Foldax valve trials

[nobog]

In theory, it "looks" like the perfect valve but I would be very wary at this point. Go to Google Patents and search "heart valves" - thousands of hits - and inventions - each one claiming to solve, and be superior to the next inventions, and in the end there are what, 4-6 players in the mechanical valve party and a dozen or so in the tissue game, and now a handful of TAVI players - and none of those are perfect. In the end what makes a good heart valve?

20 years.

 

[Humboldtgrrl]

From what I can see with googling and stumbling around the web theres not much in the way of information on the trials progress, I do recall someone here mentioning there is also a UK variation of a polymeric valve material but I cant recall where it was at, so perhaps Foldax is keeping their cards close for now.

Interestingly I did come across this from 2004-
https://academic.oup.com/ejcts/article/25/6/946/381455Which as time would suggest by the fact I have a piece of pyrolitic carbon in my chest and not a urethane valve this valve material
didn’t get off the ground.
Its only a matter time before something does.

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Thank you Warrick, for your reply & web efforts. Yes there is also a Polivalve further back in the pipeline, per online. An oversight on my part not to consider the effect that the competition might have on Foldax being extra guarded about their Trials. Thanks also for info re the 2004 German poly valve exploration that may not have set fruit back then. The general limitations of the Tissue vs Mechanic continues to motivate the research to explore the poly material & the valve design & it would be wonderful if Foldax has succeeded on both. It was worth an inquiry to this group on the odd chance that there might be some Foldax info. Regardless, this group has such a unique deep body of knowledge on the complex tradeoffs of the two established valve categories that helps inform The Decision - so thanks to you & all on the forum for their sharing.

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In theory, it "looks" like the perfect valve but I would be very wary at this point. Go to Google Patents and search "heart valves" - thousands of hits - and inventions - each one claiming to solve, and be superior to the next inventions, and in the end there are what, 4-6 players in the mechanical valve party and a dozen or so in the tissue game, and now a handful of TAVI players - and none of those are perfect. In the end what makes a good heart valve?

20 years.

In theory, it "looks" like the perfect valve but I would be very wary at this point. Go to Google Patents and search "heart valves" - thousands of hits - and inventions - each one claiming to solve, and be superior to the next inventions, and in the end there are what, 4-6 players in the mechanical valve party and a dozen or so in the tissue game, and now a handful of TAVI players - and none of those are perfect. In the end what makes a good heart valve?

20 years.

In theory, it "looks" like the perfect valve but I would be very wary at this point. Go to Google Patents and search "heart valves" - thousands of hits - and inventions - each one claiming to solve, and be superior to the next inventions, and in the end there are what, 4-6 players in the mechanical valve party and a dozen or so in the tissue game, and now a handful of TAVI players - and none of those are perfect. In the end what makes a good heart valve?

20 years.

NoBog - you are someone who cuts toTthe Chase. Thank you for your reply. Yes, that is the Great Existential Landscape of the Clinical Trials and each person has their own response to the Unknown. The Unknown is always present with any valve (& reading some of the How Old is Your Tissue Valve thread is an example), but more obvious in the Clinicals. The spectrum of comments & experiences on this forum are what makes it so helpful (once past the confusing phase).

 

[Humboldtgrrl]

Hey all, new member here and was following up reading on the Foldax valve and found this forum. I recently had aortic valve replacement surgery myself and I had the option to get this Foldax valve as well but opted for a traditional mechanical. My surgery was July 11th, 2019 with Dr. Sakwa at Royal Oak Beaumont (I lived in Rochester Hills at the time). I had the minimally invasive procedure that he is known for so I could share a few more details if folks are interested at all.

The article I read notes that it was "two days after discharge" that the patient went for a 2.5 mile walk, not two days after surgery.

