Search

Bronchial thermoplasty (BT) is a non-pharmacologic therapy for severe asthma. The proper procedure and perioperative management are very important for the effectiveness and safety of BT. China Asthma Alliance assembled a group of experts in asthma and BT to review the literature, drew on their own experiences, discussed, and then finalized by consensus to establish this standard practice guideline. This practice guideline is designed to guide clinicians as to proper patients’ selection, preoperative assessment, postoperative management and follow-up. This practice guideline also proposed “China Alair System Registry Study (NCT02206269)” as the real-world study to enhance clinical utility of BT.

Severe asthma affects between 5% and 10% of patients with asthma worldwide and requires best standard therapies at maximal doses, but there is a subgroup of patients refractory to all treatments. We share a case report of a 53-year-old woman with a history of severe allergic asthma that progressively worsened over the years despite the best therapy. She had been hospitalized 35 times, including nine admissions to the respiratory intensive care unit due to severe exacerbations. To rule out other possible diagnoses, several investigations were performed, such as computed tomography scan of the chest and neck, fiberoptic laryngoscopy, antineutrophil cytoplasmic antibodies, and complete blood cell count. The patient was first treated with omalizumab, which was completely ineffective, and then with bronchial thermoplasty (BT), again without clinical benefit. The situation remained critical for about 3 months during the last hospitalization, but in February 2017, the Italian Medicines Agency approved the treatment of severe refractory eosinophilic asthma with mepolizumab (Nucala®). Given a blood eosinophil count of 300 cells/μL, our patient was started on 100 mg mepolizumab treatment. After the second administration, symptoms improved progressively, with a reduction in the number and severity of exacerbations, so the patient could finally be discharged from hospital. At follow-up, it was possible to reduce and then suspend oral corticosteroids by continuing only with inhaled corticosteroids/long-acting beta-agonists and montelukast. No further asthmatic exacerbations occurred; symptom control and quality of life improved significantly. To our knowledge, this is the first case of a patient unresponsive to omalizumab and BT but with excellent clinical response to mepolizumab. She is also the first patient to be treated with an anti-IL5 agent in Italy in a real-life clinical setting. The availability of new effective biological agents will allow many patients to resume as normal a life as possible, with a positive outcome also from a social and economic point of view.

Francesco Menzella,1 Carla Galeone,1 Mirco Lusuardi,2 Anna Simonazzi,1 Claudia Castagnetti,1 Patrizia Ruggiero,1 Nicola Facciolongo1 1Department of Medical Specialties, Pneumology Unit, Arcispedale Santa Maria Nuova – IRCCS, Azienda USL di Reggio Emilia, Reggio Emilia, 2Unit of Respiratory Rehabilitation, Azienda USL di Reggio Emilia, S. Sebastiano Hospital, Correggio, Italy Abstract: Severe asthma affects between 5% and 10% of patients with asthma worldwide and requires best standard therapies at maximal doses, but there is a subgroup of patients refractory to all treatments. We share a case report of a 53-year-old woman with a history of severe allergic asthma that progressively worsened over the years despite the best therapy. She had been hospitalized 35 times, including nine admissions to the respiratory intensive care unit due to severe exacerbations. To rule out other possible diagnoses, several investigations were performed, such as computed tomography scan of the chest and neck, fiberoptic laryngoscopy, antineutrophil cytoplasmic antibodies, and complete blood cell count. The patient was first treated with omalizumab, which was completely ineffective, and then with bronchial thermoplasty (BT), again without clinical benefit. The situation remained critical for about 3 months during the last hospitalization, but in February 2017, the Italian Medicines Agency approved the treatment of severe refractory eosinophilic asthma with mepolizumab (Nucala®). Given a blood eosinophil count of 300 cells/µL, our patient was started on 100mg mepolizumab treatment. After the second administration, symptoms improved progressively, with a reduction in the number and severity of exacerbations, so the patient could finally be discharged from hospital. At follow-up, it was possible to reduce and then suspend oral corticosteroids by continuing only with inhaled corticosteroids/long-acting beta-agonists and montelukast. No further asthmatic exacerbations occurred; symptom control and quality of life improved significantly. To our knowledge, this is the first case of a patient unresponsive to omalizumab and BT but with excellent clinical response to mepolizumab. She is also the first patient to be treated with an anti-IL5 agent in Italy in a real-life clinical setting. The availability of new effective biological agents will allow many patients to resume as normal a life as possible, with a positive outcome also from a social and economic point of view. Keywords: severe asthma, omalizumab, bronchial thermoplasty, mepolizumab, exacerbation, eosinophilia

