Mechanical vs Tissue - need help deciding

[pellicle]

Hi

thanks for those links, very interesting reading.

I think the INR testing is a very crude way to manage the bleeding risk due to multiple factors inherent in how coumadin works and what the INR test is testing.

I noted that one of them was about only early bleeding reductions, I've not read it (or them) in full yet (busy schedule today) but it would support my understanding that the issue is in dealing with those having the genetic pre-disposition for their P450 being slower and thus having a higher INR response to initial dosing guidelines.

Anway, about crudeness, I agree that there are some issues which seem a bit crude about INR and determining it. However it has improved since PT as we now have a baseline norm if nothing else. Myself I'd like to see INR tuned better to the individual not to the "Norm" ... Back when I did my microbiology degree (over 30 years back now) I was struck by how "crude" many of the methods of classifying organisms was. One can not simply look at them, and back then there was no gene sequencing. So we did things like examine the shapes of their colonies on different growth media or add materials to their media (such as perhaps zinc oxide). As crude as these seemed they were quite accurate when triangulated.

For most people this is not an issue but for anyone who has one of these variants it can be more of an issue than we know. I will attach a few of the papers on this. ;-0

this is the key point, it comes down to how many are involved. Given that its a small percentage of the population (us) who are on anticoagulants and given that its a small section of that population who have problems with dealing with it then I think its pretty clear we're going to be simply fine tuning what we have VS hoping for much "better".

If we were to look at the history of warfarin we'd see that its one of the oldest drugs being prescribed and so has a huge history of actual in the field "live testing" and from all that data we've gathered we find that its pretty effective, not that hard to manage and essentially no clear side effects known.

Especially with self testing (well perhaps not so convenient for the US folks who seem to be struggling to get it) we have the capacity to make changes and keep within the ranges which (large amounts of) evidence has shown are safe.

Making everything safer for even more of us.

Of course these things are statistical and not a predictor of what will happen for you or me in particular, but given enough of us what will happen to the group.

In the past (and indeed right now) I have worked with helping some of those edge cases (such as a fellow who got consistent TIA's when doing "hard training", which I understood turned out to be platelet related and had an older tilting disc valve). Right now I'm helping a younger lad who has had a mitral valve done from a case of endo and due to him still being treated for ongoing vascular infection his INR is hard to bring into range. His dose varies from a stable 20mg for a few weeks, to then anything down to 10mg. They just changed his antibiotics a few days back and he's having a swing now.

Understanding it all and working with the tools I have we hope he avoids any clotting complications.

BTW in his case (with a still active infection) I understand a mechanical is the normal choice.

Again thanks for the readings.

Best Wishes

 

[Savymom]

I’ve had both a mechanical and a tissue valve. I did prefer my tissue valve as it was silent, and I never knew it was there. After full recovery, I felt completely normal. I chose mechanical on-x the second time to avoid a 3rd surgery.

The ticking was not something I was concerned about before surgery, but very surprised by after. It’s not so much the ticking/clicking noise it’s the knocking sensation. I feel each heartbeat in my chest like a mini jackhammer. Nobody really mentioned this to me. It’s an annoying sensation to me, but I’m getting used to it.

With that, even if I knew ahead of time about the knocking I’d still choose a mechanical valve to avoid a repeat surgery.

Coumadin isn’t bad, biggest hangup for me is remembering to take it. It’s my only medication, and I have a hard time remembering.

 

[rwsp768]

I had a ON-X installed in 2005, never heard any ticking and in fact the nurses have to use a stethoscope to listen as they can't believe it is so silent. Now because of the warfarin and the ON-X they lowered my INR from 2-3 to 1.5-2.5 which then caused me to have a TIA stroke so they say although they found blockage in one of the arteries that run up either side of the spine into the brain. Now I am back on INR 2-3 with no trouble in over two years. Believe me you don't want to go through a second surgery as I did because of a heart attack and needed a bypass. I woke up the following day and accused the doctor of beating me with rubber hose and baseball bats, he laughed and said the reason I hurt so bad is it is ten times worse when they have to open you more than once. My first surgery I was home in 3 days the last time was over a week.

 

[Paul1972]

I had a ON-X installed in 2005, never heard any ticking and in fact the nurses have to use a stethoscope to listen as they can't believe it is so silent. Now because of the warfarin and the ON-X they lowered my INR from 2-3 to 1.5-2.5 which then caused me to have a TIA stroke so they say although they found blockage in one of the arteries that run up either side of the spine into the brain. Now I am back on INR 2-3 with no trouble in over two years. Believe me you don't want to go through a second surgery as I did because of a heart attack and needed a bypass. I woke up the following day and accused the doctor of beating me with rubber hose and baseball bats, he laughed and said the reason I hurt so bad is it is ten times worse when they have to open you more than once. My first surgery I was home in 3 days the last time was over a week.

