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Waking people up to sleep
Cardiovascular Disease and Sleep-Disordered Breathing
Sleep PhysicianSleep Physician
ResMed SpecialistResMed Specialist
2 Cardiovascular Disease and Sleep-Disordered Breathing © ResMed 2004
Agenda
• Case study – Heart Block and Sleep Apnea
• Sleep Apnea: Definitions and Prevalence
• Cardiovascular Consequences of Sleep Apnea
• Therapeutic outcomes
• Therapeutic options
Waking people up to sleep
Case Study
Case Study: Heart Block Associated Event Associated with OSA
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• 30+ second apnea (no airflow)
• Abdominal effort throughout apnea (obstructive sleep apnea)
• Oxygen saturation drops below 80%
• Heart block event associated with apnea
Case study: ECG Trace and Heart Block Events Associated with OSA
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Each episode of heart block is preceded by an apneic event
Waking people up to sleep
Sleep Apnea: Definitions and Prevalence
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Overview of Sleep Apnea
• Sleep Disordered Breathing (SDB) describes a number of nocturnal breathing disorders
• Sleep Apnea is the dominant type of SDB
– Obstructive sleep apnea (OSA)– Central sleep apnea (CSA)
• OSA and CSA are highly prevalent in patients with cardiovascular disease
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Sleep Apnea Types
• Obstructive Sleep Apnea (OSA):– Apnea with ventilatory efforts due to pharyngeal collapse– Patient tries to breathe but can’t due to upper airway obstruction– ~90% of sleep apnea cases1
• Central Sleep Apnea (CSA):– Apnea without ventilatory effort due to withdrawal of central drive– Cheyne-Stokes respiration a subset of CSA– ~10% of sleep apnea cases1
• Mixed Sleep Apnea:– Apnea with central component followed by obstructive component– Often classified as obstructive sleep apnea
1 Young T, Palta M, et al. The Occurrence of Sleep-Disordered Breathing Among Middle-Aged Adults. N Eng J Med; 328: 1230-35.
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Sleep Apnea Definitions1
Apnea:Apnea: Cessation of Airflow > 10 sec Cessation of Airflow > 10 sec
Hypopnea:Hypopnea: >50% reduction in airflow for >10 sec>50% reduction in airflow for >10 sec
AHI:AHI: Apnea Hypopnea IndexApnea Hypopnea Index: the number of apneas : the number of apneas and hypopneas per hour of sleepand hypopneas per hour of sleep
Severity Definitions:Severity Definitions:
–Normal: AHI < 5 Normal: AHI < 5 –Mild:Mild: AHI 5 – 14AHI 5 – 14–Moderate: AHI 15 – 30Moderate: AHI 15 – 30–Severe:Severe: AHI >30AHI >30
Sleep Apnea Syndrome:Sleep Apnea Syndrome: AHI of AHI of >> 5 with symptoms. 5 with symptoms.
1 American Academy of Sleep Medicine, Sleep-Related Breathing Disorders in Adults: Recommendations for Syndrome Definition and Measurement Techniques in Clinical Research -AASM Task Force. SLEEP 1999;22(5):667-689.
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Prevalence in General Population
• Young et al., NEJM, 1993:328:1230-5– N = 602 (F 250, M 352)– Age 30-60 years, employed
• AHI>5: mild, moderate, or severe sleep apnea*– 24% of middle aged men– 9% of middle aged women– These patients stop breathing >40 times per night
• AHI>15: moderate or severe sleep apnea– 15% of middle-aged men– 5% of middle-aged women– These patients stop breathing >120 times per night
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Prevalence of Sleep Apnea increases with age
Young T, et al. Predictors of Sleep-Disordered Breathing in Community-Dwelling Adults. Arch Intern Med 2002; 162: 893-900.
