Device-related outcomes following hypoglossal nerve stimulator implantation.

IF 2.9 3区医学 Q1 CLINICAL NEUROLOGY Journal of Clinical Sleep Medicine Pub Date : 2024-09-01 DOI:10.5664/jcsm.11176

Annie E Moroco, Zhikui Wei, Israel Byrd, Andrea Rasmussen, Eugene G Chio, Ryan J Soose, Phillip Huyett, Armin Steffen, Clemens Heiser, Maurits S Boon, Colin T Huntley

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Abstract

Study objectives: Hypoglossal nerve stimulation (HGNS) has been widely used to treat obstructive sleep apnea in selected patients. Here we evaluate rates of revision and explant related to HGNS implantation and assess types of adverse events contributing to revision and explant.

Methods: Postmarket surveillance data for HGNS implanted between January 1, 2018 and March 31, 2022, were collected. Event rates and risk were calculated using the postmarket surveillance event counts and sales volume over the same period. Indications were categorized for analysis. Descriptive statistics were reported and freedom from explant or revision curves were grouped by year of implantation.

Results: Of the 20,881 HGNS implants assessed, rates of explant and revision within the first year were 0.723% and 1.542%, respectively. The most common indication for explant was infection (0.378%) and for revision was surgical correction (0.680%). Of the 5,820 devices with 3-year postimplantation data, the rate of explant was 2.680% and of revision was 3.557%. During this same interval, elective removal (1.478%) was the most common indication, and for revisions, surgical correction (1.134%).

Conclusions: The efficacy of HGNS is comparable in the real world setting to published clinical trial data. Rates of explant and revision are low, supporting a satisfactory safety profile for this technology.

Citation: Moroco AE, Wei Z, Byrd I, et al. Device-related outcomes following hypoglossal nerve stimulator implantation. J Clin Sleep Med. 2024;20(9):1497-1503.

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舌下神经刺激器植入术后与设备相关的结果。

研究目的：舌下神经刺激（HGNS）已被广泛用于治疗部分患者的阻塞性睡眠呼吸暂停。在此，我们评估了与 HGNS 植入相关的翻修和拆卸率，并评估了导致翻修和拆卸的不良事件类型：收集了 2018 年 1 月 1 日至 2022 年 3 月 31 日期间植入的 HGNS 的上市后监测数据。使用上市后监测事件计数和同期销售量计算事件发生率和风险。分析时对适应症进行了分类。报告了描述性统计数字，并按植入年份对无切除或翻修曲线进行了分组：结果：在接受评估的 20,881 例 HGNS 植入物中，第一年内的更换率和翻修率分别为 0.723% 和 1.542%。最常见的移植适应症是感染（0.378%），最常见的翻修适应症是手术矫正（0.680%）。在有植入后三年数据的 5,820 台设备中，取出率为 2.680%，翻修率为 3.557%。在相同的时间间隔内，选择性摘除（1.478%）是最常见的适应症，翻修则是手术矫正（1.134%）：结论：HGNS 在现实环境中的疗效与已公布的临床试验数据相当。结论：在现实世界中，HGNS 的疗效与已公布的临床试验数据相当。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Sleep Medicine CLINICAL NEUROLOGY-

CiteScore

6.20

自引率

7.00%

发文量

321

审稿时长

1 months

期刊介绍： Journal of Clinical Sleep Medicine focuses on clinical sleep medicine. Its emphasis is publication of papers with direct applicability and/or relevance to the clinical practice of sleep medicine. This includes clinical trials, clinical reviews, clinical commentary and debate, medical economic/practice perspectives, case series and novel/interesting case reports. In addition, the journal will publish proceedings from conferences, workshops and symposia sponsored by the American Academy of Sleep Medicine or other organizations related to improving the practice of sleep medicine.