Adaptive servo ventilation for sleep apnoea in heart failure: the FACE study 3-month data

Abstract

RationaleAdaptive servo ventilation (ASV) is contraindicated in patients with systolic heart failure (HF) who have a left ventricular ejection fraction (LVEF) below 45% and predominant central sleep apnoea (CSA). However, the effects of ASV in other HF subgroups have not been clearly defined.ObjectiveThe European, multicentre, prospective, observational cohort trial, FACE, evaluated the effects of ASV therapy on morbidity and mortality in patients with HF with sleep-disordered breathing (SDB); 3-month outcomes in patient subgroups defined using latent class analysis (LCA) are presented.MethodsConsecutive patients with HF with predominant CSA (±obstructive sleep apnoea) indicated for ASV were included from 2009 to 2018; the non-ASV group included patients who refused/were noncompliant with ASV. The primary endpoint was time to composite first event (all-cause death, lifesaving cardiovascular intervention or unplanned hospitalisation for worsening of chronic HF).Measurements and main resultsBaseline assessments were performed in 503 patients, and 482 underwent 3-month follow-up. LCA identified six discrete patient clusters characterised by variations in LVEF, SDB type, age, comorbidities and ASV acceptance. The 3- month rate of primary outcome events was significantly higher in cluster 1 patients (predominantly men, low LVEF, severe HF, CSA; 13.9% vs 1.5%–5% in other clusters, p<0.01).ConclusionFor the first time, our data identified homogeneous patient clusters representing clinically relevant subgroups relating to SDB management in patients with HF with different ASV usage, each with a different prognosis. This may improve patient phenotyping in clinical practice and allow individualisation of therapy.

Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV): protocol and cohort profile

“…Looking at an ESS score >10 only, the proportion of patients in the current registry meeting the criteria for EDS was 34%, much higher than in the SchlaHF-XT registry where 14% of patients had an ESS score of 11 or more [5]. Compared with our sleepy and symptomatic patient group, the FACE registry included a non-sleepy population with a median ESS score of 7 [29], while the mean ESS score at baseline in the SERVE-HF and CAT-HF trials was also indicative of a lack of daytime sleepiness [25,57]. This is not unexpected because patient selection criteria for the READ-ASV registry differ from those in clinical trials where it is not ethical to randomise symptomatic patients to a control/untreated group.…”

“…There is only one other registry (FACE) that has recruited patients receiving ASV therapy in the post-SERVE-HF era, but the focus was still largely on use of ASV in patients with heart failure [29]. The FACE study was initiated prior to 2015, but inclusion/exclusion criteria were modified to exclude patients with predominant CSA and a LVEF of ≤45% after publication of the SERVE-HF study findings [29]. Three-month follow-up data from that study, which included 503 patients, were used to define six clinically relevant subgroups (phenotypes) for patients with heart failure and SDB [28].…”

“…The FACE study was initiated prior to 2015, but inclusion/exclusion criteria were modified to exclude patients with predominant CSA and a LVEF of ≤45% after publication of the SERVE-HF study findings [ 29 ]. Three-month follow-up data from that study, which included 503 patients, were used to define six clinically relevant subgroups (phenotypes) for patients with heart failure and SDB [ 28 ]. Acceptance of ASV therapy was highest in the subgroups characterised by a high proportion of older, male patients with higher body mass index, hypoxia and comorbidities such as hypertension and stroke [ 28 ].…”

“…However, the prevalence of SDB is also high in patients with heart disease and preserved ejection fraction (HFpEF) [5], a population that is expected to continue to grow in number [26,27]. Although there is some data on the use of ASV in populations representative of clinical practice, these have been largely focussed on patients with heart failure [28,29]. Therefore, there remains a relative lack of data on the real-world indications for ASV, the prevalence of symptomatic CSA in ASV users, and the effects of ASV in the variety of other patient groups encountered in sleep laboratory settings [30][31][32].…”

ERS International Congress 2022: highlights from the Sleep Disordered Breathing Assembly

“…Moreover, in contrast to the previous SERVE-HF trial, the recently presented first results of the ADVENT-HF trial did not find any harm due to ASV in patients with an ejection fraction <45% [ 15 ]. With regard to CSA phenotypes, although many clinical features can be helpful for this purpose [ 16 ], pathophysiology still has a central role. In particular, higher loop gain [ 17 ], a “negative pattern” of hyperpnoea [ 18 ] and an increased chemoreceptor sensitivity are related to worse outcomes and should be considered for early CPAP/ASV titration.…”