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Background: Bronchoscopic lung volume reduction using endobronchial coils is a new treatment for patients with severe emphysema. To date, the benefits have been modest and have been suggested to be much larger in patients with severe hyperinflation and nonmulti-comorbidity. Objective: We aimed to evaluate the efficacy and safety of endobronchial coil treatment in a randomized multicenter clinical trial using optimized patient selection. Method: Patients with severe emphysema on HRCT scan with severe hyperinflation (residual volume [RV] ≥200% predicted and RV/total lung capacity [TLC] >55%) were randomized to coil treatment or control. Primary outcome measures were differences in the forced expiratory volume in 1 s (FEV1) and St George’s Respiratory Questionnaire (SGRQ) total score at 6 months. Results: Due to premature study termination, a total of 120 patients (age 63 ± 7 years, FEV1 29 ± 7% predicted, RV 251 ± 41% predicted, RV/TLC 67 ± 6%, and SGRQ 58 ± 13 points), instead of 210 patients, were randomized. At study termination, 91 patients (57 coil and 34 control) had 6-month results available. Analyses showed significantly greater improvements in favor of the coil group. The increase in FEV1 was greater in the coil group than that in the control group by + 10.3 [+4.7 to +16.0] % and in SGRQ by −10.6 [−15.9 to −5.4] points. At study termination, there were 5 (6.8%) deaths in the coil cohort reported. Conclusion: Despite early study termination, coil treatment compared to control results in a significant improvement in the lung function and quality of life benefits for up to 6 months in patients with emphysema and severe hyperinflation. These improvements were of clinical importance but were associated with a higher likelihood of serious adverse events.

Bronchoscopic lung volume reduction with one-way endobronchial valves is a guideline treatment option for patients with advanced emphysema that is supported by extensive scientific data. Patients limited by severe hyperinflation, with a suitable emphysema treatment target lobe and with absence of collateral ventilation, are the responders to this treatment. Detailed patient selection, a professional treatment performance, and dedicated follow up of the valve treatment, including management of complications, are key ingredients to success. This treatment does not stand alone; it especially requires extensive knowledge of COPD for which the most appropriate treatment is discussed in a multidisciplinary approach. We discuss the endobronchial valve treatment for emphysema and provide a guideline for patient selection, treatment guidance, and practice tools, based on our own experience and literature.

Methods BT10+ was an international, multicentre, follow-up study of participants who were previously enrolled in the AIR, RISA, and AIR2 trials and who had 10 or more years of follow-up since bronchial thermoplasty treatment. Data on patient demographics, quality of life, lung function, CT scans (AIR2 participants only), severe exacerbations, and health-care use during the previous year were collected at the BT10+ 10-year outcomes study visit. The primary effectiveness endpoint was durability of the thermoplasty treatment effect, determined by comparing the proportion of participants who had severe exacerbations during the first and fifth years after bronchial thermoplasty treatment with the proportion of participants who had severe exacerbations during the 12-month period before the BT10+ visit. The primary safety endpoint was the absence of clinically significant post-treatment respiratory image changes after bronchial thermoplasty, defined as bronchiectasis or bronchial stenosis as confirmed by pulmonary volumetric highresolution CT scan at the BT10+ visit (AIR2 participants only). All analyses were done on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03243292. The last patient was enrolled on Dec 11, 2018. The last patient completed follow-up on Jan 10, 2019.Findings The BT10+ study enrolled 192 (45%) of the 429 participants who were enrolled in the AIR, RISA, and AIR2 trials. The BT10+ participants comprised 136 who received bronchial thermoplasty (52% of the 260 participants who received bronchial thermoplasty in the original trials), and 56 sham or control participants (33% of 169 from the original trials). 18 (32%) sham or control participants received bronchial thermoplasty after the previous trials concluded. The participants included in BT10+ were followed for 10?8?15?6 years (median 12?1 years) post-treatment. Baseline characteristics were similar between participants enrolled in BT10+ and those not enrolled. Participants treated with bronchial thermoplasty had similar proportions of severe exacerbations at the BT10+ visit (34 [25%] of 136 participants) compared with 1 year (33 [24%] of 135 participants; difference 0?6%, 95% CI ?9?7 to 10?8) and 5 years (28 [22%] of 130 participants; difference 3?5%, ?6?7% to 13?6) after treatment. Quality of life measurements and spirometry were similar between year 1, year 5, and the BT10+ visit. At the BT10+ study visit, pulmonary high-resolution CT scans from AIR2 participants treated with bronchial thermoplasty showed that 13 (13%) of 97 participants had bronchiectasis. When compared with baseline high-resolution CT scans, six (7%) of 89 participants treated with bronchial thermoplasty who did not have bronchiectasis at baseline had developed bronchiectasis after treatment (5 classified as mild, 1 classified as moderate). Participants treated with bronchial thermoplasty after the original study and participants in the sham or control group also had reductions in severe exacerbations at the BT10+ visit compared with baseline.Summary Background Bronchial thermoplasty is an endoscopic treatment for uncontrolled asthma. Previous randomised clinical trials have shown that bronchial thermoplasty reduces severe exacerbations in people with asthma. However, the long-term efficacy and safety of bronchial thermoplasty beyond 5 years is unknown. The BT10+ study aimed to investigate the efficacy and safety of bronchial thermoplasty after 10 or more years of follow-up. Methods BT10+ was an international, multicentre, follow-up study of participants who were previously enrolled in the AIR, RISA, and AIR2 trials and who had 10 or more years of follow-up since bronchial thermoplasty treatment. Data on patient demographics, quality of life, lung function, CT scans (AIR2 participants only), severe exacerbations, and health-care use during the previous year were collected at the BT10+ 10-year outcomes study visit. The primary effectiveness endpoint was durability of the thermoplasty treatment effect, determined by comparing the proportion of participants who had severe exacerbations during the first and fifth years after bronchial thermoplasty treatment with the proportion of participants who had severe exacerbations during the 12-month period before the BT10+ visit. The primary safety endpoint was the absence of clinically significant post-treatment respiratory image changes after bronchial thermoplasty, defined as bronchiectasis or bronchial stenosis as confirmed by pulmonary volumetric high resolution CT scan at the BT10+ visit (AIR2 participants only). All analyses were done on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03243292. The last patient was enrolled on Dec 11, 2018. The last patient completed follow-up on Jan 10, 2019. Findings The BT10+ study enrolled 192 (45%) of the 429 participants who were enrolled in the AIR, RISA, and AIR2 trials. The BT10+ participants comprised 136 who received bronchial thermoplasty (52% of the 260 participants who received bronchial thermoplasty in the original trials), and 56 sham or control participants (33% of 169 from the original trials). 18 (32%) sham or control participants received bronchial thermoplasty after the previous trials concluded. The participants included in BT10+ were followed for 10middot8-15middot6 years (median 12middot1 years) post-treatment. Baseline characteristics were similar between participants enrolled in BT10+ and those not enrolled. Participants treated with bronchial thermoplasty had similar proportions of severe exacerbations at the BT10+ visit (34 [25%] of 136 participants) compared with 1 year (33 [24%] of 135 participants; difference 0middot6%, 95% CI -9middot7 to 10middot8) and 5 years (28 [22%] of 130 participants; difference 3middot5%, -6middot7% to 13middot6) after treatment. Quality of life measurements and spirometry were similar between year 1, year 5, and the BT10+ visit. At the BT10+ study visit, pulmonary high-resolution CT scans from AIR2 participants treated with bronchial thermoplasty showed that 13 (13%) of 97 participants had bronchiectasis. When compared with baseline high-resolution CT scans, six (7%) of 89 participants treated with bronchial thermoplasty who did not have bronchiectasis at baseline had developed bronchiectasis after treatment (5 classified as mild, 1 classified as moderate). Participants treated with bronchial thermoplasty after the original study and participants in the sham or control group also had reductions in severe exacerbations at the BT10+ visit compared with baseline.Interpretation Our findings suggest that efficacy of bronchial thermoplasty is sustained for 10 years or more, with an acceptable safety profile. Therefore, bronchial thermoplasty is a long-acting therapeutic option for patients with asthma that remains uncontrolled despite optimised medical treatment. Funding Boston Scientific. Copyright (c) 2021 Elsevier Ltd. All rights reserved.

