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Failure of Onx valve and problems with lowering INR

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Hi all -

I need the help of the smarty pants like Ross. I apologize I cannot remember everyone's name.

Not sure if you all remember me. I was actively on this forum and 2010 and part of 2011. I will briefly summarize my history. In June 2010 I was diagnosed with a bicuspid aortic valve. Of course it was a birth defect, but no one had identified at for 45 years. It was also found at that time that I had a large ascending aortic aneurysm. Heart cath revealed that heart was in severe failure… 4+. No one locally knew how to perform the surgery I needed so it was performed at Shands hospital in Gainesville. Ended up having a 13 hour surgery and basically a Bentall procedure. Put me in hypothermia. Found in aneurized aortic root. Constructed a new root, replaced ascending aorta with a Dacron graft. And I received in on X aortic valve. Of course I went mechanical because of my young age and the tissue valve would've never provided the duration I needed. In addition, they stated you reconstruct an aortic root “once”. That you can't keep reconstructing an aortic root. There was a possibility at the time of the surgery… Or 90 days after, of being admitted into Onx study that utilized Plavix and aspirin for anticoagulation. It was found that my body did not properly react to aspirin so I was removed from the study by on X. On x had it documented in their database that my body does not react to aspirin.

Fast-forward five years … Everything was pretty much fine. Of course there were the struggles with having had extensive open heart surgery and the lack of return to your prior state. Was being anticoagulated on warfarin with no problems. INR was maintained between 2.0 and 3.0. Received a letter from on X stating that INR can be properly maintained due to FDA study between 1.5 and 2.0. Forwarded information to my cardiologist who had been with me since before the first heart surgery and he prescribed reducing my INR. Said that I was safe to do that. Approximately 5 weeks later I started having pains in my legs. The pains got continually worse. Went to my cardiologist four times asking him if this was a result of lowering my INR range. Every single time he dismissed me stating that I was fine there was nothing wrong. Spent the appointments stressing that there was extremely low likelihood of anything being clinically wrong. I also started going to the primary care doctor and stressing to her also that something was horribly wrong. One day several months later I went back to the primary care and told her I was dying that I could feel my body shutting down. The next day I had a stroke. Luckily I had a full Circle of Willis… Which only 20% of people do, which was able to provide some collateral flow. Was admitted into the hospital where they started running tests. It was discovered that my left carotid was 100% occluded for 6 inches. My legs were almost completely occluded. Had an infarct in my kidneys. Had damage in my right arm. At first they were calling it atherosclerosis. Luckily, due to the insistence of one of my friends who is doctor. We insisted they do a TEE. They kept fighting us on it but finally agreed. The TEE revealed that there was a large thrombosis sitting on my valve. This thrombosis was a result of lowering my INR. It was basically shooting emboli all over my body. My body was loaded. Needless to say I cannot recover my carotid artery. Ended up having to have a second open heart surgery after sitting in the hospital for over a month in an effort to use heparin to try to dissolve all the emboli and shrink the thrombosis. After the third TEE they figured out that it was not working. Recovery from the second surgery had spent extremely challenging. I continue to have TIAs even though my INR is maintained at very high levels. They replaced the On -x valve with the St. Jude. Because again they were faced with the fact that I was in my early 50s and a tissue valve would require additional surgeries. To say that this has been hell is an understatement.

After I started recovering I learned that the FDA study was extremely small. I learned that as part of their anticoagulation therapy they were being maintained on aspirin. But I need your help for those of you that are extremely knowledgeable.

Questions:
  1. In that FDA study that showed that patients could be maintained at an INR of 1.5 to 2 did the patients have to be reactive to aspirin? Meaning were they tested for aspirin intolerance before being admitted to that study? Like I stated I had been thrown out of the on X and Plavix study because the anticoagulation therapy consisted of Plavix and aspirin and my body did not react to aspirin. I have read the study but I'm confused.
  2. I noticed in the patient INCLUSION criteria… It states “lack of platelet response to aspirin or clopidogrel” . What does this mean exactly? I am a smart woman but I am not a medical guru. I've had to learn as I have gone through this.
  3. Do you know other people that have reduced their INR to 1.5 to 2 and had a life threatening experience?
  4. I totally understand that reduction of INR or being able to maintain your INR at lower levels is a marketing gimmick. However that gimmick came very close to costing me my life and has severely impacted my length of life and quality of life. Do you have any information or thoughts about all of this? The study size, whether the study was adequate, whether they should've sent a letter, etc.
  5. In a separate attachment to the letter there was a question-and-answer sheet. It states that the addition of 81 mg of aspirin is recommended. Nowhere does it state that your body should react to aspirin or that aspirin is “necessary” . Please note that I was still taking aspirin since 2010 even though I had been told my body did not react to it
  6. What other questions should I be asking?
I need your help. I'm looking to you the experts because I know you have this knowledge. I have never been able to truly regain my strength since the second open heart surgery. I'm exhausted every single day. They say my heart is functioning as well as can be expected. Although I did have some consequences as a result of the second surgery. Also feel free to email me at cheriemo@tampabay.rr.com


