FACE study, 2016 [50] | Prospective multicentre observational cohort France 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 device | 21.6 months | ASV 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 2013–2015 | Hospitalised heart failure (HFrEF >45% or HFpEF ≥45%) and SDB (OSA or CSA) with AHI ≥15 events·h−1 via polygraphy | 126 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 months | Neutral 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 2008–2014 | Heart failure NYHA III or IV (71% NYHA IV, LVEF 33±17%) with ASV irrespective of SDB | 85 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 deaths | 2-year follow-up | Continued ASV significantly lowered all-cause mortality and cardiac death rate |
Hetland et al., 2016 [53] | Retrospective observational study Østfold, Norway 2007–2012 | Heart failure NYHA class II–IV, LVEF ≤45%; CSR pattern ≥25% of sleeping time and dominant central sleeping pattern via polygraphy | 75 patients treated with ASV (n=31 with ASV for >3–18 months versus n=44 control) (AutoSet-CS) | Mortality and hospital admission of any cause and number of days in hospital in total | 18 months | ASV 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 2006–2018 | 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 mortality | Survival | CV 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 database | CSA (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 initiation | 309 CSA patients under ASV versus healthcare utilisation | Rates of hospitalisations, emergency department visits, outpatient visits and medications prescribed per year (mean±sd) | 2 years pre- and post-ASV initiation | ASV did not change healthcare utilisation |
ADVENT-HF trial, recruiting [56] | Multicentre, multinational, randomised, parallel-group, open-label trial Canada | Chronic HFrEF (≤45%) and SDB (OSA or CSA) with AHI ≥15 events·h−1 via PSG | Estimated n>800, still recruiting 524 patients (31% CSA, 69% OSA) randomised until February 2018 on medical therapy alone or ASV (AutoSet-CS) with nasal mask | All-cause mortality, first hospitalisation for CV diseases, new-onset atrial fibrillation/flutter requiring anticoagulation but not hospitalisation or implantable cardioverter-defibrillator shock not requiring hospitalisation | Every 6 months | Awaited |