How effective are coils in the treatment of emphysema?
· The statistical power to demonstrate a superior success rate (1-sided hypothesis test) in the primary end point for the coil group vs the usual care group was anticipated to be 90% with a significance of α = .05 at a total sample size of 100 patients, based on the hypothesis of a 37% end-point achievement in the coil group and 5% in the usual care group and with 30% of …
Does lung volume reduction surgery improve cardiopulmonary function in emphysema?
Patients with severe emphysema were randomly assigned in a 1:1 ratio to lung volume reduction coil treatment or usual care and were followed during 5 years. ...
Do coils improve lung volumes and elastic recoil of the lungs?
Background: The REVOLENS study compared lung volume reduction coil treatment to usual care in patients with severe emphysema at 1 year, resulting in improved quality-adjusted life-year (QALY) and higher costs. Durability of the coil treatment benefit and its cost-effectiveness at 2 years are now assessed. Methods: After one year, the REVOLENS trial's usual care group …
Does coil therapy reduce hyperinflation in lungs?
· Background The REVOLENS study compared lung volume reduction coil treatment to usual care in patients with severe emphysema at 1 year, resulting in improved quality-adjusted life-year (QALY) and higher costs. Durability of the coil treatment benefit and its cost-effectiveness at 2 years are now assessed. Methods After one year, the REVOLENS trial’s …
Who is a candidate for lung volume reduction surgery?
The best candidates for successful surgery tend to be those who: Have severe lung damage (emphysema), particularly in the upper part of the lung. Are younger than 75 to 80 years old. Have not smoked for at least six months.
Does bronchoscopic lung volume reduction reduce mortality in severe emphysema?
There was no statistically significant difference in mortality between groups in the early period, but it was lower in the BLVR group at the end of 12th month. Conclusion: BLVR treatment significantly decreases mortality compared to SoC in patients with advanced emphysema.
Which invasive treatment is used in severe advanced emphysema?
Bronchoscopic lung volume reduction (BLVR) with one-way endobronchial valve (EBV) is a minimally invasive treatment that has been shown to improve clinical outcomes in patients with advanced emphysema and severe hyperinflation.
What is Lung Volume Reduction Coil treatment?
Abstract. Background The lung volume reduction (LVR) coil is a minimally invasive bronchoscopic nitinol device designed to reduce hyperinflation and improve elastic recoil in severe emphysema.
Does lung volume reduction surgery improve mortality?
In selected patients with COPD and an emphysema phenotype, lung volume reduction surgery (LVRS) has demonstrated improvements in symptom burden and mortality. Minimally invasive bronchoscopic techniques that reduce end-expiratory lung volume have shown improvements in lung function, dyspnea and quality of life.
What is the best treatment for emphysema?
Treatment for emphysemastopping smoking immediately and completely – this is the most effective treatment for COPD and emphysema.avoiding other air pollutants.respiratory (pulmonary) rehabilitation programs.oxygen treatment, in advanced cases.medications such as. ... stress management techniques.More items...
How is advanced emphysema treated?
TreatmentBronchodilators. These drugs can help relieve coughing, shortness of breath and breathing problems by relaxing constricted airways.Inhaled steroids. Corticosteroid drugs inhaled as aerosol sprays reduce inflammation and may help relieve shortness of breath.Antibiotics.
Is Lung Transplantation a solution for emphysema?
For the most seriously ill patients with emphysema-related COPD, lung transplant is the best option. Some patients, however, are not quite that ill but still have severe emphysema with profound limitations in physical activity and quality of life.
How do lung coils work?
The coils return elasticity to the diseased tissue, allowing the lungs to work in a more normal way,” he says. This procedure has the potential to return COPD patients to a more normal lung function, reducing the hyperinflation that causes shortness of breath.
What are endobronchial coils?
The endobronchial coils are “non-blocking” devices which are delivered by bronchoscopy into the sub-segmental airways. Unlike one-way endobronchial valves, the endobronchial coils are also effective in patients with interlobar collateral ventilation and, thus, work independent of this phenomenon.
What is vapor ablation?
Bronchoscopic thermal vapour ablation (BTVA) uses heated water vapour to produce a thermal reaction leading to an initial localised inflammatory response followed by permanent fibrosis and atelectasis. The remodelling results in reductions in tissue and air volume of the targeted regions of the hyperinflated lung.
