Did you know that there is now a non drug procedure that is available if you have severe persistent asthma that is not well-controlled with inhaled corticosteroids and long-acting beta-agonists? In fact, the Alair® Bronchial Thermoplasty System won the 2010 Popular Science "Best of What's New" Award in the Health category for development of this technology.
Bronchial thermoplasty is an outpatient (meaning most patients get to go home and sleep in their own bed) bronchoscopic procedure that decreases the ability of your airways airways to constrict and narrow when you are exposed to triggers leading to an asthma attack. Bronchial thermoplasty is a procedure that delivers thermal energy to the lungs of patients with asthma in order to decrease the amount of smooth muscle in the lungs, the muscles that lead to bronchoconstriction and asthma symptoms. Patient's gain better control of their asthma because the lungs are not able to constrict as much and react as vigorously to asthma triggers.
The Alair® Bronchial Thermoplasty System reduces excessive airway smooth muscle by directing thermal energy to the lung directly. Bronchial thermoplasty is usually performed under moderate sedation with the the patient typically going home on the same day. A complete treatment is 3 separate sessions that each treat a different area of the lung. At this time, the safety and efficacy of repeat treatments is not known.
Indications For Bronchial Thermoplasty
According to the The Alair® Bronchial Thermoplasty System website, it 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."
Your physician needs to be experienced in bronchoscopy procedures, but also needs to undergo special training in the use of bronchial thermoplasty before being able to use Alair® Bronchial Thermoplasty System.
Contraindications For Bronchial Thermoplasty
Certain patients are not eligible for treatment with bronchial thermoplasty:
- Patients with any types of implantible devices such as a pacemaker, internal defibrillator, or any other implantable electronic devices.
- Patients with a known sensitivity or allergy to the medications used during a bronchoscopy such as lidocaine, atropine, and benzodiazepines.
- Patients already treated with the Alair® Bronchial Thermoplasty System. Retreatment is not currently advised as the safety and efficacy of repeat treatments is not known.
Additionally, certain conditions may be temporary contraindications to bronchial thermoplasty. Patients with the following should not under go bronchial thermoplasty:
- Acute respiratory infection.
- Asthma exacerbation in the last 2 weeks.
- Changing dose of systemic corticosteroids for asthma (up or down) in the past 14 days
- Known coagulopathy or bleeding problem
- Patients should stop taking anticoagulants, antiplatelet agents, aspirin and NSAIDS before the procedure after talking with their physician.
Finally, there were some types of asthmatic patients that were not studied in the trials of Alair® Bronchial Thermoplasty System and it is really not know if they will demonstrate the same benefits as other patients. If any of the following are true, you need to discuss the risks and benefits of bronchial thermoplasty with your doctor as you may be at increased risk of adverse events that may be associated with the bronchial thermoplasty procedure:
- Your post-bronchodilator FEV1 is less than 65 percent of predicted.
- You have other lung diseases such as emphysema, vocal cord dysfunction, mechanical upper airway obstruction, cystic fibrosis or uncontrolled obstructive sleep apnea.
- You needed to use your short acting bronchodilator more than 12 puffs per day in the 2 days before your bronchial thermoplasty procedure.
- You are steroid dependent and require oral corticosteroids like prednisone at a dose of more of 10 milligrams per day.
- You have other medical conditions that could increase the risk of complications including insulin dependent diabetes, epilepsy, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension.
- You have had an asthma admission that required the intensive care unit or intubation in the last 2 years.
- You have had 4 or more lower respiratory tract infections in the last year.
- You have had 3 or more hospitalizations for respiratory symptoms in the last year.
- You have had 4 or more asthma exacerbations that required systemic, oral steroids in the last year.
Bronchial Thermoplasty Results
The AIR2 trial demonstrated that patients treated with bronchial thermoplasty had a number of significant clinical improvements including related to their asthma:
- Improved quality of life
- 32% reduction in asthma attacks
- 84% reduction in emergency room visits
- 73% reduction in hospitalizations
- 66% reduction in loss days from school and work
Other studies of the Alair® Bronchial Thermoplasty System have demonstrated no deterioration in FEV1 and a stable, long term safety profile. Clinical trial evidence demonstrates 5 years of safety without pneumothorax, intubation, mechanical ventilation, cardiac arrhythmias, or death as a result of bronchial thermoplasty treatment.
While there were some increases in respiratory symptoms immediately following the procedure, there were similar to what one would expect following bronchoscopy in an asthma patient.
"Approval of the Alair System for bronchial thermoplasty will enable clinicians to provide a much needed treatment option to their patients with severe asthma," according to Mario Castro, MD, principal investigator of the AIR2 Trial, in a Asthmatx press release. "These are patients who, despite receiving high levels of asthma medications, continue to suffer from asthma attacks, which often result in emergency room visits and impose significant limitations on their daily activities. Bronchial thermoplasty offers these patients an important new way to control their disease."
"After more than a decade of careful research and four separate clinical studies, the FDA approval marks the final step in bringing this first-of-its-kind treatment option to patients with an unmet medical need," said Glen French, CEO of Asthmatx. "We look forward to continuing to work closely with asthma and pulmonary experts to address the needs of patients with this debilitating disease."
ASTHMATX, Inc. Accessed November 23, 2011. About Bronchial Thermoplasty.