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A DEVICE used to treat central sleep apnoea (CSA) has been found to increase mortality in HF patients with reduced ejection fraction.
Martin Cowie, presenting results from the Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure and Reduced Ejection Fraction (SERVE-HF) at a Hot Line session yesterday, said ‘lives will be saved’ as a result of this ‘game-changer’ study, which was reported simultaneously in the New England Journal of Medicine.
Cowie, from Imperial College London, warned physicians not to treat HF patients with reduced EF and CSA with this device known as adaptive servo-ventilation therapy (ASV).
‘This study has changed our understanding of sleep-disordered breathing in systolic heart failure- the text books will have to be rewritten,’ said Cowie.
However, he did emphasise that the results from this study cannot be generalised to patients with preserved EF or obstructive sleep apnoea.
CSA, he explained, is caused by the brain failing to trigger breathing during sleep and is associated with poor prognosis as well as death in patients with HF. ASV uses a non-invasive ventilator to treat the apnoea by delivering servo-controlled inspiratory pressure support via a face mask in addition to expiratory positive airway pressure. Although algorithms employed by different ASV devices vary slightly, the principle of treatment is the same - that is, back-up rate ventilation with adaptive pressure support.
Small studies have suggested multiple beneficial effects of ASV on surrogate markers in HF patients with CSA. Improvements have been observed in LVEF, plasma BNP levels, quality of life and functional outcomes. Post-hoc data from the recent CANPAP trial suggested that continuous positive airway pressure therapy (CPAP) might improve mortality when CSA is controlled in HF patients with CSA and EF of 40% or less.
Cowie reported that the SERVE-HF trial aimed to investigate the effects of adding ASV to guideline-based medical management on survival and cardiovascular outcomes in patients with HF with reduced EF and predominant CSA. The study was conducted in 91 centres in 11 countries including Germany, France, UK and Australia.
A total of 1325 patients were randomly assigned to guideline-based medical treatment Continued on page 2 with ASV (n = 666) for a recommended five hours per night seven days a week, or guidelinebased medical treatment alone (n = 659).
The primary endpoint was time to first event of all-cause death, life-saving cardiovascular intervention or unplanned hospitalisation for worseningHF. Secondary endpoints included both all-cause and cardiovascular mortality. The median follow-up was 31 months.
The results showed a 54.1% event rate of the primary endpoint in the ASV group and 50.8% for the control group (HR 1.13; 95% CI 0.97-1.31; P=0.10). However, all-cause and cardiovascular mortality were significantly higher in the ASV group (HR 1.28; 95% CI 1.06-1.55; P=0.01) than in the control group (HR 1.34; 95% CI 1.09-1.65; P=0.006).
In the light of these results, said Cowie, manufacturers have now issued ‘a global safety notice’, and he warned that this therapy should not used in patients with central sleep apnoea and reduced ejection fraction HF.
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