unadjusted between-group difference, 11.8% [97.5% CI, 1.0% to ∞]; 1-sided P = .01). The between-group difference in median change in FEV1 was 7.0% (97.5% CI, 3.4% to ∞; 1-sided P < .001), and the between-group St George's Respiratory Questionnaire score improved -8.9 points (97.5% CI, -∞ to -6.3 points; 1-sided P < .001), each favoring the coil group. Major complications (including pneumonia requiring hospitalization and other potentially life-threatening or fatal events) occurred in 34.8% of coil participants vs 19.1% of usual care (P = .002). Other serious adverse events including pneumonia (20% coil vs 4.5% usual care) and pneumothorax (9.7% vs 0.6%, respectively) occurred more frequently in the coil group., Conclusions and Relevance: Among patients with emphysema and severe hyperinflation treated for 12 months, the use of endobronchial coils compared with usual care resulted in an improvement in median exercise tolerance that was modest and of uncertain clinical importance, with a higher likelihood of major complications. Further follow-up is needed to assess long-term effects on health outcomes., Trial Registration: clinicaltrials.gov Identifier: NCT01608490.

Background: Bronchoscopic lung volume reduction using one-way endobronchial valves (EBVs) has been proven to be effective in patients with severe emphysema. However, the selection of patients without collateral ventilation prior to treatment is critical for procedural success. Collateral ventilation can be assessed directly with the Chartis system or indirectly using computed tomography (CT) fissure analysis., Objectives: We retrospectively evaluated the diagnostic value of a combination of the quantitative CT interlobar fissure completeness score (FCS) and Chartis in predicting responders to EBV therapy., Methods: CT data from four prospective studies were pooled and analyzed using semiautomated software to quantify the completeness of interlobar fissures. These FCSs were compared to a reference standard of achieving ≥350 ml of target lobe volume reduction after EBV treatment. Using a receiver operating characteristic curve, optimal thresholds predictive of complete fissures (responders) and incomplete fissures (non-responders) were determined. A subgroup of patients with partially complete fissures was identified, where software had lower accuracy. The complementary value of Chartis was investigated in this group., Results: A fissure was defined as complete (FCS >95%), incomplete (FCS <80%), or partially complete (80% < FCS < 95%). The positive predictive value (PPV) of complete fissures is 88.1%, and the negative predictive value (NPV) is 92.9%, with an overall accuracy of 89.2%. Chartis was utilized in patients with partially complete fissures, with a PPV of 82.3%, an NPV of 84.6%, and an accuracy of 83.3%., Conclusion: Combining diagnostic tools could reduce the burden on patients and the healthcare system while providing clinicians with a better means for patient selection for EBV therapy., (© 2016 S. Karger AG, Basel.)

Background: Emphysema patients with collateral ventilation (CV) will not benefit from valve therapy, the most common endoscopic lung volume reduction procedure. A recent randomized controlled trial (STEP-UP) of the alternative bronchoscopic thermal vapor ablation (BTVA) included patients with (CV+) and without interlobar CV (CV-)., Objectives: This analysis evaluated the efficacy and safety of the CV+ population following BTVA., Method: A post hoc fissure analysis of the baseline computed tomography of all treatment and control patients was performed with the VIDA Diagnostics Apollo software. A patient was considered to be CV+ if either of the treated upper lobes was adjacent to a fissure that was <90% complete. The primary endpoints, forced expiratory volume in 1 s (FEV1) and St. George's Respiratory Questionnaire (SGRQ-C), were calculated for these CV+ patients following BTVA and safety results summarized., Results: 78% (35/45) of the patients in the treatment arm and 79% (19/24) of the patients in the control arm were found to be CV+. At 12 months, the FEV1 improvement of the treatment arm was 9.2%, as compared with a decrease of 5.4% in the control group, resulting in a mean between-group difference of 14.6% (p = 0.0137). The improvement in SGRQ-C of the treatment arm as compared to the control arm was 8.4 points (p = 0.0712). An increase in respiratory related serious adverse events was observed immediately following treatment, but most resolved with routine care., Conclusion: BTVA can achieve safe and clinically meaningful improvement in pulmonary function and quality of life in patients with CV. These randomized controlled trial subgroup results offer proof of a viable solution for CV+ patients., (© 2016 S. Karger AG, Basel.)

