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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 We extracted summary level data from the trial publications and where necessary we obtained unpublished data.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 FEV1 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 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. Copyright (C) 2019 Elsevier Ltd. 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 FEV1 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; pInterpretation 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. Copyright (C) 2019 Elsevier Ltd. All rights reserved.

Bronchoscopic thermal vapor ablation (BTVA) represents one of the endoscopic lung volume reduction (ELVR) techniques that aims at hyperinflation reduction in patients with advanced emphysema to improve respiratory mechanics. By targeted segmental vapor ablation, an inflammatory response leads to tissue and volume reduction of the most diseased emphysematous segments. So far, BTVA has been demonstrated in several single-arm trials and 1 multinational randomized controlled trial to improve lung function, exercise capacity, and quality of life in patients with upper lobe-predominant emphysema irrespective of the collateral ventilation. In this review, we emphasize the practical aspects of this ELVR method. Patients with upper lobe-predominant emphysema, forced expiratory volume in 1 second (FEV1) between 20 and 45% of predicted, residual volume (RV) > 175% of predicted, and carbon monoxide diffusing capacity (DLCO) ≥20% of predicted can be considered for BTVA treatment. Prior to the procedure, a special software assists in identifying the target segments with the highest emphysema index, volume and the highest heterogeneity index to the untreated ipsilateral lung lobes. The procedure may be performed under deep sedation or preferably under general anesthesia. After positioning of the BTVA catheter and occlusion of the target segment by the occlusion balloon, heated water vapor is delivered in a predetermined specified time according to the vapor dose. After the procedure, patients should be strictly monitored to proactively detect symptoms of localized inflammatory reaction that may temporarily worsen the clinical status of the patient and to detect complications. As the data are still very limited, BTVA should be performed within clinical trials or comprehensive registries where the product is commercially available.

Introduction: To evaluate the cardio-pulmonary hemodynamics changes before and after valve treatment, and their correlation with lobe volume reduction. Methods: This retrospective multicentre study included consecutive patients undergoing bronchoscopic valve treatment for heterogeneous emphysema. In addition to standard functional evaluation, patients underwent cardiac evaluation by Doppler trans-thoracic echocardiography. The difference in respiratory and cardio-pulmonary hemodynamics indexes before and 3-month after the procedure, and their relationship with changes in lobar volume were evaluated. Results: Seventy-seven patients were included in the study; of these 13 (17%) presented pulmonary hypertension. Only patients with target lobar volume reduction ≥ 563mL (n = 50) presented a significant improvement of forced expiratory volume in one second, residual volume, 6min-walk test, and St. George’s Respiratory Questionnaire score; a significant reduction of pulmonary artery pressure, and an improvement of left and right ventricle end-systolic volume; of left and right ventricle end-diastolic volume, and of left and right ventricle stroke volume. The change in residual volume was significantly correlated with changes in forced expiratory volume in one second (r = 0.68; p < 0.001); in 6min-walk test (r = 0.71; p < 0.001); in St. George’s Respiratory Questionnaire (r = 0.54; p < 0.001); in pulmonary artery pressure (r = 0.39; p = 0.001), in left (r = 0.28; p = 0.01) and right (r = 0.33; p = 0.002) ventricle end-systolic volume, in left (r = − 0.29; p = 0.008) and right (r = − 0.34; p = 0.007) end-diastolic volume, and in left (r = − 0.76; p = 0.009) and right (r = − 0.718; p = 0.001) ventricle stroke volume. Conclusion: Bronchoscopic valve treatment seemed to have positive effects on cardio-pulmonary hemodynamics, and these changes were correlated with reductions of lobar volume.

Introduction: Although lung volume reduction surgery and bronchoscopic lung volume reduction with endobronchial valves have both been shown to improve lung function, exercise capacity and quality of life in appropriately selected patients with emphysema, there are no direct comparison data between the two procedures to inform clinical decision making. Methods and Analysis: We describe the protocol of the CELEB study (ISRCTN19684749), a randomised controlled trial which will compare outcomes at 1 year between the two procedures, using a composite disease severity measure, the iBODE score, which includes body mass index, lung function, breathlessness and exercise capacity. Ethics and Dissemination: Ethical approval to conduct the study has been obtained from the Fulham Research Ethics Committee, London (16/LO/0286). The outcome of this trial will provide information to guide treatment choices in this population and will be presented at national and international meetings and published in peer-reviewed journals. We will also disseminate the main results to all participants in a letter.

