The St. Jude valve: Analysis of thromboembolism, warfarin-related hemorrhage, and sur

[raenderle]

Though this would be interesting especially for those who have warfarin-related hemorrhage problems like me

The St. Jude valve: Analysis of thromboembolism, warfarin-related hemorrhage, and survival
[/U]
Lawrence S.C. Czer M.D., a, b, Jack M. Matloff M.D.a, b, Aurelio Chaux M.D.a, b, Michele De Robertis R.N.a, b, Morgan E. Stewart Ph.D.a, b and Richard J. Gray M.D.a, b
aDepartment of Thoracic and Cardiovascular Surgery, Cedars-Sinai Medical Center Los Angeles, Calif., USA

In conclusion
, warfarin anticoagulation is recommended in all patients. Although the operative and late survival rates reported in this study reflect in part the inclusion of high-risk patients with advanced functional class, left ventricular dysfunction, and ischemic mitral regurgitation, a major cause of valve-related morbidity and late death was warfarin-related hemorrhage A downward revision in the target prothrombin time ratio to 1.5 to 2.0 may result in fewer bleeding complications The optimal antithrombotic regimen in children remains to be defined.


Abstract
From March 1978–1986, 590 St. Jude prostheses (232 aortic, 232 mitral, and 63 double aortic-mitral) were implanted in 527 patients (mean age 63 years) and followed for up to 8 years (mean 33 months; three lost; 99% complete). The early (30-day) mortality rate was 8.9% and was strongly associated with preoperatively depressed left ventricular function (ejection fraction <0.55), ischemic mitral regurgitation, and advanced functional class (IV) (p < 0.05). Actuarial survival rates at 5 years were 72% ± 4%, 72% ± 8%, and 63 ± 4% after aortic, double, and mitral valve replacement (p < 0.01).
There have been no structural failures. Embolism (28 events, 2.1%/patient-year) was less common with warfarin treatment (1.5%/patient-year; n = 492) than with antiplatelet (3.2%/patient-year; n = 19) or no drug therapy (18.9%/patient-year; n = 16) (p < 0.01). One embolic event was fatal (3.6%). Warfarin-treated patients remained 91% ± 1% free of emboli after 8 years. Valve thrombosis (six events; 0.4%/patient-year) occurred exclusively in patients not treated with effective warfarin therapy; one (17%) died. The most common complication was hemorrhage (39 events; 2.9%/patient-year); nine (23%) were fatal, and these constituted 82% of 11 valve-related late deaths. In warfarin-treated patients (target prothrombin time ratio 1.5 to 2.5), hemorrhage was twice as frequent (2.9%/patient-year) as embolism (1.5%/patient-year).

The link can be found at...
http://www.sciencedirect.com/scienc...0431bda6206fe5e259dd75451ce375ad&searchtype=a

Cheers
Richard

 

[ALCapshaw2]

I see that this study was from 1986, well BEFORE the INR test was developed in the early 1990's which greatly improved the accuracy and repeatability of measurements to manage anticoagulation.

Using INR testing and improved Dosing Guidelines, the incidence of "Bleeding Problems" with Coumadin / Warfarin have been GREATLY reduced. Most cases that come to light these days are the result of POOR MANAGEMENT by medical practicioneers who are seriously out of date in their training or who over-react to slightly out-of-range readings and then prescribe Huge Dose Changes alternating between Too Low and Too High hoping to end up with a stable INR somewhere in the middle. This is like trying to drive at the speed-limit while alternately stomping on the Brakes and then the Gas.

Richard -

I have to wonder about the Reason you continue to post Horror Stories about Coumadin / Warfarin on these forums. I also have to wonder how / why you let your Bleeding Symptoms continue so long that you ended up having problems from blood loss. Black tarry stools are a Well Known sign of GI Bleeding. Ideally, you should have sought medical assistance as soon as you saw the signs and not continued to bleed until other problems developed. This sounds more like an Anti-Coagulation Management Problem and NOT an anti-coagulation drug problem.

