Risk of Stoke vs risk of bleeding to death Mech HVR

[Philip B]

Blood Loss

Blood Loss

If you're really losing enough blood that your health is being negatively affected, it might be time to find a doctor who can identify the source of the bleeding. The blood has to be coming from somewhere.

Experiences vary, but I've been subjected to some pretty nasty injuries since my AVR surgery in March 2007 and none have resulted in extensive blood loss. Bruising has been the biggest issue. Even the TBI I received in June 2009 didn't result in any major brain bleeds... I did lose the month of July.

I think many of us would like to see a reasonable alternative to coumadin developed.

-Philip

 

[Protimenow]

As others have said, Pradaxa has not been approved for use by people with mechanical valves. Plus, it costs about $8 a day and, and there's apparently no antidote to reverse effects, if the anticoagulant effect is too strong (or, perhaps, if you accidentally take an extra dose).

Warfarin is being used by probably millions of people. I don't know of the 'thousands' of incidents of bleeding to death that you mention. It takes a fair amount of overdosage or dosing errors to produce adverse effects - other than serious bruising - and unless you've already got something bleeding that is hard to control, the risk of 'bleeding to death' or chronic anemia because of the effects of warfarin are negligible at best.

I don't think that blaming anemia on warfarin is based on fact. (I guess that, if someone is foolish to take a handful of warfarin tablets, internal bleeding could occur - but this would have to be an intentional act by someone who actually wants a terrible result -- it would NOT be an accidental minor error.) (Also - if you're overcoagulated and have a head injury, there may be increased risk of intercranial bleeding - but this shouldn't be a major concern if the INR is being managed. I got a concussion when my INR was 2.9, and there was NO brain bleed - everything was okay).

Two points -- if your INR is kept within range, you should have no problems with anemia or 'bleeding out' as a result of taking warfarin - some other process is at play. Your comment about doctors (and, I guess, the testers on this forum) working to support the drug companies (although warfarin patents are up and you can get it for about a dime a dose) isn't effective here -- it's been documented that there is a substantially increased risk of clots forming on and around valves in people who don't take anticoagulants, and it's been documented that keeping the INR in a particular range reduces the risk of those clots forming for MOST (and, unfortunately, not necessarily all) people.

 

[ALCapshaw2]

I have done much research on Warfin and possible alternatives. See, in July of 2009 my husband, age 46 then, had his bicuspid aortic valve replaced - a mechanical valve. His therapeutic inr was 2.5-3.5; usually hovered around 2.5-2.7. On July 27th of this year, he suffered a major hemorraghic stroke - he was in a coma and vent dependent for 12 days. At the onset of the stroke, his warfin was immediately stopped, he required vitamin K and ffp. It wasn't until December 12th that his warfin was resumed, (4 and 1/2 months with no anticoagulation) and at a very low dose - we were aiming for a 1.5 level initially, due to the risk of bleed. His stroke required a craniotomy and he spent over a month in the hospitol. Prior to restarting, we researched alternatives. What we learned is that there are studies (outside the U.S.) where folks are using aspirin and Plavix instead of warfin, but there is not yet data to support this practice. We also found anecdotals of folks who survived for years with no anticoagulation and mechanical valves - these are very few in nature. Last week my husband stroked again - this time a "shower" - several tiny clots showered throughout the brain - a TEE found a clot on the valve. As I write, he is yet in surgery, almost 11 hours at this point, to replace his valve to a tissue valve. We're not out of the woods yet.

I share, because I believe that there are no absolutes; there are real people behind the numbers and any decisions must be made on an individual basis with qualified professionals whom you trust.

Toni -

I'm sorry to hear about your husband's hemorraghic stroke.

You mentioned that he had a Bicuspid Aortic Valve.
Are you aware that there is a high degree of correlation between Congenital BAV and Connective Tissue Disorders?

