On-X and Lower INR Protocol

[Buck83]

Of course, the "ticking never stops" part is a GOOD thing!

Amen!

 

[Chuck C]

Chuck - What are the reasons for these people "... with aortic mechanical valves, and targeting normal INR range ..." to not take aspirin? Thanks!

I have an aortic On-X valve, my cardiologist and I have agreed to target the 2.0-3.0 range, and she wants me to take aspirin as long as I tolerate the aspirin well. Since the aspirin operates via a different mechanism from the Warfarin, she considers aspirin to be additional protection against strokes. She has read the various studies (she is a professor of cardiology), and she has more faith in the studies which supported use of low dose aspirin.

Hi 3mm.

First, I also take low dose aspirin of 81mg/day. I have a St Jude mechanical valve in the aortic position and my INR target is 2.5. Some would say my target is the range of 2.0 to 3.0, but when this is your range you really are targeting the center of that range.

I expect that my cardiologist is in the same camp as your cardiologist, believing that aspirin is an added safe guard against clotting. There has been some recent push back against aspirin in the past few years and this may stem from the 2018 study which found no benefit for aspirin in older people. I've linked the study below. However, very important to note that this study was not targeting those of us with mechanical valves, so the "no benefit" aspect really does not apply to us.

Also, there was a RCT published in 2011 which found that adding low dose aspirin to warfarin therapy did have a benefit and resulted in lower rates of thromboembolish for those with mechanical valves. See link below.


RCT showing benefit of combined warfarin and low dose aspirin.

"Conclusions: Following mechanical valve replacement, combined low dose aspirin and warfarin therapy was associated with a greater reduction in thromboembolism events than warfarin therapy alone. This combined treatment was not associated with an increase in the rate of major bleeding or mortality."


https://pubmed.ncbi.nlm.nih.gov/21813162/


Aspirin study which found no benefit for older patients- but this was not targeting those with mechanical heart valves.

https://www.nih.gov/news-events/new...have-no-effect-healthy-life-span-older-people

If a patient has bleeding issues, for example chronic ulcers, then in practicing individualized medicine for their patient, I can understand why some cardiologists might hold off on the aspirin, given the risk vs reward for that particular patient.

 

[Protimenow]

I wouldn't want an INR of 2.0, because INR measurement is considered accurate if it's within 20% of the real value. Thus, an INR of 2.0 could be in a range of 1.6 - 2.8. I wouldn't be comfortable with an INR that low. I have a St. Jude, Aortic position, and try to aim at 3.0 - I usually keep it slightly above 3.

As for aspirin, I take enteric coated 81 mg aspirin daily. Yes, it probably helps delay clotting slightly - but, according to a very interesting presentation that Pellicle posted a few months ago, may also have some anti-cancer benefits.

Yes, I test weekly. I've been self testing for 15 years.

 

[pellicle]

a patient has bleeding issues, for example chronic ulcers, then

a first step should be to test for heliobacter
https://www.healthdirect.gov.au/helicobacter-pylori

If you are diagnosed with H. pylori after having a test, you will be offered eradication therapy – a combination of medicines designed to kill the H. pylori bacteria. Eradication therapy is a mix of antibiotics and acid-suppressing medicine, known as triple therapy​

 

[Habana58]

Have an OnX since 2015, started with the 1.5 - 2.0 + asa which works just fine, except that you get worried about the 1.5 part, I did that program for 1.5 years all good and fine , all doctors happy, so yes, it is not BS, it works contrary to some people's opinion, and that is fine; not interested in convincing anybody of anything, after all we are not communists and dont have to do what the Castros say. Then, i moved my RANGE to 2 - 3 and kept on taking the aspiring, , 8 years later started having bleeding events, talked to the 2 sister doctors of mine and they told me to STOP the asa idea, is not necessary; IF you check your INR weekly, you can run on 1.8 -2.8 INR as per some studies, read attached doc if interested; no need for Aspirin; That said,
some times for x reason i take a test and my INR for some reason instead of been 2.5 is 2.0, THAT day, and because of the Onx, i take 1 81mg asa; just "my thing" ; So, anybody with a XXI mech valve can do 2 -3 no asa needed.
Just a thought, my opinion, no need to say things to others that think otherwise, the one thing you can not do in this life, is change people's mind, you can give them a different perspective and that is all you can do.

