Bronchial Thermoplasty In Patients Research Articles

Efficacy of bronchial thermoplasty in patients with severe asthma and frequent severe exacerbations: A randomized controlled study✰

BackgroundBronchial thermoplasty (BT) is a bronchoscopic procedure for patients with severe uncontrolled asthma, but randomized controlled studies of its efficacy in severe asthma with frequent exacerbations are lacking. The current aim was to assess BT efficacy in this patient population. MethodsThirty patients with asthma (GINA 5) who had experienced at least four severe exacerbations in the preceding year were randomized to BT (n = 15) or control groups (n = 15). All patients had four follow-up visits over the following 15 months, corresponding to 3, 6, 9, and 12 months after the last procedure for the BT group. The primary outcome was number of exacerbations at 15 months after inclusion (i.e. 12 months after bronchial thermoplasty). ResultsAll but three patients had received an asthma biologic without receiving benefit. In the year preceding enrollment, patients in the BT group had an average of five exacerbations, compared with six among controls. For patients in the BT group, oral steroid intake was 9.3 mg/d, compared with 11.0 mg/d among controls. The BT group had 1.58 fewer severe exacerbations (mean, 6.09) compared with controls (mean, 8.28) in the 12-month period after the therapy (p = 0.047). Oral steroid intake during follow-up after BT was significantly lower in the BT group (ratio vs controls: 0.61; p = 0.0002). Quality-of-life measures between inclusion and the last visit were significantly improved in the BT group, but not among controls. Few mild to moderate adverse events were reported, and all were controlled within days. ConclusionIn patients with severe asthma and frequent severe exacerbations, BT significantly decreased the rate of severe exacerbations and oral steroid intake and led to improved quality of life during the 15 months after inclusion. BT appears to offer a therapeutic option for severe asthma with frequent exacerbations.

Research on the effectiveness and safety of bronchial thermoplasty in patients with chronic obstructive pulmonary disease

ObjectivesTo investigate the clinical efficacy and safety of bronchial thermoplasty (BT) in treating patients with chronic obstructive pulmonary disease (COPD).MethodsClinical data of 57 COPD patients were randomized into the control (n = 29, conventional inhalation therapy) or intervention group (n = 28, conventional inhalation therapy plus BT). Primary outcomes were differences in clinical symptom changes, pulmonary function-related indicators, modified Medical Research Council (mMRC), 6-min walk test (6MWT), COPD assessment test (CAT) score and acute exacerbation incidence from baseline to an average of 3 and 12 months. Safety was assessed by adverse events.ResultsFEV1, FEV1(%, predicted) and FVC in both groups improved to varying degrees post-treatment compared with those pre-treatment (P < 0.05). The Intervention group showed greater improving amplitudes of FEV1 (Ftime × between groups = 21.713, P < 0.001) and FEV1(%, predicted) (Ftime × between groups = 31.216, P < 0.001) than the control group, and there was no significant difference in FVC variation trend (Ftime × between groups = 1.705, P = 0.193). mMRC, 6MWT and CAT scores of both groups post-treatment improved to varying degrees (Ps < 0.05), but the improving amplitudes of mMRC (Ftime × between groups = 3.947, P = 0.025), 6MWT (Ftime × between groups = 16.988, P < 0.001) and CAT score (Ftime × between groups = 16.741, P < 0.001) in the intervention group were greater than the control group. According to risk assessment of COPD acute exacerbation, the proportion of high-risk COPD patients with acute exacerbation in the control and intervention groups at 1 year post-treatment (100% vs 65%, 100% vs 28.6%), inpatient proportion (100% vs 62.1%; 100% vs 28.6%), COPD acute exacerbations [3.0 (2.50, 5.0) vs 1.0 (1.0, 2.50); 3.0(3.0, 4.0) vs 0 (0, 1.0)] and hospitalizations [2.0 (2.0, 3.0) vs 1.0 (0, 2.0); 2.0 (2.0, 3.0) vs 0 (0, 1.0)] were significantly lower than those pre-treatment (P < 0.05). Besides, data of the intervention group were significantly lower than the control group at each timepoint after treatment (P < 0.05).ConclusionsCombined BT therapy is superior to conventional medical treatment in improving lung function and quality of life of COPD patients, and it also significantly reduces the COPD exacerbation risk without causing serious adverse events.

