fourth annual ent for the pa-c | april 24-27, 2014 ... - surgical...3/18/2014 1 fourth annual ent...

3/18/2014

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Fourth Annual ENT for the PA-C | April 24-27, 2014 | Pittsburgh, PA

Advances in Sleep Apnea Surgery

Ryan J. Soose, MDDirector, UPMC Division of Sleep SurgeryAssistant Professor, Department of OtolaryngologyUniversity of Pittsburgh


Disclosures

• Research support

– Inspire Medical Systems

• Industry advisory

– Inspire Medical Systems

– Philips‐Respironics


Overview – OSA Surgery Update

1. Scope of the problem– Clinical significance – Need for new therapeutic options

2. Upper airway stimulation– Current technology/surgery– Clinical data (STAR trial)

3. Advanced palatal surgery – History of UPPP and rationale for change– Phenotyping the palate and new treatment options

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OSA Prevalence

• General population (1993 data1): – AHI>5: 24% of men, 9% of

women

– AHI>5 and sleepy: 4% of men, 2% of women

• Increase in obesity Increase in OSA prevalence2,3

• Estimated 12‐18 million patients with OSA in the US

1Young et al. The occurrence of sleep‐disordered breathing among middle‐aged adults. N Engl J Med1993; 328:1230‐5.

2Young et al. Excess weight and sleep‐disordered breathing. J Appl Physiol 2005; 99:1592‐9.

3Newman et al. Progression and regression of sleep‐disordered breathing with changes in weight: The Sleep Heart Health Study. Arch Intern Med 2005; 165:2408‐13.

OSA – Health Care Costs

• Compared annual medical cost prior to Dx of OSA to matched non‐OSA controls – 238 OSA cases: $2720

– 476 controls: $1384

• Conclusions:– OSA patients had higher medical costs (~2x)

– OSA severity correlated with cost

– OSA: $3.4 billion extra cost/yr in US

Kapur V et al. The medical cost of undiagnosed sleep apnea. Sleep 1999; 22:749‐55.

Kapur V . Obstructive Sleep Apnea: Diagnosis, Epidemiology, and Economics. Respir Care 2010; 55: 1155‐67.


Overview

• Upper airway that is too narrow and too collapsible

• Repetitive upper airway obstruction during sleep that impacts:

– Sleep, daytime function, quality of life

– Cardiovascular risk, health, longevity

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Impact on Sleep, QOL, andDaytime Function

• Snoring• Frequent awakenings at night• Frequent urination at night• Unrefreshing sleep• Morning headaches• Memory loss• Difficulty with attention/concentration• Mood disorder/Irritability• Daytime sleepiness (7x increased risk of MVA)*

*Teran‐Santos J et al. The association between sleep apnoea and the risk of traffic accidents. Cooperative Group Burgos‐Santander. N Engl J Med 1999; 340:847‐50.

Impact on CV risk, Health, Mortality:

• Reflux disease

• Systemic hypertension*

• Coronary artery disease

• Atrial fibrillation

• Heart attack*

• Stroke*

• Pulmonary hypertension

• Diabetes/metabolic syndrome

• Dementia

• Mortality***Marin JM et al. Long‐term cardiovascular outcomes in men with obstructive sleep apnoea‐hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet 2005; 65:1046‐53.

**Young T et al. Sleep‐disordered breathing and mortality: eighteen year follow‐up of the Wisconsin Sleep Cohort. Sleep 2008; 31:1071‐8.


Goals:

1. Improve symptoms/quality of life

2. Reduce cardiovascular/health risks

OSA Treatment

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• Anatomical – Craniofacial structure– Nose – Pharyngeal anatomy– Obesity– Airway edema– Surface tension– Lung volume

• Neuromuscular– Pharyngeal sensation– Central respiratory motor

output– Tonic activity of upper airway

dilator muscles– Arousal threshold– Loop gain (peripheral and

central chemoreceptor response)

Pathophysiolgy of OSA

Dempsey JA et al. Pathophysiology of sleep apnea. Physiol Rev 2010; 90:47‐112.

Pathophysiology of OSA• Neuromuscular feedback loop or

negative pressure reflex

• Defective compensation in OSA patients

• Possible causes?

