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Published in: Sleep and Breathing 2/2020

01-06-2020 | Sleep Apnea | Sleep Breathing Physiology and Disorders • Review

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

Authors: Andrea Costantino, Vittorio Rinaldi, Antonio Moffa, Vitaliana Luccarelli, Federica Bressi, Michele Cassano, Manuele Casale, Peter Baptista

Published in: Sleep and Breathing | Issue 2/2020

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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.
Literature
1.
go back to reference Strollo PJ, Rogers RM (1996) Obstructive sleep apnea. N Engl J Med 334(2):99–104CrossRef Strollo PJ, Rogers RM (1996) Obstructive sleep apnea. N Engl J Med 334(2):99–104CrossRef
2.
go back to reference Sateia MJ (2014) International classification of sleep disorders-third edition: highlights and modifications. Chest 146(5):1387–1394CrossRef Sateia MJ (2014) International classification of sleep disorders-third edition: highlights and modifications. Chest 146(5):1387–1394CrossRef
3.
go back to reference 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):343–356CrossRef 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):343–356CrossRef
4.
go back to reference 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):43CrossRef 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):43CrossRef
5.
go back to reference Lee EJ, Cho JH (2018) Meta-analysis of obstruction site observed with drug-induced sleep endoscopy in patients with obstructive sleep apnea. Laryngoscope Lee EJ, Cho JH (2018) Meta-analysis of obstruction site observed with drug-induced sleep endoscopy in patients with obstructive sleep apnea. Laryngoscope
6.
go back to reference 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):1396–1407CrossRef 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):1396–1407CrossRef
7.
go back to reference Sundaram S, Bridgman SA, Lim J, Lasserson TJ (2005) Surgery for obstructive sleep apnoea. Cochrane Database Syst Rev 4:CD001004 Sundaram S, Bridgman SA, Lim J, Lasserson TJ (2005) Surgery for obstructive sleep apnoea. Cochrane Database Syst Rev 4:CD001004
8.
go back to reference Dedhia RC, Strollo PJ, Soose RJ (2015) Upper airway stimulation for obstructive sleep apnea: past, present, and future. Sleep 38(6):899–906PubMedCentral Dedhia RC, Strollo PJ, Soose RJ (2015) Upper airway stimulation for obstructive sleep apnea: past, present, and future. Sleep 38(6):899–906PubMedCentral
9.
go back to reference Strollo PJ, Soose RJ, Maurer JT et al (2014) Upper-airway stimulation for obstructive sleep apnea. N Engl J Med 370(2):139–149CrossRef Strollo PJ, Soose RJ, Maurer JT et al (2014) Upper-airway stimulation for obstructive sleep apnea. N Engl J Med 370(2):139–149CrossRef
10.
go back to reference 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):129–138CrossRef 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):129–138CrossRef
11.
go back to reference Heiser C, Edenharter G, Bas M, Wirth M, Hofauer B (2017) Palatoglossus coupling in selective upper airway stimulation. Laryngoscope 127(10):E378–E383CrossRef Heiser C, Edenharter G, Bas M, Wirth M, Hofauer B (2017) Palatoglossus coupling in selective upper airway stimulation. Laryngoscope 127(10):E378–E383CrossRef
12.
go back to reference 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):101–107CrossRef 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):101–107CrossRef
13.
go back to reference 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):1254–1264CrossRef 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):1254–1264CrossRef
14.
go back to reference 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):e1000100CrossRef 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):e1000100CrossRef
15.
go back to reference 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 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
16.
go back to reference 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):1479–1486CrossRef 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):1479–1486CrossRef
17.
go back to reference Van de Heyning PH, Badr MS, Baskin JZ et al (2012) Implanted upper airway stimulation device for obstructive sleep apnea. Laryngoscope 122(7):1626–1633CrossRef Van de Heyning PH, Badr MS, Baskin JZ et al (2012) Implanted upper airway stimulation device for obstructive sleep apnea. Laryngoscope 122(7):1626–1633CrossRef
18.
go back to reference 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):360–367CrossRef 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):360–367CrossRef
19.
go back to reference Kezirian EJ, Goding GS, Malhotra A et al (2014) Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. J Sleep Res 23(1):77–83CrossRef Kezirian EJ, Goding GS, Malhotra A et al (2014) Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. J Sleep Res 23(1):77–83CrossRef
20.
go back to reference 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):1593–1598CrossRef 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):1593–1598CrossRef
21.
go back to reference 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):181–188CrossRef 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):181–188CrossRef
22.
go back to reference 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):1727–1734CrossRef 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):1727–1734CrossRef
23.
go back to reference 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):378–384CrossRef 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):378–384CrossRef
24.
go back to reference 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):509–515CrossRef 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):509–515CrossRef
25.
go back to reference 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):194–202CrossRef 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):194–202CrossRef
26.
go back to reference 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):2618–2623CrossRef 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):2618–2623CrossRef
27.
go back to reference 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):597–619CrossRef 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):597–619CrossRef
28.
go back to reference 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):735–744CrossRef 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):735–744CrossRef
29.
go back to reference 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):379–385CrossRef 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):379–385CrossRef
30.
go back to reference 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):147–154CrossRef 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):147–154CrossRef
31.
go back to reference 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):553–560CrossRef 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):553–560CrossRef
32.
go back to reference 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):1005–1013CrossRef 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):1005–1013CrossRef
33.
go back to reference Steffen A, Abrams N, Suurna MV, Wollenberg B, Hasselbacher K (2018) Upper-airway stimulation before, after, or without Uvulopalatopharyngoplasty: a two-year perspective. Laryngoscope 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.
go back to reference 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):315–318CrossRef 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):315–318CrossRef
35.
go back to reference Thaler ER, Schwab RJ (2016) Single-institution experience and learning curve with upper airway stimulation. Laryngoscope 126(Suppl 7):S17–S19CrossRef Thaler ER, Schwab RJ (2016) Single-institution experience and learning curve with upper airway stimulation. Laryngoscope 126(Suppl 7):S17–S19CrossRef
36.
go back to reference 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):501–506CrossRef 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):501–506CrossRef
37.
go back to reference Dedhia RC, Woodson BT (2018) Standardized reporting for hypoglossal nerve stimulation outcomes. J Clin Sleep Med 14(11):1835–1836CrossRef Dedhia RC, Woodson BT (2018) Standardized reporting for hypoglossal nerve stimulation outcomes. J Clin Sleep Med 14(11):1835–1836CrossRef
Metadata
Title
Hypoglossal nerve stimulation long-term clinical outcomes: a systematic review and meta-analysis
Authors
Andrea Costantino
Vittorio Rinaldi
Antonio Moffa
Vitaliana Luccarelli
Federica Bressi
Michele Cassano
Manuele Casale
Peter Baptista
Publication date
01-06-2020
Publisher
Springer International Publishing
Published in
Sleep and Breathing / Issue 2/2020
Print ISSN: 1520-9512
Electronic ISSN: 1522-1709
DOI
https://doi.org/10.1007/s11325-019-01923-2

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