In-Lab Titration. The New Standard of Care in Oral Appliance Therapy

Transcription

1 In-Lab Titration The New Standard of Care in Oral Appliance Therapy

2 Dr. Jonathan S. Lown, MD Clinical Director Delta Sleep Center of Long Island Certified in the areas of Sleep, Internal Medicine and Lipidology Assistant Professor of Medicine, Stony Brook University Medical School 1995-present Diplomate: Sleep Medicine, American Board of Internal Medicine present Internal Medicine, American Board of Internal Medicine present Diagnosed with OSA in 2000; Compliant CPAP user for 15 yrs

3 Prevalence of Sleep Apnea Last night 200 million people were apneic while they slept Current estimates of prevalence are 20% Approximately 80-90% of apneics in the USA are undiagnosed 3

4 Incidence of Sleep Apnea Every 8 years, 25% of males contract sleep apnea Every 8 years, 15% of females contract sleep apnea Every year, 7 million Americans contract sleep apnea 4

5 US OSA Population Segmented by Severity, Diagnosis Status and Treatment Type 100% 90% 307M 52M OSA Population 52M 12M Severe OSA 23M 4.1M Diagnosed 4.1M 80% 70% 60% 255M Non-OSA Population 11M Moderate OSA 18.9M Undiagnosed 50% 40% 29M Mild OSA (AHI 5-15) 30% 20% 10% 0% Total US Population Segments of OSA Population Addressable OSA Population Treatment of Diagnosed Addressable Population Appliance Surgery Untreated Price of Fatigue Report 2011 Source: McKinsey & Company analysis; Harvard Medical School, ResMed I

6 Improving our practice of sleep medicine Patient-centered management based on objective assessment of treatment options Importance of long-term outcomes in sleep apnea 6

7 OSA -Why does it Matter? Stimulate a sympathetic response ( fight or flight response, stress response) Increased Sympathetic tone -increased heart rate + blood pressure, Studies have showed: Increased tonic chemoreflex drive Abnormalities in HR and BP variabilities during normal waking hours in patients with OSA Repeated stimulation Chronic Increased sympathetic tone during the day HTN, CVD and Insulin Resistance/Diabetes, Increased Morbidity+Mortality Our goal in treatment is to reduce sympathetic activation during sleep, independent of how the patient feels. Analogy of HTN Rx

8 OSA -Why does it Matter?

9 Impact and Associations of OSA 30% of hypertensive patients have OSA 80% of Drug Resistant HTN have OSA 54% of angina patients have OSA 49% of Afib patients have OSA cardiovascular deaths related to OSA annually 70% percent of OSA patients are obese Up to 50% of Type 2 Diabetes patients have OSA Combination Obesity(BMI>30) + Type 2 DM -87% Chance of OSA 30-50% of CHF patients have OSA Wisconsin study untreated severe OSA can take 6.7 years off your life 1. Somers VK, et al. Circulation. 2008;118(10: ; 2. Somers VK, et al. J Am Coll Cardiol. 2008;52(8): Sjöström C, et al. Thorax. 2002;57(7): ; 4. Ruttanaumpawan P, et al. J Hypertens. 2009;27(7): ; 5. Le Jemtel TH, et al. J Am Coll Cardiol. 2007;49(15): ; 6. Sin DD, et al. Am J Respir Crit Care Med. 1999;160(4): ; 7. Ferrier K, et al. Chest. 2005;128(4): ; 8. Schäfer H, et al. Cardiology. 1999;92(2):79-84.; 9. Philips BG, Somers VK. Curr Opin Pulm Med. 2002;8(6): ; 10. Sanner BM, et al. Clin Cardiol. 2001;24(2): ; 11. Gami AS, et al. Circulation. 2004;110(4): ; 12. Shaw JE, et al. Diabetes Res Clin Pract. 2008;81(1):2-12.; 13. Einhorn D, et al. Endocr Pract. 2007;13(4):

10 All Cause Mortality Sleep Heart Health Study Punjabi NM, Caffo BS, Goodwin JL, Gottlieb DJ, Newman AB, et al. (2009) Sleep-Disordered Breathing and Mortality: A Prospective Cohort Study. PLoS Med 6(8): e doi: /journal.pmed

11 All Cause Mortality Wisconsin Sleep Cohort Young T; Finn L; Peppard PE; Szklo-Coxe M; Austin D; Nieto FJ; Stubbs R; Hla KM. Sleep disordered breathing and mortality: eighteen-year follow-up of the wisconsin sleep cohort. SLEEP 2008;31(8):

