Bi leaflet valves/ pradaxa/ managing INR

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markp66

Well-known member
Joined
Jul 18, 2011
Messages
177
Location
uk
Hi all

I just had a chat with Robert Emery MD of St Paul Minnesota about his experience with mechanical valves, one of many people I've spoken to over the last week. He strongly advises anyone who is in there 20's 30's to go for a mechanical valve if they don't participate in contact sports or have specific reasons why a mechanical valve wouldn't be suitable.. He pointed out that he is aware of a person who has had a bi leaflet valve for over 30+ years without any problems at present . Not bad considering the first one was implanted in 1977. Anyway, as we all know, valve failure itself is never really the issue but mainly the INR management.

Over the last few days I've spoken to numerous cardiologists and surgeons who think Pradaxa and another drug (which I can't recall the name of!!) will be a better alternative to Coumadin for heart valve patients in the not to distant future (very soon in fact), greatly reducing the risk of valve related events. This is all very promising.. If mechanical valves have an almost 0% failure rate and potentially less than 1% stroke/ bleeding event then mechanical valves could become a whole lot more attractive. There are two reasons for me why Pradaxa or a similar alternative would be so beneficial- First of all it seems to interact with very few drugs/ foods/ alcohol. Secondly, because of the few interactions- eating a healthy green diet, supplements such as omega 3, Q10, green tea etc won't be limited. Vitamin K intake also has the potential to reduce the risks of coronary heart disease...

However, even if Pradaxa wasn't a potential alternative and Coumadin was our only option for the rest of our lives......everyone I have spoken to mentioned that the 1-2% risk of bleeding/ stroke each year includes those who don't manage their INR well- people who have too much alcohol, forget the odd pill, take at different times of day, don't take care of what they eat, get involved in dangerous activities etc. I think this is very interesting as I'd like to see figures based on well managed INR levels (a few people have made this point on here over the last month). From my point of view I think the education on managing INR levels is extremely poor, especially in the UK. Sure, they give you the basic info but I find more info in hospitals about not using a razor and use a soft toothbrush etc etc. I don't know what others think but personally getting the odd cut which may result in bleeding for longer is irrelevant in the bigger picture. Regular home testing, consistent food intake (amount and content) at consistent times each day, being aware of other drug interactions etc all seem to be relatively overlooked. For me, managing the INR levels seem so easy (in theory.. I'll let you know how it goes when I'm at that stage!), mainly down to this great site and unfortunately a site that the majority of valve replacement patients don't know exists.

One other point.. I was amazed at how willing and how much time surgeons/cardiologists were able to give me (considering they all new I had no intention of using them as I'm in the uk). After emailing a quite a few, nearly all of them gave me their direct number to call and discuss. I was on the phone for nearly 45 mins to someone in New Jersey. I'm pretty sure if it wasn't for me having to go the conversation would have carried on much longer!
 
I'm not sure... sorry! The general consensus was warfarin will almost certainly be replaced at some point in the future. Pradaxa seems to be leading the way so far....
 
one major point that worries me about pradaxa/ similar coumadin alternatives is that there is no way to stop a bleeding event. Vitamin k inhibits the effect of coumadin. Hopefully they will figure something out in the not to distant future!
 
Hi Mark,

Good info. Keep posting what you learn, it is beneficial to all of us.

I have talked to my doc on Pradaxa (after seeing lot of advertisement duing US open :)). He seem to think that the drug is not yet ready as an alternative to Coumadin. He thinks that the Coumadin effects can be easily managed (i.e. can easily be reversed when needed by reducing the dosage), however no such flexibility exists with Pradaxa yet.

I am early in the usage of Coumadin (two weeks post-op), haven't found it bothersome yet. The only issue seem to be the variability of INR reading (2.1 one day, 1.6 two days later, 2.6 three days later), but am hoping that it will stabilize in next few weeks.

-Kumar
 
Kumar, I completely agree at present. I guess the whole point of Pradaxa is that it doesn't need to be managed (just taken as and when needed to). If they studied Pradaxa against WELL managed coumadin patients in the future then it would definitely be a benefit (it it came out favourably). As I said before, I'm pretty sure well managed INR reduces the 1-2% risk of a stroke/bleeding each year which is why home monitoring makes such a big difference (Does anyone agree with that?). Many people have lived on warfarin for 40 years and are still here, even when INR management was in it's infancy.

