On-X and Lower INR Protocol

[pellicle]

Just generally (not specific to SilverBullet) but

I agree that the PROACT trial didn't concretely prove that an INR goal of 1.5-2.0 is safe and associated with less bleeding even though that one trial showed exactly that.

generally one should never consider anything proven ... only in Maths. In stuff like this its all just evidence to support a view. The more evidence you have the more confident you can be that such outcomes will reflect your experience, that those results are transferable to you.

Always there are questions: classical stuff would be "well the study was only done on elderly, do these results apply to mid aged adults?"

The outcomes of the PROACT study are encouraging and imply many things. But PROOF is off the table.

 

[MrsBray]

Hey Pellicle....I read the same thing about the aspirin only study in europe; although I cant remember where at the moment. Figures, haha.

Of course, now I can't find anything on it, so I wondered if maybe my surgeon was giving me a line just to talk. But he didn't seem like that kind of guy. It was two years ago that I last had a discussion with him, and, I apologize i can't link to a study, he mentioned something about medical trials in Europe with OnX valves and aspirin only, or aspirin and plavix only, without warfarin.

I mean, I'm ok with what I'm doing now (aspirin and warfarin) and a lower INR target. My chart still says 2.5-6.56 range, but Doctor's note says 1.5-2 is acceptable. I'll take the wider range of acceptability, there's less cause for PANIC with a non-warfarin experienced medical professional when they see the wide range.

You can bet your bottom dollar, though, that as soon as I find a link to that study, I WILL post it here!

-Meredith

 

[pellicle]

Hi

.... My chart still says 2.5-6.56 range..

I hope this range is a typo ..

 

[Silver Bullet]

he mentioned something about medical trials in Europe with OnX valves and aspirin only, or aspirin and plavix only, without warfarin.

,,, My chart still says 2.5-6.56 range, but Doctor's note says 1.5-2 is acceptable. I'll take the wider range of acceptability, there's less cause for PANIC with a non-warfarin experienced medical professional when they see the wide range.

You can bet your bottom dollar, though, that as soon as I find a link to that study, I WILL post it here!

-Meredith

There was a trial with low risk recipients of an On-X valve in the aortic position comparing warfarin to ASA/Plavix, but the trial was stopped. I don't know why. On-X should tell us why it was stopped and should share the available data because the trial did get underway and patients were enrolled.

As for a goal range of 2.5-6.56, that MUST be a mistake. The upper range cannot be that high. If you're 42, otherwise healthy except for an On-X aortic valve, no atrial arrhythmias, normal ventricular function, no previous stroke or mini-stroke, your INR goal according to current guidelines of the American College of Cardiology would be 2.5 (2-3). There is some evidence (the PROACT study) that a goal INR of 1.5-2.0 would be acceptable, but that conclusion is not widely accepted because it is supported by just one On-X funded trial.

 

[MrsBray]

Of course it was a typo! 2.5-3.5

I'm pretty evenly in the 2.0-2.5 range.

 

[JulienDu]

message deleted

 

[rob1010]

I discussing getting an On-X valve at Cleveland Clinic. I asked if they actually prescribe the lower INR (1.5-2) as the therapeutic dose -- No, they recommend 2-2.5.

 

[pellicle]

Hi

I discussing getting an On-X valve at Cleveland Clinic. I asked if they actually prescribe the lower INR (1.5-2) as the therapeutic dose -- No, they recommend 2-2.5.

the thing is that these findings are new and some of the older doctors will be more conservative (and would you prefer them to be reckless with your health?). Accordingly you'll find resistance to accepting these changes in all places all at the same time.

As more studies find the same thing, and as more time allows other issues to emerge (or not emerge) then people will feel more comfortable with the lower ranges.

Its worth re-iterating that if you are 2-2.5 and your INR drops (say, due to you forgetting your pills) it gives you a margin of error. Were you at 1.5 then you may well drop into a region where a stroke is more likely, and a stroke with permanent damage to your brain is a harsh penalty for being forgetful.

There is tons of evidence so far that remaining somewhere between 2 and 4 is actually very safe.

Ask yourself this question: what is it that you expect to gain by being lower INR? Just some fluffy idea that its better for you?

