Resmed Field Safety Notice
Back on May 13, 2015, Resmed put out an urgent field safety notice that was entitled, "Increased Risk of Cardiovascular Death with Adaptive Servo-Ventilation (ASV) Therapy for Patients with Symptomatic Chronic Heart Failure with Reduced Ejection Fraction"
Does anyone know of, or does anyone have information as to whether there is any new material that may have been published regarding this subject matter??
Just want to see if there were any additional studies or additional information that was provided since the date of this last notice.
RE: Resmed Field Safety Notice
I don't have the details at hand, but I believe this relates to a study that showed poor results for people with left ventricular ejection fraction less than 45%. It was later shown that the study was flawed, but I don't know the name of the newer study, nor its details.
Others may have more information closer at hand.
Apnea Board Monitors are members who help oversee the smooth functioning of the Board. They are also members of the Advisory Committee which helps shape Apnea Board's rules & policies. Membership in the Advisory Members group does not imply medical expertise or qualification for advising Sleep Apnea patients concerning their treatment.
RE: Resmed Field Safety Notice
My summary of the original notice resulting from the SERVE-HF study and follow-up in the more recent ADVENT-HF study is in this wiki
https://www.apneaboard.com/wiki/index.ph...nd_Summary
RE: Resmed Field Safety Notice
Thank you Sleeprider for the link to the written information. You have always been there to assist me in several matters, and just want to thank you sir.
RE: Resmed Field Safety Notice
Thanks! It means a lot. I put a lot of effort into trying to make sense of what sometimes makes no sense at all. and I really appreciate when that effort is recognized.
RE: Resmed Field Safety Notice
Shout out to Sleeprider: I don't use an ASV but just to let you know how much I appreciate your comments
on the various technical issues brought out in this forum.
RE: Resmed Field Safety Notice
You may wish to review "Adaptive servo ventilation for sleep apnoea in heart failure: the FACE study 3-month data"
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8762030/
and Cohort profile: FACE, prospective follow-up of chronic heart failure patients with sleep-disordered breathing indicated for adaptive servo ventilation
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7371028/
"The object in life is not to be on the side of the majority, but to escape finding oneself in the ranks of the insane." -- Marcus Aurelius
