Choosing either the On-X or St. Jude Regent...opinions?

[ARGreenMN]

I think I did the same Pat - got a little cocky cause things were going so well the first couple weeks, and might have overdone it a little. Scaling things back again now - trying to pretend I'm sick or something so I don't do too much

 

[dtread]

Just to clarify some MISINFORMATION in this thread. The standards for INR values for mechanical heart valves are published in the Journal of the American College of Cardiology as the American College of Cardiology/American Heart Association (ACC/AHA) Guidelines. The latest are the 2006 Guidelines, titled the "ACC/AHA 2006 Guidelines for the Management of Patients with Valvular Heart Disease", in section 7.2.2.1 and in section 9.2 and 9.2.1. You can find a link to this document in the references section of this forum. Basically for low risk patients with a bileaflet mechanical heart valve the recommended INR value for the aortic position is 2.5 to 3.5 for the first three months and then 2.0 to 3.0 after that, PLUS low dose aspirin. High risk patients and valves in other positions (e.g., mitral) require higher INR. These values are not broken out by bileaflet valve brand for a higher or lower INR for a specific brand of valve. And there are no valves that have been approved to get a lower INR than what is specified in the Guidelines.

Also, the only valve that has an ongoing Clinical Trial for reduced anticoagulation is the On-X. This is Clinical Trial number NCT00291525, found at www.clinicaltrials.gov The On-X Clinical Trial for reduced anticoagulation has several test arms, one of which involves Clopidogrel (i.e., Plavix) plus low dose aspirin instead of Warfarin. For the test arm with reduced Warfarin, the INR range for the aortic position is 1.5 to 2.0 plus low dose aspirin. This Clinical Trial is not expected to be complete until around 2015. If you're not in the Clinical Trial your recommended INR values are as in the 2006 ACC/AHA Guidelines. And this applies whether you have an On-X or any other bileaflet mechanical heart valve. And if you have an On-X your recommended INR values are as in the 2006 Guidelines until the Clinical Trial is completed.

I wish that folks would not post MISINFORMATION on this site. Please do research before you post blanket statements that can have SEVERE MEDICAL CONSEQUENCES.

I am not a medical professional and nothing I have posted here is to be construed as medical advice. Consult with your Doctor.

 

[ARGreenMN]

dtread, I'm not sure if you're referring to my comments being part of the "misinformation" on here, but with respect, my surgeon set my recommended INR range at 1.8-2.2 for the St. Jude Regent he put in on 5/5/2010. And it sounds like Pat's doc has set his at 1.5 - 2.5 with his On-X he just had put in recently as well. So, either we both have quack doctors or there must be new info (post-2006) that they're both privy to. I've posted a pic of my Warfarin bottle on this site recently because others were questioning the range. I've got an appt with my surgeon on 6/6 and I'm already planning to ask him to remind me why he set my target (2.0) and range (1.8-2.2) so low and tight, but I distinctly remember him telling me (as we were discussing On-X vs. Regent) that they both tolerate lower INRs than other mechanical valves. Till then, I'm gonna try to rest well, even though I'm not in compliance with the 2006 guidelines. PS - I am on low-dose aspirin per the 2006 guidelines.

 

[ARGreenMN]

Bina, Luana and Phillip B (or anyone else with a Regent), it sounds like you all got the Regent like I did. Just out of curiosity (if you don't mind sharing) what is your recommended INR range?

 

[Dennis S]

Nearly five years ago, my surgeon put in a St Judes and
recommended INR at 1.8 to 2.5. My GP liked a range of
2-3. It turns out life is really easy between 2&3, so that's
what I shoot for.

 

[Ross]

Just to clarify some MISINFORMATION in this thread. The standards for INR values for mechanical heart valves are published in the Journal of the American College of Cardiology as the American College of Cardiology/American Heart Association (ACC/AHA) Guidelines. The latest are the 2006 Guidelines, titled the "ACC/AHA 2006 Guidelines for the Management of Patients with Valvular Heart Disease", in section 7.2.2.1 and in section 9.2 and 9.2.1. You can find a link to this document in the references section of this forum. Basically for low risk patients with a bileaflet mechanical heart valve the recommended INR value for the aortic position is 2.5 to 3.5 for the first three months and then 2.0 to 3.0 after that, PLUS low dose aspirin. High risk patients and valves in other positions (e.g., mitral) require higher INR. These values are not broken out by bileaflet valve brand for a higher or lower INR for a specific brand of valve. And there are no valves that have been approved to get a lower INR than what is specified in the Guidelines.