Bronchial thermoplasty (BT) is an endoscopic treatment for severe and uncontrolled asthma. This review provides an overview of the indications, selection criteria, treatment application, and scientific evidence regarding its mechanism of action and safety and efficacy of BT in current clinical practice. It seems that reduction in airway smooth muscle is one of the principal mechanisms of action, since it correlates with clinical benefits. Regarding safety and efficacy, recent case reports and small prospective studies appear to show benefit in more severe asthma patients. Further research is needed to better understand the physiological benefits of BT and select the best candidates for treatment. In order to achieve these goals, experts recommend performing BT only in specialized centers.

Asthma is increasingly recognised as a heterogeneous group of diseases with similar clinical presentations rather than a singular disease entity. Asthma was historically categorised by clinical symptoms; however, newer methods of subgrouping, describing and categorising the disease have sub-defined asthma. These sub-definitions are intermittently called phenotypes or endotypes, but the real meanings of these words are poorly understood. Novel treatments are currently and increasingly available, partly in the monoclonal antibody environment, and also some physical therapies (bronchial thermoplasty), but additionally small molecules are not far away from clinical practice. Understanding the disease pathogenesis and the mechanism of action more completely may enable identification of treatable traits, biomarkers, mediators and modifiable therapeutic targets. However, there remains a danger that clinicians become preoccupied with the concept of endotypes and biomarkers, ignoring therapies that are hugely effective but have no companion biomarker. This review discusses our understanding of the concept of phenotypes and endotypes in appreciating and managing the heterogeneous condition that is asthma. We consider the role of functional imaging, physiology, blood-, sputum- and breath-based biomarkers and clinical manifestations that could be used to produce a personalised asthma profile, with implications on prognosis, pathophysiology and most importantly specific therapeutic responses. With the advent of increasing numbers of biological therapies and other interventional options such as bronchial thermoplasty, the importance of targeting expensive therapies to patients with the best chance of clinical response has huge health economic importance.

Francesco Menzella,1 Mirco Lusuardi,2 Carla Galeone,1 Nicola Facciolongo1 1Department of Medical Specialties, Pneumology Unit, IRCCS – Arcispedale Santa Maria Nuova, Reggio Emilia, 2Unit of Respiratory Rehabilitation, AUSL Reggio Emilia, SSebastiano Hospital, Correggio, Italy Abstract: Asthma is characterized by inflammation of the airways that includes eosinophils, basal membrane thickening, epithelial sloughing, vascular changes, smooth muscle hypertrophy and hyperplasia, and mucous gland hyperplasia. Recently, there have been studies on the role of hypersensitivity and inflammation in asthma, but the role of bronchial smooth muscle remains unclear. Bronchial thermoplasty is an endoscopic procedure that is approved by the US Food and Drug Administration (FDA) for the treatment of severe refractory asthma, based on the local delivery of radio frequency at 65°C to the airways, with the aim of controlling bronchospasm through a reduction of airway smooth muscle (ASM). Several recent studies have shown significant improvement in clinical outcomes of bronchial thermoplasty for asthma, including symptom control, reduction in exacerbation and hospitalization rates, improved quality of life, and reduction in number of working days or school days lost due to asthma. Data from these recent studies have shown reduction in ASM following bronchial thermoplasty and changes in inflammation patterns. It has also been argued that bronchial thermoplasty may have modulating effects on neuroendocrine epithelial cells, bronchial nerve endings, TRPV1 nerve receptors, and type-C unmyelinated fibers in the bronchial mucosa. This may involve interrupting the central and local reflexes responsible for the activation of bronchospasm in the presence of bronchial hyperreactivity. Several questions remain regarding the use of bronchial thermoplasty, mechanism of action, selection of appropriate patients, and long-term effects. In this review, the role of ASM in the pathogenesis of asthma and the key aspects of bronchial thermoplasty are discussed, with a focus on the potential clinical effects of this promising procedure, beyond the reduction in ASM. Keywords: airway, nerve, receptors, asthma, inflammation

