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.
ABSTRACT
Patients with severe emphysema have limited treatment options and only derive a small benefit from optimal medical treatment. The only other therapy to have significant clinical beneficial ...effect in emphysema is LVRS but the perceived risk and invasiveness of surgery has fuelled bronchoscopic approaches to induce lung volume reduction. There are multiple bronchoscopic methods for achieving volume reduction in severe emphysema: EBV, airway bypass procedure, endobronchial coils, thermal (vapour) sclerosis and chemical sclerosis (sealants). Optimal patient selection is key to successful patient outcomes. This review discusses bronchoscopic approaches for emphysema treatment which has progressed through clinical trials to clinical practice.
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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.
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.
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%).
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.).
In patients with severe emphysema, bronchoscopic lung volume reduction using one-way valves is a promising therapeutic option to improve lung function and quality of life. The goal of this treatment ...is to achieve a complete lobar atelectasis. In a significant proportion of patients, this atelectasis cannot be achieved due to interlobar collateral ventilation. This collateral ventilation is generated through incomplete lobar fissures. Therefore, only patients with complete fissures and no collateral ventilation can be selected for endobronchial therapy with one-way valves. Incomplete fissures are very common and exhibit a great variation in anatomy. The reported prevalence is 17%-85% for the right major fissure, 19%-74% for the left major fissure, and 20%-90% for the minor fissure. There are several methods of measuring or predicting the presence of collateral ventilation, with computed tomography (CT)-fissure analysis and the Chartis measurement being the most important. CT-fissure analysis is an indirect method to measure the completeness of fissures as a surrogate for collateral ventilation. The Chartis system is an endobronchial method to directly measure the presence of collateral ventilation. Both methods have unique value, and the combination of both can accurately predict the treatment response to the bronchoscopic placement of endobronchial valves. This review provides an in-depth view of lung fissure and collateral ventilation to help understand its importance in selecting the appropriate patients for new emphysema treatments and thus avoid useless treatment in unsuitable patients.
Endobronchial valves (EBVs) have been successfully used in patients with severe heterogeneous emphysema to improve lung physiology. Limited available data suggest that EBVs are also effective in ...homogeneous emphysema.
To evaluate the efficacy and safety of EBVs in patients with homogeneous emphysema with absence of collateral ventilation assessed with the Chartis system.
Prospective, multicenter, 1:1 randomized controlled trial of EBV plus standard of care (SoC) or SoC alone. Primary outcome was the percentage change in FEV
(liters) at 3 months relative to baseline in the EBV group versus the SoC group. Secondary outcomes included changes in FEV
, St. George's Respiratory Questionnaire (SGRQ), 6-minute-walk distance (6MWD), and target lobe volume reduction.
Ninety-three subjects (age, 63.7 ± 6.1 yr mean ± SD; FEV
, % predicted, 29.3 ± 6.5; residual volume, % predicted, 275.4 ± 59.4) were allocated to either the EBV group (n = 43) or the SoC group (n = 50). In the intention-to-treat population, at 3 months postprocedure, improvement in FEV
from baseline was 13.7 ± 28.2% in the EBV group and -3.2 ± 13.0% in the SoC group (mean between-group difference, 17.0%; P = 0.0002). Other variables demonstrated statistically and clinically significant changes from baseline to 3 months (EBV vs. SoC, respectively: SGRQ, -8.63 ± 11.25 vs. 1.01 ± 9.36; and 6MWD, 22.63 ± 66.63 m vs. -17.34 ± 52.8 m). Target lobe volume reduction at 3 months was -1,195 ± 683 ml (P < 0.0001). Of the EBV subjects, 97.2% achieved volume reduction in the target lobe (P < 0.0001). Procedure-related pneumothoraces occurred in 11 subjects (25.6%). Five subjects required removal/replacement of one or more valves. One subject experienced two valve migration events requiring removal/replacement of valves.
EBV in patients with homogeneous emphysema without collateral ventilation results in clinically meaningful benefits of improved lung function, exercise tolerance, and quality of life.
Background and Objective
Both bronchoscopic lung volume reduction with endobronchial valves (BLVR‐EBV) and pulmonary rehabilitation (PR) are effective treatments for improving exercise capacity and ...patient‐reported outcomes in patients with severe Chronic Obstructive Pulmonary Disease (COPD). According to current recommendations, all BLVR‐EBV patients should have undergone PR first. Our aim was to study the effects of PR both before and after BLVR‐EBV compared to BLVR‐EBV alone.
