Mechanical Aorta Valve / Anticoagulants

Todd · Nov 26, 2024

Hello All,

I am up for my 3rd Aorta valve replacement and 4th OHS and will be choosing to go mechanical at 61 because I just cannot go through this any longer with tissue valves, they just do not last.

My question to folks with experience who have the ON-X valve and running a lower INR as the manufacture suggests or is this just marketing, looking for real life experience.

The hospital here in upstate NY uses the St Jude and not the on-x. I don’t have any issues with St Jude and would never know the difference once implanted however, just the thought of the possibility taking less warfarin sounds attractive and plus the Proact-XA trial testing with Elequis, sounds interesting.

My diet is whole food plant based with many leafy greens and vegetables on a daily basis!

Thank you- Todd

3mm · Nov 26, 2024

I have an On-X aortic valve. I keep my INR around 2.5. My cardiologist and I do not see any advantage to routinely being in the 1.5-2.0 range. I treat that range as an extra safety margin when, for example, I had pneumonia, and my INR dropped as I tried to balance changes in body chemistry, antibiotics, food, etc.

The best mechanical valve is the valve your surgeon is most comfortable with because you will spend less time on the bypass machine. There is an inverse relationship between time on bypass and successful surgery outcomes.

Todd said:
My diet is whole food plant based with many leafy greens and vegetables on a daily basis

This is compatible with Warfarin if you are attentive to your INR and your diet's impact on your INR. For example, if you consume 0 leafy greens one week, and then the following week you try to make up for that by eating large spinach salads every day, then you may need to adjust your Warfarin dose to match your increased consumption of vitamin k. I eat 6 servings of cooked vegetables every day and my INR stays very stable.

@pellicle on this forum has lots of information about INR management and a wonderful spreadsheet template that helps your INR management. Search on him to find educational threads.

pellicle · Nov 26, 2024

Good morning Todd and welcome

Todd said:
I am up for my 3rd Aorta valve replacement and 4th OHS and will be choosing to go mechanical at 61 because I just cannot go through this any longer with tissue valves, they just do not last.

As well as anyone can I understand the dilemma. My own history (here) begins young and my last OHS was Nov 2011.

My question to folks with experience who have the ON-X valve and running a lower INR as the manufacture suggests or is this just marketing, looking for real life experience.

Firstly let me say that while "real experiences" can be valuable there is also care needed in comparing that experience to you. I can talk of my own experiences but they may not transfer in any way predicting anything to you.

So let me just say; please read this post in this thread (perhaps these threads
https://www.valvereplacement.org/threads/on-x-low-inr-target.889739/post-936152 and https://www.valvereplacement.org/threads/on-x-and-lower-inr-protocol.863445/page-4#post-932581 )

Todd said:
I am 7 years with my Mosaic in the Aorta position and we are just about out of time... 6 months ago I had an echo and at that time it was 0.6cm… 2 weeks later I went in for a cath and the numbers were 1.2cm !

to me this seems like you may have high Lp(a) levels as this is quite a significant factor in rapid onset of Structural Valve Degredation in bioprostheses.

My advice would be:

get a mechanical; I can not say kind things about the On-X for the simple reason of their misleading marketing makes me wonder about everything else. This is yet another example of their "marketing claims" vs the actual measurements and tests of reality. See this post: https://www.valvereplacement.org/threads/aortic-valve-choices.887840/page-2#post-902334
The lower INR protocol is both pointless and meaningless; to my mind it is aimed at people who are suffering from a hysteria about warfarin and the fire is fuelled by the medical system which has almost entirely ignored the actual research data for over 30 years

I myself have an ATS valve, but I would steer you towards the St Jude.

Best Wishes

SatoriFound · Nov 26, 2024

Todd said:
Hello All,

I am up for my 3rd Aorta valve replacement and 4th OHS and will be choosing to go mechanical at 61 because I just cannot go through this any longer with tissue valves, they just do not last.

My question to folks with experience who have the ON-X valve and running a lower INR as the manufacture suggests or is this just marketing, looking for real life experience.

