Sleep Apnea Treatment Options, A Year After ASV Nancy Collop, MD, FAASM Emory University Associated Professional Sleep Societies, LLC 1
Conflict of Interest Disclosures for Speakers x 1. I do not have any relationships with any entities producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients, OR 2. I have the following relationships with entities producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. Type of Potential Conflict Details of Potential Conflict Grant/Research Support Jazz Pharmaceutical, PI on multicenter grants Consultant Speakers Bureaus Financial support Other Honorarium from Best Doctors; Royalties from UpToDate x 3. The material presented in this lecture has no relationship with any of these potential conflicts, OR 4. This talk presents material that is related to one or more of these potential conflicts, and the following objective references are provided as support for this lecture: 1. 2. 3. Associated Professional Sleep Societies, LLC 2
Therapies To Be Covered: PAP: CPAP, APAP, BPAP, ASV Oral appliances Surgery: Bariatric, TORS HGNS Associated Professional Sleep Societies, LLC 3
PAP Therapy for OSA AutoPAP bench data BPAP as a CPAP rescue mode ASV what is its current role? Associated Professional Sleep Societies, LLC 4
** Studies suggest outcomes are similar with fixed pressure PAP and APAP FDA does not require safety and efficacy data for APAP s Bench testing allows comparisons across devices with uniform events (OA, OH, CA, Snoring) Device is attached to apparatus via a calibrated leak port Associated Professional Sleep Societies, LLC 5
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** Name of Device Name of Company Country Made In 1 ich Apex Taiwan 2 RESmart Auto BMC China 3 isleep20i Breas Sweden 4 Floton Auto Curative China 5 SleepCube Auto Devilbiss USA 6 ICON+ Fisher Paykel New Zealand 7 PRI Remstar Auto P flex Phillips USA 8 S9 Autoset Resmed Australia 9 Dreamstar Auto Sefam France 10 Transcend Auto Somnetics USA 11 SOMNOBalance e Weinmann Germany Associated Professional Sleep Societies, LLC 7
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** Fastest to P max = 14.8 min Associated Professional Sleep Societies, LLC 10
** Limited P max to 10 Associated Professional Sleep Societies, LLC 11
Associated Professional Sleep Societies, LLC 12 **
Not all APAP are created equal! Some do not respond to anything!! Some do not respond to snoring Some do not differentiate well between obstructive and central apneas Some do not detect events adequately Buyer beware if you use these long term. ** Associated Professional Sleep Societies, LLC 13
28 OSA pts on CPAP On CPAP minimum 6 wks; use < 4 hrs/nt 4 week trial each (daytime titrations), 2 week washout Adherence, ESS, OSLER MWT, QOL, pt comfort/preference 17 who complained of exhalation intolerance did better with BPAP Associated Professional Sleep Societies, LLC 14
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Auto Bilevel PAP Associated Professional Sleep Societies, LLC 17
Characteristics of ASV Devices Associated Professional Sleep Societies, LLC 18
Associated Professional Sleep Societies, LLC 19
Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure. NEJM 9/2015 Inclusion criteria: Ejection fraction 45% Associated Professional Sleep Societies, LLC 20
Following SERVE-HF trial, new guidelines were needed for guidance in CHF pts Looked at studies for LVEF, AHI, mortality ASV is still appropriate for treatment emergent CSA, opioid induced CSA Associated Professional Sleep Societies, LLC 21
Associated Professional Sleep Societies, LLC 22
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33 pts with CHF (EF < 45%), AHI > 15 (predominantly central) 19 randomized to NOT (3 lpm) Polygraphy at 24 hrs and 6 months AHI and ODI reduced No change in QOL, EF or NYHA class Associated Professional Sleep Societies, LLC 24
Associated Professional Sleep Societies, LLC 25
Treatment for Opioid Induced CSA Drug Change Withdrawal of opioids Reducing dose Changing to less potent opioid Pharmacologic therapy Acetazolamide Theophylline Other? Positional therapy; Oxygen PAP therapy Associated Professional Sleep Societies, LLC 26
Prevalence of CSA on opioids = 24% CPAP not effective (5 retrospective studies) BPAP with backup rate has efficacy in > 50% (small numbers) ASV seems to work best Associated Professional Sleep Societies, LLC 27