How is emphysema quantified?
Emphysema was quantified in each lobe using the National Emphysema Treatment Trial visual assessment score. 17 The most severely affected lobe of each lung was targeted for coil treatment and the upper lobe was chosen when ipsilateral scores were the same. Scoring and targeting were determined by each site. No computed tomography densitometry analysis was used in this study.
How long after randomization is a coil treated?
Patients in the coil group received the same treatment as the usual care group and also received coil treatment within 15 days after randomization. The contralateral treatment was completed 1 to 3 months after the first.
How are health outcomes valued in QALYs?
Health outcomes are valued in QALYs. Health-related quality of life was assessed using the EuroQol 5 Dimensions self-administered questionnaires at baseline, 6 months, and 1 year. The utility values are based on French tariffs for the corresponding EuroQol 5 Dimensions scores. Utility curves were obtained for each group by plotting average utility values at baseline, 6 months, and 1 year. The difference in QALYs was estimated as the difference in the area between the utility curves for the 2 groups.
How many sites participated in the Euroemphysema study?
Ten sites throughout France participated in the study. This study was approved by the Ethics Committee of Dijon Est I and by the French Agency for Medicines and Health Products. A website was accessible to participants and referring physicians ( http://www.euroemphysema.com ). Enrollment of participants started in March 2013 and was completed in October 2013. The last follow-up visit was in December 2014. An independent data and safety monitoring board monitored events and reviewed efficacy results. The trial protocol has been previously published 16 and is available in Supplement 1. All participants provided written informed consent.
What are the outcomes of the 6-minute walk test?
Secondary outcomes included changes at 6 and 12 months in the 6-minute walk test, lung function, quality of life as assessed by St George’s Respiratory Questionnaire (range, 0-100; 0 being the best and 100 being the worst quality of life; minimal clinically important difference, ≥4), morbidity, mortality, total cost, and cost-effectiveness.
What does FEV mean in CT?
CT indicates computed tomography; FEV 1, forced expiratory volume in the first second.
What are baseline characteristics, QALYs, and costs?
Baseline characteristics, QALYs, and costs are described using counts (and proportions), means (with standard deviations or 95% confidence intervals), or medians (with interquartile ranges). Differences in costs and QALYs were tested using standard parametric or nonparametric tests ( t test or Mann-Whitney test) as appropriate and are described as means (with 95% confidence intervals). The incremental cost difference and generated 95% confidence intervals were calculated using nonparametric bootstrapping with 1000 replications. An acceptability curve was generated based on the bootstrap results. Statistical significance for differences among a priori comparisons was set at P = .05 (2-sided).
What is lung volume reduction surgery?
Lung volume reduction surgery (LVRS) in emphysema has demonstrated improvement in both overall survival and clinical/functional outcomes. Endobronchial coil treatment (ECT) has also demonstrated improvement in pulmonary function, exercise performance, and quality of life, although predictive factors of responders remain to be determined. We describe the first successful LVRS in an emphysematous patient who displayed no benefit, either clinically or functionally, from a previous ECT. LVRS was performed in the right lower lobe 4 years after ECT in the same lobe. An air leak persisted for 18 days after LVRS, with no requirement for surgery or endobronchial treatment. Six months after LVRS, the patient dramatically improved with a decrease in hyperinflation and dyspnea.
What is BLVR coil?
One of these, the BLVR coil procedure, is a treatment option for patients with homogeneous and heterogeneous end-stage emphysema and a forced expiratory volume in 1 second (FEV1) of 15–45%. This treatment decreases hyperinflation and improves lung function, the quality of life, and exercise capacity. It is very important to prepare patients for treatment, premedications, anesthesia applications, intubation, post-procedure follow-up and treatments. Further, it has been observed that various complications can develop during and after the procedure. Generally, the observed and reported complications are chronic obstructive pulmonary disease (COPD) exacerbation, chest pain, mild bleeding, pneumonia, pneumothorax, and respiratory failure. Rarely, aspergillus cavitation (coil-related aspergilloma), bronchopleural fistula and penetration into the pleural space, bronchiectasis, coil-associated inflammatory response and opacities, and hiccups are observed. Common complications are usually mild or moderate, while the rare ones can be life-threatening (except hiccup), so early diagnosis and treatment are necessary. However, patients treated with BLVR have lower mortality rates than untreated patients with similar morbidity. Based on the findings of this review, we can estimate that premedication one day before and just before the procedure may reduce potential complications. Some medical centers apply and recommend 30-day macrolide treatment after the procedure. New generation supraglottic devices may be preferred to avoid complications due to endotracheal intubation. Moreover, further research is needed to identify risk factors, prevent potential complications, and a common consensus is required for routine preventive treatment.
