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COPD: Journal of Chronic Obstructive Pulmonary Disease; Article: 2468328 | Published online: 10 Mar 2025. doi: 10.1080/15412555.2025.2468328
Efficacy and Safety of Lung Volume Reduction with Endobronchial Coil #2 and Coil #4 Results of the German Emphysema Registry—Lungenemphysemregister e.V.
Christian Grah 1 2 , Shiao Li Oei 2 , Joanna Krist 3 , Björn Wiesemann 4 , Bernd Schmidt 5 , Andreas Fertl 6 , Björn Schwick 7 , Ralf-Harto Hübner 8 , Birgit Becke 9 , Karl-Josef Franke 10 , Christian Geltner 11 , Stephan Eisenmann 12 , Franz Stanzel 13 , Grit Barten-Neiner 14 , Thomas Sgarbossa 8 , Katarzyna Blazejczyk 1 , Hannah Wüstefeld 1 15
Abstract
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Background: Clinical trials have shown beneficial results from lung volume reduction with endobronchial coils in patients with emphysema, but comprehensive safety data are not yet available for a new coil type, Coil #4. The objective of this study is to generate real-world data (RWD) on the safety and efficacy of endobronchial Coil #2 and Coil #4.
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Methods: This is a cohort study of prospectively collected data from the multicenter German Lung Emphysema Registry e.V. (LE-Registry) for patients with advanced lung emphysema undergoing lung volume reduction. All patients treated with Coil #2 or Coil #4 were evaluated at baseline and at 3 months for pulmonary function tests (FEV1, FVC, RV, DLCO, pCO2), exercise capacity, quality of life (mMRC, CAT, SGRQ), and adverse events. Descriptive statistics were used to analyze response rates and changes in clinical outcomes.
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Results: Data from 73 patients (37 Coil #2, 36 Coil #4) enrolled between 2017 and 2024 were evaluated. At 3 months, outcome data were available for 32 Coil #2 and 26 Coil #4 patients. In the Coil #2 cohort significant improvements in RV and SGRQ were observed. The Coil #4 cohort shows significant improvements in FVC, RV, SGRQ, and CAT. Complications occurred in 37% of Coil #2 and 37% of Coil #4 patients, with 26% of patients treated with Coil #4 experiencing pneumothorax.
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Conclusions: The outcomes observed in this RWD study are consistent with other published coil studies. The higher pneumothorax rate with Coil #4 is surprising and should be minimized by adapting the technique.
ERJ Open Res. 2025 Jan 13;11(1):00410-2024. doi: 10.1183/23120541.00410-2024
​Clinical improvements after endoscopic lung volume reduction with valves in patients with advanced emphysema and a 6-min walk test ≤140 m at baseline
​Jacopo Saccomanno 1, Lara Kilic 1, Thomas Sgarbossa 1, Konrad Neumann 2, Franz Stanzel 3, Angelique Holland 4, Christian Grah 5, Wolfgang Gesierich 6, Joanna Krist 7, Joachim H Ficker 8, Stephan Eggeling 9, Stefan Andreas 10, Bernd Schmidt 11, Stephan Eisenmann 12, Björn Schwick 13, Karl-Josef Franke 14 15, Andreas Fertl 16, Martin Witzenrath 1 17 18, Ralf-Harto Hübner 1
Abstract
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Background: Data regarding the effectiveness and safety of endoscopic lung volume reduction with valves (ELVR) in emphysema patients with a very low 6-min walk test (6MWT) are limited. Patients with severe emphysema and very low exercise capacity, as indicated by a 6MWT ≤140 m, are often excluded from clinical studies on ELVR, assuming limited therapeutic benefits and increased complication risk.
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Study designs and methods: This study utilised data from the Lungenemphysemregister e.V., a large German national multi-centre prospective open-label clinical trial, and aimed to assess the outcomes of ELVR in patients with a baseline 6MWT ≤140 m and dyspnoea primarily attributed to hyperinflation.