• Central hypoxic injury

• Systemic inflammation

• Vibrational trauma (snoring)

White DP. Pathogenesis of obstructive and central sleep apnea. Am J Resp Crit Care Med 2005; 172:1363‐70.

Pathophysiology of OSA

• Hypoglossal nerve conduction study• 16 adult OSA patients• Results

– 75% had delayed distal latency– 100% had low motor amplitude

• Conclusions– OSA patients have impaired hypoglossal nerve conduction– Neuromuscular dysfunction of the upper airway may be part of the pathophysiology and/or a consequence of untreated OSA

Ragab SM. Hypoglossal nerve conduction studies in patients with obstructive sleep apnea. Egypt J Otolaryngol 2013; 29:176‐81.

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• Anatomical – Craniofacial structure– Nose – Pharyngeal anatomy– Obesity– Airway edema– Surface tension– Lung volume

• Neuromuscular– Pharyngeal sensation– Central respiratory motor

output– Tonic activity of upper airway

dilator muscles– Arousal threshold– Loop gain (peripheral and

central chemoreceptor response)

Treatment of OSA • Positive pressure• Oral appliance• Weight loss• Surgery

• Medications?• Oropharyngeal exercises?• Electrical stimulation?

Phenotyping OSA patient/airway may have therapeutic implications

OSA Treatment

• Options:• CPAP/BIPAP• Oral appliance• Surgery• Weight loss• Adjunctive measures:

– Positional therapy– Smoking cessation– Treating allergies, reflux– Orthodontics

• New/emerging options

Positive pressure therapy (CPAP)

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CPAP: Effectiveness

• ↓Snoring, nocturnal awakenings, nocturia, ESS, motor vehicle accidents

• ↑ Neurocognitive function, QOL measures

• ↓CV events, cardiac arrhythmias, heart failure, blood pressure

Campos‐Rodriguez F, Pena‐GrinanN, Reyes‐Nunez N, et al. Mortality in obstructive sleep apnea‐hypopnea patients treated with positive airway pressure. Chest 2005;128:624.

Marin JM et al. Long‐term cardiovascular outcomes in men with obstructive sleep apnoea‐hyponoea with or without treatment with continuous positive airway pressure: an observational study. Lancet 2005; 65:1046‐53.

CPAP: Adherence

• CPAP is an effective first‐line therapy for OSA patients who use it consistently

• Results intimately tied to usage or ‘adherence’

• Minimum adherence definition: 70% nights, 4h/night.

• CPAP adherence rates– APPLES Study (2012): 39% CPAP adherence at 6‐months1

– Home PAP Study (2012): 39% (Lab) and 50% (Home) CPAP adherence at 3 months2

• Many factors limit adherence31Kushida CA et al. Effects of CPAP on neurocognitivefunction in OSA patients: the APPLES. Sleep 2012;36:1593‐1602.

2Rosen CL et al. A multisite randomized trial of portable sleep studies and PAP autotitration vs laboratory based PSG for the diagnosis and treatment of OSA: the Home‐PAP study. Sleep 2012;36:757‐67.

3Soose RJ, Strollo PJ. Medical therapy for obstructive sleepapnea. In Bailey’s Head and Neck Surgery – Otolaryngology, ed Johnson JT 2013.


Need for New OSA Treatment Options

1. Lack of treatment options targeting the neuromuscular pathophysiology

2. Suboptimal adherence rates with CPAP, oral appliances, and other medical device therapy

3. Morbidity/risk and lack of high quality data for traditional upper airway surgical procedures

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Electrical stimulation of the tongue

Oliven A et al. Effect of coactivation of tongue protrusor and retractor muscles on pharyngeal lumen and airflow in sleep apnea. J Appl Physiol 2007; 103:1662‐8.

Oliven A et al. Effect of genioglossus contraction on pharyngeal lumen and airflow in sleep apnoea patients. Eur Resp J 2007; 30:748‐58.


Implantable stimulation technology

• Spinal cord stimulation for pain

• Vagal nerve stimulation for seizures

• Sacral nerve stimulation for incontinence

• Deep brain stimulation for tremors

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Implantable HNS

Implantable HNS

Mu L et al. Human Tongue Neuroanatomy. Clin Anat 2010; 23:777‐91.