Also, the only valve that has an ongoing Clinical Trial for reduced anticoagulation is the On-X. This is Clinical Trial number NCT00291525, found at www.clinicaltrials.gov The On-X Clinical Trial for reduced anticoagulation has several test arms, one of which involves Clopidogrel (i.e., Plavix) plus low dose aspirin instead of Warfarin. For the test arm with reduced Warfarin, the INR range for the aortic position is 1.5 to 2.0 plus low dose aspirin. This Clinical Trial is not expected to be complete until around 2015. If you're not in the Clinical Trial your recommended INR values are as in the 2006 ACC/AHA Guidelines. And this applies whether you have an On-X or any other bileaflet mechanical heart valve. And if you have an On-X your recommended INR values are as in the 2006 Guidelines until the Clinical Trial is completed.

I wish that folks would not post MISINFORMATION on this site. Please do research before you post blanket statements that can have SEVERE MEDICAL CONSEQUENCES.

I am not a medical professional and nothing I have posted here is to be construed as medical advice. Consult with your Doctor.

My dear friend, please remember one thing about those guidelines, they are just that, guidelines. There is nothing set in stone about INR anywhere. They leave it up to the doctors to decide. I still do not agree with the lower INR's that some are using. I do not think there is enough evidence to suggest this is a safe thing to do, but they are doing it now. What we really need is, for all doctors to be on the same page and using the same exact protocols across the board. I don't think we'll ever see that happen, at least not in my lifetime.

In Andy's case, those of us older rat poison users know that a .5 window is near impossible, if not impossible to maintain. Whenever a physician suggests such a thing, it tells us automatically that doctor doesn't get it. INR is not a constant and is forever changing. Tests can be off as much as .5 which furthers my doubts about the safety of these lower INR's. Lets say you tested at 1.8 but your actual is 1.2. Your not anticoagulated AT ALL. I guess we'll see in due time if this is indeed safe. I just can't see placing someone in range of stroking because of someone not understanding the drug.

 

[ARGreenMN]

For what it's worth, I'd be a lot more nervous if I got down towards the lower end of my range (1.8) than I have been when I've been at or above the upper end (2.2). In my mind, I'm really shooting for 2.0 - 2.5. My primary physician agrees with that, especially given these recent a-fib events. And I must say, so far (while it's still really early in the game) we've been able to keep it fairly constant (2.5, 2.5, 2.2, 2.1, 2.7 and 2.5). But, with the recent addition of Amiodarone to my pill box, we'll be watching it closely for a while. After starting Amio, I went from 2.1 to 2.7 (and they were afraid it might be heading higher). So they lowered my Warfarin from 4 mg to 3mg. It seemed to work - getting me back down to 2.5. But we're still watching closely (going in again tomorrow). If it starts getting down close to 2.0, I'll be a little concerned about being only on 3 mg, fearing it might be heading lower. But if it's still up around 2.2-2.5, I'll feel ok about it (until we start tapering off the Amio).

By the way, I don't know this for a fact, but part of my super tight range might have been due to me telling them pre-surgery how constant my diet is (I prefer a boring, constant diet - helps me maintain my weight). And so far (although I know it's WAY early) I'm not having much trouble keeping it in a pretty tight window (2.1-2.7), even with the recent addition of Amiodarone.

 

[Ross]

Just don't get upset if your between 2 and 3. You'll soon find that 2 to 2.5 is near impossible to maintain, if you can, your more then lucky.

 

[Bill B]

Just FYI, the ACC/AHA 2006 guidelines were updated in 2008, primarily incorporating newer guidelines for endocarditis prophylaxis and management. The anticoag guidelines noted above did not change.
http://circ.ahajournals.org/cgi/reprint/118/15/e523.pdf

Also, the American College of Chest Physicians anticoagulation guidelines were updated in 2008.
http://chestjournal.chestpubs.org/content/133/6_suppl/593S.full.html

For aortic mechanical valves of the type we have, they propose:

6.0.2. In patients with a bileaflet mechanical valve
or a Medtronic Hall (Minneapolis, MN) tilting
disk valve in the aortic position who are in sinus
rhythm and without left atrial enlargement, we
recommend VKA therapy (target INR, 2.5; range,
2.0 to 3.0) [Grade 1B].

Pick your reference guideline of choice.

As to "low-intensity" warfarin +/- ASA, I wish I knew of some published data. My surgeon, clearly among the most respected there is, recommended INR 1.5-2.5 + low-dose ASA for me. My cardiologist wanted 2.5-3.5 w/o ASA. We compromised at 2-3 w/o ASA, which is consistent with the ACCP guidelines above, although 0.5 less than the ACC/AHA guidelines. All of us are happy with that. Also, at this point, we'll even let it go as high as 3.5 but not below 2 w/o requiring more frequent monitoring. When I get much older where I suspect the risks of bleeding are greater, we'll tighten that up. Honestly, despite all the studies and published guidelines, I still think this is more art than science.

