Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure
SERVE-HF trial design and results
Design
Multicentre randomised controlled trial
Treatment
Adaptive servo-ventilation plus guideline-based medical therapy
Control
Guideline-based medical therapy alone
Population
1325 patients with heart failure with reduced ejection fraction and predominantly central sleep apnoea
Follow-up
Median 31 months
Primary endpoint
Composite of death from any cause, lifesaving cardiovascular intervention, or unplanned hospitalisation for worsening heart failure
Result
Mean AHI at 12 months was 6.6 events per hour on adaptive servo-ventilation, so the apnoea was effectively treated. The primary endpoint occurred in 54.1% versus 50.8% (hazard ratio 1.13, 95% CI 0.97 to 1.31, p=0.10). All-cause and cardiovascular mortality were both significantly higher with adaptive servo-ventilation.
Secondary endpoints
All-cause mortality, cardiovascular mortality, symptoms, quality of life
Adaptive servo-ventilation had no significant effect on the primary end point in patients who had heart failure with reduced ejection fraction and predominantly central sleep apnea, but all-cause and cardiovascular mortality were both increased with this therapy.
The trial authors, in the published abstract
How it has aged
The clearest demonstration in respiratory medicine that correcting a physiological abnormality can kill people. The device did exactly what it was designed to do — the AHI fell to 6.6 — and patients died more often. Adaptive servo-ventilation is now contraindicated in heart failure with reduced ejection fraction.
Publications
Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure
Cowie MR, Woehrle H, Wegscheider K, et al. Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure. N Engl J Med 2015 Sep 17;373(12):1095-105.
No effect on the primary composite endpoint
All-cause and cardiovascular mortality both significantly increased
Central apnoeas were effectively suppressed, with AHI falling to 6.6 per hour