Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi trial): study design and rationale.
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SUBMITTER: Davey C
PROVIDER: S-EPMC4345993 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPharmacologic therapeutics for advanced emphysema have limited benefit. Bronchoscopic lung volume reduction with endobronchial valves (EBVs) have reported improvements in lung function, breathlessness, and quality of life through randomized clinical trials, with less morbidity as comparted to Surgical Lung volume Reduction. We here present a Meta-analysis and systematic review of bronchoscopic lung volume reduction in advanced chronic obstructive lung disease patients.MethodsPubMed (NLM), Embase (Elsevier), and Web of Science (Clarivate Analytics) search was conducted using a combination of keywords and subject headings. The search was confined to the last 15 years and was completed on October 23, 2020. Only placebo-controlled randomized control trials of emphysema patients with EBV were included. Quality assessment was done by 2 independent reviewers.ResultsNine studies were included for the meta-analysis with a total number of 1383 patients of whom 888 received EBV and 495 standard of care (SOC) medications. Our Metanalysis show statistically significant improvement in forced expiratory volume in first second, percentage forced expiratory volume in first second, St. George's respiratory questionnaire, and 6-minute walk distance in EBV group compared with SOC. Residual volume had statistically significant reduction after EBV placement compared with SOC. These differences continued to be present during short-term (<=6 mo) and long-term follow-up (>=6 mo). These improvements were even higher when the EBV patients'. Collateral ventilation was negative/fissure was intact (CV-/FI >90%). The rate of hemoptysis and pneumothorax was higher in the EBV group compared with SOC, however, did not lead to increased fatal outcomes.ConclusionIn conclusion, EBV has favorable effects on patients' outcomes in patients who have heterogeneous emphysema particularly with no collateral ventilation.
| S-EPMC9233031 | biostudies-literature
Project description:PurposeEndobronchial valve (EBV) therapy is increasingly being seen as a therapeutic option for advanced emphysema, but its clinical utility in Asian populations, who may have different phenotypes to other ethnic populations, has not been assessed.Patients and methodsThis prospective open-label single-arm clinical trial examined the clinical efficacy and the safety of EBV in 43 consecutive patients (mean age 68.4±7.5, forced expiratory volume in 1 second [FEV1] 24.5%±10.7% predicted, residual volume 208.7%±47.9% predicted) with severe emphysema with complete fissure and no collateral ventilation in a tertiary referral hospital in Korea.ResultsCompared to baseline, the patients exhibited significant improvements 6 months after EBV therapy in terms of FEV1 (from 0.68±0.26 L to 0.92±0.40 L; P<0.001), 6-minute walk distance (from 233.5±114.8 m to 299.6±87.5 m; P=0.012), modified Medical Research Council dyspnea scale (from 3.7±0.6 to 2.4±1.2; P<0.001), and St George's Respiratory Questionnaire (from 65.59±13.07 to 53.76±11.40; P=0.028). Nine patients (20.9%) had a tuberculosis scar, but these scars did not affect target lobe volume reduction or pneumothorax frequency. Thirteen patients had adverse events, ten (23.3%) developed pneumothorax, which included one death due to tension pneumothorax.ConclusionEBV therapy was as effective and safe in Korean patients as it has been shown to be in Western countries. (Trial registrationClinicalTrials.gov: NCT01869205).
| S-EPMC4524390 | biostudies-literature
Project description:BackgroundBronchoscopic lung volume reduction (BLVR) using 1-way endobronchial valves (EBV) has become a guideline treatment in patients with advanced emphysema. Evidence from this minimally invasive treatment derives mainly from well-designed controlled trials conducted in high-volume specialized intervention centres. Little is known about real-life outcome data in hospitals setting up this novel treatment and which favourable conditions are required for a continuous successful program.ObjectivesIn this study, we aim to evaluate the eligibility rate for BLVR and whether the implementation of BLVR in our academic hospital is feasible and yields clinically significant outcomes.MethodA retrospective evaluation of patients treated with EBV between January 2016 and August 2019 was conducted. COPD assessment test (CAT), forced expiratory volume in 1 s (FEV1), residual volume (RV), and 6-min walking test (6MWT) were measured at baseline and 3 months after intervention. Paired sample t tests were performed to compare means before and after intervention.ResultsOf 350 subjects screened, 283 (81%) were not suitable for intervention mostly due to lack of a target lobe. The remaining 67 subjects (19%) underwent bronchoscopic assessment, and if suitable, valves were placed in the same session. In total, 55 subjects (16%) were treated with EBV of which 10 did not have complete follow-up: 6 subjects had their valves removed because of severe pneumothorax (n = 2) or lack of benefit (n = 4) and the remaining 4 had missing follow-up data. Finally, 45 patients had complete follow-up at 3 months and showed an average change ± SD in CAT -4 ± 6 points, FEV1 +190 ± 140 mL, RV -770 ± 790 mL, and +37 ± 65 m on the 6MWT (all p < 0.001). After 1-year follow-up, 34 (76%) subjects had their EBV in situ.ConclusionImplementing BLVR with EBV is feasible and effective. Only 16% of screened patients were eligible, indicating that this intervention is only applicable in a small subset of highly selected subjects with advanced emphysema, and therefore a high volume of COPD patients is essential for a sustainable BLVR program.