The Most Common Symptom of Connective Tissue Disorders is Aortic Aneurysms.
A less common symptom is a Brain Aneurysm.

IF your husband also had a connective tissue disorder, there is a reasonable chance that his hemorraghic stroke was caused by a Brain Aneurysm and not necessarily because he was taking Coumadin / Warfarin (which may have added to the seriousness of his stroke). I'm thinking there has been some discussion about studies to look more closely at this association.

'AL Capshaw'

 

[Jkm7]

I have done much research on Warfin and possible alternatives. See, in July of 2009 my husband, age 46 then, had his bicuspid aortic valve replaced - a mechanical valve. His therapeutic inr was 2.5-3.5; usually hovered around 2.5-2.7. On July 27th of this year, he suffered a major hemorraghic stroke - he was in a coma and vent dependent for 12 days. At the onset of the stroke, his warfin was immediately stopped, he required vitamin K and ffp. It wasn't until December 12th that his warfin was resumed, (4 and 1/2 months with no anticoagulation) and at a very low dose - we were aiming for a 1.5 level initially, due to the risk of bleed. His stroke required a craniotomy and he spent over a month in the hospitol. Prior to restarting, we researched alternatives. What we learned is that there are studies (outside the U.S.) where folks are using aspirin and Plavix instead of warfin, but there is not yet data to support this practice. We also found anecdotals of folks who survived for years with no anticoagulation and mechanical valves - these are very few in nature. Last week my husband stroked again - this time a "shower" - several tiny clots showered throughout the brain - a TEE found a clot on the valve. As I write, he is yet in surgery, almost 11 hours at this point, to replace his valve to a tissue valve. We're not out of the woods yet.

I share, because I believe that there are no absolutes; there are real people behind the numbers and any decisions must be made on an individual basis with qualified professionals whom you trust.

Toni,
I am so very sorry to hear all you and your husband have suffered.
You have all my best wishes he comes through this surgery safely and makes a good recovery.
Please let us know how you both are doing.

 

[Lily]

Toni, you and your husband have my best wishes; I sent a PM to you last evening.

Richard, I don't know if this is helpful but one of the comments to you reminded me of an experience one of my friends had a few years ago when she was on temporary ACT following hip replacement; and a few days post-op, in a relatively short period of time, she nearly bled out internally through a previously overlooked black hole of an ulcer which was cauterized upon discovery by emergency surgery; it was a critical situation for her but she recovered nicely.

 

[ShezaGirlie]

Hi Richard -
Welcome to the site. Sorry for your struggles. I HOPE the other members will offer helpful support, and NOT be UNPLEASANT in their replies.

Well said...and a big welcome to this website Richard.

We all have different reactions to different drugs and Richard is obviously having a drastic and dangerous life threatening side effect from warfarin. His concerns are valid and it serves no purpose to doubt other than to upset someone who is trying to cope during this very, very difficult time.


Also, welcome Toni to the website. I offer my hope and prayers for a successful tissue valve implantation today for your husband (at Mayo) and hope you will be back soon to give us a positive update.:thumbup:

 

[dick0236]

It IS a fact that Coumadin / Warfarin has a Narrow Theraputic Range which is why it is monitored regularly. KNOWLEDGABLE Anticoagulation Care Providers (or self testers /dosers with appropriate dosing guides) are able to maintain stable INR's in the Vast Majority of Cases. Rat Poison uses the same basic drug in MUCH HIGHER CONCENTRATION than is used for anti-coagulation control in humans. To associate the two purposes distorts their relationship and promotes FEAR. Is that your goal for this thread?
.

Richard, I fully agree with Al. I have been on this drug longer than just about anyone and have never experienced any of the "surprises" you refer too. I have found the drug to be very predicable. If I take it and monitor it, I have very few, if any, negative surprises. If I screw around with it, I can expect problems. The ONE really bad experience I've had, almost certainly was my own fault for going off the drug for several days. Coumadin/Warfin is one of the most widely used Rx's in the world and is used by millions of people for all kinds of reasons. Valvers represent only a small percentage of the total users.