Hi rwsp768, my cardiologist suggests that I lower my inr but hearing stories like yours makes me reluctant to do so .Glad to hear you are doing well since raising your inr back up.

 

[tom in MO]

My range was initially 2-3 but lowered to 2-2.5 w/o any problems at all. For surgery I've lowered down to 1.3 w/o problem.

There are things other than your valve that can cause a stroke. I have a family member who had a stroke because they stopped warfarin to give her a tissue valve. She was on the warfarin for other things. Per stats about 5 years ago, ~25% of tissue valve patients are on warfarin for other cardiovascular problems.

 

[tom in MO]

...Especially with self testing (well perhaps not so convenient for the US folks who seem to be struggling to get it) we have the capacity to make changes and keep within the ranges which (large amounts of) evidence has shown are safe...

There is no "struggle" to get home testing supplies in the US. Everyone on this forum who is in the US has gotten home testing supplied if they wanted it. It's covered by Medicare, Medicaid and private insurance. The struggle comes if someone has their own idea of testing and it's not supported by either their doctor or insurance provider. But that's the same everywhere in the world. However in the US, if you've got the money, you can always buy what you want. If you've got the money, in the US you can even get things that are bad for you and you shouldn't have in the first place (think Michael Jackson and Prince).

 

[pellicle]

There is no "struggle" to get home testing supplies in the US. Everyone on this forum who is in the US has gotten home testing supplied if they wanted it.

Inconveniently that's not what I read here ... I'll have to start fishing out and naming you in the threads where people who live in the USA ask:

• where can I buy my own machine
• where can I buy my own supplies
• I was told I can't buy supplies because they require a preseciption

you say:

However in the US, if you've got the money, you can always buy what you want.

So unless you mean the black market or buying overseas I suggest that the medical system seems to have Gimped the US non insured citizens.

Indeed your own discussion seems to suggest this too:
https://www.valvereplacement.org/threads/couagchek-test-strips.886294/

 

[Keithl]

I have to agree with Patrick. I got my St Jude mechanical 2 1/2 years ago and it is great. I labored to decide what type of valve. Went into surgery thinking bio valve and came out with a mechanical because of size and space. Boy was I happy. As it turns out after the fact (surgery) the most important factor for me was to NEVER go through open hear surgery again. Prior to surgery warfarin was an issue for me but turns out not to be so bad. I do weekly testing and quite easily stay in my 2-3 range. I do miss being able to use anti inflammatory meds. I have a knee issue and some arthritis but Tylenol works ok. I am 68 and plan to live to 100. I consulted two surgeons (Cleveland Clinic and Duke), both were about the patient having significant input on what type of valve. However, when I had surgery at Duke the surgeon made the final decision during surgery. We talked about the options and had a joint plan before going to surgery. I do hear mine a bit at night, in bed, but no one else does, it is not bothersome to me.

Sad that Duke surgeon made a decision for you. The surgeon at Cleveland spent over 30 minutes talking to me about my condition and options and provided info for me, but let me make the final decision. Even morning of surgery the surgeon chatted with me in OR before surgery reviewing option and asking if I had read some documentation he gave me night before. Zero pressure or bias, truly respect his integrity in the process.

 

[marvsehn]

Inconveniently that's not what I read here ... I'll have to start fishing out and naming you in the threads where people who live in the USA ask:

• where can I buy my own machine
• where can I buy my own supplies
• I was told I can't buy supplies because they require a preseciption

you say:


So unless you mean the black market or buying overseas I suggest that the medical system seems to have Gimped the US non insured citizens.

Indeed your own discussion seems to suggest this too:
https://www.valvereplacement.org/threads/couagchek-test-strips.886294/

You should be able to easily have insurance in the US even if you cant get

Sad that Duke surgeon made a decision for you. The surgeon at Cleveland spent over 30 minutes talking to me about my condition and options and provided info for me, but let me make the final decision. Even morning of surgery the surgeon chatted with me in OR before surgery reviewing option and asking if I had read some documentation he gave me night before. Zero pressure or bias, truly respect his integrity in the process.

At Duke the doc made the right decision, we had discussed the possibility and it was the best solution, I completely agreed and was elated to have a mechanical valve after going through the surgery.

 

[pellicle]

You should be able to easily have insurance in the US even if you cant get

I'm unsure what this means.

However from what I see (on the outside) is this:
https://www.pbs.org/healthcarecrisis/uninsured.html
About 44 million people in this country have no health insurance, and another 38 million have inadequate health insurance. This means that nearly one-third of Americans face each day without the security of knowing that, if and when they need it, medical care is available to them and their families.

I'm willing to bet that this is the people on lower incomes.