What is flexible bronchoscopy?
Diagnostic flexible bronchoscopy is safely performed outside of the operating room with light to moderate sedation and topical anesthesia. Rigid bronchoscopy is typically performed in patients with central airway obstruction and major comorbidities. Primary concerns include the risk of complete airway obstruction and inability to ventilate or dynamic hyperventilation with hemodynamic compromise. A fluid transition between ventilation strategies is often required for these procedures. Extracorporeal membrane oxygenation may be implemented when conventional approaches are not feasible or deemed safe. Multimodal techniques employed by interventional bronchoscopists to acutely re-establish patency of obstructed central airways include stenting, laser, endobronchial electrosurgery, argon plasma coagulation, and balloon bronchoplasty. Major intraoperative complications associated with these techniques include hemorrhage, airway trauma, perforation, fire, systemic gas embolism, and dissemination of postobstructive pneumonia. Alternative indications for these procedures include treatment of low-grade malignancies and carcinoma in situ. These lesions may also respond to brachytherapy, cryotherapy, or photodynamic therapy. Interventional bronchoscopy is an evolving field with expanding applications with both diagnostic and therapeutic modalities covering benign and malignant pulmonary disease. Future indications may include endobronchial valve insertion for persistent air leaks and lung volume reduction in COPD as well as bronchial thermoplasty for treatment-resistant asthma.
What is bronchoscopy used for?
For approximately the last 50 years, bronchoscopy, especially flexible fiberoptic bronchoscopy, has been a mainstay for airway inspection, the diagnosis of airway lesions, therapeutic aspiration of airway secretions and transbronchial biopsy to diagnose parenchymal lung disorders. Its utility for the diagnosis of peripheral pulmonary nodules and for therapeutic treatments outside of the aspiration of airway secretions, however, has been limited due to problems with navigation to the lung periphery, locating lesions in the 3-dimensional structure of the lung, the avoidance of lung vasculature structures when performing diagnostic biopsies and the availability of proper tools to access the lesion and simultaneous visualizing the lesion during the biopsy real-time. The last 10-15 years has seen major advances in thoracic imaging, navigational platforms to direct the bronchoscopist to airway lesions, transparenchymally via virtual avascular pathways, and to visualize the performance of biopsy of the lesion real-time. Additionally, multiple new techniques are either now available, or currently being investigated to treat airway and lung parenchymal diseases, including malignant peripheral lung nodules. These combinations of factors create the potential for bronchoscopy, especially fiberoptic bronchoscopy, to provide the clinician with a new and expanding armamentarium of diagnostic and therapeutic tools to treat a variety of lung diseases. This state-of-the-art review succinctly provides an overview of these techniques and provides the clinician with an organized approach to the role and application of these tools in the diagnosis and therapy of a range of lung diseases.
When was LVR first used?
