Failure of Onx valve and problems with lowering INR

[Protimenow]

One more thought -- did you or your doctor report this to the FDA? If the doctor didn't, he or she should have. Adverse results from medications or medical devices are supposed to be reported to the FDA.

If the doctor ascribed this to something else - other than the valve or the low INR - this would have been a violation of FDA guidelines and may have endangered others. Who knows how many others may have died from this same issue - but without autopsies, or with somewhat compicit 'professionals' who ascribed the deaths to 'natural causes' or other medical problems - have gone unreported?

(It's not too late to report this, if it hasn't been - the life (lives) that you can save now by adding one more point of attention - won't be yours - it can possibly be many others.)

If I recall correctly, even if this is just reported to On-X, they're required to inform the FDA.

By reporting the issue, you're not intending to hurt On-X --- you may help the FDA to put some attention at the On-X ridiculously low INR recommendations.

 

[Eva]

Sorry for what you had to go through! Glad all is well which is the most important thing. Doctor “practice” medicine...hard to find a real professional who listens and takes enough time to evaluate the patient’s concerns!
My INR (general) range is 2.5-3.5. But my surgeon right after my valve replacement recommended, based upon my personal situation, that It’s ok if my INR goes up to 4!

 

[Protimenow]

INRs up to and above 4 aren't that big a problem.


In a period post-surgery, the risk of clotting is greater (while things close up and heal), so a higher INR makes sense. At one time, the recommended range for St. Jude valves was 3.0 - 4.0 - perhaps even higher.

 

[Keithl]

Well it looks like my cardiologist is going to be stubborn about sticking with the 1.5 - 2.0 INR range recommended by the surgeon. His office called and said that he had confirmed it with the surgeon.

I meet with the cardiologist Thursday but I haven't found much published information regarding lower INR ranges and the aortic ON-X valve. I've found the interim PROACT results and this: http://onlinelibrary.wiley.com/doi/10.1111/j.0886-0440.2004.04084.x/full

Does anyone know of anything else that would be relevant, on either side of the issue?

Find a new cardiologist. I switched cardiologist when mine was not being reasonable and listening to me. It is your life and a you get the veto power.

 

[Eva]

Find a new cardiologist. I switched cardiologist when mine was not being reasonable and listening to me. It is your life and a you get the veto power.

I second that!

 

[user 15848]

Back in 2014 i read everything about the On-X and the PROACT tests, and at the begining of the post op process my INR used to be as low as 1.6 for days and then jump to 2.4, after few months, 6 i would say, it became manageable. For me , when my INR goes below 2, i can hear the valve when i go to sleep in certain positions, interesting thing, when it is 2.2, i never hear it; not that this is important, but is enough for me to have a target INR of 2.1, some times it goes up, no big deal, some times it goes down to 1.8, is ok ; So far if i have an INR below 2, i just take an 81mg ASA during the day with Vitamin C, and then the other late evening with the W; we are all different, but for me, an INR of 2.7, makes my gums bleed, below 2.4, is ok; but we all have different diets and life styles, and everything matters, just a thought

 

[Protimenow]

If your gums bleed when your INR is 2.7 or above, you may have a bigger problem than merely gums bleeding when your INR is 2.7 or above. You might want to have a dentist or oral surgeon check this out -- I don't know of any of us on this forum who take warfarin having that kind of reaction. If you have gum disease, you may be more prone to infection and, gulp, endocarditis. I suggest that you get this checked out, if you haven't already.

It's interesting that you can hear the valve when your INR is below 2, and that your gums bleed at 2.7 or above -- with these indicators, I'd have to wonder if you even need a meter (you do). I used to think that I can tell, from physical signs, when my INR was out of range. I'm much more confident getting my INR from a lab or a meter (even if I shared your signs of INR out of range).

But, please, if your gums bleed at an INR of 2.7, find out why.

 

[vitdoc]

I just want to clarify a small but important issue. When companies apply for drug or device clearance from the FDA they submit their studies to the FDA for review. The FDA does not do the studies. So the companies try to put the data in the most favorable light. As I mentioned previously the data on the On x valve did show a higher rate of complications for clotting type events and a lower bleed rate. So pick your poison. I am stroke adverse so no 1.5 INR for me, with that or any other mechanical valve.

 

[pellicle]

...but for me, an INR of 2.7, makes my gums bleed

this sound suspiciously like you have sub-gingival plaque. Do you go for "scale and cleans" often?
https://en.wikipedia.org/wiki/Calculus_(dental)

I'd check this out because leaving it like that may be a recipe for endo (because the mouth just isn't a clean place).

and I strongly recommend antibiotic cover an hour before the procedure if you do go check it out.

Best Wishes

 

[Agian]

this sound suspiciously like you have sub-gingival plaque. Do you go for "scale and cleans" often?
https://en.wikipedia.org/wiki/Calculus_(dental)

I'd check this out because leaving it like that may be a recipe for endo (because the mouth just isn't a clean place).

and I strongly recommend antibiotic cover an hour before the procedure if you do go check it out.