Sharyn A Roodenburg,1,2 Karin Klooster,1,2 Jorine E Hartman,1,2 T David Koster,1,2 Marlies van Dijk,1,2 Dirk-Jan Slebos1,2 1Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; 2Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The NetherlandsCorrespondence: Sharyn A RoodenburgDepartment of Pulmonary Diseases, AA11, University Medical Center Groningen, Hanzeplein 1, Groningen, 9713, GZ, The NetherlandsTel +31 50 361 9194Fax +31 050 3619320Email s.a.roodenburg@umcg.nlBackground: Endobronchial valve (EBV) treatment is an effective treatment for patients with severe emphysema. Revision bronchoscopies after endobronchial valve treatment can be essential to prolong the effect of treatment or address long-term complications.Purpose: To evaluate the indications, endoscopic findings and outcomes of revision bronchoscopies and investigate if any predictors for granulation tissue formation, after EBV treatment, can be identified.Patients and Methods: Patients who underwent EBV treatment between 2016 and 2019 in our hospital, as routine care, were included. If a patient underwent a revision bronchoscopy, data regarding revision bronchoscopies, including indication, finding, intervention and pulmonary function testing (PFT) after revision bronchoscopy were analysed.Results: One hundred seventy-nine patients were included of which 41% required at least one revision bronchoscopy. In 43% of the revision bronchoscopy patients, the indication was loss of initial treatment effect. In 53% of the revision bronchoscopy patients, granulation tissue was found to be the underlying cause. Valve replacement(s) were performed in 51% of the revision bronchoscopy cases. Permanent valve removal was required in 13% of all patients. Overall, revision bronchoscopies led to improvements in PFT outcomes for patients experiencing no or a loss of initial treatment effect. No clinically relevant predictors for granulation tissue formation were identified.Conclusion: Performing a revision bronchoscopy after EBV treatment is a useful procedure leading to an improved treatment effect in most patients. Granulation tissue formation, causing valve dysfunction, is the most common cause of longer term problems.Keywords: bronchoscopy, lung volume reduction, one-way valve, COPD

Purpose For this study, we aimed to compare dynamic hyperinflation measured by cardiopulmonary exercise testing (CPET), a six-minute walking test (6-MWT), and a manually paced tachypnea test (MPT) in patients with severe emphysema who were treated with endobronchial coils. Additionally, we investigated whether dynamic hyperinflation changed after treatment with endobronchial coils. Methods Dynamic hyperinflation was measured with CPET, 6-MWT, and an MPT in 29 patients before and after coil treatment. Results There was no significant change in dynamic hyperinflation after treatment with coils. Comparison of CPET and MPT showed a strong association (rho 0.660, p Conclusion MPT can be a suitable alternative to CPET to measure dynamic hyperinflation in severe emphysema but may overestimate dynamic hyperinflation possibly due to a higher breathing frequency.

Symptomatic airway kinking after bronchoscopic lung volume reduction with endobronchial valves is rare. Due to the development of the desired lobar atelectasis, the position of the airways of the non-treated lobe changes and this might lead to invalidating symptoms. We present a case of a patient with symptomatic airway kinking after treatment with endobronchial valves, who was successfully treated with a single placement of a biodegradable stent. Placement of a biodegradable stent can be considered in symptomatic patients with airway kinking.

Background: Hypermetabolism and muscle wasting frequently occur in patients with severe emphysema. Improving respiratory mechanics by bronchoscopic lung volume reduction (BLVR) might contribute to muscle maintenance by decreasing energy requirements and alleviating eating-related dyspnoea. Objective: The goal was to assess the impact of BLVR on energy balance regulation. Design: Twenty emphysematous subjects participated in a controlled clinical experiment before and 6 months after BLVR. Energy requirements were assessed: basal metabolic rate (BMR) by ventilated hood, total daily energy expenditure (TDEE) by doubly labelled water, whole body fat-free mass (FFM) by deuterium dilution, and physical activity by accelerometry. Oxygen saturation, breathing rate, and heart rate were monitored before, during, and after a standardized meal via pulse oximetry and dyspnoea was rated. Results: Sixteen patients completed follow-up, and among those, 10 patients exceeded the minimal clinically important difference of residual volume (RV) reduction. RV was reduced with median (range) 1,285 mL (−2,430, −540). Before BLVR, 90% of patients was FFM-depleted despite a normal BMI (24.3 ± 4.3 kg/m2). BMR was elevated by 130%. TDEE/BMR was 1.4 ± 0.2 despite a very low median (range) daily step count of 2,188 (739, 7,110). Following BLVR, the components of energy metabolism did not change significantly after intervention compared to before intervention, but BLVR treatment decreased meal-related dyspnoea (4.1 vs. 1.7, p = 0.019). Conclusions: Impaired respiratory mechanics in hyperinflated emphysematous patients did not explain hypermetabolism. Clinical Trial Registry Number: NCT02500004 at www.clinicaltrial.gov.