12 Sleep apnea and 20-year follow-up for all-cause mortality, stroke, and cancer incidence and mortality in the Busselton Health Study Cohort. J Clin Sleep Med Apr 15;10(4): doi: /jcsm Marshall NS 1, Wong KK 2, Cullen SR 3, Knuiman MW 4, Grunstein RR 2. CONCLUSIONS: Moderate-to-Severe Sleep Apnea is independently associated with a Large Increased RIsk of All-Cause Mortality, Incident Stroke, and Cancer Incidence and Mortality in this community-based sample

13 CV Effects Long-term cardiovascular outcomes in men with obstructive sleep apnoeahypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet 2005; 365: Marin JM, Carrizo SJ, Vicente E, Agusti AGN. 13

14 How Good Is Our Compliance Reports between 30 and 70% Most Studies are short term follow up Data from 4 yr follow up study found compliance of 54%, but this was done by phone calls, not by actual downloads

15 Long-term compliance with continuous positive airway pressure in patients with obstructive sleep apnea Norman Wolkove MD FRCP, Marc Baltzan MD FRCP DABSM, Hany Kamel MD, Richard Dabrusin MD FRCP, Mark Palayew MD FRCP Eighty patients who had had a diagnosis of OSA at least four years previously and received a written prescription for CPAP were evaluated. Subjects were identified by reviewing sleep laboratory records. Participants were contacted by telephone and were asked to quantitate their CPAP use (hours per night, nights per week) and to evaluate whether there had been improvement in symptoms. Patient characteristics (n=80) Age, years, mean ± SD 58±11 Male subjects, n (%) 70 (88) Apnea-hypopnea index, events/h, mean ± SD 70±44 Continuous positive airway pressure, cm H2O, mean ± SD 8.5±2.2 Follow-up, months, mean ± SD 64.0±3.7

16 Long-term compliance with continuous positive airway pressure in patients with obstructive sleep apnea Norman Wolkove MD FRCP, Marc Baltzan MD FRCP DABSM, Hany Kamel MD, Richard Dabrusin MD FRCP, Mark Palayew MD FRCP At the time of the interview: 54% (43 of 80 patients) were Still Using CPAP and most reported an improvement in symptoms. 15% (12of 80 patients) had Abandoned CPAP after using it for months 31% (25 of 80 patients) had Never Commenced CPAP after initial diagnosis diagnosis and CPAP titration.

17 What are we doing with CPAP non-users? As Sleep Practitioners What are we doing with our non-compliant OSA patients? Compliance is between 30-70% We are lying to ourselves if we don t embrace alternative therapies besides CPAP We re doing a disservice to our OSA patients

18 The Problem with CPAP Poor compliance We can no longer ignore persistent sleep apnea Compromises outcomes We NEED an additional therapy 18

19 Alternatives to CPAP therapy Oral Appliances Weight Loss Nasal EPAP Positional Therapy Surgical Therapy Head Elevation Didgeridoo Compression Stockings 19

20 Oral Appliance Therapy (OAT)

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22 Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea (OSA) and Snoring with Oral Appliance Therapy (OAT): An Update for 2015 Recommendations: When OAT is prescribed by Sleep Physician for OSA - suggest -Qualified Dentists use a Custom, Titratable OAT. (GUIDELINE) Recommend Sleep Physicians consider prescription of OAT, rather than no treatment, for OSA Patients who are intolerant of CPAP therapy or prefer alternate therapy. (STANDARD)

23 Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015 Summary of Findings: OAs vs. CPAP for OSA -Hypertension

24 Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for Summary of Findings: OAs vs. CPAP for OSA -Hypertension OAs vs. CPAP for OSA -Systolic blood pressure

25 Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for Summary of Findings: OAs vs. CPAP for OSA Hypertension OAs vs. CPAP for OSA -Diastolic blood pressure

26 The Status of OAT Review Journal of Clinical Sleep Medicine 2014; 10(2): Oral Appliance Treatment for Obstructive Sleep Apnea: An Update On behalf of the ORANGE-Registry (Oral Appliance Network on Global Effectiveness) Kate Sutherland, Ph.D., Olivier M. Vanderveken, M.D., Ph.D. Hiroko Tsuda, Ph.D. Marie Marklund, Ph.D. Frederic Gagnadoux, M.D., Ph.D. Clete A. Kushida, M.D., Ph.D., F.A.A.S.M. Peter A. Cistulli, M.D., Ph.D. 26

