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New ASV Study
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ShadowSeeker Offline

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Posts: 16
Joined: Jun 2015

Machine: ResMed AirCurve 10 ASV
Mask Type: Nasal mask
Mask Make & Model: Fisher & Pykel
Humidifier: Built-In
CPAP Pressure: EPAP:13, MinPS: 3, MaxPS: 12
CPAP Software: SleepyHead

Other Comments:

Sex: Male
Location: North Miami, FL

Post: #1
New ASV Study
My Sleep doc warned me of a new ASV study, and how it can have fatal consequences for certain patients. Here is a copy and paste of the general information I was given.

Patients:
1. What is SERVE-HF?
- SERVE-HF is a multinational, multicenter, randomized controlled Phase IV study that was designed to assess whether treatment of moderate to severe predominant central sleep apnea with Adaptive Servo-Ventilation (ASV) therapy in addition to optimized medical care could reduce mortality and morbidity in patients with symptomatic chronic heart failure with reduced ejection fraction (Left Ventricular Ejection Fraction [LVEF] ≤ 45%).

2. What was found in the SERVE-HF study?
- SERVE-HF did not show any benefit for ASV therapy for those patients in the study and also identified increased risk of cardiovascular death for those people in the study with symptomatic chronic heart failure and central sleep apnea.

3. Who is at risk?
- Only people with symptomatic chronic heart failure and central sleep apnea were included in the clinical study leading to this safety notice.
- We’re recommending that you contact your doctor immediately and talk to your doctor about the most appropriate course of action given your situation.
- According to the study results, if you fit these specific criteria, there is an increased risk of cardiovascular death. We recommend you speak with your doctor right away.

4. Are the devices malfunctioning?
- No. There has been no malfunction or technical fault observed with ResMed’s ASV device’s operation; it operates correctly to treat central sleep apnea.

5. What if I use a CPAP or APAP device?
- CPAP and APAP are used to treat obstructive sleep apnea.
- The patients in the study had moderate to severe predominant central sleep apnea.
- The study and this warning does not apply to ResMed CPAP or APAP devices.
- This particular warning only applies to a specific therapy called ASV, and only to people with symptomatic chronic heart failure and central sleep apnea.
- If you are unsure if your device is an ASV device (or affected device), you can find out by calling your country-specific hotline below.
07-27-2015 06:02 PM
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storywizard Offline

Advisory Members

Posts: 350
Joined: Jul 2014

Machine: ResMed VPAP Adapt S9
Mask Type: Nasal pillows
Mask Make & Model: P10 taped to face
Humidifier: included with machine
CPAP Pressure: CPAP 11cm
CPAP Software: SleepyHead

Other Comments:

Sex: Male
Location: Vancouver, BC, Canada

Post: #2
RE: New ASV Study
This has been discussed in this thread: http://www.apneaboard.com/forums/Thread-...ght=safety

and this one: http://www.apneaboard.com/forums/Thread-...ss+release



Storywizard
(This post was last modified: 07-27-2015 06:16 PM by storywizard.)
07-27-2015 06:14 PM
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ShadowSeeker Offline

Members

Posts: 16
Joined: Jun 2015

Machine: ResMed AirCurve 10 ASV
Mask Type: Nasal mask
Mask Make & Model: Fisher & Pykel
Humidifier: Built-In
CPAP Pressure: EPAP:13, MinPS: 3, MaxPS: 12
CPAP Software: SleepyHead

Other Comments:

Sex: Male
Location: North Miami, FL

Post: #3
RE: New ASV Study
then we can delete this thread.. sorry
07-27-2015 06:15 PM
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OpalRose Offline

Monitors

Posts: 3,163
Joined: Nov 2014

Machine: PR System One REMstar Auto 560 with A Flex
Mask Type: Nasal pillows
Mask Make & Model: AirFit P10 For Her
Humidifier: REMStar heated humidifier with heated hose
CPAP Pressure: Auto Cpap 10-13 AFLEX 1
CPAP Software: SleepyHead EncoreBasic

Other Comments: Started CPAP Therapy October 23, 2014

Sex: Female
Location: Northeast Ohio, USA

Post: #4
RE: New ASV Study
ShadowSeeker,
Yes, the subject has been addressed, but it's good information and some may have not seen the other threads.

If every thread were deleted because someone new brings up a previous subject, then we would have mabye a third of the threads gone! Wink

Thanks for sharing!

OpalRose
07-27-2015 07:09 PM
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ShadowSeeker Offline

Members

Posts: 16
Joined: Jun 2015

Machine: ResMed AirCurve 10 ASV
Mask Type: Nasal mask
Mask Make & Model: Fisher & Pykel
Humidifier: Built-In
CPAP Pressure: EPAP:13, MinPS: 3, MaxPS: 12
CPAP Software: SleepyHead

Other Comments:

Sex: Male
Location: North Miami, FL

Post: #5
RE: New ASV Study
Thanks Opal!

When my doc discussed this with me, it seemed a bit odd that a simple machine like this could increase a mortality rate. I don't understand the logistics of it in the sense of how it would..

