1 Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
2 University of Lubeck, Lubeck, Germany.
Otolaryngol Head Neck Surg. 2018 Aug;159(2):379-385. doi: 10.1177/0194599818764896. Epub 2018 Mar 20.
Objective Upper airway stimulation (UAS) is an alternative treatment option for patients unable to tolerate continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA). Studies support the safety and efficacy of this therapy. The aim of this registry is to collect retrospective and prospective objective and subjective outcome measures across multiple institutions in the United States and Germany. To date, it represents the largest cohort of patients studied with this therapy. Study Design Retrospective and prospective registry study. Setting Ten tertiary care hospitals in the United States and Germany. Subjects and Methods Patients were included who had moderate to severe OSA, were intolerant to CPAP, and were undergoing UAS implantation. Baseline demographic and sleep study data were collected. Objective and subjective treatment outcomes, adverse events, and patient and physician satisfaction were reviewed. Results The registry enrolled 301 patients between October 2016 and September 2017. Mean ± SD AHI decreased from 35.6 ± 15.3 to 10.2 ± 12.9 events per hour ( P < .0001), and Epworth Sleepiness Scale scores decreased from 11.9 ± 5.5 to 7.5 ± 4.7 ( P < .0001) from baseline to the posttitration visit. Patients utilized therapy for 6.5 hours per night. There were low rates of procedure- and device-related complications. Clinical global impression scores demonstrated that the majority of physicians (94%) saw improvement in their patients' symptoms with therapy. The majority of patients (90%) were more satisfied with UAS than CPAP. Conclusions Across a multi-institutional registry, UAS therapy demonstrates significant improvement in subjective and objective OSA outcomes, good therapy adherence, and high patient satisfaction.
上气道刺激(UAS)是一种替代治疗方法,适用于无法耐受持续气道正压通气(CPAP)治疗阻塞性睡眠呼吸暂停(OSA)的患者。研究支持该疗法的安全性和有效性。该注册研究旨在收集美国和德国多个机构的回顾性和前瞻性客观和主观结果测量数据。迄今为止,它代表了接受该治疗的最大患者队列。
回顾性和前瞻性注册研究。
美国和德国的 10 家三级保健医院。
纳入中度至重度 OSA、不耐受 CPAP 且正在接受 UAS 植入的患者。收集基线人口统计学和睡眠研究数据。回顾客观和主观治疗结果、不良事件以及患者和医生满意度。
该注册研究于 2016 年 10 月至 2017 年 9 月期间共纳入 301 例患者。平均±标准差 AHI 从 35.6±15.3 降至 10.2±12.9 事件/小时(P<0.0001),Epworth 睡眠量表评分从基线时的 11.9±5.5 降至 7.5±4.7(P<0.0001)。患者每晚使用治疗时间为 6.5 小时。手术和设备相关并发症发生率较低。临床总体印象评分表明,大多数医生(94%)认为患者的症状通过治疗得到改善。大多数患者(90%)对 UAS 的满意度高于 CPAP。
在多机构注册研究中,UAS 治疗在 OSA 的主观和客观结局方面显示出显著改善、良好的治疗依从性和较高的患者满意度。