SERVE-HF was the first long-term randomised, controlled, international, multicentre study designed to assess the effects of adaptive servo-ventilation (ASV) on morbidity and mortality in patients with symptomatic chronic heart failure (HF) with reduced left ventricular ejection fraction ((LVEF ≤ 45%) and predominant central sleep apnoea-Cheyne-Stokes respiration (CSA-CSR).
The SERVE-HF intention-to-treat analysis1 showed that ASV had no effect on the primary endpoint: composite of death from any cause, lifesaving cardiovascular intervention, or unplanned hospitalisation for heart failure (HF).
The cardiovascular death risk observed in SERVE-HF has been confirmed as a true clinical finding.2
The mortality risk seen in SERVE-HF was seen only in patients with systolic heart failure and predominantly central sleep apnoea.3
The SERVE-HF additional analysis has confirmed that observed mortality risk occurs in patients with LVEF<45% and that the harmful effects of ASV correlate with pre-existing LV systolic impairment.3
ASV does not seem to worsen LV function.4
The mortality risk seen in SERVE-HF is unrelated to the magnitude of the PAP delivered.5
We can therefore conclude that, in the presence of significant LV dysfunction and predominantly central sleep apnoea, ASV may become a harmful intervention. People with enlarged and weakened left ventricles are a particularly vulnerable group, some of whom may also be at risk of sudden cardiac death from co-existing arrhythmias. In current clinical practice this has led to the increasing use of implantable defibrillators (ICDs).
Contraindication: ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnoea.
Patients with LVEF>45% continue to be eligible for ASV
Woehrle H, Cowie MR, Christine Eulenburg C et al. Adaptive servo ventilation for central sleep apnoea in heart failure: results of the SERVE-HF on-treatment analysis. submitted to JAMA and presented at ATS congress 2016
Eulenburg C & al. Mechanisms underlying increased mortality risk in patients with heart failure and reduced ejection fraction randomly assigned to adaptive servoventilation in the SERVE-HF study: results of a secondary multistate modeling analysis. Lancet Respiratory Medicine, 2016 Aug 31, pii: S2213-2600(16)30244-2
Cowie MR, Woehrle H, Karl Wegscheider K et al. Adaptive Servo-Ventilation for Central Sleep Apnoea in Systolic Heart Failure: Echocardiographic, cMRI and biomarker results of the major substudy of SERVE-HF (Major sub-study - presented at ATS. Submitted to Eur Heart J)