Important Safety Alerts

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom, has issued a medical device safety alert concerning ventilators with Adaptive Servo-Ventilation (ASV), manufactured by ResMed Limited. The affected devices are identified as follows:-

• AutoSet CS, AutoSet CS PaceWave, AutoSet CS2, AutoSet CS-A, VPAP Adapt, VPAP Adapt SV, VPAP Adapt SV-A, VPAP Tx, S9 AutoSet CS, S9 AutoSet CS PaceWave, S9 AutoSet CS-A, S9 AutoSet CS-A PaceWave, S9 VPAP ADAPT, S9 VPAP Adapt eASV, S9 VPAP Adapt PaceWave, S9 VPAP Tx, AirCurve 10 ASV, AirCurve 10 CS PaceWave, Lumis Tx

A serious safety concern has been identified during the preliminary primary data analysis from the SERVE-HF clinical trial. This trial investigated the effect of ASV therapy on the hospitalisation and mortality rate of 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 (AHI ≥ 15/h, CAHI/AHI ≥ 50% and CAI ≥ 10/h). The identified safety concern is a significant increase in the risk of cardiovascular death in patients with symptomatic, chronic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) being treated with ASV.

MHRA recommends affected users to take the following actions:-

• Physicians managing patients with symptomatic chronic heart failure with reduced ejection fraction who are using ResMed ASV devices should contact their patients to discuss discontinuation of treatment.
• Physicians should assess all patients currently being treated with ASV mode for symptomatic chronic heart failure and if necessary undertake an assessment of LVEF. Where appropriate discontinuation of treatment needs to be discussed with patients
• Physicians should be aware that new at risk patients should not use ASV. ASV therapy is now contraindicated in these at risk patients

For details, please refer to the MHRA websites:
https://mhra.filecamp.com/public/file/28rq-imk5u9im
https://www.gov.uk/drug-device-alerts/specific-resmed-ventilators-with-adaptive-servoventilation-asv-increased-risk-of-cardiovascular-death-in-patients-who-have-a-specific-heart-condition

Posted on 14 May 2015