Background: Currently, patients with COPD who are evaluated for bronchoscopic treatments are routinely screened for pulmonary hypertension (PH) and systolic left ventricle dysfunction by echocardiography. Objectives: We evaluated the prevalence of PH and systolic left ventricle dysfunction in this patient group and investigated if the previously proposed CT-derived pulmonary artery to aorta (PA:A) ratio >1 and PA diameter measurements can be used as alternative screening tools for PH. Methods: Two hundred fifty-five patients were included in this retrospective analysis (FEV1 25%pred, RV 237%pred). All patients received transthoracic echocardiography and chest CT scans on which diameters of the aorta and pulmonary artery were measured at the bifurcation and proximal to the bifurcation. Results: Following echocardiography, 3 patients (1.2%) had PH and 1 (0.4%) had systolic left ventricle dysfunction. Using a PA:A ratio >1, only 10.3% of the patients with a right ventricular systolic pressure (RVSP) ≥35 mm Hg were detected and none of the patients with an RVSP >50 mm Hg were detected. Patients with an RVSP ≥35 mm Hg had significantly higher PA diameters (29.5 vs. 27.5 mm; p = 0.02) but no significantly different PA:A ratios. All patients with an RVSP >50 mm Hg had PA diameters >30 mm. Conclusions: The prevalence of PH and systolic left ventricle dysfunction is low in this preselected cohort of patients with severe COPD. In this population, a PA:A ratio >1 is not a useful cardiac screening tool for PH. A PA diameter >30 mm could substitute for routinely performed echocardiography in the screening for PH in this patient group.

Background: So far, 3 randomized controlled trials have shown that the endobronchial treatment using coils is safe and effective. However, the more exact underlying mechanism of the treatment and best predictors of response are unknown. Objectives: The aim of the study was to gain more knowledge about the underlying physiological mechanism of the lung volume reduction coil treatment and to identify potential predictors of response to this treatment. Methods: This was a prospective nonrandomized single-center study which included patients who were bilaterally treated with coils. Patients underwent an extensive number of physical tests at baseline and 3 months after treatment. Results: Twenty-four patients (29% male, mean age 62 years, forced expiratory volume in 1 s [FEV1] 26% pred, residual volume (RV) 231% pred) were included. Three months after treatment, significant improvements were found in spirometry, static hyperinflation, air trapping, airway resistance, treated lobe RV and treated lobes air trapping measured on CT scan, exercise capacity, and quality of life. The change in RV and airway resistance was significantly associated with a change in FEV1, forced vital capacity, air trapping, maximal expiratory pressure, dynamic compliance, and dynamic hyperinflation. Predictors of treatment response at baseline were a higher RV, larger air trapping, higher emphysema score in the treated lobes, and a lower physical activity level. Conclusions: Our results confirm that emphysema patients benefit from endobronchial coil treatment. The primary mechanism of action is decreasing static hyperinflation with improvement of airway resistance which consequently changes dynamic lung mechanics. However, the right patient population needs to be selected for the treatment to be beneficial which should include patients with severe lung hyperinflation, severe air trapping, and significant emphysema in target lobes.

RATIONALE: Bronchoscopic lung volume reduction with endobronchial valves (EBV) significantly improves clinical outcomes in patients with severe emphysema. However, patient-reported outcomes like patient satisfaction and patient specific treatment goals were never investigated.OBJECTIVE: Therefore, our aim was to investigate patient satisfaction level 1 year after treatment and patient-specific goals before and 1 year after EBV treatment. Furthermore, to investigate whether the level of patient satisfaction or change in goals was associated with change in clinical outcome.METHODS: We prospectively included patients who underwent EBV treatment as part of regular care in our hospital and asked patients to report and score their personal treatment goals on the patient-specific complaint questionnaire (PSC) at baseline and after 1 year follow up and to complete a patient-satisfaction questionnaire at 1 year follow up.RESULTS: Of the 134 patients who were treated with EBV, 109 filled out the patient-satisfaction questionnaire and 88 the PSC at baseline and 1 year after treatment. When adjusting for the patients who were lost-to follow up, in total 91% of the patients would recommend the EBV treatment to other patients. Seventy-five percent of the patients was (very) satisfied with the treatment and 11% was (very) unsatisfied. The 3 most frequently reported patient specific goals to improve were walking (reported by 77% of the patients), taking a shower/washing/getting dressed (35%) and household chores (32%). Both the total PSC questionnaire sum score (mean change -6.01 ± 6.0) and all individual reported goals significantly improved 1 year after treatment (pCONCLUSIONS: We found that the patient satisfaction level is high and patient-specific goals significantly improve, 1 year after EBV treatment. We believe that individual patient's goals are important in the process of shared decision making before treatment as it can identify unrealistic expectations beforehand and prevent disappointment afterwards. Clinical trial registered at ClinicalTrials.gov (NCT02815683).

Introduction Bronchoscopic lung volume reduction treatment with one-way valves is an effective guideline treatment option for patients with severe emphysema. However, important challenges and adverse reactions may occur after treatment. Areas covered This review summarizes the complications after endobronchial and intrabronchial valve treatment that have been described by the currently published randomized controlled trials and other relevant papers regarding the complications and its management. In case there was no relevant literature regarding these subjects, recommendations are based on expert opinion. Complications include pneumothorax, post-obstruction pneumonia and hemoptysis. Also, the treatment may not be effective due to the presence of collateral ventilation or misplaced valves. Furthermore, an initial beneficial effect may vanish due to granulation tissue formation, valve dysfunction or valve migration. Careful follow-up after treatment with valves is important. Evaluation with a CT-scan and/or bronchoscopy is needed if there is no improvement after treatment, loss of benefit, or occurrence of important adverse events during follow-up. Expert opinion Treating severe emphysema patients with one-way valves requires continuous dedication and expertise, especially to achieve an optimal outcome and elegantly deal with the various complications after treatment.

