ON-X Valve and warfarin

[Lynlw]

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.

I agree, and how wonderful is life when we agree on something 100%

 

[rangerscat]

I have the On-X

I have the On-X

Hello All,

I can't give professional info, but I can tell you that I just recently had OHS on May 22 2007 and I chose the On-X valve. The hospital where I was operated on Normally uses the St. Jude. I asked for the On-X and the surgeon had no problem with it. After the surgery was complete and the surgeon came in to see me, I ask him how it went and what he thought of the On-X valve. He said the surgery went fine, (by the way, this was his first On-X) and that he used a 23mm On-X and he liked it. He said he would use it on his next patient if they agreed. I am 4 weeks post op and have had no complications. I feel good and can't wait to be given the go ahead to try it out running and lifting. I am 42, and can't speak for anyone, especially those who are younger. All I can say is I wouldn't have had it any other way. I believe the On-X valve will be around for a long time. I believe in it and hope that the studies that are going on will be successful and those of us who have the valve, will be granted even a better life than this valve already has given us. You have to thank God for developers like those who design these valves, they give us the hope and peace of mind knowing there is a positive solution, as we deal with such a life changing time in our lives. I was very comfortable choosing the On-X valve after I did weeks of research. All opinions are different, and everyone has their own story. I just happen to choose the On-X valve in my story and I am pleased. I wish you all well, and hope you have the same success I did, no matter what you decide to go with in the event you need a replacement. Good luck and God Speed.........

 

[Bridgette]

I find it a bit odd that a cardiologist and/or cardiac surgeon (can't remember which one you said)in the UK has NEVER heard of the On-x valve....I'm from New Zealand - a little country with a population of only 4 million - yet the
On-x is used here. I've got one!

Bridgette

 

[OldManEmu]

On-x

On-x

While I have a tissue valve and are 44 years old and hope for many years before a redo my surgeon also mentions ON-X as the best choice when a redo is required. Nothing else even holds out the possibility of no warfarin with mechanical valves. This may or may not be an issue depending on your lifestyle activities.

 

[Marty]

I wish you ON-X folks all the best. Our chief of surgery says if you are all doing well in five years he will take a look at the ON-X without warfarin. Till then, its St.Jude with warfarin.

 

[Lynlw]

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?

Have you read the 3 section pdf of some of the leading valve surgeons discussing valve selection and their thoughts? I found them really interesting to read to get an small idea of how they chose which valves for which patients. it is in the ref links

Round table on Coumadin and Valve Selection

Pt 1 Life Expectancy and Valve Selection Criteria
http://www.onevalveforlife.com/documents/1of3.pdf

Pt 2 Anticoagulation-Use, Management and Effect On Quality Of Life
http://www.onevalveforlife.com/documents/2of3.pdf

Pt 3 The Importance of Hemodynamic Function in Valve Selection
http://www.onevalveforlife.com/documents/3of3.pdf

 

[Ross]

My surgeon wanted to use the On-X, but he needed a sleeve already attached at the time and On-X didn't have a model available.

 

[Emma]

We are in the UK too and my daughter has a 25mm On-X. She has had it since June 2001 when she was 18 months old. I didn't have time (or knowledge back then!) to research the valves and went with her surgeons decision as he was so enthusiastic about it. I later found out she was the first child in the Uk to have it successfully implanted (the first child was under the same surgeon but sadly died afte replacement - unrelated to valve choice!!).

I have researched this valve as much as humanly possible since then, spoken with Catherine Burnett myself a few years ago and asked a lot of questions of the surgeon and am convinced this valve is the best available - at least the best for Chloe! I know I will be biased but I really do agree with everything Catherine says about it.

Merely our exeriences and opinions
Love Emma
xxx

 

[Bad Mad]

Brigette

It was the cardiologist who had never heard of it. I assume this means he has no patients with the On-X implanted. I'm not sure the population of a country really has or should have anything to do with whether a certain valve is used or not.

I (wrongly) once made an assumption about a cardiologist based on the country he was working in, only to be told that there are good and bad cardiologists everywhere, and their level of ability/professionalism might not nesessarily be reflected by the system they are operating under.