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Hello Beastifu, from another Newbie who found this forum googling Foldax, as their Trial is currently available locally. IF it's OK to ask about your choice (& of course it's fine to pass on disclosure), was there something specific to the Foldax design or material that was a concern for your match, or was it more the very large & significant Existential aspect of the Unknown due to the Clinical Trial phase? (Interesting that the first Foldax recipient was at Beaumont around the time of your surgery, tho don't know the surgeon's name.) The decisions on all this are so complex & evolving, so it's quite confusing for some while. This forum is such an unusual opportunity to learn more on all the valves & implantation methods & medications. Thanks in advance, if you choose to answer re Foldax valve, & congrats on being nearly 2 years "to the good"!.

 

[Humboldtgrrl]

Don’t get me wrong I hope that the Foldax valve works great and for many many years without catastrophic valve failure and little coagulation issues.
But I read the Study backs biopolymer used in Foldax’s Tria valve | Cardiovascular News link and it was typical company hype. Stuff like ”molecular engineered” or made robotically are hype phrases to make the product sound special. l.e. chemistry was involved to generate the material.
We will need to wait years to find out if these preform or not and what the longevity will be and what issues may develop. Personally I wouldn’t have one of these put in my chest at this time.

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Agree that the Style of info presentation on Foldax & other AVR innovations can be off putting, tho that's of course subjective. There was a youtube AVR vid (not for Foldax) that lost me when it began with some very bombastic music. Had to settle down a bit before the info, which was good, could sink into my nervous system. Can be difficult to tease out the info content from buzzwords or music. This is a great forum here to get more clues when making the decision. Thanks for sharing your perspective.

 

[Humboldtgrrl]

I find the "radical" new valve prostheses a lot like the newest cancer treatments. Sometimes you just have to make a decision based upon the best information available because by the time the long-term studies are out either the patient has died or that treatment has become obsolete.

I "rashly" chose a cancer treatment that "only" had 10 years of study history. I'm now almost 5 years post-treatment with favorable results. Had I gone with the "gold standard" my quality of life would have been unfavorably impacted. I took the chance and I think I'm coming out ahead. With heart valves, though, the downside is potentially far more unfavorable, though.

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Thanks for your reflective thoughts about the dynamic tension between risk & certainty over time. This issue is an innate part of the Clinical Trials & everyone's decision is very unique to their situation & personality. It seems that your calculated risk decision earlier has done well for you. Fortunately there are other options beyond Foldax if the risk seems too great & this forum is a good place to learn more about all the valves & procedures.

 

[Humboldtgrrl]

one member here has contacted me by email to discuss things "off this forum" because she was threatened by her insurance company ... so they follow these places for "anonymous" transgressions

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Thanks for this Heads Up. Interesting that insurance or other business-vestments would enter this forum to monitor comments. Sorry for unintentionally triggering any such concerns.

 

[pellicle]

Sorry for unintentionally triggering any such

All good, I have no such concerns, but I thought you may not have seen that side.

Google archives this place and it's searchable.

 

[Humboldtgrrl]

From what I can see with googling and stumbling around the web theres not much in the way of information on the trials progress, I do recall someone here mentioning there is also a UK variation of a polymeric valve material but I cant recall where it was at, so perhaps Foldax is keeping their cards close for now.

Interestingly I did come across this from 2004-
https://academic.oup.com/ejcts/article/25/6/946/381455Which as time would suggest by the fact I have a piece of pyrolitic carbon in my chest and not a urethane valve this valve material
didn’t get off the ground.
Its only a matter time before something does.

The local surgeon who is with the current Foldax Clinical Trials (6 hospitals) has access to their implantation data & recently stated that there are now 18 of these aortic Foldax implanted. The current FDA Trial approval is for up to 40 patients.