Asthma is characterized by inflammation of the airways that includes eosinophils, basal membrane thickening, epithelial sloughing, vascular changes, smooth muscle hypertrophy and hyperplasia, and mucous gland hyperplasia. Recently, there have been studies on the role of hypersensitivity and inflammation in asthma, but the role of bronchial smooth muscle remains unclear. Bronchial thermoplasty is an endoscopic procedure that is approved by the US Food and Drug Administration (FDA) for the treatment of severe refractory asthma, based on the local delivery of radio frequency at 65°C to the airways, with the aim of controlling bronchospasm through a reduction of airway smooth muscle (ASM). Several recent studies have shown significant improvement in clinical outcomes of bronchial thermoplasty for asthma, including symptom control, reduction in exacerbation and hospitalization rates, improved quality of life, and reduction in number of working days or school days lost due to asthma. Data from these recent studies have shown reduction in ASM following bronchial thermoplasty and changes in inflammation patterns. It has also been argued that bronchial thermoplasty may have modulating effects on neuroendocrine epithelial cells, bronchial nerve endings, TRPV1 nerve receptors, and type-C unmyelinated fibers in the bronchial mucosa. This may involve interrupting the central and local reflexes responsible for the activation of bronchospasm in the presence of bronchial hyperreactivity. Several questions remain regarding the use of bronchial thermoplasty, mechanism of action, selection of appropriate patients, and long-term effects. In this review, the role of ASM in the pathogenesis of asthma and the key aspects of bronchial thermoplasty are discussed, with a focus on the potential clinical effects of this promising procedure, beyond the reduction in ASM.

Francesco Menzella,1 Carla Galeone,1 Francesca Bertolini,2 Claudia Castagnetti,1 Nicola Facciolongo1 1Department of Medical Specialties, Pneumology Unit, IRCCS- Arcispedale Santa Maria Nuova, Reggio Emilia, Italy; 2Department of Animal Science, Iowa State University, Ames, IA, USA Abstract: The increasing understanding of the molecular biology and the etiopathogenetic mechanisms of asthma helps in identification of numerous phenotypes and endotypes, particularly for severe refractory asthma. For a decade, the only available biologic therapy that met the unmet needs of a specific group of patients with severe uncontrolled allergic asthma has been omalizumab. Recently, new biologic therapies with different mechanisms of action and targets have been approved for marketing, such as mepolizumab. Other promising drugs will be available in the coming years, such as reslizumab, benralizumab, dupilumab and lebrikizumab. Moreover, since 2010, bronchial thermoplasty has been successfully introduced for a limited number of patients. This is a nonpharmacologic endoscopic procedure which is considered a promising therapy, even though several aspects still need to be clarified. Despite the increasing availability of new therapies, one of the major problems of each treatment is still the identification of the most suitable patients. This sudden abundance of therapeutic options, sometimes partially overlapping with each other, increases the importance to identify new biomarkers useful to guide the clinician in selecting the most appropriate patients and treatments, without forgetting the drug-economic aspects seen in elevated direct cost of new therapies. The aim of this review is, therefore, to update the clinician on the state of the art of therapies available for refractory asthma and, above all, to give useful directions that will help understand the different choices that sometimes partially overlap and to dispel the possible doubts that still exist. Keywords: severe asthma, phenotypes, monoclonal antibodies, IL-5, bronchial thermoplasty, biomarkers

