ON-X Valve and warfarin

[Fast Eddie]

This thread seems to be on the verge of turning into a p---ing contest with no resolution.

Well said. In the best case this will all come down to patients and surgeons looking at the trial data and determining if the risk of using Plavix/aspirin vs Coumadin is within their comfort zone. Worst case we're on Coumadin till a better valve comes along.

Fast Eddie

 

[geebee]

I think valve selection comes down to just a few issues.

1.) Tissue or mechanical (or Ross procedure when applicable).

2.) Surgeon's recommendations (and if you have a surgeon you trust, his thoughts should make a difference).

3.) Whether or not you are a gambler. Having had a Bjork-Shiley valve that was recalled, I am much more conservative when it comes to "tried and true".

Granted, the On-X sounds very promising from an ACT change standpoint and has many years of successful usuage but I just wish we wouldn't get so inflamed about discussions of the pros and cons. As with any other valve choice thread (and the reason for the existence of VR.com), this is all about providing as much information to members as possible.

 

[Bad Mad]

It is understandable that emotions may run high when debating this particular topic. What we shouldn't allow ourselves to detract from, is the more valid info/theories/literature we can unearth on the On-X the better for everyone who has a particular interest in the subject.

Yes , some of us will play devils advocate from time to time, but only so we can get a true balance. The info. provided (over time) by those who have the valve already implanted is probably the most crucial of all.

Bridgette:

It somewhat surprised me too, that this particular cardiologist hadn;t come across the ON-X either, particularly as he is very thorough and highly regarded in his field. Having said that, the approach here is much more conservative, with specialists probably more sceptical about new products.
That is their perogative, not mine!

In summary: when I started this thread, I was completely ignorant (now slightly less!) to the ON-X, and was delighted that people (like you) came on to share their experiences of the valve. As this developed and we heard the views and experiences of the patients (ON-X) and Catheran Burnett, I and others probably realised that the majority of what we were hearing was all of the positives, which was great.
But was it time to see if there could possibly be another story to tell?

This wasn't to **** stir!!.....but genuinely healthy (in my view).

The fact that the topic has sparked so much debate, justifies for me, that this topic should be continued for a long time to come, as the ON-X evolves.

 

[ALCapshaw2]

Well said. In the best case this will all come down to patients and surgeons looking at the trial data and determining if the risk of using Plavix/aspirin vs Coumadin is within their comfort zone. Worst case we're on Coumadin till a better valve comes along.

Fast Eddie

For good reason, there is a LOT of interest in the Plavix / Aspirin Study.

Since I will be on Coumadin for LIFE because of my St. Jude mechanical valve in the Aortic position, this issue has little relevance to ME.

The (often overlooked) reasons that I chose an On-X Valve for my pending Mitral Valve Replacement is more basic.

#1 - The Mitral Valve is more likely to form Clots than the Aortic Vavle.

#2 - The On-X Valve has less turbulence, causes less damage to blood cells, and is the LEAST LIKELY to form CLOTS of any of the Mechanical Valves on the market today, especially with NO anticoagulation (i.e. when invasive procedures are called for).

This conclusion is supported by the South African study (performed and published by South Africans) with a largely non-compliant or non-anticoagulated population. (It is not clear to me what role On-X played in that study other than to manufacture and supply the valves).

Note that there are several GOOD mechanical valves, but the early (5 year) numbers I have seen support the On-X valve as having the LOWEST Morbid Event Rate.

I do NOT feel it would be proper for ME to bash other manufacturers publicly. That is why I encourage anyone interested in pursuing this research to do so on their own.

The EXTENSIVE information package from On-X identifies the major players and gives what they believe to be reliable and accurate numbers. Interested parties should verify these numbers from the other manufacturers if they are so inclined.

'AL Capshaw'

 

[Lynlw]

Well said. In the best case this will all come down to patients and surgeons looking at the trial data and determining if the risk of using Plavix/aspirin vs Coumadin is within their comfort zone. Worst case we're on Coumadin till a better valve comes along.

