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

Abstract 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 FEV1 improvement from baseline of 12% or greater. Changes in FEV1, 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 FEV1 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 FEV1 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).

Abstract 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 FEV1 (liters) at 3 months relative to baseline in the EBV group versus the SoC group. Secondary outcomes included changes in FEV1, 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]; FEV1, % 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 FEV1 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.

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.

Jacopo Saccomanno,1 Thomas Sgarbossa,1 Konrad Neumann,2 Franz Stanzel,3 Stefan Andreas,4,5 Stephan Eisenmann,6 Bernd Schmidt,7 Wolfgang Gesierich,8 Martin Witzenrath,1,5,9 Ralf Harto Hübner1 On behalf of the Lung Emphysema study group1Department of Infectious Diseases, Respiratory Medicine and Critical Care, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Berlin, Germany; 2Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, Germany; 3Department of Respiratory Medicine, Lungenklinik Hemer, Hemer, Germany; 4Zentrum für Pneumologie, Lungenfachklinik Immenhausen, Immenhausen, Germany; 5German Center for Lung Research (DZL), Berlin, Germany; 6Department of Respiratory Medicine, Universitätsklinikum Halle, Halle, Germany; 7Department of Internal Medicine – Respiratory and Sleep Medicine, DRK Kliniken Berlin Mitte, Berlin, Germany; 8Department of Respiratory Medicine, Asklepios Lungenklinik Gauting, Gauting, Germany; 9Capnetz Foundation, Hannover, GermanyCorrespondence: Jacopo Saccomanno, Department of Infectious Diseases, Respiratory Medicine and Critical Care, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Hindenburgdamm 30, Berlin, 12203, Germany, Email jacopo.saccomanno@charite.deBackground: Endoscopic lung volume reduction (ELVR) with valves is a treatment option for selected patients with emphysema. Collateral Ventilation (CV) is measured directly with the Chartis® bronchoscopic assessment system (PulmonX Inc. Redwood City, CA, USA) and indirectly via fissure completeness score (FCS) on computed-tomography (CT). It remains unclear, whether the additional Chartis® assessment improves treatment outcome when the target lobe shows intact fissure (FCS ≥ 95%).Study Design and Methods: This retrospective analysis used data from the German Lungenemphysemregister e.V. a prospective multicenter trial on lung volume reduction therapy. Patients with an intact fissure (FCS ≥ 95%) of the target lobe undergoing ELVR were included. Treatment outcomes were compared between patients who had a Chartis® measurement prior to ELVR and those who did not.Results: A total of 262 patients were analyzed: 175 with Chartis® and 87 without. Baseline parameters were comparable between groups. At 3-month follow-up significant improvements in lung function parameters (FEV1, RV, DLCO, pCO2), exercise capacity (6-MWT) and quality of life parameters (SGRQ, mMRC and CAT) were seen in both groups. Treatment efficacy at 3-month follow-up was comparable in patients regardless of previous Chartis® measurements. Furthermore, there was no difference in treatment outcome, when comparing improvements for the right and left lung separately. Responder rates were similar between the groups, with a comparable MCID in both. Complication rates were also largely comparable, except for a higher pneumothorax rate in the no-Chartis group (7% vs 22%).Discussion: This analysis did not find evidence that a Chartis® assessment provided additional benefit to the treatment response after ELVR at 3-month follow-up in patients with an intact fissure of the target lobe with an FCS ≥ 95%. These findings may be clinically relevant as they suggest that additional invasive Chartis® measurement might be dispensable in this subgroup.Keywords: Lung emphysema, endoscopic lung volume reduction with valves, collateral ventilation, COPD

In patients with severe emphysema, bronchoscopic lung volume reduction using one-way valves is a promising therapeutic option to improve lung function and quality of life. The goal of this treatment is to achieve a complete lobar atelectasis. In a significant proportion of patients, this atelectasis cannot be achieved due to interlobar collateral ventilation. This collateral ventilation is generated through incomplete lobar fissures. Therefore, only patients with complete fissures and no collateral ventilation can be selected for endobronchial therapy with one-way valves. Incomplete fissures are very common and exhibit a great variation in anatomy. The reported prevalence is 17%-85% for the right major fissure, 19%-74% for the left major fissure, and 20%-90% for the minor fissure. There are several methods of measuring or predicting the presence of collateral ventilation, with computed tomography (CT)-fissure analysis and the Chartis measurement being the most important. CT-fissure analysis is an indirect method to measure the completeness of fissures as a surrogate for collateral ventilation. The Chartis system is an endobronchial method to directly measure the presence of collateral ventilation. Both methods have unique value, and the combination of both can accurately predict the treatment response to the bronchoscopic placement of endobronchial valves. This review provides an in-depth view of lung fissure and collateral ventilation to help understand its importance in selecting the appropriate patients for new emphysema treatments and thus avoid useless treatment in unsuitable patients.

Abstract 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.

