Bronchial Thermoplasty

Bronchial ThermoplastyKarla ProvostPulmonary and Critical Care Medicine2015ObjectivesBT definedWhat is Severe Persistent Asthma Case Study introductionHow is BT performedPre-op, PACU and Discharge careWho does it work for the criteria for BTBrief overview of BT resultsCase Study completionSummaryWhat is Bronchial ThermoplastyNon pharmacologic treatment of asthmaOutpatient procedure performed over 3 treatment sessions by a trained physicianDelivers thermal energy to the airways via a bronchoscope to reduce airway smooth musclelimits the ability of the airways to constrict. Complements asthma therapy NOT a CURE for Severe Asthmaincrease the level of asthma control and improve quality of life

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 populationestimated to have severe asthma1ERS = European Respiratory SocietyATS = American Thoracic Society

Chung KF, et al. Eur Respir J. 2014 Feb;43(2):343-73.4Based on recent severe asthma guidelines issued by a Task Force supported by the European Respiratory Society and American Thoracic Society, the definition of severe asthma is shown on this slide.Note that this classification of asthma severity has evolved from a criteria based only on symptoms, airflow limitation and lung function variability to a classification based on the level and intensity of treatment required to control symptoms and exacerbations.The prevalence of severe asthma is not fully understood, however 510% of the total asthma population are often estimated.4Airway smooth muscle constriction during an asthma attack

Asthmatic Airway

Normal Airway

Asthma AttackRef: ENDO-15402-AB5There are muscles in the walls of your airways called Airway Smooth MusclePeople who have asthma have more airway smooth-muscle tissue surrounding their airways than people who dont have asthmaDuring an asthma attack, this excess tissue constricts the airways, making it harder to breatheWhen the airways narrow you may feel shortness of breath, chest tightness, wheezing, and coughAsthma medicines help open up the airways, but may not always work well in people who have severe asthma5Mild

ModerateSevere$12,800$4,800$2,200Cost/Patient/YearBarnett SBL, et al. Costs of asthma in the United States: 20022007. J Allergy Clin Immunol 2011;127:14552.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.American Lung Association, Trends in Asthma Morbidity and Mortality, February 2010 report.$4,000$2,000$6,000$8,000$10,000$12,000Increased healthcare utilizationEmergency Room (ER) visitsHospitalizationsHigher Cost of Severe Asthma (U.S.)Higher healthcare costs with asthma severity26Patients with exacerbations have higher health care costs than patients without exacerbations3Est. $56B total cost of asthma16Asthma also has a significant financial impact, which increases with asthma severity.In 2007, the estimated cost of asthma in the U.S. was $56 billion in direct costs and productivity losses.[Click for animation] As the severity of asthma increases, as shown by this graph, there is an exponential increase in the cost per patient associated with increased morbidity and utilization of healthcare resources. So interestingly, while severe asthma patients comprise a smaller percentage of the total asthma population, they confer the highest economic burden in asthma.And these costs continue to increase for patients who experience asthma exacerbations.Therefore, maintaining asthma control and reducing the risk of exacerbations are important goals in managing patients with severe asthma.Overall: Severe Persistent AsthmaCan have normal spirometryUsing high dose ICS + additional controlling medicationLimited by symptoms despite therapy.Frequent use of prednisoneFrequents the UC/ER, doctors visits.Consider BT.Case Study (BT)

8In this section on Bronchial Thermoplasty Delivered by the Alair System, we provide an overview on what BT is and how it works.8BT girl20 y/o FAsthma since birth, aspirated meconiumNasal polyps, ASA sensitivityFor 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 inhalerBT girlUsing 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 ExcessAirway Smooth Muscle (ASM)Reduce Airway Smooth Muscle (ASM)Reduce BronchoconstrictionReduce Asthma ExacerbationsImprove Asthma Quality of Life12Woodruff PG, et al. Am J Respir Crit Care Med. 2004;169:1001-1006.

112BT works by reducing excess airway smooth muscle (or ASM) in the airways.The first cross-section on the left shows the thickness of ASM in a normal airway compared to an increased ASM thickness in an asthma airway shown in the center. The third cross-section depicts the reduction in excess smooth muscle after BT.Note that the inner airway diameter is not changed as BT does not work as a bronchodilator.[Click for animation] Instead, the reduction in excess airway smooth muscle reduces the ability of the airway to constrict, resulting in reduced asthma exacerbations and improved asthma-related quality of life for severe asthma patients.Fewer asthma exacerbations also means reduced need for the associated oral steroid treatment and its side effects.Research is ongoing to evaluate other potential mechanism(s) of action. .The Alair SystemAlair Catheter a flexible tube with an expandable wire array at the tip to deliver therapeutic RF energy to the airway walls via a standard bronchoscopeAlair Radiofrequency (RF) Controller designed to safely and accurately deliver precise, controlled RF energy through the Catheter to the airway walls

