pap compliance and when all else fails.… · • lsg-laparoscopic sleeve gastrectomy ... (28kg)...
TRANSCRIPT
Rochelle Goldberg, MD, FCCP, FAASM
Diplomat, American Board of Sleep Medicine
Director, Sleep Medicine Services
Main Line Health
Lankenau Medical Center and Paoli Hospital
PAP Compliance
and
When All Else Fails
Disclosures
• Speaker: Teva, UCB, Purdue
• Advisory Board: Welltrinsic Sleep Network
• Consultant: Vapotherm, Inc.
• National Interpretor: Novasom
Compliance: The Dirty Secret • Medical Treatment
Acute illness:
• 20-40%
• Chronic illness:
• 30-60%
• Prevention:
• 80% Christensen AJ, Current Perspectives
in Psychology2004.
PAP Compliance
50 % of patients
discontinue CPAP in
the first year. Collen J et al: Chest 2009;135:704
46-83% of patients are
non-compliant;
defined by PAP < 4
hours/ night. Weaver TE, Proc Am Thorac Soc.
2008
PAP Compliance and CMS • Guidelines
– > 4 hours per night
– > 70% of nights
– Days 31-90
Most commercial
plans have adopted
same guidelines
• Benefits and
limitations
• Availability of
objective date,
emphasis on this
• Does not allow
leeway (clinical
realities)
Predictors: Good Compliance • Older patient, female
• Severe OSA (>30/hour)
• Early benefit (<7 days); improved sleepiness
• Mask comfort, humidification
• Partner support
• Health care support/education
• Behavioral readiness to change
• Self-management of chronic illness --SmithI, Cochrane Database of Systematic Review 2004; 4. Art. No.
CD003581.
Predictors: Poor Compliance Young and/or single adult
Mild OSA; high PAP level
Limited education on diagnosis and treatment
Limited partner, family support
Claustrophobia
Ongoing symptoms
Depression, dementia, language barrier
Denial- no “ownership of the problem”
Side effects (skin irritation, nasal congestion) --Smith I, Cochrane Database of Systematic Review 2004; 4. Art. No.
CD003581.
Non-CPAP Treatment of Sleep
Apnea: What are the Options?
• Behavior
• Devices
• Surgery
• Oxygen and Drugs
Behavioral Treatment
• Weight loss
• Avoidance of supine sleep
• Smoking cessation
• Avoidance of muscle relaxants
• Avoidance of sleep deprivation
• Exercise
• Playing a musical instrument
Question 1:
Which of the following is most correct about
behavioral treatments for sleep apnea?
A. There are no other effective treatments besides PAP
therapy.
B. Weight loss may result in significant improvement in
apnea.
C. Sedative medications may help improve sleep apnea.
D. Voice training may strengthen the upper airway.
Weight Loss for OSA
• 65% of Americans are overweight or
obese (Flegal KM, JAMA 2010)
• Only 1 in 6 adults reports maintaining a
10% weight loss for 1 year (Kraschnewski JL,
Int J Obes 2010)
• Modest (10%) weight loss results in
significant improvement in AHI (Yee BJ, Int J
Obes 2006)
CPAP Users Gain Weight (Quan SQ JCSM 2013) • N
Weight change
at 6 months
active vs.
sham CPAP Apples
trial (n=812,
p<0.001)
Change in Weight and RDI (Newman AB Arch Intern Med 2005, SHHS)
Which Weight Loss Program is Best?
RCT of 658 obese individuals.
Weight Watchers
Slimming World: group-based, community-set; 90 minute sessions with
goals set by participant; website access, awards for achievements
Rosemary Conley: group-based, community-set; 90 minute sessions with
goals set by participant
Size Down: NHS program in community with dietetic workers; 6 weekly 2
hour session, f/u 9 and 12 wks.
General practice and pharmacy: 12 one-to-one sessions, with education,
goals, motivation.
Comparator/Exercise: vouchers for 12 free exercise sessions at a local
leisure center. --JollyK, BMJ 2011
Conclusions/Caveats
• All programs resulted in significant weight loss at
12 weeks.
• Only the commercial programs resulted in
significant weight loss at one year.
• Commercial programs were less expensive than
primary care programs.
• The greatest weight loss was with Weight
Watchers.
• Weight Watchers funded the study.
