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. 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. 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. Conclusions: ELVR with one-way valves seems clinically beneficial with a remarkably good safety profile for patients with chronic hypercapnic respiratory failure.
Introduction: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality. Lung volume reduction surgery (LVRS) has been suggested as an efficacious treatment strategy with a good safety profile in patients with severe emphysema. However, current techniques such as the endoscopic lung volume reduction with endobronchial valves (ELVR-V) have gained attention and seem also to produce favorable outcomes. Using data from the lung emphysema registry (LE-R) our endeavor is to describe treatment outcomes of the applied strategies over time. Methods: The LE-R is a national multicenter open label prospective registry collecting data exclusively on patients with severe lung emphysema undergoing LVRS or ELVR-V. Local emphysema boards made treatment decision. The patients were followed up after 3-and 6-months, and the lung function as well as the clinical status and the quality of life, measured with the 6-MWT and mMRC, were documented. All patients underwent pulmonary rehabilitation before undergoing the procedure. Results: Since September 2017, 358 cases were treated at 14 specialized centers in Germany. Mean age was 65.0 y (SD 7.7) and there was a male predominance (63.6%). Table 1 displays differences of lung function and quality of life between the groups at baseline, 3- and 6-mo follow up. Conclusions: Overall, our findings highlight that LVR by surgery or valves lead to significant improvements in multiple efficacy outcomes at a long term follow up. Future randomized studies are warranted to substantiate our results due to the observational nature of our study
Introduction: Chronic obstructive pulmonary disease (COPD) is associated with high morbidity and mortality rates. Endoscopic lung volume reduction with valves (ELVR-V) can produce favorable outcomes in patients with severe emphysema. In advanced stages, emphysema can eventually lead to chronic hypercapnic respiratory failure. Since ELVR-V targets hyperinflation and thereby reduces ventilatory workload, we hypothesized ELVR-V might be beneficial for patients with hypercapnia (PCO2>45mmHg). Methods: All data were derived from the LE-R, which is a national non-profit multicenter prospective study collecting data on patients with severe lung emphysema. PCO2 was assessed at baseline and 3-months follow up and a comparison between pre-and postprocedural outcomes was conducted. Results: In this study, 157 patients with a PCO2≤ 45 mmHg and 40 patients with a PCO2>45mmHg were included. Compared with baseline, ELVR-V in patients with a PCO2>45 mmHg led to a significant decrease of PCO2 (from 52.2± 6.2 mmHg to 43.7±8.6 mmHg; p=0.008) and of RV (from 271.9%±60.1 to 215.0 ±75.4; p=0.032) at 3 months follow up. Concerning unsolicited adverse events pneumothorax occurred commonly in both groups (PCO2≤45 mmHg: 17.2% vs. PCO2>45mmHg: 10.0%; p=0.862). Not a single death occurred in patients with hypercapnic failure. Table 1 depicts both groups regarding the clinical outcome after ELVR-V at 3-months follow up. Conclusions: We believe that ELVR with EBV should be considered in hyperinflated patients with chronic hypercapnia since it led to an improvement in lung function and to a significant decrease of PCO2.
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 (DLCO). However, robust evidence is still missing. We therefore aim to compare clinical outcomes in relation to DLCO for patients treated with ELVR. Methods We assessed DLCO 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. Results In total, 121 patients treated with ELVR were analysed. Thirty-four patients with a DLCO ≤20% and 87 patients with a DLCO >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 DLCO >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 (DLCO ≤20%: 17.6% versus DLCO >20%: 16.1%; p=0.728). However, there were no significant differences in other adverse events between both groups. Conclusions ELVR improves lung function as well as quality of life in patients with DLCO >20% and DLCO ≤20%. Adverse events did not differ between groups. Therefore, ELVR should be considered as a treatment option, even in patients with a very low DLCO.
Introduction: Lung emphysema is associated with high morbidity and mortality rates. Both surgical lung volume reduction (LVRS) and endoscopic lung volume reduction with valves (ELVR-V) seem to produce good clinical outcomes.However, a systematical comparison of different treatment approaches is still missing. The main goal of the Lung Emphysema Registry (LE-R) is to analyze types of treatment applied to patients with severe lung emphysema and to describe outcomes in relation to treatment techniques over time. Methods: The LE-R is a multicenter non-randomized prospective clinical study, which is collecting data exclusively on patients with lung emphysema treated at specialized centers. The patients were followed up after 3 months, and the lung function (FEV1, RV, VC, DLCO), the clinical status, quality of life (CAT and mMRC) and exercise capacity (6-MWT) were documented. Results: Since 2017 246 patients were included. Table 1 displays improvements in lung function and quality of life in both groups at 3mo FU. Conclusions: These novel findings suggest that both techniques are beneficial to patients with severe emphysema up to 3 months after intervention in a real-world observational study. Future analyses might help to define which treatment types should be applied to the specific patients subgroups.
Talc is the most effective chemical pleurodesis agent for patients with malignant pleural effusion. However, concerns have arisen about the safety of intrapleural application of talc, after reports of development of acute respiratory distress syndrome in 1-9% of treated patients. Our aim was to establish whether use of large-particle-size talc is safe in patients with malignant pleural effusion.We did a multicentre, open-label, prospective cohort study of 558 patients with malignant pleural effusion who underwent thoracoscopy and talc poudrage with 4 g of calibrated French large-particle talc in 13 European hospitals, and one in South Africa. The primary endpoint was the occurrence of acute respiratory distress syndrome after talc pleurodesis.No patients developed acute respiratory distress syndrome (frequency 0%, one-sided 95% CI 0-0.54%). 11 (2%) patients died within 30 days. Additionally, seven patients had non-fatal post-thoracoscopy complications (1.2%), including one case of respiratory failure due to unexplained bilateral pneumothorax.Use of large-particle talc for pleurodesis in malignant pleural effusion is safe, and not associated with the development of acute respiratory distress syndrome.