You are correct in that warfarin has been on the market for 60+ years. Because of the millions that use the drug daily, it is likely that many drug companies would love to find a successful alternative.....and they have for some health conditions.....but not for mechanical heart valves....yet.

For now, we are left with two basic choices....multiple surgeries(??), or routinely monitoring a drug that works. "Youse has your druthers, and youse takes your picks". I had no choice of valve type (tissue valve did not exist). However, in hindsite, and with the few problems I have had, I would not have changed anything:smile2:.

 

[Lynlw]

Richard, I'm very sorry you might not be getting the support you hoped for.
First, I would really think hard about going off coumadin or experimenting with alternative ways to prevent clots, because not only would my worry be "would I rather die from bleeding or clotting?", but for ME personally I would fear a major stroke that didn't kill me but left me unable to do much for myself at all. Especially since you are having problems with GI bleeds, which for the most part, wouldn't do the kind of damage like if you were having brain bleeds. Also as long as you have a bleeding problem, pretty much any thing you use as an anticoagulant would still increase the amount you bleed. IF they can't find any reason for your Bleed and you want to get off Coumadin, I would really consider getting a tissue valve, yes the surgery would be a risk, but it is a 1 time risk, which unless they can find what is causing your bleeds, it will most likely continue to happen.
I know a percentage of people who have GI bleeds can't find where the bleed is coming from, even WITH upper and lower GIs ect. (AKA Obscure GI bleed) I can only imagine how frustrating it must be to have ongoing GI bleed problems that they haven't been able to find where the problem is. I think about 5% of the patients with reoccuring GI Bleeds they can't find the cause for, so to think about also needing to take an anticoagulent must give you even more to worry about, even with your INR that is pretty stable according to your first post.

I know you mentioned you've had scans and scopes ect, and I don't know if you already have seen these, or if they would help, and I don't know what hospitals /doctors you have been going to but I know a few centers like Mayo and Mass general in Boston are doing work trying to find the cause for patients with Obscure GI Bleeds. Mass Gen currently has a clinical trial going on http://clinicaltrials.gov/ct2/show/NCT00593021
Purpose
"Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by EGD and colonoscopy, the presumed source of bleeding in these patients being the small intestine. These patients fall under the category of "obscure gastrointestinal bleeding," and frequently require an extensive diagnostic work-up. For these reasons, most patients who present with obscure or occult gastrointestinal bleeding typically undergo multiple endoscopic evaluations, including capsule endoscopy and various radiologic imaging studies, including enteroclysis, small bowel series, CT scan, angiography, and radionuclide scan. Recently, many centers (included the Brigham and Women's Hospital) have begun using capsule endoscopy and CT enterography (CTE) for evaluation of suspected small bowel pathology. This is an observational study enrolling patients referred to the Brigham and Women's Hospital for obscure gastrointestinal bleeding designed to compare the diagnostic yield of various diagnostic modalities, in particular capsule endoscopy and CT enterography in the evaluation of obscure gastrointestinal bleeding."

IF you do a search for obscure gastrointestinal bleeding at the clinical trials site, you can find a couple trials.

The Mayo has alot of info, tests ect http://www.mayoclinic.org/gastrointestinal-bleeding/diagnosis.html I know you live in Cal, but if you don't want to or can't travel, maybe you could try calling and see if they could suggest some good centers/docs in your area doing the same work.

