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Hypoglossal nerve stimulation long-term clinical outcomes: a systematic review and meta-analysis

  • Sleep Breathing Physiology and Disorders • Review
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Abstract

Objective

To perform a systematic review and meta-analysis for studies evaluating hypoglossal nerve stimulation (HNS) clinical outcomes in the treatment of moderate to severe obstructive sleep apnea (OSA).

Methods

Two authors conducted a literature search to identify prospective studies in PubMed/MEDLINE, Google Scholar, and Cochrane Library databases. The last search was performed on November 17, 2018.

Results

A total of 350 patients (median age 54.3 (IQR 53–56.25) years, BMI 29.8 (IQR 28.8–31.6) kg/m2) from 12 studies were included. The procedure has obtained a surgical success rate of 72.4% (Inspire), 76.9% (ImThera), 55% (Apnex) at 12 months, and 75% (Inspire) at 60-month follow-up. At 12 months, the apnea-hypopnea index (AHI) mean differences was − 17.50 (Inspire; 95% CI: − 20.01 to − 14.98, P < 0.001), − 24.20 (ImThera; 95% CI: − 37.39 to 11.01, P < 0.001), and − 20.10 (Apnex; 95% CI: − 29.62 to − 10.58, P < 0.001). The AHI mean reduction after 5 years was − 18.00 (Inspire, − 22.38 to − 13.62, P < 0.001). The Epworth sleepiness scale (ESS) mean reduction was − 5.27 (Inspire), − 2.90 (ImThera), and − 4.20 (Apnex) at 12 months and − 4.40 (Inspire) at 60 months, respectively. Only 6% of patients reported serious device-related adverse events after 1- and 5-year follow-up.

Conclusion

HNS has obtained a high surgical success rate with reasonable long-term complication rate related to the device implanted. The procedure represents an effective and safe surgical treatment for moderate-severe OSA in selected adult patients who had difficulty accepting or adhering to CPAP treatment.

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References

  1. Strollo PJ, Rogers RM (1996) Obstructive sleep apnea. N Engl J Med 334(2):99–104

    Article  Google Scholar 

  2. Sateia MJ (2014) International classification of sleep disorders-third edition: highlights and modifications. Chest 146(5):1387–1394

    Article  Google Scholar 

  3. Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE (2011) A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev 15(6):343–356

    Article  Google Scholar 

  4. Rotenberg BW, Murariu D, Pang KP (2016) Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg 45(1):43

    Article  Google Scholar 

  5. Lee EJ, Cho JH (2018) Meta-analysis of obstruction site observed with drug-induced sleep endoscopy in patients with obstructive sleep apnea. Laryngoscope

  6. Caples SM, Rowley JA, Prinsell JR, Pallanch JF, Elamin MB, Katz SG, Harwick JD (2010) Surgical modifications of the upper airway for obstructive sleep apnea in adults: a systematic review and meta-analysis. Sleep 33(10):1396–1407

    Article  Google Scholar 

  7. Sundaram S, Bridgman SA, Lim J, Lasserson TJ (2005) Surgery for obstructive sleep apnoea. Cochrane Database Syst Rev 4:CD001004

    Google Scholar 

  8. Dedhia RC, Strollo PJ, Soose RJ (2015) Upper airway stimulation for obstructive sleep apnea: past, present, and future. Sleep 38(6):899–906

    PubMed Central  Google Scholar 

  9. Strollo PJ, Soose RJ, Maurer JT et al (2014) Upper-airway stimulation for obstructive sleep apnea. N Engl J Med 370(2):139–149

    Article  CAS  Google Scholar 

  10. Safiruddin F, Vanderveken OM, de Vries N, Maurer JT, Lee K, Ni Q, Strohl KP (2015) Effect of upper-airway stimulation for obstructive sleep apnoea on airway dimensions. Eur Respir J 45(1):129–138

    Article  Google Scholar 

  11. Heiser C, Edenharter G, Bas M, Wirth M, Hofauer B (2017) Palatoglossus coupling in selective upper airway stimulation. Laryngoscope 127(10):E378–E383

    Article  Google Scholar 

  12. Hofauer B, Strohl K, Knopf A, Bas M, Wirth M, Stock K, Heiser C (2017) Sonographic evaluation of tongue motions during upper airway stimulation for obstructive sleep apnea-a pilot study. Sleep Breath 21(1):101–107

    Article  Google Scholar 

  13. Certal VF, Zaghi S, Riaz M, Vieira AS, Pinheiro CT, Kushida C, Capasso R, Camacho M (2015) Hypoglossal nerve stimulation in the treatment of obstructive sleep apnea: a systematic review and meta-analysis. Laryngoscope 125(5):1254–1264

    Article  Google Scholar 

  14. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JPA, Clarke M, Devereaux PJ, Kleijnen J, Moher D (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med 6(7):e1000100

    Article  Google Scholar 

  15. National Institute for Health and Care Excellence (2012) Methods for the development of NICE public health guidance. National Institute for Health and Care Excellence (NICE), London

    Google Scholar 

  16. Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, Worsnop CJ, Kezirian EJ, Hillman DR (2011) Treating obstructive sleep apnea with hypoglossal nerve stimulation. Sleep 34(11):1479–1486

    Article  Google Scholar 

  17. Van de Heyning PH, Badr MS, Baskin JZ et al (2012) Implanted upper airway stimulation device for obstructive sleep apnea. Laryngoscope 122(7):1626–1633

    Article  Google Scholar 

  18. Mwenge GB, Rombaux P, Dury M, Lengelé B, Rodenstein D (2013) Targeted hypoglossal neurostimulation for obstructive sleep apnoea: a 1-year pilot study. Eur Respir J 41(2):360–367