Background Bronchoscopic lung volume reduction techniques are minor invasive treatment modalities for severely hyperinflated emphysema patients. The severity of static lung hyperinflation determines eligibility and success rate for these treatments. However, it is not exactly known what parameter should be used to optimally reflect hyperinflation. Commonly used parameters are residual volume (RV) and the RV/Total lung capacity (TLC) ratio. Other parameters reflecting hyperinflation are Inspiratory Capacity/TLC and forced vital capacity. Objectives To define which of these function parameters is the most optimal reflection of hyperinflationin in relation to patient-related outcomes. Methods In a retrospective cohort study, data from measurements during baseline visits of eight studies were pooled. Primary outcomes were RV/TLC ratio and RV as percentage of predicted (RV%pred), both measured by bodyplethysmography, compared to the patient-related outcome variables: 6-min walk distance (6MWD), the St. George’s Respiratory Questionnaire (SGRQ), and the modified Medical Research Council (mMRC). Results Two hundred seventy-four COPD patients (mean age 59 years; 66% female), FEV1 0.74 ± 0.28 L, RV 4.94 ± 1.06 L, 6MWD of 339 ± 95 m, were included in the analysis. Significant correlations (all p r = − 0.358), SGRQ (r = 0.184), and mMRC (r = 0.228). Also, there was a significant correlation between RV/TLC ratio and 6MWD (r = − 0.563), SGRQ (r = 0.289) and mMRC (r = 0.354). Linear regression analyses showed that RV/TLC ratio was a better predictor of patient outcomes than RV%pred. Conclusion This study demonstrates that both RV/TLC ratio and RV%pred are relevant indicators of hyperinflation in patients with severe emphysema in relation to patient-related outcomes. RV/TLC ratio is more strongly related to the patient-related outcomes than RV%pred.

Purpose 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. Patients and methods 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. Results 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. Conclusion Quantitative CT analysis is recommended in all patients evaluated for endobronchial valves. Patients with incomplete fissures (left major fissure: FCS 95%.

Purpose: Bronchoscopic lung volume reduction (BLVR) is a valuable treatment option for carefully selected patients with severe COPD. There is limited knowledge about the characteristics and outcomes of patients referred to a specialized center for BLVR. The study objectives were to investigate the selection rate for BLVR treatment in patients referred for this treatment and to investigate the differences between patients that were selected for BLVR and patients that were not. Patients and Methods: We performed a retrospective analysis of patients with severe COPD who were referred to our hospital to assess eligibility for BLVR treatment. Our parameters included demographics, comorbidity, chest computed tomography characteristics, reasons for rejection from BLVR treatment and patient survival. Results: In total, 1500 patients were included (mean age 62 years, 50% female and forced expiratory volume in 1 s 33% of predicted). Out of this group, 282 (19%) patients were selected for BLVR treatment. The absence of a suitable target lobe for treatment, an unsuitable disease phenotype and insufficient lung hyperinflation were the most important factors for not being selected. Patients that were selected for any BLVR option lived significantly longer than the group of patients that were not selected for BLVR (median 3060 versus 2079 days, P

Background: Absence of interlobar collateral ventilation is essential to achieve lobar volume reduction after endobronchial valve (EBV) treatment and can be assessed using the Chartis measurement. However, especially in lower lobe measurements, Chartis can be complicated by the “no-flow phenomenon”, during which a sudden cessation of flow is observed, leading to an unreliable measurement. If this phenomenon occurs in the right lower lobe, when measuring collateral flow over the right major fissure, the entrance to the right middle lobe should be occluded, and the Chartis balloon should be placed in the right upper lobe. Both Watanabe spigots and balloon catheters can be used to achieve occlusion. Objective: Our aim was to demonstrate that right middle lobe occlusion with a blocking device is helpful in obtaining a reliable Chartis outcome in case of the no-flow phenomenon in the right lower lobe. Methods: We performed a retrospective analysis of patients scheduled for EBV treatment in an EBV registry between September 2016 and September 2019. Results: We included 15 patients with severe emphysema (median age 63 years [range 47–73], 73% female, and FEV1 24% [range 19–36] of predicted), who required temporary middle lobe occlusion (12 Watanabe spigot, 3 balloon catheter). After occlusion, a reliable Chartis outcome was obtained in all patients. Conclusion: Temporary middle lobe occlusion using a blocking device is helpful in obtaining a reliable Chartis outcome in case of a right lower lobe no-flow phenomenon.

Background: Bronchoscopic lung volume reduction using the Zephyr® endobronchial valve (EBV) is a guideline treatment for patients with advanced emphysema. To achieve volume reduction, it is crucial that there is absence of collateral ventilation and a complete occlusion of the target lobe. While 3 EBV sizes (4.0; 4.0-LP; and 5.5) are currently available to accommodate all airway sizes, local anatomical variations sometimes warrant a valve with a wide diameter but shorter length. To address this, a new “low profile” 5.5-LP EBV has been introduced. Objective: In this study, we evaluated the feasibility, safety, and efficacy of this new 5.5-LP EBV. Methods: This was a single-center, prospective, open-label study. Patients were included if eligible for valve treatment with a local anatomy suitable to place at least one 5.5-LP EBV. Feasibility of placement of the 5.5-LP EBV was reported. Safety, CT parameters, pulmonary function tests, and St. George’s Respiratory Questionnaire (SGRQ) were assessed at baseline and 6 weeks after treatment. Results: We included 30 patients with severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s [FEV1] 29 ± 10%; [RV] 242 ± 46%; and SGRQ 56 ± 11 points). Besides the regular EBV sizes, a median of 1 (1–3) of the new 5.5-LP EBV was placed. No valve adjustment was needed during the initial procedure. A single asymptomatic small pneumothorax was observed in 1 patient. In 4 patients, a revision bronchoscopy was performed due to absence of clinical benefit. In 1 patient, this was related to a dislocation of the 5.5-LP EBV. Clinically relevant improvements were seen in target lobar volume reduction (–1,554 mL), FEV1 +39%, RV –960 mL, and SGRQ –18 points. Conclusions: In this first in human study, the 5.5-LP EBV could be placed into wide segments with a shorter landing length without unexpected complications and with good efficacy outcomes.

