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Nyxoah双侧舌下神经刺激器植入治疗阻塞性睡眠呼吸暂停。

Implantation of the nyxoah bilateral hypoglossal nerve stimulator for obstructive sleep apnea.

作者信息

Lewis Richard, Pételle Boris, Campbell Matthew C, MacKay Stuart, Palme Carsten, Raux Guillaume, Sommer J Ulrich, Maurer Joachim T

机构信息

Hollywood Private Hospital Perth Western Australia Australia.

Hôpital Tenon AP-HP Paris France.

出版信息

Laryngoscope Investig Otolaryngol. 2019 Nov 22;4(6):703-707. doi: 10.1002/lio2.312. eCollection 2019 Dec.

Abstract

OBJECTIVES

This report describes the surgical implantation of a novel bilateral hypoglossal nerve stimulator (Genio system®, Nyxoah S.A., Belgium) and the successful treatment of a patient with moderate obstructive sleep apnea (OSA).

STUDY DESIGN

Surgical technique description and case study report.

METHODS

The bilateral implantable stimulator (IS) simultaneously stimulates both genioglossus (GG) muscles to reduce airway obstruction. At night, patients wear an activation chip under their chin that wirelessly transmits energy to the implant and enables the nerve stimulation. Surgical implantation of the IS is performed under general anesthesia by making a small incision above the hyoid bone and dissecting through the platysma, mylohyoid, and geniohyoid muscles to the GG muscle. The hypoglossal nerve branches are then identified, followed by suturing the IS in place. The system was evaluated in an otherwise healthy, 60-year-old woman with moderate OSA (apnea hypopnea index (AHI): 25/hr, nadir O saturation: 78%). Appropriate stimulation settings were determined at 2-, 3-, and 6-months post implantation during polysomnography (PSG) and changes in apnea and hypopnea events and oxygen desaturation recorded.

RESULTS

The surgery was well tolerated by the patient with an uneventful recovery. The PSG at 6 months showed that AHI per hour, obstructive apnea events per hour, hypopnea events per hour, and oxygen desaturation index have been reduced by 88%, 92%, 88%, and 97%, respectively, and nadir O saturation improved to 91%.

CONCLUSIONS

The absence of complications and considerable reduction of apnea and hypopnea events in this case study help demonstrate the potential safety and efficacy of the bilateral hypoglossal nerve stimulator.

LEVEL OF EVIDENCE

摘要

目的

本报告描述了一种新型双侧舌下神经刺激器(Genio系统®,Nyxoah S.A.,比利时)的手术植入情况以及对一名中度阻塞性睡眠呼吸暂停(OSA)患者的成功治疗。

研究设计

手术技术描述及病例研究报告。

方法

双侧植入式刺激器(IS)同时刺激双侧颏舌肌(GG)以减轻气道阻塞。夜间,患者在下巴下方佩戴一个激活芯片,该芯片将能量无线传输至植入物并实现神经刺激。IS在全身麻醉下通过在舌骨上方做一个小切口并切开颈阔肌、下颌舌骨肌和颏舌骨肌至GG肌来进行手术植入。然后识别舌下神经分支,接着将IS缝合到位。该系统在一名60岁、患有中度OSA(呼吸暂停低通气指数(AHI):25次/小时,最低血氧饱和度:78%)的健康女性身上进行了评估。在植入后2个月、3个月和6个月的多导睡眠图(PSG)期间确定合适的刺激设置,并记录呼吸暂停和低通气事件以及氧饱和度下降的变化。

结果

患者对手术耐受性良好,恢复顺利。6个月时的PSG显示,每小时的AHI、每小时的阻塞性呼吸暂停事件、每小时的低通气事件以及氧饱和度下降指数分别降低了88%、92%、88%和97%,最低血氧饱和度提高到了91%。

结论

本病例研究中无并发症发生且呼吸暂停和低通气事件显著减少,这有助于证明双侧舌下神经刺激器的潜在安全性和有效性。

证据水平

4级。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/413c/6929572/0701c83da2b4/LIO2-4-703-g001.jpg

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