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Results: 54 patients with a baseline 6MWT ≤140 m and 365 patients with a baseline 6MWT between 140 and 450 m were included in the study. Baseline characteristics were representative for patients with advanced lung emphysema. Patients with a 6MWT ≤140 m at baseline had a lower forced expiratory volume in 1 s and diffusing capacity of the lung for carbon monoxide and higher symptom burden. In the 3-month follow-up, patients of both groups showed statistically significant improvements in lung function parameters, exercise capacity and quality of life parameters compared to baseline. Patients with a 6MWT ≤140 m at baseline showed significantly more 6MWT improvement compared to patients with baseline 6MWT between 140 and 450 m. Moreover, complication rates were similar in both groups.
Respiration​. 2024 Nov 25:1-9. doi: 10.1159/000542806.
Comparison of Efficacy and Safety of Different Types of One-Way Valves in Endoscopic Lung Volume Reduction in Patients with Severe Lung Emphysema
Thomas Sgarbossa 1, Philipp Borchers 1, Jacopo Saccomanno 1, Katharina Ahrens 1, Hannah Friederike Wüstefeld 2, Eva Pappe 1, Uta Wuelfing 3, Ulrich Klein 3, Martin Witzenrath 1, Franz Stanzel 3, Christian Grah 2, Ralf-Harto Hübner 1
Abstract
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Introduction: Endoscopic lung volume reduction (ELVR) with valves is an effective intervention in patients with severe lung emphysema. Two types of valves are established in clinical practice: Zephyr endobronchial valves (EBVs) and Spiration Valve System (SVS). We aimed to compare outcomes and the safety associated with these two types of one-way valves.
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Methods: Data were collected from three German lung emphysema centers as part of a prospective observational study focusing on lung volume reduction. Two groups were formed based on valve types. In both groups, lung function (FEV1, RV, diffusion capacity of the lung for carbon monoxide, pCO2), 6-min walking distance (6MWD), quality of life (SGRQ, mMRC, CAT), and complication rate were recorded at baseline and at follow-up 3 to 6 months later.
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Results: A total of 54 patients were treated with SVS valves and 99 patients with EBV. There were no significant differences between both groups at baseline. Notably, both types of valves exhibited significant enhancements in lung function and quality of life. Interestingly, there were no significant differences in the median change of all measured parameters for both groups, suggesting comparable improvements in EBV and SVS. Pneumothorax was the most common complication for both valve types. The incidence of adverse events did not differ significantly between groups.
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Conclusion: Our study suggests that both types of valves are safe and effective in the treatment of severe lung emphysema. We recommend choosing the valve type based on individual bronchial anatomy. However, further randomized studies are needed to confirm our results.
Chronic Obstr Pulm Dis​. 2023 Jul 26;10(3):211-223.doi: 10.15326/jcopdf.2022.0383.
Impact of Coronavirus Disease 2019 on Hospital Admissions, Health Status, and Behavioral Changes of Patients with COPD
Eva Pappe 1 , Ralf Hammerich 2 , Jacopo Saccomanno 1 , Thomas Sgarbossa 1 , Anne Pohrt 3 , Bernd Schmidt 4 , Christian Grah 5, Stephan Eisenmann 6 , Angelique Holland 7 , Stephan Eggeling 8 , Franz Stanzel 9 , Martin Witzenrath 1 , Ralf-Harto Hübner 1
Abstract
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Introduction: Patients with chronic obstructive pulmonary disease (COPD) have an increased risk of acquiring severe coronavirus disease 2019 (COVID-19), which is why self-isolation was recommended. However, long periods of social isolation, accompanied by limited access to health care systems, might influence the outcome of patients with severe COPD negatively.
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Methods: Data from COPD and pneumonia patients at Charité-Universitätsmedizin Berlin and the volume of endoscopic lung volume reduction (ELVR) surgeries from the German Lung Emphysema Registry (Lungenemphysem Register e.V.) were analyzed from pre-pandemic (2012 to 2019) to the pandemic period (2020 and 2021). In addition, 52 patients with COPD Global initiative for chronic Obstructive Lung Disease (GOLD) stage 4 status included in the lung emphysema registry received questionnaires during lockdowns from June 2020 to April 2021.
