PDF(Pubmed)
Abstract：
Background/Objectives: Hypoglossal nerve stimulation (HNS) emerged as an alternative treatment for patients with obstructive sleep apnea (OSA) a decade ago. Long-term clinical trials and real-world data show that HNS treatment provides significant and sustained improvements in both OSA disease control and quality-of-life measures over time. Given the nature of HNS treatment, with the requirement of using an implantable neurostimulation system, patient safety is a critical domain in the assessment of this technology. The objective of this review was to evaluate adverse events (AEs) and complications with HNS therapy in a systematic review of published evidence. Methods: Medline, Cochrane, and Web of Science were systematically searched to identify randomized controlled and real-world observational studies reporting relevant outcomes with HNS therapy for treatment of OSA that included procedure-, device-, and treatment-related AEs. Results: Out of 418 articles screened, 27 were reviewed for eligibility, and 17 studies, the majority found to have low-to-moderate risk of bias, with data on 1962 patients were included for further analysis. Across included studies, reporting of AEs was heterogeneous with regard to the classifications used and the extent of reporting. Over an average follow-up duration of 17.5 ± 16.9 months, the pooled mortality rate was 0.01% (95% CI = 0.0 to 0.2%), with all reported deaths being unrelated to HNS treatment. The HNS system survival probability over the follow-up time of 60 months was 0.9834 (95% CI = 0.9768 to 0.9882), with infections and request for removal by patients being the most common indications. The pooled surgical revision rate was 0.08% (95% CI 0.0 to 0.2%). Most reported treatment-related side effects were transient stimulation-related discomfort (0.08%, 95% CI = 0.0 to 0.2%) and tongue abrasions (0.07%, 95% CI = 0.0 to 0.2%). Based on the systematic review, a standardized set of endpoints was defined, aiming to harmonize safety data relevant to HNS therapy. Conclusions: In this systematic review, HNS therapy for treatment of OSA is associated with a positive patient safety profile. AEs occur mainly at device implantation and during the treatment acclimatization period. Due to a lack of available evidence, partially implantable HNS systems are underrepresented in this review, which limits the generalizability of the results. Significant heterogeneity was found for adverse event reporting. A framework for reporting HNS outcomes that includes AEs and side effects is proposed to facilitate comparability of the reported data.
摘要：
背景/目的：十年前，舌下神经刺激（HNS）已成为阻塞性睡眠呼吸暂停（OSA）患者的替代治疗方法。长期临床试验和现实世界的数据表明，随着时间的推移，HNS治疗在OSA疾病控制和生活质量测量方面提供了显著和持续的改善。鉴于HNS治疗的性质，需要使用植入式神经刺激系统，患者安全是这项技术评估的关键领域.本综述的目的是通过对已发表证据的系统评价，评估HNS治疗的不良事件（AE）和并发症。方法:Medline,科克伦,和WebofScience进行了系统搜索，以确定随机对照和真实世界的观察性研究，这些研究报告了HNS疗法治疗OSA的相关结果，包括手术，Device-,和治疗相关的AE。结果：在筛选的418篇文章中，27人接受了资格审查，和17项研究，大多数人发现有低到中等的偏见风险，纳入1962例患者的数据进行进一步分析.在纳入的研究中，在所使用的分类和报告范围方面,AE的报告具有异质性.平均随访时间17.5±16.9个月，合并死亡率为0.01%(95%CI=0.0至0.2%)，所有报告的死亡与HNS治疗无关。在60个月的随访时间内，HNS系统的生存概率为0.9834（95％CI=0.9768至0.9882），感染和患者要求切除是最常见的适应症。合并的手术翻修率为0.08％（95％CI0.0至0.2％）。大多数报告的治疗相关副作用是短暂的刺激相关不适（0.08％，95%CI=0.0至0.2%)和舌头擦伤(0.07%，95%CI=0.0至0.2%)。在系统回顾的基础上，定义了一组标准化的端点，旨在协调与HNS治疗相关的安全性数据。结论：在这篇系统综述中，用于治疗OSA的HNS疗法与积极的患者安全性相关。AE主要发生在装置植入和治疗适应期。由于缺乏现有证据,部分植入式HNS系统在这篇综述中的代表性不足，这限制了结果的泛化性。不良事件报告存在显著异质性。提出了一个包括不良事件和副作用的HNS结果报告框架，以促进报告数据的可比性。
