1. What is SERVE-HF?
- SERVE-HF is a multinational, multicenter, randomized controlled Phase IV study that was designed to assess whether treatment of moderate to severe predominant central sleep apnea with Adaptive Servo-Ventilation (ASV) therapy in addition to optimized medical care could reduce mortality and morbidity in patients with symptomatic chronic heart failure with reduced ejection fraction (Left Ventricular Ejection Fraction [LVEF] ≤ 45%).
2. What was found in the SERVE-HF study?
- SERVE-HF did not show any benefit for ASV therapy for those patients in the study and also identified increased risk of cardiovascular death for those people in the study with symptomatic chronic heart failure and central sleep apnea.
3. Who is at risk?
- Only people with symptomatic chronic heart failure and central sleep apnea were included in the clinical study leading to this safety notice.
- We’re recommending that you contact your doctor immediately and talk to your doctor about the most appropriate course of action given your situation.
- According to the study results, if you fit these specific criteria, there is an increased risk of cardiovascular death. We recommend you speak with your doctor right away.
4. Are the devices malfunctioning?
- No. There has been no malfunction or technical fault observed with ResMed’s ASV device’s operation; it operates correctly to treat central sleep apnea.
5. What if I use a CPAP or APAP device?
- CPAP and APAP are used to treat obstructive sleep apnea.
- The patients in the study had moderate to severe predominant central sleep apnea.
- The study and this warning does not apply to ResMed CPAP or APAP devices.
- This particular warning only applies to a specific therapy called ASV, and only to people with symptomatic chronic heart failure and central sleep apnea.
- If you are unsure if your device is an ASV device (or affected device), you can find out by calling your country-specific hotline below.