First in Man trial of Warfarin free Mechanical Valve

[tommyboy14]

https://www.novostia.com/sites/defa...Novostia - Press Release - September 2023.pdf
According to the release, they will implant the first trileaflet mechanical valve, which should in theory and animal models not require warfarin, in a human in December 2023.

Clearly that first human is very brave. Lets see how this progresses. If they can actually show that their mechanical valve can be warfarin free in Humans, it will truly be a game changer.

 

[pellicle]

Hi

According to the release

and also:

Caution: Novostia technology is an investigational device not yet approved for sale.​

which really backs up your above point :

Clearly that first human is very brave.

agreed

BTW:
https://www.novostia.com/inventors-pioneers-0

 

[pellicle]

oh, and @tommyboy14 I'm kinda proud of this comment

especially back in 2014 I had no idea who he was, it was perhaps the nicest compliment I've ever had on my blog.

 

[tommyboy14]

We will not know if this works for another 3-5 years or so, but if it does, it will obviously be a total game changer.
From a commercial perspective, this product would probably quickly become the dominant product in the market if it does work.

I wish them the very best of luck. This invention would make life for most valve surgery patients so much easier.

 

[tommyboy14]

@pellicle Thanks for sharing this. This comment clearly shows Dr. Lapeyre clearly cares about heart valve patients and I will keep my fingers crossed for his success.

oh, and @tommyboy14 I'm kinda proud of this comment

View attachment 889613

especially back in 2014 I had no idea who he was, it was perhaps the nicest compliment I've ever had on my blog.

 

[Keefo]

Having had an aortic valve replacement, and on warfarin, I find the potential of this new valve enlightening. Bring it on, I hope its a success.

Warfarin is a pain in the arse. Having been on it since 2007, I unfortunately suffered a stroke in 2019, due to INR falling to 1.0. Consider myself extremely lucky as I got away with no real long term side affects (apart from my terrible memory, which might just be old age, at 50 years old ).

To read the following article (discovered after research, about this new value), I was very surprised to read how low the incidence of stroke actually is. And that some people are walking around without using anticoagulants, after a valve replacement!

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477086/

 

[pellicle]

Warfarin is a pain in the arse. Having been on it since 2007

Keefo

reach out and I can give you a method to simplify warfarin and remove the pain from your arse.

also, just wondering how this happens:

I unfortunately suffered a stroke in 2019, due to INR falling to 1.0

without you missing at least 3 days of dose.

Best Wishes from Sunny Queensland

 

[nobog]

Well, their website claims:
"physiologically operates like a native human heart valve"

Yes - all valves "open and close" but that's about as close as physiologically they can claim - a native valve does not look or operate like a 3 leaflet mechanical valve.

Rebranding a 20+ year old design.

 

[pellicle]

Rebranding a 20+ year old design.

I suspect that the key guys have been in that for 20+ years pushing that specific idea (as well as perhaps others).

Personally aside from having three leaflets (instead of two) I'm not sure how it'll be better than two. However the good old tilting disc design had thrombosis issues (perhaps others I'm unaware of too) and the leaflet design improved on that.

Lots of questions in my mind about this valve but that (as a minimum) he (Dr Lapeyre ) was working on it for at least 10 years before making his comment on my blog post we have at least another 5 years before it can even be presented to meet surgical approval in developed countries.

Personally I wouldn't be flying to Bangalore for an OHS with that valve for bragging rights and the chance at avoiding warfarin (which you may end up on anyway {waves in a neighbourly way at AFib} ).

 

[slipkid]

Having had an aortic valve replacement, and on warfarin, I find the potential of this new valve enlightening. Bring it on, I hope its a success.

Warfarin is a pain in the arse. Having been on it since 2007, I unfortunately suffered a stroke in 2019, due to INR falling to 1.0. Consider myself extremely lucky as I got away with no real long term side affects (apart from my terrible memory, which might just be old age, at 50 years old ).

To read the following article (discovered after research, about this new value), I was very surprised to read how low the incidence of stroke actually is. And that some people are walking around without using anticoagulants, after a valve replacement!

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477086/

Interesting. I might have missed it, but I didn't see in the article how much aspirin per day that particular patient was on.

Also, sounds like they are postulating that some sort of genetic mutation (?) might be the reason he (or some others) were found to live 30+ years without using warfain etc:

How these valves were protected for so long remains unknown. Gül et al. (5) first demonstrated a genetic mutation in the coagulation cascade, which can explain long-term survival without anticoagulation

 

[Standardvelocity]

https://hvpl.ok.ubc.ca/research/prosthetic-heart-valves/mechanical-heart-valves/This valve maybe the one that eliminates the need for blood thinners, from what I have read it is still in the testing stage.

 

[pellicle]

Interesting. I might have missed it, but I didn't see in the article how much aspirin per day that particular patient was on.

its a good point which they also mention

The use of acetylsalicylic acid may have contributed to the favorable outcome in our patient.​

I understood that platelets do stick to pyrolytic carbon valve surfaces (meaning they'll be activated). ATS was working on this technology...

Given that what mainly jams up the works is platelets it could well be that the patients were genetically predisposed to a significantly lower in coagulation (there is natural variation) and if they were taking aspirin then that could explain it.

This image below is from an excised valve in the case of obstructive valve thrombosis ...

reference article here.