Best Wishes

Gingivitis causes gums to bleed. I guess it makes sense this would become more obvious with a higher INR. I've been schooled by the dental hygienist, a nice girl. It's not hard to maintain good dental hygiene, through proper brushing and flossing... Yes, I know it sounds like nerdy crap, but there may be some truth in it.

I'm starting to enjoy trolling the dentist. Last checkup he told me my saliva was sticky and he could tell I was dehydrated. The backlash made his assistant stuggle to keep it together.

 

[Agian]

I just want to clarify a small but important issue. When companies apply for drug or device clearance from the FDA they submit their studies to the FDA for review. The FDA does not do the studies. So the companies try to put the data in the most favorable light. As I mentioned previously the data on the On x valve did show a higher rate of complications for clotting type events and a lower bleed rate. So pick your poison. I am stroke adverse so no 1.5 INR for me, with that or any other mechanical valve.

Do you think this was because of the lower inr recommendation?

 

[Protimenow]

I just want to clarify a small but important issue. When companies apply for drug or device clearance from the FDA they submit their studies to the FDA for review. The FDA does not do the studies. So the companies try to put the data in the most favorable light. As I mentioned previously the data on the On x valve did show a higher rate of complications for clotting type events and a lower bleed rate. So pick your poison. I am stroke adverse so no 1.5 INR for me, with that or any other mechanical valve.

Just a bit about how the FDA approves new models of INR meters. What I've seen were studies (commissioned by the manufacturers) showing equivalency of results of the new meter to those of already approved meters. They don't have to show equivalency to actual lab results - just that one meter is roughly equivalent to an older, approved model. Of course, if the original model wasn't 'perfect' the 'eqivalent' new meter may be similarly imperfect (but probably close enough for testing).

I've seen similar 'equivalency' results for generic drugs. In this review process, it's not entirely unlikely that certain factors are missed during the review process. (A generic warfarin may have the same anticoagulation effect as Coumadin, and, in a normal population being tested, may show roughly equivalent results, but this doesn't account for adverse reactions to colorants or other components in the 'new' generic that patients can react to, and may impact overall performance of the newly approved generic). I've had a generic that I couldn't regulate my INR with - others here have reported other problems with 'equivalent' generic drugs.

This message just confirms that FDA approvals don't necessarily take into account all of the important factors, and rely on research results from those who submitted the application and have a lot to lose if the new drug or device isn't approved.

 

[user 15848]

My surgeon told me 2 things about On-X, one is a better engineering design, second, 1.5 - 2 range , could be accurate, or could be more or less accurate, so think of 2 - 2.5 as your range for managing INR, till , when some years have passed, there is more data about this.

 

[nobog]

My surgeon told me 2 things about On-X, one is a better engineering design, second, 1.5 - 2 range , could be accurate, or could be more or less accurate, so think of 2 - 2.5 as your range for managing INR, till , when some years have passed, there is more data about this.

They all say that ....

 

[Protimenow]

All too often, doctors say what 'drug reps' beat into their heads. Some free lunches for the office staff, free dinners for the doctors, a bundle of wall clocks, and a lot of advertising can convince the surgeons that their line of crap is ultimately correct.

On-X literature claims that they use better materials for better resistance to clot formation (they claim), but they have to say something to differentiate their valve from the long proven valves already in use.

I'm somewhat surprised that JLCSH2015's doctor at least suggested an INR that's appropriate for all mechanical aortic valves, and that he or she wants to get longer term study results before accepting the lower INR recommendations that ON-X keeps shoveling out of those big, 50 pound bags, into the Surgeon's offices.

 

[Keithl]

My cardio advised against the 1.5-2.0 for my On-X and suggested I stay within 2-3 which I was fine with as I had no intention of doing the On-X range.

 

[Gustav]

My cardio advised against the 1.5-2.0 for my On-X and suggested I stay within 2-3 which I was fine with as I had no intention of doing the On-X range.

I usually stay within the 2-3 range but still take my daily aspirin do you take aspirin too? I also realised that if I head into the 2.5 and above I start getting red spots on my ankle and the back side of my foot which looks like blood spots. When Im below that level they disappear. Not sure if the aspirin is really that necessary.

 

[Agian]

I take a baby aspirin. That's what we call them. Almost sounds cute.

 

[Protimenow]

I take an 81 mg enteric coated aspirin. They're the same dose as a 'baby aspirin' but are not designed to be dissoved in the mouth. I get a two year supply for four or five dollars, at Costco. I suspect that they're probably similarly expensive at other stores.

Do they help? I have no control testing to determine this - I only have the one body. Do they hurt? They have done practically no damage to me financially. I have no abdominal irritation from them, I don't think that they've caused any more bleeding than my normal dose of warfarin does.

I continue to take one each night. I suspect that they may help, in a minor way, and this small dose certainly couldn't hurt...

 

[Warrick]

@Gustav I get the red spots too, tops of my feet and ankles a bit, they first showed up when I had pneumonia 18 months ago.
Apparantly they are iron deposits, the old ones are still there and new ones turn up every now and then but I havent really seen a pattern in regards to inr and Ive been up to inr 4.3 in the last few months ( travelling and time zone variations).