Foldax Continues

[Aqua_Grim7]

here's the thing I don't understand: why is there a focus on the new and unproven (called bleeding edge for a reason) when there are already good alternatives around with sufficient time in the market to have more than 20 years of accumulated evidence on how they last.

People seem to get excited that their valve lasted a year ... what the hell was your expectation then? If I knew I'd only get a year out of a valve I'd be despondent. Each time I've had OHS I've assumed that I'd get 20 (although when I was a ten year old I didn't think like that, but by the time I was a teenager going to yearly follow ups I sure did and was always wondering how long will it last. At OHS #2 I certainly wanted to get durability.

What makes this viewpoint even harder for me to grasp is the highly emotional posts about "how long will I live" or "has my absolute lifespan expectation been dropped by 2 years" (with expectations of 80 years being reasonable).

I just can't fit concept A (yippee ... I got a year) and concept B (I want an untested unproven technology because it looks cool) together.

I mean if you were build a house and were told by the builder it might fall down at 12 or 15 years but would be guaranteed to 10 you'd walk away from that deal immediately.

Yet the losses of that are not "everything" ... because if you die you lose not just your house, not just your job, you lose everything.



If the focus of a person is longevity then avoiding reoperation would be significant factor.
If avoiding ACT (<organHorrorChord>blood thinners</organHorrorChord>) is the significant factor then Homograft is an option which will buy someone under 50 a statistically likely 15 years ...
https://pubmed.ncbi.nlm.nih.gov/11380096/

For all cryopreserved valves, at 15 years, the freedom was​

* 47% (0-20-year-old patients at operation), ​

* 85% (21-40 years), ​

* 81% (41-60 years) and ​

* 94% (>60 years). ​

Root replacement versus subcoronary implantation reduced the technical causes for reoperation and re-replacement (p = 0.0098).​

But to bet on an unknown dark horse ... are you feeling lucky?

I was just curious is all.

I think a lot of people (myself included) would prefer to have a valve without the need for lifelong blood thinners.

Whilst they do indeed offer lifelong durability, they certainly carry some drawbacks too, which is why I imagine a lot of people who know they’ll need to have a second valve replacement will be keeping an eye on Foldax’s progress in the coming years.

 

[Dunwanted]

Hello, in case anyone is interested in the link below this person claims to be in the foldax trial and they did a 595 days update after their AVR with a tria Foldax valve.

 

[nobog]

^^^^ I had a 27 mm valve installed, but as it happens it needed to be a tiny bit smaller. The end result is that I’ll likely be on Warfarin indefinitely.

That makes no sense whatsoever.

 

[Aqua_Grim7]

^^^^ I had a 27 mm valve installed, but as it happens it needed to be a tiny bit smaller. The end result is that I’ll likely be on Warfarin indefinitely.

That makes no sense whatsoever.

This ^ I thought the whole point of foldax was that warfarin wasn’t needed?

 

[Paleowoman]

^^^^ I had a 27 mm valve installed, but as it happens it needed to be a tiny bit smaller. The end result is that I’ll likely be on Warfarin indefinitely.

That makes no sense whatsoever.

I took this to mean that it was because the 27mm valve is a bit too big that the end result is that the person thinks they'll likely need to be on Warfarin indefinitely.

I know from having a valve that is too small for my body size that when a valve is inserted the annulus is measured during surgery and the replacement valve has to be the exact size for the annulus - you can't have a valve inserted which is too small nor too big for the annulus. In my case the size of my valve is right for my annulus but that means it's too small for my body size. With the recipient of that Foldax valve he/she suggests they got a valve which was too big for his/her annulus which, I suppose, must cause a problem necessitating warfarin ? We can't ask them though can we.

 

[nobog]

I took this to mean that it was because the 27mm valve is a bit too big that the end result is that the person thinks they'll likely need to be on Warfarin indefinitely.

I know from having a valve that is too small for my body size that when a valve is inserted the annulus is measured during surgery and the replacement valve has to be the exact size for the annulus - you can't have a valve inserted which is too small nor too big for the annulus. In my case the size of my valve is right for my annulus but that means it's too small for my body size. With the recipient of that Foldax valve he/she suggests they got a valve which was too big for his/her annulus which, I suppose, must cause a problem necessitating warfarin ? We can't ask them though can we.

So lets say he should have got a 25mm (instead of a 27mm) - there is nothing involving fluid dynamics that the net result would be the difference between warfarin or no warfarin. Something doesn't add up.

