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Acute Radiological Abnormalities after Bronchial Thermoplasty: A Prospective Cohort Trial.

ABSTRACT: 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.To assess the incidence pattern and behavior over time of acute radiological abnormalities following BT.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.Thirty-four chest X-rays were performed within <5 h following 34 BT procedures in 12 patients. In 91% of cases, radiological abnormalities were seen, designated as peribronchial consolidations (97%) and/or atelectasis (29%). Ultra-low-dose (ULD) chest CTs were performed following 16 BT procedures showing abnormalities in all. Four different radiological patterns were identified: peribronchial consolidations with surrounding ground glass opacities (94%), atelectasis (38%), partial bronchial occlusions (63%), and bronchial dilatations (19%). No bronchoscopic intervention was needed. At 6 months' follow-up, in a single patient, high-resolution chest CT showed a focal bronchiectasis in a single airway.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.

SUBMITTER: d'Hooghe JNS

PROVIDER: S-EPMC5637315 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Acute Radiological Abnormalities after Bronchial Thermoplasty: A Prospective Cohort Trial.

d'Hooghe Julia N S JNS van den Berk Inge A H IAH Annema Jouke T JT Bonta Peter I PI

Respiration; international review of thoracic diseases 20170705 3

<h4>Background</h4>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.<h4>Objective</h4>To assess the incidence pattern and behavior over time of acute radiological abnormalities following BT.<h4>Methods</h4>This is a prospective, ob ...[more]

PMID: 28675890

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Project description:ObjectivesUse data from the UK Severe Asthma Registry (UKSAR) to assess the efficacy and safety of bronchial thermoplasty (BT) in routine UK clinical practice and to identify characteristics of 'responders'.DesignProspective, longitudinal, cohort, multicentre registry study.SettingAll (11) UK centres performing BT.Participants and interventionPatients receiving BT in the UK between 01/06/2011 and 30/09/2016 who had consented to data entry into UKSAR (n=133). Efficacy data were available for 86 patients with a BT baseline and at least one follow-up record. Safety data were available for 131 patients with at least one BT procedure record.Primary and secondary outcome measuresEfficacy: AQLQ, ACQ, EuroQol, HADS anxiety and HADS depression scores, FEV1 (% predicted), rescue steroid courses, unscheduled healthcare visits (A&E/Asthma clinic/GP), hospital admissions and days lost from work/school.Safetyperi-procedural events, device problems and any other safety-related findings. Responder analysis: differences in baseline characteristics of 'responders' (?0.5?increase in AQLQ at 12 months) and 'non-responders'.ResultsFollowing Bonferroni correction for paired comparisons, mean improvement in AQLQ at 12 months follow-up compared with BT baseline was statistically and clinically significant (0.75, n=28, p=0.0003). Median reduction in hospital admissions/year after 24 months follow-up was also significant (-1.0, n=26, p<0.0001). No deterioration in FEV1 was observed. From 28 patients with AQLQ data at BTBL and 12-month follow-up, there was some evidence that lower age may predict AQLQ improvement. 18.9% (70/370) of procedures and 44.5% (57/128) of patients were affected by an adverse event; only a minority were considered serious.ConclusionsImprovement in AQLQ is consistent with similar findings from clinical trials. Other efficacy outcomes demonstrated improving trends without reaching statistical significance. Missing follow-up data impacted this study but multiple imputation confirmed observed AQLQ improvement. The safety review suggested BT is being performed safely in the UK.

Project description:PurposeBronchial thermoplasty is approved in many countries worldwide as a non-pharmacological treatment for severe asthma. This review summarizes recent publications on the selection of patients with severe asthma for bronchial thermoplasty, predictors of a beneficial response and developments in the procedure and discusses specific issues about bronchial thermoplasty including effectiveness in clinical practice, mechanism of action, cost-effectiveness, and place in management.ResultsBronchial thermoplasty is a treatment option for patients with severe asthma after assessment and management of causes of difficult-to-control asthma, such as nonadherence, poor inhaler technique, comorbidities, under treatment, and other behavioral factors. Patients treated with bronchial thermoplasty in clinical practice have worse baseline characteristics and comparable clinical outcomes to clinical trial data. Bronchial thermoplasty causes a reduction in airway smooth muscle mass although it is uncertain whether this effect explains its efficacy since other mechanisms of action may be relevant, such as alterations in airway epithelial, gland, and/or nerve function; improvements in small airway function; or a placebo effect. The cost-effectiveness of bronchial thermoplasty is greater in countries where the costs of hospitalization and emergency department are high. The place of bronchial thermoplasty in the management of severe asthma is not certain, although some experts propose that bronchial thermoplasty should be considered for patients with severe asthma associated with non-type 2 inflammation or who fail to respond favorably to biologic therapies targeting type 2 inflammation.ConclusionBronchial thermoplasty is a modestly effective treatment for severe asthma after assessment and management of causes of difficult-to-control asthma. Asthma morbidity increases during and shortly after treatment. Follow-up studies provide reassurance on the long-term safety of the procedure. Uncertainties remain about predictors of response, mechanism(s) of action, and place in management of severe asthma.

Project description:ObjectivesBronchial thermoplasty (BT) is a device-based treatment for subjects ≥18 years with severe asthma not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Bronchial Thermoplasty Global Registry (BTGR) collected real-world data on subjects undergoing this procedure.DesignThe BTGR is an all-comer, prospective, open-label, multicentre study enrolling adult subjects indicated for and treated with BT.SettingEighteen centres in Spain, Italy, Germany, the UK, the Netherlands, the Czech Republic, South Africa and Australia PARTICIPANTS: One hundred fifty-seven subjects aged 18 years and older who were scheduled to undergo BT treatment for asthma. Subjects diagnosed with other medical conditions which, in the investigator's opinion, made them inappropriate for BT treatment were excluded.Primary and secondary outcome measuresBaseline characteristics collected included demographics, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Test (ACT), medication usage, forced expiratory volume in one second and forced vital capacity, medical history, comorbidities and 12-month baseline recall data (severe exacerbations (SE) and healthcare utilisation). SE incidence and healthcare utilisation were summarised at 1 and 2 years post-BT.ResultsSubjects' baseline characteristics were representative of persons with severe asthma. A comparison of the proportion of subjects experiencing events during the 12 months prior to BT to the 2-year follow-up showed a reduction in SE (90.3% vs 56.1%, p<0.0001), emergency room visits (53.8% vs 25.5%, p<0.0001) and hospitalisations (42.9% vs 23.5 %, p=0.0019). Reductions in asthma maintenance medication dosage were also observed. AQLQ and ACT scores improved from 3.26 and 11.18 at baseline to 4.39 and 15.54 at 2 years, respectively (p<0.0001 for both AQLQ and ACT).ConclusionsThe BTGR demonstrates sustained improvement in clinical outcomes and reduction in asthma medication usage 2 years after BT in a real-world population. This is consistent with results from other BT randomised controlled trials and registries and further supports improvement in asthma control after BT.Trial registration numberNCT02104856.

Dataset Information

Acute Radiological Abnormalities after Bronchial Thermoplasty: A Prospective Cohort Trial.

Publications

Acute Radiological Abnormalities after Bronchial Thermoplasty: A Prospective Cohort Trial.

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