Lung volume reduction using one-way endobronchial valves is a bronchoscopic treatment for patients with severe emphysema without collateral ventilation between the treatment target lobe and the ipsilateral lobe(s). CT-scan fissure analysis is often used as a surrogate to predict the absence of collateral ventilation. We aimed to evaluate the predictive value of the fissure completeness score (FCS) compared to the functional Chartis measurement of collateral ventilation and to provide cut-off values of the FCS in patient selection. Multicenter study in patients eligible for treatment with one-way valves. The FCS was calculated by quantitative CT analysis (Thirona, the Netherlands) and compared to status of interlobar collateral ventilation measured with Chartis system (PulmonX, USA). Thresholds were calculated for the predictive values of the presence of collateral ventilation. An FCS >95% of the left major fissure had a positive predictive value (PPV) of 91%, with 1 in 11 fissures demonstrating collateral ventilation with Chartis measurement, whereas an FCS of ≤80% had a negative predictive value (NPV) of 100% for the presence of collateral ventilation. For the right major fissure, the NPV was 100% for an FCS ≤90%, but 69.7% for the right upper lobe fissure. Quantitative CT analysis is recommended in all patients evaluated for endobronchial valves. Patients with incomplete fissures (left major fissure: FCS <80%; right major fissure: <90%) can be excluded from Chartis measurement and endobronchial valve treatment. In patients with more complete fissures, the FCS is not specific enough for endobronchial valve treatment decisions. In this case, additional Chartis measurements are always recommended in the right lung. For the left lung, Chartis assessments may be omitted if the FCS is >95%.

Background: Endobronchial valve therapy has proven to reduce lung hyperinflation and decrease disease burden in patients with severe lung emphysema. Exclusion of collateral ventilation (CV) of the targeted lobe by using an endobronchial assessment system (Chartis; PulmonX, Drive Redwood City, CA, USA) in combination with software-based fissure integrity analysis (FCS [fissure completeness score]) of computed tomography scans of the lung are established tools to select appropriate patients for endobronchial valve treatment. So far, there is no conclusive evidence if the ventilation mode during bronchoscopy impacts the outcome of Chartis assessments. Methods: Patients with Chartis assessments and software-based quantification of FCS (StratX; PulmonX, Drive Redwood City, CA, USA) were enrolled in this retrospective study. During bronchoscopy, pulmonary fissure integrity was evaluated with the Chartis assessment system in each patient first under spontaneous breathing and subsequently under high-frequency (HF) jet ventilation. Results: In total, 102 patients were analyzed. Four Chartis phenotypes CV positive (CV+), CV negative (CV−), low flow, and low plateau in spontaneous breathing and HF jet ventilation were identified. The frequency of each Chartis phenotype per lobe was similar in both settings. When comparing Chartis assessments in spontaneous breathing and HF jet ventilation, there was an overall good concordance rate for all analyzed fissures. In agreement, receiver operating characteristic analysis of the FCS showed an almost similar prediction for CV+ and CV− status independent of the ventilation modes. Conclusion: Chartis assessment in spontaneous breathing and HF jet ventilation had similar rates in detecting CV in lung emphysema. Our results suggest that both modes are equivalent for the assessment of CV.

Endoscopic lung volume reduction (ELVR) with valves is a treatment option for selected patients with emphysema. Collateral Ventilation (CV) is measured directly with the Chartis bronchoscopic assessment system (PulmonX Inc. Redwood City, CA, USA) and indirectly via fissure completeness score (FCS) on computed-tomography (CT). It remains unclear, whether the additional Chartis assessment improves treatment outcome when the target lobe shows intact fissure (FCS ≥95%). This retrospective analysis used data from the German Lungenemphysemregister e.V. a prospective multicenter trial on lung volume reduction therapy. Patients with an intact fissure (FCS ≥95%) of the target lobe undergoing ELVR were included. Treatment outcomes were compared between patients who had a Chartis measurement prior to ELVR and those who did not. A total of 262 patients were analyzed: 175 with Chartis and 87 without. Baseline parameters were comparable between groups. At 3-month follow-up significant improvements in lung function parameters (FEV1, RV, DLCO, pCO2), exercise capacity (6-MWT) and quality of life parameters (SGRQ, mMRC and CAT) were seen in both groups. Treatment efficacy at 3-month follow-up was comparable in patients regardless of previous Chartis measurements. Furthermore, there was no difference in treatment outcome, when comparing improvements for the right and left lung separately. Responder rates were similar between the groups, with a comparable MCID in both. Complication rates were also largely comparable, except for a higher pneumothorax rate in the no-Chartis group (7% vs 22%). This analysis did not find evidence that a Chartis assessment provided additional benefit to the treatment response after ELVR at 3-month follow-up in patients with an intact fissure of the target lobe with an FCS ≥95%. These findings may be clinically relevant as they suggest that additional invasive Chartis measurement might be dispensable in this subgroup.