question about life-long Coumadin

[river-wear]

I've been reading a lot on this forum about how taking Coumadin isn't a big deal and that taking it versus not shouldn't be a major factor in choosing a valve. That sounds pretty good to me.

But then I see the stats from the Cleveland Clinic that show the vast majority of their valve replacements are tissue valves, and they note that the majority of patients avoid anticoagulation. Why is that? I know the risk gets higher after age 65 or so, but does anyone know where I can find more information/statistics on those risks?

 

[Bridgette]

I think from what I've read, that CC has links with Edwards Lifesciences (who make tissue valves). I'm sure that if you really wanted a mechanical valve they'd give you one but they definitely push tissue - and it's not just me saying that, you only have to read their website to see it.

As far as info/stats on risks of taking Warfarin goes, I have given up trying to find conclusive stats about anything health related, because for every study published that states one finding, there'll be another one that states just the opposite!

 

[acr]

Maybe they have a higher percentage of older patients. I guess at age 60+ tissue is more of an automatic choice. For me Warfarin is a non-issue, couple of pills a day. Hardest part is remembering, but that's what alarm clocks are for. FYI I had AVR at age 41, so I have maybe 40 years of Warfarin ahead of me. Does not bother me in the slightest.

 

[Ross]

Simply put, most of the Cleveland Clinic's surgeons have a financial interest in valve companies for either their valves or for surgical equipment or procedures they've invented. It's basically all about $$$$. The surgeons are now required to inform patients of these interests also.

Here is one for Dr. Gillinov:

Industry Relationships
Cleveland Clinic physicians and scientists may collaborate with the pharmaceutical or medical device industries to help develop medical breakthroughs or provide medical education about recent trends. The collaborations are reviewed as part of the Cleveland Clinic’s procedures. The Cleveland Clinic publicly discloses payments to its physicians and scientists for speaking and consulting of $5,000 or more per year, and any equity, royalties, and fiduciary relationships in companies with which they collaborate. In publicly disclosing this information, the Cleveland Clinic tries to provide information as accurately as possible about its doctors’ connections with industry and those of their immediate family members. As of 7/31/2008, Dr. Gillinov has reported the financial relationships with the companies listed below. Patients should feel free to contact their doctor about any of the relationships and how the relationships are overseen by the Cleveland Clinic. To learn more about the Cleveland Clinic’s policies on collaborations with industry and innovation management, go to our Integrity in Innovation page.

Consulting. Dr. Gillinov receives fees of $5,000 or more per year as a paid consultant or speaker for the following companies:

Edwards Lifesciences, LLC

Medtronic, Inc.

St. Jude Medical, Inc.

Inventor Share. Dr. Gillinov may receive future financial benefits from the Cleveland Clinic for inventions or discoveries related to the companies shown below:

Clear Catheter Solutions

Royalty Payments. Dr. Gillinov has the right to receive royalty payments for inventions or discoveries related to the companies shown below:

Kapp Surgical Instruments, Inc.

Equity. Dr. Gillinov owns stock or stock options in the following companies for activities as a founder, inventor, or consultant:

Clear Catheter Solutions

Viacor, Inc.

 

[tobagotwo]

The doctors there have links with a variety of valve manufacturers, including St. Jude. That's also true from a variety of high-exchelon institutions. And it's not just the doctors. Administrators can be leveraged as well.

Why was it only a relatively short time ago that one of our own members had to talk a CCF surgeon into using the On-X valve for the first time, after being told they did not use it there? Does that mean St. Jude had an undue amount of influence at CCF, or simply that all of the cardiologists at CCF were unaware of the On-X as a viable alternative?

Dr. Cosgrove of CCF helped Edwards Lifesciences develop their current valves, which was certainly a relationship. Does that mean that he was on the take, or does it mean that he was trying to use his knowledge and experience as a cardiac surgeon to create a better valve?

While it's good to recognize possible influences on doctors and institutions, it's important to also understand what their genesis is, so that they can be placed in understandable context.

I don't know the answers to the above questions, but a list of fees received can only be part of the picture, and doesn't necessarily indicate influence peddling or wrongdoing.

The doctors above accepted these fees knowing they be made public. That doesn't sound like they feel they are being compromised. As such, we need to be careful about assumptions, whether they are brand or type related.

Best wishes,

 

[Ross]

It certainly provides food for thought. There was a major hullabooloo with one surgeon being fired and filing suit over it. Don't know where that went. Whatever, this is the reason that they now disclose their industry relationships.

 

[dick0236]

I've been reading a lot on this forum about how taking Coumadin isn't a big deal and that taking it versus not shouldn't be a major factor in choosing a valve. That sounds pretty good to me.

Coumadin usage does not deserve being considered a major risk factor when deciding on a valve type. Most people on the drug find it an inconvenience, but not dangerous. Ask your doctor and he will tell you that mechanical valve patients represent a small minority of their patients on Coumadin/Warfarin. Doctors tell me that the risk does increase in the "senior years" due to aging issues that require surgery and the use of drugs that interact with warfarin etc......but they suspect many problems are due to non-compliance in the use of warfarin. Young or Old, non-compliance is, by far, the major problem with using warfarin....and that AIN'T the drugs fault.

