ST vs ASV - studies about risk

[ajack]

You replied very quickly, have you seen the video lectures from the experts before? I read your link and later edited to include this comment, as you were writing your post.
"...your own report says it's compelling, but it shouldn't prevent further reseach, from the links below, you will see that this is happening, but they won't be putting low EF in to ASV studies, it's unethical and no authority would approve such a study.
"As compelling as the SERVE-HF data appear, they raise a number of issues that should not preclude completion of other trials of devices for therapy of CSA or OSA in HFrEF patients."...."

and further to the video"The [SIC] include numerous reports in their lectures, including the resmed one that is being talked about here and was cancelled part way through, because of the unacceptable death rate with those with low EF."

No one is bagging the results including resmed who paid for it. You are at odds with everyone on this.
The trial, the trial was cancelled it was self evident that the death rate was extreme in this subset. No one is disputing this, everyone one wants more research done. The videos tell of this current research. It is the latest up to date information.

What I'm most concerned about is that someone with low EF, will read forum opinions, self prescribe an ASV and die as a result. There is a gap in the US system, where some get good healthcare and some don't and self medicate. Also world wide web would have many nations reading this forum with differing health care

[HalfAsleep]

To change the subject....

Kiwii, I have to take regular pulmonology tests. I call it the Puff test. I usually have to do some of the challenges, but most of the time not all of them. They are very likely to make you exhausted. They're a lot of work, since they have you breathe to your maximum lung capacity.

The test is to see how well your lungs work.

Problem is.....you are, like, wide awake.... It seems unlikely that a Puff test would evaluate disordered sleep breathing, just eliminate poor lung function as a cause.

On the plus side, I have found the pulmonology tech super willing to teach how the data works and what it means. My kind of medical professional. He shows me all the waves and the numerical data as we go along. He shows me what the test is supposed to indicate, and what he's looking for in a "good" test. [Mine also gets aggravated and vocal that I have to have these tests at all, since I score 100%. He has been known to call my doctor's office and tell her he won't continue the test (yes, arrogant since he doesn't know what my condition is, but I have a sense of humor about it.) But that's by the by for this discussion.]

Just to reiterate..... the Puff tests are not comfortable, and your ribs may hurt for several days 'cos your chest muscles are getting quite the workout. I never imagined this until I had one. I whinge at the doctor very time she orders the test. My whingeing has worked for the last little while, so I likely am due for another one.

Warn the tech if you have PTSD and agree on a signal to bail if an episode comes on.

Take water to drink.

[Spy Car]

You replied very quickly, have you seen the video lectures from the experts before? I read your link and later edited to include this comment, as you were writing your post.
"...your own report says it's compelling, but it shouldn't prevent further reseach, from the links below, you will see that this is happening, but they won't be putting low EF in to ASV studies, it's unethical and no authority would approve such a study.
"As compelling as the SERVE-HF data appear, they raise a number of issues that should not preclude completion of other trials of devices for therapy of CSA or OSA in HFrEF patients."...."

and further to the video"The [SIC] include numerous reports in their lectures, including the resmed one that is being talked about here and was cancelled part way through, because of the unacceptable death rate with those with low EF."

No one is bagging the results including resmed who paid for it. You are at odds with everyone on this.
The trial, the trial was cancelled it was self evident that the death rate was extreme in this subset. No one is disputing this, everyone one wants more research done. The videos tell of this current research. It is the latest up to date information.

What I'm most concerned about is that someone with low EF, will read forum opinions, self prescribe an ASV and die as a result. There is a gap in the US system, where some get good healthcare and some don't and self medicate. Also world wide web would have many nations reading this forum with differing health care

In a litigious age, it is unsurprising that ResMed would issue safety warnings. They can't afford not to do so.

It remains that this study is based on an average of 3.4 hours of non-compliant use. 

That puts the study in the area of junk-science as far as I'm concerned.

For a study to be valid, at the minimum it would include only compliant users in the samples.

The metadata analysis is reported to show findings opposite to this flawed study as do the clinical findings.

It is incorrect that "no one is bagging on this study" as it has been roundly and widely criticised and for good cause.

Meanwhile, there is no study demonstrating ST presents lower risks. ST is being prescribed w/o and proven safety advantage in cases where the technology is certainly less efficacious.

