SERVE-HF: Adaptive Servo-Ventilation Therapy to Treat Central Sleep Apnea in Systolic HF Patients
The addition of adaptive servo-ventilation (ASV) to guideline-based medical treatment did not improve outcomes in heart failure patients with a reduced ejection fraction and predominantly central sleep apnea, according to results from the SERVE-HF trial presented Sept. 1 during ESC Congress 2015 in London and simultaneously published in the New England Journal of Medicine (NEJM). Additionally, investigators noted a significant increase in risk of cardiovascular death.
The trial randomly assigned 1,325 patients with chronic heart failure, a left ventricular ejection fraction of 45 percent or less, and central sleep apnea to receive either guideline-based management alone or the addition of ASV for a recommended five hours a night, seven days a week. After a median follow-up period of 31 months, results showed ASV effectively treated central sleep apnea, but had no effect on the primary endpoint of a combination of all-cause death, life-saving cardiovascular intervention or unplanned hospitalization for worsening hear failure (54.1 percent/ASV group vs. 50.8 percent/non-ASV group).
Additionally, investigators noted the addition of ASV to standard care had no beneficial impact on function measures, such as quality of life, six-minute walk distance or symptoms. They also highlighted higher rates of all-cause and cardiovascular mortality in the ASV group (34.8 percent), compared to the control group (29.3 percent).
"This study has changed our understanding of sleep-disordered breathing in systolic heart failure," said Martin Cowie, MD, co-lead investigator on the study, from Imperial College London. "Doctors now know that treatment of central sleep-disordered breathing by mask therapy is not helpful for these patients and might be harmful."
In a corresponding NEJM editorial, Ulysses J. Magalang, MD, and Allan I. Pack, MB, ChB, PhD, write that with the SERVE-HF trial findings, the "plot thickens" in regards to heart failure and sleep-disordered breathing. "Until other studies clarify whether the results seen in the SERVE-HF trial are a consequence of the specific device that was used, we recommend that ASV not be used outside clinical trials in patients with heart failure who have predominantly central sleep apnea," they said.
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