1313BT is performed using the Alair System, which is comprised of the Alair Catheter and the Alair Radiofrequency (RF) Controller.The Alair Catheter is a sterile, single-use, disposable device with an expandable wire electrode array at the tip to deliver therapeutic RF energy to the airways via a standard flexible bronchoscope.The Alair RF Controller supplies monopolar RF energy to the catheter. The controller is designed with a proprietary set of control parameters and algorithms to safely and accurately deliver the correct intensity and duration of RF energy needed to reduce airway smooth muscle tissue. The energy delivery is designed to limit long-term impact to surrounding tissues.BT, Delivered by the Alair System

14[Video will start automatically]This video animation illustrates the BT procedure.The Alair Catheter is introduced into the lungs through the working channel of a flexible diagnostic bronchoscope.Under direct visualization, the Catheter is advanced in to the airway, the wire electrode array is expanded to touch the airway wall, and controlled RF energy is delivered for about 10 seconds per activation.Activations are performed from distal to proximal.After each activation, the electrode array is collapsed and the Alair Catheter is repositioned and subsequent activations are performed in 5mm contiguous segments along the airway (adjacent but not overlapping). The goal is to treat all accessible airways between 3-10 mm in diameter (5-6 generations depending on individual patient anatomy and size).14BT Completed in 3 Outpatient Procedures

BT is performed by a BT-certified pulmonologist in 3 outpatient visits, typically scheduled 3 weeks apart.1515BT is performed by a BT-certified pulmonologist and is completed in 3 separate outpatient procedures to treat different areas of the lung as illustrated by the image. Each procedure is typically scheduled 3 weeks apart.In the 1st procedure, BT is performed on the airways in the lower right lobe. Approximately 3 weeks later, the 2nd procedure is performed in the lower left lobe. Another 3 weeks after that, the 3rd and final procedure is performed on both upper lobes.For safety, BT is performed in 3 separate procedures so the entire lung is not treated at once, and procedure time can be kept to less than an hour. The CatheterDoes it get hot? NoIt 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 EssentiaConsult 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.Adverse events:Asthma exacerbation/wheezingSore throatAtelectasisHemoptysisRespiratory tract infection

Pre-op, PACU and Discharge care

19In this section on Bronchial Thermoplasty Delivered by the Alair System, we provide an overview on what BT is and how it works.19Pre-procedure All patients receive prophylactic prednisone (50mg/day) for 5 days (3 days before, day of, and day after procedure)

2020This slide outlines the patient follow up after the BT procedure.It should be noted that the BT treating physician will manage the BT patient throughout the BT treatment period and immediately after each procedure.This includes contacting the patient by phone at 1, 2 and 7 days post-op to assess their post procedure status.At 2 to 3 weeks, the patient comes in for an office visit to assess clinical stability and schedule their next BT procedure as appropriate.After the BT treatment period and all 3 procedures are completed, the patient is instructed to return to their primary asthma physician for ongoing asthma management and assessment for potential adjustment in their medication needs. Procedure OverviewPre-op/day of procedure- Activate anesthesia order set: Vitals, saline lock, cath, pulse ox, etc...Lung function 80% of known outpatient baseline FEV values.OR General Anesthesia- OR RN or tech perform airway mapping documentationDiagnostic Bronch ~ 1 hr.Extubated post procedure and sent to PACUPACU-Patient monitored 2-4 hrs. post-op and discharge home same dayLung function stable 80% of pre-procedure post-BD FEV2121This slide outlines the patient follow up after the BT procedure.It should be noted that the BT treating physician will manage the BT patient throughout the BT treatment period and immediately after each procedure.This includes contacting the patient by phone at 1, 2 and 7 days post-op to assess their post procedure status.At 2 to 3 weeks, the patient comes in for an office visit to assess clinical stability and schedule their next BT procedure as appropriate.After the BT treatment period and all 3 procedures are completed, the patient is instructed to return to their primary asthma physician for ongoing asthma management and assessment for potential adjustment in their medication needs. Post-Procedure/Patient Follow UpPatient contacted via phone at 1, 2 and 7 days to assess post procedure statusOffice visit at 4 weeks to assess clinical stability and schedule subsequent BT procedures as appropriateAfter BT treatment, patient returns to primary asthma physician for ongoing asthma managementPatient evaluated for step-down therapy to determine lowest level of medication necessary to maintain asthma control2222This slide outlines the patient follow up after the BT procedure.It should be noted that the BT treating physician will manage the BT patient throughout the BT treatment period and immediately after each procedure.This includes contacting the patient by phone at 1, 2 and 7 days post-op to assess their post procedure status.At 2 to 3 weeks, the patient comes in for an office visit to assess clinical stability and schedule their next BT procedure as appropriate.After the BT treatment period and all 3 procedures are completed, the patient is instructed to return to their primary asthma physician for ongoing asthma management and assessment for potential adjustment in their medication needs. Who are the Right Patients for BT?23Who qualifies for BT?In this section on Who are the Right Patients for BT?, we discuss the patient selection considerations for BT. The speakers personal patient experience with BT and actual outcomes can also be shared here if applicable.23Who 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 yearImpaired quality of lifeDespite Anti IgE, Immunotherapy