Reasons Providers Use Bilevel More comfort, improve therapy compliance Noncompliant OSA (NCOSA) 1 Scripts from lab referrals Central/Complex Sleep Apnea 2 For ventilations needs Restrictive Thoracic Disorders/Neuromuscular Disease, COPD and Hypoventilation 3 1 Ballard RD et al. J Clin Sleep Med 2007 2 Ball N et al. Sleep Breath 2011 3 Gay P et al. Sleep 2006
Studies show that many CPAP/APAP users are non-compliant When compliance is defined as greater than 4 hours of nightly use, 46-83% 1 of patients with obstructive sleep apnea have been reported to be non-adherent to treatment. 1. Terri E. Weaver and Ronald R. Grunstein Adherence to Continuous Positive Airway Pressure Therapy Proc Am Thorac Soc Vol 5. pp 173-178, 2008. 2
Consider Using Bilevel When Patient is not tolerating high pressure settings 1 Events persist at 15 cm H 2 O 2 Patient complains of not being able to exhale despite expiratory pressure relief (EPR ) feature 1 Must be a 4 cm H 2 O difference between IPAP and EPAP to be considered bilevel therapy 2 1 Gay P et al. Sleep 2006 2 Kushida CA et al. J Clin Sleep Med 2008
COPD is a National Problem COPD is the 3rd leading cause of death in the U.S., claiming the lives of 143,489 Americans in 2012. 1 In 2013, 15.7 million U.S. adults were estimated to have COPD. However, close to 24 million U.S. adults have evidence of impaired lung function. 2,3 Smoking is the number one cause of COPD. Approximately 85-90% of COPD deaths are those who smoke. 4,5 Women exceed men in the number of deaths attributable to COPD. In the US in 2012, >75,000 females died compared to >67,000 males. 1 Research has indicated a prevalence of Obstructive Sleep Apnea (OSA) in COPD patients as high as 30-66%, which is called OSA-COPD Overlap Syndrome. 6 1. Heron, M. Deaths: Leading Causes for 2012, NVSR Volume 64, Number 10 August 31, 2015 2. Wheaton AG et al. Morb Mortal Wkly Rep (MMWR) March 27, 2015;64(11):289-295. 3. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report. August 2, 2002; 51(SS06):1-16. 4. Mathers CD, Loncar D. PLoS Med 2006;3:e442. 5. U.S. Department of Health and Human Services. The Health Consequences of Smoking: A Report of the Surgeon General, 2004 6. Soler X et al. Ann Am Thorac Soc 2015
Overlap Syndrome Consists of both: o o Upper airway obstruction (OSA) during sleep Nocturnal hypoventilation (COPD) Patient may present with: o o o o o o Existing oxygen therapy for COPD History of cardio-respiratory disease Inability to sleep lying down Full regime of pulmonary medications (inhalers, steroids, etc.) without significant improvement May demonstrate prolonged hypoxemia during sleep SpO 2 often does not recover between episodes of repetitive apnea If left untreated, morbidity and mortality much higher than for either disease process alone * Douglas NJ. Sleep Disorders 1998
Bilevel Therapy Bilevel positive airway pressure, commonly referred to by the trademarked names BiPAP, is a form of NIV (Non invasive Ventilation) that uses a time-cycled or flow-cycled change between two different applied levels of positive airway pressure (IPAP and EPAP)* * Kushida CA et al. J Clin Sleep Med 2008
How Does Bilevel Work?* Prevents nocturnal hypoventilation and hypoxia Cardiovascular consequences Improves ventilation (gas exchange) Reduces nocturnal CO 2 levels Increases nocturnal O 2 levels Improves daytime blood gases Stabilizes upper airway Rests respiratory muscles Decreases daytime sleepiness by correcting sleep architecture Reduces arousals due to SDB and associated sleep fragmentation *. Antonescu-Turcu A & Parthasarathy S. Respir Care 2010
EPAP, IPAP and PS IPAP Achieve adequate tidal volume Get the respiratory rate (RR) below 25 bpm Decrease the work of breathing Pressure Support (PS) PS = IPAP - EPAP The greater the PS the greater the ventilatory support Care must be taken not to over-ventilate Reduce PaCO 2 IPAP = EPAP + PS EPAP Overcome obstructive apneas and hypopneas Improve oxygenation
Patient Benefits of Compliance on Bilevel Hospitalizations 1 Activities of daily living 2 Improves quality of life 3 1 Janssens JP et al. Chest 2003 2 Windisch W et al. Chest 2005 3 Duiverman ML et al. Respir Res 2011
Bilevel Modes of Therapy S Spontaneous (S) IPAP and EPAP S/T VAuto Spontaneous Timed (S/T) IPAP and EPAP Backup Rate VAuto with Fixed Pressure Support (PS) Max IPAP and Min EPAP PS ASV/ ASVAuto Adaptive Servo-ventilation targeting recent minute ventilation Min and Max PS EPAP (Auto EPAP) ivaps Intelligent Volume Assured Pressure Support Min and Max PS EPAP
Nocturnal Ventilation Characteristics Normals have about a 5% decrease in ventilation during sleep Increased load is counteracted by increased effort Small reductions in tidal volume are compensated by an increase in respiratory rate Respiratory insufficiency patients have an additional 10 15% drop in ventilation at sleep onset (SO) Further reduction in REM sleep (10 20%), due to falling tidal volumes not counteracted by increased respiratory rate Becker H et al. Am J Respir Crit Care Med 1999
Nocturnal Respiratory Insufficiency and Associated Physiological Impacts Respiratory muscle weakness can lead to increased work of breathing, respiratory insufficiency, morbidity and mortality Significant hypoventilation in REM sleep Physical effects of inadequate ventilation Sleep arousals Intrathoracic pressure changes Oxidative stress Sympathetic response Cardiovascular stress, hypertension Inadequate nocturnal ventilation leads to: Decreased oxygenation Hypercarbia Sleep fragmentation Decreased daytime functioning, poor outcomes Bourke SC and Gibson GJ. Eur Respir J 2002
Proximal Airway Pressure (cm H 2 O) Types of Asynchrony At plateau During pressurization Too fast, too slow At transition to expiration Premature cycle, delayed cycle At transition to inspiration Missed trigger, auto trigger Gentile MA. Respir Care 2011
CSA or CompSA Guidelines Ventilator with Non-Invasive Interfaces: Please reference ResMed s Ventilator Reimbursement Fast Facts: PN 1017230. This information is provided as of the date listed, and all coding and reimbursement information is subject to change without notice. It is the provider s responsibility to verify coding and coverage with payors directly. For a full description of the policy go to www.cms.hhs.gov. ResMed reimbursement hotline, dial 1-800-424-0737 and select option 4.