Implantable HNS

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Device Titration


Device Titration

Hypoglossal nerve stimulation: DISEPalate

Therapy OFFPalate

Therapy ON

Posterior oropharyngeal

wall

Posterior Uvula

LR

P

Epiglottis

Lingual Tonsils

LR

P

LR

P

LR

P

Reference: 2 slices

Palate

Tongue-Base

Tongue BaseTherapy OFF

Tongue BaseTherapy ON

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STAR Trial: Overview

• Prospective multicenter trial– Mod ‐severe OSA– CPAP intolerance– BMI ≤ 32.

• All underwent a screening– PSG (AHI: 20‐50)– Surgical consultation– Drug‐induced sleep endoscopy (DISE)

• Subjects were followed for at least 12 months to assess efficacy and adverse events

• Randomized therapy withdrawal arm at 12 months


Outcome measures• Primary outcomes

– AHI

– ODI (4%)

• Secondary outcomes

– ESS

– FOSQ

Follow‐up• New baseline PSG @1mo followed by

office visit and device activation

• Office visits, ESS, and FOSQ @ 2, 3, 6, 9, and 12mo

• PSGs @ 2, 6, and 12mo

Randomization• First 46 consecutive responders

randomized 1:1 to

– Therapy maintenance

– Therapy withdrawal

• Repeat PSG, ESS, and FOSQ at 1 week

STAR Trial

Characteristics Mean ± SD or N (%)Age, year 54.5 ± 10.2Male sex, no. (%) 83%Caucasian race, no. (%) 97%

Body Mass Index, kg/m2 28.4 ± 2.6

Neck size, cm 41.2 ± 3.2Systolic BP, mmHg 128.7 ±16.1Diastolic BP, mmHg 81.5 ± 9.7Hypertension, no. (%) 38%Diabetes 9%Asthma 5%Congestive heart failure 2%

Prior UPPP, no. (%) 17%

STAR Trial: Baseline characteristics (n=126)

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25.4

7.4

0

5

10

15

20

25

30

35

40

Baseline Month‐12

29.3

9.0

0

5

10

15

20

25

30

35

40

Baseline Month‐12

Primary Outcome Measures: Median AHI and ODI (n = 124)

68% reduction in AHI from baseline to Month‐12

70% reduction in ODI from baseline to Month‐12

AHI ODIp < 0.0001 p < 0.0001

2/3 of patients were ‘responders’: AHI 30 6


14.6

18.2

12

13

14

15

16

17

18

19

20

Baseline Month‐12

11.0

6.0

2

4

6

8

10

12

14

Baseline Month‐12

Secondary Outcome Measures: ESS & FOSQ (n = 123)

ESS FOSQ

p < 0.0001 p < 0.0001

31.3

7.2 8.9

30.1

7.6

25.8

0

5

10

15

20

25

30

35

Baseline Month‐12 RCT

AHI

Maintenance Group (N=23) Withdrawal Group (N=23)

Randomized Controlled Therapy Withdrawal @ Month‐12

p < 0.0001

p = n.s.

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• Serious: Device‐related – 1% Device revision

• No permanent hypoglossal nerve weakness• No serious infection requiring device explant• Non Serious: Procedure‐related

– ~ 25% Pain (minimal, most did not require narcotics ‐substantially less than UPPP)

• Non‐Serious: Device‐related– ~ 33% Tongue discomfort / abrasion (time limited)– 1% Mild or Mod Infection (cellulitis)

Summary of relevant adverse events


• 98% (124/126) of implanted participants remained active users of UAS therapy at 12‐month follow‐up. – One participant died unexpectedly due to an unrelated cause

– One participant requested a device removal for personal reasons.

• Self‐reported usage at 12 months:– 86% (106/123) still using the device daily

– 93% (115/123) using device at least 5 days a week.

• The UAS device registers the cumulative hours of stimulating pulses duration since last device interrogation. – Average stimulation time was 2.6 hours/night

– Equates to approximately 5.2 hours/night + delay/ramp time.

Adherence Data


• Long‐term safety and adherence?• Long‐term effectiveness?• Most appropriate patient/airway phenotypes?• Proper stimulation parameters and titration protocol?• New technology development?

