Studies on adaptive servoventilation since the publication of SERVE-HF

Study/authors, year [reference]DesignPopulationInterventionPrimary outcomeMedian follow-upResults
FACE study, 2016 [50]Prospective multicentre observational cohort
Up to January 31, 2013
CHF with reduced LVEF (HFrEF <40%), mid-range (HFmrEF 40–49%), preserved (HFpEF >50%)361 CHF patients with CSA eligible for ASV therapy (n=258) versus controls# (n=133) refused/not compliant with ASV (<3 h per night)
(ResMed, AutoSet CS) 66% compliant to ASV therapy
All-cause death, hospitalisation for worsening heart failure, heart transplant or ventricular assist device21.6 monthsASV improved prognosis in HFmEF in non-ischaemic heart failure; trend to increase in event rate in HFmrEF in ischaemic heart disease; improved prognosis in HFpEF CHF with severe desaturations
CAT-HF study, 2017 [51]Prospective, randomised, controlled, multicentre clinical trial
United States and Germany
Hospitalised heart failure (HFrEF >45% or HFpEF ≥45%) and SDB (OSA or CSA) with AHI ≥15 events·h−1 via polygraphy126 out of 215 patients assigned on ASV plus optimised medical therapy (n=65) versus optimised medical therapy alone (control) (n=61)Composite global rank score (death, CV hospitalisations, and percentage changes in 6-min walk distance)
Secondary end-points: sleep apnoea parameters, functional capacity, cardiovascular and all-cause death, days alive and out of the hospital, biomarkers, QoL, sleep parameters, imaging parameters and NYHA functional class
6 monthsNeutral
No improvement in 6-month cardiovascular outcomes; however, a positive effect of ASV in patients with HFpEF
Study was stopped after publication of SERVE-HF
Imamura et al., 2016 [52]Case–control study
Tokyo, Japan
Heart failure NYHA III or IV (71% NYHA IV, LVEF 33±17%) with ASV irrespective of SDB85 patients receiving ASV 1 month versus guideline-directed medical therapies
(AutoSet-CS; ResMed, Sydney, Australia) with full face mask (ResMed)
All-cause mortality and cardiac deaths2-year follow-upContinued ASV significantly lowered all-cause mortality and cardiac death rate
Hetland et al., 2016 [53]Retrospective observational study
Østfold, Norway
Heart failure NYHA class II–IV, LVEF ≤45%; CSR pattern ≥25% of sleeping time and dominant central sleeping pattern via polygraphy75 patients treated with ASV (n=31 with ASV for >3–18 months versus n=44 control)
Mortality and hospital admission of any cause and number of days in hospital in total18 monthsASV did not significantly affect CV death or combined CV death or hospital admissions after 18 months; trend toward better CV event-free survival for ASV usage
Bordier and Lataste, 2019 [54]Retrospective study
Patient from the sleep unit of the CV department treated with ASV for sleep apnoea (C/M/O apnoeas via PG)32 patients with ASV
8 deaths
CV mortalitySurvivalCV deaths not predominant
No relationship between sleep apnoea or ASV and death
Mansukhani et al., 2019 [55]Population-based study, using the Rochester Epidemiology Project databaseCSA (AHI 41.6±26.5 events·h−1), with ASV therapy (65% ≥4 h per night on ≥70% nights in their first month), and had ≥1 month of clinical data before and after ASV initiation309 CSA patients under ASV versus healthcare utilisationRates of hospitalisations, emergency department visits, outpatient visits and medications prescribed per year (mean±sd)2 years pre- and post-ASV initiationASV did not change healthcare utilisation
ADVENT-HF trial, recruiting [56]Multicentre, multinational, randomised, parallel-group, open-label trial
Chronic HFrEF (≤45%) and SDB (OSA or CSA) with AHI ≥15 events·h−1 via PSGEstimated n>800, still recruiting 524 patients (31% CSA, 69% OSA) randomised until February 2018 on medical therapy alone or ASV (AutoSet-CS) with nasal maskAll-cause mortality, first hospitalisation for CV diseases, new-onset atrial fibrillation/flutter requiring anticoagulation but not hospitalisation or implantable cardioverter-defibrillator shock not requiring hospitalisationEvery 6 monthsAwaited

ASV studies with mortality as primary outcome. The table summarises the results of additional studies on ASV in heart failure and CSA. Methodologies incompletely describe the types of masks and ASV devices used, sleep study, algorithm of titration and compliance to the device. Only one study (FACE) stratified patients in relation to the severity of HFrEF. CHF: chronic heart failure; LVEF: left ventricular ejection fraction; HFrEF: heart failure with reduced ejection fraction; HFmrEF: heart failure with mid-range ejection fraction; HFpEF: heart failure with preserved ejection fraction; CSA: central sleep apnoea; ASV: adaptive servoventilation; SDB: sleep disordered breathing; OSA: obstructive sleep apnoea; AHI: apnoea–hypopnoea index; CV: cardiovascular; QoL: quality of life; NYHA: New York Heart Association; CSR: Cheyne–Stokes respiration.