Combination Therapy. Albert Einstein 8/28/2018. Conflict of Interest Disclosure. Grant/Research Support

Transcription

1 Combination Therapy Conflict of Interest Disclosure 1. I do not have any potential conflicts of interest to disclose, OR 2. I wish to disclose the following potential conflicts of interest: Type of Potential Conflict Details of Potential Conflict Grant/Research Support Consultant Speakers Bureaus Financial support Other President of Fusion Sleep Solutions. LLC 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: a. Prehn RS, Swick T. A descriptive report of combination therapy (custom face mask for CPAP integrated with a mandibular advancement splint) for long-term treatment of OSA with literature review. JDSM, 2017;4(2): "To raise new questions, new possibilities, to regard old problems from a new angle, requires creative imagination and marks real advance in science." Albert Einstein 1

2 A Story for Dentistry DALLAS REHABILITATION INSTITUTE Post-polio patients 2

3 Problem: Constant Volume ventilators set at 45 cmw!!! Lyon mask (made by Respiratory Therapists ) I determined that not only could I improve the mask she brought in, but improve the whole technology using dental techniques W. Keith Thornton, DDS Dorothy 3

4 Deborah John One of the biggest issues was the breathing while taking the impressions. Body paralyzed except for two toes. On a ventilator. Had OSA. 4

5 We think we have problems! If this lady doesn t inspire creative solutions, then you might as well be dead! 5

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7 What is Combination Therapy? Custom Face Mask Custom Face Mask Combination Therapy TAP-PAP nasal pillows Custom Face Mask 7

8 Combination Therapy: It is a combination of two therapies. OAT CPAP Positional Myofunctional Therapy Surgery Hypoglossal Nerve Stim Combination Therapy: It is a combination of two therapies. One: CPAP therapy Two: Oral Appliance Therapy (OAT). Combination Therapy Working with a Sleep MD 8

9 CPAP (Continuous Positive Airway Pressure) Sleep MD OAT (Oral Appliance Therapy) Sleep Dentist A Review by the Positive Airway Pressure Task Force of the Standards of Practice Committee of the American Academy of Sleep Medicine Long list of side effects 51% compliance nationwide Gay P; Weaver T; Loube D et al. Evaluation of positive airway pressure treatment for sleep related breathing disorders in adults. SLEEP 2006;29(3): CPAP interface: satisfaction and side effects No difference in type or brand of interface, long list of side effects. the majority of patients consider the use of the CPAP interface disturbing Bachour, Vitikainen, Virkkula, Maasilta; CPAP interface: satisfaction and side effects; Sleep Breath (2013) 17: Treatment efficacy: how well an intervention works under ideal controlled circumstances Treatment effectiveness: how well an intervention performs in uncontrolled real world condition 9

10 When treatment usage as a portion of the total sleep time is considered: While CPAP has a higher efficacy than OAT - OAT has a higher effectiveness than CPAP Sutherland K, Phillips CL, Cistulli PA, Efficacy versus Effectiveness in the Treatment of Obstructive Sleep Apnea: CPAP and Oral Appliances. JDSM 2015;2(4): Objective Evaluation of Severity And patient preference American Academy of Sleep Medicine Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical practice guideline for the treatment of obstructive sleep apnea and snoring with oral appliance therapy: an update for Journal of Dental Sleep Medicine 2015;2(3): Oral Appliance moves the jaw forward 1. Therapy more effective 2. Increase risks of side effects 10

11 Question: What to do when monotherapy fails? Prehn Definition of Combination Therapy It is a CPAP interface to the nose or mouth or both, that either is in conjunction with a MAS or one that connects the CPAP hose directly to an oral appliance that features mandibular stabilization. CT features: Superior stability due to being connected to the skull base via the dentition. Excellent compliance and satisfaction because of the lack of straps and leakage. 11

12 REQUIRES: the proper diagnosis and treatment by a Dentist trained in OAT. OAT Failure 12

13 CPAP Failure I don t think so! Type One DUAL Therapy Combining Two Therapies + = 13

14 Type One DUAL Therapy CPAP Combined with MAS Achieves mandibular stabilization Easy to implement into a General Dental Practice No special training No management of CPAP (MD controls) Cost, insurance and chair time is a known and constant variable Improved Outcome of Full Mask CPAP Treatment with Mandibular Stabilization Using A Dental Appliance Jerald H. Simmons, MD 10 patients (one drop out) 1.Failed Full Face Mask 2.Able to fabricate Snore Free (boil and bite) 3.Recognized improvement with MAS 6 Question survey before and after Statistical improvement with combination (P < 0.001) SLEEP Journal Abstract 2010 Edition; #

15 Type Two INTEGATED Therapy Integrating Two Therapies Type Two INTEGRATED Therapy CPAP Connect Directly to MAS No straps Mandibular advancement not necessary, although advised Need special training with device Be familiar with CPAP Therapy Need to stock parts 15