 

[pellicle]

ll doctors happy, so yes, it is not BS

perhaps this needs to be clarified.

I don't think anyone is saying its BS (I'm certainly not), only that there is no evidence that alone allows you to be "event free" in the long term.

The question then becomes how you feel about losing part of your cognitive or motor-nurone capacity from the data driven predicable stroke by targeting INR = 2 (as some people here have said they do).

I'm 12 years in, Superman is more like 32 years on warfarin, and Dick is over 58 years. We all get this by being conservative (and I don't mean republican) in our INR choices.

The arguments presented against the lower INR protocol are sound and clear as are the criticisms of the study.

Remember: this is not my opinion, I am but a merkintioligist and a dingbat, what I am communicating to you (and to any reader) are the written peer reviewed expressed opinions of medical specialists who are not under the pay of the purveyors of On-X.

So I am not disagreeing with you, I am just bringing to attention those medically educated specialist opinions.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6472691/

The Authors:
Ismail Bouhout

Ismail Bouhout​

Montreal Heart Institute​

Other affiliations: Université de Montréal​

Bio: Ismail Bouhout is an academic researcher from Montreal Heart Institute. The author has contributed to research in topics: Aortic valve replacement & Ross procedure. The author has an hindex of 16, co-authored 61 publications receiving 828 citations. Previous affiliations of Ismail Bouhout include Université de Montréal.​

and Ismail El-Hamamsy

Boston, MA (February 22, 2024) Ismail El-Hamamsy, MD, PhD, Director of Aortic Surgery for the Mount Sinai Health System and the Mount Sinai Randall B. Griepp, MD Professor in Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai, was named as the new President of the Heart Valve Society (HVS) at the 2024 HVS Annual Meeting on Wednesday, February 21, in Boston. He is the first Mount Sinai surgeon to hold this prestigious position, and becomes the 11th President of HVS.​

These are the opinions I'm repeating.

Instead I always direct people to follow well established guidelines as well as follow the directions of their own medical team.

you say:

no need to say things to others that think otherwise

actually a discussion board is intended to say things to others who think otherwise. The very basis of learning is to listen to arguments and make a decision about "do you change your mind or keep your views intact". I've had friends express wishes to do unwise things, your counsel would be to shut my mouth and let them come to harm.


Lastly I would ask on a "risk taken for return obtained" basis what you gain by targeting an INR of 2 instead of 2.5


Best Wishes

 

[pellicle]

, , 8 years later started having bleeding events

have you been checked for Heliobacter pylori?

How is Helicobacter pylori treated?​

If you are diagnosed with H.pylori after having a test, you will be offered eradication therapy – a combination of medicines designed to kill the H. pylori bacteria. Eradication therapy is a mix of antibiotics and acid-suppressing medicine, known as triple therapy. The antibiotics kill the H. pylori bacteria, and the acid-suppressing medicine reduces stomach acid, so any ulcers can heal.

After you have taken the eradication therapy for the prescribed time (usually a week), you will likely be offered a breath test to make sure the treatment has worked.

If you were diagnosed with a stomach ulcer caused by H. pylori, then eradicating H. pylori will allow your existing ulcers to heal and help prevent more ulcers from developing.

 

[Chuck C]

no need to say things to others that think otherwise, the one thing you can not do in this life, is change people's mind, you can give them a different perspective and that is all you can do.

It sounds like you are trying to discourage comments on your post. Not sure, but if you put ideas out there on this forum you can expect comments. I don't agree with your statement that the one thing in life is that you can't change people's minds. Sure, some put up walls that prevent their minds from being changed, but if we are truly attempting to be critical thinkers, then we should all be open to having our minds changed with new information and/or convincing aguments. It is the truly dim whom are not open to having their minds changed.