Thank you in advance for your help,

Cherie' xx
 

honeybunny

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Oh, how horrible for you Cherie'! I don't have the knowledge you seek; just want to express my sympathy for all you've been through. I don't understand why your doctors seemed to brush off your concerns. I hope you find some answers here. God bless ~
 

Paleowoman

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Hi Cherie - I hope someone here is able to give you adivse about your INR issue. I wonder if your cardiologist didn't take your concerns seriously because of your age: I've noticed that most cardiologists seem to deal predominantly with 'older' people or those with coronary heart disease so they tend not to thnk the 'younger' patient with congenital problems like bicuspid valve will have problems once they've had valve surgery, or even the more complicated surgery you had, they think that everything is fine. When I had a TEE recently the cardiologist doing it asked "excuse me, but why did you have valve replacement - you're much younger than our usual patient" - I'm 64 ! I do hope you are getting better help now - what you went through and are going through is shocking.
 

pellicle

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Hi Cherie'

a very interesting post and one which interestingly enough isn't widely discussed here. As you mention in your post (as you following up) there should be a better discussion on the On-X anticoagulation methodology but there simply isn't. Aside from Ross (who has passed away as perhaps you know) there are few others here willing to discuss things in a scientific and rational way using any evidence to form arguments and think in a questioning manner and discuss in such a way.

You pose a number of good questions and I'll have a whack at them ... I'll need to do some more reading on subjects such as the inclusion cirteria and detals of that study. However:

Guest;n878615 said:
This thrombosis was a result of lowering my INR. It was basically shooting emboli all over my body. My body was loaded. Needless to say I cannot recover my carotid artery. Ended up having to have a second open heart surgery after sitting in the hospital for over a month in an effort to use heparin to try to dissolve all the emboli and shrink the thrombosis.
firstly are you sure that thromobsis was only related to your INR (see later) as you also said that with a raised INR it still occured.

Sadly this is an indicator of misunderstanding / ignorance and lack of currency in professoinal education on the part of the hospital. I understand it that:
1) Heparin does not dissolve clots but just stops new ones forming, it is the body that then breaks the clots down (no longer being overwhelmed by formation of new ones)
2) the gold standard for break down of clots is indeed tPA (see here) and is the recommendation of the proper management of stroke. Sadly when I have read here I see litle evidence that such is known outside the managment of stroke and cardiac seems to be in a "world of its own" on many things related to coagulation management.


I continue to have TIAs even though my INR is maintained at very high levels. They replaced the On -x valve with the St. Jude. Because again they were faced with the fact that I was in my early 50s and a tissue valve would require additional surgeries.
is this meant to be "continued" and why if your INR is / was maintained higher why were there still issues (see later). So why are now no longer with the On-X and the St Jude in? Was there evidence which somehow led them to remove the valve (something one doesn't undertake lightly).


After I started recovering I learned that the FDA study was extremely small. I learned that as part of their anticoagulation therapy they were being maintained on aspirin.
indeed ... this is a topic which Ross and I used to discuss (of line).

I'll attempt to stuff in what I know on your questions, but will perhaps need to read some more:
In that FDA study that showed that patients could be maintained at an INR of 1.5 to 2 did the patients have to be reactive to aspirin? Meaning were they tested for aspirin intolerance before being admitted to that study? Like I stated I had been thrown out of the on X and Plavix study because the anticoagulation therapy consisted of Plavix and aspirin and my body did not react to aspirin. I have read the study but I'm confused.
well I'm a bit confused by your question, so forgive me if I get it wrong.
I have no idea (and its not discussed that I've found) if the study tested for aspirin, I assume since it was an "inclusion criteria" that if you were intolerant to aspirin that you would be excluded.

