Jorine E. Hartman

Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation

BACKGROUND Bronchoscopic lung-volume reduction with the use of one-way endobronchial valves is a potential treatment for patients with severe emphysema. To date, the benefits have been modest but have been hypothesized to be much larger in patients without interlobar collateral ventilation than in those with collateral ventilation. METHODS We randomly assigned patients with severe emphysema and a confirmed absence of collateral ventilation to bronchoscopic endobronchial-valve treatment (EBV group) or to continued standard medical care (control group). Primary outcomes were changes from baseline to 6 months in forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and 6-minute walk distance. RESULTS Eighty-four patients were recruited, of whom 16 were excluded because they had collateral ventilation (13 patients) or because lobar segments were inaccessible to the endobronchial valves (3 patients). The remaining 68 patients (mean [±SD] age, 59±9 years; 46 were women) were randomly assigned to the EBV group (34 patients) or the control group (34). At baseline, the FEV1 and FVC were 29±7% and 77±18% of the predicted values, respectively, and the 6-minute walk distance was 374±86 m. Intention-to-treat analyses showed significantly greater improvements in the EBV group than in the control group from baseline to 6 months: the increase in FEV1 was greater in the EBV group than in the control group by 140 ml (95% confidence interval [CI], 55 to 225), the increase in FVC was greater by 347 ml (95% CI, 107 to 588), and the increase in the 6-minute walk distance was greater by 74 m (95% CI, 47 to 100) (P<0.01 for all comparisons). By 6 months, 23 serious adverse events had been reported in the EBV group, as compared with 5 in the control group (P<0.001). One patient in the EBV group died. Serious treatment-related adverse events in this group included pneumothorax (18% of patients) and events requiring valve replacement (12%) or removal (15%). CONCLUSIONS Endobronchial-valve treatment significantly improved pulmonary function and exercise capacity in patients with severe emphysema characterized by an absence of interlobar collateral ventilation. (Funded by the Netherlands Organization for Health Research and Development and the University Medical Center Groningen; Netherlands Trial Register number, NTR2876.).

Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema.

Bronchoscopic lung volume reduction coil (LVR‐coil) treatment has been shown to be safe and clinically effective in patients with severe emphysema in the short term; however, long‐term safety and effectiveness has not been evaluated. The aim of this study was to investigate the long‐term safety and effectiveness of LVR‐coil treatment in patients with severe emphysema.

Physical and Psychosocial Factors Associated With Physical Activity in Patients With Chronic Obstructive Pulmonary Disease

OBJECTIVES To assess physical activity and sitting time in patients with chronic obstructive pulmonary disease (COPD) and to investigate which physical and psychosocial factors are associated with physical activity and sitting time. DESIGN Cross-sectional study. SETTING Patients were recruited at outpatient clinics of general hospitals and from general practitioners. PARTICIPANTS Patients (N=113) with mild to very severe COPD. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES Physical activity and sitting time were measured with a triaxial accelerometer (24h/d). RESULTS Mean locomotion time per 24 hours was 6.8% (range, 0.7%-20.4%). Elevated physical activity was independently associated with higher self-efficacy, higher functional exercise capacity, and lower lung hyperinflation. Decreased physical activity was strongest in more severe stages of COPD, in which the patients were mainly limited by physical disease-specific factors (higher lung hyperinflation, worse dyspnea severity, worse leg muscle function, and oxygen use). In less severe patients, physical activity was independently associated with more generic factors (higher self-efficacy and the spring/summer season). Sitting time did not differ between severity stages, and longer sitting time in the total group was independently associated with more positive perception of treatment control, less autonomous motivation to exercise, not using sleep medication, and oxygen use. CONCLUSIONS Both physical and psychosocial factors were associated with physical activity in patients with COPD. The factors associated with physical activity differed between disease severity stages, raising the question of whether physical activity enhancement programs should differ as well. Sitting time should be investigated further.