Background Absence of interlobar collateral ventilation is key to successful endobronchial valve treatment in patients with severe emphysema and can be functionally assessed by using the Chartis measurement. This system has been validated during spontaneous breathing, undergoing procedural sedation (PS), but can also be performed under general anesthesia. Performing the Chartis measurement under PS is often challenging because of coughing, mucus secretion, and difficulties in maintaining an adequate level of sedation. The objective of this study was to investigate whether there is a difference in Chartis measurement outcomes between PS and general anesthesia. Methods In this prospective study, patients underwent Chartis measurements under both PS and general anesthesia. Study outcomes were Chartis measurement duration, number of measurements, feasibility, and success rate. Results The study included 30 patients with severe emphysema (mean age, 62 years; median FEV1, 29% of predicted). Chartis measurement duration was significantly longer under PS than under general anesthesia (mean, 20.3 ± 4.2 min vs 15.1 ± 4.4 min; P Conclusions This study found that Chartis measurement under general anesthesia is faster and more feasible to perform compared with performance with PS, without affecting measurement outcomes. Trial Registration Clinicaltrials.gov; No. NCT03205826 ; URL: www.clinicaltrials.gov .

During the evaluation of potential bronchoscopic lung volume reduction (BLVR) candidates in our hospital, we frequently observe patients with a lower residual volume (RV) value compared to the value measured in their referring hospital, although both measured by body plethysmography. We explored to what degree RV and other pulmonary function measurements match between referring hospitals and our hospital. We retrospectively analyzed a total of 300 patients with severe emphysema [38% male, median age 62 years (range 38-81), median forced expiratory volume in 1 s 29% (range 14-65) of predicted, and a median of 40 packyears (range 2-125)]. We measured a median RV of 4.47 l (range 1.70-7.57), which was a median 310 ml lower than in the referring hospitals (range - 3.04 to + 1.94), P

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.

Introduction: Pneumothorax is a common, well treatable complication of endobronchial valve (EBV) treatment. Aims: We aimed to investigate whether a pneumothorax after EBV-treatment affects patient reported outcomes (PRO’s). Methods: We included patients treated with EBV’s in our hospital between September 2016 and December 2019 with available 1-year follow up data including the Patient Specific Complaints questionnaire (PSC), for which patients rate their impairment on three self-chosen activities on a scale from 0 to 10. Results: 136 patients (64% female, age 63±7years, FEV1 28±8%pred, RV 233±41%pred) were included, 16 of these patients (12%) had a pneumothorax. No significant differences in the PSC and clinical outcomes between groups at one-year follow up were found (table 1). In both groups PSC, six-minute walk distance and lung function improved significantly compared to baseline (all p Conclusion: In this retrospective analysis, patients who developed a pneumothorax after EBV-treatment reported an improvement in patient reported outcomes comparable to patients who did not develop a pneumothorax after EBV-treatment.

Introduction Bronchoscopic lung volume reduction with endobronchial valves is an important treatment option in selected patients with severe emphysema and absence of collateral ventilation in the treatment target lobe. The Chartis system provides an important physiological assessment of the presence or absence of collateral ventilation. We aimed to evaluate a new feature and determine whether low flow during a Chartis measurement is predictive for the absence of collateral ventilation, and whether this allows for a procedure to be shortened by earlier terminating the Chartis measurement. This is measured with the “volume trend for the previous 20 s” (VT20). Methods We retrospectively evaluated 249 Chartis assessments of patients scheduled for bronchoscopic lung volume reduction procedures. The VT20 was calculated, and several thresholds were compared between patients with collateral ventilation (CV positive) and without collateral ventilation (CV negative). Results 100% of the CV negative patients reached a threshold of VT20 ≤6 mL, whereas all CV positive patients reached a VT20 ≥7 mL. The median “time saved” between VT20=6 mL and end of assessment was 60 s (range 5–354 s). Conclusion The threshold of VT20 ≤6 mL is a reliable method to exclude the presence of collateral ventilation when air flow rates are low and can therefore reduce bronchoscopic lung volume procedure times., The volume trend for the previous 20 s (VT20) is an adjusted method of the Chartis measurement. This feature helps to interpret the Chartis measurement more easily and it effectively shortens the Chartis assessment time, especially in cases with low flow. https://bit.ly/3wlClxv

INTRODUCTION: Bronchoscopic lung volume reduction with endobronchial valves is a recently acknowledged treatment option in patients with severe emphysema and absence of interlobar collateral ventilation. In endobronchial valve treatment, implantation of one-way valves leads to deflation of a hyperinflated lung lobe. Multiple studies showed significant improvements in lung function, exercise capacity, and quality of life in this patient subgroup which often did not have any remaining treatment options. Areas covered: In this review, efficacy outcomes and adverse events of endobronchial valve treatment are summarized. The importance of selection of the right patients and target lobe is discussed. The role of bodyplethysmography, quantitative CT analysis, and quantification of interlobar collateral ventilation in this selection process are evaluated. Furthermore, this review has a special focus on ongoing trials and future perspectives of this treatment. Expert opinion: Development of advanced diagnostic imaging methods will result in a better patient and target selection and improved outcomes. Furthermore, optimizing the device and the procedure might be an important focus in future developments to enhance outcomes and reduce adverse events.

Rationale: This is the first multicenter randomized controlled trial to evaluate the effectiveness and safety of Zephyr Endobronchial Valve (EBV) in patients with little to no collateral ventilation out to 12 months.Objectives: To evaluate the effectiveness and safety of Zephyr EBV in heterogeneous emphysema with little to no collateral ventilation in the treated lobe.Methods: Subjects were enrolled with a 2:1 randomization (EBV/standard of care [SoC]) at 24 sites. Primary outcome at 12 months was the Delta EBV-SoC of subjects with a post-bronchodilator FEV1 improvement from baseline of greater than or equal to 15%. Secondary endpoints included absolute changes in post-bronchodilator FEV1, 6-minute-walk distance, and St. George's Respiratory Questionnaire scores.Measurements and Main Results: A total of 190 subjects (128 EBV and 62 SoC) were randomized. At 12 months, 47.7% EBV and 16.8% SoC subjects had a Delta FEV1 greater than or equal to 15% (P Conclusions: Zephyr EBV provides clinically meaningful benefits in lung function, exercise tolerance, dyspnea, and quality of life out to at least 12 months, with an acceptable safety profile in patients with little or no collateral ventilation in the target lobe.

