Adaptive servoventilation may be harmful in heart failure patients with central sleep apnoea

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13 Dec Adaptive servoventilation may be harmful in heart failure patients with central sleep apnoea

Posted at 23:05h in Blog by admin

A recent study has shown that adaptive servoventilation (ASV) may be harmful in heart failure patients with central sleep apnoea.

Patients with heart failure and central sleep apnoea (CSA), including Cheyne–Stokes Respiration (CSR) have an impaired survival compared with heart failure patients without CSA/CSR. Several observational studies found improvement of left ventricular ejection fraction (LVEF), oxygen saturation and normalisation of breathing disturbances during sleep under ASV.

The impact of ASV on survival was investigated in the SERVE-HF study, an international, multicentre, prospective, randomised, controlled trial. The study aimed to assess whether ASV added to optimal cardiologic treatment improves survival in patients with symptomatic systolic heart failure New York Heart Association functional class II – IV and a left ventricular ejection fraction ≤45% and predominant CSA/CSR compared with optimal cardiologic treatment alone.

The results indicated a 10% annual risk of cardiovascular death in ASV patients compared with 7.5% in the control group. The overall survival and hospitalisation rate was not different between the groups.

These results relate only to patients with symptomatic systolic heart failure with an ejection fraction ≤45% and predominant CSA/CSR. The results do not regard patients with less severe or without heart failure and patients with other indications for treatment with ASV.

Frequently Asked Questions

 

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%).

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.

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.

 

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.

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: Australia: 1800 647 259 New Zealand: 0800 737 635

ResMed news release:

http://investor.resmed.com/phoenix.zhtml?c=70291&p=irol-newsArticle&ID=2047392