Self testing is in reality inexpensive, but appears to made expensive in the USA by the controls placed over it. I buy my strips in Australia for about AU$6 each and when I'm in Finland I buy them from Germany for about €6 each.

I pay nobody to do my INR and dose evaluation, which I self taught (and iteratively improved).

 

[rwsp768]

Hi rwsp768, my cardiologist suggests that I lower my inr but hearing stories like yours makes me reluctant to do so .Glad to hear you are doing well since raising your inr back up.

Paul my advise is don't let them lower your INR it taken a full year from them lowing it till I had my TIA. Sure hated spending another 3 days in the hospital.

 

[pellicle]

Paul my advise is don't let them lower your INR it taken a full year from them lowing it till I had my TIA. Sure hated spending another 3 days in the hospital.

I'm also one who disagrees with the benefits of lowering the INR below 2, it is to me pure marketing on the part of On-X and their test was super tightly controlled and over a short duration.

There is also very little evidence to suggest being between 2 ~ 3 (for an Aortic valve) brings any significant increase in bleeding.

I view it as playing to the public phobia of "Blood Thinners"

 

[Keithl]

I'm also one who disagrees with the benefits of lowering the INR below 2, it is to me pure marketing on the part of On-X and their test was super tightly controlled and over a short duration.

There is also very little evidence to suggest being between 2 ~ 3 (for an Aortic valve) brings any significant increase in bleeding.

I view it as playing to the public phobia of "Blood Thinners"

Yeah, I agree. To me while they are telling me after 3 months I can go 1.5-2.0 I plan on staying closer to 2.5. I can’t see that gambling with possible TIA to stay just below 2 vs. the minimal increased bleed rick to be at 2.5 is not worth it.

 

[pellicle]

Yeah, I agree. To me while they are telling me after 3 months I can go 1.5-2.0 I plan on staying closer to 2.5. I can’t see that gambling with possible TIA to stay just below 2 vs. the minimal increased bleed rick to be at 2.5 is not worth it.

agreed ... the way I interpret the On-X study findings is that you can find yourself at just under 2 and feel that you don't need to panic about raising your INR, but don't "build you house there".

I feel the same is also true of the other current bileaflet valves

 

[vitdoc]

I have had a St. Jude valve since 1983. It was replaced in 2006 with Aortic Aneurysm surgery. I have tried to keep my INR around 2.5. I have had over the years several episodes of temporary partial loss of vision due to retinal arterial transient blockages. I am a retinal surgeon so I know what they are.
Fortunately they have all cleared within a few minutes. No other neurological issues. No ASA.
I think the info on the ON X valve is a significant amount of marketing. On their site the chart they show suggests there was a significant increase in ischemic episodes at the lower INR.

Many studies are set up to show "Non inferiority". I suppose they showed this within the statistical significance of the study. The data they showed did not engender a warm and fuzzy feeling that indeed this is true. It costs a lot of money to run one of these studies. St. Jude could do the same and I would guess their results would mimic those of the ON X. If ON X did not claim that the INR could be lowered probably they would not sell too many valves. Many physicians don't look at the details of these studies. They get the bottom line often from the sales rep.
I think that probably a slightly higher INR is better at decreasing the potential embolic complications with possibly a slightly higher risk of hemorrhage. Also interestingly they did this study with the concomitant use of aspirin. Not sure why they did that other than they thought somehow it might make the study go in their hoped for direction. In real life aspirin with warfarin is not routinely used. I see the drug industry in my field inundate us with studies trying to influence our use of their products. Some of the studies are OK a lot are mediocre. The number of journals in my field have proliferated in the last few years mostly supported by drug companies to get out these studies to influence our use of their meds. I am extremely distrustful of much of these.
I think the ON X data somewhat fits in the maybe category. I would love to see follow up studies especially between the different valves with larger patient populations for longer times. Don't hold your breath for this to happen.

 

[Gordo60]

Hey @vitdoc I was thinking of you yesterday.

I attended a conference on Marfan and aneurysm / aortopathy yesterday. It included both medical specialists / surgeons and those laypeople with aneurysm and Marfan syndrome. Given the lense issue associated with these genetic disorders one of the presenters gave a talk on related eye conditions and showed a video of repositioning a dislocated lense by suturing in place a metal ring. Even some of the aortic surgeons there cringed when seeing a needle like object being inserted through the main white area of the eyeball to pull things into place.

I as a non medical person also got to see videos of aortic procedures (eg valve sparing / PEARS procedures) as well. I managed not to faint.

