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What is Bronchial Thermoplasty?
It is a new and innovative procedure in which the inside of the airways is heated using an electrode through a procedure called as bronchoscopy, done under sedation. Bronchial thermoplasty reduces the wall thickness of the smooth muscle to increase the airflow through your lungs to ease the breathing and reduce the symptoms of asthma. It is done with three sittings and is shown to significantly reduce the frequency of asthma attacks, hospital visits and improve the quality of life.
In a nutshell, who qualifies for Bronchial Thermoplasty?
Severe asthma, where all modalities of treatment have been tried, and still have persistent attacks, restricted quality of life, need for steroids, and work and existence affected due to asthma
Bronchial Thermoplasty – First and only non-drug therapy for severe asthma with clinically proven benefits out to 5 years
In the Asthma Intervention Research 2 (AIR2) Trial, one of the largest sham-controlled medical device trials in pulmonary medicine, patients with severe asthma showed significant improvement compared to sham-controlled patients 1 year after treatment with Bronchial Thermoplasty (BT) delivered by the Alair™ System. The AIR2 Trial 5-Year Extension Study evaluated the sustained effectiveness and safety of BT out to 5 years in BT-treated patients from the AIR2 Trial.1,2
Fewer exacerbations, with effectiveness maintained out to 5 years 1,2
32% decrease in severe asthma exacerbations (requiring systemic corticosteroids) at 1 year compared with sham-controlled patients1
- Reduction in percentage of patients experiencing exacerbations seen at 1 year maintained out to 5 years (primary endpoint)2
- Fewer emergency room visits, with reduction maintained out to 5 years 1,2
84% reduction in emergency room visits for respiratory symptoms at 1 year compared with sham-controlled patients1
- Reduction in ER visits seen at 1 year maintained out to 5 years2
- Safety maintained over 5 years2
- No increase was seen in hospitalizations, asthma symptoms, or respiratory adverse events over the course of 5 years in patients treated with BT2
- No structural changes in airways that were clinically significant were due to BT at 5 years2
- Absence of clinically significant deterioration in lung function (FEV1) at 5 years2
As with any procedure, there are risks, and individual results may vary. The most common adverse event of BT is a temporary worsening of respiratory-related symptoms. These events typically occur within one day of the BT procedure and usually resolve within a week with standard care. There is a small risk (3.4% per procedure) that symptoms may require hospitalization
Who is BT for?
BT is for patients with severe asthma ≥ 18 years who are on maximum-tolerated doses of asthma medications but still experience asthma symptoms and/or risk of future exacerbations. This can include patients with any one of the following:
- Chronic oral corticosteroid use
- Two or more exacerbations per year
- Omalizumab candidate
- Impaired quality of life (assessed by AIS-6, ACT, AQLQ)
What is Bronchial Thermoplasty?
Bronchial Thermoplasty (BT), delivered by the Alair™ System, is a safe and minimally invasive outpatient procedure for the treatment of severe asthma in adults.
BT provides long-lasting asthma relief by reducing excess smooth muscle.
Treatment with BT addresses airway constriction by reducing the amount of excess smooth muscle tissue. Less muscle tissue means less airway constriction during an asthma attack.1 Unlike daily asthma medications, BT continues to work for years. BT targets airway smooth muscle and complements a patient’s current asthma medication used to control inflammation.
The Alair Bronchial Thermoplasty System is indicated 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-agonists.
The Alair System
The Alair System, which delivers BT, is composed of 2 primary components: The Alair Catheter and the Alair Radiofrequency (RF) Controller.
Sterile, single-use, disposable device designed to deliver therapeutic radiofrequency (RF) energy to the airways via standard bronchoscope
Provides temperature controlled delivery of RF energy to the Alair Catheter at levels needed to safely reduce airway smooth muscle. The energy delivered is designed to limit long-term impact to surrounding tissues
BT is performed by a trained pulmonologist in 3 sessions, scheduled 3 weeks apart, to ensure safety and optimal results.