Pradaxa's main benefit however is it's lack of interaction with other food/ drugs. Going on holiday, drinking alcohol, varying food intake of vitamin K each day would not be something you would have to think about.
 
If they studied Pradaxa against WELL managed coumadin patients in the future then it would definitely be a benefit (it it came out favourably).

I'm not on ACT but seriously considered some of these issues during my pre-surgery process. When my surgeon began the "future" part of his mechanical valve discussion - covering Pradaxa and the On-X trials - I apparently got a very concerned look on my face because he quickly said "Well, YOU don't have to be a guinea pig, you could wait for adequate results before considering a switch."

I didn't ask, but sometimes I wonder how long that will be. I suppose there are always patients who because of individual circumstances are willing to volunteer, but it's not just a matter of getting trial approvals and meeting patient sample numbers, the trials themselves would need to be of sufficient length to convincingly measure results for many different age groups. Good initial results for 20 or 30 year olds may not mean much, since stroke and bleeding risks increase with age.

I have a family member with A-Fib, and based on some recent evaluations, Pradaxa certainly doesn't seem to be the definitive answer for that yet either, particularly with the bleeding issue. Anyway, like anything, things will no doubt improve in the future, we're all just left wondering how soon it will actually be.

Thanks for sharing all your research.
 
one major point that worries me about pradaxa/ similar coumadin alternatives is that there is no way to stop a bleeding event. Vitamin k inhibits the effect of coumadin. Hopefully they will figure something out in the not to distant future!

And there's no way to know if you're in danger of a bleeding event. At least with the INR the warfarin dose can be adjusted. I don't see anything about those that make Pradaxa desirable.
 
There has been a Warfarin(Coumadin) substitute "right around the corner" for at least 30+ years. Warfarin is one of the most widely used medicines in the world. Every pharmaceutical company would love to be able to PATENT a substitute....it would be worth BILLION$. Certainly, in time, someone will develop a substitute drug that can be marketed at a reasonable price....but don't hold your breath. It must not be easy to replace warfarin at a realistic cost.....and any new anti-cogulant will come with its own list of negatives. From some of the TV ads I've seen, these new meds may be an example of "the cure is worse than the disease"......but since they are not for "valve related problems", we can let the A-fibs and others work out the "bugs":wink2:. Meanwhile, take your warfarin as prescribed, test routinely.....and enjoy:thumbup:
 
I've noticed especially with heart patients there are no fix it and forget options at this point. I remember hearing a heart doctor talk about a situation that occurred with former President Bill Clinton a few years back, he said once a heart patient always a heart patient. Anything (bypass, valve repair/replace, pacemaker, heart attack) that is done with the heart at this present time comes with a "maintenance" list of some type. Don't eat this, don't do that, make sure you take this, call your doctor if you feel this...

I don't care what you have going on with your heart, once you have heart issues you are part of a special group.

I believe in my lifetime I will see the "ultimate" solution for heart valvers come to pass. There will be a valve choice that will be "one size" fits all in the next 50 years. There wont be a question of tissue or mechanical, there will just be one. These new valves will be so good that repair won't need to be an option, lets just replace it. We will get to the point to where heart disease will no longer be the #1 killer.

Till then, I'm on some kind of ACT and being thankful for still being alive. We truly need to live and enjoy one day at a time. I'm confident I'm not going to die from a heart/stroke/bleeding event, I'll probably get hit by lighting. :biggrin2:
 
My cardiologist brought this up at my yearly consult/echo appointment a couple of months ago.. he said that it has not yet been tested in the US I believe..

One of the biggest disappointments for me with Coumadin when I was diagnosed was that it crosses the placental barrier. So pregnancy and being able to carry my own child has been another huge hurdle since my mitral valve replacement. When I was told that I needed my valve replaced & would never be able to have children, not only was I upset about heart surgery & living forever on an anticoagulant, but I spent my nights thinking I'd never be a mother. In 2007 we had our son through a surrogate mother and the costs of IVF, lawyers, etc. was extremely expensive.. we are about to go through this once more next month as I've had a friend volunteer this time around, but the cost of our frozen embryo transfer, lawyer, etc. is once again, very expensive.. so I would LOVE to see a medication like coumadin that would NOT pass through the placenta come about so other young females don't have to go through all of this to have children.. I know it's a long shot.. but in my book, anything is possible..
 