Fast Eddie

I know that Arlyss brought up the question about plavix not being about to be monitorred like coumadin and also having it's own side effects. So I wonder how that will play into doctors thoughts. I know I've read posts before that people just mention the possibility of taking just aspirin w/ the on-X, so glad to see plavix being part of it mentioned here, Lyn

 

[geebee]

Neat summary! Gina, did the Bjork-Shiley seem to you a gamble at the time, as you recall? Do the discussions about On-X today remind you in any way of the discussions about the Bjork-Shiley at that time, or are there significant differences? Given what you know today, what would be your preference when it comes to mechanical valve choice? Hope this isn't too many questions

I did not get a choice ahead of time about the valve because my surgeon was so sure he could repair the valve. However, after the fact, he told me he used the Bjork-Shiley because it was considered to be superior to the ball and cage valves and that I was too young for him to consider a tissue valve. At the time the pig valves were only lasting about 5 years.

In retrospect, I do not know what I would have decided if given a choice. The Bjork-Shiley was introduced in 1976 and recalled in 1982 so the On-X has a longer lifetime at the moment. Since the BS was only on the market for 4 years when I had my first surgery, I might have gone for the old ball and cage valve. Who knows how that would have turned out. I am still here so the BS did help me for many years. Unfortunately a lot of those years were spent in some fear of failure.

I had no question about using the St. Jude valve in 1994 since it had been around for some 14 years by then. I would not hesitate to consider the On-X today if faced with replacement but I would go into surgery expecting to be on lifelong ACT. It would take a LOT of trials and years of success before I would go off ACT. I am concerned that people are counting on being able to come off coumadin as a fact and are making choices based on that.

But, then again, ACT has not been an issue for me at all. Any choice I would make today as to valve type would be the one that has the most chance of avoiding future surgeries. That has always been my stance.

 

[Mike C]

Please take information from drug or device company cautiosly
In addition, one clinical trial may not uncover all issues and FDA has been known to be wrong. If you choose to be a lead adopter go for it, just understand the risk. Look into the Vioxx drug problem as an example. also may ahve a new one developing with a cardio from cleveland clinic putting together data from a bunch of trials of a diabetes drug.

No comment for or against on-x valve , just hope people understand the no anticoagulation may not pan out, hopefully it does. even if it doenst, still may be others reason to go with on-x, each person must review, research and decide.

 

[aussie girl]

I am hoping to get the on-x valve when my time comes and I know that I will be on warfarin for at least 10 years if not forever but these trials give me comfort that if my inr levels drop to a level that would otherwise be dangerous the level of danger for me may be decreased .....Mary

 

[ALCapshaw2]

I am hoping to get the on-x valve when my time comes and I know that I will be on warfarin for at least 10 years if not forever but these trials give me comfort that if my inr levels drop to a level that would otherwise be dangerous the level of danger for me may be decreased .....Mary

EXACTLY !

That is the benefit of the On-X Valve that seems to be overlooked and oversthadowed by the emphasis on the Aspirin / Plavix trials.

Also, the benefit of Lower Risk from Clotting and other Morbid Events begins the day one receives the On-X Valve. This benefit is independent of the anti-coagulation trials or method and is MY primary reason for choosing an On-X valve for my pending MVR.

'AL Capshaw'

 

[Randy & Robyn]

In a nutshell

In a nutshell

I am hoping to get the on-x valve when my time comes and I know that I will be on warfarin for at least 10 years if not forever but these trials give me comfort that if my inr levels drop to a level that would otherwise be dangerous the level of danger for me may be decreased .....Mary

This was my primary rationale in opting for the On-X as well. I'll deal with coumadin for as long as I have to. To be honest, even if the plavix trial succeeds, unless I have had issues with coumadin by then, I may very well decide to stay on it.

It is also comforting to know about that extra level of protection in case a surgical procedure is required where anticoagulation has to be stopped. As Al has pointed out, even bridging does not eliminate the danger. It only narrows the window of opportunity for a clot to form.

Randy