Bronchial Thermoplasty Check List for Physicians
|Step 1: |
|1 History and physical examination consistent with Asthma|
2 PFT if available
Confirm appropriate medications as per GINA step 5
|Persistent symptoms despite optimal medications|
Bronchial Thermoplasty checklist for Pulmonologists
Patient name – Age- Uhid no –
|1. History and physical examination consistent with Asthma|
2. PFT (FEVI with BDR > 50%)
3. ABPA Rule out COPD/Bronchiectasis (if suspected)
Confirm appropriate medications as per GINA
|1 Appropriate medications [ICS+LABA+LAMA (as needed)]|
2 Good inhaler techniques
3 Good patient adherence to inhalers
|1 Persistent symptoms despite optimal medications|
2 Persistent Night symptoms
3 Exacerbations > 2/in last 1 year
4 Quality of life affected by exacerbations/symptoms
Patient Selection Criteria for Bronchial Thermoplasty
|Sr. No||Selection Criteria||Yes||No|
|1. Adults (18 and above) with documented diagnosis of asthma|
· Documented severity of disease in terms of FEV1 and Chest HRCT
· Historic FEV1 reversibility
2. Based on the Doctor’s judgement the PFT (FEV1 value) should be around 50%
3. ABPA ruled out
4. COPD/Bronchiectasis/asthma mimic disease ruled out
|2||Confirm appropriate medications as per GINA guidelines|
|1. Patient is symptomatic despite treatment with stable maintenance medication (according to GINA guidelines) [ICS+LABA+ Possible Others (Anticholinergics + Montelukast)]|
2. Confirmation on compliance and inhaler techniques as directed by the physician.
|1. No respiratory tract infection for past 2 weeks |
2. Frequent severe exacerbations
3. Persistent symptoms despite optimal medications
4. Quality of life affected by exacerbations/symptoms/pharmacological treatments nebulizers, oral corticosteroids.
|1 Smokers long term (> 1 year)|
2 Known sensitivity to medications required to perform bronchoscopy
3 Internal pacemaker or neurostimulator
4 Unstable comorbid conditions
· Untreated obstructive sleep apnoea
· Clinically significant cardiovascular disease
· Cancer especially Basal Cell Carcinoma
5 Patients with active bleeding and coagulation dysfunction but patients who can stop the anticoagulants just before the procedure can be included.
- FEV1-Forced expiratory volume in 1 sec
- PFT- Pulmonary function test
- ABPA-Allergic bronchopulmonary aspergillosi
- COPD- Chronic obstructive pulmonary disease
- BDR-bronchodilator Response
- ICS-Inhaled corticosteroids
- LABA-Long Acting Beta2 agonist
Parameters examined for Quality for life
- Absenteeism at work
- Family suffering
- Shortness of breath
- Asthma symptoms disturbing sleep in the night
- The patient’s ability to enjoy normal life activities since life quality is strongly related to wellbeing without suffering from sickness and treatment.
- Usage of rescue inhaler or nebulizer medication
More parameters are to be added with further research Approach to developing of the Patient selection criterion for Bronchial Thermoplasty
Review the literature
- We did an extensive literature search in the primary database about the procedure, requirements, patient selection for Bronchial Thermoplasty.
- The search was done to identify the Clinical outcomes of BT. The search items included Asthma stages, Severe asthma symptoms, Co relation between the asthma stages and pharmacological drugs administered, importance of BT in severe asthma, benefits of doing a BT, steps in the procedure, outcomes measured.
- The most common ways of documenting the improvement in Severe Asthma patients after undergoing BT procedure are:
- Safety endpoint- Decrease in rate of Emergency room visits, Hospitalization for respiratory symptoms.
- Respiratory Adverse Events such as any infections in Ear, Nose and throat, Lower respiratory infections. These are considered when occurring with >3% incidence in the patients treated with lair BT system
- Reduction in frequency of administration of Inhaled corticosteroid puffs
- Decrease in use of nebulizer
- Pre-procedure Forced Expiratory Volume in 1 Second (FEV1) should be greater than or equal to 85%. Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) to assess patient stability pre and post procedure.
- Improvement in Asthma Quality of Life Questionnaire (AQLQ) Score