As for the thousands of people who've had excessive blood loss because of Coumadin, Considerring MILLIONS of people take coumadin each year, even IF only 1% have major bleeds (which is the lowest % I see) every year, that would easily be thousands. Of course I am NOT saying coumadin caused the bleed to start, but IF you have a problem that causes bleeds of course taking a drug that slows clotting would increase the amount of blood lost in many of the patients. I can understand it is hard to imagine probably 10s of millions of people take coumadin, so even 1% is alot of people. I was surprised at how many prescriptions were written for coumadin a year I knew it was "alot" but not that much.
Here is the study the explaining why the FDA used to decide to put the Black box warning for excessive or fatal bleeding on Coumadin http://classic.muhealth.org/outcomes/development/Bleeding Complications with Warfarin Use.pdf
entitled "Bleeding Complications With Warfarin Use A Prevalent Adverse Effect Resulting in Regulatory Action"

 

[Protimenow]

Lily -- your message to Richard was probably for another thread. One thought about your friend -- I'll bet she was on Heparin, rather than the slower acting warfarin. Her near bleed-out had to do with poorly managed ACT and nothing to do specifically with warfarin.

Toni -- you and your husband, of course, have my best wishes, too.

 

[Lily]

Lily -- your message to Richard was probably for another thread. One thought about your friend -- I'll bet she was on Heparin, rather than the slower acting warfarin. Her near bleed-out had to do with poorly managed ACT and nothing to do specifically with warfarin...

Thanks but there is no need for you to correct my post: It was for this thread. Thank you for the opportunity to clarify.

And my friend was on either Coumadin or Warfarin -- and NOT Heparin. She was not poorly managed, and had only been on it for a very few days. As I may not have explained clearly enough, she had a previously undiagnosed bleeding ulcer. Shortly before surgery she'd had a scope which must have missed the thing.

 

[AgilityDog]

Well, see, that's the thing. Coumadin helps you FIND some of these ulcers/cancers/etc. that cause bleeding. My dad's use of coumadin allowed them to find his cancer early, giving him the option of surgery. The coumadin didn't cause the bleeding. The cancer did. The coumadin, like all anticoagulants, just exacerbates the bleeding, leading to the search for the cause. Of course it can be dangerous, but so can plavix, or asprin, or vioxx or.....

 

[catwoman]

Richard:

Why did you get a mechanical valve and not a tissue? Apparently, you had had GI problems long before you had your VR. If so, your doctors should have advised you to have a tissue valve. I remember being grilled about GERD numerous times by doctors before my surgery, so I knew that people with some conditions were not the best candidates for taking anticoagulation therapy. (However, Plavix and aspirin and other meds can also create havoc with conditions that are prone to cause bleeding.)
Why don't you replace it with a tissue one? The cost would no doubt be far less than medical and living expenses if you were to stroke out from not being on warfarin.

 

[ALCapshaw2]

Richard, I'm very sorry you might not be getting the support you hoped for.
First, I would really think hard about going off coumadin or experimenting with alternative ways to prevent clots, because not only would my worry be "would I rather die from bleeding or clotting?", but for ME personally I would fear a major stroke that didn't kill me but left me unable to do much for myself at all. Especially since you are having problems with GI bleeds, which for the most part, wouldn't do the kind of damage like if you were having brain bleeds. Also as long as you have a bleeding problem, pretty much any thing you use as an anticoagulant would still increase the amount you bleed. IF they can't find any reason for your Bleed and you want to get off Coumadin, I would really consider getting a tissue valve, yes the surgery would be a risk, but it is a 1 time risk, which unless they can find what is causing your bleeds, it will most likely continue to happen.
I know a percentage of people who have GI bleeds can't find where the bleed is coming from, even WITH upper and lower GIs ect. (AKA Obscure GI bleed) I can only imagine how frustrating it must be to have ongoing GI bleed problems that they haven't been able to find where the problem is. I think about 5% of the patients with reoccuring GI Bleeds they can't find the cause for, so to think about also needing to take an anticoagulent must give you even more to worry about, even with your INR that is pretty stable according to your first post.

