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How does Bronchial Thermoplasty Work?

What is Bronchial Thermoplasty?

Bronchial Thermoplasty (BT), delivered by the Alair™ System, approved by the FDA in 2010, is a safe and effective, minimally invasive, outpatient procedure for patients with severe asthma.

 

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.

Click here to review a complete list of indications for use, contraindications and precautions.


What are the benefits of Bronchial Thermoplasty?

Bronchial Thermoplasty is the first and only one-time, non-drug intervention for severe asthma with clinically proven benefits lasting for at least 5 years.1

Asthma Intervention Research 2 (AIR2) Trial: In this 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 BT2:

  • 32% decrease in severe asthma exacerbations (requiring systemic corticosteroids)2
  • 84% reduction in emergency room visits for respiratory related symptoms2
  • 66% fewer asthma-related days lost from work, school and other activities2

Additionally, 79% of patients who were treated with BT reported a significant improvement in their asthma-related quality of life.2


Durable reduction in exacerbations maintained for at least 5 years1

Reduction in percentage of patients experiencing exacerbations compared to Sham patients seen at 1 year was maintained out to 5 years1 (primary endpoint)

Additionally, a 44% decrease (average over 5 years) in the percentage of BT-treated patients having severe exacerbations, compared with 12 months prior to BT treatment.1


Durable reduction in emergency room visits maintained out to 5 years1

Reduction in ER visits compared to Sham patients seen at year 1 maintained out to 5 years1

Additionally, 78% decrease (average over 5 years) in the percentage of BT treated patients experiencing ER visits for respiratory symptoms, compared with 12 months prior to BT treatment.1


 

 

What are the risks of the Bronchial Thermoplasty?

In the pivotal clinical trial of BT in patients with severe asthma, there was a transient increase in respiratory adverse events, including asthma (multiple symptoms), upper respiratory tract infection, atelectasis, lower respiratory tract infection, wheezing, hemoptysis, and anxiety in the BT group compared to the Sham group. There is a risk (3.4%) of these symptoms requiring hospitalization around the time of the BT procedure.

During the Post-Treatment Phase (6 weeks after the third procedure out to 12 months) in the AIR2 Trial, there was a lower incidence of respiratory symptoms in the Alair group compared to the Sham group, including a 36% reduction in asthma (multiple symptoms) events and proportion of subjects with asthma (multiple symptoms) events. There was also a lower incidence of influenza, and a greater incidence of nasopharyngitis, in the BT group compared to the Sham group.


 

 

Who Benefits from BT?

Who is appropriate for Bronchial Thermoplasty?

Some patients still experience exacerbations and significantly limit their quality of life (assessed by AIS-6 or AQLQ), despite their recommended medication regimen.

These patients can benefit from Bronchial Thermoplasty to reduce their exacerbations. Fewer exacerbations means less need for the associated oral steroid treatment—and its side effects.

BT is for:

Patients on maximum tolerated doses of combined ICS and LABA such as Advair™, Dulera™ and Symbicort™, and who may also experience one or more of the following:

  • Patients who take oral steroids for acute exacerbations more than twice a year
  • Patients who are Anti-IgE therapy candidates or non-responders
  • Patients who take oral steroids as daily maintenance medication

 

Who is not appropriate for Bronchial Thermoplasty?

  • Patients who have a pacemaker, internal defibrillator, or other implantable electronic device
  • Patients who have a known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine, and benzodiazepines
  • Patients who have previously been treated with Bronchial Thermoplasty

How is BT Performed?

Who performs the Bronchial Thermoplasty procedure?

Bronchial Thermoplasty is performed by a BT-Certified and experienced pulmonologist. Physicians wanting to perform BT are carefully trained on the procedure as follows:

  • Guided didactic instruction utilizing the computer simulation-based Bronchial Thermoplasty Learning Center
  • Detailed in-service training of the Alair™ System
  • Hands-on training with Alair System in a lung model prior to initial cases
  • Proctoring of initial cases by Boston Scientific representative
  • Ongoing support of cases when requested

 

Where is the procedure performed?

BT is typically performed in an outpatient setting in the hospital. All facilities where BT is to be performed must be appropriately equipped to perform bronchoscopy and also equipped to handle respiratory emergencies.

 

How is the procedure performed?

  • Bronchial Thermoplasty is performed generally under moderate sedation in 3 outpatient visits, typically 3 weeks apart; a different lobe of the lung is treated during each session to ensure safety. Typically the right lower lobe is treated during the first session, the left lower lobe is treated during the second session, and both the right and left upper lobes are treated during the third session.
  • A standard flexible bronchoscope is introduced into the bronchial tree through either the nose or the mouth, and the Alair Catheter (connected to the Alair Radiofrequency Controller) is introduced into the patient's airways through the bronchoscope. No incision is needed.
  • The bronchoscope is then navigated to the first target treatment site, typically the most distal airway in the targeted lobe.
  • Once the Alair Catheter is positioned at the desired location of the airway, the electrode array at the tip of the Alair Catheter is expanded to contact the airway wall. The Alair Radiofrequency (RF) Controller is activated to deliver RF energy through the Alair Catheter to the patient's airway wall.
  • The Alair RF Controller delivers low-power, temperature-controlled RF energy to the airway for a maximum of 10 seconds per activation. The RF energy heats the wall of a portion of the airways in a controlled manner.
  • A single activation of the Alair Catheter delivers RF energy over a distance of 5 mm (the length of the exposed electrodes within the electrode array). Audible and visual cues from the Alair RF Controller signify proper delivery of RF energy.
  • After each activation, the Alair Catheter is repositioned and subsequent activations are performed contiguously (adjacent but not overlapping) along the airway. This technique is used in all accessible airways distal to the mainstem bronchi and ≥ 3 mm in diameter.
  • Following the BT treatment, the patient should be monitored similar to other bronchoscopy procedures. Patient can be discharged to home the same day if breathing, heart rate, blood pressure, level of oxygen in the blood are near normal levels, and the FEV1 is at least 80% of the pre-procedure value.

