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).
Project description:BackgroundChronic obstructive pulmonary disease (COPD) remains a leading cause of morbidity and mortality worldwide. Bronchoscopic lung volume reduction (BLVR) using endobronchial valves (EBV) offers a minimally invasive treatment for severe emphysema. Traditionally performed under general anesthesia (GA), this study evaluates whether BLVR performed under moderate sedation (MS) potentially has less adverse events as compared to ones done under GA.MethodsThis retrospective analysis included 65 patients who underwent BLVR with EBV placement at the University of Florida between January 2020 and June 2022. All procedures were performed under MS. Primary outcomes assessed included the incidence of pneumothorax (PTX), while secondary outcomes comprised valve removal rates, need for revision bronchoscopy, and other procedural complications.ResultsThe incidence of PTX was 16.9%, lower than the previously reported rate of 26% in studies combining GA and MS. No major complications or deaths were reported. Procedures were successfully completed in all patients, with valves deployed as planned. Revision bronchoscopy was required in 21.5% of cases.ConclusionsBLVR under MS is demonstrated to be safe and feasible, with a lower rate of complications compared to GA. These findings suggest that MS may be a preferred sedation method for BLVR, though further research is warranted to confirm these results and explore the long-term outcomes and cost implications.
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.
Project description:Emphysema is associated with irreversible loss of lung compliance leading to gas trapping and hyperinflation. Surgical lung volume reduction has proven to improve lung function, exercise capacity, cardiac health and survival in patients with advanced emphysema; however, this procedure is associated with significant morbidity and mortality. Bronchoscopic lung volume reduction (BLVR) has emerged as an alternative approach for these patients. In this article, we review the different techniques used for the purpose of this procedure, its advantages and disadvantages. In addition, we discuss in length valve therapy and the studies that led to its recent FDA approval. Finally, we provide thought-provoking challenges that may be topics for further future investigation to enhance the efficacy and benefit of this technique.
Project description:BackgroundMultiple studies have shown that patients with severe emphysema can significantly benefit from bronchoscopic lung volume reduction endobronchial valve (EBV) treatment up to 1 year after treatment. However, hardly any data exist on longer term follow-up, especially on quality of life. Our aim was to investigate long-term follow-up after EBV treatment up to 3 years including quality of life in a real-life routine clinical setting.MethodsWe retrospectively included patients who underwent EBV treatment in our hospital in the Netherlands at least 3 years prior. Patients were invited for annual visits to our hospital, and spirometry, body plethysmography, 6-min walk distance (6MWD) test and St George's Respiratory Questionnaire (SGRQ) were performed during these visits.ResultsAt 1-, 2- and 3-year follow-up, data were available from 189, 146 and 112 patients, respectively. Forced expiratory volume in 1 s, residual volume and SGRQ total score significantly improved up to 3 years after treatment compared with baseline, and 6MWD up to 2 years after treatment. In general, the magnitude of improvements gradually decreased over time.ConclusionsOur results show that patients can benefit at least up to 3 years after EBV treatment. For the first time we found that patients can also benefit in terms of quality of life in the long term, which is an important outcome for this group of patients with end-stage COPD.
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.
Project description:Purpose:Bronchoscopic lung volume reduction (BLVR) is a valuable treatment option for carefully selected patients with severe COPD. There is limited knowledge about the characteristics and outcomes of patients referred to a specialized center for BLVR. The study objectives were to investigate the selection rate for BLVR treatment in patients referred for this treatment and to investigate the differences between patients that were selected for BLVR and patients that were not. Patients and Methods:We performed a retrospective analysis of patients with severe COPD who were referred to our hospital to assess eligibility for BLVR treatment. Our parameters included demographics, comorbidity, chest computed tomography characteristics, reasons for rejection from BLVR treatment and patient survival. Results:In total, 1500 patients were included (mean age 62 years, 50% female and forced expiratory volume in 1 s 33% of predicted). Out of this group, 282 (19%) patients were selected for BLVR treatment. The absence of a suitable target lobe for treatment, an unsuitable disease phenotype and insufficient lung hyperinflation were the most important factors for not being selected. Patients that were selected for any BLVR option lived significantly longer than the group of patients that were not selected for BLVR (median 3060 versus 2079 days, P<0.001). Conclusion:We found that only a small proportion of patients that are referred for BLVR treatment is eligible for a BLVR treatment, indicating a need for both better referral tools and for the development of new therapies for this group of patients. Furthermore, our data suggest that selection for BLVR is associated with a significant survival benefit.
Project description:Bronchoscopic lung volume reduction (BLVR) procedure has expanded the treatment spectrum of patients with end-stage emphysema. These treatments include valve, coil, thermal vapor ablation, bio-lung volume reduction, targeted lung denervation, and airway bypass stent. This short review provides an up-to-date information on BLVR treatments, their clinical benefits, and an overview of complications. BLVR treatments generally affect dyspnea by reducing hyperinflation and residual volume (RV). Benefits of treatment are associated with improvement in lung function parameters (forced expiration volume in the first second, total lung capacity, RV, and 6-minute walking test) and quality of life. Serious potential pulmonary complications, such as pneumothorax, pneumonia, respiratory failure, and chronic obstructive pulmonary disease exacerbation, may also occur after BLVR treatment. In addition to these, low-cost BLVR methods, such as autologous blood and fibrin glue, are in the developmental stage. Bronchoscopic lung volume reduction treatments are a promising method with positive results for patients with severe emphysema. The widespread use of these techniques, inadequate selection of patients, and non-critical and, therefore, unsuccessful use of BLVR in non-specialist centers lead to a false negative impression of the effectiveness of these techniques. In addition to these considerations, it is obvious that these treatments, which are quite expensive, are burdening social health systems. The reduction of costs or the development of lower-cost treatment methods is important for the future and for the availability of treatments.
Project description:IntroductionAlthough lung volume reduction surgery and bronchoscopic lung volume reduction with endobronchial valves have both been shown to improve lung function, exercise capacity and quality of life in appropriately selected patients with emphysema, there are no direct comparison data between the two procedures to inform clinical decision-making.Methods and analysisWe describe the protocol of the CELEB study, a randomised controlled trial which will compare outcomes at 1 year between the two procedures, using a composite disease severity measure, the iBODE score, which includes body mass index, airflow obstruction, dyspnoeaand exercise capacity (incremental shuttle walk test).Ethics and disseminationEthical approval to conduct the study has been obtained from the Fulham Research Ethics Committee, London (16/LO/0286). The outcome of this trial will provide information to guide treatment choices in this population and will be presented at national and international meetings and published in peer-reviewed journals. We will also disseminate the main results to all participants in a letter.Trial registration numberISRCTN19684749; Pre-results.