HSC Section 3 - Trauma, Critical Care and Sleep Medicine

FUTURE DIRECTIONS Upper airway stimulation is the first therapy to directly address the pathophysiology of reduced neuro- muscular tone in the upper airway, and provides a mul- tilevel treatment effect in properly selected patients. It can be titrated to effect in a manner analogous to CPAP, requires no permanent alteration of throat tissues, and is less morbid than currently available surgeries. The adjustability of the therapy, in conjunction with the expected > 10-year battery life, may be particularly important, because OSA is most commonly a chronic long-term condition that requires continued reevaluation and management throughout the lifespan. Based on the available data, particularly the results of the STAR trial, upper airway stimulation therapy has a favorable risk– benefit profile and is well positioned as a second-line treatment for moderate–severe OSA patients. Although the upfront cost of the therapy is high, long-term cost- effectiveness data compares favorably to other OSA treatments including CPAP. 42 Additional studies are needed to better understand which anatomical and pathophysiologic patient pheno- types are associated with treatment success. Currently, there is an ongoing phase III trial of another hypoglossal nerve stimulation device (ImThera, San Diego, CA), which should shed additional light on the response of OSA patients to neuromuscular stimulation. Other limi- tations include incompatibility with magnetic resonance imaging (MRI) and the need for three external incisions for implantation, two factors that may preclude a subset of patients from considering this therapy. Continued efforts to produce a smaller MRI-compatible pulse gener- ator, more advanced and user-friendly patient program- mer, and more sophisticated and comprehensive data recording technology will further advance the treatment. BIBLIOGRAPHY 1. Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the associ- ation between sleep-disordered breathing and hypertension. N Engl J Med 2000;342:1378–1384. 2. Nieto FJ, Young TB, Lind BK, et al. Association of sleep-disordered breath- ing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA 2000;283:1829–1836. 3. Reichmuth KJ, Austin D, Skatrud JB, Young T. Association of sleep apnea and type II diabetes: a population-based study. Am J Respir Crit Care Med 2005;172:1590–1595. 4. Punjabi NM, Beamer BA. Alterations in glucose disposal in sleep- disordered breathing. Am J Respir Crit Care Med 2009;179:235–240. 5. Arzt M, Young T, Finn L, Skatrud JB, Bradley TD. Association of sleep- disordered breathing and the occurrence of stroke. Am J Respir Crit Care Med 2005;172:1447–1451. 6. Redline S, Yenokyan G, Gottlieb DJ, et al. Obstructive sleep apnea- hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med 2010;182:269–277. 7. Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med 2005;353:2034–2041. 8. Shahar E, Whitney CW, Redline S, et al. Sleep-disordered breathing and cardiovascular disease: cross-sectional results of the Sleep Heart Health Study. Am J Respir Crit Care Med 2001;163:19–25. 9. Sin DD, Fitzgerald F, Parker JD, Newton G, Floras JS, Bradley TD. Risk fac- tors for central and obstructive sleep apnea in 450 men and women with congestive heart failure. Am J Respir Crit Care Med 1999;160:1101–1106. 10. Gottlieb DJ, Yenokyan G, Newman AB, et al. Prospective study of obstruc- tive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation 2010;122:352–360. 11. Marin JM, Agusti A, Villar I, et al. Association between treated and untreated obstructive sleep apnea and risk of hypertension. JAMA 2012; 307:2169–2176. 12. Selim B, Won C, Yaggi HK. Cardiovascular consequences of sleep apnea. Clin Chest Med 2010;31:203–220.

