ResMed's "failed" trial of ASV machines

JustinD9 · Post by **JustinD9** » Wed May 13, 2015 8:29 pm

Sorry if others have seen this already (and posted) as I couldn't see it.

ResMed announced that its Serve_HF trial of its ASV machines for people that have symptomatic chronic heart failure actually caused an increase in cardiovascular mortality. It was meant to help with people that had both the heart condition plus exhibited moderate to severe central sleep apnea.

So what they said was when they did a study for people with chronic heart failure they actually had a statistically significant increase in death from heart attacks, etc compared to the control group. The stock is down around 18%.

It is counter intuitive that this would have this effect.

Krelvin · Post by **Krelvin** » Wed May 13, 2015 9:59 pm

Source?

wm_hess · Post by **wm_hess** » Wed May 13, 2015 10:16 pm

http://www.streetinsider.com/dr/news.php?id=10554522

I googled this article up

yaconsult · Post by **yaconsult** » Wed May 13, 2015 11:14 pm

I found another copy here: http://www.afr.com/business/health/biot ... 514-gh17ey

JustinD9 · Post by **JustinD9** » Wed May 13, 2015 11:38 pm

the stock dropped on the release by Resmed as 7% of its sales were ASV and 25% of them were to people who had similar profiles (congestive heart failure) to the participants in the study. Apparently many analysts had factored this market growing 5% in perpetuity. These numbers had to be removed from the companies stock multiple.

I think the interesting thing from a lay persons perspective is given CPAP is generally accepted to help prevent/lessen heart damage in otherwise healthy people it would appear the more active assisted approach appears to actually overstress the body or something. They don't really say at this stage why it has caused greater deaths. Food for thought, though, is that everything is along a spectrum.

Deep Sleep · Post by **Deep Sleep** » Thu May 14, 2015 4:30 am

Adaptive Servo-Ventilation – Health Net (the gatekeeper for TriCare North and Medicare)

This policy was been in place since 2007 and was reiterated last year.

Current Policy Statement
Health Net, Inc. considers adaptive servo-ventilation for the treatment of central or complex sleep apnea investigational due to insufficient evidence in the peer review published literature demonstrating its long- term safety and efficacy.

Jay Aitchsee · Post by **Jay Aitchsee** » Thu May 14, 2015 7:20 am

In fact, the trial found the risk of dying for those patients was 10 per cent per year, compared with 7.5 per cent for patients who did not receive the adaptive-servo ventilation treatment.

Out of context, it really doesn't mean anything. These patient could have been in much worse shape than those not treated. And we know how reporters like to throw statistics around. I doubt the study actually finds a causal relationship between ASV treatment and increased risk of dying.

IreneN · Post by **IreneN** » Thu May 14, 2015 7:25 am

Jay Aitchsee wrote:
In fact, the trial found the risk of dying for those patients was 10 per cent per year, compared with 7.5 per cent for patients who did not receive the adaptive-servo ventilation treatment.
Out of context, it really doesn't mean anything. These patient could have been in much worse shape than those not treated. And we know how reporters like to throw statistics around. I doubt the study actually finds a causal relationship between ASV treatment and increased risk of dying.

Excellent interpretation, Jay.

Darth Lady · Post by **Darth Lady** » Thu May 14, 2015 9:41 am

This was in the CPAP and Sleep Apnea News section of this very site yesterday:
http://www.prnewswire.com/news-releases ... 82445.html

There was some kind of site problem this morning and now there is no news at all. Interesting to note that Resmed itself sees this as both statistically significant and something to take notice of from a safety standpoint.

I don't have congestive heart failure, but I did have enough centrals to fail BiPAP, so I got an ASV. I have a worsening arrhythmia (odds are it's probably afib, but of course I have no way to tell for sure), and it does make me wonder if this treatment that otherwise seems so comfortable does put some kind of strain on the heart.

SleepWellCPAP · Post by **SleepWellCPAP** » Thu May 14, 2015 10:30 am

It seems the detrimental effect hinges on Left Ventricular Ejection Fraction [LVEF] ≤ 45%.

Here is another link that may be helpful.

http://www.resmed.com/content/dam/resme ... F_FAQs.pdf

robysue · Post by **robysue** » Thu May 14, 2015 1:06 pm

Jay Aitchsee wrote:
In fact, the trial found the risk of dying for those patients was 10 per cent per year, compared with 7.5 per cent for patients who did not receive the adaptive-servo ventilation treatment.
Out of context, it really doesn't mean anything. These patient could have been in much worse shape than those not treated. And we know how reporters like to throw statistics around. I doubt the study actually finds a causal relationship between ASV treatment and increased risk of dying.

There doesn't have to be a causal relationship between ASV and the increased risk of dying for this to be bad news for Resmed (in particular) and ASV therapy (in general).

If the hypothesis is that treating patients that have both symptomatic chronic heart failure and moderate to severe central sleep apnea should decrease the risk of dying from chronic heart failure, then a study like this one leads to the important questions:

Is ASV an effective treatment for the combination of symptomatic chronic heart failure and moderate to severe central sleep apnea?
Does the perceived benefit of using ASV to treat the combination symptomatic chronic heart failure and moderate to severe central sleep apnea outweigh the potential risks of ASV in this patient population?

But just because a study's results raises questions does not mean the study's results actually answers these questions.

Jay Aitchsee · Post by **Jay Aitchsee** » Thu May 14, 2015 2:04 pm

robysue wrote:There doesn't have to be a causal relationship between ASV and the increased risk of dying for this to be bad news for Resmed (in particular) and ASV therapy (in general).

I didn't say it wasn't potentially bad news for ResMed (but probably not, in the long run). My point was we haven't seen the study and until we have had a chance to see what it and ResMed says, speculation about its meaning and implications for ASV therapy are just that - speculation. Most of the news so far has been from the financial sector and the impact this has had on ResMed's stock price.
Will it lead to different treatment plans for using ASV by people with certain types of heart failure? Probably:

http://www.prnewswire.com/news-releases/resmed-provides-update-on-phase-iii-serve-hf-study-of-adaptive-servo-ventilation-asv-therapy-in-central-sleep-apnea-and-chronic-heart-failure-300082445.html wrote:ResMed is working with global regulatory authorities to proactively revise the labels and instructions for use for ResMed ASV devices to include a contraindication for people with symptomatic chronic heart failure (with left ventricular ejection fraction, LVEF, less than or equal to 45 percent). The company is also proactively informing healthcare providers, physicians, and patients of the cardiovascular safety signal observed in SERVE-HF.

As provided by SleepWellCPAP above: http://www.resmed.com/content/dam/resme ... F_FAQs.pdf

sleepstar · Post by **sleepstar** » Fri May 15, 2015 4:22 am

Jay Aitchsee · Post by **Jay Aitchsee** » Fri May 15, 2015 4:30 am

sleepstar wrote:They have released a warning that this machine should not be used in those who have this type of heart failure.

Yes, to which a link was posted earlier in this thread, http://www.resmed.com/content/dam/resme ... F_FAQs.pdf , in case anybody missed it.

Morbius · Post by **Morbius** » Fri May 15, 2015 4:37 am

So IOWs, ASV just makes the waveform look pretty.

Gee, I wish I thought of that.

At any rate, this is so not a surprise. The same conclusion was reached in CANPAP 10 years ago:

http://www.medscape.com/viewarticle/787437

However, there were plenty of other benefits in the CPAP users back then, and I'm sure with the ASV users now.

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