Bronchial Thermoplasty in Patients With Severe Asthma at 5 Years: The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma Study

Bronchial thermoplasty is a device-based treatment for subjects≥ 18 years of age with severe asthma poorly controlled with inhaled corticosteroids and long-acting beta-agonists. The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma (PAS2) study collected data on patients with severe asthma undergoing this procedure. What are the 5-year efficacy and safety results in patients with severe asthma who have undergone bronchial thermoplasty? This was a prospective, open-label, observational, multicenter study conducted in the United States and Canada. Subjects 18 to 65 years of age who were taking inhaled corticosteroids≥ 1,000 μg/d (beclomethasone or equivalent) and long-acting beta-agonists≥ 80 μg/d (salmeterol or equivalent) were included. Severe exacerbations, hospitalization, ED visits, and medication usage were evaluated for the 12months prior to and at years 1 through 5 posttreatment. Spirometry was evaluated at baseline and at years 1 through 5 posttreatment. A total of 284 subjects were enrolled at 27 centers; 227 subjects (80%) completed 5 years of follow-up. By year 5 posttreatment, the proportion of subjects with severe exacerbations, ED visits, and hospitalizations was 42.7%, 7.9%, and 4.8%, respectively, compared with 77.8%, 29.4%, and 16.1%in the 12months prior to treatment. The proportion of subjects on maintenance oral corticosteroids decreased from 19.4%at baseline to 9.7%at 5 years. Analyses of subgroups based on baseline clinical and biomarker characteristics revealed a statistically significant clinical improvement among all subgroups. Five years after treatment, subjects experienced decreases in severe exacerbations, hospitalizations, ED visits, and corticosteroid exposure. All subgroups demonstrated clinically significant improvement, suggesting that bronchial thermoplasty improves asthma control in different asthma phenotypes. ClinicalTrials.gov; No.: NCT01350336; URL: www. gov.

P9‐19: The usefulness of CT images in evaluating the effects of bronchial thermoplasty in patients with severe asthma

P9‐19: The usefulness of CT images in evaluating the effects of bronchial thermoplasty in patients with severe asthma

Bronchial thermoplasty in asthma: an exploratory histopathological evaluation in distinct asthma endotypes/phenotypes

BackgroundBronchial thermoplasty regulates structural abnormalities involved in airway narrowing in asthma. In the present study we aimed to investigate the effect of bronchial thermoplasty on histopathological bronchial structures in distinct asthma endotypes/phenotypes.MethodsEndobronchial biopsies (n = 450) were collected from 30 patients with severe uncontrolled asthma before bronchial thermoplasty and after 3 sequential bronchial thermoplasties. Patients were classified based on blood eosinophils, atopy, allergy and smoke exposure. Tissue sections were assessed for histopathological parameters and expression of heat-shock proteins and glucocorticoid receptor. Proliferating cells were determined by Ki67-staining.ResultsIn all patients, bronchial thermoplasty improved asthma control (p < 0.001), reduced airway smooth muscle (p = 0.014) and increased proliferative (Ki67 +) epithelial cells (p = 0.014). After bronchial thermoplasty, airway smooth muscle decreased predominantly in patients with T2 high asthma endotype. Epithelial cell proliferation was increased after bronchial thermoplasty in patients with low blood eosinophils (p = 0.016), patients with no allergy (p = 0.028) and patients without smoke exposure (p = 0.034).In all patients, bronchial thermoplasty increased the expression of glucocorticoid receptor in epithelial cells (p = 0.018) and subepithelial mesenchymal cells (p = 0.033) and the translocation of glucocorticoid receptor in the nucleus (p = 0.036). Furthermore, bronchial thermoplasty increased the expression of heat shock protein-70 (p = 0.002) and heat shock protein-90 (p = 0.001) in epithelial cells and decreased the expression of heat shock protein-70 (p = 0.009) and heat shock protein-90 (p = 0.002) in subepithelial mesenchymal cells. The effect of bronchial thermoplasty on the expression of heat shock proteins -70 and -90 was distinctive across different asthma endotypes/phenotypes.ConclusionsBronchial thermoplasty leads to a diminishment of airway smooth muscle, to epithelial cell regeneration, increased expression and activation of glucocorticoid receptor in the airways and increased expression of heat shock proteins in the epithelium. Histopathological effects appear to be distinct in different endotypes/phenotypes indicating that the beneficial effects of bronchial thermoplasty are achieved by diverse molecular targets associated with asthma endotypes/phenotypes.

