Search

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., (© 2021 The Author(s) Published by S. Karger AG, Basel.)

Endoscopic lung volume reduction (ELVR) is an emerging therapy option for the treatment of severe emphysema in COPD. To which extent patients profit from lung volume reduction via coils (LVRC) regarding morbidity, mortality, and quality of life is not clear yet. In this monocentric prospective cohort study, 13 COPD patients with severe emphysema (residual volume [RV] >225%) were enrolled at the University Hospital of Bonn. Activity measurements were assessed by a validated accelerometer wristband. By LVRC, RV could be reduced by 0.13 L to 5.54 ± 1.29 L. We could show a clinically relevant improvement in patients' physical activity after LVRC, measured as daily step count (497.7 ± 72.6 vs. 1,913.7 ± 182.7 steps/day, p = 0.03) and mean daily active energy expenditure (714.4 ± 73.6 vs. 2,321.3 ± 163.9 joules, p = 0.03). This improvement in physical activity is possibly associated with a positive effect on patients' morbidity and mortality., (© 2019 S. Karger AG, Basel.)

Rationale: Targeted lung denervation (TLD) is a bronchoscopic radiofrequency ablation therapy for chronic obstructive pulmonary disease (COPD), which durably disrupts parasympathetic pulmonary nerves to decrease airway resistance and mucus hypersecretion. Objectives: To determine the safety and impact of TLD on respiratory adverse events. Methods: We conducted a multicenter, randomized, sham bronchoscopy-controlled, double-blind trial in patients with symptomatic (modified Medical Research Council dyspnea scale score, ≥2; or COPD Assessment Test score, ≥10) COPD (FEV 1 , 30-60% predicted). The primary endpoint was the rate of respiratory adverse events between 3 and 6.5 months after randomization (defined as COPD exacerbation, tachypnea, wheezing, worsening bronchitis, worsening dyspnea, influenza, pneumonia, other respiratory infections, respiratory failure, or airway effects requiring therapeutic intervention). Blinding was maintained through 12.5 months. Measurements and Main Results: Eighty-two patients (50% female; mean ± SD: age, 63.7 ± 6.8 yr; FEV 1 , 41.6 ± 7.3% predicted; modified Medical Research Council dyspnea scale score, 2.2 ± 0.7; COPD Assessment Test score, 18.4 ± 6.1) were randomized 1:1. During the predefined 3- to 6.5-month window, patients in the TLD group experienced significantly fewer respiratory adverse events than those in the sham group (32% vs. 71%, P  = 0.008; odds ratio, 0.19; 95% confidence interval, 0.0750-0.4923, P  = 0.0006). Between 0 and 12.5 months, these findings were not different (83% vs. 90%; P  = 0.52). The risk of COPD exacerbation requiring hospitalization in the 0- to 12.5-month window was significantly lower in the TLD group than in the sham group (hazard ratio, 0.35; 95% confidence interval, 0.13-0.99; P  = 0.039). There was no statistical difference in the time to first moderate or severe COPD exacerbation, patient-reported symptoms, or other physiologic measures over the 12.5 months of follow-up. Conclusions: Patients with symptomatic COPD treated with TLD combined with optimal pharmacotherapy had fewer study-defined respiratory adverse events, including hospitalizations for COPD exacerbation.Clinical trial registered with www.clinicaltrials.gov (NCT02058459).