20 patients receiving long-term opioid therapy, referred for OSA severe sleep apnea (average AHI, 61/h); CSA predominated (CAI mean = 32/h) Overnight and short-term (up to 8 weeks) efficacy of CPAP and ASV CPAP ineffective: AHI mean, 33/h; CAI mean = 19/h ASV reduced AHI: CAI mean = 0; hypopnea index = 11/h 17 pts used 9 months - 6 years: long-term = 5.1 h/night Associated Professional Sleep Societies, LLC 28
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18 patients with CSA > 5 due to opioids Randomized, crossover of 1 night PSG with ASVauto and bilevel PAP ST PSG examined for SDB parameters 2 questionnaires: Morning after Pt Satisfaction and PAP Comfort Associated Professional Sleep Societies, LLC 30
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Recommendations for sleepdisordered breathing in the setting of congestive heart failure If OSA predominant, CPAP is the mainstay of therapy If CSA persists or emerges (>5/hr) with OSA controlled, ASV trial recommended If CSA predominant, CPAP trial to see if AHI<15 can be achieved If not, ASV trial recommended (if EF>45%) Otherwise, optimize heart failure, may consider CPAP plus oxygen Avoid autotitrating devices Associated Professional Sleep Societies, LLC 32
Recommendations for sleepdisordered breathing in the setting of opioid use If OSA predominant, CPAP titration first If CSA emerges (>5/hr), ASV recommended Weak recommendation that bilevel PAP ST could be tried first If CSA predominant, ASV or bilevel PAP - ST Associated Professional Sleep Societies, LLC 33
Recommendations for management of treatmentemergent CSA Start with CPAP and follow >50% likely to resolve over time Could try lowering pressure, controlling leak If persistent X 1 month, ASV trial reasonable Possible role for positional therapy Allow lower PAP pressures and decrease CSA Associated Professional Sleep Societies, LLC 34
Mode(s) Clinical Use CPAP Auto CPAP Bilevel PAP (S) OSA OSA (CPAP failure, comfort) Bilevel PAP (ST) ASV AVAPS / IVAPS OSA with treatment emergent CSA Obesity hypoventilation CSA due to neuromuscular disease Comorbid OSA / CSA OSA with treatment emergent CSA Ensure adequate ejection fraction (>45%) Obesity hypoventilation syndrome Neuromuscular disease with daytime hypoventilation Associated Professional Sleep Societies, LLC 35
Oral Appliances 10 year followup study Use vs CPAP in positional OSA Predictors of OA adherence Effect on sleepiness Meta-analysis of OA vs CPAP Associated Professional Sleep Societies, LLC 36
77 pts prescribed an OA 3 died, 64 agreed to study 45 still using OSA, 9 on CPAP, 10 no tx 89% of OA pts using nightly, 21/30 OSA pts using OA were adequately treated Those with inadequate response had gained weight Associated Professional Sleep Societies, LLC 37
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Retrospective matched case control study from one center Examined patients with positional vs NP OSA treated with CPAP or OA Showed P-OSA is treated similarly with CPAP or OA; NP-OSA better treated with CPAP JCSM in press Associated Professional Sleep Societies, LLC 39
JCSM in press Associated Professional Sleep Societies, LLC 40
JCSM in press Associated Professional Sleep Societies, LLC 41
70 pts referred for OA, 51 obtained and used for at least 3 months Objective adherence obtained with microsensor Responders AHI reduced by 50%; success = AHI < 5 Completed ESS and side effects questionnaires Associated Professional Sleep Societies, LLC 42
AHI reduced from 14 to 8.3 Mean usage 6.4 hrs/night 82% compliant users, 71% regular users ESS reduced from 10. to 6.8 Side effects common but tolerable Associated Professional Sleep Societies, LLC 43
Compliance did not correlate with ESS, AHI, ODI Did correlate with snoring reduction and presence of dry mouth Associated Professional Sleep Societies, LLC 44
96 pts (91 completed) with EDS and AHI < 30 OA vs placebo device Primary outcomes: ESS, KSS, OSLER, SF36, FOSQ Secondary outcomes: AHI, headache, RLS and insomnia symptoms Associated Professional Sleep Societies, LLC 45
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ESS, KSS, OSLER, SF36, FOSQ not different between groups (53% had ESS > 10) Snoring, AHI, RLS better on active OA Associated Professional Sleep Societies, LLC 47
51 studies: 44 CPAP vs control 3 MAD vs control 1 MAD vs CPAP 3 CPAP, MAD, control Associated Professional Sleep Societies, LLC 48