The increasing understanding of the molecular biology and the etiopathogenetic mechanisms of asthma helps in identification of numerous phenotypes and endotypes, particularly for severe refractory asthma. For a decade, the only available biologic therapy that met the unmet needs of a specific group of patients with severe uncontrolled allergic asthma has been omalizumab. Recently, new biologic therapies with different mechanisms of action and targets have been approved for marketing, such as mepolizumab. Other promising drugs will be available in the coming years, such as reslizumab, benralizumab, dupilumab and lebrikizumab. Moreover, since 2010, bronchial thermoplasty has been successfully introduced for a limited number of patients. This is a nonpharmacologic endoscopic procedure which is considered a promising therapy, even though several aspects still need to be clarified. Despite the increasing availability of new therapies, one of the major problems of each treatment is still the identification of the most suitable patients. This sudden abundance of therapeutic options, sometimes partially overlapping with each other, increases the importance to identify new biomarkers useful to guide the clinician in selecting the most appropriate patients and treatments, without forgetting the drug-economic aspects seen in elevated direct cost of new therapies. The aim of this review is, therefore, to update the clinician on the state of the art of therapies available for refractory asthma and, above all, to give useful directions that will help understand the different choices that sometimes partially overlap and to dispel the possible doubts that still exist.

The treatment of asthma largely depends on guideline-based pharmacologic therapies. However, nonpharmacologic therapies for asthma such as pulmonary rehabilitation, focused breathing techniques, and bronchial thermoplasty have an important, yet underappreciated, role. Structured pulmonary rehabilitation programs can reduce dyspnea and increase cardiopulmonary fitness. The educational component of these programs can ensure that therapies are being used appropriately, increase compliance, and decrease health care utilization. Studies have demonstrated a reduction in inflammatory mediators in patients with asthma who are engaged in an exercise program. Focused breathing techniques are commonly used by patients with asthma, yet benefit has not been clearly shown in randomized controlled trials. For the patients with severe asthma who are unresponsive to maximum medical therapy and have evidence of airway remodeling, bronchial thermoplasty has demonstrated long-term improvement in quality of life and reduction in severe exacerbations and health care utilization. Recent airway biopsy studies have demonstrated bronchial thermoplasty's disease-modifying effect on smooth muscle, inflammatory mediators, and bronchial nerve endings. These nonpharmacologic therapies are complementary to current guideline-based treatment, including the use of biologic modifiers, for severe asthma.

The implementation of new technology is vital to the success of health care organizations. New technology provides health care organizations an opportunity to obtain new patients, increase revenue, and stay competitive. In 2014, a union hospital in Southern California successfully implemented a bronchial thermoplasty program. To implement this new technology, the administration created a strategy, identified financial risks and benefits, created an implementation model, established a plan based on Lewin's change model and Roger's diffusion of innovations theory, and recognized adult learning needs through an interdepartmental, open communication, and collaborative approach. In addition, the implementation of the bronchial thermoplasty program allowed the organization to meet the goals, mission, and vision of the organization, which is key to remaining viable and marketable.

The inflammatory makeup of severe asthma is heterogeneous. Identification of the predominant cellular endotype via biomarkers can aid in the selection of more advanced therapies. This review is clinically focused on how to use these biomarkers to help select between biologic agents and/or bronchial thermoplasty.Several Th2 biomarkers exist for the detection of eosinophilic disease; however, the best biomarker for clinical practice is debatable depending upon local resources. Currently, there are three federal drug agency-approved biologic agents (omalizumab, mepolizumab and reslizumab) to treat severe asthma with frequent exacerbations despite standard medical therapy. Several others are either in clinical trials or in the development phase for the treatment of eosinophilic asthma. To date, agents targeting neutrophilic inflammation have been largely unsuccessful. Bronchial thermoplasty has emerged as an option for the treatment of severe asthma.The appropriate selection of patients through the use of eosinophilic biomarkers has led to significant reductions in exacerbations with the use of mAb therapy. Bronchial thermoplasty has also shown reductions in asthma exacerbations and improved quality of life; however, it is unclear which patients may respond best to this intervention.

