ON-X Valve and warfarin

[Bad Mad]

I asked my cardiologist(s) about the ON-X. The first reply is from a well respected Cardiologist in Belfast who has been in the game for over 30 years.

The 2nd one is from the head of Cardiology in the Belfast City Hospital (my new Cardiologist - other one is retiring)


"Afraid I've never heard it - I presume it is a mechanical valve - if so people have talked for years about their device being the one that will crack the difficulties - there would need to be pretty compelling long term evidence to be convincing."

"I had a look at the web page and info. Its interesting but probably too early to say about it
.
From a cardiologist point of view (and not the industry) there are no long term data with this valve. Also there are no safety data regarding the anti coagulation. While there are theoretical benefits ? until they have been proven in clinical practice (and not just lab settings) you cannot say for sure. They claim that you may not need warfarin with this valve but have no long term data.
Also aspirin and plavix together would also be associated with increased bleeding and gaelic would still be out.

So I suspect it?s a mater of keeping and eye on it ? but wouldn?t rush into getting one. I have seen these type of claims before only for the valves to be recalled a few years latter (which is difficult if they are in a patient!!)."

 

[Ross]

I asked my cardiologist(s) about the ON-X. The first reply is from a well respected Cardiologist in Belfast who has been in the game for over 30 years.

The 2nd one is from the head of Cardiology in the Belfast City Hospital (my new Cardiologist - other one is retiring)


"Afraid I've never heard it - I presume it is a mechanical valve - if so people have talked for years about their device being the one that will crack the difficulties - there would need to be pretty compelling long term evidence to be convincing."

"I had a look at the web page and info. Its interesting but probably too early to say about it
.
From a cardiologist point of view (and not the industry) there are no long term data with this valve. Also there are no safety data regarding the anti coagulation. While there are theoretical benefits ? until they have been proven in clinical practice (and not just lab settings) you cannot say for sure. They claim that you may not need warfarin with this valve but have no long term data.
Also aspirin and plavix together would also be associated with increased bleeding and gaelic would still be out.

So I suspect it?s a mater of keeping and eye on it ? but wouldn?t rush into getting one. I have seen these type of claims before only for the valves to be recalled a few years latter (which is difficult if they are in a patient!!)."

You might be just the person to introduce the valve to them!!! I know there are studies that have been done in Europe, so I'm not sure that I buy they've never heard of it, but perhaps On-X used a different name in the studies.

 

[Randy & Robyn]

I asked my cardiologist(s) about the ON-X. The first reply is from a well respected Cardiologist in Belfast who has been in the game for over 30 years.

The 2nd one is from the head of Cardiology in the Belfast City Hospital (my new Cardiologist - other one is retiring)


"Afraid I've never heard it - I presume it is a mechanical valve - if so people have talked for years about their device being the one that will crack the difficulties - there would need to be pretty compelling long term evidence to be convincing."

"I had a look at the web page and info. Its interesting but probably too early to say about it
.
From a cardiologist point of view (and not the industry) there are no long term data with this valve. Also there are no safety data regarding the anti coagulation. While there are theoretical benefits ? until they have been proven in clinical practice (and not just lab settings) you cannot say for sure. They claim that you may not need warfarin with this valve but have no long term data.
Also aspirin and plavix together would also be associated with increased bleeding and gaelic would still be out.

So I suspect it?s a mater of keeping and eye on it ? but wouldn?t rush into getting one. I have seen these type of claims before only for the valves to be recalled a few years latter (which is difficult if they are in a patient!!)."

The On-X was introduced in 1996 and no structural problems have surfaced yet so I am pretty confident it is a well-designed valve with little chance of a major recall.

I don't buy the story of a cardiologist not having heard of the On-X either. It has a solid reputation and is being utilized by more and more surgeons. When I first came to this site in early 2005, there were at most two people on the forum who had the On-X. That number has grown steadily.

As for there still being a bleeding risk with Plavix, I do agree and I doubt I would ever switch over to it as long as I am having no difficulty with the Coumadin. Why mess with what works?

It's just comforting to know there might be an added degree of thromboresistance and perhaps someday an aspirin only regimen might still be possible.

Randy

 

[ALCapshaw2]

The On-X valve has been in use in the World market for over 10 years with over 50,000 implanted to date. They have had FDA approval in the USA for 5 years.

