Kim Minjee, Xu Lucy J, Shih E'Ching, Gipson Kevin S, Skotko Brian G, Scheffler Patrick, Hartnick Christopher J
Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA.
Department of Pediatric Pulmonary and Sleep Medicine, Massachusetts General Hospital for Children, Boston, MA, USA; Department of Pediatrics, Harvard Medical School, Boston, MA, USA.
Int J Pediatr Otorhinolaryngol. 2025 Sep;196:112497. doi: 10.1016/j.ijporl.2025.112497. Epub 2025 Jul 23.
Obstructive Sleep Apnea (OSA) is prevalent among children with Down syndrome (DS). While adenotonsillectomy is the first-line treatment for these patients, many do not achieve resolution of OSA. The U.S. Food and Drug Administration has approved HGNS implantation for children with DS, ages 13 and above. However, there remains a need for HGNS implantation in children under 13 with severe OSA. The objective of this study was to determine the safety and efficacy of HGNS placement in children <13 years of age with DS and severe OSA.
Retrospective cohort study.
Two academic institutions.
This study included children <13 years of age with DS and severe OSA who had HGNS implantation. Patient characteristics, postoperative complications, and response to therapy were recorded.
A total of 29 children were included. The median age of the patients was 10 years old (range 4-12 years), with 19 patients (65.5 %) male. All 29 children were safely implanted with no serious adverse events. There was one mild wound dehiscence (Adverse Event), which resolved with antibiotic ointment and pressure dressing, and no adverse device effects. The median pre-op OAHI was 18.4 (IQR 13.2-22.3), and the median post-op OAHI was 3.9 (IQR 2.3-5.5) (p < 0.001). At 6 months post-op, 20 patients (95.2 %) had OAHI reduction of 50 % or more.
HGNS implantation in children with DS and severe OSA can be safely performed in children ages 4-13, and initial efficacy studies demonstrate outcomes similar to children over 13.
阻塞性睡眠呼吸暂停（OSA）在唐氏综合征（DS）患儿中很常见。虽然腺样体扁桃体切除术是这些患者的一线治疗方法，但许多患者的OSA并未得到解决。美国食品药品监督管理局已批准为13岁及以上的DS患儿植入HGNS。然而，对于13岁以下患有严重OSA的儿童，仍需要进行HGNS植入。本研究的目的是确定在13岁以下患有DS和严重OSA的儿童中植入HGNS的安全性和有效性。
回顾性队列研究。
两个学术机构。
本研究纳入了13岁以下患有DS和严重OSA且已植入HGNS的儿童。记录患者特征、术后并发症和治疗反应。
共纳入29名儿童。患者的中位年龄为10岁（范围4 - 12岁），其中19名患者（65.5%）为男性。所有29名儿童均安全植入，无严重不良事件。有1例轻度伤口裂开（不良事件），经抗生素软膏和加压敷料处理后痊愈，且无器械不良影响。术前中位阻塞性呼吸暂停低通气指数（OAHI）为18.4（四分位间距13.2 - 22.3），术后中位OAHI为3.9（四分位间距2.3 - 5.5）（p < 0.001）。术后6个月，20名患者（95.2%）的OAHI降低了50%或更多。
在4 - 13岁的DS和严重OSA患儿中，HGNS植入术可以安全进行，初步疗效研究表明其结果与13岁以上儿童相似。