 

[daveguy14]

Does anyone know the rationale for the recommendation of 2.5-3.5 the first three months, and 2-3 thereafter? My doc told me this too, but I forgot to ask why.

 

[Ross]

Does anyone know the rationale for the recommendation of 2.5-3.5 the first three months, and 2-3 thereafter? My doc told me this too, but I forgot to ask why.

Some believe that your more so able to develop a clot early on after replacement. I don't think this is true, but more of myth. There is little diffference between the two ranges, so I wouldn't let it bother me any.

 

[Woodbutcher]

It would seem that the most numerous and common guidelines are either 2.0-3.0 or 2.5-3.5 for mech valves. I have to agree with Ross and others, especially as I've been using Warfarin for some time too, that an INR between 2.0 and 4.0 really is a practical range. If I were to go from 4mg a day to 3mg a day my inr would be dramatically effected, personally I have to only tweek mine by 1 or 2 mg per week to make a difference ! There are so many things that will effect your inr every day that to change your dose because of a rise from 2.1 to 2.7 is probably asking for trouble ? A broarder range and constant dose really is the way to go, otherwise you'll just end up chasing your target up, down and all over the place ?

 

[ARGreenMN]

I'm starting to see a pattern where it's the surgeons (in these rare cases like mine) who are recommending the lower range, then a more general practice type guy/girl that feels more comfortable w/ the traditional 2-3. That's true in my case, and I think I've read it a couple more times in here now.

Anyone have thoughts on what might be going on there? Do surgeons get a kickback from the valve mfg. for recommending a lower range or something? Or, are the general practice guys just a little "behind the times"? The right answer is probably what Bill said - it's all more of an art than a science... But it will be interesting to see what Dr. Emery has to say about all this here in a week or so. And he's not a guy to pull any punches, so it should be an interesting conversation. When I was asking about all the options (minimally invasive, tissue vs. mechanical, St. Judes Regent vs. On-X, etc, etc.) one thing I asked was whether I might be a candidate for a Ross procedure. He said if you want that, go somewhere else (i.e. he's pretty direct). Anyway, it should be interesting! Bottom line for me right now, I'm gonna feel comfortable anywhere between 2 and 3, with something at or just below 2.5 being 'perfect'.

 

[Ross]

Like I said earlier, to us older self dosers, what that doctor is saying translates into, he doesn't understand INR. "Behind the times", I like that.

 

[daveguy14]

My surgeon said he'd ideally like to see me around 2.0, but admitted a bias as a surgeon that he is more worried about bleeding than, say, a cardiologist is. Recommending different ranges doesn't mean the docs don't know what they're doing; they just have different values and experiences. Besides, there is no single ideal value for everyone.

 

[Ross]

Thing is, all of these doctors treat Coumadin as if it changes your blood to water and it's not like that at all. They overthink things without realizing that being too low can cause a stroke.

 

[james]

Recommendations are just that....recommendations.

They say medicine is a practice.

Disclaimer: I am on Plavix and aspirin.

 

[dtread]

I'm just wondering how it would play out with some Doctors apparently recommending lower INRs than the recommended ACC/AHA guidelines if they have a patient that strokes. Does the patient have a case for a lawsuit? Perhaps. Just wondering what scientific or clinical basis these Doctors are basing lower INRs than the recommended ACC/AHA guidelines. Just gut instinct? You have to figure that the guidelines probably have some margin for error; i.e., in favor of over-anticoagulating. But its a dangerous game to play since stroking is not fun. And for a Doctor to be recommending lower INR values than the ACC/AHA guidelines possibly leaves them open for a lawsuit in the event of a stroke. So that is why most would not want to adjust the values lower than the ACC/AHA guidelines.

 

[Ross]

I'm just wondering how it would play out with some Doctors apparently recommending lower INRs than the recommended ACC/AHA guidelines if they have a patient that strokes. Does the patient have a case for a lawsuit? Perhaps. Just wondering what scientific or clinical basis these Doctors are basing lower INRs than the recommended ACC/AHA guidelines. Just gut instinct? You have to figure that the guidelines probably have some margin for error; i.e., in favor of over-anticoagulating. But its a dangerous game to play since stroking is not fun. And for a Doctor to be recommending lower INR values than the ACC/AHA guidelines possibly leaves them open for a lawsuit in the event of a stroke. So that is why most would not want to adjust the values lower than the ACC/AHA guidelines.

In my opinion, that is a valid question. I'm wondering myself given the history of how they react to situations.

Doctors fear bleeding, they do not fear stroking.

Bottom line, you can replace blood cells, you cannot replace brain cells.

 

[a4wanman]

My INR range is 2.5 - 3.5. Still working on getting it stable.

I have a St. Jude Regent.

Scott