N. Ireland, incidently has a population of about 1.7 million.

Intrigued by this whole subject, i emailed this guy, who I have been in touch with through email in the past:
Craig T. Basson, MD, PhD, FAHA, FACC
Professor of Medicine
Director, Cardiovascular ResearchGreenberg Division of Cardiology, Department of Medicine
Weill Medical College of Cornell University
The New York Presbyterian Hospital.

I asked him first of all:

I know there have been approx. 55,000 procedures done using this
> fairly new valve, but wondered if you:

> 1. Were familiar with this valve
> 2. Had an opinion of its quality thus far

His reply: not suprisingly companies all tout their own valves with "data".
we do not generally use this valve but that does not mean that it's a problem.

in our experience mechanical failure rates for aortic valve replacements or even pannus ingrowth with the St.
Jude's valve we standardly use are not really the issue, and we don't generally worry about other valve types
except in unusual cases or when we are trying various types of tissue valves to avoid antiocaogulation.

Not satisfied with the answer, I emailed him again:

If this study concludes that anti-coagulation is not required (or
> aspirinonly) with the ON-X, then surely this will/would be a major
> breakthroughin the field of mechanical valve replacement?
His answer:
would not be unique to this valve. And I would be skeptical of the company's study.[/B]

 

[Fast Eddie]

What other valve?

What other valve?

> If this study concludes that anti-coagulation is not required (or
> aspirin only) with the ON-X, then surely this will/would be a major
> breakthrough in the field of mechanical valve replacement?
His answer:
would not be unique to this valve. And I would be skeptical of the company's study.

Admittedly I am no expert on this. and I haven't done an exhaustive search of the web, but I have not seen mention of any other valve that is currently in trials for Plavix/aspirin AC therapy. Can the cardiologist point you to another one? (I am, of course, somewhat biased as I just received an On-X 5 weeks ago.)

As far as trusting the company's data: In the next couple of years there should be enough data gathered from the current FDA approved On-X trial for each surgeon to decide if certain patients can move to the Plavix/aspirin therapy. This will not be just the company's data. It will data from a trial that the FDA is looking at. I can't believe that MCRI would/could 'fudge' that data.

This discussion reminds me of the statement:

Everyone is entitled to their own opinion, but not their own facts.

Once the trial data is gathered, there will be some facts (albeit statistical) to look at, and hopefully those of us with the On-X and low additional risk factors can come off Coumadin.

Fast Eddie...enjoying my new 25mm On-X aortic valve

 

[starfish11040]

Eddie, you don't have to be an expert in the field to know that there is no approved mechanical valve which does not require anti-coagulation.
And the "company study", as you pointed out, is an FDA-approved extensive clinical trial.
Bad Mad, this doctor's statements are so factually inaccurate I wouldn't take anything he says seriously.

 

[Fast Eddie]

Well said

Well said

Eddie, you don't have to be an expert in the field to know that there is no approved mechanical valve which does not require anti-coagulation.
And the "company study", as you pointed out, is an FDA-approved extensive clinical trial.
Bad Mad, this doctor's statements are so factually inaccurate I wouldn't take anything he says seriously.

I am just so PC that I didn't want to offend anyone! But I guess that was what I was implying.

Fast Eddie

 

[Bad Mad]

I can't comment on whether what this doc is saying is factually inaccurate or not. All I know is that any doc that I have ever dealt with seem to sceptical about things that are perhaps alien to them.

I don't know this guy. I have never met him. But the fact that he is a professor/director of cardiology in NY must give him some credability.

I do think it is healthy, however, to try and seek as many opinions as possible
to try and get a balanced view on all of these things.

 

[RCB]

Hold on folks, let have some perspective here.

Hold on folks, let have some perspective here.

I don’t know what part of the web you searched, but you sure didn’t do one on the history of ACT and the early valves. If you had, you would find that their was a common believe at that time that the body would “adjust” to the valve and because of the bleeding risk, ACT was discontinue after a few months. It wasn’t till the late ‘60s that the data began to show that people who stayed on ACT had less problems, even with the risk of major bleeds, than pts on no ACT. I didn’t go on regular ACT till 1968 (on the hunch of my cardiologist that warfarin might be helpful) and testing then was a nightmare. It wasn’t till about the early ‘70s that ACT was SOP across the US. So there was a lot of clinical research done at the time and it all showed that ACT was better then no ACT.

