Advancement and the future of Mechanical Valves/ Blood Thinners, ETC

[Projohta]

Hi everyone,

These threads often are about TAVR, tissue valves and the exciting medical advancements coming in the future for those things.

wonder if anyone has any links or info on advancements on mechanical valves and blood thinners? I know On-X was a big big advancement when that came out. Any hope for mech valves that wouldn’t need blood thinners?Or less monitoring needed.

let’s try to keep this post optimistic!

 

[pellicle]

I know On-X was a big big advancement when that came out.

the On-X was no significant advance over the ATS or St Jude, only a marketing one. Mech valves are already very advanced, and AC therapy management are where the real advances are.

What's wrong with a valve that lasts 50 years?

and with respect to "positive" when I was born the outlook was to be dead at 20 with my heart as it was. I'm 56 and expect that my heart will not be the thing which causes my death. How much better can it get?

 

[Warrick]

I assume you know about the Foldax valve?
https://foldax.com/
If this valve pans out it will be the holy grail of valve advancements and the biggest thing since the Starr Edwards valve, the introduction of pyrolitic carbon and POC INR testing combined IMO

 

[nobog]

The Foldax valve would be considered a "hybrid" valve combining the durability of a mechanical valve with the (relatively) soft closing action of a tissue valve - time will tell. Nothing is happening on the mechanical side. Years (decades) ago, SJM once had a marketing line - Not New, Not Improved and indeed it has never been changed since the original design. This is a good thing - copied multiple times but nothing of significance has been made better.

 

[Jmprosser.lab]

I agree with Warrick. The Tria Valve would potentially change EVERYTHING. December 21 we will hear more. And a 5 year follow up in 2024.

I was recently told many people in the cardio industry are very excited about this. Huge potential.

 

[Projohta]

Oh wow...I’m surprised more people don’t discuss the Foldax valve. After some research it seems like they got approved for certain things and huge funding. HOW EXCITING!!!

 

[nobog]

This valve, or similar, has been out and about for over 20 years - there's a reason its not on the market - yet.

 

[LondonAndy]

I see that the clinical trial that has been approved is expected to complete in December 2024, so will watch with interest. Having already got my mechanical valve it won't affect me, but good to see the innovations coming through.

 

[Mark M]

the On-X was no significant advance over the ATS or St Jude, only a marketing one. Mech valves are already very advanced, and AC therapy management are where the real advances are.

What's wrong with a valve that lasts 50 years?

and with respect to "positive" when I was born the outlook was to be dead at 20 with my heart as it was. I'm 56 and expect that my heart will not be the thing which causes my death. How much better can it get?

The On-X has an improved resistance to clotting, and lower INR requirement range 1.5 to 2.0 .. ergo less Warfarin needed. Over a lifetime, that's a significant advantage, and by extension, more fault-tolerant in the event of missed dosing. When I had surgery for prostate, my INR had to be lowered to 1.0 for a very long period due to bleeding. Another advantage to fault tolerance.

 

[nobog]

The On-X has an improved resistance to clotting, and lower INR requirement range 1.5 to 2.0 .. ergo less Warfarin needed. Over a lifetime ....

and.. from the On-X website: It is well documented that the On-X valve does not produce the turbulence and blood damage commonly produced by other mechanical heart valve prosthesis and therefore significantly reduces the potential for life-threatening blood clots.

Well, I don't believe it. "Turbulence" (especially in blood) is tricky business and one cannot simply make that blanket statement. Hint: most people associate the turbulence and the associated blood damage when the leaflets are open but its the damage caused when the leaflets are closed.

An example of turbulent flow (and some tech info)

 

[pellicle]

The On-X has an improved resistance to clotting, and lower INR requirement range 1.5 to 2.0 .. ergo less Warfarin needed.

some points:

• improved compared to what?
• what is the benefit of less warfarin needed? Its not been demonstrated at all that the puny mg per day dose difference to give a lowered INR will have any difference. My view is that the difference is only in the minds of those who equate warfarin to the boogy man.
• you REALLY need to look CAREFULLY at that INR range and remember the caveats: NOT ALL PATIENTS and you MUST be testing weekly and you MUST be on aspirin therapy (and one size does not fit all) This patient had thrombosis while following the INR guidance.
• Since that time the INR guidance for other bileaflet valves (St Jude, ATS / Medtronic ...) has snuggled down to 2~3

I mean if you were looking at the advertising blurb on a car would you swallow that hook line an sinker too? Somehow because people are verging on psychotic about warfarin you just have to mention "lowering" and its like an avalanche of trust for marketing blurb.

despite the drama having an INR of 2.7 will not result in this from a shaving nick

however I can see their marketing taps a highly emotional nerve in the public, so I guess that's "good for them".

Some light reading on the basics of what valves do
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2752693/
and between valves
https://www.jtcvs.org/article/S0022-5223(19)30484-2/fulltext?rss=yes

Despite the design differences that characterize On-X mechanical valves (On-X Life Technologies, Kennesaw, Ga), the hemodynamic and turbulence parameters were not necessarily improved in comparison with a St Jude Medical valve (St Jude Medical, St Paul, Minn). ​

I mean people always say they want to make informed decisions right?

 

[pellicle]

copied multiple times

now that's not fair ... "developed from" ;-)

IP lawyers will get all excited about 0.1 ° opening difference and promoted underside washing ... copy sounds so ... Chinese ;-)

 

[ATHENS1964]

Three months ago I took the valve livanova slimline and it says about low (INR 1.5-2,5), the surgeon and the cardiologist told me to be 2-3 and that the results for low INR are from a small sample of patients and without any other problem.
I have to make sure I am over 2 and I feel calm when I am close to 2.5.
https://www.livanova.com/en-GB/Home...art-Valves/Aortic/Bicarbon-Aortic-Family.aspx

 

[Warrick]

@nobog
I’d be interested if you could elaborate on this-
“This valve, or similar, has been out and about for over 20 years - there's a reason its not on the market - yet.”
Is this a case of ‘we should be driving cars running on water by now’ oil company scenerio ?

 

[pellicle]

I have to make sure I am over 2 and I feel calm when I am close to 2.5.

and I'd also feel no stress for short term dips down to 1.5 too (but indeed steer it back to 2.5)

 

[nobog]

@nobog
I’d be interested if you could elaborate on this-
“This valve, or similar, has been out and about for over 20 years - there's a reason its not on the market - yet.”
Is this a case of ‘we should be driving cars running on water by now’ oil company scenerio ?

I could elaborate but I can't. Lets just say for legal reasons. And no, the industry is not trying to hide something - if someone can make a buck off of these things they would - and get stuff like this to market ASAP.

 

[Projohta]

This valve, or similar, has been out and about for over 20 years - there's a reason its not on the market - yet.

Really? I didn’t see anything about this exact valve being around that long before? Can you send links?

 

[Projohta]

Seems like a lot of people’s impulse is to diminish optimism in this forum sometimes. I think you can be excited for the potential of something and still understand company bias, data, and facts.

 

[pellicle]

Seems like a lot of people’s impulse is to diminish optimism in this forum sometimes.

weird ... I thought my post was optimistic. I got to live longer, I got a future withou surgery and I got for myself good control over my INR (by advances in tech) that enabled me to travel the world.

Perhaps by optimistic you mean your own particular view of what we all should have?

 

[nobog]

Really? I didn’t see anything about this exact valve being around that long before? Can you send links?

You'll have to trust me on that one, I can assure you with 100% certainty that this has been around that long.