Patient Contacts Practice

PATIENT MANAGEMENT FLOW CHART

Patient from Internal Data Base or External Referral Physician

Initial Patient Qualification

Does not meet Qualification

Meets Initial Qualification

Appt w/ Bronchoscopist PFT/ P&H/Stability

Does not meet Indication

RESPONSIBILITY
Practice Hospital Meets Indication Communicate with Referral Physician

Bronchoscopist PreAuthorization (Practice/TRG) Denial

Approval

Appeal (Practice/TRG) )

Assess Patient Stability

Postpone Procedure

Patient Stable: Schedule/Confirm Procedure

Office Visit @ 2 Weeks Post-Op

Patient Prescribed OCS

Patient Unstable

3 Days Pre-Procedure:
Assess Patient Stability Reminder to take Prescribed OCS

Day of Procedure Assess Patient Stability

BT Procedure

Communicate with Referral Physician

Post Op Assessment

Patient Unstable

Hospital Admittance

Patient Stable: Discharged

Post-Op Day 7 F/U Phone Call

Post-Op 48 Hrs F/U Phone Call

Post-Op 24 Hrs F/U Phone Call

PATIENT SELECTION
INDICATION The Alair Bronchial Thermoplasty System is indicated for: Patients with severe persistent asthma who are not well controlled despite treatment with inhaled corticosteroids and long acting beta2 agonists. Patients 18 years and older

CONTRAINDICATIONS Patients with the following conditions should not be treated: Known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepine) Presence of an internal pacemaker or other implantable devices Patients previously treated with the Alair System in the same area

Patients with the following conditions should not be treated while the following are present: Active respiratory infection Asthma exacerbation or changing dose of systemic corticosteroids for asthma (up or down) in the past 14 days Coagulopathy Inability to stop taking anticoagulants or antiplatelet agents, aspirin or NSAIDS before the procedure.

PRECAUTIONS Caution should be taken in patients with the following conditions due to a potential increased risk of adverse events that may be associated with the procedure Post-bronchodilator FEV1 < 65% predicted Other respiratory diseases including emphysema, vocal cord dysfunction, mechanical upper airway obstruction, cystic fibrosis or uncontrolled obstructive sleep apnea Use of short acting bronchodilator in excess of 12 puffs per day within 48 hours of bronchoscopy (excluding prophylactic use for exercise) Use of oral corticosteroids in excess of 10 mg per day for asthma. Increased risk for adverse events associated with bronchoscopy or anesthesia, such as, pregnancy, insulin dependent diabetes, epilepsy or other significant co-morbidities, such as uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension. Intubation for asthma or ICU admission for asthma within the prior 24 months Any of the following within the past 12 months: o Four or more lower respiratory tract infections (LRTI) o Three or more hospitalizations for respiratory symptoms o Four or more oral corticosteroid pulses for asthma exacerbation

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PRE-OPERATIVE PATIENT OCS PREPARATION

Prescribe prophylactic prednisone or equivalent at a dosage of 50 mg/day for each of 3 days before the procedure, day of the procedure and day after procedure to minimize post procedure inflammation

PRE- OPERATIVE PATIENT STABILITY

Patients MUST BE STABLE to undergo bronchoscopy. Postpone bronchial thermoplasty procedure if any of the following conditions are present: Active respiratory infection Asthma exacerbation or changing dose of systemic corticosteroids for asthma (up or down) in the past 14 days Coagulopathy Inability to stop taking anticoagulants or antiplatelet agents, aspirin or NSAIDS before the procedure. Failure to take prescribed pre-operative prednisone for three days before the procedure

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Mayse et al, J Bronchology and Interventional Pulmonology 14: 115-123

PATIENT ASSESSMENT DAY OF PROCEDURE

Perform post-bronchodilator (BD) FEV1 for later comparison to post-procedure FEV1. Re-evaluate patient and ensure that patient remains a good candidate for BT. Postpone the procedure for any of the following reasons: Prescribed prednisone (50 mg) or equivalent was not taken for three days before bronchoscopy SpO2 less than 90% on room air Increase in asthma symptoms in last 48 hrs requiring more than 4 puffs/d on average of rescue bronchodilator over pretreatment usage Less than 14 days from completion of a course of oral corticosteroid use for an exacerbation of asthma Postbronchodilator FEV1 is less than 85% of pretreatment value Active respiratory infection, active allergic sinusitis, or other clinical instability Physician feels for any reason the treatment should be postponed
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Mayse et al, J Bronchology and Interventional Pulmonology 14: 115-123