Methods
We included patients with severe COPD who were eligible for BLVR‐EBV and PR. Participants were randomized into three groups: PR before BLVR‐EBV, PR after BLVR‐EBV or BLVR‐EBV without PR. The primary outcome was change in constant work rate cycle test (CWRT) endurance time at 6‐month follow‐up of the PR groups compared to BLVR‐EBV alone. Secondary endpoints included changes in 6‐minute walking test, daily step count, dyspnoea and health‐related quality of life.
Results
Ninety‐seven participants were included. At 6‐month follow‐up, there was no difference in change in CWRT endurance time between the PR before BLVR‐EBV and BLVR‐EBV alone groups (median: 421 IQR: 44; 1304 vs. 787 123; 1024 seconds, p = 0.82) or in any of the secondary endpoints, but the PR after BLVR‐EBV group exhibited a smaller improvement in CWRT endurance time (median: 107 IQR: 2; 573, p = 0.04) and health‐related quality of life compared to BLVR‐EBV alone.
Conclusion
The addition of PR to BLVR‐EBV did not result in increased exercise capacity, daily step count or improved patient‐reported outcomes compared to BLVR‐EBV alone, neither when PR was administered before BLVR‐EBV nor when PR was administered after BLVR‐EBV.
Our findings suggest that a combination of pulmonary rehabilitation and bronchoscopic lung volume reduction with endobronchial valves (BLVR‐EBV) may not provide additional benefits compared to BLVR‐EBV alone at a group‐level. Future challenges lie in selecting patients for whom a combined rehabilitation trajectory would be beneficial.
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Over the past decade, several non‐surgical and minimally invasive bronchoscopic lung volume reduction (BLVR) techniques have been developed to treat patients with severe chronic obstructive pulmonary ...disease (COPD). BLVR can be significantly efficacious, suitable for a broad cohort of patients, and associated with a solid safety profile at a reasonable expense. The introduction of BLVR is also expected to accelerate the further development of interventional pulmonology worldwide. Recently, results from clinical studies on BLVR techniques have been published, providing valuable information about the procedure's indications, contraindications, patient‐selection criterion and outcomes. BLVR utilizing one‐way endobronchial valves is gaining momentum as an accepted treatment in regular medical practice because of the identification of best responders. Patients with a heterogeneous emphysema distribution and without inter‐lobar collateral ventilation show encouraging results. Furthermore, for patients with collateral ventilation, who are not considered candidates for valve treatment, and for patients with homogeneous emphysema, the introduction of lung volume reduction coil treatment is a promising solution. Moreover, with the development of newer treatment modalities, that is, biochemical sealant and thermal water vapor, the potential to treat emphysema irrespective of collateral flow, may be further increased. Nevertheless, patient selection for BLVR treatment will be crucial for the procedure's success and should be performed using a multidisciplinary team approach. Consequently, BLVR needs to be concentrated in high‐volume centres that will offer better quality and experience with treatment challenges and adverse events. This review gives a general overview of BLVR from an expert and scientific perspective.
Endoscopic lung volume reduction (ELVR) is being adopted as a treatment option for carefully selected patients suffering from severe emphysema. ELVR with the one-way endobronchial Zephyr valves (EBV) ...has been demonstrated to improve pulmonary function, exercise capacity, and quality of life in patients with both heterogeneous and homogenous emphysema without collateral ventilation. In this "expert best practices" review, we will highlight the practical aspects of this therapy. Key selection criteria for ELVR are hyperinflation with a residual volume >175% of predicted, forced expiratory volume <50% of predicted, and a 6-min walking distance >100 m. Patients with repeated infectious complications, severe bronchiectasis, and those with unstable cardiovascular comorbidities should be excluded from EBV treatment. The procedure may be performed with either conscious sedation or general anesthesia and positive pressure mechanical ventilation using a flexible endotracheal tube or a rigid bronchoscope. Chartis and EBV placement should be performed in 1 procedure when possible. The sequence of valve placement should be orchestrated to avoid obstruction and delivery of subsequent valves. If atelectasis has not occurred by 1 month after procedure, evaluate valve position on CT and consider replacing the valves that are not optimally positioned. Pneumothorax is a common complication and typically occurs in the first 2 days following treatment. A management algorithm for pneumothorax has been previously published. Long-term sequelae from EBV therapy do occur but are easily manageable.
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