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Results: Admissions and ventilation therapies administered to COPD patients significantly decreased during the COVID-19 pandemic. Likewise, there was a reduction in ELVR treatments and follow-ups registered in German emphysema centers. Mortality was slightly higher among patients hospitalized with COPD during the pandemic. Increasing proportions of COPD patients with GOLD stage 3 and GOLD stage 4 status reported behavioral changes and subjective feelings of increasing COPD symptoms the longer the lockdown lasted. However, COPD symptom questionnaires revealed stable COPD symptoms over the pandemic time period.
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Summary: This study reveals reduced COPD admissions and elective treatment procedures of COPD patients during the pandemic, but a slight increase in mortality among patients hospitalized with COPD, irrespective of COVID-19. Correspondingly, patients with severe COPD reported subjective deterioration of their health status, probably caused by their very strict compliance with lockdown measures.
ERJ Open Res​ 2023 Aug 21;9(4):00190-2023. doi: 10.1183/23120541.00190-2023. eCollection 2023 Jul.
Assessment of efficacy and safety of endoscopic lung volume reduction with one-way valves in patients with a very low FEV1
Thomas Sgarbossa,1,17 Pavlina Lenga,1,17 Franz Stanzel,2 Angelique Holland,3 Christian Grah,4 Wolfgang Gesierich,5 Andreas Gebhardt,6 Joachim Ficker,7 Stephan Eggeling,8 Stefan Andreas,9 Bernd Schmidt,10 Stephan Eisenmann,11 Björn Schwick,12 Karl-Josef Franke,13 Andreas Fertl,14 Martin Witzenrath,1,15,16 and Ralf-Harto Hübner1, on behalf of the Lungenemphysemregister e.V.
Abstract
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Introduction: Endoscopic lung volume reduction (ELVR) with one-way valves produces beneficial outcomes in patients with severe emphysema. Evidence on the efficacy remains unclear in patients with a very low forced expiratory volume in 1 s (FEV1) (⩽20% predicted). We aim to compare clinical outcomes of ELVR, in relation to the FEV1 restriction
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Methods: This was a multicentre prospective study of patients with severe lung disease who were evaluated based on lung function, exercise capacity (6-min walk test [6-MWT]), and quality-of-life tests.
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Results: 33 patients with FEV1 ⩽20% pred and 265 patients with FEV1 21–45% pred were analysed. After ELVR, an increase in FEV1 was observed in both groups (both p<0.001). The mMRC and CAT scores, and 6MWD improved in both groups (all p<0.05). The SGRQ score improved significantly in the FEV1 21–45% pred group, and by trend in the FEV1 ⩽20% pred group. Pneumothorax was the most frequent complication within the first 90 days in both groups (FEV1 ⩽20% pred: 7.7% versus FEV1 21–45% pred: 22.1%; p=0.624). No deaths occurred in the FEV1 ⩽20% pred group up to 6 months.
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Conclusion: Our study highlights the potential efficacy of one-way valves, even in patients with very low FEV1, as these patients experienced significant improvements in FEV1, 6MWD and quality of life. No death was reported, suggesting a good safety profile, even in these high-risk patients.
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Respiration. 2022;101(9):823-832. doi: 10.1159/000524996. Epub 2022 Jul 4.
Endoscopic Lung Volume Reduction with One-Way Valves in Patients with Severe Chronic Obstructive Pulmonary Disease with Hypercapnia
Pavlina Lenga 1, Christian Grah 2, Christoph Ruwwe-Glösenkamp 3, Jacopo Saccomanno 3, Jens Rückert 4, Stephan Eggeling 5, Sven Gläser 6, Sylke Kurz 7, Stephan Eisenmann 8, Marcus Krüger 9, Bernd Schmidt 10, Paul Schneider 10, Stefan Andreas 11, Marc Hinterthaner 12, Joachim Pfannschmidt 13, Andreas Gebhardt 14, Franz Stanzel 15, Angélique Holland 16, Andreas Kirschbaum 17, Birgit Becke 18, Ralf-Harto Hübner 3; Lung Emphysema Registry Study Group
Abstract
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Background: Robust clinical evidence on the efficacy and safety of endoscopic lung volume reduction (ELVR) with one-way valves in patients with severe lung emphysema with chronic hypercapnic respiratory failure is lacking.
