Experimental treatments for OSA

1. Experimental treatments for OSA J. Verbraecken, E. Hamans Dept of Pulmonary Medicine and Sleep Disorders Center University Hospital Antwerp Belgium Johan.verbraecken@uza.be

2. Surgery of the upper airway Indications: • Patients with underlying specific surgically correctable abnormality • Patients for whom other noninvasive treatments have been unsuccesful or have been rejected, who desire surgery and are medically stable to undergo the procedure (American Academy of Sleep Medicine, Sleep 1996)

3. Surgery of the upper airway • Surgical goal: correction of anatomical abnormalities contributing to UA collapse • 3 modalities: • Soft tissue surgery (UPPP, ...) • Skeletal framework surgery (hyoıd, mandıble) • Tracheotomy

4. Target: hyoid bone

5. Hyoid suspension -general anesthesia -3 days hospitalisation - few post-op complaints - fpr patients with tongue base obstruction - combined with other interventions (UPPP, RF)

6. Hyoid expansion Oro-ph Hypo-ph The relationship of the hyoid bone to the lateral hypopharyngeal walls makes it an ideal substrate to stabilize the airway

7. Hyoid expansion Increased airway space Decreased collapsibility

8. Hyoid expansion Air Frame ™ system (Aspire Medical, Palo Alto, USA) Hyoid bone Expanded hyoid bone

9. ProtocolHyoid Myotomy and Lateral Suspension as a Treatment for Obstructive Sleep Apnea; an evaluation of the Aspire Medical AirFrame™ System • Size: n=30 patients • Centers: University Clinic Antwerp; University Clinic Mannheim • PrimaryObjectives • Demonstrate the SAFETY of the AirFrame™ System by measuring adverse events • Demonstrate the EFFECTIVENESS of hyoid expansion using the Aspire Medical AirFrame™ System to treat obstructive sleep apnea by a reduction in the apnea-hypopnea index • SecondaryObjectives • Evaluate the effects of the AirFrame™ System on QUALITY OF LIFE • Assess the FEASIBILITY of hyoid expansion using the AirFrame™System

10. Advance: patient-selection AHI between 15-50 Age < 60 y BMI < 32 Tongue base obstruction Intolerance to CPAP

11. Hyoid expansion: procedure in humans

12. Hyoid expansion procedure Titanium implant 30 min surgery 3 days hospitalisation almost any post-up complaints

13. Hyoid expansion: patients January – July 2005: 17 procedure in UZ Antwerpen 7 procedures in Mannheim -22 men, 2 women -mean age 45 y (29-54) -mean BMI 26.7 (22-30)

14. Hyoid expansion: methods All patients had pre- and post-op (3m): • objective assessment of OSAS and UA: • PSG, sleep-endoscopy, MRI and CT scan • subjective assessment of snoring, sleepiness and quality of life: • VAS Snoring, Epworth Sleepiness Score, SF 36 • Assessment of feasibility and safety: • Feasability of the procedure: ease of procedure, procedure time • Safety: • morbidity of the procedure • (serious) adverse events

15. Results: Apnea-Hypopnea Index 50% responders 50% nonresponders 27.7 23.6 Not significant

16. Sleep-endoscopy: results -sleep-endoscopy: predictive value? NO -palatal and lateral wall collapse decreases in responders: procedure stretches the UA mucosa -no change in collapse in non-responders -no influence of BMI, pre-op AHI, tonsil size, Mallampati or age -2 out of 3 responders are women

17. Results: CT 3-D Modelling No significant increase in UA size

18. Results: MRI airway size Post-operative Pre-operative No significant increase in UA size

19. Results: Visual Analogue Scale Snoring 7.9 4.9

20. Results: Epworth Sleepiness Scale 12,5 7,6 Significant decrease of sleepiness

21. Results: SF 36 Quality of Life

22. Results: SF 36 Quality of Life

23. Results: feasibility Procedure time 80 min 50 min

24. Results: feasibility Procedure feasibility: -implantation fulfilled in al cases -no complications during procedure -easy use of implant and supportive instruments

25. Results: safety Adverse events: -common cold -foot trauma -granulation tissue at wound -neckpain due to procedure Serious adverse events: -wound infection -granulation at implant and removal of implant

26. Results: paın

27. Conclusions • Hyoid expansion is a safe and feasible procedure in patients with OSAS • There are responders and non-responders • The overall result on AHI is not significant • Responders have visible decreased UA collaps on sleep-endoscopy • Sleep-endoscopy has no predicitive value on outcome for hyoid expansion

28. Conclusions • Significant decrease in snoring • Significant decrease in daytime sleepiness • Significant increase in quality of life • No significant increase in UA size

29. Conclusions • Hyoid expansion probably not suitable as single treatment for OSAS • Predictive and influencing factors yet to be determined • Part of multi-level treatment plan

31. Advance™ System: The Antwerp Experience Johan Verbraecken, Evert Hamans Dept Pulmonary Medicine and ENT, Sleep Disorders Center University Hospital Antwerp Belgium

32. Advance: patient-selection AHI between 15-50 Age < 60 y BMI < 32 Tongue base obstruction Intolerance to CPAP

33. Advance: patient-selection Since February 2006 13 patients selected according to: • screenings PSG (AHI=28) • baseline PSG (AHI= ) (7 days wash-out period CPAP) • sleep-endoscopy: 11 patients only tongue base collapse 2 patients multilevel tongue base - palate

34. Advance implantation Under general anaesthesia with nasal intubation 2 cm horizontal submental incision Dissection of the caudal ridge of the mandible Fluoroscopy during: • Introduction of the trocar with manual guidance in the mouth • Introduction of the delivery device

35. Advance implantation Release of tissue anchor and check the position and the effect on the upper airway on fluoroscopy Snaring tetherline at the bone anchor Fixation of bone anchor (rinsing the bone dust) Figure-8 knot – surgical knot close to the spool Wound closure – vacuum drain

36. Advance implantation

37. Advance implantation

38. Advance implantation

39. Advance implantation

40. Advance implantation

41. Advance implantation

42. Advance implantation

43. Advance implantation

44. Advance implantation

45. Advance implantation: post-op care Vacuum drain untill no more drainage (1-2 days) IV antibiotics untill discharge (1-2 days) PO antibiotics for 7 days Stiches removal after 10 days CPAP in peri-operative period (take care of wash-out period for Watch Pat study)

46. Advance implantation

47. Titration Advance Under sedated sleep (midazolam and propofol) Profylactic antibiotics (cefazolin) 2 mm incision 1 cm under original incision Blunt dissection to the bone anchor Introduction of titration needle (under fluoroscopy) Start with one click and check palpability of the clicks -clicks may be difficult to notice!! Remove slack under fluoroscopy Start advancing the tongue

48. Titration Advance How far to advance? -decrease of snoring (sedated sleep) -behaviour of upper airway on fluoroscopy -pain! (-fiberoptic endoscopy)

49. Titration Advance

50. Challenges detachment(knot issue – during titration) recapture procedure (potential adverse events) granulation tissue – wound infection device related?? tissue anchor positioning(optimal efficacy)