    Article  Google Scholar 

  19. Kezirian EJ, Goding GS, Malhotra A et al (2014) Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. J Sleep Res 23(1):77–83

    Article  Google Scholar 

  20. Strollo PJ, Gillespie MB, Soose RJ et al (2015) Upper airway stimulation for obstructive sleep apnea: durability of the treatment effect at 18 months. Sleep 38(10):1593–1598

    Article  Google Scholar 

  21. Woodson BT, Soose RJ, Gillespie MB, Strohl KP, Maurer MDJT, de Vries N, Steward DL, Baskin JZ, Badr MS, Lin HS, Padhya TA, Mickelson S, Anderson WMD, Vanderveken OM, Strollo PJ Jr, on Behalf of STAR Trial Investigators (2016) Three-year outcomes of cranial nerve stimulation for obstructive sleep apnea: the STAR trial. Otolaryngol Head Neck Surg 154(1):181–188

    Article  Google Scholar 

  22. Heiser C, Knopf A, Bas M, Gahleitner C, Hofauer B (2017) Selective upper airway stimulation for obstructive sleep apnea: a single center clinical experience. Eur Arch Otorhinolaryngol 274(3):1727–1734

    Article  Google Scholar 

  23. Heiser C, Maurer JT, Hofauer B, Sommer JU, Seitz A, Steffen A (2017) Outcomes of upper airway stimulation for obstructive sleep apnea in a multicenter German Postmarket study. Otolaryngol Head Neck Surg 156(2):378–384

    Article  Google Scholar 

  24. Steffen A, Sommer JU, Hofauer B, Maurer JT, Hasselbacher K, Heiser C (2018) Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study. Laryngoscope 128(2):509–515

    Article  Google Scholar 

  25. Woodson BT, Strohl KP, Soose RJ, Gillespie MB, Maurer JT, de Vries N, Padhya TA, Badr MS, Lin HS, Vanderveken OM, Mickelson S, Strollo PJ Jr (2018) Upper airway stimulation for obstructive sleep apnea: 5-year outcomes. Otolaryngol Head Neck Surg 159(1):194–202

    Article  Google Scholar 

  26. Friedman M, Jacobowitz O, Hwang MS, Bergler W, Fietze I, Rombaux P, Mwenge GB, Yalamanchali S, Campana J, Maurer JT (2016) Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: six-month results. Laryngoscope 126(11):2618–2623

    Article  Google Scholar 

  27. Berry RB, Budhiraja R, Gottlieb DJ et al (2012) Rules for scoring respiratory events in sleep: update of the 2007 AASM manual for the scoring of sleep and associated events. Deliberations of the sleep apnea definitions task force of the American Academy of sleep medicine. J Clin Sleep Med 8(5):597–619

    Article  Google Scholar 

  28. Pietzsch JB, Liu S, Garner AM, Kezirian EJ, Strollo PJ (2015) 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 38(5):735–744

    Article  Google Scholar 

  29. Boon M, Huntley C, Steffen A, Maurer JT, Sommer JU, Schwab R, Thaler E, Soose R, Chou C, Strollo P, Kezirian EJ, Chia S, Withrow K, Weidenbecher M, Strohl K, Doghramji K, Hofauer B, Heiser C, on Behalf of the ADHERE Registry Investigators (2018) Upper airway stimulation for obstructive sleep apnea: results from the ADHERE registry. Otolaryngol Head Neck Surg 159(2):379–385

    Article  Google Scholar 

  30. Lin H-C, Friedman M, Chang H-W, Bonzelaar L, Salapatas AM, Lin MC, Huang KT (2017) Minimally invasive, single-stage, multilevel surgery for obstructive sleep apnea in Asian patients. JAMA Otolaryngol Head Neck Surg 143(2):147–154

    Article  Google Scholar 

  31. Heiser C, Maurer JT, Steffen A (2016) Functional outcome of tongue motions with selective hypoglossal nerve stimulation in patients with obstructive sleep apnea. Sleep Breath 20(2):553–560

    Article  CAS  Google Scholar 

  32. Samutsakorn P, Hirunwiwatkul P, Chaitusaney B, Charakorn N (2018) Lingual tonsillectomy with palatal surgery for the treatment of obstructive sleep apnea in adults: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol 275(4):1005–1013

    Article  Google Scholar 

  33. Steffen A, Abrams N, Suurna MV, Wollenberg B, Hasselbacher K (2018) Upper-airway stimulation before, after, or without Uvulopalatopharyngoplasty: a two-year perspective. Laryngoscope

  34. Weeks B, Bao G, Gilbert TM, Emdur L (2018) Hypoglossal nerve stimulator implantation in a non-academic setting: two-year result. Laryngoscope Investig Otolaryngol 3(4):315–318

    Article  Google Scholar 

  35. Thaler ER, Schwab RJ (2016) Single-institution experience and learning curve with upper airway stimulation. Laryngoscope 126(Suppl 7):S17–S19

    Article  Google Scholar 

  36. Murphey AW, Baker AB, Soose RJ, Padyha TA, Nguyen SA, Xiao CC, Gillespie MB (2016) Upper airway stimulation for obstructive sleep apnea: the surgical learning curve. Laryngoscope 126(2):501–506

    Article  Google Scholar 

  37. Dedhia RC, Woodson BT (2018) Standardized reporting for hypoglossal nerve stimulation outcomes. J Clin Sleep Med 14(11):1835–1836

    Article  Google Scholar 

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Correspondence to Antonio Moffa.

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Costantino, A., Rinaldi, V., Moffa, A. et al. Hypoglossal nerve stimulation long-term clinical outcomes: a systematic review and meta-analysis. Sleep Breath 24, 399–411 (2020). https://doi.org/10.1007/s11325-019-01923-2

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  • DOI: https://doi.org/10.1007/s11325-019-01923-2

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