I know you mentioned you've had scans and scopes ect, and I don't know if you already have seen these, or if they would help, and I don't know what hospitals /doctors you have been going to but I know a few centers like Mayo and Mass general in Boston are doing work trying to find the cause for patients with Obscure GI Bleeds. Mass Gen currently has a clinical trial going on http://clinicaltrials.gov/ct2/show/NCT00593021
Purpose
"Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by EGD and colonoscopy, the presumed source of bleeding in these patients being the small intestine. These patients fall under the category of "obscure gastrointestinal bleeding," and frequently require an extensive diagnostic work-up. For these reasons, most patients who present with obscure or occult gastrointestinal bleeding typically undergo multiple endoscopic evaluations, including capsule endoscopy and various radiologic imaging studies, including enteroclysis, small bowel series, CT scan, angiography, and radionuclide scan. Recently, many centers (included the Brigham and Women's Hospital) have begun using capsule endoscopy and CT enterography (CTE) for evaluation of suspected small bowel pathology. This is an observational study enrolling patients referred to the Brigham and Women's Hospital for obscure gastrointestinal bleeding designed to compare the diagnostic yield of various diagnostic modalities, in particular capsule endoscopy and CT enterography in the evaluation of obscure gastrointestinal bleeding."

IF you do a search for obscure gastrointestinal bleeding at the clinical trials site, you can find a couple trials.

The Mayo has alot of info, tests ect http://www.mayoclinic.org/gastrointestinal-bleeding/diagnosis.html I know you live in Cal, but if you don't want to or can't travel, maybe you could try calling and see if they could suggest some good centers/docs in your area doing the same work.

As for the thousands of people who've had excessive blood loss because of Coumadin, Considerring MILLIONS of people take coumadin each year, even IF only 1% have major bleeds (which is the lowest % I see) every year, that would easily be thousands. Of course I am NOT saying coumadin caused the bleed to start, but IF you have a problem that causes bleeds of course taking a drug that slows clotting would increase the amount of blood lost in many of the patients. I can understand it is hard to imagine probably 10s of millions of people take coumadin, so even 1% is alot of people. I was surprised at how many prescriptions were written for coumadin a year I knew it was "alot" but not that much.
Here is the study the explaining why the FDA used to decide to put the Black box warning for excessive or fatal bleeding on Coumadin http://classic.muhealth.org/outcomes/development/Bleeding Complications with Warfarin Use.pdf
entitled "Bleeding Complications With Warfarin Use A Prevalent Adverse Effect Resulting in Regulatory Action"

Good Post Lyn !

You never cease to amaze me with the quality of your research.

Well Done!

'AL'

 

[Lynlw]

Good Post Lyn !

You never cease to amaze me with the quality of your research.

Well Done!

'AL'

Thank you. I hope it helps him.

 

[Duffey]

I've been reading these Forums for MANY Years and have NEVER heard of excessive blood loss from taking Warfarin. I've NEVER heard of anyone reporting problems similar to those you report on these forums. I also find it hard to believe that if you truly were loosing blood in your stools that a source of the problem could not be found. I have to wonder about how well your INR was managed. BTW, THE Most Common "side effect" of taking Coumadin / Warfarin that I am aware of is BRUISING, and NOT Blood Loss. I'll ask my (very knowledgable and well trained) Coumadin Clinic Nurse Practicioneers about your claims.

It IS a fact that Coumadin / Warfarin has a Narrow Theraputic Range which is why it is monitored regularly. KNOWLEDGABLE Anticoagulation Care Providers (or self testers /dosers with appropriate dosing guides) are able to maintain stable INR's in the Vast Majority of Cases. Rat Poison uses the same basic drug in MUCH HIGHER CONCENTRATION than is used for anti-coagulation control in humans. To associate the two purposes distorts their relationship and promotes FEAR. Is that your goal for this thread?

OLD School Doctors and Nurses whose anticoagulation training is Way Out of Date are OFTEN the cause of anticoagulation 'mishaps' due to POOR MANAGEMENT, typically over-reacting to slightly out-of-range results resulting in dosing recommendations that end up causing the notorious Roller-Coaster Effect.