 

[Paul1972]

I have had a St. Jude valve since 1983. It was replaced in 2006 with Aortic Aneurysm surgery. I have tried to keep my INR around 2.5. I have had over the years several episodes of temporary partial loss of vision due to retinal arterial transient blockages. I am a retinal surgeon so I know what they are.
Fortunately they have all cleared within a few minutes. No other neurological issues. No ASA.
I think the info on the ON X valve is a significant amount of marketing. On their site the chart they show suggests there was a significant increase in ischemic episodes at the lower INR.
View attachment 887084

Many studies are set up to show "Non inferiority". I suppose they showed this within the statistical significance of the study. The data they showed did not engender a warm and fuzzy feeling that indeed this is true. It costs a lot of money to run one of these studies. St. Jude could do the same and I would guess their results would mimic those of the ON X. If ON X did not claim that the INR could be lowered probably they would not sell too many valves. Many physicians don't look at the details of these studies. They get the bottom line often from the sales rep.
I think that probably a slightly higher INR is better at decreasing the potential embolic complications with possibly a slightly higher risk of hemorrhage. Also interestingly they did this study with the concomitant use of aspirin. Not sure why they did that other than they thought somehow it might make the study go in their hoped for direction. In real life aspirin with warfarin is not routinely used. I see the drug industry in my field inundate us with studies trying to influence our use of their products. Some of the studies are OK a lot are mediocre. The number of journals in my field have proliferated in the last few years mostly supported by drug companies to get out these studies to influence our use of their meds. I am extremely distrustful of much of these.
I think the ON X data somewhat fits in the maybe category. I would love to see follow up studies especially between the different valves with larger patient populations for longer times. Don't hold your breath for this to happen.

I have had a St. Jude valve since 1983. It was replaced in 2006 with Aortic Aneurysm surgery. I have tried to keep my INR around 2.5. I have had over the years several episodes of temporary partial loss of vision due to retinal arterial transient blockages. I am a retinal surgeon so I know what they are.
Fortunately they have all cleared within a few minutes. No other neurological issues. No ASA.
I think the info on the ON X valve is a significant amount of marketing. On their site the chart they show suggests there was a significant increase in ischemic episodes at the lower INR.
View attachment 887084

Many studies are set up to show "Non inferiority". I suppose they showed this within the statistical significance of the study. The data they showed did not engender a warm and fuzzy feeling that indeed this is true. It costs a lot of money to run one of these studies. St. Jude could do the same and I would guess their results would mimic those of the ON X. If ON X did not claim that the INR could be lowered probably they would not sell too many valves. Many physicians don't look at the details of these studies. They get the bottom line often from the sales rep.
I think that probably a slightly higher INR is better at decreasing the potential embolic complications with possibly a slightly higher risk of hemorrhage. Also interestingly they did this study with the concomitant use of aspirin. Not sure why they did that other than they thought somehow it might make the study go in their hoped for direction. In real life aspirin with warfarin is not routinely used. I see the drug industry in my field inundate us with studies trying to influence our use of their products. Some of the studies are OK a lot are mediocre. The number of journals in my field have proliferated in the last few years mostly supported by drug companies to get out these studies to influence our use of their meds. I am extremely distrustful of much of these.
I think the ON X data somewhat fits in the maybe category. I would love to see follow up studies especially between the different valves with larger patient populations for longer times. Don't hold your breath for this to happen.

Hi vitdoc, I’ve had a couple of episodes since my surgery of sudden double vision lasting up to 10 minutes then clearing.Maybe my symptoms are retinal blockages like you have had, could they of caused double vision?Ive never let my inr go below 2 since surgery so I’m thinking mine could be micro particles left from surgery.

 

[Paul1972]

Paul my advise is don't let them lower your INR it taken a full year from them lowing it till I had my TIA. Sure hated spending another 3 days in the hospital.

Hiresp768, thanks for your reply I’m not going to let them lower my inr I will keep it as it is.Sorry to here about your issues, wishing you well for the future. Regards Paul

 

[Gordo60]

Hopefully this hasn’t been posted before. An excellent discussion between aortic valve surgeons. Also includes discussion on a new mechanical TAV which doesn’t require anti-coagulant treatment. I didn’t realise that warfarin is needed because of the open / close nature of the mechanical valve as opposed to it being a foreign body.

https://www.eacts.org/vimeo-video/choosing-mechanical-or-bioprosthetic-valves-for-younger-patients/

 

[egar]

Ive never let my inr go below 2 since surgery so I’m thinking mine could be micro particles left from surgery.

In the first couple of months after surgery, I had a few episodes to the blockages above 2.5 INR, so my cardiologist asked me to keep my range between 3-3.5. No blockages since. I’d been toying with the idea that issues I had before were related to how close I was to surgery, microparticles (if that’s a thing) or something similar. Can anyone comment on that? I’d like to move to a little larger and lower INR range. I’m talking to the cardiologist soon, but experience from members here is sometimes as (or more) valuable than the cardio’s.