Background No currently approved intervention counteracts airway metaplasia and mucus hypersecretion of chronic bronchitis in COPD. However, metered cryospray (MCS) delivering liquid nitrogen to the tracheobronchial airways ablates abnormal epithelium and facilitates healthy mucosal regeneration. The objective of this study was to evaluate the feasibility, efficacy and safety of MCS in chronic bronchitis. Methods Patients with a forced expiratory volume in 1 s of 30–80% predicted who were taking optimal medication were recruited. Primary outcomes were feasibility (completion of treatments), efficacy (3-month change in St George's Respiratory Questionnaire (SGRQ)) and safety (incidence of adverse events). Secondary outcomes were lung function, exercise capacity and additional patient-reported outcomes. Results 35 patients, 19 male/16 female, aged 47–76 years, Global Initiative for Chronic Obstructive Lung Disease grade I (n=3), II (n=10) and III (n=22), underwent staggered liquid nitrogen treatments to the tracheobronchial tree. 34 patients completed three treatments, each lasting 34.3±12.1 min, separated by 4–6 weeks; one withdrew after the first treatment. ∼1800 doses of MCS were delivered. Clinically meaningful improvements in patient-reported outcomes were observed at 3 months: change in SGRQ −6.4 (95% CI −11.4 to −1.3; p=0.01), COPD Assessment Test (CAT) −3.8 (95% CI −6.4 to −1.3; p, RejuvenAir system treatment for individuals with chronic bronchitis in COPD is safe, feasible, well tolerated, and resulted in clinically meaningful improvements in multidimensional measures of cough, sputum production, breathlessness and quality of life https://bit.ly/30KBfPs

Introduction: In patients evaluated for bronchoscopic lung volume reduction (BLVR) with endobronchial valves, selection of the treatment target lobe is based on the emphysema score and the fissure completeness evaluated using quantitated HRCT analysis. However, often additional perfusion scintigraphy is necessary to make a final decision, which comes with additional testing, radiation and costs. Aims and Objectives: Investigate whether quantitative HRCT-approximated perfusion is comparable to perfusion scintigraphy. Methods: Retrospective analysis of patients evaluated for BLVR. Quantification software (Thirona, Nijmegen, NL) was used to approximate perfusion from HRCT by combining regional information from the arteries, veins and parenchymal tissue and summarized per lung using the respective anatomical segmentations. This outcome was compared to the scintigraphy scan, see Figure. Results: 207 patients were included. A strong correlation (Pearson’s r=0,93; p Conclusion: HRCT-approximated perfusion is well correlated with nuclear perfusion scintigraphy and the difference is not clinically important. The perfusion per lung can be calculated with CT-approximated perfusion and this can help in the treatment target lobe selection.

Introduction: Targeted lung denervation (TLD) is a novel bronchoscopic treatment for COPD GOLD-D patients, specifically targeting the pulmonary parasympathetic nerves. TLD has shown a positive effect on the occurrence of COPD exacerbations. As frequent COPD exacerbations are related to a more rapid lung function decline we were interested in lung function decline before and after TLD. Aim: To investigate the annual decline in FEV1 before and up to 3 year after TLD. Methods: COPD patients were included who underwent TLD in our hospital in the AIRFLOW trial (NCT02058459) and who completed their 3 year follow up visit. All available previous spirometry results from their referring hospitals were collected. Results: Fourteen patients (6 male, mean age 62 years,FEV1 32%predicted) were included. We obtained pre-treatment results of 11 patients in which the mean FEV1 decline before treatment was -57mL per year. Three years after treatment the mean decrease in FEV1 compared to baseline was -24mL per year (See Figure). Conclusions: Our results show that the lung function remains stable up to 3 year after TLD and that the annual decline in FEV1 is significantly less compared to before treatment. The stabilization of FEV1 may be a positive result of the previously reported decrease in COPD exacerbations. The currently executed large clinical trial with 5 year follow up (Airflow-3, NCT03639051) will need to confirm our results.

Background and Purpose In patients with severe emphysema, dynamic hyperinflation is superimposed on top of already existing static hyperinflation. Static hyperinflation reduces significantly after bronchoscopic lung volume reduction (BLVR). In this study, we investigated the effect of BLVR compared to standard of care (SoC) on dynamic hyperinflation. Methods Dynamic hyperinflation was induced by a manually paced tachypnea test (MPT) and was defined by change in inspiratory capacity (IC) measured before and after MPT. Static and dynamic hyperinflation measurements were performed both at baseline and 6 months after BLVR with endobronchial valves or coils (treatment group) or SoC (control group). Results Eighteen patients underwent BLVR (78% female, 57 (43–67) years, FEV1 25(18–37) %predicted, residual volume 231 (182–376) %predicted). Thirteen patients received SoC (100% female, 59 (44–74) years, FEV1 25 (19–37) %predicted, residual volume 225 (152–279) %predicted. The 6 months median change in dynamic hyperinflation in the treatment group was: + 225 ml (range − 113 to + 803) (p p = 0.422). An increase in dynamic hyperinflation was significantly associated with a decrease in residual volume (r = − 0.439, p Conclusion Bronchoscopic lung volume reduction increases the ability for dynamic hyperinflation in patients with severe emphysema. We propose this is a consequence of improved static hyperinflation.

Rationale: Bronchoscopic lung volume reduction with Zephyr Valves improves lung function, exercise tolerance, and quality of life of patients with hyperinflated emphysema and little to no collateral ventilation. Objectives: Post hoc analysis of patient-reported outcomes (PROs), including multidimensional measures of dyspnea, activity, and quality of life, in the LIBERATE (Lung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema) study are reported. Methods: A total of 190 patients with severe heterogeneous emphysema and little to no collateral ventilation in the target lobe were randomized 2:1 to the Zephyr Valve or standard of care. Changes in PROs at 12 months in the two groups were compared: dyspnea with the Transitional Dyspnea Index (TDI), focal score; the Chronic Obstructive Pulmonary Disease Assessment Test (CAT; breathlessness on hill/stairs); Borg; the EXAcerbations of Chronic pulmonary disease Tool–PRO, dyspnea domain; activity with the TDI, magnitude of task/effort/functional impairment, CAT (limited activities), and the St. George’s Respiratory Questionnaire (SGRQ), activity domain; and psychosocial status with the SGRQ, impacts domain, and CAT (confidence and energy). Results: At 12 months, patients using the Zephyr Valve achieved statistically significant and clinically meaningful improvements in the SGRQ; CAT; and the TDI, focal score, compared with standard of care. Improvements in the SGRQ were driven by the impacts and activity domains (P

