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CV Effects of Adaptive Servo-Ventilation Therapy in HF
Study Questions:
Does adaptive servo-ventilation (ASV) improve outcomes in patients with heart failure HF)?
Methods:
Hospitalized patients with acute HF (ages >21 years) were recruited from 14 centers in the CAT-HF (Cardiovascular Improvements With MV-ASV Therapy in Heart Failure) trial. Patients with heart failure with reduced and preserved ejection fraction (HFrEF and HFpEF) were included. Sleep apnea was assessed by portable monitor device (ApneaLink, ResMed Ltd). Eligible HF patients had an apnea-hypopnea index (AHI) >15 events/hour. Patients were then randomized to ASV plus optimal medical therapy (OMT) or OMT alone. The primary endpoint was composite of death, cardiovascular hospitalization, and 6-minute walk distance. The secondary endpoint included functional status, biomarkers, quality of life, sleep, and breathing. Follow-up was 6 months.
Results:
A total of 126 patients were randomized over 18 months (average age 62 years, 26% women, 41% black). Atrial fibrillation was present in 41%. The majority of patients (n = 102; 81%) had HFrEF and (n = 24) 19% had HFpEF. Average use of the ASV device was 2.7 hours/day. The ASV device reduced AHI to normal range (<5 events/hour) at 1, 3, and 6 months. The primary endpoint did not differ significantly between the ASV and control group. There was no impact of EF on endpoint analysis. However, a subgroup analysis suggested a positive effect of ASV in HFpEF patients (p = 0.036).
NOTE: Initial targets for patient recruitment to the CAT-HF trial were impacted by the SERVE-HF trial, which showed increased mortality among HFrEF patients randomized to ASV.
Conclusions:
The authors concluded that among hospitalized patients with HF and moderate-severe OSA, the addition of ASV to OMT did not improve 6-month cardiovascular outcomes.
Perspective:
Sleep apnea is common among hospitalized patients with CHF and has been associated with increased cardiovascular mortality. Noninvasive ASV is better tolerated and more effective in treating sleep apnea in HF than standard continuous positive airway pressure therapy. Results of SERVE-HF trial did not confirm previous smaller studies, and therefore, impacted study enrollment here in the CAT-HF trial. Taken together, these two trials suggest that ASV therapy should not be used in HFrEF (EF <45%) and moderate to severe sleep apnea. The positive signal in the subgroup analysis among HFpEF patients is encouraging; however, it needs to be confirmed in a larger trial. Longitudinal trials assessing the role of sleep apnea intervention on cardiovascular events are also needed to confirm any potential favorable impact of sleep apnea therapy on cardiovascular morbidity and mortality.
Keywords: Atrial Fibrillation, Biomarkers, Continuous Positive Airway Pressure, Heart Failure, Hospitalization, Noninvasive Ventilation, Quality of Life, Secondary Prevention, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Stroke Volume
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