On-x valve w/aortic aneurysm repair or replacement

[andrewg]

Susan,

I had the aortic valve replaced.

Below is some information I copied from the On-X web site about the trials.

Based on existing clinical data and the submitted protocol, the FDA has determined that a clinical trial of the On-X valve with three specific patient groups at reduced anticoagulation levels is clinically reasonable. The patient groups include low-risk aortic valve replacement patients, higher risk aortic valve replacement patients and mitral valve replacement patients. Higher risk patients include those with heart rhythm problems, left ventricular dysfunction, previous thrombo-embolism and condition of hypercoagulability.

The low-risk aortic patient group will be maintained using non-warfarin anticoagulation medication of clopidogrel (Plavix®) and aspirin. Higher-risk aortic patients will be maintained using warfarin (Coumadin®) at reduced International Normalized Ratio (INR) levels of between 1.5 and 2.0, plus aspirin. The mitral valve replacement patients will be maintained with warfarin at a target INR of 2.0 to 2.5 and aspirin. The first three months for all patient groups include traditional warfarin anticoagulation protocols. To ensure that patients remain within target INR range, each patient will be required to self-monitor their anticoagulation levels. Results of this self-monitoring will be communicated to the patient?s physician.

 

[ALCapshaw2]

I was more hoping for specific studies or test results..

The LOW / NO Anti-Coagulation study results should be available in 2015. I'm guessing you don't want to wait that long.

Contact On-X directly to discuss interim results. Call Catheran Burnett, RN at 888-339-8000 ext 265 or write her at [email protected]

The conservative approach would be to go with the St. Jude Masters Series Valve with the attached dacron graft.

 

[Mike C]

Contact On-X directly to discuss interim results. Call Catheran Burnett, RN at 888-339-8000 ext 265 or write her at [email protected]

I do not recommend relying on this information. Nothing against this person or company, as I do not know either.
Its about the clinical trial business...Think of the financial difference to the company related to results of the trial.

 

[srwieland]

just got into on-x trial

just got into on-x trial

Hi all!

I was just admitted into the trial for the On-x valve late last week. (I am scheduled for AVR redo on 5/29 with the On-X valve.)

I have been assessed as low risk and so, as others have reported above, will undergo 3 months of regular coumadin before being randomized to receive either a reduced coumadin regimen or Plavix + aspirin.

Anyone have info/experience with risks of Plavix vs risks of Coumadin?

By the way, sknydave, this will also be my second AVR at Shands. Who is your surgeon/cardiologist? What has your experience with them been?

 

[sknydave]

Any idea why they won't take you for a trial after the fact? Or do you still want to participate?

I actually thought I'd read of about three or more members in the trial... Does anyone else recall? The posts about it have been here, there, and yonder.

I was told they have to run tests and go over things prior to the surgery. I was foolish and asked to take part rather close to my actual surgery date.

 

[Ross]

Hi all!

Anyone have info/experience with risks of Plavix vs risks of Coumadin?

To be perfectly honest, this is not fact, but experience, I believe Plavix to be as risky, if not more so, because when I took it, I was coughing up blood and had random diarrehea so bad, that I couldn't tell a difference. Others have done just fine on it, but it doesn't play well with me.

 

[srwieland]

Plavix still a question for me

Plavix still a question for me

Thanks Ross!

I've heard things about Plavix, both anecdotal and through research. Seems to cause some such as yourself gastrointestinal problems, potentially dangerous for those who have a history of ulcers.

I've also heard it is given to those who have problems taking aspirin. I've been taking 325 mg aspirin since my first AVR 7 years ago, without problem.

Ross, did you have a history of GI problems or problems with aspirin?

Also, do you or anyone else know anything about bleeding problems with Plavix such as exist with Coumadin/warfarin?

 

[srwieland]

on-x trial inclusion

on-x trial inclusion

skynydave: I did everything over the phone in just a few minutes and consented by fax last Thursday, just 3 weeks prior to my scheduled surgery.

However, I've had a lot of lab tests and echos recently, and so maybe they already had enough to go on to make their decision. They also determined that I was low risk just from my records.

Out of curiosity, I'll ask Nancy Staples, the study coordinator at Shands at UF, what the criteria for inclusion are. If I find out anything interesting, I'll let you all know.

 

[sknydave]

Thanks! I would love to get in on this

good luck!

 

[dtread]

Randomized On-X Anticoagulation Clinical Trial

Randomized On-X Anticoagulation Clinical Trial

The information on the Randomized On-X Anticoagulation Clinical Trial is found at: http://www.clinicaltrials.gov/ct2/show/NCT00291525?show_locs=Y#locn

The information was recently updated and now shows 29 participating centers. The Clinical Trial was approved for a total of 40 centers, so the information will be updated as more centers are added over time.

Although not stated (it is implied), one of the inclusion criteria is that you have to have the valve implanted at one of the participating centers. And then go to the same center for periodic follow-ups. Another criteria is either isolated aortic valve replacement or isolated mitral valve replacement. Not both. Refer to the Clinical Trial for complete information or contact the study personnel.

-Dan

 

[srwieland]

Thanks dtread

Thanks dtread

That link was very helpful and has all the official inclusion & exclusion criteria.

It also confirms everything I was told when I consented (& more).