1.5 - 2.0 + asa which works just fine, except that you get worried about the 1.5 part, I did that program for 1.5 years all good and fine , all doctors happy, so yes, it is not BS

It works fine and is not BS, until it does not work fine. This is clearly survivor bias in my view. For those who went with the 1.5-2.0 protocal and had major events, I believe that they might disagree with you here.

Then, i moved my RANGE to 2 - 3

I'm glad to hear this. In my view this is a much more reasonable range.

Also, it sounds like you self test weekly, if I am understanding your post, and this reduces the overall risk of events, with or without aspirin. Weekly self testing most definitely does change things and could reduce the need for taking low dose aspirin. But, personally, even with weekly self testing, I would not forgo the aspirin if I was subscribing to the 1.5-2.0 INR range. That would be almost suicide in my view.

 

[tom in MO]

Chuck C, St. Jude reduced their suggested INR range for their mechanical valve in the aortic position from 2-3 to 2-2.5 about 10 years ago. My cardio dropped me from 2-3 to 2-2.5 with aspirin and it's worked fine for at least 10 years.

The utility of a mechanical valve accepting a lower INR also is expressed when you get sick and your INR tanks and also when you want a spinal injection, surgery, etc. and you need to lower your INR to 1 for a short time. You don't need to bridge.

Pellicle/Chuck - When it comes to Habana58's request to not argue with him, you should respect that. He's not looking for your "expertise". He's offering a data point...i.e. his experience, which is really not up for argument since it's his life not yours.

 

[Chuck C]

The question then becomes how you feel about losing part of your cognitive or motor-nurone capacity from the data driven predicable stroke by targeting INR = 2 (as some people here have said they do).

And unfortunately, many are targeting lower than 2.0. The range of 1.5 to 2.0 suggests a target of 1.75.

 

[Chuck C]

Chuck C, St. Jude reduced their suggested INR range for their mechanical valve in the aortic position from 2-3 to 2-2.5 about 10 years ago.

Tom,
You've said this before. Do you have any support for this? I've found nothing in the guidelines and nothing from Abbott labs about this "change". My surgery was just 3 years ago and I was given a target of 2.0 to 3.0. I am aware that your cardiologist had you switch from 2.0 to 3.0 to 2.0 to 2.5, but this does not mean the guidelines changed. Perhaps this was specific for you, as you have had issues with bleeding, if I recall correctly.

To be clear, I'm not trying to argue about this, but would like to see the support that the guidelines have changed, if they truly changed. Can you provide this? A letter from Abbott perhaps?

Also, I am personally very comfortable keeping my INR in the range of 2.0 to 2.5. There was a study published a few years back suggesting that this range is safe for St Jude, but, to my knowledge, this did not lead to a change in the guidelines.

Edit:
I just looked into the guidelines and I believe that your statement about the guidelines being lowered for the St Jude valve is incorrect.

You indicated that for St Jude the guidelines changed about 10 years ago. from the range of 2.0 - 3.0 to the range of 2.0 - 2.5. To my knowledge, 2020 was the last time that the guidelines addressed INR for mechanical valves. As of 2020, the target had not been lowered to the range of 2.0-2.5, as you suggest happened 10 years ago. Please see the link to the 2020 ACC/AHA Heart Valve Guidelines below:

"For mechanical bileaflet or current-generation single-tilting disk AVR with no risk factors: INR of 2.5."

"For mechanical On-X AVR and no thromboembolic risk factors: A lower INR of 1.5-2.0, starting 3 months after surgery with addition of aspirin (ASA) 75-100 mg daily (Class 2b)."

https://www.acc.org/Latest-in-Cardi...0/12/16/22/01/2020-ACC-AHA-VHD-GL-Pt-3-GL-VHD

 

[Chuck C]

Delete

 

[Chuck C]

Pellicle/Chuck - When it comes to Habana58's request to not argue with him, you should respect that.

That is not actually what he said.

