The minimal important difference of the constant work rate cycle test in severe COPD

Background: The Constant Work Rate Cycle Test (CWRT) is a commonly used and sensitive test to detect treatment success in patients with Chronic Obstructive Pulmonary Disease (COPD). Earlier, the Minimal Important Difference (MID) of the CWRT was estimated at 101 s (or 34%) change from baseline based on one well executed study. However, this study was performed in a population of patients with mild-to-moderate COPD, and we have learned that MIDs might be quite different in patients with severe COPD. Therefore, we aimed to establish the MID of the CWRT in patients with severe COPD.Methods: We included 141 patients with severe COPD, who underwent either pulmonary rehabilitation, bronchoscopic lung volume reduction with endobronchial valves, or a sham bronchoscopy as a control group. CWRT workload was set at 75% of the peak work capacity, as determined by an incremental cycle test. We used the change in 6-min walking test (6-MWT), forced expiratory volume in 1s (FEV1), residual volume (RV), and St. George's Respiratory Questionnaire (SGRQ) total score as anchors to calculate the MID.Results: All anchors had an association of ≥0.41 with change in CWRT. The MID estimates for the different anchors were: 6-MWT 278 s (95%), FEV1 273 s (90%), RV 240 s (84%), and SGRQ 208 s (71%). The average of these four MID estimates resulted in an MID of 250 s (or 85%).Conclusion: We established the MID for CWRT at 250 s (or 85%) change from baseline in patients with severe COPD.</p

Survival in COPD patients treated with bronchoscopic lung volume reduction

Background and objective: Severe COPD patients can significantly benefit from bronchoscopic lung volume reduction (BLVR) treatments with coils or endobronchial valves. However, the potential impact of BLVR on survival is less understood. Therefore, our aim was to investigate the survival rate in patients who are evaluated for BLVR treatment and whether there is a difference in survival rate between patients who undergo BLVR treatment and patients who do not. Methods: We included patients with COPD who visited our hospital for a consultation evaluating their eligibility for BLVR treatment and who performed pulmonary function tests during this visit. Furthermore, vital status was verified. Results: In total 1471 patients were included (63% female, mean age 61 years). A total of 531 patients (35%) died during follow-up and the median survival time of the total population was 2694 days (95% confidence interval(CI) 2462–2926) which is approximately 7.4 years. The median survival time of patients who were treated with BLVR was significantly longer compared to patients who were not treated with BLVR (3133 days versus 2503 days, p < 0.001), and BLVR was found to be an independent predictor of survival when adjusting for other survival-influencing factors such as age, gender or severity of disease. Conclusions: Our results suggest that bronchoscopically reducing lung volume in patients with severe hyperinflation may lead to a survival benefit for a population with a severely reduced life expectancy

Significant Differences in Body Plethysmography Measurements Between Hospitals in Patients Referred for Bronchoscopic Lung Volume Reduction

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 < 0.001). In conclusion, this retrospective analysis demonstrated differences in RV measurements between different hospitals in patients with severe emphysema. Overestimation of RV can lead to unnecessary referrals for BLVR and potential treatment failures. To avoid disappointment and unnecessary hospital visits, it is important that body plethysmography measurements are accurately performed by applying preferably the unlinked method in these patients

Identifying Responders and Exploring Mechanisms of Action of the Endobronchial Coil Treatment for Emphysema

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

Considerations in the use of different spirometers in epidemiological studies

Abstract Background Spirometric lung function measurements have been proven to be excellent objective markers of respiratory morbidity. The use of different types of spirometers in epidemiological and clinical studies may present systematically different results affecting interpretation and implication of results. We aimed to explore considerations in the use of different spirometers in epidemiological studies by comparing forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC) measurements between the Masterscreen pneumotachograph and EasyOne spirometers. We also provide a correction equation for correcting systematic differences using regression calibration. Methods Forty-nine volunteers had lung function measured on two different spirometers in random order with at least three attempts on each spirometer. Data were analysed using correlation plots, Bland and Altman plots and formal paired t-tests. We used regression calibration to provide a correction equation. Results The mean (SD) FEV1 and FVC was 3.78 (0.63) L and 4.78 (0.63) L for the Masterscreen pneumotachograph and 3.54 (0.60) L and 4.41 (0.83) L for the EasyOne spirometer. The mean FEV1 difference of 0.24 L and mean FVC difference of 0.37 L between the spirometers (corresponding to 6.3 and 8.4% difference, respectively) were statistically significant and consistent between younger ( 30 years) and between males and females. Regression calibration indicated that an increase of 1 L in the EasyOne measurements corresponded to an average increase of 1.032 L in FEV1 and 1.005 L in FVC in the Masterscreen measurements. Conclusion Use of different types of spirometers may result in significant systematic differences in lung function values. Epidemiological researchers need to be aware of these potential systematic differences and correct for them in analyses using methods such as regression calibration

Supplementary Material for: Identifying Responders and Exploring Mechanisms of Action of the Endobronchial Coil Treatment for Emphysema

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

Safety and Dose Study of Targeted Lung Denervation in Moderate/Severe COPD Patients

RATIONALE: Targeted lung denervation (TLD) is a novel bronchoscopic treatment for the disruption of parasympathetic innervation of the lungs. OBJECTIVES: To assess safety, feasibility, and dosing of TLD in patients with moderate to severe COPD using a novel device design. METHODS: Thirty patients with COPD (forced expiratory volume in 1 s 30-60%) were 1:1 randomized in a double-blinded fashion to receive TLD with either 29 or 32 W. Primary endpoint was the rate of TLD-associated adverse airway effects that required treatment through 3 months. Assessments of lung function, quality of life, dyspnea, and exercise capacity were performed at baseline and 1-year follow-up. An additional 16 patients were enrolled in an open-label confirmation phase study to confirm safety improvements after procedural enhancements following gastrointestinal adverse events during the randomized part of the trial. RESULTS: Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group, p = 0.6. Five patients early in the randomized phase experienced serious gastric events. The study was stopped and procedural changes made that reduced both gastrointestinal and airway events in the subsequent phase of the randomized trial and follow-up confirmation study. Improvements in lung function and quality of life were observed compared to baseline values for both doses but were not statistically different. CONCLUSIONS: The results demonstrate acceptable safety and feasibility of TLD in patients with COPD, with improvements in adverse event rates after procedural enhancements.status: publishe