As well as lung volume reduction surgery, different minimally invasive endoscopic techniques are available to achieve lung volume reduction in patients with severe emphysema and significant hyperinflation. Lung function parameters and comorbidities of the patient, as well as the extent and distribution of the emphysema are factors to be considered when choosing the patient and the intervention. Endoscopic bronchial valve placement with complete occlusion of one lobe in patients with heterogeneous emphysema is the preferred technique because of its reversibility. The presence of high interlobar collateral ventilation will hinder successful treatment; therefore, endoscopic coil placement, polymeric lung volume reduction, or bronchoscopic thermal vapor ablation as well as lung volume reduction surgery can be used for treating patients with incomplete fissures. The effect of endoscopic lung volume reduction in patients with a homogeneous distribution of emphysema is still unclear and this subgroup should be treated only in clinical trials. Precise patient selection is necessary for interventions and to improve the outcome and reduce the risk and possible complications. Therefore, the patients should be discussed in a multidisciplinary approach prior to determining the most appropriate treatment for lung volume reduction.

Rationale: Chartis Pulmonary Assessment System (Pulmonx Inc., Redwood, CA) is an invasive procedure used to assess collateral ventilation and select candidates for valve-based lung volume reduction (LVR) therapy. Quantitative computed tomography (QCT) is a potential alternative to Chartis and today consists primarily of assessing fissure integrity (FI)., Objectives: In this retrospective analysis, we aimed to determine QCT predictors of LVR outcome and compare the QCT model with Chartis in selecting likely responders to valve-based LVR treatment., Methods: Baseline CT scans of 146 subjects with severe emphysema who underwent endobronchial valve LVR were analyzed retrospectively using dedicated lung quantitative imaging software (Apollo; VIDA Diagnostics, Coralville, IA). A lobar volume reduction greater than 350 ml at 3 months was considered to be indicative of positive response to treatment. Thirty-four CT baseline variables, including quantitative measurements of FI, density, and vessel volumetry, were used to feed a multiple logistic regression analysis to find significant predictors of LVR outcome. The primary predictors were then used in 33 datasets with Chartis results to evaluate the relative performance of QCT versus Chartis., Measurements and Main Results: FI (P < 0.0001) and low attenuation clusters (P = 0.01) measured in the treated lobe and vascular volumetric percentage of patient's detected smallest vessels (P = 0.02) were identified as the primary QCT predictors of LVR outcome. Accuracy for QCT patient selection based on these primary predictors was comparable to Chartis (78.8 vs. 75.8%)., Conclusions: Quantitative CT led to comparable results to Chartis for classifying LVR and is a promising tool to effectively select patients for valve-based LVR procedures.

Background: One of the most common forms of pulmonary hypertension (PH) is that associated with chronic obstructive pulmonary disease (COPD). So far, patients with severe emphysema and established PH have been excluded from endoscopic lung volume reduction (ELVR) therapy due to the risk of right heart decompensation., Objective: The aim of this pilot study was to evaluate the feasibility and efficacy of ELVR using one-way endobronchial valves (EBV) in this specific group of patients., Methods: We prospectively included 6 patients with COPD, severe heterogeneous emphysema, and established PH who underwent right heart catheterization and clinical assessments before and 90 days after ELVR with unilateral EBV placement., Results: This study was not powered to measure any statistical differences in endpoints. Ninety days after ELVR, the symptoms, lung function, and hemodynamics improved in 5 out of 6 patients (1 patient normalized and 1 slightly worsened). The mean hemodynamics improved from baseline to 90 days after ELVR as follows: mean pulmonary artery pressure, -2.5 ± 3.5 mm Hg; pulmonary arterial wedge pressure, -4.3 ± 8.3 mm Hg; cardiac index, +0.3 ± 0.6 l/min/m(2), and 6-min walk distance, +59 ± 99 m. ELVR was performed without PH-related complications in all patients., Conclusion: To our knowledge, this is the first prospective, single-center pilot study to evaluate the feasibility and efficacy of ELVR in patients with established PH. ELVR was feasible and resulted in an improvement of clinical and hemodynamic parameters in 5 out of 6 patients. These results have to be further confirmed in larger-scale controlled studies., (© 2014 S. Karger AG, Basel.)

