Complements asthma therapy NOT a CURE for Severe. Non pharmacologic treatment of asthma. limits the ability of the airways to constrict.

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1 Bronchial Thermoplasty Karla Provost Pulmonary and Critical Care Medicine 2015 What is Bronchial Thermoplasty Non pharmacologic treatment of asthma Outpatient procedure performed over 3 treatment sessions by a trained physician Delivers thermal energy to the airways via a bronchoscope to reduce airway smooth muscle limits the ability of the airways to constrict. Complements asthma therapy NOT a CURE for Severe Asthma increase the level of asthma control and improve quality of life Objectives 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 Severe Persistent Asthma? ERS/ATS 2014 Guidelines: Severe asthma is defined as 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 asthma 1 ERS = European Respiratory Society ATS = American Thoracic Society 1. Chung KF, et al. Eur Respir J Feb;43(2):

2 Airway smooth muscle constriction during an asthma attack Normal Airway Asthmatic Airway Asthma Attack Ref: ENDO AB Overall: Severe Persistent Asthma 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. 5 $4,800 Severe Higher healthcare costs with asthma severity2 Est. $56B total cost of asthma1 $2,200 Moderate 8 6 Patients with exacerbations have higher health care costs than patients without exacerbations3 Hospitalizations Emergency Room (ER) visits Increased healthcare utilization $12,800 Higher Cost of Severe Asthma (U.S.) $12,000 $10,000 $8,000 $6,000 $4,000 $2,000 Mild Case Study (BT) 1. Barnett SBL, et al. Costs of asthma in the United States: J Allergy Clin Immunol 2011;127: 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): American Lung Association, Trends in Asthma Morbidity and Mortality, February 2010 report. Cost/Patient/Year

3 BT girl 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 puffs BID, Albuterol nebs and short acting inhaler How is Bronchial Thermoplasty performed? BT girl 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. BT Reduces Excess Airway Smooth Muscle (ASM) 1 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:

4 The Alair System 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 Alair Radiofrequency (RF) Controller designed to safely and accurately deliver precise, controlled RF energy through the Catheter to the airway walls BT Completed in 3 Outpatient Procedures BT is performed by a BT-certified pulmonologist in 3 outpatient visits, typically scheduled 3 weeks apart BT, Delivered by the Alair System The Catheter 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. 14

5 How it is performed at Essentia Consult with all candidates/referrals in pulmonary outpatient office prior to approval. Evaluated for Asthma and other diagnoses. Labs, CXR, PFTs, record review, history. If meets all criteria then await insurance approval. Pre-op, PACU and Discharge care 19 Adverse events: Asthma exacerbation/wheezing Sore throat Atelectasis Hemoptysis Respiratory tract infection Pre-procedure All patients receive prophylactic prednisone (50mg/day) for 5 days (3 days before, day of, and day after procedure) 20

6 Procedure Overview Pre-op/day of procedure- Activate anesthesia order set: Vitals, saline lock, cath, pulse ox, etc... Lung function 80% of known outpatient baseline FEV¹ values. OR General Anesthesia- OR RN or tech perform airway mapping documentation Diagnostic Bronch ~ 1 hr. Extubated post procedure and sent to PACU PACU- Patient monitored 2-4 hrs. post-op and discharge home same day Lung function stable 80% of pre-procedure post-bd FEV¹ Who are the Right Patients for BT? Who qualifies for BT? Post-Procedure/Patient Follow Up Patient contacted via phone at 1, 2 and 7 days to assess post procedure status Office visit at 4 weeks to assess clinical stability and schedule subsequent BT procedures as appropriate After BT treatment, patient returns to primary asthma physician for ongoing asthma management Patient evaluated for step-down therapy to determine lowest level of medication necessary to maintain asthma control Who qualifies for BT? Patients with: Diagnosed severe persistent asthma 18 years and older Not well controlled with adherence to inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) 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. 22

7 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 COPD/emphysema Patients that have previously been treated with the Alair System Reference the Alair Bronchial Thermoplasty System Directions for Use for more information. High Patient Satisfaction with BT 97% of BT patients would probably or definitely recommend BT to a friend or family member Data on file. Reported at 1 year follow-up 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. 26 Overall - Proven clinical benefits In a clinical study of patients with severe asthma, patients treated with BT experienced: 32% decrease in severe asthma attacks 1 84% reduction in asthma-related emergency room visits 1 66% fewer days lost from work, school, and daily activities due to asthma 1 Additionally: 79% of patients treated with BT saw a significant improvement in their asthma-related quality of life. 1 Maintained effects at 5 years Castro, Am J Respir Crit Care Med. 2010;181(2): Ref: ENDO AA

8 Summary: Definition of BT and Severe Persistent Asthma What is BT How is it performed 3 sessions, outpatient Criteria to qualify, contraindications, adverse events Clinical trial results Decreased ER/UC visit, improved quality of life, less prednisone usage over a year, less days lost from school/work. Back to our patient 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 Domestic US BT Centers 12/2014 Here with you

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