Bariatric Surgery Improves
Comorbidities(Dumon K Surg Clin NA 2011)
• AGB (LAGB)-adjustable gastric banding
• RGB (RYGB- Roux-en-Y gastric bypass (most common
procedure, by far)
• BPD (DS) biliopancreatic diversion + duodenal switch
• LSG-laparoscopic sleeve gastrectomy
Bariatric Surgery or
Conventional Weight Loss? • Laparoscopic gastric bypass is probably surgical treatment of
choice
• Complications are significant
– 10% morbidity/ 1% mortality
• Bariatric Surgery results in 75-88% cure rate of OSA at 1 year, independent of approach
--GuardianoSA, Chest 2003; CrooksPF, Ann Rev Med 2006
• Surgical group lost more weight (28kg) than diet (5kg) but improvement in AHI was not statistically significantly different (-28 vs -11 events/hr)
-- Surgical vs conventional therapy for weight loss.Dixon, JAMA 2012
Sleeping Position and OSA
• Up to 50% of patients have position-dependent
OSA. These patients may be thinner, milder,
younger. --Richard W Eur Arch Otolaryngol 2006
• Position-dependent OSA may be defined as a
difference of 50% or more in AHI between
supine and non-supine positions.
Positional Therapy
• Snoring-reduced in non-apneic patients, but not in apneic
ones. (7 studies; 118 pts)
• OSA- all studies show “positive effect” on AHI, and self-
reported compliance is better than CPAP.(16 studies; 293 pts)
• Side effects: backache, discomfort, no benefit.
--Ravesloot MJL Sleep Breath 2012
• Positional therapy is an effective secondary RX or can be a
supplement to primary therapies for OSA in patients who
have a low AHI in the non-supine position.
• --Practice Parameters for Medical Therapy of OSA, MorganthalerT Sleep
2006
Cigarette Smoking and OSA
• Most data indicates relationship.
• Second-hand smoke appears to be a
risk for snoring.
–FranklinKA, AJRCCM 2004
• Ex-smokers do NOT appear to have
increased risk for OSA.
• Parental smoking appears to be a
risk for SDB in children.
–KadatisAG, Ped Pulm 2004; SnowA, Ped
Pulm 2009
Alcohol and OSA
“Most but not all studies … have
demonstrated harmful effects on
nocturnal respiration, including
increased number and duration of
hypopnea and apnea events.”
--Young T, AJRCCM 2002
Sleep Deprivation and OSA
• Sleep deprivation does not consistently
worsen sleep apnea. --Desai AV Sleep 2003, n=39
• Sleep deprivation worsens SDB.
--Series F AJRCCM 1994, n=8
• Treated OSA patients drive as safely as
controls, but are worse after sleep
deprivation. --Filtness AJ Sleep Med 2011, n=19
OSA: Sleep Deprivation and Alcohol (Vakulin A Ann Intern Med 2009 n=58)
For sleep-deprived vs not
For alcohol vs not
Exercise for OSA
• 4275 SHHS participants
• > 3 hrs/week of self-reported vigorous
exercise reduced risk of AHI > 15
• Similar but weaker associations for less
vigorous exercise or different definitions of
OSA --Quan SF, Sleep Breath 2007
Exercise for OSA: Interventions
• RCT for 12 weeks (n=20)
– Exercise group-improved AHI, FOSQ, SF-35 but not
BMI compared with baseline, but not with control. -- Sengul YS Sleep Breath 2011
• Supervised exercise for 6 months (n=11) – Decrease in RDI (33 to 24), no change in BMI
--Biebelhaus KP Sleep Breath 2000
• Supervised exercise for 6 months (n= 9) – Decrease AHI,improved sleep, reduced BMI
--Norman JF Sleep Res Online 2000
Playing a Musical Instrument
• Musicians playing a double reed
instrument** had reduced risk of OSA, by
Berlin score, compared to non-wind
instruments. Number of hours predicted
lower risk. --Ward CP JCSM 2012
• Digeridoo playing improved sleepiness
and AHI compared with not playing with
OSA in an RCT --Puhan MA BMJ 2006, n=25
Non-CPAP Treatment of Sleep
Apnea: What are the Options?
• Behavioral Changes
• Devices (OAT, EPAP, OPT)
• Surgery
• Oxygen and Drugs
Question 2 MC is a 55 year old woman followed for severe
sleep apnea. She is doing well with PAP but just
saw her dentist who recommended an oral
appliance (OAT). Which of the following would you
advise?
A. OAT is as effective as PAP for improving AHI.
B. Patients are more likely to adhere to PAP than OAT.
C. Side effects include jaw discomfort and bite changes.
D. She should try a boil and bite device first.
Indications for Oral Appliances (Kushida C, Sleep 2006)
– Primary snoring
– Mild to moderate OSA patients who:
• Prefer OAs to CPAP
• Do not respond to CPAP
• Are not appropriate candidates for CPAP
• Fail treatment attempts with CPAP or behavioral changes
– Patients with severe OSA should have an initial trial of
nasal CPAP [before considering OAs]
– Upper airway surgery may also supersede use of OAs in
patients for whom these operations are predicted to be
highly effective in treating sleep apnea
Rigid, Non-adjustable and
Movable, Adjustable Appliances
OAT: How it Works; Compliance
• 1 year compliance (48-
84%)
• 4 year compliance (62% and 76%) De Almeida, J Clin Sleep Med, 2005
OAT vs CPAP & UPPP
OAT v PAP
• CPAP is more
effective in
improving AHI
• Adherence was
better with the
OA.