No one wants to see patients endangered. It is a shame that such flawed studies are conducted and published. It is bad science.

Bill

[SarcasticDave94]

HalfAsleep, would this be pulmonary function tests, like what I take for COPD on a spirometer? If so, agreed they'll make one tired out. Just be armed with a carefulness kiwii.

[kiwii]

Yelling doesn't make your point stronger...

I found the bolded information to be helpful. It brought attention to the key points, and I appreciated that Spy Car had done that.

---

I also found the first linked video to be of particular interest. I am not concerned about EF, but he also mentions tachycardia and this is the first time I've heard that word in association with ASV. I don't understand any of it, and it is probably of no concern, but I'll be sure to speak to my cardiologist before considering either machine.

[kiwii]

To change the subject....

Kiwii, I have to take regular pulmonology tests. I call it the Puff test. I usually have to do some of the challenges, but most of the time not all of them. They are very likely to make you exhausted. They're a lot of work, since they have you breathe to your maximum lung capacity...

Ewww. Thank you for the heads up!

Yeah, these tests are for asthma (coughing) and not the sleep disordered breathing.

He mentioned that one particular challenge had something to do with being injected with something. I'm not liking the sound of that.

He also said the tests will take about 45 minutes, but it never occurred to me that it would be tiring or uncomfortable. Thank you (and Dave) so much for the advance warning!

[SarcasticDave94]

Welcome. To all a good night.

[ajack]

You replied very quickly, have you seen the video lectures from the experts before? I read your link and later edited to include this comment, as you were writing your post.
"...your own report says it's compelling, but it shouldn't prevent further reseach, from the links below, you will see that this is happening, but they won't be putting low EF in to ASV studies, it's unethical and no authority would approve such a study.
"As compelling as the SERVE-HF data appear, they raise a number of issues that should not preclude completion of other trials of devices for therapy of CSA or OSA in HFrEF patients."...."

and further to the video"The [SIC] include numerous reports in their lectures, including the resmed one that is being talked about here and was cancelled part way through, because of the unacceptable death rate with those with low EF."

No one is bagging the results including resmed who paid for it. You are at odds with everyone on this.
The trial, the trial was cancelled it was self evident that the death rate was extreme in this subset. No one is disputing this, everyone one wants more research done. The videos tell of this current research. It is the latest up to date information.

What I'm most concerned about is that someone with low EF, will read forum opinions, self prescribe an ASV and die as a result. There is a gap in the US system, where some get good healthcare and some don't and self medicate. Also world wide web would have many nations reading this forum with differing health care

In a litigious age, it is unsurprising that ResMed would issue safety warnings. They can't afford not to do so.

It remains that this study is based on an average of 3.4 hours of non-compliant use. 

That puts the study in the area of junk-science as far as I'm concerned.

For a study to be valid, at the minimum it would include only compliant users in the samples.

The metadata analysis is reported to show findings opposite to this flawed study as do the clinical findings.

It is incorrect that "no one is bagging on this study" as it has been roundly and widely criticised and for good cause.

Meanwhile, there is no study demonstrating ST presents lower risks. ST is being prescribed w/o and proven safety advantage in cases where the technology is certainly less efficacious.

No one wants to see patients endangered. It is a shame that such flawed studies are conducted and published. It is bad science.

Bill

apologies, you weren't yelling, it's the forum software that won't allow resizing or unbolding. I had a lot of trouble bring it back to normal.

Your link is from 2015, it references the other advent-HF study that is being done, there is a 2017 update on this study in the videos. The videos really are the latest knowledge on ASV.

You link doesn't disagree with the decision, it clearly says it should not be generally used

"The SERVE-HF data indicate that ASV should not be used to treat CSA in patients with HFrEF outside of the setting of a randomized trial. Any such trial would require close monitoring by an independent data and safety monitoring board (DSMB) to detect any early potential adverse effects of ASV."

it then goes on to mention the current trial.

The ADVENT-HF trial (7), while similar to SERVE-HF in that it includes HFrEF patients with CSA and employs ASV as the intervention, differs from SERVE-HF in several respects. First, unlike SERVE-HF, it includes non-sleepy patients with OSA (7,8). To date, 64% of patients enrolled have OSA. Second, the ASV device used is made by another company, and its algorithm has lower default end-expiratory and minimum pressure support settings (4 cmH2O and 0 cmH2O, respectively) than that used in SERVE-HF.