Here was what he said:

"Just a thought, my opinion, no need to say things to others that think otherwise,"

But, this is a discussion board. You can't put out your "opinions" and not expect to have them challenged if they don't line up with science or other's experiences. He said that keeping an INR range of 1.5 to 2.0 "works just fine". This is an opinion and many disaggree with this, including many medical professionals, such as my surgeon and his colleagues. This is a discussion board and Habana58 has every right to express his opinion that 1.5 to 2.0 INR is "just fine", but it is not reasonable to expect that the discussion about INR ends there and that no one should comment on this view.

He's offering a data point...i.e. his experience, which is really not up for argument since it's his life not yours.

Of course it's his life. I don't see anyone telling him what to do, so that's somewhat of a strawman argument.

The fact is that people other than Habana58 and you read these boards and the idea that somehow people would just share their experiences and opinions, based on their personal experience, and that the matter is then closed for discussion is pretty unenlightened.

Also, given the high percentage of your posts that seem to be argumentative, pointing out when you disagree with someone, I find it ironic that you would lecture anyone about "not arguing."

 

[Protimenow]

I've seen it said that once people develop an opinion, it can't be changed.

Not true.

I was taking 81 mg aspirin for years, then stopped because I saw some material suggesting that it wasn't necessary. I saw a presentation that Pellicle posted, suggesting that aspirin has some effects on reducing cancer risk. I'm back on 81 mg aspirin - it doesn't seem to make much difference as far as clotting, from what I can tell (I had an ablation on my heart on April 2 - I dropped my INR to 1.5, but the effect of aspirin on platelets lasts longer. My doctor had no problems with it).

I've been on Warfarin since 1991. I have a St. Jude valve, test weekly, and shoot for around 2.5-3.5.

If I need emergency surgery, the surgeons should be able to handle the extra bleeding. If I need it the next day, a good shot of Vitamin K will handle the bleeding. It's manageable.

As far as 1.5 - 2.0 versus, say, 2.5 - 3.5 goes - the difference is probably almost imperceptible. You'll probably not even notice the change. Sure, small cuts that clot in 5 seconds may take 15 or so to clot - but pressing on them (which most of us instinctively do) will probably not show any difference in clotting time.

BUT - if you insist on 1.5 + aspirin, your risk of stroke increases. Going from 1.5 to 2.5 is NOT that big a deal -- the On-X was marketed as requiring a lower INR - but this is marketing -- the difference between being at 1.5 versus 2.5 is negligible - the RISK IS.

 

[pellicle]

I've seen it said that once people develop an opinion, it can't be changed.

Not true.

Depends on the person.

 

[pellicle]

The utility of a mechanical valve accepting a lower INR also is expressed when you get sick and your INR tanks and also when you want a spinal injection, surgery, etc. and you need to lower your INR to 1 for a short time. You don't need to bridge.

can you show me where On-X (or any modern bileaflet mechanical valve maker) says you don't need to bridge?

@nobog are you aware of any such things? (perhaps you aren't)

 

[Protimenow]

Oddly enough, I find myself agreeing with Tom.
In a paper from Duke Clinic (and I'm still trying to find it), the conclusion is that the risk of clots forming on valves begins at about day 10 without anticoagulation. Not being anticoagulated for a few days poses a minimal risk. OTOH - certain procedures may increase the risk of clots - just as they would in a person who doesn't have a mechanical valve or otherwise need anticoagulation. In my case, I've reduced my INR for procedures - my most recent was an ablation in April 2. I didn't bridge. My cardiologist didn't push it. After the procedure, I restarted my usual dose of warfarin, and in a few days, my INR was back into normal range. The three or four days with my INR below 2 didn't seem to be a risk for me. I use the Duke study as a source of information about WHEN the risk of clot on my heart valve to become an issue -- as many as 5 or six days underanticoagulated don't really bother me.

Whether it's On-X or one of the other valves, the need for bridging when INR is low for a short amount of time may not be real. Of course, if you WANT to bridge, you certainly can. But you may not be actually lowering the risk of clots.

