Foldax valve trials

[Warrick]

I have been keeping an eye on the foldax valve over the last several months regarding the start of their human trials, nothing new on their site recently
But then I came across this from several days ago and trials have started-

https://foldax.com/wp-content/uploads/2019/09/FINAL_FOLDAXPressRelease_3.pdf

Beaumont doctors implant world’s first Tria flexible polymer heart valve

www.beaumont.org

Heart valve made of biopolymer implanted successfully

www.bioplasticsmagazine.com

 

[Protimenow]

Wow.

I hope it gets through the trials with continuous positive results, zero failures, zero clots, and 90 year survival times.

It would certainly be nice, in the future, for people with aortic or mitral valve issues - detected early - treated with a relatively low cost outpatient (or, perhaps, overnight stay) procedure. If this thing really works, and the price is good, and we still have a planet that is inhabitable, perhaps the procedure can be extended across the planet, providing extra life and vitality to those that most of us don't even think about. (My ophthalmologist spends a few weeks a year in Africa, operating on people's cataracts and giving them back their vision. Imagine a group of cardiac surgeons doing the same with heart valves. With the Internet, artificial intelligence, high speed communications, and other advanced tools, scans or echoes are being done in fairly remote places, the data is analyzed locally or over a network, and diagnoses are done quickly. It may not be that much of a stretch to expect that, within a decade or so, processes like valve replacements might be available even in remote areas.)

 

[SiestaKeyJimmy]

Very interesting - but it is not clear to me exactly how the new valve was placed - was it open heart surgery or transcatheter ? It doesn't say how long the hospital stay was? Would like to see more details.

 

[Protimenow]

Apparently, the valve can be placed either way - no doubt, depending on the position and status of the valve being replaced (or for some other reason).

The article said something about the patient walking around a few hours after the surgery - and being discharged the next day or so (I'm not looking at the paper while I write this). In this case, it's pretty obvious that this was replaced using catheter -- an OHS would require much more time in the hospital.

One good result is promising -- it'll be good to see more reported results, and, down the road, something about the actual longevity of the valve in vivo.

 

[rich01]

Very interesting - but it is not clear to me exactly how the new valve was placed - was it open heart surgery or transcatheter ? It doesn't say how long the hospital stay was? Would like to see more details.

From article

The complete Tria heart valve platform will include valves developed for use in aortic and mitral valve disease with transcatheter and surgical applications.

 

[Protimenow]

From article

The complete Tria heart valve platform will include valves developed for use in aortic and mitral valve disease with transcatheter and surgical applications.

That's not what he asked. In this case, it seems that this was inserted through a catheter. His recovery time was too fast for this to have been an OHS.

 

[SiestaKeyJimmy]

Now that I read a few of the links and researched this it appears that while the future plans call for this new foldax valve to be inserted by transcatheter techniques, according to his surgeon (Dr. Sakwa), “he was an ideal candidate for a minimally invasive approach".

(It appears that Dr. Sakwa is somewhat well known for his “Minimally Invasive" valve replacements that (I think) only require 2-3 inch incisions between ribs.)

Also of interest to me is that this first patient, (Bob Murley), was from Chesterfield Michigan, (where I am also from).

Lastly interesting is that apparently Dr. Sakwa is leaving Michigan’s Beaumont Hospital for sunny California. (As a former Michigan resident, who now lives in sunny Florida, I totally “get it”!)

 

[trinitymcdermott]

I’m keeping an eye on these types of things as well. I anticipate science/technology will improve enough that one day my son may want to have his mechanical valve valve removed and a valve with longevity like this without coumadin requirements. Downside would be another OhS, which might not be a smart thing as it would be his 3rd.....and he’s only 14. Not for many, many years, of course. We did not do a bioprosthetic valve 2 1/2 years ago as the surgeons felt that they rapidly calcify in pediatric patients. He would not have gotten the 10-30 years out of it like adults can. I’m trying to wrap my head around any transcatheter or between the ribs approach to that. Thoughts?

 

[Agian]

Trin, he'll be an adult soon. As we get older we accumulate medications we take. He has a valve for life. There'll eventually be an anticoagulant that doesn't need testing, but even if there isn't.... meh.

Don't try to wrap your head around a transcatheter. It's too hard because they're pretty small.

 

[Agian]

Jimmy, Bob Marley was from Jamaica.

 

[tom in MO]

I agree with Agian, he's 14, in 4 years he'll be making his own decisions.

 

[trinitymcdermott]

Trin, he'll be an adult soon. As we get older we accumulate medications we take. He has a valve for life. There'll eventually be an anticoagulant that doesn't need testing, but even if there isn't.... meh.

Don't try to wrap your head around a transcatheter. It's too hard because they're pretty small.

Thank you Again.
Less worried about INR testing - he’s a champ. It’s the potential brain bleeds if in an accident and not being able to snow ski any longer. You long time warfarin takers have experience there?

 

[Agian]

I agree will Pellicle. People like us tend to be healthier. No, seriously. My problem now is weight gain. I have embraced my inner fat bastard, but would like to be healthier. Pretty soon, I'll be an old bastard. It's all good.

Your son, sweetie, will be a young man, then a middle aged man and then an old geezer with an attitude, like the guys at the lodge. If he can't snow ski, then so what? Most people don't.

Having said that, some woman climbed Everest on warfarin. I'm planning to do an Everest eventually. I just need to find the time.

 

[tom in MO]

Unless you are a daredevil, isn't the risk in skiing similar to riding a bike? Is that doctor's orders? I was told I could do anything I wanted except exercises where you hold your breath.

 

[newarrior]

woman climbed Everest on warfarin WOW COOL !

 

[Protimenow]

Thank you Again.
Less worried about INR testing - he’s a champ. It’s the potential brain bleeds if in an accident and not being able to snow ski any longer. You long time warfarin takers have experience there?

The closest that I've come to worry about a brain bleed was when a person 'dropped' a dishwasher, and it hit my head. (Don't ask). I had a concussion, and worried about a brain bleed. CT showed nothing.

Clearly, this isn't anywhere near as severe as a skiing accident, but there's always the concern about injury from major impacts.

Many people on this site have had some pretty dreadful accidents. They live active, sometimes dangerous, lifestyles, and the fact that they're taking warfarin (and will bleed more than 'normals') doesn't seem to have slowed them down.

 

[Warrick]

Polymeric trileaflet prosthetic heart valves: evolution and path to clinical reality

Tria heart valve shows potential of polymer in heart surgery | The Engineer

In a world first, a US patient has successfully received an aortic heart valve made of a polymer jointly developed by CSIRO and Foldax.

www.theengineer.co.uk