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[News]  Special Safety Notice: ASV therapy for CSA patients with heart failure
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DocWils Offline

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Post: #11
RE: Special Safety Notice: ASV therapy for CSA patients with heart failure
(05-22-2015 02:36 AM)DocWils Wrote:  Okay, let's be a bit clearer on this - yes, the level of ejection degradation is not good, and if your ejection rate is over 50% this study does not address it. It is a narrow group of symptoms and conditions.
The risk is significant in medical terms. Enough to issue a warning. 35% mortality risk is significant to us. (odd in a way, sing real mortality risk in all people is 100%, but we look at a shorter window than that... our job is to try and keep you alive, after all....)
It is not a legal thing at all on Resmed's part - no one will sue Resmed for this, but they may sue the prescribing doctor. Resmed did these docs a solid and made sure they knew about this, although it should have disseminated through normal channels anyway. Good on them.
GP49, you were lucky as anything, and well done. Keep getting better. And yes, do consult your sleep specialist about this, and even your cardiologist, perhaps together, to see if an alternative therapy can be as effective. I would bet anything that getting those two together on this little bit of information will be interesting for both of them. Nothing like cross-discipline consultations to break up the routine and get the old grey cells working laterally.
06-01-2015 05:28 AM
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britincanada Offline

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Post: #12
RE: Special Safety Notice: ASV therapy for CSA patients with heart failure
I had a phone call yesterday to go into the sleep center Today 03/06/2015 this is a letter i got handed to me

https://www.dropbox.com/s/mg2q7qai9c82873/20150603_105522.jpg?dl=0

After a chat with the doctor hes sending me for a Heart test and having me back for a overnight Study

He did say i have a few options 1 Stick with the Asv 2 Try Cpap with Oxygen I SIGNED A WAVER AND KEPT MY ASV Until the testing tells me different

Looks like you have to be in deep sh*t health wise to be taken off the ASV Machine
(This post was last modified: 06-03-2015 01:36 PM by britincanada.)
06-03-2015 01:34 PM
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storywizard Offline

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Post: #13
RE: Special Safety Notice: ASV therapy for CSA patients with heart failure
(06-03-2015 01:34 PM)britincanada Wrote:  I had a phone call yesterday to go into the sleep center Today 03/06/2015 this is a letter i got handed to me

https://www.dropbox.com/s/mg2q7qai9c82873/20150603_105522.jpg?dl=0

After a chat with the doctor hes sending me for a Heart test and having me back for a overnight Study

He did say i have a few options 1 Stick with the Asv 2 Try Cpap with Oxygen I SIGNED A WAVER AND KEPT MY ASV Until the testing tells me different

Looks like you have to be in deep sh*t health wise to be taken off the ASV Machine

Thanks for posting that....

Storywizard
06-03-2015 06:37 PM
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TEDSLEEP1 Offline

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Post: #14
RE: Special Safety Notice: ASV therapy for CSA patients with heart failure
I meet the criterion for the VPAP recall but an ultrasound test showed 56% ejection rate and aSpect Scan showed 45%.

As I believe the Spect scan is more reliable I stopped VPAP and switched to CPAP mode but can't get the AHI below 22.5 and I find expiration difficult against the set pressure of 12 cm leaving me weary after nights sleep.

I was getting AHI average of 2.0 on VPAP>

Any thoughts would be appreciated
06-06-2015 12:57 AM
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DocWils Offline

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Post: #15
RE: Special Safety Notice: ASV therapy for CSA patients with heart failure
Off the cuff, and for what it is worth, you have to do a risk assessment calculation - which is the lesser of the two evils? An AHI of 22.5 and a disturbed difficult sleep may be the more dangerous of the two choices, and you have to take that up with your sleep specialist and cardiologist. The two parts of this calculation is risk of mortality over 5/10/15 years and quality of life. Which gives you a better quality of life? What are the relative mortality rates? Which is more important?

And I also remind you that what you are looking at is a risk assessment, meaning there is a chance - if there is a 10% rise in risk of mortality over a ten year period, then it is not a guarantee of death in that time period, but the possibility of one person out of ten has an increased risk of mortality over that time period. You may be one of the nine instead, etc. Of course, in this warning the risk is 33%, so you have some hard thinking to do and you need to go over this carefully with your health team.
(This post was last modified: 06-06-2015 08:57 AM by DocWils.)
06-06-2015 07:12 AM
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TEDSLEEP1 Offline

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Post: #16
RE: Special Safety Notice: ASV therapy for CSA patients with heart failure
Thanks for the comments DocWils as they are in line with my thoughts and a deep and meaningful discussion needs to take place with my Medicos this coming Tuesday.

One of my concerns is that the normal ultrasound stress test is showing 56% LVEF at rest while the Spect scan shows less than 45% last October and again last week.

It doesn't give one much confidence with such a disparity and leaves me in predicament as to the reliability of ultrasound testing of LVEF.

Last week I had meaningful discussion with a Medical Officer from Resmed and they have noticed that patients resting LVEF on ultrasound can vary dramatically from test to test and day to day.

Will keep in touch and thanks agin for your comments.
06-07-2015 04:43 AM
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DocWils Offline

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Post: #17
RE: Special Safety Notice: ASV therapy for CSA patients with heart failure
Good luck Ted. I think it is a good point to bring up to your medical team, along with the comments from Resmed, and at this point there has to be another, cold calculation brought into this, one that is very uncomfortable for most people - given your condition, with or without treatment, what is your mean life expectancy and quality of life, and how will it manifest itself as it goes downhill? At some point we must all face this question, of course, certainly when we hit a certain age, regardless of our health, but given your cardiac condition, it has to asked anyway, and the answer weighed against the two risk questions - with CPAP or ASV? So there are three calculations here - one, the touchstone of life expectancy without treatment, against life expectancy with ASV against same with relatively ineffective CPAP and then overall quality of life in all three scenarios.

I do not envy you this discussion, but it has to be made. On the one hand, you have more or less a one in three chance of death within a given time period, on the other perhaps a longer life, but by how much, and with what quality, all weighed against the same question if there is no treatment (obviously the worst results there, but it helps to see the entire picture). There isn't a good, happy answer to any of this, and no good outcome, just a choice between which is the nastier outcome. On the occasions I have had to be part of a discussion of this nature, I can tell you that no one comes away from it unscathed - we doctors may seem a bit removed, but it is a professional mask that we use to help us to make a clear informed decision and offer clear and untainted opinions, but I have certainly felt the patient's distress in this and identified with it deeply and took it home with me and lived with it as well and I can tell you that your team, who know you well, will be thinking very hard and feeling with you all the the way through. I wish you clarity and wisdom in this process, and a good, clear and above all bearable outcome.
(This post was last modified: 06-07-2015 05:49 AM by DocWils.)
06-07-2015 05:47 AM
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