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What have we learned about OA s? OA s lose efficacy with increasing BMI Work as well as CPAP for positional OSA Reduced adherence associated with lack of snoring control and/or AM dry mouth Work as well as CPAP for reduction in BP Associated Professional Sleep Societies, LLC 51
Surgery in OSA Bariatrics: CPAP use drops off Use of transoral robotic surgery Update on hypoglossal nerve stimulation Associated Professional Sleep Societies, LLC 52
Long term (avg 7.2 yrs) observational study of bariatric surgery pts with OSA PSG done both pre-surgery and one year post-surgery; CPAP use, demographics examined over time 22 patients examined (original study cohort = 25, 1 died postop from PE, 2 lost to followup) Associated Professional Sleep Societies, LLC 53
73% female Mean preop BMI = 51.1 kg/m 2 Avg weight loss at 1 year = 121 lbs Mean preop AHI = 48.2 95% (21/22) had persistent OSA at one year (AHI 24.5); 36% were using CPAP (n = 8) Associated Professional Sleep Societies, LLC 54
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As shown in prior studies, most bariatric patients continue to have OSA after surgery although severity is reduced Meta-analysis showed that 62% have persistent moderate-severe OSA (AHI > 15) Need more data on CPAP adherence in this population as studies to date suggest that usage drops as weight drops, despite continued OSA Associated Professional Sleep Societies, LLC 56
Transoral Robotic Surgery https://med.uth.edu/orl/newsletter/transoral robotic surgery for the treatment of obstructive sleep apnea/ Associated Professional Sleep Societies, LLC 57
TORS is becoming treatment of choice for base of tongue surgeries for OSA This study provides one center s experience with TORS TORS ± epiglottectomy ± UPPP 39 pts with pre and post PSG data Associated Professional Sleep Societies, LLC 58
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Surgical response (50% reduction in AHI + AHI < 15) + resolution of EDS + response in 54% BMI, AHI and velopharyngeal collapse predicted poorer outcomes Associated Professional Sleep Societies, LLC 60
Hypoglossal nerve stimulation Implanted device Receives input from sensing lead to time delivery of stimulation to nerve with onset of inspiration NEJM 2014 study 126 pts (83% male) Reduced AHI by 68%; 29.3 to 9.0 Therapy maintenance group showed sustained reduction Associated Professional Sleep Societies, LLC 61
Hypoglossal nerve stimulation Associated Professional Sleep Societies, LLC 62
VIDEO Associated Professional Sleep Societies, LLC 63
18 Months Data from STAR Trial 123/126 reported on Functional thresholds unchanged 991 days (mean) of safety followup 2 with serious device related event which required re-positioning of transmitter No tongue weakness, rare tongue soreness Sleep 2015;38(10):1593 1598 Associated Professional Sleep Societies, LLC 64
18 Months Data from STAR Trial Sleep 2015;38(10):1593 1598 Associated Professional Sleep Societies, LLC 65
18 Months Data from STAR Trial Sleep 2015;38(10):1593 1598 Associated Professional Sleep Societies, LLC 66
Following STAR trial, FDA approved Inspire device and centers have started implanting This paper describes 1 center s experience of its first 20 patients 19/20 had AHI reduced to < 15 with excellent adherence (Average 7 hrs/nt) Soose etal, OtolaryngolHeadNeck 2016 Associated Professional Sleep Societies, LLC 67
Soose etal, OtolaryngolHeadNeck 2016 Associated Professional Sleep Societies, LLC 68
LSAT unchanged: 79.8% to 82.2% % time < 90% unchanged: 15.5 to 14.1 mins Complications: 2 postop seromas 1 prolonged incision pain 3 AM dry mouth 1 tongue abrasion Soose etal, OtolaryngolHeadNeck 2016 Associated Professional Sleep Societies, LLC 69
Conclusions PAP: not all APAP s are equivalent and even the good ones have their faults BPAP may be salvage therapy for a minority of OSA pts intolerant to CPAP ASV can be used in CHF pts with EF >45%, opioid and treatment emergent CSA (Awaiting ADVENT-HF) Associated Professional Sleep Societies, LLC 70
Conclusions OA s have good long term adherence and efficacy; beware of increased BMI OA s reduce BP as much as CPAP; as effective in reducing AHI vs CPAP in positional OSA OA s adherence may be reduced if pts snoring is not controlled or if they have a dry mouth Associated Professional Sleep Societies, LLC 71
Conclusions Continued CPAP use in bariatrics associated with sustained weight loss TORS has reasonable success rates in base of tongue surgeries HGNS is gaining popularity and appears to have sustained efficacy Associated Professional Sleep Societies, LLC 72