Background Bronchial thermoplasty (BT) is a non-pharmacologic, endoscopic treatment for asthma not well controlled with long-acting b-agonists and inhaled corticosteroids. Long-term efficacy and safety of BT beyond 5 years is unknown. The BT10+ study was designed to evaluate the efficacy and safety of BT at 10+ years follow-up. Methods BT10+ is an international, multi-center, ≥10yrs follow-up study on subjects who were enrolled in the AIR, RISA and AIR2 BT trials. Demographics, quality of life, lung function, severe exacerbations (SE, defined as asthma exacerbations requiring systemic corticosteroids) and healthcare utilisation for the previous year were collected at the BT10+ study visit. Additionally, AIR2 subjects who received a pulmonary high-resolution CT (HRCT) at baseline had a second scan at the BT10+ study visit to determine if clinically relevant changes, such as bronchiectasis, occur after BT. Results Of 429 subjects enrolled AIR, RISA, and AIR2, 192 were followed-up at 10.6–15.8 years (12.1 median) post-treatment at 16 centers; of these, 136 were treated with BT and 38 were control/sham subjects in previous studies. Baseline characteristics between subjects enrolled and not enrolled in BT10+ did not show meaningful differences. For BT subjects, no increases in the rate of hospitalisations or ER visits were observed compared to baseline and rates of SE were stable compared to Year 1 (figure 1). While both groups experienced fewer SE after treatment, BT subjects had fewer SE than control/sham subjects at the BT10+ visit; this was not significant. Quality of life (AQLQ, ACQ) and spirometry results were comparable between Years 1, 5, and 10+ for both groups. Pulmonary HRCT scans from AIR2 subjects at the BT10+ study visit showed 9.5% (2/21) of control/sham subjects and 13.4% (13/97) of BT subjects had bronchiectasis; however, when these were compared with baseline HRCT scans, only 5.3% (5/94) of BT subjects had developed bronchiectasis after their baseline visit. Conclusion The BT10+ study suggests that efficacy of BT is sustained over 10 years and that BT has an acceptable safety profile.

Background and objective Bronchoscopic lung volume reduction using endobronchial valves (EBV) is an effective new treatment option for severe emphysema patients without interlobar collateral ventilation. The objective of this study was to perform an economic evaluation including the costs and cost-effectiveness of EBV treatment compared with standard medical care (SoC) from the hospital perspective in the short term and long term. Methods For the short-term evaluation, incremental cost-effectiveness ratios (ICER) were calculated based on the 6-month end point data from the STELVIO randomized trial. For the long-term evaluation, a Markov simulation model was constructed based on STELVIO and literature. The clinical outcome data were quality-adjusted life-years (QALY) based on the EuroQol5-Dimensions (EQ5D) questionnaire, the 6-min walking distance (6MWD) and the St George's Respiratory Questionnaire (SGRQ). Results The mean difference between the EBV group and controls was €16 721/patient. In the short-term (6 months), costs per additional QALY was €205 129, the ICER for 6MWD was €160 and for SGRQ was €1241. In the long term, the resulting cost-effectiveness ratios indicate additional costs of €39 000 per QALY gained with a 5-year time horizon and €21 500 per QALY gained at 10 years. In comparison, historical costs per additional QALY 1 year after the coil treatment are €738 400, 5 years after lung volume reduction surgery are €48 415 and 15 years after double-lung transplantation are €29 410. Conclusion The positive clinical effects of EBV treatment are associated with increased costs compared with SoC. Our results suggest that the EBV treatment has a favourable cost-effectiveness profile, also when compared with other treatment modalities for this patient group.

COPD is diagnosed and evaluated by pulmonary function testing (PFT). Chest computed tomography (CT) primarily serves a descriptive role for diagnosis and severity evaluation. CT densitometry-based emphysema quantification and lobar fissure integrity assessment are most commonly used, mainly for lung volume reduction purposes and scientific efforts.A shift towards a more quantitative role for CT to assess pulmonary function is a logical next step, since more, currently underutilised, information is present in CT images. For instance, lung volumes such as residual volume and total lung capacity can be extracted from CT; these are strongly correlated to lung volumes measured by PFT.This review assesses the current evidence for use of quantitative CT as a proxy for PFT in COPD and discusses challenges in the movement towards CT as a more quantitative modality in COPD diagnosis and evaluation. To better understand the relevance of the traditional PFT measurements and the role CT might play in the replacement of these parameters, COPD pathology and traditional PFT measurements are discussed.

BACKGROUND AND OBJECTIVE: Target lobar volume reduction (TLVR) is an important efficacy outcome measure for bronchoscopic lung volume reduction (BLVR) treatment using one-way endobronchial valves (EBV) in patients with severe emphysema. The commonly used cut-off value for TLVR that expresses a perceivable clinical benefit is -350 mL. However, a scientifically determined minimal important difference (MID) for TLVR never has been published. The objective of the present study was to determine the MID for TLVR on HRCT in patients who were treated with EBV. METHODS: A total of 318 patients with severe emphysema from two BLVR trials were analysed. Anchor-based methods were used to define the TLVR MID at 6 months follow-up. Forced expiratory volume in 1 s (FEV1 ), residual volume (RV) and St. George's Respiratory Questionnaire (SGRQ) were used as anchors. RESULTS: The calculated TLVR MID with each anchor was: FEV1 -587 mL, RV -534 mL and SGRQ -560 mL. The combined MID (average of the three anchor-based MIDs) was -563 mL. CONCLUSION: Using the anchor-based method, we established a TLVR MID of -563 mL in patients with severe emphysema at 6 months follow-up after EBV treatment. This value can be useful for both interpreting the results from trials and clinical practice, as well as for designing future studies on lung volume reduction.

Severe emphysema patients who have been treated with endobronchial coils have been shown to initially benefit, but slowly decline in the years thereafter. Re-treating a patient with endobronchial coils could potentially lead to new improvements and may again reduce the rate of further decline. To our knowledge, until now, no results are published about patients who are re-treated. The primary aim of this study is to investigate the safety and feasibility of re-treating severe emphysema patients with endobronchial coils, using the PneumRx coil system. Furthermore, as secondary aim, we will evaluate the efficacy of re-treating these patients. Patients who at least 2 years ago were treated with endobronchial coils and responded clinically meaningful to this treatment were included in the study and re-treated. Safety was evaluated by the number of reported adverse events. Efficacy was evaluated 6 months after re-treatment, and measured by the change in quality of life, exercise capacity and pulmonary function testing. Eight patients were re-treated at a median of 1382 days (range 849-1545) after initial coil treatment with a median additional of 12 (10-15) coils per patient. During treatment, and until 6 months of follow-up, no unexpected adverse events occurred. Quality of life, exercise capacity and lung function did not change significantly 6 months after re-treatment. The results of this pilot study suggest that re-treating patients with endobronchial coils is feasible and safe. However, larger studies are needed to confirm these results and to investigate the efficacy and thus the clinical relevance.