 

[dick0236]

........Its worth re-iterating that if you are 2-2.5 and your INR drops (say, due to you forgetting your pills) it gives you a margin of error. Were you at 1.5 then you may well drop into a region where a stroke is more likely, and a stroke with permanent damage to your brain is a harsh penalty for being forgetful.

There is tons of evidence so far that remaining somewhere between 2 and 4 is actually very safe.

Ask yourself this question: what is it that you expect to gain by being lower INR? Just some fluffy idea that its better for you?

Pellicles' post is well worth re-iterating. The ONLY problem(stroke) I've had in 49 years on warfarin came as a result of a low, not high, INR. The phrase that is often posted here..."blood cells are more easily replace than brain cells" was certainly true for me. My range has always been 2.5-3.5 and I've never had any issues when staying in, or close to, that range......and no issues at all when at the high side of my range.

 

[user 15848]

Hi,

Had AVR surgery past november, was given choice of Tissue valve or On-X, choose On-X,

Pellicle has very good articles regarding many topics Re how to manage INR, for me was very educative
his article on AFB, where one can find lots of info regarding supplements and warfarin

I bought a coagucheck machine, test INR one week at home , one week at lab,

Family doctor asked to keep it between 2.0 and 3.0, for the most part i keep it at 2.1, although On-X tells you
1.5 - 2 is ok, so based on that, i dare to keep my INR around 2, sometimes it goes higher up to 2.5 sometimes
sometimes goes less than 2, but because i do the weekly check, it has not been a problem for me

The one thing i like about the On-X, is that what they say about the noise, "for me" is 100% true, i never hear
the valve unless i place my head in certain position with my arms when sleep.

Just wanted to share my thoughts,

This forum was VERY helful for me when choosing type of valve, and the Warfarin Boogie-Man that the industry
portrays for some reason or other

Thank you

 

[Protimenow]

There were a few questions asked earlier. The one that rang loudest for me was 'how long should I wait?'

You might consider my personal experience:

I was 41 years old. I was fairly healthy, but my color and my endurance were compromised by my bad valve. I had a good job with good insurance. I chose to get the AVR while still relatively young, even though I probably could have waited a few more years.

Six months later, I didn't have the great job. I had no medical insurance. I may not have been able to get that surgery if I had waited. (There's a question about whether my employer, who self-insured, may have thought I was a bit of a risk because I had two surgeries (an orthopedic procedure, and the AVR a year later) in two years.) In my case, getting the surgery done at the time that I had it was a great choice.

As far as fears of warfarin are concerned, you'll see a LOT at this site that talks about it not being the terrible, unmanageable drug that some people still think it is. For me, an INR between 2.4 and 3.5 is comfortable -- it greatly minimizes the risk of clotting and only slightly increases bruising.

 

[RobThatsMe]

I discussing getting an On-X valve at Cleveland Clinic. I asked if they actually prescribe the lower INR (1.5-2) as the therapeutic dose -- No, they recommend 2-2.5.

Not a true statement. I know surgeons at CCF that do not have an issue with the 1.5 lower limit. That being said, it also depends on which valve you are talking about within your body.
The blood pressure force is much stronger through the aortic valve than the other remaining heart valves, thus reducing the clotting risk.

Pellicles post above is spot on.
Yeah you can go to 1.5, but why? Too risky in my opinion if you slip below it! I am a very happy camper, and don't panic if I am between 2.0 - 4.0, and I target my range between 2.5 and 3.0.
This gives me a bit of a buffer on both sides of the tolerance.

 

[Johnpb]

Eric, at the age of 39, I certainly agree that a mechanical valve makes the most sense. A Ross procedure also makes sense if you can get a surgeon who is a master at doing it, preferably with published results indicating excellent long term outcome (like Dr. Tirone David) and if your aortic root is not dilated. In similar shoes to yours, I didn't like the idea of creating a situation where I had to worry about 2 valves, so I chose to go with a mechanical valve.