Background: Endoscopic lung volume reduction by means of endobronchial valve implantation is an established therapy in patients with severe emphysema. However, long-term complications such as chronic obstructive pulmonary disease (COPD) exacerbations are a limitation of this method., Objectives: As the mechanisms underlying increased rates of COPD exacerbations are unknown, the aim of our study was to determine whether infectious or inflammatory factors may contribute to these events and to investingate the consequent need for valve explantation., Methods: Tissue surrounding explanted endobronchial Zephyr valves was examined by microbiological, histological and cytological methods. Additionally, we performed a microbiological analysis of tracheal aspirates before both valve implantation and valve explantation. Moreover, blood samples were collected for the analysis of inflammatory markers., Results: Endobronchial valves were explanted from 16 patients. Reasons for explantation were frequent postprocedural COPD exacerbations (group 1: 8 patients) or loss of clinical benefit (group 2: 8 patients). Compared to group 2, the microbiological examinations of valve lavage and tracheal aspirates from patients in group 1 showed a higher detection of Gram-negative bacteria. In particular, infection with Pseudomonas aeruginosa was more predominant in group 1, while no presence could be detected in group 2. Blood inflammatory markers tended to be slightly higher in group 1 than in group 2; however, without reaching statistical significance., Conclusions: Increased rates of COPD exacerbations after endobronchial valve implantation are associated with the presence of P. aeruginosa. The finding warrants further investigation., (© 2016 S. Karger AG, Basel.)

Background: Randomized controlled trials indicate that significant lung volume reduction (ELVR) can be obtained with Zephyr® valves by occluding the target lobe in the absence of collateral ventilation, leading to relevant functional benefits in advanced emphysema patients., Objectives: To observe the long-term effects of endobronchial valve (EBV) implantation in emphysema patients screened by Chartis assessment in the context of daily pulmonology practice., Methods: The LIVE Study is a prospective, observational, open-label, single-arm, multicenter trial conducted in Germany. 498 patients included in this interim analysis were enrolled between July 2, 2012, and September 16, 2014. The 6-month follow-up visit data were recorded for 343 patients (safety population), and complete data sets were available for 321 treated patients (efficacy population) - 56.4% male, age: 64.5 years, forced expiratory volume in 1 s (FEV1) % predicted: 31.3%, residual volume (RV) % predicted: 252%., Results: Efficacy results at 6 months: FEV1 (l) increased by +100 ml (+11.9%), RV (l) decreased by -0.42 liter, and the COPD Assessment Test score decreased by -3.14 points (each p < 0.0001). Safety outcomes: A total of 66 adverse events (AEs; with 50 serious AEs - SAEs) were reported in 55 patients (16%) during the hospital stay for EBV placement - pneumothorax (35 cases), chronic obstructive pulmonary disease (COPD) exacerbation (5 cases), and pneumonia (4 cases). During the subsequent 6-month follow-up window, 170 SAEs were recorded in 125 patients (36.4%), predominantly COPD exacerbation (53% of the SAEs)., Conclusion: The current results of this large-scale German observational study performed in the context of daily practice further demonstrates that ELVR with Zephyr® valves is an effective and well-tolerated treatment option in advanced emphysema., (© 2016 S. Karger AG, Basel.)

Introduction: Endoscopic lung volume reduction (ELVR) provides a minimally invasive therapy for patients with severe lung emphysema. As its impact on right ventricular (RtV) function is undefined, we examined the extent of RtV functional changes following ELVR, as assessed by use of speckle tracking-based RtV deformation analysis. Methods: We enrolled 32 patients with severe emphysematous COPD scheduled for bronchoscopic LVR using endobronchial valves (Zephyr, PulmonX, Inc.), comprising 16 matched clinical responders and 16 non-responders. Echocardiography was conducted one day prior to ELVR and at an eight-week postprocedural interval. Results: Patients were predominantly of late middle-age (65.8±8.7yrs), male (62.5%) and presented advanced COPD emphysema (means FEV1 and RV: 32.6% and 239.1% of predicted, respectively). After ELVR, RtV apical longitudinal strain improved significantly in the total study cohort (-7.96±7.02% vs. -13.35±11.48%, p=0.04), whereas there were no significant changes in other parameters of RtV function such as RtV global longitudinal strain, TAPSE or pulmonary arterial systolic pressure. In responding patients, 6MWT-improvement correlated with a decrease in NT-proBNP (Pearson´s r: -0.53, p=0.03). However, clinical non-responders did not exhibit any RtV functional improvement. Discussion: ELVR beneficially impacts RtV functional parameters. Speckle tracking-based RtV apical longitudinal strain analysis allows early determination of RtV contractile gain and identification of clinical responsiveness. [ABSTRACT FROM AUTHOR]