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Turkish Thoracic Society 9 th Annual Congress. All OSA Patients Should Not Be Treated. Patrick J. Strollo, Jr., M.D., FCCP, D,ABSM University of Pittsburgh Medical Center. All OSA Patients Should Not Be Treated. Define Obstructive Sleep Apnea What is the impact of treatment?
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Turkish Thoracic Society 9th Annual Congress All OSA Patients Should Not Be Treated Patrick J. Strollo, Jr., M.D., FCCP, D,ABSM University of Pittsburgh Medical Center
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 Neuro-cognitive Complications Metabolic Complications
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 1999 22:667-689
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 2006 29:375-380
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 Results • CPAPther 5.4 hours/night • ESS: 15.5 => 7.0 * • MWT: 22.5 => 32.9 * • SF-36: 35.4 => 73.0 * • CPAPsham 4.6 hours/night • ESS: 15.0 => 13.0 * • MWT: 20.0 => 23.5 • SF-36: 33.9 => 50.9 * * P < 0.001 Lancet 1999 353:2100-05
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 Mean Blood Pressure Time from wake and sleep onset A BP fall of 3.3 mm Hg would be expected to be associated with a stroke risk reduction of about 20% & a coronary heart disease event risk reduction of about 15% Lancet 2001 359:204-10
Effect of CPAP on Afib Recurrence p = 0.009 Population p = 0.013 Patients referred for cardioversion Age 65 + 10 yrs Male (81%) BMI 37 + 11 AHI: 45 + 38 (treated) 34 + 29 (untreated) p = ns 12 Month Recurrence of Afib % 82% 53% 42% n = 12 n = 79 n = 27 Circulation 2003 107:2589-94
Long-term cardiovascular outcomes in men with OSA 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 AHI 18.2 + 3.5 AHI 43.3 + 5.7 Cumulative Incidence of Fatal CV Events Cumulative Incidence of Non-fatal CV Events AHI 42.4 + 4.9 Months Months Conclusion:In men, severe OSA significantly increases the risk of fatal and non-fatal cardiovascular events. CPAP treatment reduces this risk. Lancet 2005 365: 1046–53 .
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
Long-term cardiovascular outcomes in men with OSA 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 AHI 18.2 + 3.5 AHI 43.3 + 5.7 Cumulative Incidence of Fatal CV Events Cumulative Incidence of Non-fatal CV Events AHI 42.4 + 4.9 Months Months Conclusion:In men, severe OSA significantly increases the risk of fatal and non-fatal cardiovascular events. CPAP treatment reduces this risk. Lancet 2005 365: 1046–53 .
Prevalence of an AHI > 15 by age Arch Intern Med 2002 162:893-900
Impact of Gender on Survival AHI < 5 AHI > 5 n = 59 n = 190 n = 73 n = 32 Thorax 1998 53:s16-19
Gender Difference in Cardiovascular Mortality Women Deaths in Thousands Men Years 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%) AHIbase 33.7 + 16.8 Treated n = 25 p < 0.01 Event-free survival Untreated n = 29 AHIbase 29.0 + 12.8 Time (months) EHJ 2004 25:728-34
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. Vitality Score (SF -36 Units) Months of Follow-up 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. CHEST 2002 122:1679–1685
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 Prospective evaluation of CPAP use (n = 1,211) Adherence at 5 yrs (68%): 3 month use predictive • Snoring history. • Apnea / hypopnea index ( > 30). • Epworth sleepiness score ( > 10). AJRCCM 1999 159:1108-14
The Relationship of Self Reported Sleepiness to Sleep Apnea n = 4653 Sleepy Sleep Apnea Epworth Sleepiness Scale Non-Sleepy Sleep Apnea Apnea – Hypopnea Index
Pleiotrophic Effects of Adiopkines on Vascular Risk Obesity Sleep Apnea Diabetes Adipokines & Leptin LV Hypertrophy
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.
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 Sleepiness A 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 Sleepiness A Randomized, Controlled Trial Ann Intern Med. 2001;134:1015-1023 White Bars Pre Rx Gray Bars Post Rx
CPAP does not reduce blood pressure in non-sleepy hypertensive OSA patients Eur Resp J (in press)