'AL Capshaw'

 

[dick0236]

Abstract
From March 1978–1986, 590 St. Jude prostheses (232 aortic, 232 mitral, and 63 double aortic-mitral) were implanted in 527 patients (mean age 63 years) and followed for up to 8 years (mean 33 months; three lost; 99% complete). The early (30-day) mortality rate was 8.9% and was strongly associated with preoperatively depressed left ventricular function (ejection fraction <0.55), ischemic mitral regurgitation, and advanced functional class (IV) (p < 0.05). Actuarial survival rates at 5 years were 72% ± 4%, 72% ± 8%, and 63 ± 4% after aortic, double, and mitral valve replacement (p < 0.01).
There have been no structural failures. Embolism (28 events, 2.1%/patient-year) was less common with warfarin treatment (1.5%/patient-year; n = 492) than with antiplatelet (3.2%/patient-year; n = 19) or no drug therapy (18.9%/patient-year; n = 16) (p < 0.01). One embolic event was fatal (3.6%). Warfarin-treated patients remained 91% ± 1% free of emboli after 8 years. Valve thrombosis (six events; 0.4%/patient-year) occurred exclusively in patients not treated with effective warfarin therapy; one (17%) died. The most common complication was hemorrhage (39 events; 2.9%/patient-year); nine (23%) were fatal, and these constituted 82% of 11 valve-related late deaths. In warfarin-treated patients (target prothrombin time ratio 1.5 to 2.5), hemorrhage was twice as frequent (2.9%/patient-year) as embolism (1.5%/patient-year).

Richard

This Abstract seems to prove the point....if you have a mechanical valve, do not go off warfarin:rolleyes2:. This is a very old study. I lived thru this entire time with a mechanical valve and can attest to very poor information flow, management, and archaic testing protocals of anti-coagulant therapy. My "event" was four years before this study began and seven years post surgery....and I will tell you, without any doubt, that neither patients nor physicians really knew how to handle anti-coagulant therapy.....and the "pro-time" testing protocals where :eek2:.

 

[raenderle]

Warfarin IS the problem.....
I call a spade is a spade...I do not "sugar coat" the facts like some....Warfarin is NOT an M & M....it was used for Rat poison...and still is.....the fact that it is prescribed for our condition and other people conditions is besides the the point...the point is.... it is a very DANGEROUS drug with MANY dangerous side effects . My REASON for posting is to share information...my 'Horror"story included ..so we can all learn something NEW.. and maybe share information on how to "think outside the box" for alternatives... or new and better treatments, drugs..natural supplements instead of this type drug or at least cut down on the dosage needed. I realize we need some sort of treatment to keep us from having an Embolism, and in no way encourage people to stop taking what their Dr. prescribes.

I see that this study was from 1986, well BEFORE the INR test was developed in the early 1990's which greatly improved the accuracy and repeatability of measurements to manage anticoagulation.

Using INR testing and improved Dosing Guidelines, the incidence of "Bleeding Problems" with Coumadin / Warfarin have been GREATLY reduced. Most cases that come to light these days are the result of POOR MANAGEMENT by medical practicioneers who are seriously out of date in their training or who over-react to slightly out-of-range readings and then prescribe Huge Dose Changes alternating between Too Low and Too High hoping to end up with a stable INR somewhere in the middle. This is like trying to drive at the speed-limit while alternately stomping on the Brakes and then the Gas.

Richard -

I have to wonder about the Reason you continue to post Horror Stories about Coumadin / Warfarin on these forums. I also have to wonder how / why you let your Bleeding Symptoms continue so long that you ended up having problems from blood loss. Black tarry stools are a Well Known sign of GI Bleeding. Ideally, you should have sought medical assistance as soon as you saw the signs and not continued to bleed until other problems developed. This sounds more like an Anti-Coagulation Management Problem and NOT an anti-coagulation drug problem.

'AL Capshaw'

 

[kfay]

raenderle, Obviously, You've had many Dr's be involved in your medical care. Who are we to second guess what is going on with your bleeding episodes. However, I, too, would hate to see you stroke out by stopping your coumadin and I think that is what is going to happen to you with a mechanical valve. Have you had a conversation with your cardio and or your surgeon about removing your mechanical valve and replacing with a tissue valve? The risk for a 2nd surgery is the same as the 1st, still around 1-2%, and considering all the other issues you are having with bleeding and coumadin, I would have to think this would be less of a risk to you.


Kim

 

[Protimenow]

Richard: The paper quoted earlier showed an 18.9/patient-year EMBOLISM rate for those who were on no drug therapy (no warfarin, no aspirin). This is a horrific consequence of what you claim you are intending to do. This means that you are at an 18.9% risk of embolism -- forget about five year survival.