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Nasal airflow
Thorax effort
Abdominal effort
SaO2
Snore
Normal Breathing
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Obstructive Sleep Apnea
• Most common type of SDB
• Muscles that control the tongue and soft palate relax causing the airway to narrow and close
• Patient tries to breathe but cannot due to airway obstruction
• Patient stops breathing for more than 10 seconds
Obstructive apnea
Normal breathing
ClosedAirway
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Obstructive Sleep Apnea (OSA)
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Central Sleep Apnea
• Patient makes no effort to breathe in thorax nor abdomen during apnea
• Patient stops breathing for more than 10 seconds
• Typical in severe heart failure patients
• May be characterized by Cheyne-Stokes respiration (CSR) separated by periods of apnea or hypopnea
Normal breathing
Central apnea
OpenAirway
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Central Sleep Apnea (CSA)
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Waking people up to sleep
Cardiovascular Consequences of Sleep Apnea
Increase in blood pressure
Plunging blood oxygen
saturation
Apnea
Surge in sympatheticnerve activity
Negative swingsin intra-thoracic
pressure
Physiological Consequence of Sleep Apnea (Morgan et al. Sleep 1996)
Cardiovascular Disease and Sleep-disordered Breathing
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Mechanisms of Sleep Apnea Inducing Cardiovascular Disease
Mechanisms Discussed in Literature:
• Hypoxia resulting directly from apnea
• Negative intra-thoracic pressure from effort to breathe increases cardiac stress
• Pulmonary and systemic hypertension
• Increased sympathetic nerve activity during arousal (neuro-hormonal surge)
• Stimulation of inflammatory pathways
• Endothelial dysfunction
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Sleep Apnea and Hypertension
• SDB has a dose-response relationship with hypertension, independent of all known risk factors (age, gender, BMI, smoking, alcohol, others)– Nieto et al. JAMA 2000 (SHHS n=6132) – Lavie et al. BMJ 2000 (n=2677) – Bixler et al. Arch Intern Med 2000 (n=1741) – Peppard et al. NEJM 2000 (WSCS n=709)
Apnea/Hypopnea Index (AHI)
Sleep Apnea and Odd-ration for Developing Hypertension (Lavie et al. BMJ 2000)
Dose-Response relationship between AHI and risk for developing hypertension, independent of confounding factors
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80%
50%
45%
35%
30%
30%Angina
Coronary ArteryDisease
All Hypertension
Atrial Fibrillation
Congestive HeartFailure
Drug-ResistantHypertension
Sleep Apnea Prevalence in Cardiovascular Disease Patients
Sjostrom et al.Thorax 2002
Logan et al.J. Hypertension 2001
Javaheri et al.Circulation 1999
Schafer et al.Cardiology 1999
Sanner et al.Clin Cardiology 2001
Somers et al.Circulation 2004
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Sleep Apnea is an Identifiable Cause of Hypertension
- NIH, JNC7 (2003)
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Sleep Apnea and Coronary Artery Disease
• >30% of patients with CAD have sleep apnea
• OSA is an associated with an increased risk of cardiovascular mortality in patients with CAD with a dose-response relationship
Figure 1. By use of a Poisson model the death hazard was calculated as a function of RDI, current age, and time elapsed after the intensive care episode for CAD. The bolded curve gives the function at the current age 70 yr and 3 yr after intensive care. The dotted curves represent 95% CI. Peker Y, Hedner J, Kraiczi H, et al. Am J Respir Crit Care Med. 2000 Vol. 162. Pp 81-86.
AHI
Waking people up to sleep
Therapeutic Outcomes
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CPAP treats OSA providing a pneumatic splint to keep the upper airway open
Sullivan et al.