BACKGROUND Bronchial thermoplasty (BT) is an approved bronchoscopic intervention for the treatment of severe asthma. However, limited published experience exists outside of clinical trials regarding patient selection and outcomes achieved. AIMS To evaluate the effectiveness and safety of BT in patients with severe asthma encountered in clinical practice. METHODS This is a retrospective analysis of the first 'real world' data from Australia. The following outcomes were measured prior to, and 6 months following BT: spirometry, Asthma Control Questionnaire-5 (ACQ-5) score, reliever and preventer medication use and exacerbation history. RESULTS Twenty patients were treated from June 2014 to December 2015 at three university teaching hospitals. All subjects met the European Respiratory Society/American Thoracic Society definition of severe asthma. Mean pre-bronchodilator forced expiratory volume in 1 s was 62.8 ± 16.6% predicted (range: 33-95%). All patients were being treated with high dose inhaled corticosteroids, long-acting beta2 agonists and long-acting muscarinic antagonists. Ten patients (50%) were taking maintenance oral prednisolone. Most subjects also required at least one of montelukast (65%), omalizumab (30%) and methotrexate (20%). ACQ-5 improved from 3.6 ± 1.1 at baseline to 1.6 ± 1.2 at 6 months, P

Background and objective Bronchial thermoplasty (BT) has been shown to be effective at reducing asthma exacerbations and improving asthma control for patients with severe persistent asthma but it is also expensive. Evidence on its cost-effectiveness is limited and inconclusive. In this study, we aim to evaluate the incremental cost-effectiveness of BT combined with optimized asthma therapy (BT-OAT) relative to OAT for difficult-to-treat and severe asthma patients in Singapore, and to provide a general framework for determining BT's cost-effectiveness in other healthcare settings. Methods We developed a Markov model to estimate the costs and quality-adjusted life years (QALYs) gained with BT-OAT versus OAT from the societal and health system perspectives. The model was populated using Singapore-specific costs and transition probabilities and utilities from the literature. Sensitivity analyses were conducted to identify the main factors determining cost-effectiveness of BT-OAT. Results BT-OAT is not cost-effective relative to OAT over a 5-year time horizon with an incremental cost-effectiveness ratio (ICER) of $US138 889 per QALY from the societal perspective and $US139 041 per QALY from the health system perspective. The cost-effectiveness of BT-OAT largely depends on a combination of the cost of the BT procedure and the cost of asthma-related hospitalizations and emergency department (ED) visits. Conclusion Based on established thresholds for cost-effectiveness, BT-OAT is not cost-effective compared with OAT in Singapore. Given its current clinical efficacy, BT-OAT is most likely to be cost-effective in a setting where the cost of BT procedure is low and costs of hospitalization and ED visits are high.

Bronchial thermoplasty (BT) is a novel technique used in the treatment of severe asthma. A catheter is advanced through the bronchoscope and directed radiofrequency waves are applied to the segmental bronchi to reduce airway smooth muscle mass. Several randomized clinical trials demonstrate improvement in quality of life and reduction in exacerbation rates after treatment. BT is a safe and cost effective treatment option for severe asthma which is refractory to medical treatment. Further studies are needed in order to better describe the mechanism of action and the asthma subphenotype that was best benefit from this treatment.

Background: Bronchial thermoplasty (BT) is a novel treatment for severe asthma based on radiofrequency energy delivery to the larger airways. Although impressive radiological abnormalities have been reported, the incidence, pattern, and behavior over time of acute radiological abnormalities following BT are not well established. Objective: To assess the incidence pattern and behavior over time of acute radiological abnormalities following BT. Methods: This is a prospective, observational imaging study of severe asthma patients participating in the TASMA trial. Imaging of the lung (chest X-ray and/or computed tomography [CT]) was performed routinely before and directly after BT, within 6 weeks and at 6 months' follow-up. Results: Thirty-four chest X-rays were performed within Conclusions: There is a high incidence of acute radiological abnormalities after BT. Four distinct radiological patterns can be identified on ULD chest CT, which resolve without clinical impact in virtually all cases.