Before I got the machine, they said there was a study that came out about the ASV machines and that you had to have an echo done before being prescribed the machine. They didn't go into full detail about it, but since I had a stress test with echo earlier this year, they were able to use the numbers from that.

I believe my PCP said to me at the time that my ef was 65%. So I don't fall into the at-risk category.

Makes you wonder then, what are the possible long-term effects of this machine on normal people who aren't at risk?
07-28-2015 07:56 AM
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Sleeprider Online
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Advisory Members

Posts: 3,317
Joined: Dec 2014

Machine: Resmed Aircurve 10 Vauto
Mask Type: Nasal pillows
Mask Make & Model: Resmed Airfit P10
Humidifier: Resmed Climateline
CPAP Pressure: Auto Bilevel 18/9, PS 3
CPAP Software: ResScan SleepyHead EncoreBasic

Other Comments:

Sex: Male
Location: Where they make Respironics

Post: #6
RE: New ASV Study
If you have congestive heart failure and are being treated by ASV, this might be a concern. On the other hand CHF is eventually always fatal and untreatable. It's not the greatest conundrum to be in. CHF is closely tied to Cheyne-Stokes respiration. I watched my dad pass from this terrible disease. I don't know that he felt a lot of discomfort, although watching the repetitive cessations of breathing was hard. Eventually, he just stopped breathing and sleep turned to death. Should you treat these people or not? Apparently there is no long-term benefit, and there may be some risks in using ASV. Risk to someone in the long process of dying might not be a big deal?

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07-28-2015 08:48 AM
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storywizard Offline

Advisory Members

Posts: 350
Joined: Jul 2014

Machine: ResMed VPAP Adapt S9
Mask Type: Nasal pillows
Mask Make & Model: P10 taped to face
Humidifier: included with machine
CPAP Pressure: CPAP 11cm
CPAP Software: SleepyHead

Other Comments:

Sex: Male
Location: Vancouver, BC, Canada

Post: #7
RE: New ASV Study
I am one of those folks who have been using an ASV to deal with the discomfort of CPAP pressure. It has been great, no effort at all to stay on the machine, just a few mask issues to deal with.

However, as the ASV is really only for treating CA's and CS respiration and similar ailments, I am going to try an Auto BiPAP this week, to see if I get the same level of comfort on the ASV.

It is not that I have any heart issues at this time, I am 65, had full cardiac testing last year, its just that I don't want to put any extra strain on the body when I may not need to.

Storywizard
07-28-2015 11:06 AM
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Sleeprider Online
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Advisory Members

Posts: 3,317
Joined: Dec 2014

Machine: Resmed Aircurve 10 Vauto
Mask Type: Nasal pillows
Mask Make & Model: Resmed Airfit P10
Humidifier: Resmed Climateline
CPAP Pressure: Auto Bilevel 18/9, PS 3
CPAP Software: ResScan SleepyHead EncoreBasic

Other Comments:

Sex: Male
Location: Where they make Respironics

Post: #8
RE: New ASV Study
I really like the Auto Bilevel and the EPAP pressure relief makes it feel like nothing is there. I actually have a few more CA events with bilevel than with an auto CPAP, but it so effectively eliminates OA hypopnea and RERA it doesn't matter. The large clusters of CA and periodic breathing are a concern, and it is problems like that which make ASV essential. If you don't experience significant numbers of CA, a BiPAP can be much more comfortable than CPAP or APAP. I don't know why you were prescribed ASV if you didn't need it, but if you find bilevel works, maybe the two Canadians in this thread could get together and figure something out.

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07-28-2015 11:15 AM
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storywizard Offline

Advisory Members

Posts: 350
Joined: Jul 2014

Machine: ResMed VPAP Adapt S9
Mask Type: Nasal pillows
Mask Make & Model: P10 taped to face
Humidifier: included with machine
CPAP Pressure: CPAP 11cm
CPAP Software: SleepyHead

Other Comments:

Sex: Male
Location: Vancouver, BC, Canada

Post: #9
RE: New ASV Study
I was never prescribed an ASV, it was suggested I had CA's from my sleepyhead reports, some folks thought I should give it a try, it works, but I don't actually have many centrals, according to sleepstudy/titration...
It will be interesting using the BiPAP...:-)

two Canadians, where??

Storywizard
(This post was last modified: 07-28-2015 06:45 PM by storywizard.)
07-28-2015 11:22 AM
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Sleeprider Online
Wiki Editor
Advisory Members

Posts: 3,317
Joined: Dec 2014

Machine: Resmed Aircurve 10 Vauto
Mask Type: Nasal pillows
Mask Make & Model: Resmed Airfit P10
Humidifier: Resmed Climateline
CPAP Pressure: Auto Bilevel 18/9, PS 3
CPAP Software: ResScan SleepyHead EncoreBasic

Other Comments:

Sex: Male
Location: Where they make Respironics

Post: #10
RE: New ASV Study
(07-28-2015 11:22 AM)storywizard Wrote:  two Canadians, where??

Storywizard

Sorry, wrong thread. Take a look at Robotman's post here: http://www.apneaboard.com/forums/Thread-Frightening-results This is an example of breathing that might benefit from ASV.

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07-28-2015 12:11 PM
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