Continuing Training and Education Noninvasive Ventilation in the

Continuing Training and Education Non-invasive Ventilation in the Home A Valuable Tool in Managing COPD Readmission Mike Risko, CRT Chief Respiratory Care Confidential

Course Objectives • Identify at least four goals of home NIV • Identify candidates for home NIV therapy • Explain the use of NIV in chronic respiratory insufficiency • Understand the protocol for initiation and management of NIV Confidential

Neuro Muscular Disorder Bi. PAP AVAPS COPD BIPAP AVAPS Confidential Obesity Hypoventilation OSA Auto CPAP/ BIPAP S S Bi. PAP AVAPS Periodic. Central SDB Auto. SV

The Use of NIV in Chronic Respiratory Insufficiency Confidential

What is Chronic Respiratory Insufficiency? Chronic respiratory insufficiency is the inability to adequately provide oxygen to the cells and eliminate carbon dioxide from them. This may result from different diseases. v. Decreased Pa. O 2 (hypoxemia) v. Increased Pa. CO 2 (hypercapnia) Confidential

Consequences of Respiratory Insufficiency Ø Ø Confidential Excessive work of breathing Respiratory muscle dysfunction Inadequate alveolar ventilation Severe hypoxemia

• Treatment of chronic respiratory insufficiency with noninvasive ventilation in the home has increased over the past decade. • With the development of nasal ventilation, it has become easier, safer and more economical to provide ventilatory support within the home setting. Confidential

NIV definition • Noninvasive ventilation refers to the delivery of mechanical ventilation to the lungs using techniques that do not require an artificial airway. Confidential

Advantages of home noninvasive ventilation • • • Ease of use Reduced need for skilled caregivers Elimination of tracheostomy-related complications Improved patient comfort Allows speech, improved communication Lower overall cost of care Confidential

Goals of noninvasive ventilation • • • Relieve symptoms Reduce work of breathing Improve or stabilize gas exchange Improve duration and quality of sleep Maximize quality of life Prolong survival Nicholas Hill, Noninvasive Positive Pressure Ventilation: Principles and Applications Confidential

COPD patient <70% FEV 1/FVC <30% Mild stage Moderate stage Severe stage Mild airflow limitation Worsening airflow limitation Severe airflow limitation Drugs and pulmonary rehabilitation Long-term oxygen therapy Noninvasive ventilation As the disease progresses, hypoxemia occurs and hypercapnia is seen in advanced disease. Global Strategy for the Diagnosis, Management, and Preventation of Chronic Obstructive Pulmonary Disease Gold Scientific Committee, NHLBI/WHO workshop summary, AJRCCM 2001 Confidential

COPD patients who may benefit from NIV • Severe COPD and persistent symptoms despite medical therapy • Substantial daytime CO 2 retention Pa. CO 2 > 50 mm Hg • Hospitalization related to recurrent episodes of hypercapnic respiratory insufficiency (> 2 episodes in 1 year) • Patient using current CPAP/Bi. PAP during the day or for extended periods of time • Patient would benefit from a secondary NIV setting for daytime use with a mouth piece (Dual prescription mode with Trilogy) Confidential

Amyotrophic Lateral Sclerosis Disease information ALS or Lou Gehrig’s disease Charcot’s disease in France Incurable, fatal neuromuscular disease Confidential

ALS Lung disease § When ALS affects the neurons that control the respiratory muscles, breathing becomes strained or weak § Begins with shortness of breath during exercise or at night § 15 percent never have a breathing problem § In the past, diminished breathing was the usual cause of death. Now, there are NIV options. Living with ALS: Adapting to Breathing Changes, 1997, ALS Assoc. Confidential

ALS Lung disease during sleep u. Weakened bulbar muscles can cause closing of the airway u. Nerve and muscle functions relax during sleep causing under- ventilation • With complaints of morning headaches, lethargy, and SOB Confidential

Trilogy 100 Ø Trilogy is lightweight (11 lbs. ) and portable Ø 6 hour battery (continued therapy in power failures and mobility away from home) Ø Ability to provide dual prescriptions for separate day and nigh settings Ø Adaptability to patients changing needs Ø Targeted tidal volumes with AVAPS to help manage hypoventilation Ø Sip circuit (mouth piece) ventilation allows the patient alleviation from extended time wearing mask during the day Ø Improved quality of life Confidential

NIV Modes Featuring • AVAPS (Average Volume Assured Pressure Support) On • Reliable Bi. PAP S/T platform With • Key Synchrony features – T and PC modes – Minute ventilation alarm Confidential

Bi. PAP AVAPS is the ONLY noninvasive bi-level mode to provide guaranteed tidal volume for patients with changing respiratory needs. Combined with Auto-Trak and Direct View software, Bi. PAP AVAPS raises the bar for improved patient care Confidential

Bi. PAP AVAPS Who Benefits ØNeuromuscular Disorders ØPatients respiratory capabilities decline as the disease progresses ØAmyotrophic Lateral Sclerosis (ALS) ØDuchenne Muscular Dystrophy ØPost Polio Syndrome ØSpinal Muscular Atrophy (SMA) Confidential