– Smaller device– MRI compatibility– Improved patient programmer

• Role of combination therapy?– Upper airway stimulation + oral appliance– Upper airway stimulation + palatal surgery

Questions and future directions

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Conclusions

• Advantages– Sustainable multilevel

treatment of mod-sev OSA in carefully selected patients

– Good patient acceptance/adherence

– Low morbidity

• Disadvantages– MRI incompatibility

– Cosmesis/external incisions

– Possible tongue abrasion

Upper airway stimulation may provide…• Alternative for patients who are CPAP intolerant• Adjunct to oral appliance or airway surgery• More physiological approach to treat OSA• Insight into phenotyping OSA patients






History of UPPP

Fujita et al. Surgical correction of anatomic abnormalities in obstructive sleep apnea syndrome: uvulopalatopharyngoplasty. Otolaryngol Head Neck Surg1981; 89:923‐34.

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• 37 papers, ~500 patients

• “Success” = RDI <20 and 50% reduction OR AI <10 and 50% reduction

• 41% success rate

History of UPPPMetric Preop Postop Mean change

RDI 60 27 55%

AI 45 28 38%

Sher et al. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome. Sleep. 1996; 19:156‐77.


UPPP – Effectiveness

• VA cohort: 18,754 CPAP; 2,072 UPPP

• 31% greater mortality with CPAP than UPPP (Adjusted for age, gender, race, year of treatment, and

comorbidities)

• Supports notion that partially effective treatment may provide benefit compared to therapy with significant non‐adherence

Weaver EM, et al. Survival of veterans with sleep apnea: continuous positive airway pressure versus surgery. OtoHead Neck Surg 2004; 130:659‐65.


UPPP – Morbidity

• 3130 UPPP VA patients reviewed 1991‐2001– 68% had another procedure– 31% smokers

• Serious complications – uncommon (1.6%): pneumonia, resp failure, MI, DVT, hemorrhage

• Other side effects – common and potentially very bothersome and irreversible: globus/mucous sensation, dry throat, VPI, dysphagia, change in taste

Kezirian EJ, Weaver EM, et al. Incidence of serious complications after uvulopalatopharyngoplasty. Laryngoscope2004; 114:450‐453.

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• Why does surgery fail?

• Do we have the proper procedures?

• 84% of patients with persistent OSA after UPPP still have primarily palatal/oropharyngeal obstruction

Improving treatment outcomes

Woodson BT, Wooten MR. Manometric and endoscopic localization of airway obstruction after UPPP. Otolaryngol Head Neck Surg 1994; 111:38‐43.

7 Responders

(AHI 14 4)

13 Non‐responders

(AHI 14 25)

Improving treatment outcomes

Langin et al. Upper airway changes in snorers and mild sleep apnea sufferers after UPPP. Chest 1998; 113:1595‐1603.


Reduce morbidity

• Reconstructive approach (rather than excisional/destructive)– Maximal mucosal preservation– Minimal thermal injury (less electrocautery)– Uvular preservation

• Improved perioperative medical care– IV tylenol– Carafate suspension– Steroids– NSAIDs/Cox‐2 Inhibitors– Humidifier

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Uvula ‐ Function

• Muscle contraction during speech and swallowing– Highest concentration of type II (fast‐twitch) muscle fibers in the human body

– Rapid superior/posterior movement of velum

• Induction of mucosal tolerance to inhaled and ingested antigens

Finklestein Y et al. The riddle of the uvula. Otolaryngol Head Neck Surg 1992; 107:444‐51.

Olofsson et al. Human uvula: characterization of resident leukocytes and local cytokine production. Ann Otol RhinolLaryngol 2000; 109:488‐96.

Uvula ‐ Function

• “Highly organized lubricating organ”• Highest concentration of serous glands (rest of soft palate mucous glands)– Large storage ducts– Activated by muscle contraction– Capable of quickly secreting large volume of thin saliva

• Theory: uvula bastes the posterior pharyngeal wall

Back GW et al. Why do we have a uvula?: literature review and a new theory. Clin Otolaryngol 2004; 29: 689‐93.

Finklestein Y et al. The riddle of the uvula. Otolaryngol Head Neck Surg 1992; 107:444‐51.