As a Cardiologist, my sense is that the top Cardiologists and Cardiac Surgeons are skeptical that only the On-X valve can safely be used with INR1.5-2 plus ASA. The problem is that there isn't any evidence that such a regimen is safe with other valves. This is a case where absence of evidence does not equal evidence of absence. It could well be that all modern bileaflet valves in the aortic position of low risk patients can safely be managed with INRs of 1.5-2.0. We just don't know. The downside of the On-X valve is that it hasn't been around as long as the others and though it's longevity so far seems good, we also just don't know what the future will hold. Also, keep in mind that only one relatively small clinical trial that was sponsored by On-X exists suggesting that an INR of 1.5-2 is safe. Good science demands that provocative findings be repeated. Of course, that almost certainly won't happen for practical reasons, but it's nevertheless reasonable to conclude that the evidence favouring a low intensity INR range for the On-X valve is not based upon the best possible evidence, so there remains some room for skepticism. While the evidence satisfied the FDA (doesn't actually take much to do that), it hasn't seemed to change the minds of those cardiac surgeons who write guidelines and speak at valve conferences.

As for your job, I think that you need to make the choice that's best for your health first, and worry about your job later. If I were you - a firefighter - my worry would be suffering head trauma while anti coagulated. That could be devastating. How often does your job result in a bonk on your noggin?

A good thing to remember is that bleeding complications on warfarin in young people are rare. Bleeding on warfarin is mostly a problem for older people. Also remember that structural bioprosthetic valve deterioration occurs earliest in young people. Accordingly, the younger you are, the more, I think, a mechanical valve makes sense.

Dr David will do my procedure next month. Are you saying he won't do a Ross procedure if your aortic root is dilated? Even a minimal amount?

 

[JLmatus]

I've had an ON-X valve since 2017. My Cardiologist recommended range is 2 to 3. I'm happy with this range. So far it has worked for me, and if my INR does get a bit lower at times I still feel safe having an ON-X valve and the low does aspirin regimen.

 

[Chuck C]

I've had an ON-X valve since 2017. My Cardiologist recommended range is 2 to 3.

That's reasonable. I'm glad that your cardiologist does not subscribe to the marketing BS about the 1.5 to 2.0 range promoted by Cryolife. We've seen a number of members have issues at that lower range. It puts people needlessly in the danger zone.

 

[pellicle]

the 1.5 to 2.0 range promoted by Cryolife

needs:

1. the agreement of (and I assume due dilligence on the part of) your cardiologist
2. concomitant aspirin administration
3. measurement more like weekly than the montly some seem to have

Just make sure you cardiologist does more than read the brochures handed out promoting it at the last conference

 

[Buck83]

The one thing i like about the On-X, is that what they say about the noise, "for me" is 100% true, i never hear
the valve unless i place my head in certain position with my arms when sleep.

My On-X is loud. The ticking never stops and is extremely loud. Especially at lower heart rate.

I still feel safe having an ON-X valve and the low does aspirin regimen.

Is everyone with an On-X supplementing warfarin with aspirin? After my stroke and possible 2nd clot, my cardiologist raised my INR to 3-3.5 and said aspirin was no longer necessary. I see him tomorrow for results of my 6 month ct. I’m going to ask him to widen that range to 2-3 or 2.5-3.5.

 

[Chuck C]

Is everyone with an On-X supplementing warfarin with aspirin?

In the PROACT Trial, which Cryolife(now Artivion) sponsored in their attempt to get the FDA to approve the 1.5-2.0 target, low dose daily aspirin was given. Though many question how PROACT was conducted and the interpretation of the outcomes, somehow Cryolife was able to get the FDA to approve the lower INR range of 1.5-2.0 based on the PROACT results. But those using the lower range need to be on low dose aspirin in order to follow the protocal in PROACT.

In that your INR target range is 3.0 to 3.5 your cardiologist may feel that low dose aspirin is not needed. There is some debate as to whether those with aortic mechanical valves, and targeting normal INR ranges, should be on aspirin.

 

[3mm]

There is some debate as to whether those with aortic mechanical valves, and targeting normal INR ranges, should be on aspirin

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.

 

[3mm]

My On-X is loud. The ticking never stops and is extremely loud. Especially at lower heart rate.

I only hear my aortic On-X in a silent room when I focus my listening.

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