Transcript Bronchial Thermoplasty

Bronchial Thermoplasty
Karla Provost
Pulmonary and Critical Care Medicine
2015
Objectives
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BT defined
What is Severe Persistent Asthma
Case Study introduction
How is BT performed
Pre-op, PACU and Discharge care
Who does it work for – the criteria for BT
Brief overview of BT results
Case Study completion
Summary
What is Bronchial Thermoplasty
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Non pharmacologic treatment of asthma
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Delivers thermal energy to the airways via a
bronchoscope to reduce airway smooth muscle
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Outpatient procedure performed over 3 treatment sessions by
a trained physician
limits the ability of the airways to constrict.
Complements asthma therapy NOT a CURE for Severe
Asthma
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increase the level of asthma control and improve quality of life
What is Severe Persistent Asthma?
ERS/ATS 2014 Guidelines:
 Severe asthma is defined as
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‘‘asthma which requires treatment with high dose inhaled
corticosteroids (ICS) plus a second controller (and/or systemic
corticosteroids) to prevent it from becoming ‘uncontrolled’ or which
remains ‘uncontrolled’ despite this therapy.’’1
5%-10% of total asthma population
estimated to have severe asthma1
ERS = European Respiratory Society
ATS = American Thoracic Society
1. Chung KF, et al. Eur Respir J. 2014 Feb;43(2):343-73.
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Airway smooth muscle constriction
during an asthma attack
Normal Airway
Asthmatic
Airway
Asthma Attack
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Ref: ENDO-15402-AB
Higher Cost of Severe Asthma (U.S.)
Higher healthcare costs with asthma severity2
Cost/Patient/Year
$12,000
$12,800
Est. $56B
total cost of asthma1
Increased healthcare
utilization
Emergency Room (ER) visits
$10,000
Hospitalizations
$8,000
Patients with exacerbations
have higher health care costs
than patients without
exacerbations3
$6,000
$4,000
$2,000
$4,800
$2,200
Mild
Moderate
Severe
1. Barnett SBL, et al. Costs of asthma in the United States: 2002–2007. J Allergy Clin Immunol 2011;127:145–52.
2. Cisternas M, et al., A comprehensive study of the direct and indirect costs of an adult with asthma. J Allergy
Clin Immunol 2003;111(6):1212-1218.
3. American Lung Association, Trends in Asthma Morbidity and Mortality, February 2010 report.
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Overall: Severe Persistent Asthma
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Can have normal spirometry
Using high dose ICS + additional controlling medication
Limited by symptoms despite therapy.
Frequent use of prednisone
Frequents the UC/ER, doctors visits.
Consider BT.
Case Study (BT)
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BT girl
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20 y/o F
Asthma since birth, aspirated meconium
Nasal polyps, ASA sensitivity
For the last 6 months has had 3 flares of asthma requiring
prednisone.
Current meds: Singulair, BID Claritin, BID Flonase, PPI.
Dulera 200 2 puffs BID, Albuterol nebs and short acting
inhaler
BT girl
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Using albuterol inhaler 2-3 times per day, anytime she
ambulates, 2-3 times per night.
Prednisone tapers monthly for the last 4 months
Gained 50 lbs. in the last 6 months.
Never been able to run, afraid to be alone due to asthma
symptoms, mobility limited due to SOB.
Referred to you for further asthma management.
How is Bronchial Thermoplasty performed?
BT Reduces Excess
Airway Smooth Muscle (ASM)
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Reduce Airway
Smooth Muscle
(ASM)
Reduce
Bronchoconstriction
Reduce Asthma
Exacerbations
Improve
Asthma
Quality of Life
1. Woodruff PG, et al. Am J Respir Crit Care Med. 2004;169:1001-1006.
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The Alair™ System
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Alair Catheter – a flexible tube
with an expandable wire array at
the tip to deliver therapeutic RF
energy to the airway walls via a
standard bronchoscope
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Alair Radiofrequency (RF)
Controller – designed to safely
and accurately deliver precise,
controlled RF energy through the
Catheter to the airway walls
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BT, Delivered by the Alair™ System
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BT Completed in 3 Outpatient
Procedures
BT is performed by a BT-certified pulmonologist in 3 outpatient
visits, typically scheduled 3 weeks apart.
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The Catheter
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Does it get hot? No
It uses impedance of the radio waves (RFA) at the level of
the smooth muscle and creates heat only at the muscle
level.
