Arzt Michael, Munt Oliver, Pépin Jean-Louis, Heinzer Raphael, Kübeck Raphaela, von Hehn Ulrike, Ehrsam-Tosi Daniela, Benjafield Adam, Woehrle Holger
Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany.
ResMed Science Centre, Martinsried, Germany.
ERJ Open Res. 2023 Apr 17;9(2). doi: 10.1183/23120541.00618-2022. eCollection 2023 Mar.
Although adaptive servo-ventilation (ASV) effectively supresses central sleep apnoea (CSA), little is known about real-world indications of ASV therapy and its effects on quality of life (QoL).
This report details the design, baseline characteristics, indications for ASV and symptom burden in patients enrolled in the Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV). This multicentre, European, non-interventional trial enrolled participants prescribed ASV in clinical practice between September 2017 and March 2021. An expert review board assigned participants to ASV indications using a guideline-based semi-automated algorithm. The primary end-point was change in disease-specific QoL based on the Functional Outcomes of Sleep Questionnaire (FOSQ) from baseline to 12-month follow-up.
The registry population includes 801 participants (age 67±12 years, 14% female). Indications for ASV were treatment-emergent or persistent CSA (56%), CSA in cardiovascular disease (31%), unclassified CSA (2%), coexisting obstructive sleep apnoea and CSA (4%), obstructive sleep apnoea (3%), CSA in stroke (2%) and opioid-induced CSA (1%). Baseline mean apnoea--hypopnoea index was 48±23 events·h (≥30 events·h in 78%), FOSQ score was 16.7±3.0 (<17.9 in 54%) and Epworth Sleepiness Scale (ESS) score was 8.8±4.9 (>10 in 34%); 62% of patients were symptomatic (FOSQ score <17.9 or ESS score >10).
The most common indications for ASV were treatment-emergent or persistent CSA or CSA in cardiovascular disease (excluding systolic heart failure). Patients using ASV in clinical practice had severe sleep-disordered breathing and were often symptomatic. One-year follow-up will provide data on the effects of ASV on QoL, respiratory parameters and clinical outcomes in these patients.
尽管适应性伺服通气（ASV）能有效抑制中枢性睡眠呼吸暂停（CSA），但对于ASV治疗在现实世界中的适应证及其对生活质量（QoL）的影响却知之甚少。
本报告详细介绍了“适应性伺服通气治疗中枢性和复杂性睡眠呼吸障碍注册研究（READ - ASV）”中患者的设计、基线特征、ASV适应证及症状负担情况。这项多中心、欧洲的非干预性试验纳入了2017年9月至2021年3月在临床实践中被处方使用ASV的参与者。一个专家评审委员会使用基于指南的半自动算法为参与者确定ASV适应证。主要终点是基于睡眠功能结局问卷（FOSQ）从基线到12个月随访期间特定疾病生活质量的变化。
注册研究人群包括801名参与者（年龄67±12岁，14%为女性）。ASV的适应证为治疗中出现的或持续性CSA（56%）、心血管疾病中的CSA（31%）、未分类的CSA（2%）、同时存在阻塞性睡眠呼吸暂停和CSA（4%）、阻塞性睡眠呼吸暂停（3%）、中风后的CSA（2%）以及阿片类药物诱导的CSA（1%）。基线时平均呼吸暂停低通气指数为48±23次/小时（78%的患者≥30次/小时），FOSQ评分为16.7±3.0（54%的患者<17.9），爱泼沃斯嗜睡量表（ESS）评分为8.8±4.9（34%的患者>10）；62%的患者有症状（FOSQ评分<17.9或ESS评分>10）。
ASV最常见的适应证是治疗中出现的或持续性CSA或心血管疾病中的CSA（不包括收缩性心力衰竭）。在临床实践中使用ASV的患者存在严重的睡眠呼吸障碍，且常伴有症状。一年的随访将提供关于ASV对这些患者生活质量、呼吸参数和临床结局影响的数据。
