Hypoglossal nerve stimulator
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The hypoglossal nerve stimulator is a novel strategy for the treatment of obstructive sleep apnea.[1][2] It has been gaining popularity over the last few decades and was approved in Europe in 2013 and the Food and Drug Administration (FDA) in April 2014.[3] The purpose of the hypoglossal nerve stimulator is to relieve tongue base obstruction during sleep by stimulating the tongue to protrude during inspiration (i.e., inhale).[1]
Eligibility criteria
[edit] | This section contains close paraphrasing of a non-free copyrighted source, https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38307&ver=10&= (Copyvios report). (January 2024) |
Certain patients with obstructive sleep apnea who are deemed eligible candidates may be offered the hypoglossal nerve stimulator as an alternative. FDA-approved hypoglossal nerve neurostimulation is considered medically reasonable and necessary for the treatment of moderate to severe obstructive sleep apnea when all of the following criteria are met:[4]
- Age ≥ 22 years
- Body mass index < 35 kg/m2
- Polysomnography performed within 24 months of initial consult for hypoglossal nerve stimulator implant
- Predominantly obstructive sleep apnea (ie, central and mixed apneas < 25% of the total apnea–hypopnea index)
- Apnea–hypopnea index is 15 to 65 events per hour
- Failure of continuous positive airway pressure (ie, apnea–hypopnea index > 15 despite continuous positive airway pressure usage) or continuous positive airway pressure intolerance (ie, < 4 hours per night, 5 nights per week or the continuous positive airway pressure has been returned)
- Drug-induced sleep endoscopy procedure showing <75% complete concentric collapse at the soft palate
- No other anatomical findings that would compromise performance of device (e.g., tonsil size 3 or 4 per standardized tonsillar hypertrophy grading scale).
Procedure details
[edit]In this procedure, an electrical stimulator lead is placed around branches of the hypoglossal nerve that control tongue protrusion (e.g., genioglossus) via an incision in the neck.[5] A sensor lead is then placed in the chest between the ribs in the layer between the internal intercostal muscles and external intercostal muscles. The stimulator and sensory lead are then connected via a tunneled wire to an implantable pulse generator. When turned on during sleep, the sensory lead in the chest detects the respiratory cycle. During inspiration (i.e., inhale), an electrical signal is fired via the stimulator lead in the neck, stimulating the hypoglossal nerve, and causing the tongue to protrude, thereby alleviating obstruction.[6]
Post-operative and long term care
[edit]Once implanted, the hypoglossal nerve stimulator is typically activated in clinic approximately 4 weeks afterwards.[7] The implant may be configured to best accommodate the patient's comfort and sleeping habits (e.g., set a delay based on sleep latency).
The hypoglossal nerve stimulator implantable pulse generator battery life typically lasts 8–12 years, after which the implantable pulse generator may be safely replaced with another surgery.[8]
References
[edit]- ^ a b Yu, Jason L.; Thaler, Erica R. (February 2020). "Hypoglossal Nerve (Cranial Nerve XII) Stimulation". Otolaryngologic Clinics of North America. 53 (1): 157–169. doi:10.1016/j.otc.2019.09.010. ISSN 1557-8259. PMID 31699408. S2CID 207937455.
- ^ Mashaqi, Saif; Patel, Salma Imran; Combs, Daniel; Estep, Lauren; Helmick, Sonia; Machamer, Joan; Parthasarathy, Sairam (2021-02-09). "The Hypoglossal Nerve Stimulation as a Novel Therapy for Treating Obstructive Sleep Apnea-A Literature Review". International Journal of Environmental Research and Public Health. 18 (4): 1642. doi:10.3390/ijerph18041642. ISSN 1660-4601. PMC 7914469. PMID 33572156.
- ^ Strohl, Kingman P.; Baskin, Jonathan; Lance, Colleen; Ponsky, Diana; Weidenbecher, Mark; Strohl, Madeleine; Yamauchi, Motoo (July 2016). "Origins of and Implementation Concepts for Upper Airway Stimulation Therapy for Obstructive Sleep Apnea". Respiratory Investigation. 54 (4): 241–249. doi:10.1016/j.resinv.2016.01.006. ISSN 2212-5345. PMC 4955664. PMID 27424823.
- ^ "LCD - Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea (L38307)". www.cms.gov. Retrieved 2024-01-01.
- ^ "Hypoglossal Nerve Stimulator Implantation (Selective Upper Airway Stimulation) | Iowa Head and Neck Protocols". medicine.uiowa.edu. Retrieved 2024-01-01.
- ^ Mashaqi, Saif; Patel, Salma Imran; Combs, Daniel; Estep, Lauren; Helmick, Sonia; Machamer, Joan; Parthasarathy, Sairam (January 2021). "The Hypoglossal Nerve Stimulation as a Novel Therapy for Treating Obstructive Sleep Apnea—A Literature Review". International Journal of Environmental Research and Public Health. 18 (4): 1642. doi:10.3390/ijerph18041642. ISSN 1660-4601. PMC 7914469. PMID 33572156.
- ^ "Hypoglossal Nerve Stimulation". Mass Eye and Ear. Retrieved 2024-01-01.
- ^ Magaña, Linda C.; Strollo, Patrick J.; Steffen, Armin; Ravesloot, Madeline; van Maanen, Peter; Harrison, Christine; Maurer, Joachim T.; Soose, Ryan J. (October 2023). "Long-Term Generator Replacement Experience in Hypoglossal Nerve Stimulator Therapy Recipients With CPAP-Intolerant Obstructive Sleep Apnea". Otolaryngology–Head and Neck Surgery. 169 (4): 1064–1069. doi:10.1002/ohn.340. ISSN 1097-6817. PMID 37003598. S2CID 257901315.
External links
[edit]- Video demonstrating the procedure in detail (viewer discretion is advised): Hypoglossal Nerve Stimulator Implantation for Obstructive Sleep Apnea.