Peak-flow-triggered adaptive servo-ventilation plus standard care
Control
Standard care alone
Population
731 patients with heart failure and reduced ejection fraction and sleep-disordered breathing, obstructive or central
Follow-up
Median 3.6 years; enrolment terminated early because of COVID-19 restrictions
Primary endpoint
Composite of all-cause mortality, cardiovascular hospitalisation, new atrial fibrillation requiring treatment, and delivery of an appropriate ICD shock
Result
No effect on the primary composite outcome (hazard ratio 0.95, 95% CI 0.77 to 1.18, p=0.67) or on all-cause mortality (88 deaths in control versus 76 with adaptive servo-ventilation; hazard ratio 0.89, 0.66 to 1.21, p=0.47). For obstructive apnoea the mortality hazard ratio was 1.00 (0.68 to 1.46) and for central apnoea 0.74 (0.44 to 1.23). No safety issue related to adaptive servo-ventilation was identified.
Secondary endpoints
All-cause mortality, mortality by apnoea subtype, safety
In patients with heart failure and reduced ejection fraction and sleep-disordered breathing, ASV had no effect on the primary composite outcome or mortality but eliminated sleep-disordered breathing safely.
The trial authors, in the published abstract
How it has aged
The essential counterweight to SERVE-HF. Same therapy, same population, different device algorithm and a peak-flow rather than minute-ventilation trigger — and no mortality signal. That does not resurrect adaptive servo-ventilation as a treatment, since it did not help either, but it does suggest the earlier harm may have been device-specific rather than intrinsic.
Publications
Adaptive servo-ventilation for sleep-disordered breathing in patients with heart failure with reduced ejection fraction (ADVENT-HF): a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial
Bradley TD, Logan AG, Lorenzi Filho G, et al. Adaptive servo-ventilation for sleep-disordered breathing in patients with heart failure with reduced ejection fraction (ADVENT-HF): a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial. Lancet Respir Med 2024 Feb;12(2):153-166.
No effect on the primary composite outcome or on mortality
No safety signal, in contrast to SERVE-HF
Enrolment terminated early because of COVID-19 restrictions