The hospital here in upstate NY uses the St Jude and not the on-x. I don’t have any issues with St Jude and would never know the difference once implanted however, just the thought of the possibility taking less warfarin sounds attractive and plus the Proact-XA trial testing with Elequis, sounds interesting.

My diet is whole food plant based with many leafy greens and vegetables on a daily basis!

Thank you- Todd

I believe that Pellicus has posted studies that show that the On-X has a higher rate of events when the lower inr level is actually used. My husband got the St. Judes because his surgeon worked with those most often. His surgeon stated the only reason that On-X can market the lower required inr level is because they have paid for the studies. He stated they needed a way to break into the market and differentiate themselves from the St. Judes. I would say On-X and St. Judes are pretty comparable in quality/safety and you can't go wrong with either of them. I would, personally, choose to keep my inr higher than 2 after reading much literature. I am pushing to have my hubby kept at the higher side of the 2-3 range with his St. Judes. His chances of getting having an accident in his life that would make a bleeding event an actual risk are very low. A stroke however would be devastating. We both very much agree that our level of brain function is very important to us in terms of who we are.

pellicle · Nov 26, 2024

SatoriFound said:
I would, personally, choose to keep my inr higher than 2 after reading much literature. I am pushing to have my hubby kept at the higher side of the 2-3 range with his St. Judes.

worth reiterating and underscoring

Beach77 · Nov 26, 2024

I got my On-X 5 days before my 65th birthday in Dec. 2020. My surgeon was part of the study that was researching the lower range but I declined to participate. My cardiologist agreed that was probably a good call. Since then, the study was stopped early. I like my INR at 2.5 but the clinic I go to was keeping me at 2. My range at that time was 2 to 3. Since they wouldn't cooperate with me
, I asked my doctor to move my range to 2.5 to 3. He did, and I'm very happy with that! Warfarin hasn't been the monster I thought it would be. Takes a few weeks to get a handle on it and then it's fine.

Timmay · Nov 27, 2024

I’ll reiterate what others have said and add a tiny thought.

I have an On-X

I manage my own INR (thanks to “you know who” for training me)

I keep my INR a little higher: 2.4-3.1 (ish)

I eat HUGE meatless salads for dinner 2-3 times a week. Other nights you’ll find large helpings of broccoli or mixed veggies or asparagus (with fish, chicken, or turkey).

Lean toward whatever mechanical valve your surgeon is the most comfortable installing. If it doesn’t matter to him then maybe a coin toss

. The science says mortality is the same between the two. That said, if I could do it all over again, I would go with a St. Jude’s and not On-X. My reasoning is two-fold. First, I think the On-X marketing is unethical. Just my opinion. Second, I think my small frame would have appreciated a smaller valve (same diameter opening). The on-X valve … at the same opening plate diameter … is substantially larger than thr St. Jude valve. Probably doesn’t matter. But in my head it does

Todd · Nov 27, 2024

Thanks to all who responded with your thoughts and experience . Just as the surgeon said about the On-X, it is not necessarily true with running a lower INR , much marketing involved.
I just have to get over the thought of blood clots and with my personality, I will want to check my levels too often but I am sure most went though this initially .

Just curious, how often do you check your levels and how long before bad things start to happen if levels get too low and unchecked for maybe a couple of weeks>
I do not see myself doing that because I am extremely healthy and responsible but just a thought running through my head trying to accept this and also going through another surgery.
My anatomy is small and tight and lots of scar tissue I'm sure, which was the case in 2012 when removing my 2003 tissue valve , it was a real mess and very long surgery .
Thanks again-T

vitdoc · Nov 27, 2024

In 2006 I was faced with a third open heart due to an aortic aneurysm. I had initially a tissue valve and then a St. Jude in the aortic position. I remember distinctly the surgeon say “ you don’t want anyone in your chest again”. So another St Jude was placed pre ON-X.
Then ON-X came out with their low INR study which to me seemed somewhat bogus. But they have used it to gain market share. So there is some skepticism about a company that acts this way.
So if your surgeon wants to use the St. Jude I would not hesitate since it has the longer track record and as mentioned the low INR protocol to many of us is risky when it comes to avoiding strokes.
As been said here before blood cells are easier to replace than brain cells.
Good luck.