Phenotype the anatomy:Drug‐induced sleep endoscopy (DISE)

• Evaluate anatomical locations and pattern of obstruction (NOT “site” or “level”)

• Phenotype the skeletal and muscle buttress components

• Assess the impact of mandibular advancement or patient’s oral appliance

• Predict proper treatment plan

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Patterns of palatal obstruction

Maxillary retrusionVertical soft palateAP/coronal closure

Open maxillaOblique soft palateCircumferential closure

Endoscopic view

Woodson et al. Expansion sphincter pharyngoplasty and palatal advancement pharyngoplasty: airway evaluation and surgical techniques. Operative Tech Otolaryngol 2012; 23:3‐10.

Expansion sphincter pharyngoplasty (ESP)

• Ideally suited for:

– Large lateral wall component

– Circumferential collapse

– Oblique configuration

• Mucosal‐sparing technique

Pang K, Woodson BT. Expansion sphincter pharyngoplasty: a new technique for the treatment of obstructive sleep apnea. Otolaryngol Head Neck Surg 2007; 137:110‐114.

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Expansion sphincter pharyngoplasty

Woodson et al. Expansion sphincter pharyngoplasty and palatal advancement pharyngoplasty: airway evaluation and surgical techniques. Operative Tech Otolaryngol 2012; 23:3‐10.

ESP ‐ Intraop


ESP ‐ Intraop

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• AHI‐50 (supine 80), O2 nadir‐71%, 50% sats <90.

• AHI‐4, 99.9% sats >90

ESP – Postop

ESP – Preop/Postop

ESP ‐ Data

• Prospective randomized controlled trial• Compare efficacy of ESP vs UPPP• 45 patients

– Small tonsils– Friedman II or III– Lateral wall collapse– BMI <30– CPAP intolerance

• Randomized to UPPP (22) or ESP (23)• Postop PSG at 6 months

Pang K, Woodson BT. Expansion sphincter pharyngoplasty: a new technique for the treatment of obstructive sleep apnea. Otolaryngol Head Neck Surg2007; 137:110‐114.

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Transpalatal advancement (TPA)• Ideally suited for:

– Maxillary retrusion

– Coronal/A‐P collapse

– Vertical configuration

• Mucosal‐sparing technique

Woodson BT, Toohill RJ. Transpalatal advancement pharyngoplasty for obstructive sleep apnea. Laryngoscope1993; 103:269‐76.

• AHI: 52.8 to 12.3 (n= 11)• Assessment of postoperative cross‐sectional area and airway collapsibility

• Maximal retropalatal airway size increased: 29.7 to 95.3 mm2 (321%)

• Pcrit decreased: 4.7 to ‐3.8 cm H2O (‐8.5)

Transpalatal advancement – data

Woodson BT. Changes in airway characteristics after transpalatal advancement pharyngoplasty compared to UPPP. Sleep 1996; 19:S291‐3.

Woodson BT. Retropalatal airway characteristics in UPPP compared with transpalatal advancement pharyngoplasty. Laryngoscope 1997; 107:735‐40.

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• Odds ratio of “success” with TPA vs UPPP = 5.8

(after controlling for BMI and concomitant tongue procedures)

• Fistula rate – 12%

Transpalatal advancement – data

Woodson et al. Transpalatal advancement pharyngoplasty outcomes compared with uvulopalatopharyngoplasty. Otolaryngol Head Neck Surg2005; 133:211‐7.

Anterior palatoplasty and final remarks

Pang et al. Anterior palatoplasty for the treatment of OSA: three year results. Otolaryngol Head Neck Surg2009; 141:253‐6.

• Prospective study – 77 patients

• Friedman II, BMI <33

• Anterior palatoplasty +/‐tonsillectomy

• ESS 16.2 7.9

• Mean AHI 25.3 11.0

• 71% “success rate”

• Quick, easy to perform, minimal discomfort, low morbidity

ESP TPA


• “Cookie‐cutter” approach does not work• Different palate configurations and anatomical patterns of

obstruction.• Phenotype OSA patients based on the anatomy and

pathophysiology – not just the AHI.• Muscular and skeletal anatomy (not mucosa) determine

airway structure• Integrate this anatomy into surgical technique• Customize the treatment plan to each individual patient.• Employ more reconstructive and physiologic surgical

techniques to improved effectiveness and reduce morbidity

Palatal surgery ‐ Summary

fourth annual ent for the pa-c | april 24-27, 2014 ... - surgical...3/18/2014 1 fourth annual ent...

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