27 O Journal of Clinical Sleep Medicine (2014; 10(2): ) Oral Appliance Treatment for Obstructive Sleep Apnea: An Update Study Oral appliance Inclusion Patients n (%male) Pre-treatment AHI Treatment success with oral appliances Aarab Two-piece (9.6 ± 2.1 mm) AHI symptoms Treatment success (%) AHI < 5 AHI < 10 AHI 50% 17 (71%) 21.6 ± Andren Monobloc (70-75% maximum advancement) AHI > 10 + hypertension 30 (83%) 23 ± 16 (mild 39%, moderate 47%, severe 14%) 78 Blanco Monobloc (75% maximum advancement) AHI > symptoms Bloch Monobloc and Herbst (initial 75% of maximum advancement) AHI > 5 + CPAP failure Fleury Two-piece (128.9 ± 23.8% maximum advancement) AHI > 5 + CPAP failure ± (96%) 26.7 ± ± Gotsopoulos Two-piece (80 ± 9% maximum advancement) AHI > symptoms 73 (81%) 27.1 ± 15.3 (mild 15%, moderate 56%, severe 29%) Mehta Two-piece AHI > ± 17 (mild 46%, moderate 29%, severe 25%) Petri Monobloc (74% range 64-85% maximum advancement) AHI > ± 23.8 (mildmoderate 44%, severe 56%) Pitsis Two-piece (87 ± 4% advancement, 4 mm/14 mm vertical) AHI > 5 23 (83%) 21 ± 12 (range 6-47) Tegelberg Monobloc (75% maximum advancement) AI 5-25 (mild- moderate) ± 4.7^ (mild- moderate) Vanderveken Monobloc AHI < ± 11 (range 0-40) K Sutherland, OM Vanderveken, H Tsuda et al Walker- Engstrom Monobloc (75% maximum advancement) AI < 20 (severe) 40 (100%) 50.4 ± 4.7^ n Mean 48% 64% 35%

28 Oral Appliance Therapy Accounts for roughly 5% of the total OSA therapy Preferred by most patients; compliance is better So why are oral appliances under utilized? 28

29 Inconsistent Efficacy AHI < 5 (i.e. complete response) occurs in 48% of patients AHI < 10 (very mild disease) occurs in 64% of patients Which ones? Sutherland K, Vanderveken OM, Tsuda H, Marklund M, Gagnadoux F, Kushida CA, Cistulli PA; on behalf of the ORANGE-Registry. Oral appliance treatment for obstructive sleep apnea: An update. J Clin Sleep Med 2014; 10(2):

30 CPAP vs. OAT Where are we today? Randomized clinical trials with CPAP vs. OAT have yielded comparable outcomes Why? Inconsistent efficacy of OAT offsets poor compliance of CPAP With accurate patient selection OAT outcomes will be better than CPAP Phillips CL et al. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: A randomized controlled trial. Am J Respir Crit Care Med 2013; 187(8):

31 Another Concern The dentist uses a trial and error method to adjust the mandible 31

32 Dr. White s Point of View The real problem is our current inability to determine if (an oral appliance) will work in a given patient... We should use a temporary, inexpensive device (that) can be mechanically advanced during a sleep study to determine efficacy. If it is efficacious, a custom device could be fabricated and used by the patient. White DP, Continuous positive airway pressure versus the mandibular advancement splint; Are they equally effective in obstructive sleep apnea management? Am J Resp Crit Care Med 2013 Editorial; Vol 187:

33 Important Points Patient characteristics relating to OAT success and reliable prediction methods are a high research priority Predictions tests must be able to discriminate OAT responders and non-responders Studies using remote-controlled mandibular advancement shows good accuracy in predicting OAT outcome and efficacious protrusive position Sutherland K, Vanderveken OM, Tsuda H, Marklund M, Gagnadoux F, Kushida CA, Cistulli PA; on behalf of the ORANGE-Registry. Oral appliance treatment for obstructive sleep apnea: An update. J Clin Sleep Med 2014; 10(2):

34 Consensus of the Experts The ORANGE-Registry identifies MATRx as a significant advance in the field of oral appliance therapy Overall the initial study using this device as a prediction tool shows good accuracy in identifying patients who will be fully treated by OA as well as the likely mandibular protrusion level. Sutherland K, Vanderveken OM, Tsuda H, Marklund M, Gagnadoux F, Kushida CA, Cistulli PA; on behalf of the ORANGE-Registry. Oral appliance treatment for obstructive sleep apnea: An update. J Clin Sleep Med 2014; 10(2):

35 MATRx A remotely-controlled mandibular protrusion device enabling physicians to: 1. Accurately select patients who will respond to oral appliance therapy and 2. Prescribe the therapeutic protrusive position for each responder 35

36 Temporary Dental Trays Remote-controlled Mandibular Positioner Trays with Impressions 36

37 Patient Workflow 37

38 The MATRx Study Night Polysomnogram (PSG) based study using temporary titration trays Mandible is protruded by mouse click in the control room, while the patient sleeps Mandibular position is titrated within the specified range using 0.2mm steps, in response to respiratory events If possible, patient is studied in supine and lateral, REM and NREM 38

