ON-X Valve and warfarin

[Bad Mad]

Being relatively new to this site, I have found it to be such a fantastic tool to be able to share experiences and find out answers to questions.

I've just came across this ON-X valve, having never heard of it previously.

Just a couple of questions:

Can this valve be implanted as a AVR along with the Dacron graft (composite)
to repair the aorta?

What are the warfarin implications?

As I suspect they are little or none, does this mean that contact sport would be a real possibility?

What are the durability prospects?

Thanks

BM

 

[Ross]

BM Yes it's possible to sew a graft to one, but they have no models with a graft attached already like St. Jude does. You would still have to take Warfarin with the On-X valve, any mechanical valve period. What type of contact sports are you thinking of? You can continue to do most everything you always have, but you might what to do more to protect your noggin.

 

[ALCapshaw2]

Studies are being conducted in Europe (Germany?) and the USA on Aspirin or Plavix Anti-Coagulation Therapy (NO warfarin) for Low Risk Patients (Aortic Valve only and NO other medical complications). Other studies are being conducted with LOW Level Warfarin ACT on Mild Risk patients. It will be some time before we know the results of those studies.

The IMMEDIATE benefit of the On-X valves is that they have a significantly LOWER "Morbid Event Rate" than any of their competitors according to their data which I 'believe' is based on data supplied to the FDA in the USA.

Contact [email protected] for an information package on the On-X Valves and/or visit their website at www.onxvalves.com Catheran is the Education and Promotion Manager for MCRI, manufacturer of the On-X valves.

'AL Capshaw'

 

[Bad Mad]

Ross

My sport is Gaelic Football, which I have had to give up in the past year because of a dilated ascending aorta of 4.4cm. I also had a homograft implanted in 2001 to replace my BAV. I miss my sport terribly, but have had to move on.

It's pretty certain that in the next 5 years, I will have to get both of these things sorted. Another homograft is probably not a good idea, considering a definite 3rd op. would have to follow in another 10 -15 (or 20 with 3rd generation valve) years.

But if I were able to get a combination which had both the benefits of little or no warafrin and a durability to almost certainly last me my days, then that would be super. I would even consider pre -empting surgery, while I am still fit to play. Maybe this sounds obsurd??

My sport is physical with a lot of contact. Not as robust as rugby but more contact (especially upper body) than soccer.

 

[Fast Eddie]

Hi Bad

I just had an On-X installed 3 weeks ago. I wanted to avoid a second OHS in 10-15 years, as by then I will be 70-75. I initially was hoping the clinical trials for the On-X would be complete in 3-4 years at which point, if the trial was successful, I could stop using Coumadin. However, it looks like the expected completion date for the trial is 2015!

Here is a link to the clinical trial document: http://clinicaltrials.gov/show/NCT00291525

Fast Eddie

 

[Bad Mad]

Interesting to hear Eddie. Hope your recovery goes well.

Do you take the normal dose of warafrin now then?

Shucks....I'll be well past my level of competitive sport at that stage, but it would be nice to have a life-long valve without having to take any crappy medication!

 

[starfish11040]

Surprised and disappointed to see the 2015 completion date. But I have the feeling that if, as the trial progresses, there is strong evidence supporting the On-X on low or no warfarin the news will be out long before 2015.

 

[Fast Eddie]

Interesting to hear Eddie. Hope your recovery goes well.

Do you take the normal dose of warafrin now then?

Shucks....I'll be well past my level of competitive sport at that stage, but it would be nice to have a life-long valve without having to take any crappy medication!

Bad and Starfish

Bad:
I am not in the trial, so I am just another 'normal' Coumadin user. I believe for the On-X the INR target is 2.5 - 3.0. I believe that everyone in the trial starts out on the normal INR path, then after 3 months different groups start using the dosage that gets them to the target INR for their group.

If you can get in on the On-X trial, you MIGHT be able to get in on the lower dosage group, but as I understood it, you would not have the choice. You would be randomized into either the normal INR or lower INR group. I might ask if I can still possibly get into the trial at this point. But my wife will probably give me grief about going into the lower INR group!

Starfish:
I really hpe you are right and that if the results look good that the trial could be cut short. On 6/21 I visit my surgeon. The hospital I was in, Beth Israel Deaconess Medical center here in Boston, is one of the hospitals that is recruiting patients for the trials. I'm going to ask about the possibility of earlier results if all looks good.

I'll post whatever I find out.

Fast Eddie

 

[Bad Mad]

I emailed catheran Brunnet and this is the answer she gave me:

The On-X valve gives a possibility of very low anticoagulation medicine or maybe even an aspirin/Plavix regime if you have no other risk factors. We will know in about 2 years, hopefully. For now, you would need the regular dose of anticoagulation medicine with the On-X valve.

This sounds encouraging.

 

[aussie girl]

I was told by the australian on-x rep that over 600 patients in africa had the on-x valve implanted and most never returned to get their warfarin. When they tracked these patients down nearly all were doing fine without the medication. The same thing has happened with aborigines here in australia. This is why they were given approval to conduct these current tests in america. ....Mary

 

[Bad Mad]

Thats interesting Aussie G.

Do you know of any people who have had the ON-X implanted with the graft to repair the aorta also?

Does anyone know if theyt have started to use the ON-X anywhere in the UK?

If this study proves to be successful, surely everyone who qualifies will want to go for this option.