| S-EPMC9153356 | biostudies-literature
Project description:BackgroundBronchoscopic lung volume reduction (BLVR) using Zephyr endobronchial valve (EBV) and intrabronchial valve (IBV) has been shown to improve lung function and exercise capacity in severe emphysema. However, changes in airway structures and whether these are related to the clinical improvements remain unclear.MethodsA retrospective study was performed on patients treated with BLVR. We compared changes in 2nd-, 3rd-, and 4th-generation bronchial structures after therapy, including wall thickness (WT), percentage of wall thickness (WT%), intraluminal area (LA), wall area (WA), and WA%. Responder and non-responder subgroup analysis according to minimum clinically important difference (MCID) which was defined as an improvement of 15% in forced expiratory volume in 1 s (FEV1) and 26 m in 6 min walk distance (6MWD) was conducted.ResultsOf the 19 patients, 11 were treated with EBV and 8 with IBV. In ipsilateral non-target lobes, WT% decreased significantly in 3rd-generation bronchi at 1 month, 3, and 6 months, as well as their WA% at 1 month and 6 months. Non-responders, who were unable to achieve MCID, showed no consistent bronchial wall changes. And their LA of 3rd-generation bronchi decreased especially at 1 month. After BLVR, the target lobe volume decreased significantly until 12 months of follow-up. The volume of ipsilateral lobes could increase correspondingly and achieve the best improvements at 6 months. The contralateral lung volume showed slight amelioration but there was no statistical significance.ConclusionsBoth airway structures and lung volumes showed changes after BLVR. The 3rd- and 4th-bronchial walls tend to be thinner, which were consistent with clinical improvements. Further studies are needed to prove this conclusion and find detect potential mechanics.
| S-EPMC9264089 | biostudies-literature
Project description:BackgroundEndobronchial valve (EBV) therapy, a validated method for bronchoscopic lung volume reduction (BLVR) in severe emphysema, has been explored for persistent air-leak (PAL) management. However, its effectiveness and safety in the Asian population require further real-world evaluation. In this study, we assessed the outcomes of treatment with EBV within this demographic.MethodsWe conducted a retrospective analysis of medical records from 11 Korean centers. For the emphysema cohort, inclusion criteria were patients diagnosed with emphysema who underwent bronchoscopy intended for BLVR. We assessed these patients for clinical outcomes of chronic obstructive pulmonary disease. All patients with PAL who underwent treatment with EBV were included. We identified the underlying causes of PAL and evaluated clinical outcomes after the procedure.ResultsThe severe emphysema cohort comprised 192 patients with an average age of 70.3 years, and 95.8% of them were men. Ultimately, 137 underwent treatment with EBV. Three months after the procedure, the BLVR group demonstrated a significant improvement in forced expiratory volume in 1 s (+160 mL vs. +30 mL; P = 0.009). Radiographic evidence of lung volume reduction 6 months after BLVR was significantly associated with improved survival (adjusted hazard ratio 0.020; 95% confidence interval 0.038-0.650; P = 0.010). Although pneumothorax was more common in the BLVR group (18.9% vs. 3.8%; P = 0.018), death was higher in the no-BLVR group (38.5% vs. 54.5%, P = 0.001), whereas other adverse events were comparable between the groups. Within the subset of 18 patients with PAL, the predominant causes of air-leak included spontaneous secondary pneumothorax (44.0%), parapneumonic effusion/empyema (22.2%), and post-lung resection surgery (16.7%). Following the treatment, the majority (77.8%) successfully had their chest tubes removed. Post-procedural complications were minimal, with two incidences of hemoptysis and one of empyema, all of which were effectively managed.ConclusionsTreatment with EBV provides substantial clinical benefits in the management of emphysema and PAL in the Asian population, suggesting a favorable outcome for this therapeutic approach.