Early radiologic and bronchoscopic changes after bronchial thermoplasty in patients with severe asthma.

Bronchial thermoplasty (BT) is a treatment to reduce the airway smooth muscle mass by delivering radiofrequency thermal energy to the airways. BT is used in patients with severe asthma. The present study reported on cases of pneumothorax directly after BT and retrospectively analyzed early radiologic and bronchoscopic modifications after BT. The clinical data and radiologic and bronchoscopic findings of 12 patients with severe asthma who were subjected to BT between July 2014 and October 2017 were analyzed. A total of 33 chest radiographs were collected within 18-24 h after BT. Radiological abnormalities were observed in 32 radiographs as atelectasis (53.1%), peribronchial consolidations (84.4%), pleural effusion (18.8%), effusion in oblique fissures (3.1%), pleural thickening (6.3%) and pneumothorax (3.1%). Of note, one patient suffered pneumothorax after the third BT session and underwent chest drain insertion, followed by mechanical ventilation at the intensive care unit and multiple bronchoscopic interventions, which revealed extensive phlegm plugs. A total of six patients with worsened symptoms and lobar atelectasis also required bronchoscopic intervention, which revealed that phlegm plugs occluded the bronchus in the treated lobe. No bronchoscopic intervention was required in the remaining five patients. During 16-30 days of follow-up, 95.7% of the findings on chest radiography were resolved. To the best of our knowledge, the present study reported the first case of pneumothorax following BT. Early radiologic modifications such as atelectasis and peribronchial consolidations appear common after BT. However, whether bronchoscopic intervention is required for atelectasis following BT warrants further investigation. Of note, BT should be audited and recorded in detail to ideally contribute to a framework of clinical trials to improve risk-benefit evaluations and the selection of patients likely to benefit from treatment.

Evaluation of the effectiveness of bronchial thermoplasty in patients with severe asthma in the real world two years after bronchial thermoplasty treatment

Objective: To assess the effectiveness of bronchial thermoplasty (BT) in "real-world" patients with severe asthma at 2 years post therapy. Method: Outcomes of 70 patients with severe asthma undergoing bronchial thermoplasty from March 2014 to November 2017 in China-Japan Friendship Hospital were retrospectively analyzed two years post therapy. The scores of Asthma Control Test (ACT) and Mini Asthma Quality of Life Questionnaire (mini-AQLQ), the number of severe exacerbations, emergency department visits and hospitalizations for asthma symptoms in the past year, indicators of pulmonary function including forced expiratory volume in one second (FEV(1)), FEV(1) as a percentage of predicted value (FEV(1)%pred) and FEV(1)/forced vital capacity (FEV(1)/FVC), maintenance asthma medications, the cost of asthma drugs and the total annual cost of asthma treatment were evaluated and analyzed before and 2 years after BT therapy, and the subjective assessment about effectiveness of BT were given by the patients. Results: Before and 2 years after BT, the numbers of subjects suffering severe exacerbations in the past year were 70 (100%) and 37 (52.9%), and the numbers of total severe exacerbations were 575 and 162 respectively. The numbers of patients having emergency department visits due to asthma exacerbation were 46 (65.7%) and 9 (12.9%), and the numbers of emergency department visits were 186 and 19 respectively. The numbers of patients hospitalized due to asthma exacerbation were 43 (61.4%) and 16 (22.9%), and the numbers of total hospitalizations were 124 and 24, respectively. The rate of severe exacerbation, emergency department visit and hospitalization were significantly reduced two years after the treatment by 71.9%, 88.9% and 83.3% (all P<0.001). The scores of ACT and mini-AQLQ were significantly increased [22 (21, 24) vs 17 (13, 19), (5.57±0.89) vs (3.83±0.92); both P<0.001]. Two years after BT, 4 patients (5.7%) were weaned off inhaled corticosteroids (ICS) and long-acting β(2)-agonist (LABA), while 14 patients (37.8%) were weaned off oral corticosteroid (OCS), with daily dose of ICS and OCS significantly decreased (both P<0.05). The proportion of patients treated with montelukast sodium and theophylline was also significantly reduced after BT (40.0% vs 81.4%, 27.1% vs 71.4%; both P<0.001). In addition, the indicator of FEV(1), FEV(1)%pred and FEV(1)/FVC ratio were all greatly improved two years after the treatment [2.27 (1.84, 2.82) vs 2.10 (1.70, 2.61) L, (76.8±19.5)% vs (72.5±19.8)%, (66.3±13.6)% vs (63.8±13.0)%; all P<0.05]. The annual cost for asthma drug and asthma treatment after BT were significantly decreased (P<0.001). Fifty-nine patients (84.3%) subjectively assessed the treatment as effective. Conclusion: The bronchial thermoplasty in "real-world" patients with severe asthma could significantly improve the asthma control, lung function and quality of life, and reduce severe exacerbations, emergency department visits and hospitalizations for asthma symptoms, while the maintenance asthma medications, the cost of asthma drugs and the total annual cost of asthma treatment are significantly decreased.