• Pts preferred the
OA over CPAP.
OAT v UPPP
• 4 year success
– 50% decrease RDI
– OAT 81% v 53% UPPP
• Normalization
– AHI< 10, AI<5
– OAT 63% v 33% UPPP
• Compliance
– OAT 62%
– UPPP 75% (no further RX)
Side Effects of Oral Appliances • Very common; usually minor transient; resolve
quickly with appliance removal
• Dry mouth
• Increased salivation or drooling
• Tooth soreness or looseness
• Jaw or muscle discomfort
• Bite changes (jaw remains in forward position, improvement accelerated with squeezing back teeth together (chewing gum); repositioners
Oral Appliances: Summary Indicated for patients with mild-to-moderate
obstructive sleep apnea who prefer oral appliances to CPAP
do not respond to CPAP
are not appropriate candidates for CPAP
fail treatment attempts with CPAP (Kushida Sleep 2006)
Not as effective as CPAP
Lower blood pressure 3-4 mmHg (Otsuka Sleep Breath
2006; Yoshida K, Int J Prosthodont 2006)
Outperformed surgery in the only head-to-head trial.
Preferred to CPAP in head-to-head trials.
Caveats About OA’s
• They may not work as well for non-
position-depending sleep apnea (Lee
CH Arch Otolarngol Head Neck Surg
2012).
• Non-adjustable, “boil and bite” OA’s
do not work as well as custom-made
ones (Ahrens A, Eur J Orthodon,
2011)
Expiratory Positive Airway Pressure (EPAP) Mean BMI 32-34; mild to
moderate AHI
– EPAP reduced AHI from
13.8 to 5 at one week, and
from 14.4 to 5.6 at 3
months.
– Oxygenation also improved
– “Severe” subset : AHI fell
from 48 to 19
– Reported adherence 88%
– Note:1013 refused to
participate
--Berry, RB Sleep 2012
Oral Pressure Therapy (ApniCure)
Oral Pressure Therapy (WINX) Malhotra A et al, ATS 2012 ABSTRACT, n=60
Upper Airway Stimulation for OSA
Results, n=126 (Means/Medians, all significant)
Outcome Baseline 12 months
AHI 32/29.3 15/9.0
ODI 28.9/25.4 13.9/7.4
% time with Sa02<90% 8.7/5.4 5.9/0.9
FOSQ 14.3/14.6 17.3/18.2
Epworth 11.6/11.0 7.0/6.0
• Withdrawal
phase (n=46)
• Device turned off
for 5 days in 23
patients
• Means+SD, all
significant
Non-CPAP Treatment of Sleep
Apnea: What are the Options?
• Behavioral Changes
• Devices
• Surgery
• Oxygen and Drugs
Rationale for Surgical Treatment of Sleep Apnea
• Sleep apnea is prevalent (~5%, Young,
2002)
• Sleep apnea kills (needs treatment !)