BT PROCEDURE-PATIENT MANAGEMENT PROTOCOL

Follow all patient management protocols according to staffing, training and individual institution specific policies and guidelines for bronchoscopy. The following are recommendations unless specified as required PRE-PROCEDURE MEDICATIONS SteroidPrednisone 50-mg IV or equivalent (required) Albuterol nebulizer2.5 to 5.0mg or 4 to 8 puffs with a metered dose inhaler Antisialogogueglycopyrrolate 0.2 to 0.4-mg IV/IM or atropine 0.6 mg IM Anxiolyticmidazolam 1 to 2-mg IV prn Preemptive analgesiafentanyl 25 to 50 mg IV prn SUPRAGLOTTIC TOPICAL ANESTHESIA 1% lidocaine jelly to nostril being used Consider oxymetazoline 0.05% or phenylephrine 0.25% spray to prevent epistaxis 2% Lidocaine gargle 5mL then expectorate or 2% lidocaine nebulized200 mg maximum VOCAL CORD & SUBGLOTTIC TOPICAL ANESTHESIA 1 to 2% lidocaine (2 to 10 mL) at vocal cords 1% lidocaine2mL aliquots in airways to be treated. Maximum lidocaine dose 600mg or 8 mg/kg Consider reapplication of topical anesthesia at 30 to 40 min, as needed SEDATION Anxiolysismidazolam 1 to 2-mg IV prn loading dose Incremental dose 0.5 to 1.0-mg IV q 3 to 5 min prn Analgesia/antitussivefentanyl 50 to 100-mg IV prn loading dose Incremental dose 25 to 50-mg IV q 3 to 5 min prn Antiemeticsondansetron 4 to 8-mg IV, metoclopramide 10-mg IV, promethazine 12.5-mg IV, or dexamethasone 4-mg IV

CONSIDERATIONS ON DAY OF BRONCHOSCOPY

During bronchoscopy, terminate the procedure if any of the following observations are made Airways are unusually edematous or inflamed Extensive and/or prolonged bronchoconstriction Airways accessed in previous bronchoscopy session do not seem to be sufficiently healed Presence of purulent or abnormally tenacious sputum or mucus plugging Inability to access airways because of excessive secretions, excessive coughing, or tortuous anatomy Physician feels for any reason that the treatment should be terminated
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Mayse et al, J Bronchology and Interventional Pulmonology 14: 115-123

POST PROCEDURE PATIENT ASSESSMENT

Follow institutional guidelines for post procedure care. Patients should be monitored and discharged only after they are deemed to be stable. Key post procedure assessments after BT include: 2 to 4-hour recovery/monitoring period following each procedure Spirometry, breath sounds, and vital signs (heart rate, blood pressure, temperature, respiratory rate, pulse oximetry) before discharge Verify patient has gag reflex and is able to take liquids Discharge if post-bronchodilator FEV1 is within 80% of the pre-procedure value and patient is feeling well Remind patient to take prophylactic prednisone or equivalent (50 mg) the day following bronchoscopy. Caution patient about the potential adverse events that they might experience after Bronchial Thermoplasty. These can include: Worsening of asthma symptoms Upper and lower respiratory tract infections Hemoptysis Fever, cough Acute Sinusitis Anxiety, headaches Throat pain or irritation Chest pain These effects typically occur within a day of the procedure and resolve on average within a week with standard care. Patients should be advised to consult their physician if they experience any adverse events, or asthma symptoms that are not controlled by their reliever medications.
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Mayse et al, J Bronchology and Interventional Pulmonology 14: 115-123

POST PROCEDURE FOLLOW-UP REQUIREMENTS

Verify prophylactic use of prednisone (50 mg) or equivalent the day following bronchoscopy Contact patient via phone calls 24 hours, 48 hrs, and 7 days to assess post procedure status Follow up with referring physician regarding patient status post-procedure Office visit at 2 to 3 wk to assess FEV1 and schedule subsequent bronchial thermoplasty procedures as appropriate Follow-up visits for long-term monitoring of improvement of asthma status as needed

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Mayse et al, J Bronchology and Interventional Pulmonology 14: 115-123