Background Endobronchial valves had been utilized for many years to treat patients with advanced emphysema, despite unfavorable results. In this meta-analysis, we aimed to assess the efficacy and safety of the use of endobronchial valves in patients with heterogeneous advanced emphysema. Methods We performed systematic database searches to identify clinical trials that met all our inclusion criteria. Direct-comparison and mixed-treatment-comparison (MTC) meta-analyses were conducted to estimate the mean difference or odds ratio of outcomes. Each outcome was analyzed with Review Manager 5 statistical software. Results Eight prospective clinical trials assessing this therapy were retrieved, with a total of 744 patients. Outcomes, including the forced expiratory volume in 1 second (FEV1), 6-minute walk test (6MWT), and St. George's Respiratory Questionnaire (SGRQ), were analyzed, and the odds ratio of reported complications related to endobronchial valve therapy was calculated. Significant improvement in the mean difference of FEV1 (5.61 [4.42, 6.80]), 6MWT (25.75 [12.30, 39.20]), and SGRQ (−10.96 [−13.88, −8.05]) was observed after endobronchial valve treatment. Moreover, the rate of adverse events related to endobronchial valves was low. Conclusions Endobronchial valve treatment offers benefits in terms of lung function and quality of life. Endobronchial valve treatment is feasible and safe for patients with advanced heterogeneous emphysema, especially those with no evidence of collateral ventilation.

Chronic obstructive pulmonary disease (COPD) is a progressive condition comprising a constellation of disorders from chronic bronchitis, airflow obstruction through to emphysema. The global burden of COPD is estimated at more than 6% of the population. The standard of care is based on a combination of smoking cessation, immunization, pharmacological treatments and pulmonary rehabilitation. However, the more advanced stages of COPD are challenging to manage. In this situation, our current standards of care do not adequately control patient symptoms nor halt the progressive decline. For the emphysema phenotype, lung volume reduction surgery has shown a beneficial effect in selected patients but is counterbalanced by the morbidity experienced by some patients. Bronchoscopic volume reduction technologies have been developed to improve the clinical situation of emphysema patients. This expert statement provides broad guidance regarding patient selection and the current position of the available techniques for patients with advanced emphysema. (C) 2016 S. Karger AG, Basel

Chronic obstructive pulmonary disease remains one of the most common causes of morbidity and mortality globally. The disease is generally managed with pharmacotherapy, as well as guidance about smoking cessation and pulmonary rehabilitation. Endoscopic lung volume reduction (ELVR) has been proposed for the treatment of advanced emphysema, with the aim of obtaining the same clinical and functional advantages of surgical lung volume reduction whilst potentially reducing risks and costs. There is a growing body of evidence that certain well-defined sub-groups of patients with advanced emphysema may benefit from ELVR, provided the selection criteria are met and a systematic approach is followed. ELVR devices, particularly unidirectional valves and coils, are currently being rolled out to many countries outside of the USA and Europe, although very few centres currently have the capacity to correctly evaluate and provide ELVR to prospective candidates. The high cost of these interventions underpins the need for careful patient selection to best identify those who may or may not benefit from ELVR-related procedures. The aim of this review is to provide the practicing pulmonologist with an overview of the practical aspects and current evidence for the use of the various techniques available, and to suggest an evidence-based approach for the appropriate use of these devices, particularly in emerging markets, where there should be a drive to develop and equip key specialised ELVR units. (C) 2015 S. Karger AG, Basel

Over the past decade, several non-surgical and minimally invasive bronchoscopic lung volume reduction (BLVR) techniques have been developed to treat patients with severe chronic obstructive pulmonary disease (COPD). BLVR can be significantly efficacious, suitable for a broad cohort of patients, and associated with a solid safety profile at a reasonable expense. The introduction of BLVR is also expected to accelerate the further development of interventional pulmonology worldwide. Recently, results from clinical studies on BLVR techniques have been published, providing valuable information about the procedure's indications, contraindications, patient-selection criterion and outcomes. BLVR utilizing one-way endobronchial valves is gaining momentum as an accepted treatment in regular medical practice because of the identification of best responders. Patients with a heterogeneous emphysema distribution and without inter-lobar collateral ventilation show encouraging results. Furthermore, for patients with collateral ventilation, who are not considered candidates for valve treatment, and for patients with homogeneous emphysema, the introduction of lung volume reduction coil treatment is a promising solution. Moreover, with the development of newer treatment modalities, that is, biochemical sealant and thermal water vapor, the potential to treat emphysema irrespective of collateral flow, may be further increased. Nevertheless, patient selection for BLVR treatment will be crucial for the procedure's success and should be performed using a multidisciplinary team approach. Consequently, BLVR needs to be concentrated in high-volume centres that will offer better quality and experience with treatment challenges and adverse events. This review gives a general overview of BLVR from an expert and scientific perspective.

