How effective is bronchial thermoplasty for severe asthma in clinical practice?

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. Safety: peri-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 FEV1was 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.

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Effectiveness and Safety of Bronchial Thermoplasty in Severe Asthma in Clinical Practice in Spain

Biomedicine Hub ◽

10.1159/000492075 ◽

2018 ◽

Vol 3 (3) ◽

pp. 1-9 ◽

Cited By ~ 1

Author(s):

Luis Puente-Maestu ◽

Milagros Llanos Flores ◽

Paola Benedetti ◽

Ingrid Frías Benzant ◽

Alicia Oliva Ramos ◽

...

Keyword(s):

Clinical Practice ◽

Asthma Control ◽

Severe Asthma ◽

Inhaled Corticosteroids ◽

Invasive Procedure ◽

First Year ◽

Asthma Control Test ◽

Bronchial Thermoplasty ◽

Oral Corticosteroids ◽

Predominantly Female

Background: Bronchial thermoplasty (BT) is a minimally invasive procedure consisting of application of thermal energy into the airways to produce ablation of the hypertrophic smooth muscle. It was approved for use in moderate-severe asthma in Spain in 2010. Objectives: The aims of the present study are to analyze the effectiveness and the safety of BT in clinical practice in our center. Methods: Participants had a confirmed diagnosis of severe asthma and poor control without therapeutic alternative. Effectiveness was measured by comparing exacerbations, admissions rates, asthma control, and medication 1 year prior and 1 year after BT was completed. All complications appearing during the procedure and in the first year were recorded. Results: Patients had a mean age of 51 (SD 8) years and were predominantly female (17/23). The average number of activations per patient was 147 (16). The number of severe exacerbations was reduced by 75% (p < 0.001). A 38% reduction in admissions per year was also observed (p = 0.03). The Asthma Control Test improved by 7.1 (3.7) points (p = 0.018). Before BT, the dose of inhaled corticosteroids was 1,621 (1,015) µg of budesonide-equivalent and the dose of oral corticosteroids was 15 (13) mg of prednisone-equivalent. There was a reduction in 430 (731) µg of budesonide-equivalent (p = 0.02) and 4 (11) mg of prednisone (p = 0.094). No changes in lung function were observed. Complications were related mostly to exacerbation of asthma in the days following the procedure. Conclusions: BT is effective and safe for severe uncontrolled bronchial asthma in real clinical practice.

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