Histopathological Comparison of Endobronchial Biopsies from Different Pulmonary Lobes of Severe Asthmatic Patients

Histopathological Comparison of Endobronchial Biopsies from Different Pulmonary Lobes of Severe Asthmatic Patients

Efficacy of bronchial thermoplasty in patients with severe asthma

Objective: To investigate the efficacy and safety of bronchial thermoplasty (BT) in clinical practice in adults with severe, refractory asthma.Methods: Prospective, single-center, open, observational study comprising patients with uncontrolled asthma (asthma control questionnaire (ACQ) >1.5) and/or frequent exacerbations despite treatment with at least high dose inhaled corticosteroids plus a second controller. Efficacy outcomes was change from baseline 4, 8, 12 and 24 months in FEV1, FVC and FEV1/FVC ratio, asthma control questionnaire (ACQ) score and asthma quality of life score (mini-AQLQ). Results are presented as median with interquartile ranges (IQR). The following were recorded as adverse events: Un-scheduled health care contacts, rescue courses of oral corticosteroid (OCS) and/or antibiotics for exacerbation for exacerbations/respiratory tract infections (RTI).Results: Six-teen patients were enrolled (nine males, median age 50 years; 14 followed for 24 months). Compared to baseline, an improvement in FEV1, FVC, FEV1/FVC ratio, mini-AQLQ and ACQ was observed, i.e.FEV1 (IQR) 1.98 L (1.65-2.45) vs. 2.45 L (2.09-2.93) (p = 0.006), FVC (IQR) 3.23 L (2.76-4.05) vs. 3.75 L (3.22-4.36) (p = 0.041), FEV1/FVC 0.60 (IQR: 0.55-0.70) vs. 0.66 (IQR: 0.63-0.71) (p = 0.016), mini-AQLQ 4.0 (IQR: 3.2-4.9) vs. 5.6 (IQR 4.5-6.5) (p = 0.008, and ACQ 2.9 (IQR: 2.1-3.7) versus 1.5 (IQR 1.0-2.4) (p = 0.004). On the other hand, an increase was observed in unscheduled visits (p = 0.005), as well as use of OCS and antibiotics (p = 0.009 and p = 0.003, respectively).Conclusion: BT in adults with severe asthma improved ACQ, mini-AQLQ and lung function, but resulted in an increased frequency of unscheduled doctor-visits and rescue courses of OCS and antibiotics.

