FACIL-VAA-eng

The study: This study involved patients with certain forms of central, or combined but predominantly central, sleep apnea syndrome (SAS), managed at home with a SAV device. Patients with SAS associated with heart failure with impaired ejection fraction were not included in the study. A total of 541 patients were included by 27 centres in France.
Its primary objective was to evaluate the impact of a 6-month treatment with SAV on the quality of life of these patients with central or combined sleep apnea syndrome (SAS) excluding systolic heart failure (HF) with altered ejection fraction, with predominantly central SAS. This observational cohort study aimed also to characterize the different patient populations that can benefit from this therapy, to evaluate the functional and quality of life benefits according to the etiology of SAS, central or combined, to collect morbidity and mortality data, and to perform a medico-economic evaluation of this treatment.
Methodology of the statistical analysis conducted by ICUREsearch: models allowing to limit the impact of potential over-dispersion of the data (mixed models of negative binomial regression, univariate then multivariate) were predefined to evaluate the variation of functional and quality of life scores. The change in sleep quality score over 12 months was assessed via a 2-level hierarchical model, center and patient, to detect whether the effect of VAA was different between centers, and at which interval after patient inclusion this effect was most marked. The duration of VAA was also taken into account, using a linear mixed model. Finally, the duration without occurrence of cardiovascular adverse events was analyzed via a Cox model, assessing the impact of improved sleep quality on the occurrence of these events.

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