 

[Paleowoman]

So lets say he should have got a 25mm (instead of a 27mm) - there is nothing involving fluid dynamics that the net result would be the difference between warfarin or no warfarin. Something doesn't add up.

I would have thought maybe he meant a tiny bit smaller than 27mm, say his annulus measured 26mm - there isn't a 26mm valve is there. If, for the sake of argument his annulus was 26mm then having a 27mm valve would mean there was an element of obstruction...though I don't know...I mean how do they insert a valve that is a bit too big ? Distort it ? Would that necessitate Warfarin ? I don't know but it's just his inference....pity we can't ask.

 

[Lucker]

It was me who asked him for an update
Yeah, this issue with the valve sizing is strange. AFAIK, the surgeons always try to install the largest possible valve.
But most importantly, his valve keeps going strong.

 

[Paleowoman]

Yeah, this issue with the valve sizing is strange. AFAIK, the surgeons always try to install the largest possible valve.

A cardiac surgeon who I was referred to (not the one who did my surgery) explained to me that they can only put in the size valve of the size of the annulus, and that there is no 'give' in the annulus as it is "very fibrous". I believe the way they can give a patient a bigger valve is by placing the valve in the supra-annular position.

 

[Lucker]

A cardiac surgeon who I was referred to (not the one who did my surgery) explained to me that they can only put in the size valve of the size of the annulus, and that there is no 'give' in the annulus as it is "very fibrous". I believe the way they can give a patient a bigger valve is by placing the valve in the supra-annular position.

And still there are techniques in the annulus enlargment and reduction.

 

[Springdogg]

Hello, in case anyone is interested in the link below this person claims to be in the foldax trial and they did a 595 days update after their AVR with a tria Foldax valve.

Hello all new member here but AVR veteran. I found this post and other from rblue and they seem to have a lot of complications going on. Afib, pacemaker and AVR. Hopefully things get resolved but I am not jumping to the conclusion that the foldax valve is the cause.

I have only recently become aware of this valve and am now monitoring the trials closely. I am 2x bio-prosthetic valve recipient. First at 26 years old in 2009 and second at 35 in 2016. I play ice hockey 2x a week and overall am very active. A lifelong valve that does not require anticoagulation to me is the golden ticket. Recovering from both open hearts was pretty tolerable for me at a young age. Timeline has it doubtful for me to get it as an option but glad for anyone else that gets that news at 26 out of no where.

 

[Humboldtgrrl]

Hello all new member here but AVR veteran. I found this post and other from rblue and they seem to have a lot of complications going on. Afib, pacemaker and AVR. Hopefully things get resolved but I am not jumping to the conclusion that the foldax valve is the cause.

I have only recently become aware of this valve and am now monitoring the trials closely. I am 2x bio-prosthetic valve recipient. First at 26 years old in 2009 and second at 35 in 2016. I play ice hockey 2x a week and overall am very active. A lifelong valve that does not require anticoagulation to me is the golden ticket. Recovering from both open hearts was pretty tolerable for me at a young age. Timeline has it doubtful for me to get it as an option but glad for anyone else that gets that news at 26 out of no where.

The first Foldax recipient was a middle aged male Oregonian runner, who did a slow 10K a few months post surgery. Would guess rblue may be somewhere around recipient #20? Bless him for staying resilient with the complications. The Foldax Clinicals surgeon that my sister consulted with (she opted for a bio valve) related after his first Foldax implant surgery that her heart would have been too small for Foldax. Wonder if the "fit" is especially critical with Foldax? The summary report on the Foldax clinicals should be interesting. Can't recall what length trials were approved.

 

[Humboldtgrrl]

So lets say he should have got a 25mm (instead of a 27mm) - there is nothing involving fluid dynamics that the net result would be the difference between warfarin or no warfarin. Something doesn't add up.

might the "misfit" or unusual placement cause turbulence & thus be a clot risk?

 

[pellicle]

Timeline has it doubtful for me to get it as an option but glad for anyone else that gets that news at 26 out of no where

its a laudable goal ... but we're a long way from knowing it lasts. We know the durability of the mechanical valve, very well actually.

I'll trade taking a pill and paying a little attention to my dose in exchange for not having multiple (more) surgeries. The reality is the only people that are worried about managing warfarin are those who don't.

Either way, welcome to the forum
Best Wishes

 

[Teapotimus]

Timeline has it doubtful for me to get it as an option but glad for anyone else

I've been watching the Foldax news for a while too. It would certainly be nice for people who are contraindicated to Warfarin to have a long lasting valve choice that isn't the Ross procedure.