An epithelial–mesenchymal interaction governed by HSP60-regulated PRMT1 expression regulates airway remodelling and is reversed by bronchial thermoplastyhttp://bit.ly/2NDCKGW

Bronchial thermoplasty (BT) is a recent treatment for moderate-to-severe asthma in which the airway smooth muscle (ASM) layer is targeted directly using thermal energy delivered during bronchoscopy. Although direct targeting of the ASM is appealing because of its role in bronchoconstriction in asthma, BT is not widely used because direct physiological effects after treatment (e.g. changes forced expiratory volume in 1 s (FEV1) or the concentration of methacholine required to decrease FEV1 by 20%) have not been shown consistently [1–3]. Instead, clinical response is demonstrated through indirect measurements, such as improved Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire scores, and reduced use of rescue medication [1, 2], acknowledging that there is also a considerable placebo component [3]. These findings leave doubt about the efficacy and mechanism of action of BT. Recent work, however, has demonstrated a direct change in a new physiological measure, namely airway volume assessed by high-resolution computed tomography (CT) [4]., High-resolution CT assessment of airway volumes after bronchial thermoplasty (BT), together with model predictions regarding the efficacy and underlying mechanism of action of the treatment, combine to help to elucidate the underlying mechanism of BT http://bit.ly/2WPHY6y

A 57‐year‐old woman with poorly controlled diabetes was admitted to our hospital for additional treatment of severe asthma. Although bronchial thermoplasty was performed in the both upper lobes, cough and dyspnoea gradually appeared 2 weeks later. High‐resolution computed tomography revealed thickness of intralobular septa and a diffuse ground‐glass attenuation in the lung fields. Laboratory examination revealed elevated levels of serum eosinophils and total immunoglobulin E. Bronchoalveolar lavage fluid showed a remarkable increase of eosinophils as high as 48.5%, then eosinophilic pneumonia was diagnosed. Although treatment with steroids resulted in an improvement of eosinophilic pneumonia, the treatment was discontinued after 4 days because it worsened her diabetic condition. Since eosinophilic pneumonia recurred after discontinuing steroid, mepolizumab was administered, which subsequently improved her disease condition. Clinicians should be aware that bronchial thermoplasty can lead to eosinophilic pneumonia and mepolizumab might be an effective treatment in this setting., Bronchial thermoplasty (BT) is a bronchoscopic procedure for treating severe asthma using thermal energy to reduce airway smooth muscle. There are some reports of complications such as bronchitis and atelectasis due to transient inflammation and oedema, but, to the best of our knowledge, no studies have reported eosinophilic pneumonia (EP) due to BT. Mepolizumab is an anti‐interleukin‐5 monoclonal antibody that is reportedly effective against eosinophilic inflammation such as bronchial asthma; however, only few studies have reported its use in treating EP. Here, we report the effectiveness of mepolizumab in treating EP following BT.

The past several years ushered in an exciting era for asthma management. In the midst of discussions around population health management, health economics, changing asthma guidelines, and personalized medicine, we have also seen the introduction of several classes of new medications. This review will summarize the key observations derived from adult clinical trials with biologic therapy and will highlight the limited amount of information available for the pediatric population including adolescents and young children. Currently approved biologics including anti-IgE, anti-IL-5, and anti-IL-4/13 type molecules are primarily directed toward the T2 pathway that is usually associated with allergic disorders. There are a number of new medications in clinical trials that go beyond the T2 pathway association with allergy, such as anti-TSLP, and likely many more to follow. This review will also briefly summarize key observations from adult and pediatric trials with bronchial thermoplasty, long-acting muscarinic agents, and macrolide therapy. Aside from the extensive experience with omalizumab, there is a gap in information on the efficacy of these therapies in children. It will be important to gain this experience if we are to focus on preventing the development of asthma and preventing asthma exacerbations in young children. This review will end with a summary of items to consider in selecting therapies for the management of asthma in children.