Lung volume reduction (LVR) procedures for emphysematous patients were firstly introduced in the second half of the twentieth century. Over time, from the first invasive surgical procedures, new less invasive techniques have been conceived. In regards to the surgical approach, the adoption of VATS and the execution, in selected centers, of a non-resectional approach, with folding of less functional lung tissue, reduced mortality and adverse events risks. As regards to the bronchoscopic approach, endobronchial valves (EBV) and intrabronchial valves (IBV) were initially proposed in the early 2000s to obtain segmental or lobar atelectasis of the more compromised lung parenchyma. Despite showing promising results with respect to improvement of pulmonary function tests, particularly forced expiratory volume in 1st second (FEV1), and quality of life, and a good safety profile, valves showed disappointing results in presence of collateral ventilation, such as in cases of incomplete fissures. To overcome this technical issue, in the last 10 years, endobronchial coils have been designed and used. Having a compressive effect on the lung parenchyma where they are located, they are not affected by collateral ventilation. Randomized control trials (RCTs) on endobronchial coils showed a significant improvement in FEV1 and quality of life, however this technique was not immune to side effects, particularly low respiratory tract infections and pneumothoraces. Besides bronchial valves (BV) and coils, airway by-pass stents have also been evaluated in a RCT but without reaching the desired endpoints. Other innovative procedures recently considered and delivered through bronchoscopy regards thermal energy, with vapour therapy, to achieve a scarring reaction of the emphysematous lung parenchyma, and polymeric foams used as lung sealants to achieve absorptive atelectasis. In conclusion, LVR procedures may be considered in carefully selected patients with symptomatic emphysema and severe lung hyperinflation, and might be personalized according to the anatomical characteristics of emphysematous area.
Is COPD a heterogeneous disease?
Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease associated with significant morbidity and mortality. Over the past few years, there has been cumulating interest in describing this heterogeneity and using this information to group patients into different COPD phenotypes. The term phenotype is defined as single or combination of disease attributes that describe differences between individuals with COPD as they relate to clinically meaningful outcomes. It describes also the physical appearance or biochemical characteristics which result from the genotype-environment interaction. Furthermore, it clearly identifies subgroups with a significant impact in the prognosis. Recently, approaches to COPD phenotyping have been significantly enhanced in tandem with developments in understanding the disease's various pathological, clinical and genetic features. This knowledge inspired the researchers to investigate more tailored therapeutic strategies that could not only give a more potent effect but also help to avoid the traditional therapy's undesirable side effects. Eventually, it could be said that the phenotypic approach to COPD in the last decade had a huge impact on daily practice and management delivered to COPD patients. In this review, we highlight the impact of pharmacological and non-pharmacological treatment options on COPD outcomes, using a personalized treatment strategy based on different phenotypes.
Is emphysema with hyperinflation a therapeutic challenge?
Severe emphysema with hyperinflation presents a therapeutic challenge. Inhaled medication has limited efficacy in individuals with mechanical constraints to the respiratory pump and impaired gas exchange. Lung volume reduction surgery (LVRS) reestablishes some semblance of normal physiology, resecting grossly expanded severely diseased tissue to restore the function of compromised relatively healthy lung, and has been shown to significantly improve exercise capacity, quality of life, and survival, especially in individuals with upper-lobe predominant emphysema and low-baseline exercise capacity, albeit with higher early morbidity and mortality. Bronchoscopic lung volume reduction achieved by deflating nonfunctioning parts of the lung is promoted as a less invasive and safer approach. Endobronchial valve implantation has demonstrated comparable outcomes to LVRS in selected individuals and has recently received approvals by the National Institute of Clinical Excellence in the United Kingdom and the Food and Drug Administration in the United States of America. Endobronchial coils are proving a viable treatment option in severe hyperinflation in the presence of collateral ventilation in selected cases of homogeneous disease. Modalities including vapor and sealant are delivered using a segmental strategy preserving healthier tissue within the same target lobe-efficacy and safety-data are, however, limited. This article will review the data supporting these novel technologies.
Abstract
The REVOLENS study compared lung volume reduction coil treatment to usual care in patients with severe emphysema at 1 year, resulting in improved quality-adjusted life-year (QALY) and higher costs. Durability of the coil treatment benefit and its cost-effectiveness at 2 years are now assessed.
Background
Usual medical treatments have limited effectiveness in patients with severe emphysema, justifying the development of alternative interventional treatments such as endobronchial lung volume reduction treatments including valves, coils, and thermal vapor ablation [ 1 ].
Methods
The design of the REVOLENS trial has been previously reported and will be briefly summarized [ 4 ].
Results
Of 116 patients screened, 100 patients were randomized, 50 to the first line coil treatment group and 50 to the second line coil treatment group.
Discussion
This health economic analysis of the REVOLENS study results was prospectively designed to inform healthcare payers in France.
Conclusion
In conclusion, REVOLENS-2 study results showed that first-line coil treatment was more expensive but also more effective than second-line coil treatment at 2 years, with a 2-year ICER of €75,978 / QALY.
