All OSA Patients Should Not Be Treated

Patrick J. Strollo, Jr., M.D., FCCP, D,ABSMUniversity of Pittsburgh Medical Center

Turkish Thoracic Society9th Annual Congress

All OSA Patients Should Not Be Treated

• Define Obstructive Sleep Apnea

• What is the impact of treatment?

• Who benefits from treatment?

• What are the barriers?

Sleep Apnea is Associated with Significant Co-morbidities

Cardiovascular Complications

MetabolicComplications

Neuro-cognitiveComplications

Obstructive Sleep Disordered Breathing

• Mild: 5 – 15 events per hour• Moderate: 15 – 30 events per hour• Severe: > 30 events per hour

Level 2 Evidence Variable(s) on which the severity rating is based have been demonstrated to have a statistically significant relationship with excess morbidity in a prospective cohort study that has properly controlled for important covariates.

Sleep 199922:667-689

AASM Levels of Recommendation

AASM Classification of Evidence

All OSA Patients Should Not Be Treated

• Define Obstructive Sleep Apnea

• What is the impact of treatment?

• Who benefits from treatment?

• What are the barriers?

Current evidence that treatment impacts outcome

• CPAP is indicated for the treatment of moderate to severe OSA (Standard)

• CPAP is indicated for improving self reported sleepiness in patients with OSA (Standard)

• CPAP is recommended for the treatment of mild OSA (Option)

• CPAP is recommended for improving quality of life in patients with OSA (Option)

• CPAP is recommended as an adjunctive therapy to lower blood pressure in hypertensive patients with OSA (Option)

Sleep 200629:375-380

Effect of CPAP on Daytime Function

• Design: Double blinded, randomized, controlled trial

• Patients: CPAPther n =54, CPAPsham n=53• Outcome variables: Subjective sleepiness (ESS),

Objective sleepiness (MWT), SF-36

Lancet 1999Lancet 1999

353:2100-05353:2100-05

CPAPther 5.4 hours/nightESS: 15.5 => 7.0 *MWT: 22.5 => 32.9 * SF-36: 35.4 => 73.0 *

CPAPsham 4.6 hours/nightESS: 15.0 => 13.0 *MWT: 20.0 => 23.5 SF-36: 33.9 => 50.9 *

Results

* P < 0.001* P < 0.001

Effect CPAP on Blood Pressure

• Objective: Compare change in BP in men with OSA

• Design:: Randomized parallel trial

• Subjects: ODI 41.4 + 20• Outcome variable: Change

in mean BP at 4 weeks• Results: NCPAPther

decreased BP 2.5 mm Hg vs. NCPAPsubther 0.8 mm Hg– Effect was greater in

patients taking antihypertensive meds

Lancet 2001359:204-10

A BP fall of 3.3 mm Hg would be expected to be associatedwith a stroke risk reduction of about 20% & a coronary heartdisease event risk reduction of about 15%

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Effect of CPAP on Afib Recurrence

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Circulation 2003107:2589-94

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n = 79 n = 12 n = 27

53% 42%

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p = 0.013

p = 0.009Population

Patients referred for cardioversionAge 65 + 10 yrsMale (81%)BMI 37 + 11AHI: 45 + 38 (treated) 34 + 29 (untreated)

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AIM: Observational study to compare incidence of fatal and non-fatal cardiovascular events in simple snorers, patients with untreated OSA,patients treated with CPAP, and healthy men recruited from the general population.Design: Prospective observational cohort. 264 healthy men, 377 simple snorers, 403 with untreated mild-moderate OSA (AHI 5-30), 235 with untreated severe OSA (AHI > 30), and 372 with OSA and treated with CPAP

Lancet 2005 365: 1046–53

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Conclusion: In men, severe OSA significantly increases the risk of fatal and non-fatal cardiovascular events. CPAP treatment reduces this risk.

Long-term cardiovascular outcomes in men with OSA

AHI 43.3 + 5.7

AHI 42.4 + 4.9

AHI 18.2 + 3.5

All OSA Patients Should Not Be Treated

• Define Obstructive Sleep Apnea

• What is the impact of treatment?

• Who benefits from treatment?

• What are the barriers?

Vulnerable populations

• Phenotypes– Severe apnea (AHI > 30)– Individuals < 55 years– Women?– Coexisting CV disease

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AIM: Observational study to compare incidence of fatal and non-fatal cardiovascular events in simple snorers, patients with untreated OSA,patients treated with CPAP, and healthy men recruited from the general population.Design: Prospective observational cohort. 264 healthy men, 377 simple snorers, 403 with untreated mild-moderate OSA (AHI 5-30), 235 with untreated severe OSA (AHI > 30), and 372 with OSA and treated with CPAP

Lancet 2005 365: 1046–53

MonthsMonths

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Conclusion: In men, severe OSA significantly increases the risk of fatal and non-fatal cardiovascular events. CPAP treatment reduces this risk.

