Earlier this week ResMed notified the American Academy of Sleep Medicine that it has updated the description of the contraindicated population originally described in the Field Safety Notice issued May 13, 2015, to address the safety concern identified during the preliminary primary data analysis from the SERVE-HF clinical trial of adaptive servo-ventilation (ASV) therapy for central sleep apnea. ResMed announced that it is updating and narrowing the contraindication of ASV therapy to patients with symptomatic, chronic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.
According to ResMed, the announcement was based on consultation with various regulatory authorities and expert opinion expressed by professional medical societies. Including moderate to severe predominant central sleep apnea as part of the contraindication aligns it with the inclusion criteria from the SERVE-HF trial. Noting that it is updating the User Guides for ASV devices, ResMed advised that the updated, narrower contraindication is considered the most appropriate identification of at-risk patients.
ResMed encourages physicians to use this updated contraindication to identify at-risk patients and reassess the use of ASV therapy in these specific heart failure patients. Health care providers and patients who have questions or would like more information are encouraged to call 1-800-478-9010 and visit www.SERVE-HFFAQs.com.
Read the May 15 article from the AASM – Special Safety Notice: ASV therapy for central sleep apnea patients with heart failure