Hey Al,
Ross went through something similar a few years back. If you recall, he ended up in the hospital for almost a week as they attempted to find the source of his bleed. And Ross did manage his act effectively. Here's the thread.http://www.valvereplacement.org/forums/showthread.php?17375-Please-keep-Ross-in-your-prayers./page5

 

[normofthenorth]

Just one small point, Richard: Like you, I often look for incentives and vested interests and biases in trying to explain human and institutional behavior.

But UNlike you, I see the incentives and vested interests and biases all pushing toward replacing Coumadin/Warfarin with a fancier (and more $$$) alternative. On-X has been working hard (so far without success) trying to prove that their mech valve is non-thrombotic enough that it can work (in the Aortic position) without Coumadin/Warfarin. If they, or a competitor, could make that stick, the market for tissue valves might be limited to the truly geriatric. Big bucks would change hands.

Anybody who found a replacement for Coumadin/Warfarin would likely become rich beyond the dreams of avarice. That seems like a reasonable incentive.

 

[Protimenow]

Norm:

I'm not quite certain that it would be all that easy to completely replace warfarin -- unless the replacement is actually affordable. Generic Warfarin now costs about a dime or two each day. Testing - even weekly testing - shouldn't cost more than $30 or $40 a month (just a guess for the high point). For a vast majority of people taking warfarin, it's a cheap, manageable medication that is somewhat inconvenient, requires minor life and dietary changes, but is pretty well tolerated.

I suspect that other, new, anticoagulants may have the same effects (increased INR, risk of bruising and slightly slower coagulation times), but may not require the testing that is necessary with Warfarin. At $8 a day, versus less than a quarter a day - I'm not sure that it would be worth $250 or so a month for people to be able to avoid INR testing - especially if it's often as simple as a finger stick.

A reasonably priced medication that reduces or eliminates the risk of valvular clots or clots resulting from A-Fib, and that required no special testing or attention to INR certainly COULD make the manufacturer a LOT of money -- but it would have to be absolutey effective and somewhat competitively priced.

 

[ALCapshaw2]

SNIP

On-X has been working hard (so far without success) trying to prove that their mech valve is non-thrombotic enough that it can work (in the Aortic position) without Coumadin/Warfarin. If they, or a competitor, could make that stick, the market for tissue valves might be limited to the truly geriatric. Big bucks would change hands.

SNIP

Your "so far without success" comment would seem to be a misrepresentation and an inaccurate description of the PROACT NO/LOW Anticoagulation Study with the On-X Mechanical Valves.

This study was approved by the FDA starting in 2006 and will continue until early 2015. The Fact that the study has NOT been terminated would seem to indicate that NO worrisome complications have been found to date and the study is expected to continue until it's scheduled completion in 2015. (I will make an inquiry to confirm this status).

 

[ShezaGirlie]

Good Post Lyn !

You never cease to amaze me with the quality of your research.

Well Done!

'AL'

Isn't that the truth...:thumbup:

As a sidenote: I know a guy who tried to commit suicide by taking rat poison. This was over 30 years ago and I don't know how much he took. He didn't succeed, but he did saddle himself with lifelong physical morbidities which are certainly not pleasant. It's obvious the rat poison caused a major stroke and in those days, there wasn't rehab like there is now. It's very sad for him and his family.

 

[catwoman]

Isn't that the truth...:thumbup:

As a sidenote: I know a guy who tried to commit suicide by taking rat poison. This was over 30 years ago and I don't know how much he took. He didn't succeed, but he did saddle himself with lifelong physical morbidities which are certainly not pleasant. It's obvious the rat poison caused a major stroke and in those days, there wasn't rehab like there is now. It's very sad for him and his family.

A U.S. Army inductee tried the same in 1951. He survived.

Per wikipedia, warfarin is on the decline as a rodenticide. It appears that rat populations are becoming resistant to it.