Guiding principles for use of newer biologics and bronchial thermoplasty for patients with severe asthma

BackgroundSevere asthma poses significant disease-related and economic burdens in the United States. Challenges in practice include how to define “severe asthma” for a given patient, knowing which are the right tests to perform and when, and having a better understanding of a patient's asthma phenotype. Furthermore, current guidelines do not address a clear, practical approach to treatment that is based on a patient's asthma phenotype. ObjectiveTo develop a consensus on the definition of severe asthma, the role of biomarkers and phenotyping severe asthma, and the use of newer biologic therapies and bronchial thermoplasty to help guide practicing clinicians. MethodsA roundtable meeting was convened with a panel of severe asthma experts to discuss areas in practice that are not adequately addressed by current guidelines, specifically phenotype-guided treatment. ResultsWe describe a consensus on the definition of severe asthma, asthma phenotyping with the use of available biomarkers, and guiding principles for newer biologic therapies and bronchial thermoplasty. ConclusionTo optimize therapy and improve outcomes such as daily symptoms, quality of life, exacerbations, and hospitalizations, a clear picture of a patient's asthma phenotype is needed to guide therapy. Determining asthma phenotypes is the foundation of precision medicine for this persistent, often difficult-to-treat disease.

PRS10 - Budget Impact of Bronchial Thermoplasty In Patients with Uncontrolled Severe Asthma

PRS10 - Budget Impact of Bronchial Thermoplasty In Patients with Uncontrolled Severe Asthma

Effectiveness of bronchial thermoplasty in patients with severe refractory asthma: Clinical and histopathologic correlations

The effectiveness of bronchial thermoplasty (BT) has been reported in patients with severe asthma, yet its effect on different bronchial structures remains unknown. We sought to examine the effect of BT on bronchial structures and to explore the association with clinical outcome in patients with severe refractory asthma. Bronchial biopsy specimens (n=300) were collected from 15 patients with severe uncontrolled asthma before and 3months after BT. Immunostained sections were assessed for airway smooth muscle (ASM) area, subepithelial basement membrane thickness, nerve fibers, and epithelial neuroendocrine cells. Histopathologic findings were correlated with clinical parameters. BT significantly improved asthma control and quality of life at both 3 and 12months and decreased the numbers of severe exacerbations and the dose of oral corticosteroids. At 3months, this clinical benefit was accompanied by a reduction in ASM area (median values before and after BT, respectively: 19.7% [25th-75th interquartile range (IQR), 15.9% to 22.4%] and 5.3% [25th-75th IQR], 3.5% to 10.1%, P<.001), subepithelial basement membrane thickening (4.4μm [25th-75th IQR, 4.0-4.7μm] and 3.9μm [25th-75th IQR, 3.7-4.6μm], P=0.02), submucosal nerves (1.0 ‰ [25th-75th IQR, 0.7-1.3 ‰] immunoreactivity and 0.3 ‰ [25th-75th IQR, 0.1-0.5 ‰] immunoreactivity, P<.001), ASM-associated nerves (452.6 [25th-75th IQR, 196.0-811.2] immunoreactive pixels per mm2 and 62.7 [25th-75th IQR, 0.0-230.3] immunoreactive pixels per mm2, P=.02), and epithelial neuroendocrine cells (4.9/mm2 [25th-75th IQR, 0-16.4/mm2] and 0.0/mm2 [25th-75th IQR, 0-0/mm2], P=.02). Histopathologic parameters were associated based on Asthma Control Test scores, numbers of exacerbations, and visits to the emergency department (all P≤.02) 3 and 12months after BT. BT is a treatment option in patients with severe therapy-refractory asthma that downregulates selectively structural abnormalities involved in airway narrowing and bronchial reactivity, particularly ASM, neuroendocrine epithelial cells, and bronchial nerve endings.

Effectiveness and safety of bronchial thermoplasty in patients with severe asthma