 

[Warrick]

Not sure if this ones been posted yet, bit further away from human trials than Foldax-
https://healthcare-in-europe.com/en/news/new-heart-valve-could-transform-open-heart-surgery.html

 

[Warrick]

Interview with the developer/inventer of the Foldax valve with some good insight into the progress they are making-

“Our longest patient is about twenty-two months and he’s doing exceptionally well. We can’t quite believe how much of an impact it’s had on him. He is a runner and recently reported that he is running roughly six miles.”

https://vivitrolabs.com/interview-jason-beith/

 

[Captain Cavemen]

Interview with the developer/inventer of the Foldax valve with some good insight into the progress they are making-

“Our longest patient is about twenty-two months and he’s doing exceptionally well. We can’t quite believe how much of an impact it’s had on him. He is a runner and recently reported that he is running roughly six miles.”

https://vivitrolabs.com/interview-jason-beith/

Thanks Warrick a facinating interview and almost definitely where the future lies with either polymer or other probably stem cell based tissues and 3d bioprinting. Interestingly my surgeon said they are looking at using the polymer material for the Osaki procedure and also for TAVR with a single fit valve holding device that will enable multiple TVARs to be fitted and then retrieved and replaced all minimally invasively. He also said within 10/15 years all valves and aneurysms will likely be repaired via percutaneous and endovascular methods thus changing valve and aneurysm repairs from a surgical basis to a cardiology basis.

 

[vitdoc]

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?

I am one of I believe many that have been very active on warfarin. Started in 1983 till now. Skied at a pretty high level until a few years ago. Still road biking over 100 miles / wk. Had one bike fall around 15 years ago where I bleed significantly into my leg. Had trouble climbing Mt.Ventoux in France a week later. So not really inhibited much by warfarin. Also didn’t have access to self testing for years. I was a terrible patient who hardly tested. Now I am much better with self testing. I really hope that synthetic valves will be made with long lifetimes and no need for anticoagulants but personally I would not sign up to be in a trial. Not a big stroke fan.

 

[Chuck C]

Interview with the developer/inventer of the Foldax valve with some good insight into the progress they are making-

“Our longest patient is about twenty-two months and he’s doing exceptionally well. We can’t quite believe how much of an impact it’s had on him. He is a runner and recently reported that he is running roughly six miles.”

https://vivitrolabs.com/interview-jason-beith/

Thanks Warrick. Those are encouraging results so far. 22 months is still early, so the annual result publications will be eagerly awaited.

 

[pellicle]

I really hope that synthetic valves will be made with long lifetimes and no need for anticoagulants but personally I would not sign up to be in a trial. Not a big stroke fan.

I know just how your feel ... or indeed reoperations because it didn't last 20 years.

I feel that the psychology at work here is the same as "Financial Planning" failures, most people can't think 20 years from now when they'll need those plans more.

 

[vitdoc]

I am a big fan of the fewer things needed to be done the better. Yet I have this long list of procedures. Each procedure has it's own risk so when one adds procedure to procedure the risk adds up. For example when I had my last big surgery in 2006 which was an aortic aneurysm repair with replacement of my previous St. Jude with a new valve I developed complete heart block requiring a pacemaker. Now this is a well know risk of multiple surgeries so I was not surprised. When the surgery is done a lead is placed coming out of the wound in the chest to provide pacing since in some people the block is temporary and permanent pacing may not be needed. So around the third day after surgery a nurse was cleaning the wound area and managed to pull on the wire coming out of the chest. Suddenly the heart rate went to 0 and the external pacer had to have the voltage increased to maximum. I actually had sparks jumping across my chest and it hurt like hell. They gave me morphine and took me to the cath lab were a temporary pacing wire was placed through the neck. Ultimately several days later I had my first permanent pacer.

So the moral of the story is every procedure has risks, emboli from placing a TAVR valve, infection, bleeding etc.etc. so keeping the procedure count down, to me is a good thing.

 

[pekster11]

It seems as though R&D work to develop an artificial heart valve made from a copolymer is progressing in the UK too :

https://www.bhf.org.uk/informationsupport/heart-matters-magazine/medical/new-artificial-heart-valve
https://www.bhf.org.uk/informationsupport/heart-matters-magazine/research/new-heart-valve

 

[pellicle]

infection

ahmen to that brother