Background Bronchial thermoplasty (BT) is a non-pharmacologic, endoscopic treatment for asthma not well controlled with long-acting b-agonists and inhaled corticosteroids. Long-term efficacy and safety of BT beyond 5 years is unknown. The BT10+ study was designed to evaluate the efficacy and safety of BT at 10+ years follow-up. Methods BT10+ is an international, multi-center, ≥10yrs follow-up study on subjects who were enrolled in the AIR, RISA and AIR2 BT trials. Demographics, quality of life, lung function, severe exacerbations (SE, defined as asthma exacerbations requiring systemic corticosteroids) and healthcare utilisation for the previous year were collected at the BT10+ study visit. Additionally, AIR2 subjects who received a pulmonary high-resolution CT (HRCT) at baseline had a second scan at the BT10+ study visit to determine if clinically relevant changes, such as bronchiectasis, occur after BT. Results Of 429 subjects enrolled AIR, RISA, and AIR2, 192 were followed-up at 10.6–15.8 years (12.1 median) post-treatment at 16 centers; of these, 136 were treated with BT and 38 were control/sham subjects in previous studies. Baseline characteristics between subjects enrolled and not enrolled in BT10+ did not show meaningful differences. For BT subjects, no increases in the rate of hospitalisations or ER visits were observed compared to baseline and rates of SE were stable compared to Year 1 (figure 1). While both groups experienced fewer SE after treatment, BT subjects had fewer SE than control/sham subjects at the BT10+ visit; this was not significant. Quality of life (AQLQ, ACQ) and spirometry results were comparable between Years 1, 5, and 10+ for both groups. Pulmonary HRCT scans from AIR2 subjects at the BT10+ study visit showed 9.5% (2/21) of control/sham subjects and 13.4% (13/97) of BT subjects had bronchiectasis; however, when these were compared with baseline HRCT scans, only 5.3% (5/94) of BT subjects had developed bronchiectasis after their baseline visit. Conclusion The BT10+ study suggests that efficacy of BT is sustained over 10 years and that BT has an acceptable safety profile.

Aim In the UK, the British Thoracic Society (BTS)/Scottish Intercollegiate Guidelines Network (SIGN) and the National Institute for Health and Care Excellence (NICE) have published guidelines for the management of people with asthma. However, although the clinical evidence used for the guidelines development were similar, BTS/SIGN appraised the clinical evidence alone while NICE reviewed also the health economic evidence and supplemented it with further health economic analyses. The aim of this study is to propose a cost-effectiveness value pyramid of asthma interventions in the UK using all available evidence for the additional healthcare cost per an extra quality-adjusted life year (QALY) with different interventions. Method We followed a three-stage approach. Firstly, the UK-relevant cost-effectiveness findings from economic evaluations of asthma interventions were identified following a systematic review of peer-reviewed economic evaluation studies. Secondly, economic analyses developed or reviewed (e.g. external published studies or pharmaceutical company submissions to NICE) were added. Finally, our review was extended to economic findings for common interventions recommended by BTS/SIGN and NICE in the context of general populations in the absence of results in people with asthma specifically. Results The totality of available evidence on cost-effectiveness of asthma interventions in UK is presented separately for adolescents/adults (aged 12 years and over) and children (aged 6–14 years). The most cost-effective treatments of interventions with reported ICER Conclusions Lack of cost-effectiveness evidence leads to possible confusion when prioritizing asthma interventions that provide the most benefits for required resources. While our study provides some guidance for highest priority interventions, we have also identified gaps in the cost-effectiveness evidence. Future studies assessing the cost-effectiveness of SABAs, theophylline, oral steroids, immunosuppressant, bronchial thermoplasty, allergy avoidance, exercise and other complimentary therapies are required.