Plavix is not approved for Aortic Valve patients by the FDA as far as I know (and I"m Australian and its certainly not approved here)

I believe that there is deliberate effort to obscure the actual meaning and outcomes of the trial and replace it with a "feeling" in the community that the simple single (moronic) bottom line is that On-X can have reduced warfarin (and ignore the inconvenient details and risks). Why? Because people are naturally lazy and intellectual laziness is even more common. On-X can successfully have that extra feather in its cap for a nation who are irationally worried about warfarin and fantasize that a miniscule reduction in dose of it will have any benefit.

As you yourself say:
I totally understand that reduction of INR or being able to maintain your INR at lower levels is a marketing gimmick. However that gimmick came very close to costing me my life and has severely impacted my length of life and quality of life. Do you have any information or thoughts about all of this?
As you can see it doesn't. I can only say that I'm sorry that you one of the ones that are wearing the consequences of this ... Myself I regularly caution people here to be more in the mind that the 1.5 lower limit is exactly that, a lower limit which should give you some comfort if you find your INR has dropped below 2. It gives you time to rectify this without the fear that you need to bridge on a heparin. It

I have argued for some years that indeed the On-X valve and the ATS and the St Jude are indeed all more or less the same. Studies on the thrombogenic potential of these valves show indeed they are virtually indistinguishable.

I can share some papers on this if you are interested but I guess that its more or less moot now for you.

You next ask:
In a separate attachment to the letter there was a question-and-answer sheet. It states that the addition of 81 mg of aspirin is recommended. Nowhere does it state that your body should react to aspirin or that aspirin is “necessary” . Please note that I was still taking aspirin since 2010 even though I had been told my body did not react to it
I'm not sure what this means "my body did not react to it", does this mean there was no measureable antiplatelet reduction effect?

you ask:
What other questions should I be asking?
and I guess that this depends on what you intend to do. Are you considering any litigation?

To me now the best thing you can do is just manage your INR to a "target" of 2.5 and have assessments (such as a d-dimer test) to determin if your body is still getting clots in the stream. If so then you'll need to consult with a specialist on management of your INR because while INR Target = 2.5 (meaning in essence a range of 2 ~ 3) is shown to be safe for many, its not a golden rule.

Lastly I wonder about the On-X and if it was placed properly in the first place. Improper alignment can cause greater pressures and exactly cause "a stream of clots". This is a few images showing pressure gradients in the stream of blood caused by the valve. We can talk about this if you are interested to know more.

[IMG2=JSON]{"data-align":"none","data-size":"full","src":"https:\/\/c2.staticflickr.com\/2\/1532\/26222758115_f2e5ef54fe_b.jpg"}[/IMG2]

[IMG2=JSON]{"data-align":"none","data-size":"full","src":"https:\/\/c2.staticflickr.com\/2\/1695\/26222758215_2f4dac2353_b.jpg"}[/IMG2]

there is a threshold of pressure gradient known to be more likely to cause platelet activation (for instance)
 

pellicle

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Hi

almost_hectic;n878623 said:
How is this considered a failure of the valve as the subject line states?
I suspect its that point (which was hard to find and is unclarified) about her having the On-X replaced with a St Jude...

This part makes me think there was a thrombosis obstruction of the valve and thus it was replaced.
Ended up having to have a second open heart surgery after sitting in the hospital for over a month in an effort to use heparin to try to dissolve all the emboli and shrink the thrombosis.
 

Paleowoman

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pellicle;n878624 said:
This part makes me think there was a thrombosis obstruction of the valve and thus it was replaced.
Cherie writes above: "The TEE revealed that there was a large thrombosis sitting on my valve"
 

Cherie'

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Thank you everyone for your detailed and thoughtful responses. I probably should have named the title something differently… Was not really a failure of the Onx valve, but a failure of the INR protocol with the Onx valve. There were so many things that came into play in this situation. First of all we know that the thrombosis was a result of improper coagulation. Within weeks of lowering my INR I started having tremendous leg pain. I would later learned that with improper anticoagulation The first sign will be pain in your legs. I had an incredible pain in my legs one that worsened as the months wore on. I had had many many tests since the valve was originally planted in 2010 and no one ever mentioned the valve not being placed correctly. I'm sure I can go back and look at some of the test, but I'm thinking somebody would've mentioned that and that there would've been a problem sooner rather than five years later once the warfarin was reduced.