Acknowledgements
The members of the REVOLENS Study Group includes all authors and Sandra Dury, MD, Hervé Vallerand MD, François Lebargy MD PhD, Claire Launois MD (Hôpital Universitaire de Reims), Johanna Pradelli MD, Jonathan Benzaquen MD, Matthieu Buscot MD, Celine Sanfiorenzo MD, Sylvia Korzeniewski MD, Andrea Mazzetta MD, Jennifer Griffonnet, Ariane Guillemart, Demosthenes Makris MD (Hôpital Universitaire de Nice), Marie Christine Dombret MD, Frédérique Servin MD, Marie Pierre Debray MD (Hôpital Universitaire Bichat, Paris), Sophie Laroumagne MD, Fabienne Bregeon MD PhD, Carine Gomez MD, Philippe Astoul MD PhD (Hôpital Universitaire de Marseille), Nathalie Lesavre MD (Centre d’Investigation Clinique 1409, AP-HM, Marseille), Jean Pierre Mallet MD, Anne Sophie Gamez MD, Philippe Tarodo MD, Christophe Brousse MD, Clément Broissin MD (Hôpital Universitaire de Montpellier), Yoann Thibout MD, Fabrice Di Palma MD, Frédéric Costes MD (Hôpital Universitaire de Saint Etienne), Amandine Briault MD, François Arbib MD, Emilie Reymond MD, G.
When was lung volume reduction first used?
Lung volume reduction was attempted as early as the 1950s, with Brantigan often credited with the first attempts at surgical lung volume reduction (8). However, this approach was not widely adopted due to an increased operative mortality of 18% and a lack of documented post-operative improvements. Interest in LVRS was reinvigorated in 1995, when Cooper published a case series of 20 patients that showed significant improvement in lung function and 6-minute walk distance (6-MWD) (9). This series was followed by a larger, 150 patient series by the same group, with the benefits of LVRS confirmed by the first RCT in 1999 by Criner et al.(10,11) This was quickly followed by a second RCT with similar outcomes (12).
What are the minimally invasive techniques used in the NETT study?
These include the use of one-way endobronchial valves (EBVs), endobronchial nitinol coils, foam sealant, and thermal ablation. These bronchoscopic techniques all attempt to provide comparable improvements in function via lung reduction but with reduced perioperative morbidity and mortality that is associated with traditional surgical approaches.
What is high exercise capacity?
High exercise capacity is defined as >25 W for women and >40 W for men , as measured on post-pulmonary rehab CPET. Exercise capacity defined as a 10 W improvement on CPET. Symptom improvement defined as 8+ change in SGRQ. *, patients with a decreased diffusion capacity in the upper lobes may have a mortality benefit. NETT, National Emphysema Treatment Trial; FEV1, forced expiratory volume in one second; DLCO, diffusion capacity for the lungs using carbon monoxide; SGRQ, St. George’s respiratory questionnaire; CPET, cardiopulmonary exercise test.
What are the outcomes of Nett study based on?
Outcomes of NETT study based on distribution of emphysema and exercise capacity
Is COPD a heterogeneous disease?
Despite advances in medical and interventional techniques, COPD remains a complex, heterogeneous disease with significant morbidity and mortality. As we enter the age of personalized medicine, interventional techniques need to be refined and tailored to specific patients with clearly defined pathophysiologic processes and specific phenotypes.
Can you get lung transplant with LVRS?
Given the advanced level of lung disease, there is concern that LVRS would preclude lung transplantation. However, multiple studies have demonstrated the safety and efficacy of lung transplantation following LVRS (23,24). Sequential LVRS followed by lung transplantation has shown an improvement in mortality when compared to lung transplant alone (25).
Does LVRS increase mortality?
Among patients with a high exercise tolerance and a non-upper lobe distribution of emphysema, LVRS is also associated with an increase in mortality when compared to medical therapy alone. These patients should not be offered LVRS. Given high exercise capacity, optimal medical therapy in conjunction with assessment for bronchoscopic lung volume reduction (BLVR) should be undertaken.
Abstract
Patients with chronic obstructive pulmonary disease and lung emphysema may benefit from surgical or endoscopic lung volume reduction (ELVR). Previously reported outcomes of nitinol coil-based ELVR techniques have been ambiguous. The analysis was done to analyse outcomes of ELVR with nitinol coils in patients with severe pulmonary emphysema.