Bronchial thermoplasty (BT) is a cost-effective (ZafarinZ et al. PLoS One. 2016, 11:1) therapy for severe asthma (SA) delivered in three bronchoscopic procedures. National Institute for Health and Care Excellence recently recognized the safety and efficacy of BT for SA treatment (NICE IPG635,2018). Aims Measure patient outcomes pre and post BT treatment and compare the actual cost of BT to national reference costs and tariff income to assess the adequacy of current payment in the UK. Methods We performed a retrospective micro costing study on 53 BT procedures (total of 18 patients) over the 2012–2017 period at a UK hospital. We collected patient outcomes 12 months before and after BT. For comparison we used 2017/18 national reference costs and national tariffs of the HRG DZ67Z Major Therapeutic Bronchoscopy. Results After BT, we observed a significant improvement in mean FEV1 (1.99L p 0.64 vs 2.50L p 0.66; p=0.001), and a reduction of mean rescue oral corticosteroid/year (6.6 p 4.2 vs 1.5 p 1.7; p=0.00004). The average cost of a BT session was p3362 for day cases (DC) performed under sedation (n=22), p4354 for elective admissions (EL) under sedation (n=27), p6925 for EL under general anesthesia (n=4). This compares to 2017/18 reference costs for DC and EL of p1380 and p2563 respectively, demonstrating an average deficit of p2064. 2017/18 tariff for DC and EL of p2050 does not cover BT admission costs whether BT is done as a DC or EL. Conclusions In this patient group BT improved health outcomes. Micro costing reveals that reference costs do not reflect the actual cost of BT. Since reimbursement is based on reference costs, BT is underfunded, which may represent a barrier to patient access.

Bronchial thermoplasty (BT) is a cost-effective (Zafari Z et al. PLoS One. 2016, 11:1) therapy for severe asthma (SA) delivered in three bronchoscopic procedures. National Institute for Health and Care Excellence recently recognized the safety and efficacy of BT for SA treatment (NICE IPG635,2018). Aim: Measure patient outcomes pre and post BT treatment and compare the actual cost of BT to national reference costs and tariff income to assess the adequacy of current payment in the UK. Methods: We performed a retrospective micro costing study on 53 BT procedures (total of 18 patients) over the 2012-2017 period at a UK hospital. We collected patient outcomes 12 months before and after BT. For comparison we used 2017/18 national reference costs and national tariffs of the HRG DZ67Z Major Therapeutic Bronchoscopy. Results: After BT, we observed a significant improvement in mean FEV1(1.99L ± 0.64 vs 2.50L ± 0.66; p=0.001), and a reduction of mean rescue oral corticosteroid/year (6.6 ± 4.2 vs 1.5 ± 1.7; p=0.00004). The average cost of a BT session was £3362 for day cases (DC) performed under sedation (n=22), £4354 for elective admissions (EL) under sedation (n=27), £6925 for EL under general anesthesia (n=4). This compares to 2017/18 reference costs for DC and EL of £1380 and £2563 respectively, demonstrating an average deficit of £2064. 2017/18 tariff for DC and EL of £2050 does not cover BT admission costs whether BT is done as a DC or EL. Conclusions: In this patient group BT improved health outcomes. Micro costing reveals that reference costs do not reflect the actual cost of BT. Since reimbursement is based on reference costs, BT is underfunded, which may represent a barrier to patient access.

Background: Bronchial Thermoplasty (BT) reduces exacerbations and improves asthma quality of life questionnaire (AQLQ) scores in asthma [1]. Studies have shown reductions in airway smooth muscle (ASM) mass and reticular basement membrane (RBM) thickness after BT, but are limited by small sample size. Aims: To investigate airway remodeling responses to BT, and compare these to clinical outcomes. Methods: Pre- and post-BT data was pooled for 99 patients at 7 centres. ASM mass and RBM thickness were measured on bronchial biopsies, and compared to clinical outcomes. Results: Mean (SD) age was 48.4 years (11.7) and BMI was 29.0 kg/m2 (6.4). Baseline FEV1 was 68.8% predicted (23.1) and blood eosinophils were 0.25x10-9/L (0.26). 59 of 99 patients were taking maintenance oral Prednisolone (mean dose 25.7mg). In response to BT, mean (SD) annual exacerbation rate decreased from 6.4 (5.5) to 1.1 (1.7) (p= Conclusion: ASM mass and RBM thickness reduce rapidly following BT, and effects persist beyond 1 year. The observed improvements in airway remodeling parameters are not related to improvements in clinical outcomes. Other bronchial mucosal changes or mechanisms may play a role in the clinical response to BT. Reference: 1) Castro et al, AJRCCM. 2010;181(2):116-24