Prospective multi-center study on expansion sphincter pharyngoplasty

Abstract

Background and objective: The aim of this study was to demonstrate the long-term effectiveness of Expansion Sphincter Pharyngoplasty (ESP) as a standalone surgical treatment of obstructive sleep apnea-hypopnea syndrome (OSAHS) patients through a prospective multi-center study.

Material and methods: A prospective non-comparative multicenter study of patients suffering from OSHAS selected after drug-induced sleep endoscopy, with ESP as standing alone procedure was performed. Inclusion criteria were lateral collapse on oropharynx and preoperative AHI between 5 and 70. Minimum follow-up was >12 months. Outcome measures were Epworth sleepiness scale (ESS), AHI, success rate and CPAP need after surgery.

Results: A total of 75 ESP were performed. Mean patient age was 46.7 ± 10.5 years. Mean pre-operative and post-operative AHI was 22.1 ± 12.2 and 8.6 ± 6.7, respectively (p < .001). Mean pre-operative and post-operative ESS score was 11.5 ± 4.7 and 4.6 ± 6.6, respectively (p < .001). AHI <5 was obtained in 25 patients (33.3%), and CPAP was not further needed after surgery in a total of 62 patients (82.6%).

Conclusions and significance: In this prospective multi-center study, patients undergoing ESP standing alone for the treatment of OSAHS have a reasonable expectation for success with minimal morbidity.

Chinese abstract

背景和目的：本研究的目的是通过一项前瞻性多中心研究, 证明扩张括约肌咽成形术（ESP）作为阻塞性睡眠呼吸暂停低通气综合征（OSAHS）患者的独立手术治疗的长期有效性。

材料和方法：一项前瞻性非比较性多中心研究, 对患有OSHAS的患者进行药物诱导的睡眠内窥镜检查, 并进行了作为独立手术的ESP。选择标准是口咽侧向塌陷, 术前AHI在5-70之间。最短随访时间> 12个月。结果度量指标为Epworth嗜睡量表（ESS）、AHI、手术成功率和术后对CPAP的需求。

结果：共进行了75项ESP。平均患者年龄为46.7±10.5岁。平均术前和术后AHI分别为22.1±12.2和8.6±6.7（p <.001）。平均术前和术后ESS评分分别为11.5±4.7和4.6±6.6（p <.001）。25名患者（33.3％）获得AHI <5；62名患者（82.6％）术后不再需要CPAP。

结论和意义：在这项前瞻性多中心研究中, 接受ESP独立治疗的OSAHS患者具有一定的成功期望值, 并且发病率很低。

Keywords:

• Pharyngoplasty
• sleep apnea
• technique
• surgery
• expansion level of evidence: 4 (multi-center case series)

Ethical statement

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent was obtained from all individual participants included in the study.

Disclosure statement

No potential conflict of interest was reported by the authors.