13. Young T, Finn L, Peppard PE, et al. Sleep disordered breathing and mor- tality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep 2008; 31:1071–1078. 14. Rich J, Raviv A, Raviv N, Brietzke SE. An epidemiologic study of snoring and all-cause mortality. Otolaryngol Head Neck Surg 2011;145:341–346. 15. Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ 2009;108:246–249. 16. Garrigue S, Pepin JL, Defaye P, et al. High prevalence of sleep apnea syn- drome in patients with long-term pacing: the European Multicenter Pol- ysomnographic Study. Circulation 2007;115:1703–1709. 17. Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or with- out treatment with continuous positive airway pressure: an observation- al study. Lancet 2005;365:1046–1053. 18. McNicholas WT. Cardiovascular outcomes of CPAP therapy in obstructive sleep apnea syndrome. Am J Physiol Regul Integr Comp Physiol 2007; 293:R1666–R1670. 19. Siccoli MM, Pepperell JC, Kohler M, Craig SE, Davies RJ, Stradling JR. Effects of continuous positive airway pressure on quality of life in patients with moderate to severe obstructive sleep apnea: data from a randomized controlled trial. Sleep 2008;31:1551–1558. 20. Engleman HM, Wild MR. Improving CPAP use by patients with the sleep apnoea/hypopnoea syndrome (SAHS). Sleep Med Rev 2003;7:81–99. 21. Weaver TE, Sawyer AM. Adherence to continuous positive airway pressure treatment for obstructive sleep apnoea: implications for future interven- tions. Indian J Med Res 2010;131:245–258. 22. Caples SM, Rowley JA, Prinsell JR, et al. Surgical modifications of the upper airway for obstructive sleep apnea in adults: a systematic review and meta-analysis. Sleep 2010;33:1396–1407. 23. Maurer JT, Van de Heyning P, Lin HS, et al. Operative technique of upper airway stimulation: an implantable treatment of obstructive sleep apnea. Oper Tech Otolaryngol 2012;23:227–233. 24. Maurer JT. Update on surgical treatments for sleep apnea. Swiss Med Wkly 2009;139:624–629. 25. Won CH, Li KK, Guilleminault C. Surgical treatment of obstructive sleep apnea: upper airway and maxillomandibular surgery. Proc Am Thorac Soc 2008;5:193–199. 26. Kezirian EJ, Goldberg AN. Hypopharyngeal surgery in obstructive sleep apnea: an evidence-based medicine review. Arch Otolaryngol Head Neck Surg 2006;132:206–213. 27. McGinley BM, Schwartz AR, Schneider H, Kirkness JP, Smith PL, Patil SP. Upper airway neuromuscular compensation during sleep is defective in obstructive sleep apnea. J Appl Physiol 2008;105:197–205. 28. Patil SP, Schneider H, Marx JJ, Gladmon E, Schwartz AR, Smith PL. Neuromechanical control of upper airway patency during sleep. J Appl Physiol 2007;102:547–556. 29. Miki H, Hida W, Shindoh C, et al. Effects of electrical stimulation of the genioglossus on upper airway resistance in anesthetized dogs. Am Rev Respir Dis 1989;140:1279–1284. 30. Yoo PB, Durand DM. Effects of selective hypoglossal nerve stimulation on canine upper airway mechanics. J Appl Physiol 2005;99:937–943. 31. Bishara H, Odeh M, Schnall RP, Gavriely N, Oliven A. Electrically-activat- ed dilator muscles reduce pharyngeal resistance in anaesthetized dogs with upper airway obstruction. Eur Respir J 1995;8:1537–1542. 32. Schwartz AR, Thut DC, Russ B, et al. Effect of electrical stimulation of the hypoglossal nerve on airflow mechanics in the isolated upper airway. Am Rev Respir Dis 1993;147:1144–1150. 33. Eisele DW, Schwartz AR, Hari A, Thut DC, Smith PL. The effects of selec- tive nerve stimulation on upper airway airflow mechanics. Arch Otolar- yngol Head Neck Surg 1995;121:1361–1364. 34. Eastwood PR, Barnes M, Walsh JH, et al. Treating obstructive sleep apnea with hypoglossal nerve stimulation. Sleep 2011;34:1479–1486. 35. Van de Heyning PH, Badr MS, Baskin JZ, et al. Implanted upper airway stimulation device for obstructive sleep apnea. Laryngoscope 2012;122: 1626–1633. 36. Friedman M, Jacobowitz O, Hwang MS, et al. Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: six-month results [published online March 24, 2016]. Laryngoscope doi: 10.1002/ lary.25909. 37. Strollo PJ Jr, Soose RJ, Maurer JT, et al. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med 2014;370:139–149. 38. Rombaux P, Hamoir M, Bertrand B, et al. Postoperative pain and side effects after uvulopalatopharyngoplasty, laser-assisted uvulopalato- plasty, and radiofrequency tissue volume reduction in primary snoring. Laryngoscope 2003;113:2169–2173. 39. Strollo PJ Jr, Gillespie MB, Soose RJ, et al. Upper airway stimulation for obstructive sleep apnea: durability of the treatment effect at 18 months. Sleep 2015;38:1593–1598. 40. Soose RJ, Woodson BT, Gillespie MB, et al.; STAR Trial Investigators. Upper airway stimulation for obstructive sleep apnea: self-reported out- comes at 24 months. J Clin Sleep Med 2016;12:43–48. 41. Woodson BT, Soose RJ, Gillespie MB, et al.; STAR Trial Investigators. Three-year outcomes of cranial nerve stimulation for obstructive sleep apnea: the STAR trial. Otolaryngol Head and Neck Surg 2016;154:181– 188. 42. Pietzsch JB, Liu S, Garner AM, et al. Long-term cost-effectiveness of upper airway stimulation for the treatment of obstructive sleep apnea: a model-based projection based on the STAR trial. Sleep 2015;38:735–744.

Laryngoscope 126: September 2016

Soose and Gillespie: Upper Airway Stimulation Therapy

176