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FACE 研究:慢性心力衰竭患者睡眠呼吸障碍自适应伺服通气的 2 年随访。

FACE study: 2-year follow-up of adaptive servo-ventilation for sleep-disordered breathing in a chronic heart failure cohort.

机构信息

Univ. Grenoble Alpes, Inserm 1300, HP2, Grenoble, France; Service Hospitalo-Universitaire Pneumologie et Physiologie, Pole Thorax et Vaisseaux, CHU de Grenoble Alpes, Grenoble, France.

Service de Cardiologie, Centre de Référence Amyloses Cardiaques, GRC ARI, DHU ATVB, AP-HP, Hôpital Henri Mondor, Créteil, France; UFR médecine Université Paris-Est Créteil, France; Unité INSERM U981, Créteil, France.

出版信息

Sleep Med. 2024 Jan;113:412-421. doi: 10.1016/j.sleep.2023.07.014. Epub 2023 Jul 22.

Abstract

BACKGROUND

Sleep-disordered breathing (SDB) is a common comorbidity in patients with heart failure (HF) and is associated with worse prognosis.

OBJECTIVES

This study evaluated the effects of adaptive servo-ventilation (ASV) on morbidity and mortality in a large heterogeneous population of HF patients with different etiologies/phenotypes.

METHODS

Consecutive HF patients with predominant central sleep apnea (± obstructive sleep apnea) indicated for ASV were included; the control group included patients who refused or stopped ASV before three months follow-up. Six homogenous clusters were determined using the latent class analysis (LCA) method. The primary endpoint was time to composite first event (all-cause death, lifesaving cardiovascular intervention, or unplanned hospitalization for worsening of chronic HF).

RESULTS

Of 503 patients at baseline, 324 underwent 2-year follow-up. Compared to control group, 2-year primary endpoint event-free survival was significantly greater in patients in ASV group only in univariable analysis (1.67, 95% [1.12-2.49]; p = 0.01). Secondary endpoints, event-free of cardiovascular death or heart failure-related hospitalization and all-cause death or all-cause hospitalization were positively impacted by ASV (univariate and multivariable analysis). LCA identified two groups, with preserved and mid-range left ventricular ejection fraction (LVEF) and severe hypoxia, in whom ASV increase prognosis benefit.

CONCLUSIONS

Patients with HF and SDB are a highly heterogeneous group identified using LCA. Systematic deep phenotyping is essential to ensure that ASV is prescribed to those benefit from therapy, as ASV use in patients with severe hypoxic burden and those with HFpEF was associated with a significant reduction in cardiovascular events and mortality.

CLINICAL TRIAL REGISTRATION

https://clinicaltrials.gov/ct2/show/NCT01831128.

摘要

背景

睡眠呼吸障碍(SDB)是心力衰竭(HF)患者的常见合并症,与预后更差相关。

目的

本研究评估适应性伺服通气(ASV)对不同病因/表型 HF 患者的发病率和死亡率的影响。

方法

纳入因主要为中枢性睡眠呼吸暂停(伴或不伴阻塞性睡眠呼吸暂停)而需要 ASV 的连续 HF 患者;对照组包括在 3 个月随访前拒绝或停止 ASV 的患者。使用潜在类别分析(LCA)方法确定 6 个同质簇。主要终点是复合首发事件(全因死亡、挽救生命的心血管干预或因慢性 HF 恶化而计划外住院)的时间。

结果

在基线时的 503 例患者中,有 324 例进行了 2 年随访。与对照组相比,ASV 组的 2 年主要终点无事件生存率在单变量分析中显著更高(1.67,95%[1.12-2.49];p=0.01)。次要终点,心血管死亡或心力衰竭相关住院无事件生存率和全因死亡或全因住院无事件生存率也受到 ASV 的积极影响(单变量和多变量分析)。LCA 确定了两组,一组左心室射血分数(LVEF)保留和中等范围,另一组严重低氧血症,ASV 增加了这两组的预后获益。

结论

使用 LCA 确定 HF 和 SDB 患者是一个高度异质的群体。系统的深度表型分析对于确保将 ASV 用于从治疗中获益的患者至关重要,因为在严重低氧负担和 HFpEF 患者中使用 ASV 与心血管事件和死亡率的显著降低相关。

临床试验注册

https://clinicaltrials.gov/ct2/show/NCT01831128。

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