Background: Bronchoscopic coil treatment has been shown to improve pulmonary function, exercise capacity, and quality of life in patients with severe emphysema., Objectives: To perform a meta-analysis of the results of four independent European clinical trials investigating this coil therapy for emphysema., Methods: Data on all patients included in the four European clinical trials were analyzed for efficacy and safety outcomes., Results: A total of 2,536 coils were placed during 259 procedures in 140 patients. A total of 37 chronic obstructive pulmonary disease exacerbations and 27 pneumonias were recorded as serious adverse events up to 1 year after treatment. The pneumothorax rate was 6.4%. Both 6 and 12 months after treatment, significant (all p < 0.001) improvements were observed for: forced expiratory volume in 1 s [+0.08 liters (±0.19) and +0.08 liters (±0.21)], residual volume [RV; -510 ml (±850) and -430 ml (±720)], 6-min walking distance [6MWD; +44.1 m (±69.8) and +38.1 m (±71.9)], and St. George's Respiratory Questionnaire score [SGRQ; -9.5 points (±14.3) and -7.7 points (±14.2)]. No differences in any outcome measures were observed between heterogeneous and homogeneous emphysema patients. Only a high baseline RV was found to be an independent predictor of successful treatment., Conclusions: Bronchoscopic coil treatment improves pulmonary function, 6MWD, and quality of life in patients with severe emphysema up to 1 year after treatment, independent of the distribution of the disease., (© 2015 S. Karger AG, Basel.)

Purpose: Distinct morphological emphysema phenotypes were assessed by CT to show characteristic perfusion defect patterns., Material/methods: Forty-one patients with severe emphysema (GOLD III/IV) underwent three-dimensional high resolution computed tomography (3D-HRCT) and contrast-enhanced magnetic resonance (MR) perfusion. 3D-HRCT data was visually analyzed for emphysema phenotyping and quantification by consensus of three experts in chest-radiology. The predominant phenotype per segment was categorized as normal, centrilobular, panlobular or paraseptal. Segmental lung perfusion was visually analyzed using six patterns of pulmonary perfusion (1-normal; 2-mild homogeneous reduction in perfusion; 3-heterogeneous perfusion without focal defects; 4-heterogeneous perfusion with focal defects; 5-heterogeneous absence of perfusion; 6-homogeneous absence of perfusion), with the extent of the defect given as a percentage., Results: 730 segments were evaluated. CT categorized 566 (78%) as centrilobular, 159 (22%) as panlobular and 5 (<1%) as paraseptal with no normals. Scores with regards to MR perfusion patterns were: 1-0; 2-0; 3-28 (4%); 4-425 (58%); 5-169 (23%); 6-108 (15%). The predominant perfusion pattern matched as follows: 70 % centrilobular emphysema - heterogeneous perfusion with focal defects (score 4); 42% panlobular--homogeneous absence of perfusion (score 5); and 43% panlobular--heterogeneous absence of perfusion (score 6)., Conclusion: MR pulmonary perfusion patterns correlate with the CT phenotype at a segmental level in patients with severe emphysema., Key Points: • MR perfusion patterns correlate with the CT phenotype in emphysema. • Reduction of MR perfusion is associated with loss of lung parenchyma on CT • Centrilobular emphysema shows heterogeneous perfusion reduction while panlobular emphysema shows loss of perfusion.