[Spy Car]

You replied very quickly, have you seen the video lectures from the experts before? I read your link and later edited to include this comment, as you were writing your post.
"...your own report says it's compelling, but it shouldn't prevent further reseach, from the links below, you will see that this is happening, but they won't be putting low EF in to ASV studies, it's unethical and no authority would approve such a study.
"As compelling as the SERVE-HF data appear, they raise a number of issues that should not preclude completion of other trials of devices for therapy of CSA or OSA in HFrEF patients."...."

and further to the video"The [SIC] include numerous reports in their lectures, including the resmed one that is being talked about here and was cancelled part way through, because of the unacceptable death rate with those with low EF."

No one is bagging the results including resmed who paid for it. You are at odds with everyone on this.
The trial, the trial was cancelled it was self evident that the death rate was extreme in this subset. No one is disputing this, everyone one wants more research done. The videos tell of this current research. It is the latest up to date information.

What I'm most concerned about is that someone with low EF, will read forum opinions, self prescribe an ASV and die as a result. There is a gap in the US system, where some get good healthcare and some don't and self medicate. Also world wide web would have many nations reading this forum with differing health care

In a litigious age, it is unsurprising that ResMed would issue safety warnings. They can't afford not to do so.

It remains that this study is based on an average of 3.4 hours of non-compliant use. 

That puts the study in the area of junk-science as far as I'm concerned.

For a study to be valid, at the minimum it would include only compliant users in the samples.

The metadata analysis is reported to show findings opposite to this flawed study as do the clinical findings.

It is incorrect that "no one is bagging on this study" as it has been roundly and widely criticised and for good cause.

Meanwhile, there is no study demonstrating ST presents lower risks. ST is being prescribed w/o and proven safety advantage in cases where the technology is certainly less efficacious.

No one wants to see patients endangered. It is a shame that such flawed studies are conducted and published. It is bad science.

Bill

apologies, you weren't yelling, it's the forum software that won't allow resizing or unbolding. I had a lot of trouble bring it back to normal.

Your link is from 2015, it references the other advent-HF study that is being done, there is a 2017 update on this study in the videos. The videos really are the latest knowledge on ASV.

You link doesn't disagree with the decision, it clearly says it should not be generally used

"The SERVE-HF data indicate that ASV should not be used to treat CSA in patients with HFrEF outside of the setting of a randomized trial. Any such trial would require close monitoring by an independent data and safety monitoring board (DSMB) to detect any early potential adverse effects of ASV."

it then goes on to mention the current trial.

The ADVENT-HF trial (7), while similar to SERVE-HF in that it includes HFrEF patients with CSA and employs ASV as the intervention, differs from SERVE-HF in several respects. First, unlike SERVE-HF, it includes non-sleepy patients with OSA (7,8). To date, 64% of patients enrolled have OSA. Second, the ASV device used is made by another company, and its algorithm has lower default end-expiratory and minimum pressure support settings (4 cmH2O and 0 cmH2O, respectively) than that used in SERVE-HF.

If good studies replicable the findings of the SERVE-HF study then it should be taken seriously.

But SERVE-HF alone is too deeply flawed to overwhelm the positive results that contradict the conclusions that are reportedly seen in metadata analysis and clinical practice IMO.

Are the ADVENT-HF findings released?

Are there any studies showing ST is risk-free for this subset?

In order to follow good medical science--which I'm sure is a common aim for both of us--we need to have good science. I don't think SERVE-HF met the minimum standards by making recommendations based on a largely non-compliant group of patients.

Bill

[Sleeprider]

The ADVENT-HF trial (7), while similar to SERVE-HF in that it includes HFrEF patients with CSA and employs ASV as the intervention, differs from SERVE-HF in several respects. First, unlike SERVE-HF, it includes non-sleepy patients with OSA (7,8). To date, 64% of patients enrolled have OSA. Second, the ASV device used is made by another company, and its algorithm has lower default end-expiratory and minimum pressure support settings (4 cmH2O and 0 cmH2O, respectively) than that used in SERVE-HF.

All of the ASV machines on the market are now capable of lower minimum EPAP and PS, and also have auto ASV modes to adjust EPAP pressure that the first study did not have.  Many factors have changed.