16 Difficult to implement into General Dental practice Chair time varies-staff frustrations Insurance is unknown and not appropriate The New TAP-PAP Custom Face Mask for CPAP Compliance and Satisfaction Ronald S. Prehn, DDS Number of Patients More Less Custom Mask Stock Mask SLEEP Journal Abstract 2010 Edition; #

17 Who gets a Fusion Custom Mask? Combination Therapy -Integrated Therapy 75 patients on combination therapy with a Custom Face Mask Most often CPAP intolerant CPAP intolerant patients had higher CPAP pressures than others in study CPAP pressures were reduced Long term compliance (10yrs) Long term cost less than stock mask Prehn RS, Swick T. A descriptive report of combination therapy (custom face mask for CPAP integrated with a mandibular advancement splint) for long-term treatment of OSA with literature review. JDSM, 2017;4(2): Combination Therapy -Integrated Therapy Conclusion: The application of the CFM is for patients with more severe OSA and is well tolerated with improved compliance. The CFM should be considered when other therapeutic methods of treating OSA have failed or when CPAP or the CPAP mask are intolerable to the patient Prehn RS, Swick T. A descriptive report of combination therapy (custom face mask for CPAP integrated with a mandibular advancement splint) for long-term treatment of OSA with literature review. JDSM, 2017;4(2):

18 Study of 75 patients who had received a Fusion Custom Mask at my Dental Sleep Center Failed Therapy Number of Patients TAP3 (OAT monotherapy) 11 (15%) TAP-PAP CS (Type II CBT) 21 (28%) CPAP (monotherapy) 43 (57%) RS Prehn, T Swick, A Descriptive Report of Combination Therapy (custom face mas for CPAP integrated with a mandibular advancement splint) for long term treatment of OSA with literature review, JDSM 2017,4(2):29-36 Type II interfaces are a CLASS II Medical Device Two Things to Know United States Patent and Trademark Office An Agency of the Department of Commerce Dr. Keith Thornton Inventor Patent Holder 18

19 501(c) Approved Device Exclusive License to fabricate, distribute and educate the Fusion Custom Mask Ronald S. Prehn, ThM, DDS Fusion Combination System FusionCustomMask.com 19

20 Two styles of CPAP interfaces TAP - PAP CS Nasal Pillows Fusion Custom Mask Monoblock OR TAP - PAP nasal pillow (Chairside) Custom Face Mask (lab fabricated) TAP - PAP CS nasal pillow Simple to do chairside Fully adjustable Optional head set for hose Works best CPAP under 15cm H

21 TAP - PAP CS From TAP3 with TAP Post TAP - PAP CS From Fusion Monoblock Fusion Custom Mask Phase one - Chairside 1. Fusion Monoblock 2. Screw on TAP post 2. Thermacryl upper and lower, slightly protruded Phase two - Chairside 3. Take face impression Prehn, R. and T. Colquitt, Fabrication technique for a custom face mask for the treatment of obstructive sleep apnea. J Prosthet Dent 2016;115(5):

22 Phase two-fusion Dental Lab Fabricate FCM Fusion Custom Mask 22

23 Validated superior compliance and satisfaction Can tolerate high pressures Can modify airflow to nose or mouth or both Adjustable Fusion Custom Mask Can lower CPAP pressure Modified FCM Who gets a Fusion Custom Mask? 23

24 Study of 75 patients who had received a Fusion Custom Mask at my Dental Sleep Center Failed Therapy Number of Patients TAP3 (OAT monotherapy) 11 (15%) TAP-PAP CS (Type II CBT) 21 (28%) CPAP (monotherapy) 43 (57%) Journal of Dental Sleep Medicine, In Print. When to consider Combination Therapy Dual Therapy: Unable to achieve therapeutic goals with OAT alone Unable to manage side effects while advancing mandible with OAT CPAP required but intolerant MD requires CPAP for patient and needs mandible stable (leakage) 24

25 Integrated Therapy: OSA severe and CPAP intolerant CPAP pressures are high Significant co-morbidities Unable to achieve goals with Dual Therapy Patient preference Rickey H. Age 40 BMI 40 RDI 70 AHI 43 PSO 2 66% BPAP 26/20 Honey The Sleep Lab called 25

26 Medical discharge from Navy 24 hr Oxygen Organ failure Polypharmacy Too sick for surgery BiPAP not working We Tried Type 1 CT! 26

27 60% Genioglossus reduction Mandibular Advancement:11mm Maxillary Advancement: 16mm Hope Ease of mind Able to address his other issues now. 27

28 Future of Combination Therapy Type one DUAL THERAPY can be implemented today in any Dental Sleep aspect of General Practice. Dentists and Sleep Physicians need more awareness of benefit Need more research validation Type two INTERGRATED THERAPY should done in a more advanced Dental Sleep Practice. Learn and practice Establish relationship with MD More development More research validation Profit issues Final Considerations Consider Dual Therapy now for your OAT failures Consider learning Integrated Therapy if you desire to treat the more challenging cases Consider using this combination therapy to build bridges to your MD referrals 28

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