I believe in my lifetime I will see the "ultimate" solution for heart valvers come to pass. There will be a valve choice that will be "one size" fits all in the next 50 years. There wont be a question of tissue or mechanical, there will just be one. These new valves will be so good that repair won't need to be an option, lets just replace it. We will get to the point to where heart disease will no longer be the #1 killer.

That would be wonderful.

But there always seems to be more than one option or choices in life.
With insulin-dependent diabetes, some people give themselves injections. Some use a pump. Some use the OmniPod. Some are able to lose enough weight to no longer require insulin.
There are numerous ways of replacing hip joints and numerous prosthetic joints available. Some are marketed for athletes, who put more stress on the artificial joints.
There are numerous protocols for treating cancers. Doctors use one plan, then go to another...

"One size fits all" -- I don't see it.
What would be great is more research into genetics/cause of valve disease and how to prevent the defect from ever occurring.
However, that would not rule out surgery needed to correct damage to heart valves due to accidents.
But it's a starter. Some families have a higher incidence of BAV than the general population. Other families have a high incidence of MV issues. Yet other families are affected by Marfans.
If you could reduce those, that would be terrific.
But I don't see it happening overnight or even within several decades. And no "one size fits all," for a variety of reasons.
 
I actually agree with Julian. A mechanical valve without coumadin would be the answer and I personally don't think this is unrealistic within the next few decades. Technology is moving at an amazing pace. I know it's not the same thing but who would have thought we would have a mobile phone where we can call, email, take photos, use the Internet, pay for stuff etc etc. That seemed way off 10 years ago! The same with medicine... Medical advances that we wouldn't have even thought of are now happening.

50 years ago heart valve surgery was a last resort with rare success with few exceptions. Now valve surgery had a 1% mortality rate, multiple reops are possible at a v low risk and coumadin is easier than ever to manage/ control. To the point where surgeons and csrdiologists are saying it is unlikely we will die from our valve issues..!Many new anticoagulant drugs seem promising and even stem cell advances to create heart valves are just around the corner. In fact we should be very lucky to be around now where we can expect a normal life (with a few complications nd modifications) after surgery. Mech valves will last forever, the coumadin risks are potentially less than 1% if taken correctly. My surgeon said he expects me to be around in 50 years. I certainly expect to be along with everyone else here!

Marsha- I agree about the whole genetics issue although is is probably beyond our lives. However, as I said, who knows what is around the corner! And yes there are many choices at the moment although that's a good thing in my opinion. However, as I mentioned before a mech valve that doesn't require coumadin would be a 'cure' in my opinion.

Julian, yes we are heart patients for life but there are more people out there with worse heart problems than us. We should all be thankful that we are checked on a regular basis. I'm sure many problems such as aortic aneurisms have been detected before a major event because we are check annually. Most people aren't so lucky... I know a lot of us feel more fragile being heart patients but again, who isn't.. I'd rather know about my condition rather than drop dead without having the chance to live.

Sorry my post has got a bit random but I started the post talking about bi leaflet valves being in patients 30+ years with no problems. 30 years time Im sure there will be people with these valves in for 60 years especially if we can find an even safer drug than coumadin.
 
However, as I mentioned before a mech valve that doesn't require coumadin would be a 'cure' in my opinion.

I know what you're saying, and agree, but let's be careful about the word "cure". I hesitate saying this, because I am an optimist by nature, but we should all be careful about our optimism too. While a mechanical valve without coumadin, or for that matter a tissue valve that could last 50 or more years, would change everything and improve so many lives, it unfortunately still wouldn't be a cure. There would still be risks (although slight) for things like pannus, endocarditis, and yes, stroke still too. As an example, tissue valves aren't risk free.

You know what, though...the treatment of a condition can often be close enough to normal to make a cure not as important anymore. I've been diabetic for 28 years, and they've been talking about a cure for it for a long time too. It's not here, yet, but I have a full range of treatment options that keep me very close to normal.