Objective: The aim of this study was to compare patient characteristics, clinical outcome measures, and incidences of adverse events between patients with severe COPD undergoing ELVR with one-way valves and with either a partial pressure of carbon dioxide (pCO2) of ≤45 mm Hg or with pCO2 >45 mm Hg.
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Methods: This was a multicentre prospective study of patients with severe lung disease who were evaluated based on lung function, exercise capacity (6-min walk test [6-MWT]), and quality-of-life tests.
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Results: Patients with pCO2 ≤45 mm Hg (n = 157) and pCO2 >45 mm Hg (n = 40) showed similar baseline characteristics. Patients with pCO2 ≤45 mm Hg demonstrated a significant increase in forced expiratory volume in 1 s (p < 0.001), a significant decrease in residual volume (RV) (p < 0.001), and significant improvements in the quality of life and 6-MWT at the 3-month follow-up. Patients with pCO2 >45 mm Hg had significant improvements in RV only (p < 0.05). There was a significant decrease in pCO2 between baseline and follow-up in hypercapnic patients, relative to the decrease in patients with pCO2 ≤45 mm Hg (p = 0.008). Patients who were more hypercapnic at baseline showed a greater reduction in pCO2 after valve placement (r = -0.38, p < 0.001). Pneumothorax was the most common adverse event in both groups.
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Conclusions: ELVR with one-way valves seems clinically beneficial with a remarkably good safety profile for patients with chronic hypercapnic respiratory failure.
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ERJ Open Res. 2021 Jan 25;7(1):00449-2020. doi: 10.1183/23120541.00449-2020. eCollection 2021 Jan.
Endoscopic lung volume reduction with endobronchial valves in very low D LCO patients: results from the German Registry - Lungenemphysemregister e.V
Pavlina Lenga 1 2, Christoph Ruwwe-Glösenkamp 1 2, Christian Grah 3, Joachim Pfannschmidt 4, Jens Rückert 5, Stephan Eggeling 6, Sven Gläser 7, Bernd Schmidt 8, Paul Schneider 9, Sylke Kurz 10, Gunda Leschber 11, Andreas Gebhardt 12, Birgit Becke 13, Olaf Schega 14, Jakob Borchardt 15, Ralf-Harto Hübner 1
Abstract
Background: Endoscopic lung volume reduction (ELVR) with valves has been suggested to be the key strategy for patients with severe emphysema and concomitant low diffusing capacity of the lung for carbon monoxide (D LCO). However, robust evidence is still missing. We therefore aim to compare clinical outcomes in relation to D LCO for patients treated with ELVR.
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Methods: We assessed D LCO at baseline and 3 months follow-up and compared pre- and postprocedural pulmonary function test, quality of life, exercise capacity and adverse events. This is a retrospective subanalysis of prospectively collected data from the German Lung Emphysema Registry.
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Results: In total, 121 patients treated with ELVR were analysed. Thirty-four patients with a D LCO ≤20% and 87 patients with a D LCO >20% showed similar baseline characteristics. After ELVR, there was a decrease of residual volume (both p<0.001 to baseline) in both groups, and both demonstrated better quality of life (p<0.01 to baseline). Forced expiratory volume in 1 s (FEV1) improved significantly only in patients with a D LCO >20% (p<0.001 to baseline). Exercise capacity remained almost unchanged in both groups (p=0.3). The most frequent complication for both groups was a pneumothorax (D LCO ≤20%: 17.6% versus D LCO >20%: 16.1%; p=0.728). However, there were no significant differences in other adverse events between both groups.
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Conclusions: ELVR improves lung function as well as quality of life in patients with D LCO >20% and D LCO ≤20%. Adverse events did not differ between groups. Therefore, ELVR should be considered as a treatment option, even in patients with a very low D LCO.
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