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      Long-term follow up after endoscopic valve therapy in patients with severe emphysema

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          Abstract

          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.

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          Most cited references22

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          A randomized study of endobronchial valves for advanced emphysema.

          Endobronchial valves that allow air to escape from a pulmonary lobe but not enter it can induce a reduction in lobar volume that may thereby improve lung function and exercise tolerance in patients with pulmonary hyperinflation related to advanced emphysema. We compared the safety and efficacy of endobronchial-valve therapy in patients with heterogeneous emphysema versus standard medical care. Efficacy end points were percent changes in the forced expiratory volume in 1 second (FEV1) and the 6-minute walk test on intention-to-treat analysis. We assessed safety on the basis of the rate of a composite of six major complications. Of 321 enrolled patients, 220 were randomly assigned to receive endobronchial valves (EBV group) and 101 to receive standard medical care (control group). At 6 months, there was an increase of 4.3% in the FEV1 in the EBV group (an increase of 1.0 percentage point in the percent of the predicted value), as compared with a decrease of 2.5% in the control group (a decrease of 0.9 percentage point in the percent of the predicted value). Thus, there was a mean between-group difference of 6.8% in the FEV1 (P=0.005). Roughly similar between-group differences were observed for the 6-minute walk test. At 12 months, the rate of the complications composite was 10.3% in the EBV group versus 4.6% in the control group (P=0.17). At 90 days, in the EBV group, as compared with the control group, there were increased rates of exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization (7.9% vs. 1.1%, P=0.03) and hemoptysis (6.1% vs. 0%, P=0.01). The rate of pneumonia in the target lobe in the EBV group was 4.2% at 12 months. Greater radiographic evidence of emphysema heterogeneity and fissure completeness was associated with an enhanced response to treatment. Endobronchial-valve treatment for advanced heterogeneous emphysema induced modest improvements in lung function, exercise tolerance, and symptoms at the cost of more frequent exacerbations of COPD, pneumonia, and hemoptysis after implantation. (Funded by Pulmonx; ClinicalTrials.gov number, NCT00129584.)
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            The minimal important difference of exercise tests in severe COPD.

            Our aim was to determine the minimal important difference (MID) for 6-min walk distance (6MWD) and maximal cycle exercise capacity (MCEC) in patients with severe chronic obstructive pulmonary disease (COPD). 1,218 patients enrolled in the National Emphysema Treatment Trial completed exercise tests before and after 4-6 weeks of pre-trial rehabilitation, and 6 months after randomisation to surgery or medical care. The St George's Respiratory Questionnaire (domain and total scores) and University of California San Diego Shortness of Breath Questionnaire (total score) served as anchors for anchor-based MID estimates. In order to calculate distribution-based estimates, we used the standard error of measurement, Cohen's effect size and the empirical rule effect size. Anchor-based estimates for the 6MWD were 18.9 m (95% CI 18.1-20.1 m), 24.2 m (95% CI 23.4-25.4 m), 24.6 m (95% CI 23.4-25.7 m) and 26.4 m (95% CI 25.4-27.4 m), which were similar to distribution-based MID estimates of 25.7, 26.8 and 30.6 m. For MCEC, anchor-based estimates for the MID were 2.2 W (95% CI 2.0-2.4 W), 3.2 W (95% CI 3.0-3.4 W), 3.2 W (95% CI 3.0-3.4 W) and 3.3 W (95% CI 3.0-3.5 W), while distribution-based estimates were 5.3 and 5.5 W. We suggest a MID of 26 ± 2 m for 6MWD and 4 ± 1 W for MCEC for patients with severe COPD.
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              Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation.

              Bronchoscopic lung-volume reduction with the use of one-way endobronchial valves is a potential treatment for patients with severe emphysema. To date, the benefits have been modest but have been hypothesized to be much larger in patients without interlobar collateral ventilation than in those with collateral ventilation.
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                Author and article information

                Contributors
                Journal
                Ther Adv Respir Dis
                Ther Adv Respir Dis
                TAR
                sptar
                Therapeutic Advances in Respiratory Disease
                SAGE Publications (Sage UK: London, England )
                1753-4658
                1753-4666
                02 August 2019
                Jan-Dec 2019
                : 13
                : 1753466619866101
                Affiliations
                [1-1753466619866101]Pneumology and Critical Care Medicine, Thoraxklinik at University of Heidelberg, Roentgenstr. 1, Heidelberg, 69126, Germany Translational Lung Research Center Heidelberg (TLRCH), German Center for Lung Research, Heidelberg, Germany
                [2-1753466619866101]Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany
                [3-1753466619866101]Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany
                [4-1753466619866101]Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany
                [5-1753466619866101]Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany Translational Lung Research Center Heidelberg (TLRCH), German Center for Lung Research, Heidelberg, Germany
                [6-1753466619866101]Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany Translational Lung Research Center Heidelberg (TLRCH), German Center for Lung Research, Heidelberg, Germany
                [7-1753466619866101]Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany Translational Lung Research Center Heidelberg (TLRCH), German Center for Lung Research, Heidelberg, Germany
                Author notes

                The reviews of this paper are available via the supplemental material section.

                Author information
                https://orcid.org/0000-0002-4857-9854
                Article
                10.1177_1753466619866101
                10.1177/1753466619866101
                6681249
                31373259
                5aa4139d-65cb-4158-ab50-cb1c1be1d7c7
                © The Author(s), 2019

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 16 March 2019
                : 2 July 2019
                Categories
                Original Research
                Custom metadata
                January-December 2019

                bronchoscopy,copd,emphysema,endoscopic lung volume reduction,interventional pneumology

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