There is an impressive study from South Africa where On-X valves were implanted in a largely non-compliant population resulting in a significant reduction in Stroke events attesting to lower propensity to produce Clots compared with other (older) mechanical valves.

Any surgeon who claims not to know of the On-X valve has his head in the sand and is grossly 'out of touch' with what is happening in the artificial valve market.

'AL Capshaw'

 

[Ross]

The culture here is slightly different from the US, where people seem to shop around a lot more. I'm learning a lot from this site.

Alan this is true for those that know better. Do you have any idea how many don't even know they have choices? It's quite a few.

 

[Arlyss]

In searching the FDA database, here is record that mentions being part of a study

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=527617

Here is one where the valve was replaced due to blood clots in the aspirin only study - apparently a monitoring device was used to indicate a problem.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=649604

I assume the addition of an antiplatelet drug, clopidogrel(Plavix), to aspirin is an attempt to see if inhibiting just platelet "clumping" is enough rather than requiring an anticoagulant such as coumadin.

However, there is no test for therapeutic range for Plavix and it also has side effects. Coumadin/warfarin does have the INR to indicate where the blood is at.

Best wishes,
Arlyss

 

[HarleyM]

I have the Dacron graft and the ON-X valve. Search my name for the 411 on this valve. I am enjoying life and very happy with my valve choice.

 

[Bad Mad]

I do find it a little strange that neither of them were familiar with the ON-X. Perhaps it hasn't properly broken into the UK market as of yet.

The comments about freedom of choice are correct though. Many people are not aware that they can make choices. Particularly as our Health Service is a public one, too many of us believe that we must get what the doctor decides/advises.

Personally, I can understand anyone with scepticisms of a valve that is just 10 years old.
Of course this study looks promising, but then again if it doesn't go according to plan, it wouldn't of been the first false dawn. If, when the study is completed (2015 or before), the recomendations are aspirin with plavix, then what has been achieved? Another standard mechanical valve?
Perhaps this is the reason for the scepticism/ignorance of my cardiologist(s) in regard to the ON-X. They have heard it all before.

Forgive me, if I come across a little dismissive. Being honest, if faced with a choice right now of what mechanical valve to go for, I don't know what I would do. As someone who would take the odd risk, maybe I would take the chance on the On-X in the hope that the study is successful. Or then again,
"better the devil you know, than the one you don't."

Harley M:
Are you not taking any medication with your ON-X? See you had none listed.

 

[aussie girl]

Send Catheran Burnett an email and ask for the name/phone number of the on-x rep in the uk/ Ireland. The rep will be able to give you the name of surgeons in your area. I did this and I now have an appointment with a top surgeon in adelaide who is experieced with on-x valves ...Mary

 

[Bad Mad]

Thanks Auusie Girl.
Catheran Burnett already sent me these details.
My research at the minute is merely to see what is out there for the future.

I am unsure when my valve/graft will need replaced/fitted.
Probably not for a couple of years at least.

So I'll be watching all developments closely. As someone else said, it's important not just to choose the right valve but also a surgeon who is skilled
in that field. That would be my worry, considering my cardiologist(s) have never heard of it!

 

[John35]

I have just been fitted with a on-x valve in london last month. I wasn't really given a choice on type of valve but after careful research I was happy with the surgeon's choice.

One of his quotes that I remember is that "if a perfect valve was invented today we would not know about it until 15 or 20 year had passed".

Most people like to stick with the thing they know well. With a new valve the company have to convince the surgeon to move away from the thing they know will work. Luckily some surgeon's will move forward so that we will all benefit from advances in design and manufacture of mechanical valves.

IF you want this valve or any other then insist that you get it. Its your choice even with the NHS.

 

[ALCapshaw2]

To MY mind, the MAIN advantage of the On-X Valve has nothing to do with anti-coagulation (and the study results).

The MAIN advantage of the On-X Valve is that it has the Lowest Morbid Event Rate of ANY Mechanical Valve on the Market according to statistics which the company will gladly provide from FDA Data submissions and other studies.

MY reason for choosing On-X for my upcoming MVR is to minimize the risk of Clot Formation. Low turbulence and Low Pressure Gradient are additional benefits REGARDLESS of the outcome of the anticoagulation studies.