• CPAP compliance is problematic
• Some individuals have physical
obstruction contributing to or causing the
sleep-disordered breathing (2% of adult
OSA patients, Sher)
Surgical Approaches to SDB • -nasal septal surgery
• -turbinate reduction surgery
• -Somnoplasty turbinate reduction
• -Uvulopalatopharyngoplasty
• -partial uvulectomy/ Pillar Procedure
• - CO2 laser palatoplasty (LAUP)
• -uvulopalatal flap
• -Woodson Procedure (transpalatal palatopharyngoplasty)
• -Somnoplasty - turbinate reduction - tongue base reduction - soft palate for snoring
• -adenoidectomy
• -Tonsillectomy (total/ partial)
• -lingual tonsillectomy
• -tongue base reduction
• -epiglottectomy
• -epiglottoplasty
• -glossectomy (anterior vs. posterior)
• -linguoplasty (CO2)
• -tongue-base suspension sutures (Repose procedure)
• -hyoid suspension and advancement to mandible
• -hyoid myotomy and suspension to thyroid cartilage
• Expansion hyoidplasty
• -geniotubercle/genioglossus skeletal advancement (with multiple variants)
• -jaw advancement (telegnathic) surgery (LeFort I, Bilateral Sagittal split Advancement Osteotomies)- ? Distraction Osteogenesis
• -maxillary transverse expansion
• -tracheostomy
• -hyoepiglottoplasty
• -Genioglossus electrical pacing (hypoglossal nerve stimulation)
Surgery and OSA: The History
“There is an urgent need for high quality randomised controlled trials to
be carried out in the field of surgery for obstructive sleep apnoea.” –
Cochrane, 2000
“ The studies assembled in the review do not provide evidence to support
the use of surgery in sleep apnoea/hypopnea syndrome, as overall
significant benefit has not been demonstrated…” –Cochrane, 2005
“The published literature is comprised primarily of case series, with few
controlled trials and varying approaches to preoperative evaluation
and post-operative follow-up…Further research is needed to better
clarify patient selection, as well as efficacy and safety of upper airway
surgery in those with OSA.”—Caples, Sleep 2010
“Surgical treatments are associated with risks and harms. Current
evidence evaluating surgery was limited and insufficient to show the
benefits of surgery as an approach to treat OSA; therefore, surgery
should not be used as an initial treatment of OSA.” -- ACP
CPG:Management of OSA in Adults, Ann Int Med 2013
Tracheostomy • The surgical “gold standard” for OSA
• Success 100% (Thatcher, 2003, n=79)
• Early cure in 83% – residual central apneas resolve over time
• Significant endpoints: – Sleepiness resolves in 82-100%
• 3 studies with 98 patients
– Hypertension improves or resolves
– Hypercapnia, cor pulmonale, and cardiac arrhythmias resolve
• Morbid procedure (Conway W, Jama 1981)
– Psychosocial problems,local granulation,recurrent bronchitis
Question 3 Which of the following is most correct
regarding UPPP treatment for sleep apnea? A. The success rate (reduce AHI by 50%) is over 75%.
B. The relapse rate (recurrence of OSA) is about 15%.
C. AutoPAP is preferred for patients failing UPPP.
D. Patients are less likely to accept PAP after UPPP
failure.
UPPP OUTCOMES SHORT TERM:
Mean decrease AI 55%; RDI 38%
Success: 60-67% (reduce AHI by 50%)
Complications: velopharyngeal insufficiency, post-op
bleeding, voice change, death
LONG TERM:
Success rate after > 4 years 44-50%
50% relapse rate (often related to weight gain)
Limited long term studies; limited comprehensive reports
of adverse events.
Maxillomandibular Advancement (MMA)
• Success rates >90%
– Carefully selected
patients
– Best outcomes in
patients with “birdlike”
facies (i.e. mandibular
deficiency
• Prinsell 2002
CPAP After Surgery: Long Term
Follow up • Compliance/acceptance are lower than non-
surgerical patients (Han F Sleep Breath 2006).
• Lower pressures may be required than pre-operatively.
• Higher pressures may be required.
• A chin strap or full face style masks may be required to prevent air leak.
• Autotitrating CPAP is contraindicated.
Non-CPAP Treatment of Sleep
Apnea: What are the Options?
• Behavioral Changes
• Devices
• Surgery
• Oxygen and Drugs
Oxygen Compared to CPAP
for OSA • Improves Sa02, but not sleep quality Loredo JS, Sleep 2006
• Improves Sa02, but does not lower blood
pressure Norman D, Hypertension 2006
• Improves Sa02 and neuropsychological
tests, but does not improve MSLT
Phillips B, Chest, 1988
Drugs for OSA
“There is insufficient evidence to recommend the use of drug therapy in the treatment of OSA. For fluticasone, mirtazipine, physostigmine and nasal lubricant, studies of longer duration are required to establish whether this has an impact on daytime symptoms. It is likely that better matching of drugs to patients according to the dominant mechanism of their OSA will lead to better results and this also needs further study.”—Cochran 2006
Practice Parameters for Medical
Therapy of OSA (Morganthaler T Sleep 2006)
• SSRI’s, protriptyline, xanthines, estrogen are not recommended.
• Modafinil is recommended for Rx of residual daytime sleepiness in OSA patients who have sleepiness despite effective PAP Rx and who are lacking any other identifiable cause for their sleepiness.
• Oxygen supplementation is NOT recommended as a primary treatment for OSA.
• Topical nasal steroids may improve AHI in those with rhinitis.
Non-PAP Treatment for OSA: Bottom Line
• Even modest weight loss helps. Bariatric surgery
provides most evidence for weight loss effects on
OSA.
• Oral appliances are now vetted as reasonably
effective second-line Rx.
• Stay tuned on newer devices and treatments.
• MMA may be effective in very carefully selected
patients.
• Oxygen improves oxygenation, but not much else.
• Drugs are not appropriate as monotherapy.