
Tiny Device Is a ‘Huge Advance’ for Treatment of Severe Heart Failure - aj7
https://www.nytimes.com/2018/09/23/health/heart-failure-valve-repair-microclip.html
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jphoward
So this is currently fairly controversial in the cardiology world. This trial
(COAPT) is tremendously positive, but only months earlier a very similar trial
run from France, MITRA-FR, was dead negative (neutral).

Some of the authors of COAPT are trying to explain this by slightly worse
valvular parameters and larger heart chambers. MITRA-FR also had a slightly
higher complication rate.

However, my personal feeling is we need a third trial.

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victor106
> but only months earlier a very similar trial run from France, MITRA-FR, was
> dead negative (neutral).

From the article:

A smaller study in France with similar patients failed to find a benefit for
the MitraClip.

The study from France:-
[https://www.nejm.org/doi/full/10.1056/NEJMoa1805374](https://www.nejm.org/doi/full/10.1056/NEJMoa1805374)

But that research included many patients with less severe valve problems, the
procedure was not performed as adeptly, and the patients’ medications were not
as well optimized as in the new study.

In the new trial, 614 patients with severe heart failure in the United States
and Canada were randomly assigned to receive a MitraClip along with standard
medical treatment or to continue with standard care alone. \------------------

Bottom line it seems like this is a net positive considering the fact the
patients were randomized. The only thing to be suspicious of is that Abbott
funded the study but it does say that the data was reviewed by outside
experts.

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SpikeDad
Guess I get less optimistic about this sort of stuff considering the study was
funded by Abbott, the company that makes the device. Sure it was reviewed by
independent "sources" but still not something that's a positive feature of the
study.

There's also very little research on why it works - to me that would be an
important body of knowledge.

~~~
protomyth
> Guess I get less optimistic about this sort of stuff considering the study
> was funded by Abbott, the company that makes the device.

In the US, the clinical trials are funded by the company that made the
product. The way they did the trial is
[https://www.nejm.org/doi/suppl/10.1056/NEJMoa1806640/suppl_f...](https://www.nejm.org/doi/suppl/10.1056/NEJMoa1806640/suppl_file/nejmoa1806640_appendix.pdf)
and it includes quite a lot of independent entities.

[edit] Table S19 is a bit interesting

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Someone
[https://en.wikipedia.org/wiki/MitraClip](https://en.wikipedia.org/wiki/MitraClip):

 _”MitraClip was first implanted in 2003, obtained the CE mark Europe in 2008,
and in 2013 was approved by the FDA. The FDA obligated the company to run
post-marketing studies to confirm the safety and efficacy of the device.”_

I think this is the report on those post-marketing studies.

Also, compare _”The device itself costs about $30,000”_ with
[http://www.onlinejacc.org/content/accj/60/17_Supplement/B229...](http://www.onlinejacc.org/content/accj/60/17_Supplement/B229.1.full.pdf),
which says the device is only cost effective at that price for “patients with
acute procedural success”. I don’t know what “acute procedural success” means.
Taking it literally it would mean that excludes patients for whom the
operation wasn’t deemed a success immediately after the operation, but that
would seem like cheating to me. By such logic, roulette would bring all
players profits.

~~~
jphoward
Actually these trials were about expanding Mitraclip's indications.

The old EVEREST trial resulted in it being licensed for degenerative valve
disease (damaged valves), but here they wanted a license for treating
otherwise healthy valves which are leaky due to being stretched open by a
dilated ventricle in heart failure (functional valve disease).