Despite my constant questioning, and multiple visits to the cardiologist, he kept insisting that my warfarin dosage was correct, and that I could safely maintain my INR between 1.5 and 2.0. I did try to keep to the upper end of that range but there were definitely weeks where I was around 1.6. I did later learn upon reading the FDA study that the average INR was 1.89 with a variance of approximately .5. So in reality the 1.5 to 2.0 is very misleading.

The thrombosis was sitting on my valve and was interfering with the leaflets. I think they had multiple concerns. I was in neuro ICU for several weeks while they figured out how to deal with the situation. I was even transferred to a tertiary care hospital where I had a team of 15 doctors that we're having conferences over my situation. Even the original surgeon was looped in. He is supposed to be one of the best in the United States.

The thrombosis apparently was huge. And took on the life of its own acting like a snake ducking in and out of the valve and interfering with the operation of the valve. I believe they were also concerned about the possibility of the thrombosis launching. Seeing as I had already lost one carotid it was an extremely high-risk situation.

At the last TEE they figured out that the thrombosis had actually grown even larger. It was at that point that they said they needed to open me up. They said the situation was far too risky. Even the head neurologist at Cleveland clinic was involved.

I figured out yesterday after posting this that the pro-act study actually consisted of three groups. The lowest group which was studying the use of Plavix and aspirin versus warfarin for mechanical valve. (this is the study that I was actually removed from for failure to properly react with aspirin or aspirin resistance using the urine thromboxane test) Yes, lack of platelet response.. The second group was the high-risk group for AVR where they reduce the warfarin and the target of 1.5 to 2. The warfarin was used in conjunction with aspirin. And then the third group was the mitral valve group.

Thing I find interesting is that I had been removed from the low risk group. They actually have this information in their database and I confirmed that after the surgery that I was still in the onx database showing as I had been removed from the lower a study for failure to react to aspirin as needed. Yet they sent me the letter stating that it was OK for me to follow the high-risk protocol even though I was not appropriate for the low risk. To me they placed me in a high-risk situation without warning me.

The other thing that's interesting is the conclusion of the FDA approves study states… : INR may be maintained safely between 1.5-2.0 in AVR patients after implantation of this approved bileaflet mechanical prosthesis. "In combination with low-dose aspirin", this therapy resulted in significantly lower risk of bleeding than customary INR 2.0-3.0, without significant increase in TE.

Obviously aspirin was part of the anticoagulation therapy. Yet I do not react to aspirin as needed. yet the conclusion states "combined with aspirin", which I don't react with. Yet inclusion criteria references you can include those with lack of platelet response. So why does conclusion specifically state "combined with aspirin". Hope I am making sense.

All my best, Cherie'
 

pellicle

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Hi (and good morning from Australia)

When I read:

Cherie';n878648 said:
Despite my constant questioning, and multiple visits to the cardiologist, he kept insisting that my warfarin dosage was correct, and that I could safely maintain my INR between 1.5 and 2.0.
I see an absolute failure to apply the precationary principal and a abject failure to read the facts and respond to them.

I would be changing cardio post haste


I did try to keep to the upper end of that range but there were definitely weeks where I was around 1.6
Does this mean you were self managing? Out of interest what was your INR reading frequency (weekly, monthly)? What was your INR variance and do you have graphs or at the very least a diary of INR records?



. I did later learn upon reading the FDA study that the average INR was 1.89 with a variance of approximately .5. So in reality the 1.5 to 2.0 is very misleading.
Well actually thats within the range , indeed that variance exceeds their range which makes their stated range acceptable.

IE 1.89 - 0.5 = 1.39


The thrombosis was sitting on my valve and was interfering with the leaflets. I think they had multiple concerns.
Indeed, the thing is however thrombosis like that take time to grow. This underscores my hesitation with the On-X protocol as in (as voiced in that 2014 thread you replied to yesterday) that no long term study has been conducted on this to gauge the potential for thrombosis growth.

Your outcomes suggests this is needed.

Was a study done of the excised valve? This is normally done. I would be very interested to see if that thrombosis was not vegetative. Your descriptions imply it might be.

