On another forum, the research that showed the very limited evidence supporting an INR of 1.5 - 2.0 for On-X didn't provide long-term follow-up, and was a very limited study. If I had an On-X valve, I wouldn't bet my life on the results of this limited study. It's not a big deal to live with an INR of 2.0 to 3.0 (more difficult to keep in range between 1.5 and 2.0, or between 2.0 and 2.5 - especially because these numbers can't be considered to be 'exact,' anyway).
It's difficult to keep INR between 1.5 and 2.0, just as it's difficult to keep it between 2.0 and 2.5, or 2.5 and 3.0. That's the nature of INR testing - it's not exact, management isn't as easy as dialing up a 'dosage' wheel and locking it in. The issue with On-X isn't that it's hard to maintain 1.5 - 2.0 -- the risk is higher than the benefit of not having to maintain a slightly higher INR.
Perhaps I don't believe that 'high is good' -- I believe that 'high (2.0 - 3.0 or so) is SAFE.' There's a difference.
The reason for this group of biased ignoramuses (ignoramusi?), myself included, advocate for ranges above 2.0 - even for On-X - is that the slightly higher INR is protective and doesn't alter lifestyle or daily activities any more than a 1.5 - 2.0 does. WHY NOT BE SAFE?
A paper, May 18, 2015, from the American College of Cardiology specified a 'target' value of 2.5 for Aortic Valves, with a range of 2.0 - 3.0 (most likely because it's not possible to 'hit' and maintain INR at that target). For a mechanical Mitral valve, it's .5 higher.
Global RxPH also shows a target of 2.5, with a range of 2.0 - 3.0.
If it's possible to maintain a range of 2.0 - 2.5, as your clinic wants to do, this range will be ignoring the recommended range of 2.0 - 3.0. It will ignore the recommendation that 2.5 - 3.0 is ALSO within the recommended range. SO - we (the 'higher is better' bigots) aren't actually advocating for INR that's out of range - we're just advocating for the use of recommendations as recent as those from 2017. I'd like to see what you're quoting as the source of this recommended 'narrower' range. I don't think it really makes much of a difference, anyway.
The 'attractiveness' of a valve that may require lower INR (ON-X) is pure marketing B.S. You still have to take Warfarin (I haven't seen where one 81 mg aspirin a day is adequate), and you still have to take your INR. Where's the benefit? The other valves have decades of positive results - I'm not sure what the On-X delivers aside from slightly better design (maybe) and materials (maybe), and a still unproven ability to function at lower INR. (Perhaps the manufacturer should play up the possible advantages, and ignore the bogus claim about INR). (Perhaps, in a few years, something else will come along, and none of this would matter to patients getting new treatments).
One other thing -- the CoaguChek XS has a history of reporting .2 or so above labs. If your INR, according to a CoaguChek XS is right at 1.5, it's not impossible that your LAB results would be closer to a spot slightly UNDER 1.5. Personally, this biased 'higher is better' bigot would rather have an INR above 2 for an On-X valve than to keep it below 2. If I was convinced that 1.5 on a CoaguChek XS is safe, would a lab's 1.3 ALSO be safe?
Until long term studies confirm that it's safe for On-X recipients to maintain INRs between 1.5 and 2.0, I wouldn't want to take - or recommend - that risk.
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Disparaging comments have been made about the clinics because some clinics deserver to be disparaged. These clinics often use outdated and, in some cases, completely inaccurate protocols. ANY anticoagulation clinic that wants you tested every month, or even less often, has a real problem keeping up with the literature. It's irresponsible to test that infrequently - unless the clinic knows that you also test weekly with your own meter. (There's abundant literature that says people who self-test weekly are in range for longer periods than clinics that test less frequently - weekly self-testing is a standard of care). I've gone to a clinic that used outdated protocols - and these protocols come from the medical 'experts' -- not the technicians at the clinic. Worse, the people in the clinic could not deviate from the protocols or make changes from the protocol's recommendations.
You won't get an argument from me to your comment that the clinics probably know more than your cardiologist or surgeon. They probably DO. But there's a medical director somewhere, and the protocols defined by that medical director may be outdated or just incorrect.
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I haven't polled the 'majority of the medical profession involved in Warfarin therapy' as you must have, so I don't know their recommendations, but I would be surprised to see the overall recommendations for mechanical valves (other than On-X) being 2 - 2.5. My doctors have never suggested this. It's hard to keep within that narrow a range.
