Pavelec Vaclav, Rotenberg Brian W, Maurer Joachim T, Gillis Edward, Verse Thomas
LENTE Clinic, Plzeň, Czech Republic; Faculty of Health Studies of West Bohemia University, Plzeň, Czech Republic.
Department of Otolaryngology, Head and Neck Surgery, Western University, London, ON, Canada.
Nat Sci Sleep. 2016 May 4;8:137-44. doi: 10.2147/NSS.S103702. eCollection 2016.
Many cases of obstructive sleep apnea (OSA) involve collapse of the tongue base and soft palate during sleep, causing occlusion of the upper airway and leading to oxygen desaturation. Existing therapies can be effective, but they are plagued by patient adherence issues and the invasiveness of surgical approaches. A new, minimally invasive implant for OSA has been developed, which is elastic and contracts a few weeks after deployment, stabilizing the surrounding soft tissue. The device has had good outcomes in preclinical testing; this report describes the preliminary feasibility and safety of its implementation in humans.
A prospective, multicenter, single-arm feasibility study was conducted. Subjects were adults with moderate-to-severe OSA who had previously failed or refused conventional continuous positive airway pressure treatment. Intraoperative feasibility data, postoperative pain, and safety information were collected for a 30-day postoperative period.
Forty subjects participated (37 men, three women; average age of 46.1 years); each received two tongue-base implants and two soft-palate implants. Surgical procedure time averaged 43 minutes. Postsurgical pain resolved readily in most cases; at 30 days post implantation, <20% of subjects reported pain, which averaged less than two out of ten. Adverse events were generally the mild and expected sequelae of a surgical procedure with general anesthesia and intraoral manipulation. The device was well tolerated. Implant extrusions were reported with soft-palate implants (n=12), while tongue-base implants required few revisions (n=2). Quantitative and qualitative sleep effectiveness outcomes (including full-night polysomnographic and quality-of-life measures) will be presented in a subsequent report.
Implantation of the device was feasible. Although a relatively high rate of extrusions occurred in the now-discontinued palate implants, tongue-base implants were largely stable and well tolerated. The minimally invasive and maintenance-free implant may provide a new alternative to higher morbidity surgical procedures.
许多阻塞性睡眠呼吸暂停（OSA）病例涉及睡眠期间舌根和软腭塌陷，导致上气道阻塞并引起氧饱和度下降。现有疗法可能有效，但存在患者依从性问题以及手术方法的侵入性等困扰。一种用于OSA的新型微创植入物已被研发出来，它具有弹性，在植入几周后会收缩，从而稳定周围软组织。该装置在临床前测试中取得了良好结果；本报告描述了其在人体中实施的初步可行性和安全性。
进行了一项前瞻性、多中心、单臂可行性研究。受试者为患有中重度OSA且先前常规持续气道正压通气治疗失败或拒绝接受该治疗的成年人。收集了术后30天内的术中可行性数据、术后疼痛情况及安全信息。
40名受试者参与研究（37名男性，3名女性；平均年龄46.1岁）；每人接受了两枚舌根植入物和两枚软腭植入物。手术平均时长43分钟。在大多数情况下，术后疼痛很快缓解；植入后30天，不到20%的受试者报告有疼痛，疼痛平均强度小于十分制中的两分。不良事件通常是全身麻醉和口腔内操作的手术常见的轻微且可预期的后遗症。该装置耐受性良好。软腭植入物有植入物挤出的报告（n = 12），而舌根植入物需要很少的翻修（n = 2）。后续报告将呈现定量和定性的睡眠有效性结果（包括整夜多导睡眠图和生活质量指标）。
该装置的植入是可行的。尽管现已停产的腭部植入物出现了相对较高的挤出率，但舌根植入物在很大程度上是稳定的且耐受性良好。这种微创且无需维护的植入物可能为发病率较高的手术提供一种新的替代方案。
