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AAST Special Update: ASV Notice

Posted by admin on May 28, 2015 2:00:00 AM

On May 13th, 2015, ResMed issued a press release and related Urgent Field Safety Notice, "An update on Phase IV SERVE-HF Study of Adaptive Servo-Ventilation (ASV) Therapy in Central Sleep Apnea and Chronic Heart Failure." ResMed and regulatory authorities cautioned against the use of ASV therapy in patients with symptomatic chronic heart failure (NYHA 2-4) and reduced LVEF&lt;/=45%, AND moderate to severe predominant central sleep apnea.

On May 15th, Respironics responded to the update. Respironics is conducting their own investigation and working with ResMed in order to better understand the ResMed study data. Until more information is available both companies are recommending that physicians should assess individual risks before prescribing ASV therapy for the at-risk patient population. No other patient populations have been identified as at-risk for adverse outcomes.

The AASM released a statement on May 15th as well. The AASM recommends that:

  1. Physicians stop prescribing ASV to treat central sleep apnea in patients with symptomatic heart failure and LVEF &le; 45%,
  2. Before starting a patient on ASV, each patient should be assessed for the presence of heart failure, and if heart failure symptoms are present, an objective assessment of LVEF be performed to see if they are in the higher risk group, and
  3. Prior patients with symptomatic heart failure and with an ejection fraction &le; 45% whom you have treated with ASV since 2005 should be contacted to advise them of the risks and strongly consider recommending that they stop ASV treatment. Which alternative treatments for central sleep apnea to recommend, if any, will need to be individualized.

What is the role of the sleep technologist in this situation?

  1. Be sure your medical director is aware of the results of the SERVE-HF study and discuss the information in the links below.
  2. Develop a plan with your medical director for responding to this urgent announcement. The role of the sleep technologist may include:
    1. Helping to identify patients currently treated with ASV (one method would be to review ASV titrations)
    2. Contacting patients and providing information as authorized by your medical director
  3. Review your policy and procedures manual and consider with your medical director whether modifications to achieve compliance with current treatment recommendations are necessary. Any patient authorized for ASV titration should be evaluated for heart failure.
  4. Monitor the AAST and AASM web sites for additional information.

The findings of the research study are statistically significant and of urgent concern. It is recommended that sleep centers implement the recommended changes in patient evaluation and treatment immediately. However, additional review of the data and the results of other similar studies may influence future recommendations for assessing and treating this patient population. It is important to keep abreast of news releases and treatment recommendations.

RESOURCES for more information:

ResMed news release: ResMed Provides Update on Phase IV SERVE-HF Study of Adaptive Servo-Ventilation (ASV) Therapy In Central Sleep Apnea and Chronic Heart Failure. Learn more about the rationale and design of the SERVE-HF study. Visit the ResMed SERVE-HF FAQs webpage.

Philips response: Philips Response to ResMed Update on Phase IV SERVE-HF Study of Adaptive Servo-Ventilation (ASV) Therapy in Central Sleep Apnea and Chronic Heart Failure.

AASM News Special Safety Notice: ASV therapy for central sleep apnea patients with heart failure. Plan to attend the AASM Special Session at APSS: ASV Therapy for CSA Patient with Heart Failure: SERVE-HR Results on Monday, June 8, 2015 at 10:30AM in room 620. During this discussion group, Dr. Timothy Morgenthaler, American Academy of Sleep Medicine President, and Dr. Glenn Richards, ResMed Chief Medical Officer, will review the preliminary findings of the study, as well as discuss steps that physicians must take to appropriately manage this patient population.