The minimal important difference for residual volume in patients with severe emphysema

Residual volume (RV) measured by body plethysmography is a routine measurement in clinical pulmonary practice and is often an important outcome variable in clinical trials. However, it is not known what size of improvement can be regarded as being important in severe emphysema patients. Therefore, the aim of the study is to establish the minimal important difference (MID) for RV in severe emphysema patients undergoing bronchoscopic lung volume reduction. 91 severe emphysema patients were included. RV and total lung capacity (TLC) were measured by body plethysmography. MID estimates were calculated by anchor-based and distribution-based methods. Forced expiratory volume in 1 s, 6-min walk distance and St George’s Respiratory Questionnaire total score were used as anchors and Cohen’s effect size was used as distribution-based method. The calculated MID estimates according to the different anchors and methods ranged between -0.31 and -0.43 L for RV, -6.1 and -8.6% for percentage change in RV (RV%) from baseline, and -2.8 and -4.0% for RV/TLC. These MID estimates are useful for sample size determination in new studies on interventions aimed at reducing RV and for interpreting the results from clinical trials in severe emphysema patients.

Self-efficacy for physical activity and insight into its benefits are modifiable factors associated with physical activity in people with COPD: a mixed-methods study

QUESTIONS What are the perceived reasons for people with chronic obstructive pulmonary disease (COPD) to be physically active or sedentary? Are those reasons related to the actual measured level of physical activity? DESIGN A mixed-methods study combining qualitative and quantitative approaches. PARTICIPANTS People with mild to very severe COPD. OUTCOME MEASURES Participants underwent a semi-structured interview and physical activity was measured by a triaxial accelerometer worn for one week. RESULTS Of 118 enrolled, 115 participants (68% male, mean age 65 years, mean FEV1 57% predicted, mean modified Medical Research Council dyspnoea score 1.4) completed the study. The most frequently reported reason to be physically active was health benefits, followed by enjoyment, continuation of an active lifestyle from the past, and functional reasons. The most frequently reported reason to be sedentary was the weather, followed by health problems, and lack of intrinsic motivation. Mean steps per day ranged between 236 and 18 433 steps. A high physical activity level was related to enjoyment and self-efficacy for physical activity. A low physical activity level was related to the weather influencing health, financial constraints, health and shame. CONCLUSION We identified important facilitators to being physically active and barriers that could be amenable to change. Furthermore, we distinguished three important potential strategies for increasing physical activity in sedentary people with COPD, namely reducing barriers and increasing insight into health benefits, tailoring type of activity, and improvement of self-efficacy.

Bronchoscopic Coil Treatment for Patients with Severe Emphysema: A Meta-Analysis.

Background: Bronchoscopic coil treatment has been shown to improve pulmonary function, exercise capacity, and quality of life in patients with severe emphysema. Objectives: To perform a meta-analysis of the results of four independent European clinical trials investigating this coil therapy for emphysema. Methods: Data on all patients included in the four European clinical trials were analyzed for efficacy and safety outcomes. Results: A total of 2,536 coils were placed during 259 procedures in 140 patients. A total of 37 chronic obstructive pulmonary disease exacerbations and 27 pneumonias were recorded as serious adverse events up to 1 year after treatment. The pneumothorax rate was 6.4%. Both 6 and 12 months after treatment, significant (all p < 0.001) improvements were observed for: forced expiratory volume in 1 s [+0.08 liters (±0.19) and +0.08 liters (±0.21)], residual volume [RV; -510 ml (±850) and -430 ml (±720)], 6-min walking distance [6MWD; +44.1 m (±69.8) and +38.1 m (±71.9)], and St. Georges Respiratory Questionnaire score [SGRQ; -9.5 points (±14.3) and -7.7 points (±14.2)]. No differences in any outcome measures were observed between heterogeneous and homogeneous emphysema patients. Only a high baseline RV was found to be an independent predictor of successful treatment. Conclusions: Bronchoscopic coil treatment improves pulmonary function, 6MWD, and quality of life in patients with severe emphysema up to 1 year after treatment, independent of the distribution of the disease.

The minimal important difference for the St George's Respiratory Questionnaire in patients with severe COPD