Lancet (1981)
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OSA: Oxygen Desaturation OSA: Oxygen Desaturation BeforeBefore CPAP CPAP
0102030405060708090
100
0 1 2 3 4 5
Hours
Perc
en
t
O2 Sat
Sullivan, et al., 1981
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OSA: Oxygen Desaturation OSA: Oxygen Desaturation AfterAfter CPAP CPAP
0102030405060708090
100
0 1 2 3 4 5
Hours
Perc
en
t
O2 Sat
Sullivan, et al., 1981
A
A = Introduction of CPAP
v
Control Arm
Therapeutic Arm
Effect of nCPAP on Blood Pressure (Becker et al. Circulation 2003)
Average 10 mm Hg reduction in BP predicts:
• Coronary artery disease risk reduced by 37%
• Stroke risk reduced by 56%
29 Cardiovascular Disease and Sleep-disordered Breathing
60
80
100
120
140
MA
P (
mm
Hg
)
b a se line
e ffe c tive nC P A P
715 pm 1115 pm 315 am 715 am
6 0
8 0
1 0 0
1 2 0
1 4 0
MA
P (
mm
Hg
)
b a se line
sub the ra p e utic nC P A P
7 1 5 pm 11 1 5 pm 3 1 5 am 7 1 5 am
Effect of CPAP on LVEF (Kaneko et al. N Engl J Med 2003)
• Average 35% relative increase in LVEF
• OSA may have an adverse effect in heart failure that can be addressed by CPAP therapy
30 Cardiovascular Disease and Sleep-disordered Breathing
N=24
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Event-free Survival in CAD Patients with OSA: CPAP Therapy and Control Arms
Milleron et al. Eur Heart J 2004;25:728
N=54
n = 64
CPAP Therapy
n = 64
CPAP Therapy
Comparison of Transplant Free Survival in CHF Patients: CPAP vs Control (Sin et al. Circulation 2000)
• 75% five-year survival rate for CHF patients with CSA/CSR on CPAP
• 25% five-year survival rate for CHF patients with CSA/CSR not on CPAP
32 Cardiovascular Disease and Sleep-disordered Breathing
Waking people up to sleep
Therapeutic Options
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OSA Therapeutic Methods
• Current:– Nonsurgical treatment:
• Behavior modifications• Nasal Continuous Positive Airway Pressure (CPAP)*• AutoSet CPAP (APAP) devices – increased compliance*
– Surgical treatment:• Uvulopalatopharyngoplasty (UPPP)• Laser-assisted uvulopalatoplasty (LAUP)
• Future:– Adaptive Servo Ventilation
* Discussion focused on CPAP/APAP – Standard of Care
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Behavioral Modifications
Methods:
• Weight loss
• Avoidance of alcohol, sedatives, antihistamines, smoking
• Sleeping on side vs. back
Pros:
• Lower risk (vs. surgical/invasive methods)
• Easier to implement and lower cost
• Even a moderate weight loss of 10% corresponds to ~30% decrease in AHI
Cons:
• Requires active patient participation
• Patient compliance low
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Positive Airway Pressure
Methods:– Pneumatic stent to keep upper airway open– Continuous positive airway pressure (CPAP): one pressure set – Bi-level (VPAP/BiPAP): two pressures set (inhalation/exhalation)– Auto-CPAP (APAP/AutoSet): device adjusts pressure automatically
Pros:– Non-invasive therapy– Demonstrated to improve AHI, SA symptoms, hypertension, heart
failure status, and other CVD outcomes with effective use– Effective in 80-90% of patients (when used appropriately)
Cons:– Patient compliance is an issue
• Intensive HME support and customization improves compliance• New mask / device technologies improve compliance / efficacy
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Patient Using Small, Effective Mask
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Autotitration CPAP (APAP or AutoSet)
• AutoSet devices adjust positive airway pressure on a breath-by-breath basis to suit patient needs as they vary throughout the night.
• Acts like a “pacemaker” for sleep apnea with a “preemptive ICD” – algorithm senses and adjusts pressure support as needed to prevent apnea, hypopneas, snore, and flow limitation
• Record patient specific data regarding compliance, device/mask function, and efficacy.