 

[nobog]

The discussion about valve size is mostly academic. It doesn't matter if we are talking tissue or mechanical the same principle applies. For the most part putting in a prosthetic valve is some sort of a restriction to flow. Some valves are less restrictive that others - you cannot tell by looking at them which is "better". It is better to have less restriction than more, that means a lower pressure drop as well as a larger EOA (Effective Orifice Area).

Here's an example of a "popular" 25mm tissue valve - one can have a pressure drop (restriction to flow) of 15 mmHg and one can have a pressure drop of 30 mmHg (5 lpm @ 70 bpm) - there is that much difference valve-to-valve. So for you statistician's out there, that means there is a HUGE std. deviation. Of course mechanical valves have none of this. Does any of this affect whether you need warfarin or not? I don't think so.

And yes, your surgeon will always try to cram the largest valve he can into orifice X, sometimes too large as to interfere with leaflet function.

 

[Timmay]

Hello all new member here but AVR veteran. I found this post and other from rblue and they seem to have a lot of complications going on. Afib, pacemaker and AVR. Hopefully things get resolved but I am not jumping to the conclusion that the foldax valve is the cause.

I have only recently become aware of this valve and am now monitoring the trials closely. I am 2x bio-prosthetic valve recipient. First at 26 years old in 2009 and second at 35 in 2016. I play ice hockey 2x a week and overall am very active. A lifelong valve that does not require anticoagulation to me is the golden ticket. Recovering from both open hearts was pretty tolerable for me at a young age. Timeline has it doubtful for me to get it as an option but glad for anyone else that gets that news at 26 out of no where.

If you’re getting a new bioprosthetic valve every 10 years then you’re gonna need to have 4 more OHSs in your lifetime. I don’t think that’s a reasonable goal that meshes well with staying alive.

I’d recommend changing your path before it’s too late. Just my opinion so take it for what it’s worth … maybe nothing.

 

[Lucker]

The discussion about valve size is mostly academic. It doesn't matter if we are talking tissue or mechanical the same principle applies. For the most part putting in a prosthetic valve is some sort of a restriction to flow. Some valves are less restrictive that others - you cannot tell by looking at them which is "better". It is better to have less restriction than more, that means a lower pressure drop as well as a larger EOA (Effective Orifice Area).

Here's an example of a "popular" 25mm tissue valve - one can have a pressure drop (restriction to flow) of 15 mmHg and one can have a pressure drop of 30 mmHg (5 lpm @ 70 bpm) - there is that much difference valve-to-valve. So for you statistician's out there, that means there is a HUGE std. deviation. Of course mechanical valves have none of this. Does any of this affect whether you need warfarin or not? I don't think so.

And yes, your surgeon will always try to cram the largest valve he can into orifice X, sometimes too large as to interfere with leaflet function.

How realistic is the scenario when patient's annulus is too large for most valves? Mine for example is 29 mm. I heard sometimes the only option is using the mitral valve in aortic position.

 

[Chuck C]

How realistic is the scenario when patient's annulus is too large for most valves? Mine for example is 29 mm. I heard sometimes the only option is using the mitral valve in aortic position.

I've never heard of such a thing. Is this someone in the medical field telling you this? Hopefully someone with more specific knowledge of this can chime in, but here are my thoughts.
-It is not uncommon for patients to have annulus at 29mm and larger. It is the high end of the range, but not uncommon.
-They make prosthetic valves 29mm diameter. So, having a 29mm annulus should not be a problem.
-I've never heard of replacing an aortic valve with a patient's mitral valve. In the Ross Procedure, the pulmonary valve is transplanted to the aortic position, but this valve is a tricuspid valve with similar function as the aortic. The mitral is significantly different than the aortic valve. It is bicuspid and has strings attached to it, which play a vital role in its function. Moving this valve would also need to involve removing and re-attaching the strings. That would seem to really complicate things.
-If you did that, now you need to get a prosthetic mitral valve as well.

Anyway, if this is a medical person telling you this, get another opinion. I don't know if that is possible in Russia, but perhaps at least get a zoom consult from someone in another clinic.
I really can't see how having a 29mm annulus is a problem, but perhaps someone who knows more than I do can give comment.

 

[pellicle]

heard sometimes the only option is using the mitral valve in aortic position.

Wouldn't that then need to be fitted backward facing?
Just wondering