'AL Capshaw'

 

[Susan BAV]

To MY mind, the MAIN advantage of the On-X Valve has nothing to do with anti-coagulation (and the study results).

The MAIN advantage of the On-X Valve is that it has the Lowest Morbid Event Rate of ANY Mechanical Valve on the Market according to statistics which the company will gladly provide from FDA Data submissions and other studies.

MY reason for choosing On-X for my upcoming MVR is to minimize the risk of Clot Formation. Low turbulence and Low Pressure Gradient are additional benefits REGARDLESS of the outcome of the anticoagulation studies.

'AL Capshaw'

Not a hijack post but a brief detour maybe?

Al, has there been research done regarding the On-X and your condition? When will you be going in for MVR?
Hope all goes well.

 

[ALCapshaw2]

Here is Catheran Burnett's response to this thread
(with her permission and Hank's approval)

(QUOTE)

Hi Al:

These are standard answers for a physician who is resistant to change for good reasons. It is not too early to tell for On-X--ten years on the market, 55,000 implants, no structural failures and no pannus ingrowth like the other valves. Also, the very lowest rates of thrombosis and stroke for On-X proven time and time again. It is the first valve on the market to have gradients under 10mmHg. Tissue valves and most other mechanicals cannot make these claims that. St. Jude has managed to copy the hemodynamics only.

This cardiologist needs a visit from someone with the company if this patient wants On-X. Many surgeons and cardiologists change their view after they look at it closely. Or I would be glad to communicate with the cardiologist if the potential patient wants that.

Thanks for the info. If you want to feed that back to the website, it is okay.

Catheran (end QUOTE)

 

[ALCapshaw2]

Not a hijack post but a brief detour maybe?

Al, has there been research done regarding the On-X and your condition? When will you be going in for MVR?
Hope all goes well.

Thanks for asking Susan.

I will start a New Thread in the Pre-Surgery Forum to address your question.

I neglected to include Catheran Burnett's e-mail address in my last post. She can be contacted at [email protected] Also note that Medical Carbon Research Institute (MCRI) has been re-named On-X Technologies

'AL Capshaw'

 

[Bad Mad]

I have to say the results of the ON-X so far, sound impressive.

It would be interesting, however, to read an independant report on the valve thus far.

 

[ALCapshaw2]

I have to say the results of the ON-X so far, sound impressive.

It would be interesting, however, to read an independant report on the valve thus far.

Ask Catheran Burnett to send you a copy of the South African Study results where many recipients never took (or even received) medication for anticoagulation. It that study doesn't convince you, nothing will.

'AL Capshaw'

 

[ALCapshaw2]

When assessing a mechanical valve, there are three separate issues, as I see them: (1) patient outcomes, morbidity rates etc (2) anticoagulants now and in the future, (3) the surgeon's professional comfort zone. Studies will show statistical data about (1) and (2), but not about (3). I would like to know a little more about the challenges faced by a surgeon not familiar with a particular valve - in my imagination I can see how exactly the same movements performed time after time would give the surgeon a sense of security. But how strange and different are the movements required for implanting a different type of valve?

One surgeon told me he did not see any problem implanting an On-X valve. " A valve is a valve".
They ALL have a supporting Ring and a Sewing Cuff.

Another surgeon told me it's like changing a tire.
What is the difference between installing a Goodyear Tire and a Michelin Tire?

FWIW, at least 3 of our members have been "First Time" On-X Valve implant recipients and all are doing WELL.

The ONLY valve with a 30 year track record (and a very good one) is the Standard St. Jude. By comparison, ALL of the others are 'new kids on the block'.

'AL Capshaw'

 

[Bad Mad]

Al

Don't think that I or (probably) anyone else are dismissing how potentially
brilliant the On-X may be.
After all, as I have said, if in your position right now, I would possibly do the same.

I still think it is important to consider that when CB talks of the ON-X she is essentially responsible for the promotion of the product.
I am not questioning her claims, but would be interested to hear an independant assessment. To get a balanced view and all that.

 

[RCB]

Bias?

Bias?

I agree. And here's another one to throw in the pot - who does have a balanced, unbiased view? Would it be the surgeon? If not, then who?

Everyone is biased-even me. Most won't admit to it.

I always go with the one who will be slicing me open and closing me back up.
If you trust them with that, the valve is secondary.