Tiny Device Is a ‘Huge Advance’ for Treatment of Severe Heart Failure
nytimes.com
nytimes.com
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.
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
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.
There's also very little research on why it works - to me that would be an important body of knowledge.
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... and it includes quite a lot of independent entities.
[edit] Table S19 is a bit interesting
”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..., 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.
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).