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AutoSet for OSA -How it works
• AutoSet Sensors (algorithm triggers)– apneas, – hypopneas, – flow limitation (shape-change of flow-time curve), – snore (flow vibration),– compensation for mask leak
• Ramp pressure to maintain open airway – algorithm approach – preemptive to apnea
• Able to compensate for both intra-night as well as night-to-night variability
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AutoSet for OSA – Advantages for Patients
• AutoSet more comfortable than basic CPAP
• Patients report more restful sleep, better quality of sleep, less discomfort from pressure
• Immediate benefits once therapy begins: patients report less trouble getting to sleep
• Varies therapy dose automatically
• Electronic feedback to home medical equipment company – no need for patient diary
• Improves compliance and efficacy
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AutoSet for OSA Advantages for Clinicians - 1
• Easier to initiate and titrate – out of the box
• AutoSet has improved patient comfort, compliance, and quality-of-life outcomes (Massie
et al. Am J Crit Care Med v167 pp 20-23 2003)
• Equivalent apnea prevention as CPAP (Lloberes et al. Am J Crit Care Med v154; pp1755-1758 1996)
• Especially useful in patients requiring higher treatment pressures (Randerath et al. Med Sci Monit 2003)
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AutoSet for OSA Advantages for Clinicians - 2
• Lower mean pressure overnight– AutoSet mean pressure 37% lower than traditional CPAP– Reduces pressure related side-effects: only uses high pressure
when clinically necessary – No negative effects on sleep architecture or fragmentation
• Automatically adjusts as patient’s needs change both inter-night and intra-night – e.g., weight gain or loss, improving or decompensated
CHF, REM-related apnea, sleeping position, alcohol, etc.
• AutoSet tracks compliance and efficacy– Compliance – hours of use at pressure– Efficacy – Mask Leak, and treatment AHI
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Patient Using APAP and Mask
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Conclusions on Therapy
• Sleep Apnea is common in patients with cardiovascular disease
• CPAP treatment of sleep apnea is safe and effective
• AutoSet devices (APAP) improve patient comfort, compliance, and quality-of-life outcomes
Waking people up to sleep
Therapeutic OutcomesNew Therapies for OSA and CSA
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Obstructive Sleep Apnea - OSA (effort to breathe; no flow)
Effort/Abdn
EEG
EOG/LEOG/REMGEKGLAT/RAT
FLOW
Effort/Thorax
SaO2
SNORING
NEED REFERENCES FOR THIS SLIDE
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AutoSet Spirit (APAP) for Obstructive Sleep Apnea (OSA)
• Pilot Data of AutoSet on OSA in CHF patients
• After 3 months of AutoSet therapy (n=10)– Apnea-Hypopnea Index – reduced by 90%– BNP – reduced by 45%– 6 minute walk – increased by 20%– LVEF – increased by 5%– Cardiac Output – no significant change
Source: Maisel et al., UCSD, VA Hospital, 2004Source: Maisel et al., UCSD, VA Hospital, 2004
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0
50
100
150
200
250
300
350
400
450
Baseline 1.5 Months 3 Months 8 Months
Obstructive Sleep Apnea and Congestive Heart Failure
Case Study: 69 year-old, male
BNP
(pg/mL)
AutoSet downloadMask Leak noted
AutoSet downloadCompliance > 4 hrs/nightAHI<5 events/hour
AHI = 26 events per hourNadir O2 was 81%
Source: Maisel et al., UCSD, VA Hospital, 2004Source: Maisel et al., UCSD, VA Hospital, 2004
Leak eliminatedC>4h/n AHI<5
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0
500
1000
1500
2000
Baseline 3 Months 8 Months
Obstructive Sleep Apnea and Congestive Heart Failure
Case Study: 69 year-old, male
6 m
in. w
alk
(fe
et)
AHI = 26 per hourNadir O2 = 81%
AutoSet downloadMask Leak noted