Catheter itself heats to 65C – 149F for 10 seconds OR
120 joules which ever comes first.
How it is performed at Essentia
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Consult with all candidates/referrals in pulmonary
outpatient office prior to approval.
Evaluated for Asthma and other diagnoses.
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Labs, CXR, PFTs, record review, history.
If meets all criteria then await insurance approval.
Adverse events:
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Asthma exacerbation/wheezing
Sore throat
Atelectasis
Hemoptysis
Respiratory tract infection
Pre-op, PACU and Discharge care
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Pre-procedure
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All patients receive prophylactic prednisone (50mg/day) for 5 days
(3 days before, day of, and day after procedure)
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Procedure Overview
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Pre-op/day of procedure
Activate anesthesia order set: Vitals, saline lock, cath, pulse ox, etc.…..
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Lung function ≥ 80% of known outpatient baseline FEV¹ values.
OR General Anesthesia
OR RN or tech perform airway mapping documentation
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Diagnostic Bronch ~ 1 hr.
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Extubated post procedure and sent to PACU
PACU
Patient monitored 2-4 hrs. post-op and discharge home same day
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Lung function stable ≥ 80% of pre-procedure post-BD FEV¹
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Post-Procedure/Patient Follow Up
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Patient contacted via phone at 1, 2 and 7 days to assess post
procedure status
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Office visit at 4 weeks to assess clinical stability and schedule
subsequent BT procedures as appropriate
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After BT treatment, patient returns to primary asthma
physician for ongoing asthma management
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Patient evaluated for step-down therapy to determine lowest
level of medication necessary to maintain asthma control
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Who qualifies for BT?
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Who qualifies for BT?
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Patients with:
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Diagnosed severe persistent asthma
18 years and older
Not well controlled with adherence to inhaled corticosteroids
(ICS) and long-acting beta-agonists (LABA)
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Two or more severe exacerbations in the prior year
Impaired quality of life
Despite Anti IgE, Immunotherapy
<10 pack year smoking history, non smoker for at least 1 year.
Contraindications
BT should not be performed on:
Patients
that have a pacemaker, defibrillator, or other implantable
electronic device
Patients
that have a known sensitivity to medications required to
perform bronchoscopy, including lidocaine, atropine, and
benzodiazepines
Documented
Patients
COPD/emphysema
that have previously been treated with the Alair™ System
Reference the Alair Bronchial Thermoplasty System Directions for Use for more information.
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Contraindications
BT should be delayed for the following:
Active
respiratory infection
Asthma
attack or changing dose of systemic corticosteroids (up
or down) in the past 14 days
Known
bleeding disorder
Patient
is unable to stop taking anticoagulants, antiplatelet
agents, aspirin or non-steroidal anti-inflammatory medications
(NSAIDS) before the procedure with physician guidance
Reference the Alair™ Bronchial Thermoplasty System Directions for Use for more information.
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High Patient Satisfaction with BT
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97% of BT patients would “probably” or “definitely” recommend BT to a
friend or family member.1
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Definitely
No
Probably
No
Probably
Yes
Definitely
Yes
1. Data on file. Reported at 1 year follow-up.
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Overall - Proven clinical benefits
In a clinical study of patients with severe asthma, patients treated
with BT experienced:
32%
decrease in severe asthma attacks1
84% reduction in asthma-related emergency room visits1
66% fewer days lost from work, school, and daily activities due to
asthma1
Additionally:
79%
of patients treated with BT saw a significant improvement in their
asthma-related quality of life. 1
Maintained effects at 5 years.
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1. Castro, Am J Respir Crit Care Med. 2010;181(2):116-24.
Ref: ENDO-144502-AA
Summary:
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Definition of BT and
Severe Persistent Asthma
What is BT
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How is it performed
 3 sessions, outpatient
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Criteria to qualify,
contraindications, adverse
events
Clinical trial results
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Decreased ER/UC visit,
improved quality of life, less
prednisone usage over a
year, less days lost from
school/work.
350 Domestic US BT Centers 12/2014
Back to our patient…
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We tried multiple additional inhalers all with side effects
She started receiving allergy shots, was not a candidate
for Xolair therapy.
Underwent bronchial thermoplasty
Now on allergy controllers, moderate ICS
Ran a 5K for the first time in her life this summer.
Lost 60 lbs. since BT
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http://www.wdio.com/article/stories/s3608951.shtml
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Here…with you
Questions?