Studies on adaptive servoventilation since the publication of SERVE-HF
| Study/authors, year [reference] | Design | Population | Intervention | Primary outcome | Median follow-up | Results |
| 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 |
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.