To assess the effectiveness and safety of bronchial thermoplasty (BT) in patients with severe asthma. The China-Japan Friendship Hospital recruited 12 patients with severe asthma who were voluntary to take BT treatment from March 2014 to November 2014. The levels of airway inflammation and biological markers (percentage of blood eosinophils, percentage of sputum eosinophils, serum IgE, fractional exhaled nitric oxide) of the patients were examined before the treatment in order to identify the types of airway inflammation. The numbers of severe exacerbations and related hospitalizations within 1 year before and after BT were obtained for each patient. The occurrence of adverse events within 3 weeks after the treatment was collected. And the patient status within 1 year after the BT treatment was compared with that before the treatment, in terms of the number of severe exacerbations, exacerbation rate, the number of related hospitalizations, hospitalization rate and oral corticosteroid dose. For before and 1 year after the treatment, the numbers of subjects suffering severe exacerbations were 11 and 6, the numbers of total severe exacerbation were 76 and 16, the numbers of patients hospitalized due to acute attacks were 10 and 3, and the numbers of total hospitalizations were 56 and 6, respectively. The severe exacerbation rate, hospitalization rate and oral corticosteroid dose were significantly reduced 1 year after the treatment [(1.3±0.48 vs. 6.3±1.9) events/subject/year, (0.50±0.26 vs. 4.67±1.90) events/subject/year, (8.5±4.6 vs. 22.0±2.6) mg/d, P<0.05]. The most common adverse events within 3 weeks after BT treatment were cough (8 events), expectoration (20 events), temporary PEF reduction (7 events), wheezing (4 events), but most of these symptoms were relieved in 1 week. One subject suffered pneumonia after each of the 3 procedures but also recovered soon after an antibiotic therapy. No adverse events occurred because of BT treatment within 3 weeks after the treatment. Computed tomographic scans from baseline to 1 year after the BT treatment showed no structural abnormalities related to BT. These data demonstrate the benefits of BT with regard to both asthma control (based on reduction in severe exacerbations and hospitalizations due to acute exacerbations) and safety. BT might offer a new approach to treating severe asthma.

Long-term efficacy and safety of bronchial thermoplasty in patients with moderate-to-severe persistent asthma: a systemic review and meta-analysis

Objective: To evaluate the long-term efficacy and safety of bronchial thermoplasty (BT) in the treatment of patients with moderate-to-severe persistent asthma. Methods: We therefore performed a systematic literature review of peer-reviewed studies focusing on BT intervention in asthma control published between January 2000 and June 2014. Three randomized controlled studies and extension studies met the inclusion criteria (n = 6). Outcomes assessed after BT included spirometric data, adverse respiratory events, emergency room (ER) visits and hospitalization for respiratory illness. One-year and 5-year follow-up data were defined as V1 and V5, respectively. Results: There were 249 BT-treated subjects in total who had a 1-year follow-up (V1), whereas 216 of them finished a 5-year follow-up (V5). No evidence of significant decline was found in pre-bronchodilator FEV1 (% predicted) (WMD = 0.75; 95% CI: 3.36 to 1.85; p = 0.57), or in post-bronchodilator FEV1 (% predicted) (WMD = 0.62; 95% CI: 3.32 to 2.08; p = 0.65) between V1 and V5. In addition, the frequency of respiratory adverse events was reduced significantly during the follow-up (RR = 3.41, 95% CI: 2.96–3.93, p < 0.00001). The number of ER visits for adverse respiratory events remained unchanged (RR = 1.06, 95% CI: 0.77–1.46, p = 0.71) after BT treatment. There was no statistically significant increase in the incidence of hospitalization for respiratory adverse events (V5 vs. V1, RR = 1.47, 95% CI: 0.69–3.12, p = 0.32). Conclusions: These data demonstrate long-term benefits of BT with regard to both asthma control and safety for moderate-to-severe asthmatic patients.

Cost effectiveness of bronchial thermoplasty in patients with severe uncontrolled asthma

Rationale: Based on its clinical effectiveness, bronchial thermoplasty (BT) was approved by the Food and Drug Administration in 2010 for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well-controlled with inhaled corticosteroids and long-acting beta-agonist medicines. Objective: Assess the 10 year cost-effectiveness of BT for individuals with severe uncontrolled asthma. Methods: Using a Markov decision analytic model, the cost-effectiveness of BT was estimated. The patient population involved a hypothetical cohort of 41-year-old patients comparing BT to usual care over a 10-year time frame. The main outcome measure was cost in 2013 dollars per additional quality adjusted life year (QALY). Results: Treatment with BT resulted in 6.40 QALYs and $7512 in cost compared to 6.21 QALYs and $2054 for usual care. The incremental cost-effectiveness ratio for BT at 10 years was $29 821/QALY. At a willingness to pay per QALY of $50 000, BT continues to be cost effective unless the probability of severe asthma exacerbation drops below 0.63 exacerbation per year or the cost of BT rises above $10 384 total for all three bronchoscopic procedures needed to perform thermoplasty and to cover the entire bronchial tree (baseline = $6690). Conclusions: BT is a cost-effective treatment for asthmatics at high risk of exacerbations. Continuing to follow asthmatics treated with BT beyond 5 years will help inform longer efficacy and support its cost-effectiveness.