Sure, it would be great to have a cure, and make my treatment no longer necessary. But if I had a choice tomorrow for a transplant to cure my diabetes, I would certainly not jump at the chance, it would be a very tough decision. I might just stay as is, and keep doing what I've been doing. I wonder sometimes what a heart patient in a similar circumstance would do. Suppose somebody invents a mechanical valve that not only eliminates anticoagulation, but eliminates stroke and other risks completely...0.0%. If the option were available, would a mechanical valve patient risk another heart surgery to trade up to the new model?

I guess my point is this: we all are experiencing amazing technology and results already, in the here and now. If there ever should be a "cure" out there, maybe it won't help us. But that's ok too. We know at the very least it could help our kids or grandkids. And for the young members here, plan on being around to see it.

I hope I don't sound like I'm disagreeing with you...I probably do, but I'm really not. Just offering another random perspective on the future. Pradaxa or no Pradaxa, you still have very good reason to be optimistic.
 
I personally think we will see either a near perfect mech valve or 30-50 year tissue valve within the next 30 years. If this was the case I would risk surgery for this mainly because in 20-30 years time surgery will probably be less than 0.5% mortality rate for a relatively fit person. Multiple reops will be common. Although present mech valves can't be taken out by catheter, they will be certainly able to be replaced by minimal invasive surgery. This would make it easier to get past scar tissue, major bleeding events etc.

With the reliability of mech valves and low risk of complication at present, I would say we are as good as cured if we manage INR levels. As I mentioned before I'm pretty sure the 1-2% stroke/ bleed risk also includes people who don't manage their INR as well as others and who are irresponsible. As we know by now, the 1-2% risk per year does not add up over the years like some people (and even do doctors) think. Therefor the odds of living 20,30, even 50 years with one valve is very likely if there are no underlying conditions. Sure, we could have problems such as pannus, leaks etc but we could also get cancer or one of any other illnesses. And as I Previously said, we are constantly monitored over our lives so in most cases we can treatment as and when needed.

There are many patients coming over 30 years with the bi leaflet valves. In 30 years time some of these patients will still have these original valves!
 
Besides the bleeding reversal issue mentioned above, I forgot to mention another consideration my surgeon brought up about Pradaxa. It is effective (duration) and dosed for 12 hours, i.e. two a day. While this might seem a fairly trivial consideration, when you have a mechanical valve, any unnecessary exposure to stroke risk is likely still a little scary. So while it may be fairly easy overall to take the same pill at the same time every day when once a day, for 12 hours apart, though, that could actually be a little tougher. On most days, sure no big deal, but for those rare days that schedule is unexpected, etc, a late or missed dose (I think the rule is with Pradaxa you have to skip after 6 hours) could leave a valve patient in particular susceptible to stroke.

Now, I know a temporary lack of anticoagulation doesn't definitely mean stroke with a mechanical valve, in fact, it actually may only happen at a surprisingly low rate. But, you just never know, and I thought it was an interesting point to consider as Pradaxa, or others like it, move forward into valve patient trials. Transportable pill boxes and alarms even more important!
 
There is a 4% chance of a stroke without anticoagulation per year. I know it's not as simple as this but if you divided that by 365 days in a year that would give you a 0.01% chance each day so missing a tablet or taking it a few hours late wouldnt be terrbile news. However, if this happened often then you could get into trouble. But yes, any increase is significant. Who knows what the results of Pradaxa will be in the long term, the great thing is that we already have coumadin which millions of people cope with every day. For me it will be slightly annoying as I'm only 27 but it could be worse.
 
There is a 4% chance of a stroke without anticoagulation per year.

I'd seen you mention that in another thread...I'm curious where that number comes from? In other words, specific valve, patient age, etc? Does anyone actually volunteer to study this, or is it from something like the recent post on the On-X site about a poorly anticoagulated South Africa group?

You know, it may be only one individual patient and case, but Dick's story about a few days off Warfarin and the consequence certainly resonates too.
 
I think it is 4% per year without anticoagulation. I've read it on a few articles over the last few years. I'll try and dig them out. However, like you said, Dick is a prime example of what happens if you don't take it. But remember the old valves, don't mean to scare you Dick (as I'm sure you know anyway) are twice as likely to form clots per year.
 

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