pellicle · Nov 27, 2024

Good morning

Todd said:
I just have to get over the thought of blood clots

basically if you keep your INR over 2 the chances of blood clots are something approaching zero

I share this graph and table a lot

URL for study
http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/415179

so, with an incidence of about 2 events per 100 patient years its "unlikely"

Just curious, how often do you check your levels

weekly but occasionally more often ... for instance
https://cjeastwd.blogspot.com/2022/05/rapid-dust-off-inr-management.html

and how long before bad things start to happen if levels get too low and unchecked for maybe a couple of weeks

there is some basis for concern but really once you're on a dose and you don't make too many changes in lifestyle (as may happen on a holiday) its reasonable to expect that you wouldn't dip too low or too high for lengthy periods.

IIRC I've been about a month (once) without testing at all.

I do not see myself doing that because I am ... and responsible

good attributes to have, especially if you're also rigorous and dilligent.

My anatomy is small and tight and lots of scar tissue I'm sure, which was the case in 2012 when removing my 2003 tissue valve , it was a real mess and very long surgery .

that's all factors that will concern the surgeon

Best Wishes

RobThatsMe · Nov 28, 2024

I have had an On-X mech valve since 2010. Prior to that I had a St Jude's Mechanical valve for 10 years.
The St Jude's failed when pannus tissue grew and locked the valve from working.
I choose the On-X because it is built to deflect and pannus tissue away from the valve. I did not choos it just because of the lower approved INR range. In fact, I continues to use the old range given to me when I had the St Judes valve.
I have had my On-x now for almost 15 yrs and it is functioning well. I see my surgeon at Cleveland Clinic annually to check on the valve and other work he has done on my aortic dissection, Everything is stable.
Side note: When I selected the On-X the lower range values were not even approved, now that it is, it just gives me a safety buffer for my own peace of mind. Flirting with the lower limits can be dangerous to your health iMO.

Timmay · Nov 28, 2024

Good point about the Pannus protection. I had forgotten about that. Hmmmmm.

https://academic.oup.com/icvts/article/31/3/415/5873328?login=false

3mm · Nov 28, 2024

RobThatsMe said:
I choose the On-X because it is built to deflect and pannus tissue away from the valve

This is a very important point for all of us to understand. These "simple" valves are actually fairly complicated, and they are installed in a VERY complicated environment. Which valve is "best" for a particular case depends on the patient, their heart's structure, the surgeon's experience with the particular valve's features, the installation procedure for that particular valve, etc.

I do expect a surgeon to explain their choice to a patient if the patient asks. Then the patient needs to decide if that explanation makes sense.

dornole · Nov 28, 2024

Just had On-X put in and my surgeon also said their practice generally prefers them for pannus prevention, and said no way to lower INR range. Mine is mitral position anyway so 2.5 - 3.5

Habana58 · Nov 28, 2024

i was given 2 choices by my surgeon, tissue or OnX, no mech, just Onx; as it is the only mech valve that opens 90 degrees and better for panus protection, he said nothing about inr range. My surgeon says...., nothing wrong with other mech valves, OnX is just a newer valve with some design improvements; i did the inr 1.5 -2 + aspirin for 18 months, nothing went wrong, but i dropped it for the standard 2 - 3 , and i dont take aspirin dasily, just 1 a week just in case; tissue valve would've been a great solution for me if i had been 75+; but at 62; i was not happy with the certainty of having to go back to a hospital for surgery, but thats just me, some people have no problems with hospitals, and that is fine too.

Todd · Dec 5, 2024

Thanks everyone for the comments and thoughts. After much reading, I do agree that the On-x lower INR claim is something that shouldn't be a deciding factor in mechanical valve choice for me, I am over that

However, the pannus growth thing is a thought with the design of the On-x , does this really help prevent the pannus growth or keep it out of the way of the leaflets ?
I must meet the surgeon for a 3rd time, and I need to ask however, he does not use the On-x , prefers the St Jude so I will need to go elsewhere for that valve if I want the On-x.
Am I over thinking this, are there any particular factors which can lead to pannus growth , I must ask these questions to both surgeon and cardiologist.