Cost-Effectiveness of Bronchial Thermoplasty in Patients with Poorly Controlled, Severe, Persistent Asthma

Despite many pharmacological and immunological treatments for asthma, some patients remain not well-controlled and continue to experience asthma exacerbations. Existing FDA-approved treatments for asthma do not address excessive airway smooth muscle mass (ASM), an anatomical feature associated with increased asthma severity and morbidity in some patients. We sought to examine the cost-effectiveness of Bronchial Thermoplasty (BT) to treat poorly controlled, severe, persistent asthma patients. This novel technology uses thermal energy to target and reduce ASM, resulting in a durable reduction in asthma exacerbations.

Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma

Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma

Bronchial thermoplasty for moderate or severe persistent asthma in adults.

Bronchial thermoplasty is a procedure that consists of the delivery of controlled radiofrequency-generated heat via a catheter inserted into the bronchial tree of the lungs through a flexible bronchoscope. It has been suggested that bronchial thermoplasty works by reducing airway smooth muscle, thereby reducing the ability of the smooth muscle to bronchoconstrict. This treatment could then reduce asthma symptoms and exacerbations, resulting in improved asthma control and quality of life. To determine the efficacy and safety of bronchial thermoplasty in adults with bronchial asthma. We searched the Cochrane Airways Group Specialised Register of Trials (CAGR) up to January 2014. We included randomised controlled clinical trials that compared bronchial thermoplasty versus any active control in adults with moderate or severe persistent asthma. Our primary outcomes were quality of life, asthma exacerbations and adverse events. Two review authors independently extracted data and assessed risk of bias. We included three trials (429 participants) with differences regarding their design (two trials compared bronchial thermoplasty vs medical management and the other compared bronchial thermoplasty vs a sham intervention) and participant characteristics; one of the studies included participants with more symptomatic asthma compared with the others.The pooled analysis showed improvement in quality of life at 12 months in participants who received bronchial thermoplasty that did not reach the threshold for clinical significance (3 trials, 429 participants; mean difference (MD) in Asthma Quality of Life Questionnaire (AQLQ) scores 0.28, 95% confidence interval (CI) 0.07 to 0.50; moderate-quality evidence). Measures of symptom control showed no significant differences (3 trials, 429 participants; MD in Asthma Control Questionnaire (ACQ) scores -0.15, 95% CI -0.40 to 0.10; moderate-quality evidence). The risk of bias for these outcomes was high because two of the studies did not have a sham intervention for the control group.The results from two trials showed a lower rate of exacerbation after 12 months of treatment for participants who underwent bronchial thermoplasty. The trial with sham intervention showed a significant reduction in the proportion of participants visiting the emergency department for respiratory symptoms, from 15.3% on sham treatment to 8.4% over 12 months following thermoplasty. The trials showed no significant improvement in pulmonary function parameters (with the exception of a greater increase in morning peak expiratory flow (PEF) in one trial). Treated participants who underwent bronchial thermoplasty had a greater risk of hospitalisation for respiratory adverse events during the treatment period (3 trials, 429 participants; risk ratio 3.50, 95% CI 1.26 to 9.68; high-quality evidence), which represents an absolute increase from 2% to 8% (95% CI 3% to 23%) over the treatment period. This means that six of 100 participants treated with thermoplasty (95% CI 1 to 21) would require an additional hospitalisation over the treatment period. No significant difference in the risk of hospitalisation was noted at the end of the treatment period.Bronchial thermoplasty was associated with an increase in respiratory adverse events, mainly during the treatment period. Most of these events were mild or moderate, appeared in the 24-hour post-treatment period, and were resolved within a week. Bronchial thermoplasty for patients with moderate to severe asthma provides a modest clinical benefit in quality of life and lower rates of asthma exacerbation, but no significant difference in asthma control scores. The quality of life findings are at risk of bias, as the main benefits were seen in the two studies that did not include a sham treatment arm. This procedure increases the risk of adverse events during treatment but has a reasonable safety profile after completion of the bronchoscopies. The overall quality of evidence regarding this procedure is moderate. For clinical practice, it would be advisable to collect data from patients systematically in independent clinical registries. Further research should provide better understanding of the mechanisms of action of bronchial thermoplasty, as well as its effect in different asthma phenotypes or in patients with worse lung function.