Introduction: A heterogeneous emphysema is one of the most severe forms of chronic obstructive pulmonary disease (COPD). In some cases, besides the standard pharmacotherapy, a new treatment option of emphysema can be used—bronchoscopic lung volume reduction (BLVR) with the use of intrabronchial valves. Objectives: To examine the health-related quality of life (HRQoL) of patients with severe emphysema after intrabronchial valve (IBV) implantation for the treatment of one lung. Materials and Methods: From 2011 to 2013 a single centre prospective observational study was performed. The study assessed the effect of the therapeutic BLVR intervention, measured by St. George Respiratory Questionnaire (SGRQ). A statistical analysis by use of Wilcoxon test for dependent variables was performed. Results: Twenty patients were enrolled to the study (mean age 63 ± 10 years), all ex-smokers with tobacco exposure 38 ± 11.3 packyears. After 3 months of IBV treatment the average SGRQ score improved significantly in total (–12.8; p < 0.001) and in domains and the differences were for: “symptoms” (–8.5; p < 0.001), “activity” (–13.9; p < 0.001) and “influence on life”(–13.5; p < 0.002). Conclusions: The presented study revealed a significant improvement of the quality in the life measured by SGRQ after IBV treatment for heterogeneous emphysema. For the first time our study showed the significant improvement of all three domains of SGRQ after IBV treatment.

Dynamic hyperinflation (DH) is a pathophysiologic hallmark of Chronic Obstructive Pulmonary Disease (COPD). The aim of this study was to investigate the impact of emphysema distribution on DH during a maximal cardiopulmonary exercise test (CPET) in patients with severe COPD. This was a retrospective analysis of prospectively collected data among severe COPD patients who underwent thoracic high-resolution computed tomography, full lung function measurements and maximal CPET with inspiratory manouvers as assessment for a lung volume reduction procedure. ΔIC was calculated by subtracting the end-exercise inspiratory capacity (eIC) from resting IC (rIC) and expressed as a percentage of rIC (ΔIC %). Emphysema quantification was conducted at 3 predefined levels using the syngo PULMO-CT (Siemens AG); a difference >25% between best and worse slice was defined as heterogeneous emphysema. Fifty patients with heterogeneous (62.7% male; 60.9 ± 7.5 years old; FEV1% = 32.4 ± 11.4) and 14 with homogeneous emphysema (61.5% male; 62.5 ± 5.9 years old; FEV1% = 28.1 ± 10.3) fulfilled the enrolment criteria. The groups were matched for all baseline variables. ΔIC% was significantly higher in homogeneous emphysema (39.8% ± 9.8% vs.31.2% ± 13%, p = 0.031), while no other CPET parameter differed between the groups. Upper lobe predominance of emphysema correlated positively with peak oxygen pulse, peak oxygen uptake and peak respiratory rate, and negatively with ΔIC%. Homogeneous emphysema is associated with more DH during maximum exercise in COPD patients.

Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy of ELS in a randomised controlled setting.Patients were randomised to ELS plus medical treatment or medical treatment alone. Despite early termination for business reasons and inability to assess the primary 12-month end-point, 95 out of 300 patients were successfully randomised, providing sufficient data for 3- and 6-month analysis.57 patients (34 treatment and 23 control) had efficacy results at 3 months; 34 (21 treatment and 13 control) at 6 months. In the treatment group, 3-month lung function, dyspnoea, and quality of life improved significantly from baseline when compared to control. Improvements persisted at 6 months with >50% of treated patients experiencing clinically important improvements, including some whose lung function improved by >100%. 44% of treated patients experienced adverse events requiring hospitalisation (2.5-fold more than control, p=0.01), with two deaths in the treated cohort. Treatment responders tended to be those experiencing respiratory adverse events.Despite early termination, results show that minimally invasive ELS may be efficacious, yet significant risks (probably inflammatory) limit its current utility.