Given the substantial nature of this I will be surprised if there is no paper written to examine the outcome.

Lastly I recommend you follow the following guidelines for INR management.

# Keep your INR around 2.5, steer up when you see 2, steer back when you see 4

# test weekly

Observe this chart for why [IMG2=JSON]{"data-align":"none","data-size":"full","src":"https:\/\/farm4.staticflickr.com\/3868\/14626794599_442e809525_o.jpg"}[/IMG2]




Best wishes
 

Cherie'

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I now have a St Jude Valve and am perfectly fine with that. The warfarin does not scare me. Its more the doctors. I maintain my INR around 3 now. I do not want to risk that again. I

pellicle I appreciate your very detailed and thoughtful replies. By the misleading range I meant that promoting a range of 1.5-2.5 really would have more representative of the data. And would paint a completely different picture to consumers, and in my case medical doctors. He was encouraging me to stay in the range of 1.5 to 2. Obviously, that did not work.

Needless to say, he is no longer my cardiologist. When I was transferred from that hospital to a tertiary care facility I received a whole new team. They were basically appalled at what was happening and could not believe that no one had listened to my begging and pleading for 4-5 months.

Prior to my receiving the letter from on X I always kept my INR around 2.5. My stated range was 2 to 3. That letter encouraging me to lower INR almost cost me my life. They placed me in a high risk situation without telling me. Of course the fact my cardiologist endorsed it also did not help.

Trying to figure out where to go from here. Very blessed that I am alive. Of course I cant explain to anyone what it's like to literally have the equivalent of a nuclear bomb in your chest waiting for it to explode, while laying in neuro ICU and everyone's figuring out what to do. That fear cannot be put into words. The fact I've lost my left carotid has definitely impacted my life in a negative way and the toll my body took going through the second open heart surgery and that entire event. But trust me on not discounting the fact I'm still here. That is a gift and I try to live every day to its fullest.

Just trying to figure out who all erred in this situation. Obviously the cardiologist. I have my own thoughts but interested to hear yours. Thoughts...

Cherie'
 

AZ Don

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"Just trying to figure out who all erred in this situation. Obviously the cardiologist. I have my own thoughts but interested to hear yours. Thoughts..."
In your situation, I'd probably try to find a legal team that specializes in malpractice and let them figure it out. Glad you made it through your ordeal.
 

pellicle

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AZ Don;n878666 said:
...
In your situation, I'd probably try to find a legal team that specializes in malpractice and let them figure it out. Glad you made it through your ordeal.
Agreed, that's the best way.

I'd add that one should always be more pessimistic of a good outcome than the legal groups are. They'll talk it up as more certain than it may be...
 
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ForeverThankful

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Hi Cherie'

So sorry that you had to go through such an awful ordeal but glad that you came through it!

I may not be a medical professional but as someone who takes Warfarin I would say that an INR of 1.5 - 2.0 is just too low to be safe.

I remember my surgeon saying that he doesn't like to see an INR under 2.2 regardless of valve for two reasons, the first is that a 2.2 INR has some room to fall in the event of it dropping say 0.4 to 1.8 as opposed to an INR of 1.8 which would drop to 1.4 which is way too low. The second reason is that there is a variance in INR depending on where it's taken (lab, meter etc) and 2.2 gives room for error while 1.8 and certainly 1.5 do not give any room for error.

Personally, I think it's totally irresponsible of manufacturers to recommend such a low INR.It seems to me that they're willing to risk lives for a marketing gimmick.

You might want to look into that lawyer!
 

Cherie'

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That is the way I feel. It is totally irresponsible of the manufacturer to recommend this and want to know how many other patients have had the experience I did.

CHerie'
 

pellicle

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Cherie';n878778 said:
That is the way I feel. It is totally irresponsible of the manufacturer to recommend this ...
If you take that angle you will very probably fail; the better angle is the (to me obvious) mismanagement of the protocol by your medical team.

Just my view...
 
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LondonAndy

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This has been an interesting thread to read, though I am very sorry, Cherie, for all that you have been through, despite your protestations to medical professionals. I have seen the On-X advertised a lot since I started looking around AVR forums, (I have a St Jude) and am surprised nobody else who has one has commented so far. There must be somebody else who has one here? Any experiences to add?
 
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