ResMed has updated its identification of the contraindicated population that was first described when the company announced the SERVE-HF Phase III trial did not meet its primary endpoint. SERVE-HF was designed to assess whether the treatment of moderate to severe predominant central sleep apnea with adaptive servo-ventilation (ASV) therapy could reduce mortality and morbidity in patients with symptomatic chronic heart failure in addition to optimized medical care. A preliminary analysis identified a statistically significant 2.5% absolute increased risk of cardiovascular mortality for those patients in the trial who received ASV therapy per year compared to those in the control group, and the original contraindication was issued.
ResMed’s updated contraindication is as follows:
“ResMed 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 apnea.”
The change was to include “moderate to severe predominant central sleep apnea” to the contraindication, a ResMed corporate communications representative tells Sleep Review. The official Field Safety Notice did not include this, and this update is considered the most appropriate identification of at risk patients.