Calling Warfarin 'rat poison' completely misses the mark. It's a matter of DOSAGE, not the fact that it's being used therapeutically. Chlorine is a dreadful poison - but they routinely put it into our water to kill microbes that will otherwise make us sick. If you take a bottle of aspirin, it'll kill you -- does this make it a poison to be avoided? Tylenol, if taken in high enough doses for a long enough time - will destroy your liver - does this make it a poison to be avoided? How about Alcohol? If you drink too much of it, it WILL kill you -- that's why they use blood alcohol tests or breathalyzers (just another meter to determine the effects of a particular dosage on the body)? Just BECAUSE it CAN kill you, does it mean that, in therapeutic doses it is to be avoided?

When I was in school, years ago, it was determined that glucose (I think it was glucose - it could have been plain old water) dropped onto the same tissue, over and over, could cause cancer. (The constant irritation of the tissue was responsible - not the glucose). Does this mean that you should avoid all sugars because they can be carcinogenic?

And, as far as your claim about warfarin being a rat poison - FWIW - there are rats and mice that have developed an insensitivity to warfarin, so it DOESN'T kill them.

I'm with Al. It sure seems as if you have some kind of irrational anti-warfarin agenda. If you want to put yourself in with the 18.9% untreated group who have roughly 1 in 5 chance of developing an embolus because you don't take Warfarin, go ahead - but I don't think anyone here would endorse or encourage it.

(Also - I was told by the manufacturer of one of the meters that there are a handful of drugs being developed to handle INRs using a different method of effect on Vitamin-K metabolism. Warfarin may have some challengers within the next five or 10 years)

 

[Lily]

Thinking Outside the Box?

Thinking Outside the Box?

In regard to this discussion, relating a personal experience or "sharing information," no matter if it's regarding positive or negative results, can be beneficially informative and would probably not be defined by most people as a "horror story."

Think of how many members here with Medtronic Mosaic valves were concerned about some less-than-positive personal member experiences and medical information published about the valves. It wasn't a horror story; but many of us were concerned, for the other members and for ourselves.

And consider this: Maybe anticoagulation therapy (coumadin or warfarin) is not unlike radiation therapy in that both kinds of treatment, used properly, have saved or extended lives -- and both serious kinds of treatment, whether used incorrectly or excessively -- or not -- have contributed to other health issues, sadly including death.

 

[Philip B]

Poo Poo Who?

Poo Poo Who?

Sorry, I just don't see a research study dated 1986 as new information. Thank god valve technology and INR monitoring techniques have improved since 1986.

Sure, we're still stuck with coumadin/warfarin, but I think monitoring and management techniques have improved over the last twenty-four years.

I still think you'd be better off if you'd get with a doctor who can find the source of your GI bleed issue, but that's just me and you seem to be happy making warfain your bug-a-boo. Good luck with that.

-Philip

 

[Protimenow]

Old studies can still produce good data. The study that showed a 19% rate of embolism in those not taking warfarin or platelet drugs (aspirin) should be as valid today as it was 24 years ago. I suspect that, should anyone want to try to live without ACT when they've got an implanted mechanical valve will probably still have the same risks.

Science is built on old research and old data -- some 'facts' remain facts, regardless of how old they are.

But I agree with Philip B -- find a doctor who can find the source of GI bleed - and then, perhaps, your disdain for warfarin will subside, once the bleed is controlled.

 

[olefin]

Sounds like you are in bad need of a good GI doctor and some warfarin education.

I had black tarry stools the year before taking warfarin. Had no stomach pain what so ever. I always thought my stomach was made of cast iron. The GI doctor, using the endoscopy found a large duodenal ulcer squirting blood. He was able to stop the bleeding. After that I took sucralfate (carafate) for several months to help heal the ulcer. There was a concern about using a mechanical valve because of warfarin with a history of bleeding ulcer. But I've had no more problem and been on warfarin for 19.5 years.
Thank God for that "rat poison"! :wink2:

 

[MarkU]

Don't feed the troll, folks.

Mark

 

[Lynlw]

I find it interesting, the post someone gets IF they complain about coumadin, I find it rather sad.

 

[MarkU]

I find it interesting, the post someone gets IF they complain about coumadin, I find it rather sad.