Background: One-way endobronchial valve (EBV) treatment has shown safety and efficacy at 6 months after treatment in patients with severe emphysema and confirmed absence of interlobar collateral ventilation. Longer follow-up in this subgroup is not available. Objectives: To investigate the efficacy and safety of EBV treatment of the STELVIO cohort at a 1-year follow-up. Methods: Emphysema patients who have been treated with EBV in the STELVIO trial were invited for a voluntary 1-year follow-up visit. Both the original treatment group and the control group who crossed over to treatment have been included. Analyses are performed on the patients who attended the 1-year follow-up visit. Results: Sixty-four patients received EBV treatment. At 1 year, 40 patients (26 female; mean age 59 ± 8 years; FEV1 0.86 ± 0.29 L; RV 4.56 ± 1.00 L; 6MWD 367 ± 78 m; and SGRQ 56 ± 13 points) visited the hospital. Significant improvements (p < 0.001) were found for FEV1 (+17%, 95% CI, 11 to 24), RV (-687 mL, 95% CI, -918 to -456), 6MWD (+61 m, 95% CI, 42 to 80), and SGRQ (-11 points, 95% CI, −17 to −6). Two patients died: 1 after 58 days due to progressive respiratory failure and 1 after 338 days of follow-up due to a myocardial infarction. Seventeen percent of the patients underwent valve replacement and 22% of the initially treated patients had permanent valve removal. In 22% of the patients, pneumothoraces occurred before 6 months, and none occurred between 6 and 12 months. Conclusions: EBV treatment results in clinically relevant benefits at 1 year of follow-up. Maintenance bronchoscopies to achieve this are needed. This study supports the use of EBV treatment in carefully selected patients with severe emphysema without collateral ventilation.

Background: Pneumothorax after bronchoscopic lung volume reduction using one-way endobronchial valves (EBVs) in patients with advanced emphysema occurs in approximately 20% of patients. It is not well known which factors predict the development of pneumothorax. Objective: To assess whether pleural adhesions on pretreatment high-resolution computed tomography (HRCT) scans are associated with pneumothorax occurrence after EBV treatment. Methods: HRCT scan analyses were performed on all patients who received EBV treatment in a randomized controlled trial. Three blinded readers scored adhesions by number and by measuring the longest axis of each pleural adhesion in the treated lung. The Pleural Adhesion Score (PAS) was calculated by adding 1 point for each small pleural lesion (5 mm). Results: The HRCT scans of 64 treated patients were assessed, of whom 14 developed pneumothorax. Patients who developed pneumothorax had a higher median number of pleural adhesions, 2.7 (IQR 1.9-4) compared to 1.7 (1-2.7) adhesions in the group without pneumothorax (p < 0.01). The PAS in the group with pneumothorax was higher compared to that in the group without: 14.3 (12.4-24.1) versus 6.7 (3.7-11.2) (p < 0.01). A threshold PAS of ≥12 was associated with a higher risk of pneumothorax (OR 13.0, 95% CI 3.1-54.9). A score Conclusion: A higher number of pleural adhesions on HRCT with a subsequent higher PAS in the treated lung is associated with a higher occurrence of pneumothorax after EBV treatment.

Background: No current medication counteracts the excessive mucus secretion or reverses the airway metaplasia of Chronic Bronchitis (CB) in COPD. Metered Cryospray (RejuvenAir® System) is a novel procedure delivering liquid N2 to the bronchial airways to target mucus overproduction, ablate abnormal epithelium, reduce chronic airway inflammation and promote regeneration of a healthy mucosal lining. Methods: This is a prospective, multicenter single-arm study of CB patients with an FEV1 of 30-80% predicted. Primary outcomes were safety and feasibility; secondary outcomes, SGRQ and 6MWT, were measured. Results: We included 35 subjects with Gold Grade II (31.4%) and III (68.6%) COPD (mean age 67.2+7.0 years, FEV1% 50.2±14.5, 54% male). Full treatment was accomplished of intended lobes with median times of 34 (right lower), 30 (left lower) and 41 minutes (upper lobes + trachea) during 3 separate outpatient visits. Approximately 1800 doses of MCS were delivered without inducing pneumothorax or unanticipated device-related serious adverse events (SAEs). Efficacy data showed clinically meaningful improvements of SGRQ-symptom score of -9.5±22.0 (95% CI; -17.7 to -1.3; p=0.025), SGRQ-impact score of -10.2±19.4 (95% CI: -17.5 to -3.0; p=0.007) and SGRQ-total score of -7.9±16.8 (95% CI: -14.2 to -1.6; p=0.008); most pronounced when baseline SGRQ-total ≥50 points (n=19). 6MWT significantly improved by 28 meters (95% CI: 3.0 to 62.0; Wilcoxon signed rank, p=0.034; n=25). Conclusions: These data indicate MCS treatment is safe, feasible and associated with clinically significant improvements in health-related quality of life in COPD patients with CB over 9 months.

Background Bronchoscopically placed endobronchial coils is an additional treatment option for severe emphysema patients. The motivation for treatment varies widely between patients in terms of a desired change in specific activity. To our knowledge, this is the first study to investigate patient-specific goals before and after coil treatment in severe emphysema. Methods Patients who participated in the RENEW CROSS-OVER study (NCT02059057) in our hospital were asked to complete the Dutch Patient Specific Complaints questionnaire (PSK). Patients reported in the PSK their personal 3 most important treatment goals, and scored on a VAS scale (0-10) the level of disability per activity before and 1 year after treatment. Results Thirteen patients (3 male, median age: 58, median FEV1: 28%) completed the PSK-questionnaire both at baseline and after 1 year. Most frequently reported goals were walking (n=12), taking a shower/washing (n=5) and cycling (n=3). The combined VAS score of all 3 reported goals significantly decreased from median 24 to 16 points (-33%) (See figure). Conclusions Patient-specific goals significantly improved after coil treatment. We believe that patient-specific outcomes should be included in clinical trials investigating treatment options for severe COPD. Larger trials should investigate the relationship between change in patient-specific outcomes and physiological outcomes after coil treatment.