I do have a meeting with a surgeon at CC soon.

Thanks

dornole · Dec 5, 2024

I think I’d choose the surgeon over the valve brand, I think both are good. And I think a lot of them just like what they are used to. Which I would too. Craftspeople need their tools.

pellicle · Dec 5, 2024

Todd said:
However, the pannus growth thing is a thought with the design of the On-x , does this really help prevent the pannus growth or keep it out of the way of the leaflets ?

Can't find a single study that's suggested it does. IIRC the risk factors in order of significance are

Female
Smaller diameter annulus (under 20)
Poor anticoagulation control

A study https://pmc.ncbi.nlm.nih.gov/articles/PMC3493295/

The exact etiology of pannus formation is not known. Multifactors are involved in its formation. Basically, pannus represent a bioreaction to prosthetic valves associated with coexisting factors such as surgical technique, thrombus organization from inadequate anticoagulation, infection and wall shear stress ...

Recent study by Teshima and colleagues [4] found that patients with prosthetic valve dysfunction secondary to pannus are associated with significant increase in the level of transforming growth factor beta(TGF-B1). This cytokine is essential for regulation of cell growth, differentiation, and matrix production. Thus, the increase production of these cytokines is implicated in the formation of pannus by inducing exaggerated healing, fibrosis and scar tissue formation.

Prosthetic valve dysfunction at aortic position is commonly caused by pannus formation which is an uncommon, but serious complication. Its incidence varies between 1.8% in tilting disc to 0.73% in bileaflet valves [2]. All types of available prosthetic valves can be affected by pannus formation.

In my view the On-X is a robust mechanical valve that appears to have no other advantage than to pander to the fears of patients. I've found nothing ever to suggest it fails more or less nor performs more or less in terms of clinical outcomes ... it just talks itself up in the mind of patients. I can however find evidence where the marketing claims are not bourn out. This last fact makes me glad my surgeon avoided it.

Best Wishes

pellicle · Dec 5, 2024

So, now, coffee in hand :

https://pmc.ncbi.nlm.nih.gov/articles/PMC4777461/

Pannus is a non-immune inflammatory reaction of the body to the valve prosthesis, a proliferation of fibroelastic tissue and collagen, with a starting point in the suture area and subacute or chronic centripetal evolution [8]. It usually proliferates on the ventricular side of aortic prostheses and is associated with certain risk factors such as operative technique, characteristics of the prosthesis, size of valves in patients with a small valve ring, young age, female sex, pregnancy, low cardiac output, turbulent flow, infection, inadequate anticoagulation [1,8,9]. The differential diagnosis of pannus-related prosthetic valve dysfunction with other causes of prosthetic valve dysfunction, mainly thrombotic involvement, is frequently difficult but essential, because therapeutic approaches are different [10,11,12].

Todd · Dec 5, 2024

Thank you Pellicle for the information . I am feeling better about all of this and a somewhat better understanding of the mechanical valve and have additional questions to ask the cardiologist and surgeon.
I am scheduled for surgery here in NY for the 3rd week of January, here I go again !

Mechanical Aorta Valve / Anticoagulants

Help Support Valve Replacement Forums:

Member

VR.org Supporter

Professional Dingbat, Guru and Merkintologist

VR.org Supporter

Professional Dingbat, Guru and Merkintologist

VR.org Supporter

Grandfather Clock

Member

VR.org Supporter

Professional Dingbat, Guru and Merkintologist

Well-known member

Grandfather Clock

VR.org Supporter

VR.org Supporter

VR.org Supporter

Member

VR.org Supporter

Professional Dingbat, Guru and Merkintologist

Professional Dingbat, Guru and Merkintologist

Member

Join the conversation!

Join today and get all the highlights of this community direct to your inbox. It's FREE!