Bi. PAP AVAPS Who Benefits ØRestrictive Thoracic Disorders ØPatients have a decrease in the amount of air they can take in ØKyphoscoliosis ØPulmonary Fibrosis Confidential

Bi. PAP AVAPS Who Benefits ØObstructive Lung Diseases ØPatients have a decreased amount of Expiratory Airflow ØEmphysema (COPD) ØObesity Hypoventilation Syndrome ØPatients weight inhibits them from taking deep breaths Confidential

We’re expanding the versatility of our Trilogy Series mixed-mode ventilators • Expanding ventilatory support • Expanding volume targeting • Expanding clinical control Confidential

AVAPS-AE is a auto-titration mode of noninvasive ventilation designed to better treat respiratory insufficiency patients (OHS, COPD and NMD) in the hospital and homecare environments Achieving a targeted volume is now completely automatic • Proven performance of AVAPS – Maintains targeted tidal volume • Auto EPAP – Maintains patent upper airway at comfortable pressure • Auto backup rate – Applies an auto backup rate near a patient’s resting rate Confidential 23

AVAPS-AE: Why do we need it? Confidential 24

AVAPS: proven effective • Automatically titrates pressure support – Changes in body position – Sleep stage – Changes in respiratory mechanics • Delivers average tidal volume – Within the night – Long-term progression • AVAPS produces results comparable to sleep lab titration of PS 1 – CO 2 reduction – Health-related quality of life – Sleep quality 1 Murphy, PBThorax thoraxjnl-2011 -201081: Published Online First: 1 March 2012 doi: 10. 1136/thoraxjnl-2011 -201081 Confidential 25

Bi. PAP AVAPS enhancements • Flexible – Clinicians can now select AVAPS rate of change from 1. 0 to 5. 0 cm H 2 O of pressure based on patient need • Stable Vt – AVAPS now tracks spontaneous and timed breaths separately – Applies correct amount of pressure support to each breath type • Accurate – Enhanced leak estimation algorithm in Trilogy – Better leak estimation means better Vt tracking and targeting Confidential 26

AVAPS-AE: Auto EPAP • Auto EPAP provides airway patency – Patient benefit: lower, more comfortable EPAP pressure • AVAPS-AE and patient overlap – 29% to 40% of COPD patients have OSA 1 – 90% of OHS patients have OSA 2 • AVAPS-AE: 1 st NIV therapy with Auto EPAP designed for respiratory insufficiency and respiratory failure patients 1 Jelic International Journal of COPD 2008: 3(2)269 -275 2 Mohklesi. Chest 2007: 131; 1624 -1626 Confidential 27

AVAPS-AE Maintaining tidal volume and airway patency PS max EPAP max PS min IPAP EPAP min EPAP Target Vt Resistance Confidential 28

Auto Back-up rate Auto backup rate combined with the tidal volume assurance of AVAPS provides a minimum level of ventilation • Auto backup rate is near resting rate • Comfortable assistance when needed • No manual adjustments (auto-default setting) Confidential 29

Auto backup rate: Patient comfort features • Comfort feature intent: Minimizes patient/device asynchrony – Rate will not exceed patient’s initial resting spontaneous rate – Machine breath delayed if patient is still exhaling – AVAPS-AE allows patient to terminate a machine delivered breath Confidential 30

AVAPS-AE • Proven performance of AVAPS – Confidence that tidal volume targets are being met • Auto EPAP – Auto adjusting EPAP to meet changing patient needs – Maintains a patent airway • Auto backup rate – Maintains a breath rate designed for patient comfort (easy to use) Confidential 31

Expanding ventilatory support Mouthpiece ventilation (MPV) MPV is a form of volume ventilation whereby the patient’s normal state is disconnected from the ventilator and the patient initiates a breath, as needed, through an oral interface. Confidential

What type of patient could benefit from MPV? • Conditions with respiratory muscle dysfunction Ø Muscular dystrophies Ø ALS Ø Other myopathies: acid maltase deficiency, polymyositis, mitochondrial disorders Ø Neurological disorders: spinal muscular atrophies (SMA l, lll) Ø Neuropathies: Guillain-Barre syndrome, Ø Multiple Sclerosis Ø Skeletal pathologies such as kyphoscoliosis, rigid spine syndrome Ø Severe COPD with chronic respiratory insuficiency Confidential

Which would the patients choose? Confidential

What is the risk of using Trilogy’s MPV feature • The MPV feature represents no more risk than any other form of NIV • MPV may be used an entire lifetime by some patients and may extend the quality of life for patients who will eventually need invasive ventilation Confidential

Trilogy Qualifying Criteria ØTrilogy is a coded item (E 0464) device for NIV applications. ØCovered for treatment of neuromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure consequent to chronic obstructive pulmonary disease. ØThe DME company will need the prescription, and documentation to show medical necessity to substantiate the claim. It is best to have chart notes, discharge summary, ABG, PFTs etc. in the file. ØThere is no CMN for a ventilator. Confidential

Expanding ventilatory support Trilogy Series mixed-mode ventilators are lightweight, versatile and easy to use. The addition of MPV is a unique upgrade that offers an opportunity to improve the quality of life for patients and the possibility of increasing the time before a tracheostomy becomes a patient’s only option. Confidential 13