| S-EPMC10988911 | biostudies-literature
Project description:Chronic obstructive pulmonary disease (COPD) is the major causes of disability and mortality. The efficacy of maximal medical treatment, although effective at the early stages of the disease, becomes limited when extensive alveolar destruction is the main cause of respiratory failure. At this stage of the disease more aggressive options, when feasible, should be considered. Lung transplantation and lung volume reduction surgery (LVRS) are currently available for a selected group of patients. Endoscopic alternatives to LVRS have progressively gained acceptance and are currently employed in patients with COPD. They promote lung deflation searching the same outcome as LVRS in terms of respiratory mechanics, ameliorating the distressing symptom of chronic dyspnea by decreasing the physiological dead space.
| S-EPMC6297441 | biostudies-literature
Project description:Chronic obstructive pulmonary disease is a prevalent and progressive disease. The recently developed bronchoscopic lung volume reduction (BLVR) techniques offer personalized therapeutic options in subgroups of patients with severe emphysema. Endobronchial and intrabronchial valves (EBV/IBV) achieve lung volume reduction by lobar atelectasis. The lung volume reduction coils (LVRCs) and bronchoscopic thermal vapor ablation (BTVA) induce tissue compression, either mechanically or through inflammatory processes. While the effects of EBV/IBV are reversible by removing the implants, the effects of LVRC are partially reversible and that of BTVA is irreversible. The presence of interlobar collateral ventilation (CV) impacts on EBV/IBV treatment outcome due to its mechanism of action. Therefore, using radiological and endoscopic techniques to assess CV has a vital importance. Current evidence of BLVR demonstrates acceptable safety and short-term clinical efficacy. However, head-to-head trials are lacking, and further research is needed to establish long-term clinical benefit, durability, and cost-effectiveness of these techniques.
| S-EPMC7879872 | biostudies-literature
Project description: Not available
| S-EPMC6373582 | biostudies-literature
Project description:BackgroundCentral airway obstruction related to endobronchial malignancy is one of the most difficult oncological complications and requires efficient palliative intervention.MethodsFifty-three consecutive patients with unresectable endobronchial malignancy receiving bronchoscopic cryotherapy as palliative treatment were retrospectively reviewed. Efficiency was evaluated by the improvement of performance status (PS), and the best achievement of tumor removal was assessed as complete or partial removal.ResultPatients' PS after cryotherapeutic tumor removal improved from the baseline PS (P = 0.006). In multivariate logistic regression analysis, the compression part of the tumor (odds ratio [OR] 0.42; 95% confidence interval [CI] 0.23∼0.75, P = 0.004) and the thin tumor stalk (OR 87.86; 95% CI 2.31∼3337.37, P = 0.016) were independent predictors of complete tumor removal. Tumors larger than 9.3 cm, including compression and invasion parts, had the highest odds of being only partially removed (positive predictive value [PPV]: 88.2%, likelihood ratio [LR]+: 10.49); tumors smaller than 9.3 cm were likely to be completely removed (negative predictive value [NPV]: 80.6%, LR-: 0.34). After cryotherapy, re-obstruction was significantly associated with non-squamous cell carcinoma (65.7 vs. 16.7%, P = 0.001) and patients who had longer overall survival (11.7 vs. 1.5 months, P < 0.001). Odds of tumor re-obstruction increased 2.28-fold (PPV: 81.6%, LR+: 2.28) beyond two months; the odds decreased by 81% (NPV: 73.3%, LR-: 0.19) within two months.ConclusionDebulking of a tumor using cryotherapy is a useful palliative treatment for endobronchial obstruction secondary to a variety of malignancies.
| S-EPMC4632924 | biostudies-literature
Project description:COPD is a highly prevalent, chronic and irreversible obstructive airway disease without curative treatment. Standard therapeutic strategies, both non-pharmacological and pharmacological, have only limited effects on lung function parameters of patients with severe disease. Despite optimal pharmacological treatment, many patients with severe COPD still have a high burden of dyspnoea and a poor quality of life. If these patients have severe lung emphysema, with hyperinflation as the driver of symptoms and exercise intolerance, lung volume reduction may be an effective treatment with a significant impact on lung function, exercise capacity and quality of life. Currently, different lung volume reduction approaches, both surgical and bronchoscopic, have shown encouraging results and have been implemented in COPD treatment recommendations. Nevertheless, choosing the optimal lung volume reduction strategy for an individual patient remains challenging. Moreover, there is still room for improving durability of effect and safety in all available procedures. Ongoing and innovative research is essential to push this field forwards. This review provides an overview of results and limitations of the current lung volume reduction options for patients with severe lung emphysema and hyperinflation.
| S-EPMC10731473 | biostudies-literature