Onyx aortic valve with 1.5-2.0 INR target

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bdryer

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I was implanted with an Onyx aortic valve in March of 2011. I started home anticoagulation monitoring shortly after the surgery. I kept my INR close to 2 with no issues, often I would be 1.6-1.8. I was also taking 81 mg aspirin. Home anticoagulation monitoring was expensive and I botched too may $8.00 test strips, so I reverted to lab testing under a general practitioner. He and my cardiologist wanted me to maintain a range of 2.5 to 3. I target 2.0 to 2.5 to this day. They are happy when INR is close to 2.

After 11 years after I was implanted with the Onyx aortic valve, I'm curious if anyone else has ever maintained an INR of 1.5 to 2.0 or is presently targeting this range?

Thanks
Bruce
 

dick0236

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After 11 years after I was implanted with the Onyx aortic valve, I'm curious if anyone else has ever maintained an INR of 1.5 to 2.0 or is presently targeting this range?

Thanks
Bruce

Thanks for posting this Bruce. It's been about 12 hours since you started this thread and no one, so far, has indicated that they are targeting the Onyx range of 1.5-2. My suspicion is that few, if any, GPs. Cardios or Surgeons would suggest such a low monitoring level for a mechanical valve........regardless of what Onyx marketing says. The risk of problems at a low INR far outweighs any perceived advantage of that low INR.

Remember that blood cells that are lost due to a bleed will be replaced.....but brain cells that die due to a clot can't be replaced. That probably is not a medically correct statement....but you get the point. I had a stroke (blood clot in brain) due to low PT (pre-INR) in 1974 that caused partial blindness that has never improved.....not even a little. I have had numerous cuts over the years that required closure by stitches and all of those body parts have returned to normal. You can't even see the scars. I'll take the bleed anytime over the clot.
 
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pellicle

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It's been about 12 hours since you started this thread and no one, so far, has indicated that they are targeting the Onyx range of 1.5-2. My suspicion is that
Hey Dick, my suspicion is that its close to christmas and everyone is busy ... I only just got back from work, so it was posted after I went to work, not to mention I don't have an On-X ;-)

Merry Christmas btw
 

Superman

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Hey Dick, my suspicion is that its close to christmas and everyone is busy ... I only just got back from work, so it was posted after I went to work, not to mention I don't have an On-X ;-)

Merry Christmas btw
Part of it too, and this is no fault of the OP, but it has been discussed a lot lately in valve decision threads. Could just be topic fatigue.

Recommend the OP peruse the top few threads on, “What’s New” and they’ll find a lot of discussion about this.
 

slipkid

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Without going into a very long story with INR twists & turns that I've gone through already detailed in another thread or two, will say that after On-x mailed me the letter to announce that they had USA-FDA approval for 1.5 to 2.0 effective INR range (at the time I was still using 2.0-2.5 although was already aware that 1.5-2.0 was the approved range outside USA, think it was UK or Europe about a year earlier than us here), anyways I took that letter to the Dr who was overseeing my INR and he thought that was great and was very happy with it, told me to reduce my weekly dosage and we targeted for that range IIRC; I actually remember him exclaiming out loud "NICE!!!!!" (referring to the 1.5 lower end like it was an amazingly great achievement).

If not for this forum and especially Pellicle's posts I would have been taken in by the hype as well, however after really thinking about it I concluded myself that there was very little (if anything) to gain by targeting 1.5 to 2.0 and too much to lose, discussed it again with my Dr and told him I was more comfortable with targeting using the range we were already using of 2-2.5 if for nothing else but to give me wiggle room for periods when I dip lower at which point that would take me into the 1.5 to 2.0 territory which was supposedly "great" as opposed to targeting 1.5 on the low end and dipping below 1.5 at times & risk a stroke. I gave him the "it's a lot easier to replace lost blood cells than brain cells" rational which he thought was an interesting way to look at it and agreed with the logic to go back to > 2.

But if not for this forum, & if not for my wanting to discuss it further and voicing my reservations, my range would be 1.5 to 2.0.
 

pellicle

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My cardio wants 1.5 to 2 but
that's a narrow range to target ... does your INR sit so flat or does it squiggle around a bit (like for instance mine)? How much adjustment is needed to keep it in that range (a few % either way now and then?)
 

Cactus52

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that's a narrow range to target ... does your INR sit so flat or does it squiggle around a bit (like for instance mine)? How much adjustment is needed to keep it in that range (a few % either way now and then?)
My cardio only says the 1.5-2 because that’s what on-x recommends. My surgeon wanted 2-3 so that’s what I go by. I take 5mg a day and it moves around a bit anywhere from 1.9 -2.7. I it trends lower 2 weeks in a row then I ad a 1 mg once or twice a week evenly spaced out until it returns to a more central reading.
 

pellicle

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I take 5mg a day and it moves around a bit anywhere from 1.9 -2.7. I it trends lower 2 weeks in a row then I ad a 1 mg once or twice a week evenly spaced out until it returns to a more central reading.
cool, thanks for that ... I expected that it was pretty much impossible to have sat between 1.5 and 2.0 without major micro-management
Personally (like for what its worth 🤷‍♂️) I think you're doing an excellent job of minimal interference management.
 

Chuck C

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I took that letter to the Dr who was overseeing my INR and he thought that was great and was very happy with it, told me to reduce my weekly dosage and we targeted for that range
Interesting that his first reaction was not to look up and review the study that was the basis for the letter from On-x, and to apply his critical thinking skills to evaluate whether it was a robust study before he had you move to the lower INR.