It's one thing to to "complain" about Coumadin. Its quite another to suddenly appear on a forum making outlandish statements, and then use ancient research references to support your position.
I don't think any of us would choose to be on Coumadin if we didn't think it was an effective medication. Like any drug there are associated risks, but one also needs to consider the consequences.
My "horror" story is that I'm still here after being on it for ten years now - no blood loss, no passing out or any other of the alleged "common side effects". Worst thing I've had to do is Lovenox bridges for colonoscopies.
I think the OP is just trying to stir the pot here. He's got other medical issues that he's trying to lay back on Coumadin. I hope he can get with someone who can correctly diagnose his issues.
Playing Russian roulette with Coumadin therapy is just plain irresponsible, IMHO.
Mark

 

[dick0236]

I don't think any of us would choose to be on Coumadin if we didn't think it was an effective medication. Like any drug there are associated risks, but one also needs to consider the consequences.
Mark

I agree with Mark. AVR surgery...and warfarin(coumadin), have made it possible for me to live many, many more years than was possible just a few years before my surgery. Many new people visit this site and it serves no purpose to attack, or slander, the only drug that has been proven to work as an anticoagulant for mechanical valve patients. Like Mark, I have had very few problems with the drug. Unfortunately, a few have issues with the it, usually due to other causes, including non-compliant patients:redface2:.

 

[yotphix]

I find it interesting, the post someone gets IF they complain about coumadin, I find it rather sad.

If he were just complaining that would be one thing but he is spreading his own misapprehensions and wild suppositions, and a good dose of hysteria along with his complaints. It is entirely possible that he has a rare or even unique response to well managed, warfarin based anti-coagulation therapy. What is unfortunate is that he seems not to understand that even if warfarin was responsible for all of the evils of the world, it would still not be capable of hiding the source of a gastro-intestinal bleed. In another post he was looking for the thoughts and advice of others. When he gets the considered opinions of some bright and learned people he dismisses them out of hand and then carries on raving about "Rat Poison". This is not the irrational ranting forum, it is the anti-coagulation forum.

For a more up to date viewpoint on haemorrhage vs. thrombotic event check
http://circ.ahajournals.org/cgi/content/full/107/12/1692
It is not light reading but the information is all there, including references to further articles.

Another interesting point mentioned on the linked page is that warfarin prevents thrombosis, and slows coagulation through two separate mechanisms. This holds out the hope that we may one day benefit from a drug which is able to do one without the other, making us all happy. Let's hope that it never get's used for anything else, like an herbicide!

 

[neil]

hi.....i think what lynn is saying is that if any body comes on here with a problem with a tissue valve there then seems to be a lot of jumping on the bandwagon saying why would anybody choose tissue etc, when all you have to do with mech is take a pill a day no problems, well some people have major problems with anti coag,and just because that is pointed out there are then put down, imo both valves are exellent choices but both have risks,

 

[yotphix]

hi.....i think what lynn is saying is that if any body comes on here with a problem with a tissue valve there then seems to be a lot of jumping on the bandwagon saying why would anybody choose tissue etc, when all you have to do with mech is take a pill a day no problems, well some people have major problems with anti coag,and just because that is pointed out there are then put down, imo both valves are exellent choices but both have risks,

Perhaps that is what she means. I find that perception interesting in that when I first came to this forum, having already decided on a mechanical valve, I thought that the whole forum seemed heavily skewed toward the choice of tissue. I did find it reassuring though, that a small minority here seemed to be living healthy active lives with mechanical valves and seemed to have worked out the bulk of the potential difficulties with anti-coagulation. It is probably more balanced than either of us thinks.

I don't think anyone here has ever said "all you have to do with mech is take a pill a day, no problems". What I understand to be the tone of the ACT forum in particular, is that if you take the initiative in understanding and educating yourself about ACT with Warfarin, you should be able to solve any problems.

Look, there apparently are people who simply cannot take warfarin ("Andre Lamy, MD, an associate professor in the departments of surgery and clinical epidemiology and biostatistics at McMaster University in Hamilton, Ontario, told Cardiovascular Business that about 8-10 percent of the atrial fibrillation patient population cannot tolerate vitamin K antagonists." from http://www.cardiovascularbusiness.com/index.php?option=com_articles&article=21232) but I have seen no one here present evidence of their belonging to this hypothetical group. The particular poster we are discussing now just appears in the forum screaming "RAT POISON" and then covers his ears to any helpful considered advice. It doesn't contribute to the conversation or advance anyone's understanding. I think we'd all be better off if he actually read the replies to his posts, or if he just posted somewhere else in the first place.

 

[yotphix]

But if Raenderle really wants to try something new, perhaps he should look into this:

http://en.wikipedia.org/wiki/Hirudo_medicinalis