Steffen Armin, Sommer Ulrich J, Maurer Joachim T, Abrams Nils, Hofauer Benedikt, Heiser Clemens
Department of Otorhinolaryngology, University of Lübeck, Klinik für HNO-Heilkunde, Ratzeburger Allee 160, 23538, Lübeck, Germany.
Department of Otorhinolaryngology, Head and Neck Surgery, Helios University Hospital Wuppertal, University Witten/Herdecke, Wuppertal, Germany.
Sleep Breath. 2020 Sep;24(3):979-984. doi: 10.1007/s11325-019-01933-0. Epub 2019 Sep 4.
Upper airway stimulation (UAS) is an effective treatment for obstructive sleep apnea (OSA) in positive airway pressure (PAP) failure. Most reports have presented short-term data, so long-term safety and efficacy reports are rare. The German post-market study (G-PMS) has followed approximately 60 patients from three implanting centers for several years.
Patients with OSA and PAP failure qualified for the G-PMS by the absence of obesity class 2 an AHI between 15 and 65 events/h and absence of complete concentric collapse at the velum during drug-induced sleep endoscopy. Optional 2- and 3-year follow-ups after implantation were collected during routine clinical practice. We measured respiratory parameters such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) and daytime sleepiness using the Epworth sleepiness scale (ESS) in a per protocol analysis. Usage was calculated from device-downloaded reports. Device-related complications were documented.
Of the 60 original patients, 41 returned for 2-year follow-up, and 38 for 3 years. About 76% at 2 years and 68% at 3 years met the criterion of therapy success defined as an AHI below 15/h. The median AHI was reduced from 28.6/h (baseline) to 9.0/h (2 years) and 10.0/h (3 years); whereas median ODI decreased from 27.0 to 6.3/h (2 years), and 8.3/h (3 years). Median ESS improved from baseline 13 points to 4 (2 years) and 6 (3 years). Usage was stable at approximately 45 h per week at 2 and 3 years. Serious device-related adverse events were rare, with two-device explantation between 12 to 36 months postoperatively.
The German multi-center long-term outcomes compare favorably with previously published studies. Respiratory and sleepiness efficacy outcomes were sustained over 2 and 3 years, with a favorable safety profile, supporting the safety and efficacy of a chronic implantable therapy.
上气道刺激（UAS）是治疗气道正压通气（PAP）失败的阻塞性睡眠呼吸暂停（OSA）的一种有效方法。大多数报告提供的是短期数据，因此长期安全性和疗效报告较为罕见。德国上市后研究（G-PMS）对来自三个植入中心的约60例患者进行了数年的随访。
患有OSA且PAP治疗失败的患者若符合以下条件则纳入G-PMS：无2级肥胖，呼吸暂停低通气指数（AHI）在15至65次/小时之间，且在药物诱导睡眠内镜检查时软腭无完全同心塌陷。在常规临床实践中收集植入后可选的2年和3年随访数据。在符合方案分析中，我们使用Epworth嗜睡量表（ESS）测量呼吸参数，如呼吸暂停低通气指数（AHI）、氧饱和度下降指数（ODI）和日间嗜睡情况。使用情况根据设备下载报告计算得出。记录与设备相关的并发症。
60例初始患者中，41例返回进行2年随访，38例进行3年随访。2年时约76%、3年时约68%的患者达到治疗成功标准，即AHI低于15次/小时。AHI中位数从28.6次/小时（基线）降至9.0次/小时（2年）和10.0次/小时（3年）；而ODI中位数从27.0降至6.3次/小时（2年）和8.3次/小时（3年）。ESS中位数从基线的13分改善至4分（2年）和6分（3年）。2年和3年时使用时间稳定在每周约45小时。与设备相关的严重不良事件罕见，术后12至36个月有两例设备取出。
德国多中心长期结果与先前发表的研究相比更具优势。呼吸和嗜睡疗效结果在2年和3年期间持续存在，安全性良好，支持了慢性可植入治疗的安全性和有效性。