I gave him the "it's a lot easier to replace lost blood cells than brain cells" rational which he thought was an interesting way to look at it and agreed with the logic to go back to > 2.
I'm glad that he agreed with the logic to go back to 2+ INR.
 

Chuck C

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I'm curious if anyone else has ever maintained an INR of 1.5 to 2.0 or is presently targeting this range?
This woman moved to the lower INR range and had serious problems. She had been doing well with an INR range of 2-3 for years, but after receiving the On-x letter, her cardiologist moved her to 1.5 to 2.0 and within 5 weeks she had major issues and eventually a stroke. Some may do fine on the lower INR range, but some do not. There is a greater risk of clotting at that low range, and even the study purporting to support the range found more strokes in the low INR arm of the trial.

 
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pellicle

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Interesting that his first reaction was not to look up and review the study that was the basis for the letter from On-x
this point is what I was going to expand on, IIRC (not having got one myself) there was a mention in fine print that the decision to accept this lower INR value should be taken with the cardiologist and in the light of evidence as to stroke or TIA events. This suggests that a case by case is required (but suggested in a way to not be given the appropriate clarification). One word comes to mind: disingenuous .

On-X themselves in the conduct of the PROACT trial not only had a protocol to examine for this but to then immediately take any lower INR range patients out and put them into the "control" group ... which in proper scientific rigor invalidates the experiment (meaning it should have failed). IE

where they write:
Any patient who experienced a TE event in the study group was crossed over to the standard INR group, though they remained in the test group through an intention-to-treat analysis.

really ... not left there to suffer the actual consequences (as the above case was), and then not taken out of the test group numbers and followed as if they were test group but not treated as test group. Verges on fraud IMO.

Its also worth noting that this above paper is an analysis of the PROACT trial and despite being (I hope) peer reviewed also presents one of the significant issues which I was trained to be triggered by (when doing my masters and studying how to do a critical review of literature): it inserts a lie (or at the kindest interpretation, a demonstration of deliberate blindness) that fits their own agenda

In contrast, the Ross procedure (pulmonary autograft replacement) alleviates the need for lifelong anticoagulation and is the only operation that guarantees long-term viability of the aortic valve substitute.

Its misinformation because cryo-preserved homograft is at least as good (and doesn't leave you with now two diseased valves). Given that this was published in 2001 its hard to imagine that the "researchers" in the above study did due dilligence on that assertion.


This underscores why critical thinking cap must be on in all readings, because despite the benefits of "peer review"
  1. peers may share the authors bias
  2. peer reviewers are busy and only paid about an hours worth or work per review.
 

tom in MO

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About 20% of all biological valve recipients have to take an anticoagulant for some reason after their valve replacement for some reason other than their valve. If you have an On-C and are at an INR of 1.5-2 and have problems, it might not be the On-X valve that's causing the problem but some other part of your circulatory system, but since you have a valve, that will be blamed.
 

Fireman

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I was implanted with an Onyx aortic valve in March of 2011. I started home anticoagulation monitoring shortly after the surgery. I kept my INR close to 2 with no issues, often I would be 1.6-1.8. I was also taking 81 mg aspirin. Home anticoagulation monitoring was expensive and I botched too may $8.00 test strips, so I reverted to lab testing under a general practitioner. He and my cardiologist wanted me to maintain a range of 2.5 to 3. I target 2.0 to 2.5 to this day. They are happy when INR is close to 2.

After 11 years after I was implanted with the Onyx aortic valve, I'm curious if anyone else has ever maintained an INR of 1.5 to 2.0 or is presently targeting this range?

Thanks
Bruce
I had On-X installed 2021 and like INR at 2
 

PeterII

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I was implanted with an Onyx aortic valve in March of 2011. I started home anticoagulation monitoring shortly after the surgery. I kept my INR close to 2 with no issues, often I would be 1.6-1.8. I was also taking 81 mg aspirin. Home anticoagulation monitoring was expensive and I botched too may $8.00 test strips, so I reverted to lab testing under a general practitioner. He and my cardiologist wanted me to maintain a range of 2.5 to 3. I target 2.0 to 2.5 to this day. They are happy when INR is close to 2.

After 11 years after I was implanted with the Onyx aortic valve, I'm curious if anyone else has ever maintained an INR of 1.5 to 2.0 or is presently targeting this range?

Thanks
Bruce
I did that during first 12 months, but decided to be worry free and past 6 years my target is 2.0, range 2-2.5;
 

PeterII

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About 20% of all biological valve recipients have to take an anticoagulant for some reason after their valve replacement for some reason other than their valve. If you have an On-C and are at an INR of 1.5-2 and have problems, it might not be the On-X valve that's causing the problem but some other part of your circulatory system, but since you have a valve, that will be blamed.
But, it gives you worry free life just targeting 2, and let it go up to 2.5 if so my liver decides :)
 

pellicle

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Recommend you follow cardiac surgeons advice. He probably has seen problems with ranges he doesn't Recommend
while on the subject, if I may take it for a little trip somewhere else, the biggest problem I see (and its well known too) is compliance: meaning actually taking it.

Many either forget it, don't care, don't know the outcomes and then fall foul of horror like this:


that we are all on a forum like this suggests we aren't like that poor wretch, but there are thousands of surgeries replacing valves per year in the US alone.

Actually taking it properly is more than half the battle
 
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