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

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.

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest J-L.P., T.D., J-M.D., R.T. and M-P.d’O. are FACE study investigators and steering committee members for ResMed. A.P. and F.G. are FACE study investigators for ResMed. R.T. has received unrestricted research grants from ResMed, Vitalaire, Philips and the AGPMC Foundation, consultant fees from ResMed, Inspire, Navigant, Bioprojet and Jazz Pharmaceuticals, and travel grants from Agiradom. T.D. reports grants and fees from Pfizer, ResMed, GSK, Alnylam, Akcea Therapeutics, Ionis, Sanofi-Aventis, and Novartis. J.A.V. reports grants and personal fees from ResMed, Bioproject and Jazz Pharmaceuticals, personal fees from Philips, Sanofi, Agfa-Gevaert and Springer, and grants from AirLiquide, Nyxoah, Westfalen Medical, Sefam, SomnoMed, Vivisol, Total Care, Medidis, Fisher & Paykel, Wave Medical, Micromed OSG, MediqTefa, NightBalance, Heinen & Löwenstein, AstraZeneca, Accuramed, Bekaert Deslee Academy, Ectosense, Idorsia, Desetin and UCB Pharma, all outside the submitted work. M.P.d’O. has received unrestricted research grants from ResMed and Philips, consultant fees from ResMed, Somnomed and Jazz Pharmaceuticals, speaker fees from ResMed, Philips, LinaNova and Jazz Pharmaceuticals, and traveling grants from ISIS medical, Orkyn, SOS Oxygene and Vitalaire. S.B. has no conflicts of interest to declare. F.L. is an employee of ResMed.