 

[TXGal]

For me, my surgeon tried repairing my valve before replacing with mechanical because I was young and close to child bearing age and it's not recommended to get pregnant while on Coumadin.. unfortunately he had to go back in and replace anyways.. so that is another factor..

 

[river-wear]

Thanks for your stories, everyone. Dick, you are truly an amazing pioneer! It's incredible that one valve has lasted 42 years too.

Kristen, you had a baby while on Coumadin? I knew it wasn't recommended, but I didn't know it was even possible.

Michele

 

[Lionheart]

I think from what I've read, that CC has links with Edwards Lifesciences (who make tissue valves). I'm sure that if you really wanted a mechanical valve they'd give you one but they definitely push tissue - and it's not just me saying that, you only have to read their website to see it.

Bridgette, Ross, and others,

Just to set the record straight with my experience at Cleveland Clinic. No one, including my surgeon "pushed" a tissue valve on me at 53 years old. In fact my surgeon at CC (Dr. Pettersson) was one of the few if not the only doctor that actually listened to my needs as a patient and left the decision up to me based on the issues I raised that would influence my choice.

Back home my cardiologist and the local surgeon asked no questions about my background, lifestyle, or provided a comparison of the pros and cons of one valve type over the other. They provided the bromide of "you need a mechanical valve, because you don't want to have to have that surgery a second time". That response provides no guidance to the patient.

Prior to my consult at CC, I was leaning toward a tissue valve but having doubts. During the consultation with the CC surgeon, he made no strong recommendation for a valve type except to explain how each valve type would address my concerns or not. He said I could wait until surgery day to make my decision, but I needed it done then and so I settled on a mechanical valve. He suggested the On-X. I spent a week at home before my surgery date agonizing over that decision and finally realized that my initial choice for a tissue valve was the best for me. My surgeon had no problem with me changing my mind and once I did I felt at peace.

So, to be clear, it was I and not my surgeon that selected a tissue valve.

River-wear,
Sorry for hijacking the thread. Please be aware that I am not suggesting that you get the same type of valve as me. You will have to make your own decision. For either choice you need to weigh the risks of each and see how they align with your medical background, lifestyle and risk factors (including age). Either choice is a good one, just be willing to accept the risks associated with that choice.

To your question:

I know the risk gets higher after age 65 or so, but does anyone know where I can find more information/statistics on those risks?

Apparently, older patients (>75 years old) have more risk factors for bleeding including hypertension, prior stroke, history of falling, and renal dysfunction. See: http://www.clotcare.com/clotcare/warfarinbleedinginelderly.aspx THere are probably other issues as well associated with age. You could also google something like "elderly bleeding risk with warfarin". [Next day edit- Leave out the quotes on the google search].
I wish you the best.

John

 

[Ross]

I knew it wasn't recommended, but I didn't know it was even possible.

Michele

It is possible, but it's very dangerous and requires a special team of doctors to care for you and the baby all through pregnancy. In other words, not recommended.

 

[river-wear]

John - thank you for the link and the "balance" on your experience with the CC.

Ross - good clarification. I'm past the age where I'm interested in having children anyway. Knowing it's possible makes Coumadin a bit less scary too. My main concern (and reason to start this thread) was to look at the long-term consequences.

 

[olefin]

Apparently, older patients (>75 years old) have more risk factors for bleeding including hypertension, prior stroke, history of falling, and renal dysfunction.

Dang, I only got another year.... maybe.

 

[Ross]

Ross - good clarification. I'm past the age where I'm interested in having children anyway. Knowing it's possible makes Coumadin a bit less scary too. My main concern (and reason to start this thread) was to look at the long-term consequences.

Well RCB, Dick and Olefin been on it for along time and they don't plan on going anywhere soon. RCB has been on it nearly 50 years.

I would venture the guess to say, that the older population, that haven't been home testing, will have higher bad incidences because of their management of the drug. It's harder then it should be to find a Doctor that really understands the drug and how to dose it. That's the largest draw back to the drug.

 

[river-wear]

That makes sense. I would expect that someone who is 75 and has been managing their Coumadin for 20+ years will have a real advantage over someone the same age who just got a new prescription.

But isn't an elderly patient more likely to have bleeding incidents solely because of age, regardless of whether they're taking the drug or not? If so, then is there a real difference in the outcome because of it (the drug)? I suppose a stroke would be bad no matter what. Sorry for sounding negative. I just want to make a decision with my eyes open to reality.

Michele

 

[Ross]

I'm no pro on geriatrics, but I do beleive that the older we get, the easier we tend to bruise and bleed. Now whether it's because of instability, falling or the like, I tend to think yes, but at this point, I don't have solid evidence to suggest otherwise.

This is one study I found:

http://www.annals.org/content/124/11/970.full



But again, it depends on who and how the patients are/were being managed. If you have a lousy manager, your going to have adverse events. We are trying hard to teach people the right way of working with this drug. If you respect it, you'll have little, if any problems.