 

[pellicle]

Oddly enough, I find myself agreeing with Tom.

to be clear here I've also argued that you may not need to bridge but it has some strict dependencies:

1. your ability to measure and know your INR
2. what your actual known risk factors are (such as have you had a stroke)
3. permission of your team

I have even written quite extensively about this.

However Tom has made a specific statement, which he has the right to do. Rights should not come without responsibility. In this case responsibility for the truth. Tom seldom has ever supported his claims with anything better than "my cardiologist told me". Without recording or a copy of a written submission this it is at best "I recall my cardiologist said this; but I could be wrong"

As a Scientist Tom should know that claims require support (just as they do in courts of law) and to say what he did requires support.

Let me draw your attention to a post here fom 2021
https://www.valvereplacement.org/threads/cryolife-on-x-inr-claims.888035/

There is quite good discussion there and a copy of the letter in question

Let me again reiterate some points from that letter.

I think that's all pretty clear from On-X and its wise to not get excited and by dint of "chinese whispers" turn that letter into saying something else (like On-X advice is you don't need to bridge)

I call this "due diligence" and "responsible distributing of information"

Best Wishes

 

[tom in MO]

can you show me where On-X (or any modern bileaflet mechanical valve maker) says you don't need to bridge?

@nobog are you aware of any such things? (perhaps you aren't)

I have had 3 procedures dropping my INR to 1 w/o bridging. This is due to my St. Jude aortic valve being able to withstand a low INR w/o clotting. My cardiologist said this was due to the "robust performance of the St. Jude aortic valve over a long period of time (>25 years.)"

 

[tom in MO]

Tom,
You've said this before. Do you have any support for this? I've found nothing in the guidelines and nothing from Abbott labs about this "change". My surgery was just 3 years ago and I was given a target of 2.0 to 3.0. I am aware that your cardiologist had you switch from 2.0 to 3.0 to 2.0 to 2.5, but this does not mean the guidelines changed. Perhaps this was specific for you, as you have had issues with bleeding, if I recall correctly.

To be clear, I'm not trying to argue about this, but would like to see the support that the guidelines have changed, if they truly changed. Can you provide this? A letter from Abbott perhaps?

Also, I am personally very comfortable keeping my INR in the range of 2.0 to 2.5. There was a study published a few years back suggesting that this range is safe for St Jude, but, to my knowledge, this did not lead to a change in the guidelines.

Edit:
I just looked into the guidelines and I believe that your statement about the guidelines being lowered for the St Jude valve is incorrect.

You indicated that for St Jude the guidelines changed about 10 years ago. from the range of 2.0 - 3.0 to the range of 2.0 - 2.5. To my knowledge, 2020 was the last time that the guidelines addressed INR for mechanical valves. As of 2020, the target had not been lowered to the range of 2.0-2.5, as you suggest happened 10 years ago. Please see the link to the 2020 ACC/AHA Heart Valve Guidelines below:

"For mechanical bileaflet or current-generation single-tilting disk AVR with no risk factors: INR of 2.5."

"For mechanical On-X AVR and no thromboembolic risk factors: A lower INR of 1.5-2.0, starting 3 months after surgery with addition of aspirin (ASA) 75-100 mg daily (Class 2b)."

https://www.acc.org/Latest-in-Cardi...0/12/16/22/01/2020-ACC-AHA-VHD-GL-Pt-3-GL-VHD

I first learned about the lower range for St. Jude on this board. I asked my surgeon and he said he thought it had been lowered, but I should ask my cardiologist since that's their specialty. My cardiologist told me that 2-3 was now 2-2.5 for my model and valve position. I've had 2 different cardios and each has told me 2-2.5 every year for >10 years. One thing about survey articles is they are not specific to valve type, thus 2-3 is a good compromise, but St. Jude can be 2-2..5 and OnyX is 1.5-2.

Why not ask your cardio? If I remember correctly, the sports you participate in can lead to cuts, scrapes and bruises, thus 2-2.5 INR may be useful to you.