2. )Role of Airway Smooth Muscle (ASM
There is typically an increase in the amount of airway
smooth muscle in the lungs of patients with asthma.
This increased airway smooth muscle mass has the
potential to increase airway responsiveness and
constriction in response to external stimuli, such as
dust, allergens, cold air or stress.
The excessive and inappropriate constriction of airway
smooth muscle is recognized as a predominant feature
of asthma, and therefore makes the airway smooth
muscle a key target for drug therapy
3. Role of Airway Smooth Muscle (ASM)
Although current medications are reasonably
successful in controlling inflammation and
contraction of airway smooth muscle in the majority
of patients with asthma.
some patients with severe persistent asthma continue
to suffer from excessive bronchoconstriction that is
integral to an asthma “attack” (exacerbation).
Reduction of airway smooth muscle helps reduce the
ability of the airways to narrow in response to a
trigger, thereby providing a therapeutic benefit for
patients with severe asthma.
4. The Procedure
Bronchial thermoplasty is delivered by the Alair®
System and is performed in three outpatient procedure
visits, each scheduled approximately three weeks
apart. The first procedure treats the airways of the
right lower lobe, the second treats the airways of the
left lower lobe and the third and final procedure
treats the airways in both upper lobes. After all three
procedures are performed the bronchial thermoplasty
treatment is complete.
5. The Procedure
The patients prepped and placed under moderate
sedation.“conscious sedation”.
A standard flexible bronchoscope is introduced into
the bronchial tree through either nose or the mouth,
and the Alair® Catheter is introduced into airways
through the bronchoscope.
6. The Procedure
The bronchoscope is then navigated to the first target
treatment site, typically the most distal airway in the
targeted lobe.
BT is delivered by the Alair® System, which is
comprised of an Alair® Catheter and an Alair®
Controller.
7. The Procedure
Once the Alair® Catheter is positioned at the desired
location of airway, the electrode array at the tip of the Alair®
Catheter is expanded to contact airway wall; the physician
activates the Alair® Radiofrequency (RF) Controller to
deliver RF energy through the Alair® Catheter to 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 airways in a controlled manner.
The application of heat to the airway wall is intended to
reduce the amount of excessive airway smooth muscle
present in the airways and limit its ability to contract and
narrow the airway.
8. The Procedure
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 airway. This
technique is used in all of accessible airways distal to the
mainstem bronchi and ≥ 3 mm in diameter. The Alair®
Catheter is deployed from the distal to the proximal end of
airway being treated. This process is repeated in all of
airways that are accessible and planned for that
bronchoscopy session.
9. The Procedure
BT is delivered by the Alair® System, which is
comprised of an Alair® Catheter and an Alair®
Controller.
Once the Alair® Catheter is positioned at the desired
location of airway, the electrode array at the tip of the
Alair® Catheter is expanded to contact airway wall; the
physician activates the Alair® Radiofrequency (RF)
Controller to deliver RF energy through the Alair®
Catheter to airway wall.
10. SystemAlairThe
Alair® Catheter
The Alair® Catheter is a single-use device designed to
be delivered through the working channel of a
standard bronchoscope.
Expandable electrode array with four 5 mm electrodes
that deliver RF energy to airways ≥ 3 mm in diameter
and distal to main stem bronchi
Requires ≥ 2.0 mm working channel diameter
standard high-frequency compatible flexible
bronchoscope
11.
12. SystemAlairThe
Designed with proprietary control parameters and
algorithms to deliver the correct intensity and
duration of thermal energy sufficient to reduce
excess ASM, while limiting long-term impact to
surrounding tissues
13.
14. (Indication for Use)
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.
15. (Contraindications)
• An implant with electronic such as a pacemaker.
BT may keep the implant from working correctly.
• Problems taking certain medicines.
needs to make sure the medicine he or she uses
will not hurt you.
16. )(Contraindications
Have had this treatment before.
• You cannot have this treatment if you are less
than 18 years old. No one has tested BT in patients
younger than 18 y
• An active respiratory infection.
17. Contraindications)(
• Have had an asthma attack or changed oral
corticosteroid dose in the last 2 weeks. BT may
harmfull.
• A blood clotting problem.
18. Preparation of patients
You will prepare for each treatment by taking a 50-
mg steroid pill by mouth once a day for 3 days
before the treatment.
• You will also take a 50-mg steroid pill on the day
of the treatment.
• On each BT treatment day, pulmonary function
test must be done.
19. What are the benefits of bronchial
thermoplasty
32% reduction in asthma attacks
84% reduction in emergency room visits for respiratory
symptoms
66% reduction in days lost from work, school, or other
daily activities due to asthma symptoms
73% reduction in hospitalizations for respiratory symptoms
These benefits were observed during clinical studies where
patients continued to take their standard maintenance
asthma medications which included combinations of
inhaled corticosteroids and long-acting bronchodilators
20. Are there any post-procedure
complications?
Adverse events (whether considered procedure-related
or not procedure-related by the investigator) occurring
with ≥ 3% incidence that were more common in the
Alair® group are presented for 288 patients in
22. yProcedure Availabilit
The Alair® Bronchial Thermoplasty System was
approved in April 2010 by the Food & Drug
Administration (FDA) for the treatment of severe
asthma in adults.