INTRODUCTION
The health burden of chronic obstructive pulmonary disease (COPD) is increasing world-wide [ 1–3 ]. COPD pathogenesis is triggered mostly be inhaled irritants, e.g. tobacco smoke, causing airway remodelling and consecutive obstruction.
METHODS
The necessity for informed consent was waived for the retrospective, anonymous analysis and publication of the data by the local ethics committee (Ärztekammer des Saarlandes). Patients gave written informed consent for the intervention.
DISCUSSION
The main results of this study are: (i) the implantation of coils for ELVR does not result in a clinically relevant or sustained benefit for patients with severe COPD and (ii) there is no long-term survival benefit after 48 months.
CONCLUSION
In this retrospective analysis, ELVR coils led to small and short-lived benefits in lung function and/or exercise capacity in some patients with severe emphysema. Benefits could not be sustained longer than 6 months on average. Response in lung function to ELVR does not adequately correlate to benefits in exercise capacity or quality of life.
Data availability
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Author contributions
Sebastian Mang: Data curation; Formal analysis; Writing—original draft. Niklas Huss: Data curation; Formal analysis; Writing—review & editing. Hans-Joachim Schäfers: Formal analysis; Supervision; Writing—review & editing. Holger Wehrfritz: Data curation; Writing—review & editing. Alexander Massmann: Methodology; Writing—review & editing.
What is a biologic lung volume reduction system?
Biologic lung volume reduction systems, which induce localized inflammation that results in atelectasis by blockage and remodeling, improves lung function. These methods have the advantage that they can be used in patients with homogeneous disease and are not affected by collateral ventilation, but they are not reversible.
How does nitinol coil work?
Coils such as the Nitinol coil are deployed as a straight wire in the airway, where they resume their native coiled state and twist and compress surrounding lung tissue. This reduces lung volume and improves lung function without being confounded by collateral ventilation. This method is likely irreversible. More recently, a randomized superiority trial that compared Nitinol coils with usual care in 100 patients at 10 French university hospitals found that use of the coils resulted in improved exercise capacity but significant short-term costs. 3
What is an airway bypass?
Airway bypass is based on the placement of stents that establish communication between the large airways and hyperinflated lung segments to decrease trapping of air. This method can be used in patients with homogeneous disease but improvements in early trials were short-term.
Is ELVR successful in emphysema?
According to Dr. Benzaquen, the success of ELVR is dependent on two patient characteristics: extent of collateral ventilation between lung segments and heterogeneity in emphysema between regions of the lung. Extensive collateral ventilation is typically an insignificant issue in patients with normal lungs but is present in the majority of patients with severe emphysema. Further, collateral ventilation is present more often in patients with homogeneous emphysema than in those with heterogeneous disease, perhaps explaining why patients with upper lobe predominant disease have better outcomes with ELVR than those with heterogeneous disease. 2
Is emphysema surgery considered a surgical procedure?
Current surgical approaches to the care of emphysema patients including lung transplantation and lung volume reduction surgery are welcome options for motivated patients who qualify for these advanced procedures, however, many chronic obstructive pulmonary disease (COPD) patients at University of Cincinnati (UC) Medical Center are too ill to be considered. “I am optimistic about the potential for endoscopic lung volume reduction (ELVR), which is approved in other countries and is being trialed in the U.S., to change the standard of care for patients with advanced obstructive lung disease,” says Sadia Benzaquen, MD, assistant professor and director of interventional pulmonology.
Can emphysema be a candidate for ELVR?
Patients with heterogeneous emphysema and a complete fissure (i.e., based on total separation of the upper and lower lobe on CT of the chest by a full length fissure) are candidates for ELVR with valves. Patients with incomplete fissure may be candidates for ELVR with coils, foam, or vapor; emerging approaches to endoscopic lung volume reduction.
Abstract and Figures
Objectives: Patients with chronic obstructive pulmonary disease and lung emphysema may benefit from surgical or endoscopic lung volume reduction (ELVR). Previously reported outcomes of nitinol coil-based ELVR techniques have been ambiguous.
References (22)
ResearchGate has not been able to resolve any citations for this publication.