39 Just like CPAP titration 39

40 Interpretation of MATRx data Criteria needed for predicting success with oral appliance therapy: 1 or less apnea or hypopnea in a 5 minute window of REM supine REM lateral can be used if REM supine is not observed AND the patient is a confirmed side sleeper 40

41 Case Study 1 Obese Patient with Severe OSA Patient Profile 42 year old female Pre-study AHI = 41.4 BMI = 32.3 Tray Fitting Lower Limit (Resting Position) = 10.0mm Upper Limit (Maximum Protrusion) = 17.0mm 41

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43 Case Study 2 Obese Patient with Moderate OSA Patient Profile 76 year old male Pre-study AHI = 17.9 BMI = 32.0 Tray Fitting Lower Limit (Resting Position) = 12.0mm Upper Limit (Maximum Protrusion) = 19.0mm 43

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45 Research & Validation Three prospective studies have validated the MATRx device Most recent clinical trial on 67 patients showed high predictive accuracy See October 2013 issue, SLEEP Remmers J, Charkhandeh S, Grosse J, Topor Z, Brant R, Santosham P, Bruehlmann S. Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. SLEEP 2013; 36(10):

46 Inclusion Criteria Broad spectrum of patients: Obstructive sleep apnea (AHI > 10 hr -1 ) Body mass index < 40 kg/m 2 46

47 Therapeutic Outcome 29

48 Predicting Outcome - by Clinical Features Baseline AHI, BMI or Positional dependence of AHI None of these, alone or in combination, predicted therapeutic outcome Adjusted neck circumference and age were weakly predictive 48

49 Predicting Outcome - by MATRx Results 49

50 Predictive Accuracy 50

51 Target Predictive Accuracy Correct Target Prediction 27 Incorrect Target Prediction 2 PPV = 93% 51

52 AHI (events hr -1 ) BMI (kg m -2 ) Results - Protrusion Baseline AHI & BMI vs. Final Therapeutic Position Full Protrusion Full Protrusion 52

53 Thinking outside the box Patient Selection and the Relationship of AHI to BMI AHI (events hr -1 ) BMI (kg m -2 ) 53

54 Patient Acceptance Readily accepted; overall much better tolerated than a CPAP titration Trays were comfortable No difficulty falling asleep Trays did not dislodge during the study 54

55 Sleep Medicine Harvard Medical School The Price of Fatigue We estimate the annual economic cost of moderate to severe OSA in the United States to be $65 - $165B, which are greater than asthma, heart failure, stroke and hypertensive disease ($20B - $80B) Unmanaged moderate-severe OSA is estimated to cost an incremental $2,700 - $3,000 in healthcare costs/person in the US Current technology, while effective at treating the disease, is cumbersome and uncomfortable for many Low patient compliance limits the cost effectiveness of treatment for payors 55

56 Diagnosis to Treatment Fallout Identification of OSA Symptoms Diagnosis of OSA (20%) Titration Study (10%) Treatment Ordered Treatment Accepted (10%) If 100 patients are referred for a sleep study, 42 will end up compliant with treatment per Medicare criteria Compliant with Treatment (35%) Treated 56

57 Projected Growth in OAT Utilization Revenues reflect sale of goods from appliance manufacturers to dentists 57

58 3 Key Points There is a new standard of care for patients seeking oral appliance therapy MATRx diversifies the Sleep Center s testing capability, and provides a competitive edge MATRx enables a new channel for attended studies, adding to occupancy rates and revenue 58

59 Test More Patients Patients who discontinue PAP Patients who reject PAP or diagnostic study up front Dental referral network 59

60 How does MATRx change things? For the physician: Informs management decisions Increases confidence in the efficacy of oral appliance therapy 60

61 How does MATRx change things? For the dentist: Improves treatment efficiency with oral appliances Increases percentage of therapeutic success 61

62 How does MATRx change things? For the patient: Provides an additional therapy to CPAP Improves treatment compliance, quality of life and wellness 62

63 OSA treatment-final Thoughts Unique opportunity to help patients with both there quality of life but also with their potential longevity Exciting time for Sleep Practitioners(Sleep Dentists, RPSGTs, and Sleep Physicians/Sleep NP s/sleep PA s) to have a major impact on their patients health Need to stress the importance of OSA treatment in terms of broader picture and not only in terms of improvement in symptoms. We need to embrace alternatives to CPAP that are evidence based and quantifiable (e.g. OAT/MATRx) Need to work together all Sleep Practitioners, great time to learn from each other Remember treatment is not always easy

64 Questions?