 

What should patients expect before the Bronchial Thermoplasty procedure?

  • Pre-operative patient stability will be assessed by clinical staff 3 days and 1 day before the BT procedure.
  • BT should only be performed in patients who are safely able to undergo bronchoscopy.
  • Postpone or reschedule the BT procedure if any of the following conditions are present:
    • Active respiratory infection
    • Asthma exacerbation or changing dose of systemic corticosteroids (up or down) for asthma in the past 14 days
    • Known coagulopathy
  • Inability to stop taking anticoagulants, antiplatelet agents, aspirin, or NSAIDS before the BT procedure
  • The BT physician will prescribe a prophylactic administration of prednisone prior to each procedure
    • 50 mg/day for each of the 3 days before the procedure
    • The day of the procedure
    • The day after the procedure

 

What should patients expect after the Bronchial Thermoplasty procedure?

  • Following the BT treatment, the patient should be monitored similar to other bronchoscopy procedures. Patient can be discharged to home the same day if breathing, heart rate, blood pressure, level of oxygen in the blood are near normal levels, and the FEV1 is at least 80% of the pre-procedure value.
  • Patient will have a follow-up appointment with their BT treating doctor 2-3 weeks after each session to determine if they are ready for the next procedure
  • After all 3 procedures are performed, the BT treatment is complete
  • Patients do not have to be retreated with BT
  • Patients will return back to their regular asthma physician to continue managing their asthma (BT is meant to work with current asthma reliever and controller medications)

Additional Information

Is Bronchial Thermoplasty recommended in the NAEPP Guidelines as a treatment option?

Most physicians in the United States use the NAEPP guidelines for managing asthma patients. However, the NAEPP asthma management guidelines have not been updated since 2007 which was prior to the FDA approval of the Alair Bronchial Thermoplasty System in 2010.

The Global Initiative for Asthma (GINA) 2014 update represents the most current global guideline for managing asthma. The GINA guidelines developed by leading asthma experts from around the world recommend BT as a preferred add on therapy at Step 5 to help patients who are still symptomatic on ICS and LABA.3 To see the current 2014 guidelines click here.

 

What is the Global Initiative for Asthma (GINA)?

GINA was launched in 1993 in collaboration with the National Heart, Lung, and Blood Institute, National Institutes of Health, USA, and the World Health Organization.

GINA works with health care professionals and public health officials around the world to reduce asthma prevalence, morbidity, and mortality.

For more information on GINA visit ginasthma.org.

 

What are the side effects of oral steroids and other asthma medications?

Asthma medications can have potentially serious side effects. As with any medication, side effects become a greater concern when treatment is ongoing and as dosages increase, which is the case for patients with severe asthma.

  • Corticosteroids (oral steroids): Side effects of prednisone and other oral corticosteroids range from mild annoyances to serious, irreversible damage. These side effects occur more frequently with higher doses and longer treatment. Side effects with ongoing use include suppression of the immune system, adrenal system, and growth; osteoporosis; skin thinning; hypertension; cataracts; glaucoma; muscle weakness; and increased risk of infection. Short-term side effects include stomach upset, headache, dizziness, trouble sleeping, fluid retention, weight gain, high blood pressure, loss of potassium, elevation of cholesterol levels, and vision changes.
  • Bronchodilators: The possible side effects of short-acting rescue medications include rapid heartbeat, skeletal muscle tremor, potassium deficiency, increased lactic acid, headache, and hyperglycemia. Long-acting beta-agonists may even cause severe asthma symptoms in some patients, and death when those episodes occur.2
  • Other drugs: The side effects of Anti-IgE therapy (omalizumab, Xolair™) include anaphylaxis (severe allergic reaction), injection-site reactions, and viral infections.

 

Is Bronchial Thermoplasty covered by health insurance plans?

Currently there are 20 health plans that have implemented a policy to cover the Bronchial Thermoplasty procedure. However, other plans that do not have a policy established for BT are covering the procedure on a case-by-case basis. For a complete up to date list of these plans visit www.BTCoverage.com

 


Brief Statement of Relevant Indications for Use, Contraindications, Warnings, and Adverse Events: The Alair™ Bronchial ThermoplastySystem 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 is not for use in patients with an active implantable electronic device or known sensitivity to medications used in bronchoscopy. Previously treated airways of the lung should not be retreated with the Alair System. Patients should be stable and suitable to undergo bronchoscopy. The most common side effect of BT is an expected transient increase in the frequency and worsening of respiratory-related symptoms. ENDO-551804-AA May 2018
 

References:

  1. Wechsler ME et al. J Allergy Clin Immunol. 2013 Dec;132(6):1295-302.
  2. Castro M et al. Am J Respir Crit Care Med. 2010 Jan 15;181(2):116-24.
  3. From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2014. Available from: ginasthma.org/.
  4. CHEST American College of Chest Physicians. Bronchial Thermoplasty for the Treatment of Severe Asthma. May 2014
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