Abstract
Background: Patients with severe obstructive sleep apnea (OSA) require safe and effective surgical treatment.
Objectives: To evaluate the effectiveness of combined Z-palatopharyngoplasty (ZPPP) and partial glossectomy via 70-degree endoscopy-assisted coblation (Eco-TBR) on severe OSA.
Materials and methods: Twenty-two consecutive patients with severe OSA were enrolled between September 2014 and July 2016. The lingual artery was evaluated by contrasted computed tomography (CT). Drug-induced sleep endoscopy (DISE) was performed to determine the necessity of multilevel surgery. Combined ZPPP and Eco-TBR were performed. Polysomnographic parameters were collected pre-operatively and 6 months post-operatively.
Results: No adverse events were observed postoperatively. The short-term ( < 12 months) rate of total surgical effectiveness was 63.6% (14/22), with Friedman classifications as follows: I (1/1), Friedman II (6/10) and Friedman III (7/11). There were no differences between Friedman classification groups. The differences in AHI, apnea index (AI), mean blood oxygen, and percentage of cumulative time with oxygen saturation < 90% (CT 90%) were different compared to preoperative levels. Tonsil size was also significantly larger in the multi-level surgery group (2.14 ± 1.03) compared with the control group (1.13 ± 0.64).
Conclusions and significance: Combined ZPPP and Eco-TB is safe and effective, with good surgical effectiveness for the treatment of severe OSA patients.
Trial registration: Chinese Clinical Trial Registry identifier: ChiCTR-CCC-13003415.
Chinese abstract
背景:严重阻塞性睡眠呼吸暂停(OSA)患者需要安全有效的手术治疗。
目的:评估联合Z-腭咽成形术(ZPPP)和70度内镜辅助下低温消融(Eco-TBR)的部分舌切除手术对严重OSA的有效性。
材料和方法:在2014年9月至2016年7月期间, 共有22名患有严重OSA的患者加入。通过对比计算机断层扫描(CT)评估舌动脉。进行药物诱导的睡眠内窥镜检查(DISE)以确定多级手术的必要性。进行ZPPP和Eco-TBR的组合。在手术前和手术后6个月收集多导睡眠图参数。
结果:术后未观察到不良事件。短期(<12个月)总手术有效率为63.6%(14/22), Friedman分类如下:Friedman I(1/1)、Friedman II(6/10)和Friedman III(7/11)。弗里德曼分类组之间没有差异。 AHI、呼吸暂停指数(AI)、平均血氧和累积时间与氧饱和度<90%(CT 90%)的差异与术前水平不同。与对照组(1.13±0.64)相比, 多级手术组的扁桃体大小也显著增大(2.14±1.03)。
结论和意义:ZPPP和Eco-TB联合手术安全有效, 对重症OSA患者的治疗具有良好的手术效果。
Acknowledgements
Compliance with ethical standards: This research did not increase the risk and economic burden of patients; the patients’ rights were fully protected. The study was carried out in accordance with the guidelines of the Ethics Committee of Nanfang Hospital and approved by the institutional review board of Nanfang Hospital. The study conforms to the Declaration of Helsinki. The project was approved by Chinese ClinicalTrials.gov (ChiCTR-CCC-13003415) on 31 May 2013.
Informed consent statement: All participants in this study have provided informed written consent prior to enrollment.
Data sharing statement: All data generated during the project will be made freely available via the Nanfang Hospital’s Research Data Repository. There are no security, licensing, or ethical issues related to these data.
Disclosure statement
No potential conflict of interest was reported by the authors.