The St Georges Respiratory Questionnaire (SGRQ) is a validated, commonly used questionnaire for measuring quality of life in patients with chronic obstructive pulmonary disease (COPD). The current established minimal important difference (MID) for SGRQ scores in an average COPD population is −4 units. However, for patients with severe COPD, the MID has not been thoroughly validated. We re-determined the SGRQ MID for this patient group. 115 severe COPD patients (forced expiratory volume in 1 s (FEV1) 26±9% of predicted, SGRQ score 62±11 units; mean±sd,) who participated in seven different bronchoscopic lung volume reduction clinical trials were included in the analysis. Anchor- and distribution-based methods were used to define the MID for SGRQ scores. FEV1, 6-min walk distance and residual volume were used as anchors. Combining both anchor- and distribution-based methods, we identified a SGRQ MID of −8.3 units at 1 month and −7.1 units at 6 months. This study proposes an alternative SGRQ MID for patients with severe COPD of −8.3 units at 1 month and −7.1 units at 6 months follow-up after intervention. Our new MID estimates could be applied for both interpreting SGRQ outcomes as well as sample size determination in future clinical trials investigating interventions in severe COPD patients. In patients with severe COPD the redefined MID for SGRQ is –8.3 units at 1 month and –7.1 units at 6 months http://ow.ly/RSYO0

Advanced glycation end products in the skin are enhanced in COPD

BACKGROUND Cigarette smoking is the main cause of chronic obstructive pulmonary disease (COPD) inducing oxidative stress and local tissue injury, resulting in pulmonary inflammation. Advanced glycation end products (AGEs) are produced by glycation and oxidation processes and their formation is accelerated in inflammatory conditions. In this study we assessed whether AGE accumulation in the skin is elevated in COPD and associates with disease severity. METHODS 202 mild-to-very-severe COPD patients and 83 old (40-75 years) and 110 young (18-40 years) healthy smokers and never-smokers were included. AGEs were measured by skin autofluorescence (SAF). Demographic variables, smoking habits, co-morbidities and lung function values were obtained. RESULTS COPD patients (FEV₁=55% predicted) had significantly higher SAF values than old and young healthy controls: 2.5 vs. 1.8 and 1.2 (arbitrary units, p<0.05). No differences in SAF values were found between GOLD stages I-IV (2.4, 2.3, 2.5, 2.5 respectively). Lower function (FEV₁/FVC, MEF₅₀/FVC, RV/TLC) and higher number of packyears were significantly associated with SAF (p<0.05). CONCLUSIONS SAF is increased in mild-to-very severe COPD patients compared with healthy controls. Interestingly, SAF was not associated with disease severity as values were comparable between different GOLD stages (stage I-IV) of COPD. This may suggest that AGEs play a role in the induction phase of COPD in susceptible smokers. Future studies should further investigate the mechanisms underlying AGEs formation and accumulation in COPD.

Treatment of emphysema using bronchoscopic lung volume reduction coil technology: an update on efficacy and safety:

In the last decade several promising bronchoscopic lung volume reduction (BLVR) treatments were developed and investigated. One of these treatments is BLVR treatment with coils. The advantage of this specific treatment is that it works independently of collateral flow, and also shows promise for patients with a more homogeneous emphysema disease distribution. Seven years ago, the very first patients were treated with BLVR coil treatment and currently large randomized, controlled trials are underway. The aim of this article is to review the available literature and provide an update on the current knowledge on the efficacy and safety of BLVR treatment with coils.

Physical Activity Recommendations in Patients with Chronic Obstructive Pulmonary Disease

Background: Physical activity recommendations are hardly studied in patients with chronic obstructive pulmonary disease (COPD), and specifically recommendations that are individualized to a patients aerobic fitness level are not studied. Objectives: To compare individualized (relative) and nonindividualized (absolute) physical activity recommendations in patients with COPD and to assess whether there are differences between patients with mild to moderate and (very) severe COPD. Methods: We compared 7 different physical activity recommendations that were described in the literature. Four recommendations were individualized based on the patients aerobic fitness level measured by a maximal cycle ergometer test. Three recommendations were nonindividualized. The recommendations were measured with an accelerometer, pedometer or questionnaire in 115 patients with mild to very severe COPD (68% male, mean age 65 years, mean FEV1 58% predicted). Results: The percentage of patients that met the different recommendations ranged from 22 to 86% and only 8 patients met all 7 recommendations. The agreement between the different recommendations was poor (intraclass correlation coefficient, 0.28). Individualizing the recommendations resulted in a higher number of patients with severe or very severe COPD meeting the individualized recommendations compared to the nonindividualized recommendations. In contrast, patients with mild to moderate COPD less frequently met the individualized recommendations. Conclusions: Our study showed that applying various physical activity recommendations with small differences in frequency, intensity or time led to large differences in the classification of patients with COPD into being sufficiently physically active or not. Consequently, the used recommendation will highly affect the proposed physical activity advice to the patient.