 

[Philip B]

On-X & Graft

On-X & Graft

Yes, in the last couple of months a number of members have opted for an On-X with a Dacron graft. The post-op reports they have posted have been positive. I'm sure some of these folks will respond to your question.

-Philip

 

[Randy & Robyn]

The African study did look exceptionally promising for a potential aspirin-only regimen with the On-X. However, a more formal aspirin-only study was conducted in Germany that was terminated more than a year ago after several incidents, including one death. I think that failure effectively took the option of "aspirin-only" off the table.

Catheran mentioned to me that most people with the On-X in the aortic position, with normal heart function, and who respond well to aspirin would probably do well on aspirin only. However, some people don't get the same level of protection from aspirin that others do. The trouble is it is impossible to know exactly who those people are until it is too late.

I've also read about a young man who went twelve years without any anticoagulation with a St. Jude valve and he didn't have any problems. But it's all a roll of the dice. And right now, coumadin puts the odds greatly in our favor so I'll stick with it.

Randy

 

[Fast Eddie]

Do you have a URL for the German study?

Do you have a URL for the German study?

However, a more formal aspirin-only study was conducted in Germany that was terminated more than a year ago after several incidents, including one death. I think that failure effectively took the option of "aspirin-only" off the table.
Randy

Hi R & R

Do you have a URL that discusses this German study? If it was stopped early because of 'incidents', why did the FDA approve another aspirin/Plavix trial? Was the German study aspirin w/o Plavix?

Just curious

Fast Eddie

 

[liam13]

Find this On-X option very interesting to say the least. Even a lower dose of coumadin would be fine with me as a means of keeping the blood flowing. Liam

 

[ALCapshaw2]

Here is what Catheran Burnett, Education and Promotion Manager of MCRI (Medical Carbon Research Institute) and manufacturer of the On-X Valves had to say about the German study.

Hi AL,

Randy is correct in how he quoted me except that I did not give him the whole tale evidently.

If you want, you can share with Randy and the other gentleman that the results of the German aspirin study showed no significant differences in the aspirin group and the Coumadin group with On-X. We stopped the study in favor a larger expanded FDA study with an aspirin/clopidogrel arm here in the USA so it would be more widely applicable. There is still a group of patients in Germany on aspirin only and so far so good four years later. Yes, the patients on aspirin need to be aspirin responders and have no arrhythmias or other major problems. There is a test for responsiveness to aspirin.

It would be nice if this was on the patient web site for everyone to see the entire story.

Thanks.

Catheran

(Contact info is [email protected])

 

[starfish11040]

Thanks Al for clarifying.
So it appears that the German trial did not take the possibility of aspirin-only off the table. In fact it supports the possibility.
A positive outcome to the current trial would make the process of valve selection very simple for many people. Let's hope.

 

[Randy & Robyn]

Thank you for posting this, Al. And thank you, Catheran, for sharing more details of the German study that I wasn't aware of. Also, my apologies for jumping to conclusions. I had assumed that adverse events were the reason the study was halted.

In any event, I still believe the On-X to be the best shot we have at a replacement valve that has the potential to last a lifetime and also the potential at reducing or eliminating coumadin in the not so distant future.

I just had my one year echo and my On-X is doing its job admirably. I feel 100% back to normal. I'm back to lifting weights and can even run a seven minute mile again so I certainly have no complaints!

Randy

Here is what Catheran Burnett, Education and Promotion Manager of MCRI (Medical Carbon Research Institute) and manufacturer of the On-X Valves had to say about the German study.

Hi AL,

Randy is correct in how he quoted me except that I did not give him the whole tale evidently.

If you want, you can share with Randy and the other gentleman that the results of the German aspirin study showed no significant differences in the aspirin group and the Coumadin group with On-X. We stopped the study in favor a larger expanded FDA study with an aspirin/clopidogrel arm here in the USA so it would be more widely applicable. There is still a group of patients in Germany on aspirin only and so far so good four years later. Yes, the patients on aspirin need to be aspirin responders and have no arrhythmias or other major problems. There is a test for responsiveness to aspirin.

It would be nice if this was on the patient web site for everyone to see the entire story.

Thanks.

Catheran

(Contact info is [email protected])

 

[Mike C]

Here is what Catheran Burnett, Education and Promotion Manager of MCRI (Medical Carbon Research Institute) and manufacturer of the On-X Valves had to say about the German study.

I am not expressing any opinion or bias towards or against ON-X.
I do not know Catherian Burnett

I would be cautious with some of the information. Potential of conflicts of interest. Medical device or drug companies have a great deal of $ at stake.

 

[Arlyss]

I was interested to see the mention of an aspirin/clopidogrel study. The brand name of clopidogrel is Plavix. It is an antiplatelet drug. Unlike coumadin which has the INR, there is currently no blood test to monitor or determine whether one is in a therapeutic range. I have heard that something was being worked on. I also am not aware of a quick way to reverse this drug.
Doing a search on the net will give some idea of its side affects.

Before doing your home work, do not assume that taking clopidogrel with a mechanical valve would be more desirable than taking coumadin.

In the course of his experience, my husband has taken coumadin (for many years with his mechanical valve), plavix for some months, and at one point briefly aspirin along with the other two.

Today I am happy to have him on aspirin only with his tissue valve.

Best wishes,
Arlyss