1. Bronchial Thermoplasty Karla Provost Pulmonary and Critical Care Medicine 2015

2. 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

3. 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

4. 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. 2014 Feb;43(2):343-73. 4

5. Airway smooth muscle constriction during an asthma attack Asthmatic Airway Normal Airway Asthma Attack Ref: ENDO-15402-AB 5

6. Mild ModerateSevere $12,800 $4,800 $2,200 Cost/Patient/Year 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. $4,000 $2,000 $6,000 $8,000 $10,000 $12,000 Increased healthcare utilization Emergency Room (ER) visits Hospitalizations Higher Cost of Severe Asthma (U.S.) Higher healthcare costs with asthma severity 2 6 Patients with exacerbations have higher health care costs than patients without exacerbations 3 Est. $56B total cost of asthma 1

7. 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.

8. Case Study (BT) 8

9. 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 200 2 puffs BID, Albuterol nebs and short acting inhaler

10. 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.

11. How is Bronchial Thermoplasty performed?

12. BT Reduces Excess Airway Smooth Muscle (ASM) Reduce Airway Smooth Muscle (ASM) Reduce Bronchoconstriction Reduce Asthma Exacerbations Improve Asthma Quality of Life 12 1.Woodruff PG, et al. Am J Respir Crit Care Med. 2004;169:1001-1006. 1

13. 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 13

14. BT, Delivered by the Alair™ System 14

15. BT Completed in 3 Outpatient Procedures BT is performed by a BT-certified pulmonologist in 3 outpatient visits, typically scheduled 3 weeks apart. 15

16. 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.

17. 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.

18. Adverse events:  Asthma exacerbation/wheezing  Sore throat  Atelectasis  Hemoptysis  Respiratory tract infection

19. Pre-op, PACU and Discharge care 19

20. Pre-procedure  All patients receive prophylactic prednisone (50mg/day) for 5 days (3 days before, day of, and day after procedure) 20

21. 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 21

22. 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 22

23. Who are the Right Patients for BT? 23 Who qualifies for BT?

24.  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.

25. 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. 25

26. 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

27. High Patient Satisfaction with BT  97% of BT patients would “probably” or “definitely” recommend BT to a friend or family member. 1 1.Data on file. Reported at 1 year follow-up. 27

28. 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. 1. Castro, Am J Respir Crit Care Med. 2010;181(2):116-24. Ref: ENDO-144502-AA 28

29. 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.

30. 350 Domestic US BT Centers 12/2014

31. 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  http://www.wdio.com/article/stories/s3608951.shtml http://www.wdio.com/article/stories/s3608951.shtml

32. Here…with you

33. Questions?