Department of Respiratory Diseases, Montpellier University Hospital, Hôpital Arnaud de Villeneuve, 371 avenue du Doyen Gaston Giraud, 34295, Montpellier, Cedex 5, France.
Pulmonary Disorders and Respiratory Sleep Disorders Unit, Polyclinic Saint-Privat, 34760, Boujan sur Libron, France.
Respir Res. 2019 Oct 29;20(1):235. doi: 10.1186/s12931-019-1221-9.
As a consequence of the increased mortality observed in the SERVE-HF study, many questions concerning the safety and rational use of ASV in other indications emerged. The aim of this study was to describe the clinical characteristics of ASV-treated patients in real-life conditions.
The OTRLASV-study is a prospective, 5-centre study including patients who underwent ASV-treatment for at least 1 year. Patients were consecutively included in the study during the annual visit imposed for ASV-reimbursement renewal.
177/214 patients were analysed (87.57% male) with a median (IQ) age of 71 (65-77) years, an ASV-treatment duration of 2.88 (1.76-4.96) years, an ASV-usage of 6.52 (5.13-7.65) hours/day, and 54.8% were previously treated via continuous positive airway pressure (CPAP). The median Epworth Scale Score decreased from 10 (6-13.5) to 6 (3-9) (p < 0.001) with ASV-therapy, the apnea-hypopnea-index decreased from 50 (38-62)/h to a residual device index of 1.9 (0.7-3.8)/h (p < 0.001). The majority of patients were classified in a Central-Sleep-Apnea group (CSA; 59.3%), whereas the remaining are divided into an Obstructive-Sleep-Apnea group (OSA; 20.3%) and a Treatment-Emergent-Central-Sleep-Apnea group (TECSA; 20.3%). The Left Ventricular Ejection Fraction (LVEF) was > 45% in 92.7% of patients. Associated comorbidities/etiologies were cardiac in nature for 75.7% of patients (neurological for 12.4%, renal for 4.5%, opioid-treatment for 3.4%). 9.6% had idiopathic central-sleep-apnea. 6.2% of the patients were hospitalized the year preceding the study for cardiological reasons. In the 6 months preceding inclusion, night monitoring (i.e. polygraphy or oximetry during ASV usage) was performed in 34.4% of patients, 25.9% of whom required a subsequent setting change. According to multivariable, logistic regression, the variables that were independently associated with poor adherence (ASV-usage ≤4 h in duration) were TECSA group versus CSA group (p = 0.010), a higher Epworth score (p = 0.019) and lack of a night monitoring in the last 6 months (p < 0.05).
In real-life conditions, ASV-treatment is often associated with high cardiac comorbidities and high compliance. Future research should assess how regular night monitoring may optimize devices settings and patient management.
The OTRLASV study is registered on ClinicalTrials.gov (Identifier: NCT02429986 ) on 1 April 2015.
由于 SERVE-HF 研究中观察到的死亡率增加,许多关于 ASV 在其他适应证中的安全性和合理使用的问题出现了。本研究的目的是描述在真实情况下接受 ASV 治疗的患者的临床特征。
OTRLASV 研究是一项前瞻性、5 中心研究,纳入了至少接受 ASV 治疗 1 年的患者。患者在每年进行 ASV 报销续费时连续入组。
共分析了 177/214 例患者(87.57%为男性),中位(IQR)年龄为 71(65-77)岁,ASV 治疗持续时间为 2.88(1.76-4.96)年,ASV 使用时间为 6.52(5.13-7.65)小时/天,54.8%的患者此前曾接受持续气道正压通气(CPAP)治疗。Epworth 量表评分从治疗前的 10(6-13.5)分降至 6(3-9)分(p<0.001),呼吸暂停低通气指数从 50(38-62)/h 降至残余设备指数 1.9(0.7-3.8)/h(p<0.001)。大多数患者被分类为中枢性睡眠呼吸暂停组(CSA;59.3%),其余患者分为阻塞性睡眠呼吸暂停组(OSA;20.3%)和治疗后出现的中枢性睡眠呼吸暂停组(TECSA;20.3%)。左心室射血分数(LVEF)>45%的患者占 92.7%。与心脏相关的合并症/病因占患者的 75.7%(12.4%为神经系统疾病,4.5%为肾脏疾病,3.4%为阿片类药物治疗)。9.6%的患者为特发性中枢性睡眠呼吸暂停。6.2%的患者在研究前一年因心脏原因住院。在纳入前的 6 个月内,34.4%的患者进行了夜间监测(即 ASV 使用期间的多导睡眠图或血氧饱和度监测),其中 25.9%的患者需要进行后续的设备调整。多变量逻辑回归分析显示,与低依从性(ASV 使用时间≤4 小时)相关的独立变量为 TECSA 组与 CSA 组(p=0.010)、较高的 Epworth 评分(p=0.019)和过去 6 个月无夜间监测(p<0.05)。
在真实情况下,ASV 治疗常伴有严重的心脏合并症和较高的依从性。未来的研究应评估定期夜间监测如何优化设备设置和患者管理。
OTRLASV 研究于 2015 年 4 月 1 日在 ClinicalTrials.gov 注册(标识符:NCT02429986)。