Hello again!

[akaShei]

Thanks for your kind words & helpful links in the significant others forum. I did some reading & printing of the info on Coumadin & gave them to my husband, Nick. He had a talk with his cardiologist today & again was urged to go with a mechanical valve. The valve his surgeon recommends is ON-X.
The hospital is doing a study on lower dose ACT with the ON-X valve, and Nick has been told that he is a good candidate for the study. I'm pretty sure he has abandoned the thought of a tissue valve after today & is considering participating in the study. One of the groups in the study is treatment with Plavix and aspirin. The control group is regular dose Coumadin and the third group is low dose Coumadin. Any thoughts? (esp. on taking Plavix for ACT)

 

[briansmom]

We are planning to put my son in the low dose ACT group. We will try to keep his INR between 1.8-2.5. This will hopefully allow him to continue to drive an off-road car. Someday, we hope that the trial goes well and he can discontinue ACT.

 

[Arlyss]

Participation in Clinical Trials

Participation in Clinical Trials

Please be sure that information has been thoroughly explained to you and that you clearly understand the risks of participation in any clinical trial.

Those conducting a study are working towards their goals of completing the study and, assuming a successful trial, bringing a product to market. Patients should be focused on receiving the best possible solution for their situation - and should be very clear about any risks they are asked to take.

One way to get an objective view is to get an opinion some where else, from someone who is not engaged in a study of any kind but understands and is familiar with or uses the technology in question.

In participating in a trial to determine whether or not a mechanical valve requires coumadin or something less, some of the participants (those trying lower dose coumadin or plavix/aspirin) have to be willing to risk a stroke or TIA.

I would encourage anyone thinking of a study like this, which has the potential for injury to the brain if a stroke should occur, to think carefully about what that might mean to them.

It is over a year now since my husband experienced a major stroke. It is a world that I would like to spare others from entering.

For Nick, who has a bicuspid aortic valve, please be sure that his aorta is evaluated. He needs an evaluation not just by a valve surgeon, but by someone who understands aortic disease and can give him a thorough evaluation of his aorta. Even if there is a wonderful experience with whatever valve choice is made, if the aorta tears or ruptures it can end life with little warning. If the cardiologist involved has read the AHA 2006 guidelines for heart valve patients, he/she will be aware of the association of aortic aneurysm with bicuspid aortic valves.

Those who are younger and have BAV with leakage are very often found to have a more severe abnormality of the aorta at a younger age. Sadly, many bicuspids get into emergencies because they have a diseased aorta that they do not even know about.

Best wishes,
Arlyss

 

[Magic8Ball]

What Arlyss says..ditto ditto.

Who gives a stuff if they can be on a low dose anti-coagulant, unless its been proven for 10+ years with 1000's of people i'm not interested.

Granted, someone has to be in a study but why take the risk, being on warfarin does limit some of the things you can do but it doesn't make you housebound....a stroke will.

Really, i'm 37, and some of the things i can no longer do such as martial arts etc i was really getting too old for anyway time to grow older gracefully is my new motto..

I respect your husband if he wants to take part in this but follow Arlyss's instructions above as the people running the trial do not necessarily have your husbands best interests in their thinking.

Regards.

 

[michellep]

Shei,
You may want to do a quick search of threads and read Arlyss's story of her husband in detail. Not to scare you, but to make you aware of potential situations.
I am 38 with a quadricuspid aorta (sim. to a bicuspid). I just received a tissue valve. I only take aspirin daily. Make sure that your husband isn't being forced into a situation without all of the facts. His age doesn't have to dictate which valve he gets (that is a common, OLD, assumption). Be wary of trials. Read as much info as possible.
Good luck to you. I know you are in a very scary position but he is young and strong.

 

[Ross]

I would not do it as a trial or test subject. Take the On-X, but take it with full anticoagulation in mind. If it pans out later that full anticoag is unnecessary, that can be compensated for, but you cannot replace dead brain cells from stroke.

Plavix, in my opinion, is dangerous. While I was on it, things started bleeding that hadn't in years. Also, that stuff gave me diarrhea like you wouldn't believe. Plus it is VERY expensive.

 

[geebee]

It is somewhat difficult for me to give opinions about medical trials/studies. None of us would be here today if it were not for medical studies and the brave people who went through them.

That being said, I would hesitate to take place in a study to REPLACE a know medical procedure. We all know that ACT and mechanical valves work very well together. While I am following the concept of the ON-X and lower INR, I guess I just don't see the reason for it. If you are on coumadin anyway, who really cares if the INR is 1.5 - 2.5 or 2.5- 3.5? Also, a study like this one that doesn't work can kill you. Coumadin very rarely causes death.

I admire pioneers - I just wouldn't want to be one.

I do wish your husband very well on any path he takes.

 

[Arlyss]

I should clarify that my husband's stroke was not from blood clotting issues or from bleeding.

But his stroke was valve-related, and it took us into a world of brain injury, which is a very devastating place. I had no idea. Stroke is the leading cause of disability in this country, the third leading cause of death.

Traditionally it has been thought that after about 6 months, if the brain did not recover any more function, it never would. That thought is changing and the brain is now being described as having "plasticity" and the ability to recover much more. But that idea has not translated into continued payment by insurance. They give up on the brain much too soon.

We are grateful for every day that we have together - I have described those days as perfect, not because they are easy, but because we are still together. We are very painfully aware of what has been lost and determined to continue the fight to regain as much as possible.

So, if you are choosing anything that will expose you to some unknown level of risk to the brain, please understand what it might mean. Read the fine print.....what will happen in the event that your brain is injured?

Best wishes,
Arlyss

 

[LUVMyBirman]

I agree with Ross. Onyx with full anti-coagulation. You could always adjust your meds at a later date. It would be great to see this valve make it through the trial removing the Coumadin factor. Whatever your decision may be....I do commend you for considering the trial!

If you go with a tissue valve...there are no guarantees that you will not require a blood thinner immediately or down the road.

Very personal choice. We can offer our input. Bottom line....your decision....your life.

Good luck to you. Please keep us posted.