Long-term cardiovascular outcomes in men with OSA

AHI 43.3 + 5.7

AHI 42.4 + 4.9

AHI 18.2 + 3.5

Arch Intern Med 2002 162:893-900

Prevalence of an AHI > 15 by age

Impact of Gender on Survival

AHI < 5 AHI > 5

Thorax 199853:s16-19

n = 190

n = 32

n = 73

n = 59

Years

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sGender Difference in Cardiovascular Mortality

Women

Men

Source: CDC / CHS

Effect of OSA Rx on Cardiac Events

• Design: Prospective observational study (86.5 + 39 months)

• Patients:– N = 54 (53 M / 1 F)– Age 57.3 + 10.1– CAD (> 70% stenosis)

& AHI > 15• Endpoints:

– Cardiovascular death– Acute coronary artery

syndrome– Hospitalization for CHF– Coronary Artery

Revascularisation• Results:

– Treated 6/25 (24%)– Untreated 17/29 (58%)

p < 0.01

EHJ 200425:728-34

Treated n = 25

Untreated n = 29 E

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Time (months)

AHIbase 33.7 + 16.8

AHIbase 29.0 + 12.8

Cost Effectiveness of CPAP

Aims: To determine the short-term and long-term impacts of CPAP on HRQL in patients OSA.Design: Prospective longitudinal cohort study.Patients: Three hundred sixty-five patients with an AHI > 20 per hour of sleep and 358 patients with an AHI of < 20.Interventions: All patients with AHIs > 20 received CPAP therapy; those with AHIs < 20 did not. The HRQL of all study participants was measured using the SF-36 questionnaire at baseline and then at 3 and 12 months.

CHEST 2002122:1679–1685

Months of Follow-up

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Conclusions: CPAP therapy was associated with marked short-term and long-term improvements in the vitality of patients with moderate- to- severe OSA in the community. These findings suggest that CPAP therapy is effective in improving the long - term HRQL of patients with OSA.

All OSA Patients Should Not Be Treated

• Define Obstructive Sleep Apnea

• What is the impact of treatment?

• Who benefits from treatment?

• What are the barriers?

Sleep Apnea: Treatment Options

• Lifestyle– Fitness– Avoid sleep deprivation, Alcohol, Sedatives– Lateral position or Elevated HOB

• Medical – Positive Pressure via a mask

• CPAP • Bi-level pressure

• Oral appliances• Surgical

– Upper airway bypass (trach)– Upper airway reconstruction

• Phase 1 : UPPP & Genioglossal advancement• Phase 2: Maxillomandibular advancement

Medical- Positive Pressure via a mask

• CPAP• Bi-level pressure

Factors Affecting CPAP Adherence

• Snoring history.

• Apnea / hypopnea index ( > 30).

• Epworth sleepiness score ( > 10).

Prospective evaluation of CPAP use (n = 1,211)

Adherence at 5 yrs (68%): 3 month use predictive

AJRCCM 1999159:1108-14

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Apnea – Hypopnea Index

The Relationship of Self Reported Sleepiness to Sleep Apnea

n = 4653

Non-Sleepy Sleep Apnea

Sleepy Sleep Apnea

Obesity

Sleep Apnea Diabetes

LV Hypertrophy

Pleiotrophic Effects of Adiopkines on Vascular Risk

Adipokines & Leptin

All OSA Patients Should Not Be Treated

• OSA is associated with neuro-cognitive, cardiovascular, and metabolic complications.

• Rx favorably impacts all three domains.• CPAP is well tolerated in the Sleepy Sleep Apnea

phenotype with moderate to severely elevated AHIs.

• Observational and placebo controlled data confirms Rx robustly improves sleepiness as well as HRQOL.

• Observational and placebo controlled data* suggests that cardiovascular risk can be reduced with treatment.

Teşekkürler

All OSA Patients Should Not Be Treated

• Response

Treatment with Continuous Positive Airway Pressure Is Not Effective in Patients with Sleep Apnea but No Daytime SleepinessA Randomized, Controlled Trial Ann Intern Med. 2001;134:1015-1023

Treatment with Continuous Positive Airway Pressure Is Not Effective in Patients with Sleep Apnea but No Daytime SleepinessA Randomized, Controlled Trial Ann Intern Med. 2001;134:1015-1023

White Bars Pre RxGray Bars Post Rx

CPAP does not reduce blood pressure in non-sleepy hypertensiveOSA patients Eur Resp J (in press)