Leak eliminatedC>4h/n AHI<5
Up 35%
Source: Maisel et al., UCSD, VA Hospital, 2004Source: Maisel et al., UCSD, VA Hospital, 2004
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Conclusions
• AutoSet devices are easier to initiate, adjust to changes over time, and provide feedback
• AutoSet devices may increase the number of patients successfully treated for Sleep Apnea leading to improved cardiovascular outcomes
• Summary of key cardiovascular outcomes improved with positive airway pressure:– Blood Pressure– Ejection Fraction– Quality of Life– Survival Rate
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Central Sleep Apnea - CSA (no effort to breathe; no flow)
Effort/Abdn
EOG/L
EOG/R
EMG
EKG
LAT/RAT
FLOW
Effort/Thorax
SaO2
EEG
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Adaptive Servo Ventilation for Central Sleep Apnea (CSA)
• Pressure Support Adaptive Servo Ventilator
• Design Goals:– Direct suppression of CSA/CSR– More comfortable than traditional CPAP– Easier to introduce than CPAP & bi-level– Similar hemodynamic/cardiovascular benefits
• Called AutoSet CS*– Central Sleep Apnea– Cheyne-Stokes Respiration
* Informational purposes onlyCurrently in FDA trialNot available for sale in the U.S.
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Adaptive Servo Ventilation for Central Sleep Apnea (CSA)
Mechanism of Action:
• Supplements ventilation during apneic and hypopneic phases of breathing cycle
• Reduces support during hypercapneic phase to avoid hyperventilation
• Target overall minute ventilation of 90% of the ventilation of the past 300 seconds
54 Cardiovascular Disease and Sleep-Disordered Breathing © ResMed 2004
Adaptive Servo Ventilation for Central Sleep Apnea (CSA)
• Patients with central sleep apnea treated with oxygen, CPAP, bi-level, and Adaptive Servo Ventilator (AutoSet CS*)
• N = 14 patients in Acute Setting
(Teschler H, et al., Am J Respir Crit Care Med 164: 614-19, 2001)
* Informational purposes onlyCurrently in FDA trialNot available for sale in the U.S.
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N=14
* Informational purposes onlyCurrently in FDA trialNot available for sale in the U.S.
56 Cardiovascular Disease and Sleep-Disordered Breathing © ResMed 2004
N=14
* Informational purposes onlyCurrently in FDA trialNot available for sale in the U.S.
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Adaptive Servo VentilationEssen Long-term Study
• N=20 Patients in Chronic Setting (Home Study)– N=10 patients– N=10 placebo controls
• 6 months home therapy on AutoSet CS*
• Assess cardiac, respiratory, and QOL data
• N=12 completed and available
* Informational purposes onlyCurrently in FDA trialNot available for sale in the U.S.
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Pilot Data: Essen Long-term StudyAdaptive Servo-Ventilation
Compliance 6.3 hr/night for 6 months
Key Outcomes:
• 27% improvement in VO2 max
• 35% improvement in 6 minute walk
• 38% improvement in MLHFQ
• 55% reduction in nocturia episodes
• 88% reduction in AHI N=12
* Informational purposes onlyCurrently in FDA trialNot available for sale in the U.S.
59 Cardiovascular Disease and Sleep-Disordered Breathing © ResMed 2004
Adaptive Servo-Ventilation and CSA/CSR
AutoSet CS* [on]
Airflow Measurement
Pressure from AutoSet CS
Blood Oxygen Level (SaO2%)
AutoSet CS* [off]
* Informational purposes onlyCurrently in FDA trialNot available for sale in the U.S.
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Conclusions
• Adaptive Servo Ventilation suppresses CSA and CSR
• Adaptive Servo Ventilation is more effective than:– Oxygen– CPAP– Bi-level
• Summary of key cardiovascular outcomes improved with adaptive servo ventilation:– VO2 max– Six minute walk– Minnesotta Living with Heart Failure Questionnaire
• AutoSet CS is currently in FDA trials
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