 

[Lynlw]

That makes sense. I would expect that someone who is 75 and has been managing their Coumadin for 20+ years will have a real advantage over someone the same age who just got a new prescription.
But isn't an elderly patient more likely to have bleeding incidents solely because of age, regardless of whether they're taking the drug or not? If so, then is there a real difference in the outcome because of it (the drug)? I suppose a stroke would be bad no matter what. Sorry for sounding negative. I just want to make a decision with my eyes open to reality.
Michele

A few Members here had babies after being on coumadin, some had relative easier times of it others had MUCH worse, but Kristen did not carry her own baby http://www.valvereplacement.com/forums/showthread.php?t=29907
I don't know of any place/ study that list the stats for everything overall. and of course different studies will come up with different results, so I usually read quite a few of the articles, to see what the majority seem to say. (luckily, I have problems sleep and am disabled/don't work so the one thing I have alot of is time. A few of the valve choice studies have some of the different stats long term (which is usually taking it over 1 year) coumadin or reops as parts of their studies like http://www.circ.ahajournals.org/cgi/content/full/116/11_suppl/I-294
IT is hard to find 1 or 2 studies that show all the stats about coumadin Most articles/studies are broken down by different things, when you search on pubmed.com like preinjury coumadin +head, coumadin +bone density coumadin +elderly ect. for bleeding risks or coumadin +stroke and of course they aren't "proper" studies, since they aren't going to push old people down the steps to see how they do on coum or not so they are usually retrospective review type data. Also as far as most studies I read, "long term coumadin" is over just 1 year, which surprised me at first.
My Dad will be 80 on Dec and has been on coum for Afib for a few years now, with no problem, (knocking on wood) and probably the healthiest, most active people I know. But one of the concerns with elderly is concerns about coumadin and how it CAN, complicate other things that people tend to get as they get "older" 65 and ^ or the "super elderly" 80 and up (I can't wait to tell Dad on his BDay is not not just "elderly" not he is "super Elderly", he'll probably want a cape and Mask If I know him.) like back problems, stomache problems, bones or even falling (I was surpised to see that thousands of elderly people are admited to ERs for head injuries just from "Falling from Standing") and the stats are worse for the patients IN range, and not just taking it. like http://www.ncbi.nlm.nih.gov/pubmed/...med_ResultsPanel.Pubmed_RVDocSum&ordinalpos=2
"Preinjury warfarin worsens outcome in elderly patients who fall from standing"
or http://www.ncbi.nlm.nih.gov/pubmed/18073596?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_SingleItemSupl.Pubmed_Discovery_RA&linkpos=2&log$=relatedarticles&logdbfrom=pubmed
"Degree of anticoagulation, but not warfarin use itself, predicts adverse outcomes after traumatic brain injury in elderly trauma patients." CONCLUSIONS: Therapeutic anticoagulation with warfarin, rather than warfarin use itself, is associated with adverse outcomes after traumatic brain injury in elderly patients
or other issues that can involve bridging
Of course the problem with Pubmed ect, is you have to really watch the dates, especially for things that involve coumadin, since things got much better with the INR,home testing, alot of the things from even 2001 have changed as far as valve longevity, surgery stats and are outdated, which is why finding doctors you trust and talking to thim and getting their thoughts, is so important.
Even with all of these potential issues, the Vast majority of people never have a problem, it is why Valve choice is not cut an dry, You will never know until it happens how you will do thru surgery/surgeries or how you will do on coumadin, and why there are no clear cut answers. BUT this plays a role in why surgeons in some of the largest centers, (like CCF) are giving tissue to younger patients, because in THEIR centers, they have very good stats on not only first time OHS, but REDOS. So for THEM, their patient has better odd, surviving multiple OHS w/ low amounts of not only mortality , but morbidity, than they do on long term coumadin. BUT NOT every center has the same Stats as the BEST ONES, for first time surgeries let alone REDOs or Multiple REDOS.

 

[olefin]

But isn't an elderly patient more likely to have bleeding incidents solely because of age, regardless of whether they're taking the drug or not? If so, then is there a real difference in the outcome because of it (the drug)?

If I was needing AVR and if I was age 42, it would definitely not be a hard decision to make for type of valve. From my past experience I know for sure, I don't want to have another OHS. Yeah, the bleeding risk may increase as I get older but at least I've lived long enough to get old. Thank God for that "drug".

 

[Ross]

I can't wait to tell Dad on his BDay is not not just "elderly" not he is "super Elderly.

Death wish?

 

[dick0236]

If I was needing AVR and if I was age 42, it would definitely not be a hard decision to make for type of valve. From my past experience I know for sure, I don't want to have another OHS. Yeah, the bleeding risk may increase as I get older but at least I've lived long enough to get old. Thank God for that "drug".

AMEN!!!!

When I get to be one of these "elderly" people, I'll post any problems I experience.....don't hold your breath 'cause it may take a while.