New Mechanical Trileaflet Valve in development

[tommyboy14]

Professor Hans Sievers (Now retired, but used to be Germany's Ross procedure expert and one of the leading surgeons in that country) is working on new trileaflet mechanical valve.

They first tested in in a lab:
https://pubmed.ncbi.nlm.nih.gov/30590696/
Now they have shown you can put in sheep without any anticoagulation and without thrombosis:
https://pubmed.ncbi.nlm.nih.gov/36003713/
They say in the article that baby aspirin every day may still be required.

This was too late for me, but from speaking to them I do know that they are planning to put this in clinical trial within the next couple of years.

Obviously, if this works (prob still a big if), then it will become the future of heart valve replacement. (I.e. not more Ross vs tissue vs mech valve decision to make).

 

[Lucker]

For some reason they still didn't start trials on humans. Is it because the sheep model is much more tolerable to the mechanical valves than humans?
But surely all new technologies are welcome.
It's also remarkable that a Ross expert works on mechanical valves.

 

[pellicle]

Again...

https://www.valvereplacement.org/threads/mechanical-vs-tissue-need-help-deciding.887097/post-888538
And again

https://www.valvereplacement.org/threads/new-mechanical-valve-in-evolution.849100/
And again...
https://www.valvereplacement.org/th...-valves-blood-thinners-etc.887758/post-900836
So don't hold your breath

 

[pellicle]

For some reason they still didn't start trials on humans.

Apparently sheep families don't pursue the surgeon in court if the patient dies unexpectedly...

 

[gjkahn]

Apparently sheep families don't pursue the surgeon in court if the patient dies unexpectedly...

That's a baaaahd joke.

 

[nobog]

Tri-leaflet mechanical valves has been around, in prototype form, for years - decades actually (the French, Dassault, at least that's where it started). This (Triflo) looks like a plastic leaflet version of such. Nothing new.

 

[pellicle]

That's a baaaahd joke.

I'm going to ruminate on that ;-)

 

[pellicle]

Tri-leaflet mechanical valves has been around, in prototype form, for years - decades actually (the French, Dassault, at least that's where it started). This (Triflo) looks like a plastic leaflet version of such. Nothing new.

IMO, until someone builds a better more durable mousetrap (unlikely because the focus and profit margins are now on the least durable method) I'm quite happy to be using my old faithful one.

thup ... thup ... thup ... thup ... thup ... thup ...

 

[tommyboy14]

For some reason they still didn't start trials on humans. Is it because the sheep model is much more tolerable to the mechanical valves than humans?
But surely all new technologies are welcome.
It's also remarkable that a Ross expert works on mechanical valves.

From my understanding, he retired from active surgery and wanted to continue helping his patients. Speaking to some people around this project, it appears that they have been working on this for almost 30 years. The reason these papers were only published now is because they came across a bio-compatible material that would allow the mechanical valve to have three leaflets. I believe that this is the same material that has been used in knee replacements for quite some time now.

I get that this dream of an anticoagulant free mechanical valve has been around from the beginning and that people have been working on this for a long time. So perhaps we shouldnt raise our hopes too much (At the time of the Moon landings, people thought we would be on Mars by now). But I think that there is now more than one credible group working on this suggests that this is probably a bit more likely than before.

I think we will only know with clinical trials really if this makes a difference or not. And you have to wonder who will actually volunteer for such a trial? My best guess is it will be done on people who are terminally ill? This is what happened with the very first TAVI in France in 2002.

However, obviously these technologies will only one go in a human, even if they are terminally ill. So the people developing them will be incredibly cautious and perfectionist with their product. I wonder if this is one of the reasons why this is taking decades....

 

[Lucker]

I think we will only know with clinical trials really if this makes a difference or not. And you have to wonder who will actually volunteer for such a trial? My best guess is it will be done on people who are terminally ill?

The same kind of people like those who participate in trials for the Foldax valve now (at least 40 in USA and a few in India). There are young and otherwise healthy people there too. Also it's best to do trials on generally healthy people for getting cleaner results. And severe valvular disease is more or less terminal itself if not cured, isn't it? Actually I'd probably volunteer too, had I the surgery promptly needed.

As for the valve, it looks eerily similar to the Bjork-Shiley, but times 3.

 

[nobog]

This one (tri-leaflet mechanical valve) has been around for almost 20 years - there are more - so nothing new:
https://patents.google.com/patent/US20040249451

 

[Protimenow]

For some reason they still didn't start trials on humans. Is it because the sheep model is much more tolerable to the mechanical valves than humans?
But surely all new technologies are welcome.
It's also remarkable that a Ross expert works on mechanical valves.

I don't think this is AT ALL remarkable. Many (if not most) physicians are mainly interested in helping their patients - and if there's a better, safer, way to deal with a bad heart valve, I'm not surprised that some doctors will try to find it.

If cancer researchers some day come up with a vaccine or two that stops all cancers, or cures the current ones (and I have serious doubts that this will ever happen), I think oncologists would be among the first in line to celebrate. Ongoing improvements in cancer detection and treatment are embraced by oncologists.

I suspect that any physicians that specialize in one area or another would not be disappointed when a treatment or cure for what they've specialized in comes along -- they'll probably switch to another area of medicine.

Their primary goal should be to CURE people - not make money off of them