If you don't mind risking a stroke, pulmonary embolism, or other pleasant 'gift of the day,' set your INR as low as you want. If not, there's really no harm listening to us idiots advocating for ranges above 2.0 -- even for On-X valves.
It's difficult to keep INR between 1.5 and 2.0, just as it's difficult to keep it between 2.0 and 2.5, or 2.5 and 3.0. That's the nature of INR testing - it's not exact, management isn't as easy as dialing up a 'dosage' wheel and locking it in. The issue with On-X isn't that it's hard to maintain 1.5 - 2.0 -- the risk is higher than the benefit of not having to maintain a slightly higher INR.
Perhaps I don't believe that 'high is good' -- I believe that 'high (2.0 - 3.0 or so) is SAFE.' There's a difference.
The reason for this group of biased ignoramuses (ignoramusi?), myself included, advocate for ranges above 2.0 - even for On-X - is that the slightly higher INR is protective and doesn't alter lifestyle or daily activities any more than a 1.5 - 2.0 does. WHY NOT BE SAFE?
A paper, May 18, 2015, from the American College of Cardiology specified a 'target' value of 2.5 for Aortic Valves, with a range of 2.0 - 3.0 (most likely because it's not possible to 'hit' and maintain INR at that target). For a mechanical Mitral valve, it's .5 higher.
Global RxPH also shows a target of 2.5, with a range of 2.0 - 3.0.
If it's possible to maintain a range of 2.0 - 2.5, as your clinic wants to do, this range will be ignoring the recommended range of 2.0 - 3.0. It will ignore the recommendation that 2.5 - 3.0 is ALSO within the recommended range. SO - we (the 'higher is better' bigots) aren't actually advocating for INR that's out of range - we're just advocating for the use of recommendations as recent as those from 2017. I'd like to see what you're quoting as the source of this recommended 'narrower' range. I don't think it really makes much of a difference, anyway.
The 'attractiveness' of a valve that may require lower INR (ON-X) is pure marketing B.S. You still have to take Warfarin (I haven't seen where one 81 mg aspirin a day is adequate), and you still have to take your INR. Where's the benefit? The other valves have decades of positive results - I'm not sure what the On-X delivers aside from slightly better design (maybe) and materials (maybe), and a still unproven ability to function at lower INR. (Perhaps the manufacturer should play up the possible advantages, and ignore the bogus claim about INR). (Perhaps, in a few years, something else will come along, and none of this would matter to patients getting new treatments).
One other thing -- the CoaguChek XS has a history of reporting .2 or so above labs. If your INR, according to a CoaguChek XS is right at 1.5, it's not impossible that your LAB results would be closer to a spot slightly UNDER 1.5. Personally, this biased 'higher is better' bigot would rather have an INR above 2 for an On-X valve than to keep it below 2. If I was convinced that 1.5 on a CoaguChek XS is safe, would a lab's 1.3 ALSO be safe?
Until long term studies confirm that it's safe for On-X recipients to maintain INRs between 1.5 and 2.0, I wouldn't want to take - or recommend - that risk.
---
Disparaging comments have been made about the clinics because some clinics deserver to be disparaged. These clinics often use outdated and, in some cases, completely inaccurate protocols. ANY anticoagulation clinic that wants you tested every month, or even less often, has a real problem keeping up with the literature. It's irresponsible to test that infrequently - unless the clinic knows that you also test weekly with your own meter. (There's abundant literature that says people who self-test weekly are in range for longer periods than clinics that test less frequently - weekly self-testing is a standard of care). I've gone to a clinic that used outdated protocols - and these protocols come from the medical 'experts' -- not the technicians at the clinic. Worse, the people in the clinic could not deviate from the protocols or make changes from the protocol's recommendations.
You won't get an argument from me to your comment that the clinics probably know more than your cardiologist or surgeon. They probably DO. But there's a medical director somewhere, and the protocols defined by that medical director may be outdated or just incorrect.
---
I haven't polled the 'majority of the medical profession involved in Warfarin therapy' as you must have, so I don't know their recommendations, but I would be surprised to see the overall recommendations for mechanical valves (other than On-X) being 2 - 2.5. My doctors have never suggested this. It's hard to keep within that narrow a range.
If you don't mind risking a stroke, pulmonary embolism, or other pleasant 'gift of the day,' set your INR as low as you want. If not, there's really no harm listening to us idiots advocating for ranges above 2.0 -- even for On-X valves.
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