I should have thought to look there in the first place, since I'm the one that puts the requirement to register with clinicaltrials.gov in all our contracts with clinical trial sponsors! (I guess I was too trusting since I am so overly familiar with the clinical trials process.)

 

[Ross]

Ross, did you have a history of GI problems or problems with aspirin?

Also, do you or anyone else know anything about bleeding problems with Plavix such as exist with Coumadin/warfarin?

No problems GI or with aspirin until after I was taken off of it.

Not sure what you mean by bleeding problems? I will say that I think it rivals Coumadin in much the same way, even though it doesn't do the same thing to the blood. What I don't get is, Coumadin does not cause my lungs to bleed, but add Plavix to the diet and I do.

 

[SteveInFlorida]

Plavix

Plavix

Thanks Ross!

It seems that Plavix is less predictable than Coumadin in any case, which is a problem in itself beyond whatever actual side effects one may have. Maybe low dose Coumadin would be a better alternative to the standard dose than the Plavix plus aspirin regimen? Anyway, I guess I'll be finding out more how my particular body reacts to it soon, as I will begin a brief trial with it in the next day or so.

That's the great thing about this site. You get the perspective of those who have already tried what we're about to try ourselves, and you can't get that anywhere else.

Working in medical research administration, I am bombarded with the perspective of the doctors and the pharmaceutical industry. However, from this site, I have learned to be attentive to consult the other perspective when it's my own skin on the line! (especially those of fellow patients such as you Ross, who is not only very experienced but has also heard it all in your long-time participation on this site)

Anyway, when I start the brief trial of Plavix in the next day or so, thanks to your sharing of your experience, I will have a better idea of what problems I could possibly have with it.

 

[Duff Man]

Here's a study where South African Non-Compliant patients were implanted with the On-x and had similar embolism rates to a tissue valve.


http://www.onxvalves.com/pdf/Clinical Update 19.pdf

 

[ALCapshaw2]

The low-dose coumadin is what I would go for, if I had the On-x. I have no side effects with coumadin, but I do with aspirin. Can't take even low-dose aspirin on a daily basis; it tears up my stomach.

Rachel -

Have you tried enteric (coated) aspinin in the low dose?

Also, please tell me how you do multiple Quotes in one post. When you quote only one line, are you deleting the rest of the full previous text or is there a way to highlight the desired sentence and quote it alone?

'AL Capshaw'

 

[Leah]

Does Plavix have its own complications?

Does Plavix have its own complications?

Since one of the "test" regimens is Plavix plus aspirin, does anyone have information about the consequences of being on Plavix? Are there serious complications? Is there monitoring involved? Are there contraindicated activities or lifestyle issues? (I know there are debates on this site about whether and how much coumadin involves lifestyle issues. I'm not trying to re-open that, just get a sense of how big or small a deal it is to take Plavix, should the On-X trial of that regimen prove successful.)

 

[tomflies1]

Mechanical/bovine

Mechanical/bovine

I just met with my surgeon and I'm scheduled for July 21st,(Cedars Sinai) and we had to go over the choices for the valve. I went in thinking mechanical (I'm 55 now with BAV) but after talking about it and seeing all the options, we decided to go bovine. I asked my surgeon what he would do at my age, and his answer surprised me. The company that makes the bovine valves are making them so that 10, 15 years down the road I'll be able to get another valve (presumibly to last the rest of my life) via a catheter procedure. The new type valve is very flexible, has some memory metal, will actually twist down to fit in the catheter tube and then when it's positioned in the heart it pops open and fits into place within the old valve. Kinda reminds me of a satellite antenna array being popped open in space. So, I'm going to rely on technology, not deal with the coumidan for now, and hopefully not need another valve for a long time.

 

[Karlynn]

Tomflies1 - At 55, you are in that age range where it really can be a toss-up. I think at that age, if I were to need my mech replaced for some reason, I'd probably still go mechanical (particularly since it would be my 2nd surgery) and most likely the On-X. But I think tissue is not a bad option at your age.

I would echo Bicuspidboy's comments on whether a catheter replacement will be viable when you are ready for another valve. As he mentioned it is now mainly being done on patients who would not survive an open chest procedure. There are many doctors who believe that the open chest VR wlll be around for quite a while as the best way to replace a valve (and Port, and minimal are included in this.) One of the big questions is whether these valve that are being placed via catheter will hold up well enough (and for how long) in a normal, active person to be a viable option.

My personal opinion is that you make your choice based on what they know can be done now. Let future technology be a nice plus - but don't hang your hat on it.

 

[Arlyss]

Tomflies1,

I did not see any mention of your aorta, just your bicuspid aortic valve. Did anyone (cardiologist or surgeon) talk to you about your aorta? Is it enlarged at all?

In order to plan the big picture now and as you go forward after surgery, you need information about your aorta as well as your valve.

I encourage you to explore some of the information at this link

http://www.bicuspidfoundation.com

and follow up with your physicians about any questions you have. In light of the AHA/ACC guidelines for heart valve patients published in 2006, which includes the risk of ascending aortic aneurysm with BAVs, this should be thoroughly covered with you.

Best wishes,
Arlyss

 

[Plumber1]

I have an On-x with a dacron aorta. My surgeon seemed to think nothing of attaching what dacron was needed to the valve. I was worried that one day it might come untied or something, he said no way.

Mark