How to: Bronchial thermoplasty in asthma

Educational aims To provide an overview on how to perform bronchial thermoplasty for the treatment of asthma To summarise the development, mode of action and evidence for the effectiveness of bronchial thermoplasty as well as its place in the management of asthma Summary Bronchial thermoplasty, which involves the delivery of radio frequency energy to the airways, is a nonpharmacological intervention developed for the treatment of moderate-to-severe asthma. The mode of action of bronchial thermoplasty is not established, but could be due to reduction in airway smooth muscle mass induced by thermal energy. Bronchial thermoplasty results in modest improvements in asthma quality of life questionnaire scores and clinically worthwhile reductions in severe exacerbations and emergency department visits in the year post-treatment, which may persist for up to 5 years. The procedure involves systematic, controlled heating of the airways using dedicated radiofrequency equipment during a series of three bronchoscopy sessions. Bronchial thermoplasty causes short-term increases in asthma-related morbidity, including hospital admissions. Follow-up data, to date, supports the long-term safety of the procedure. Bronchial thermoplasty is a novel treatment option for selected patients with moderate-to-severe asthma that is poorly controlled despite maximal therapy. Key points Bronchial thermoplasty, which involves the delivery of radio frequency energy to the airways, is a nonpharmacological intervention developed for the treatment of patients with moderate-to-severe asthma that is poorly controlled despite maximal therapy Randomised controlled clinical trials of bronchial thermoplasty in patients with moderate and severe asthma have shown modest improvements in asthma quality of life and clinically worthwhile reductions in severe exacerbations and emergency department visits The treatment involves three bronchoscopy sessions with repeated, precise and carefully recorded activations of a radiofrequency catheter within the medium and large airways Bronchial thermoplasty causes short-term increases in asthma-related morbidity including increased admissions to hospital for asthma; follow-up data, to date, supports the longterm safety of the procedure

Safety of bronchial thermoplasty in patients with severe refractory asthma

BackgroundPatients with severe refractory asthma treated with bronchial thermoplasty (BT), a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle, were followed up for 5 years to evaluate long-term safety of this procedure. ObjectivesTo assess long-term safety of BT for 5 years. MethodsPatients with asthma aged 18 to 65 years requiring high-dose inhaled corticosteroids (ICSs) (>750 μg/d of fluticasone propionate or equivalent) and long-acting β2-agonists (LABAs) (at least 100 μg/d of salmeterol or equivalent), with or without oral prednisone (≤30 mg/d), leukotriene modifiers, theophylline, or other asthma controller medications were enrolled in the Research in Severe Asthma (RISA) Trial. Patients had a prebronchodilator forced expiratory volume in 1 second of 50% or more of predicted, demonstrated methacholine airway hyperresponsiveness, had uncontrolled symptoms despite taking maintenance medication, abstained from smoking for 1 year or greater, and had a smoking history of less than 10 pack-years. ResultsFourteen patients (of the 15 who received active treatment in the RISA Trial) participated in the long-term follow-up study for 5 years. The rate of respiratory adverse events (AEs per patient per year) was 1.4, 2.4, 1.7, and 2.4, respectively, in years 2 to 5 after BT. There was a decrease in hospitalizations and emergency department visits for respiratory symptoms in each of years 1, 2, 3, 4, and 5 compared with the year before BT treatment. Measures of lung function showed no deterioration for 5 years. ConclusionOur findings suggest that BT is safe for 5 years after BT in patients with severe refractory asthma. Trial Registrationclinicaltrials.gov Identifier: NCT00401986