To get a better discussion of ACT, this discussion should be moved to the ACT forum where AL Lodwick can put a historical perspective on the current studies being research. I am always perturbed by discussions of ACT in this forum, because the resident expert here rarely monitors this forum and a lot of things get said here as fact, that are simply not true. You have to realize that many of the people doing current research weren’t even out of diapers when these thing first started being studied and have no idea of the thinking that guided their teachers on ACT.

Medicine is a science, and like all pure sciences, tend to be very conservative in favor of the status quo. We have known for a long time that certain pathophysiological human body types have to ability to adjust to foreign materials in the body. The cloting “cascade” is a very complex mechanism that is still not completely understood. We also know that certain people tend to throw clots even without having a HVR. We know that warfarin, the only real miracle drug developed almost over 70 years ago can help these people. That is the overwhelming fact that guides every medical association that deals with heart and blood issues. To change that mountain of evidence, you are going to need a lot of data, A LOT OF data.

Current researchers need to understand the foundations of valve history are laid by the likes of Hufnagel, Braunwald, Harkin, Starr, Kay, all giants who had many valve failures before they succeeded. Today, none of their successful valves are implanted in the top heart centers. I would take all bets that 50 years in the future, the same would be true for any valve in use today. Time and data helped them to develop the valve science that today’s scientist all owe a huge debt of gratitude. The ON-X will have to prove itself with time and data, just like its predecessors - no more, no less!

 

[Fast Eddie]

Hi RCB. Just some responses.

I don?t know what part of the web you searched, but you sure didn?t do one on the history of ACT and the early valves. If you had, you would find that their was a common believe at that time that the body would ?adjust? to the valve and because of the bleeding risk...

I assume from the comment about not knowing 'what part of the web' I searched that you were responding to my post. My comment about not knowing of any other valves in trials for no Coumadin, I was thinking of the valves currently implantable. Not what may have been thought to be true in the past. If there are other valves currently in trials, I'm sure everyone would LOVE to know which ones.

To get a better discussion of ACT, this discussion should be moved to the ACT forum where AL Lodwick can put a historical perspective on the current studies being research.

If someone knows how to move a thread to another group that's fine. Ross?

Medicine is a science, and like all pure sciences, tend to be very conservative in favor of the status quo. We have known for a long time that certain pathophysiological human body types have to ability to adjust to foreign materials in the body. The cloting ?cascade? is a very complex mechanism that is still not completely understood. We also know that certain people tend to throw clots even without have a HVR. We know that warfarin, the only real miracle drug developed almost over 70 years ago can help these people. That is the overwhelming fact that guides every medical association that deals with heart and blood issues. To change that mountain of evidence, you are going to need a lot of data, A LOT OF data.

Well, we aren't going to be CHANGING any evidence...bad practice from a scientific point of view! But new evidence that is reliable and is generated from scientifically and statistically valid studies does need to be presented. It is of course not sufficient to accept a company's marketing materials as valid data. But the data that comes from an FDA supported clinical trial has a pretty fair chance of being valid on all fronts. The On-X trial is expected to complete in 2015. That's eight years of data. Even then, the data can only be evaluated statistically. And there is no certainty that in individual cases clotting wouldn't occur with the On-X while on Plavix/aspirin. It's a risk that has to be evaluated by each of us.

Current researchers need to understand the foundations of valve history are laid by the likes of Hufnagel, Braunwald, Harkin, Starr, Kay, all giants who had many valve failures before they succeeded. Today, none of their successful valves are implanted in the top heart centers. I would take all bets that 50 years in the future, the same would be true for any valve in use today. Time and data helped them to develop the valve science that today?s scientist all owe a huge debt of gratitude. The ON-X will have to prove itself with time and data, just like its predecessors - no more, no less!

Well, I agree with the last line to some extent. Not sure what to make of the first part, though. The data for the On-X will be presented in time. If people wait until the 2015 end of the trial, all the data will be in. But in a few years, there may be partial data available. If that data strongly supports the notion that the Plavix/aspirin regimen is safe in a high percentage of cases, there may in fact be surgeons and patients that are comfortable with stopping Coumadin. Conversely, if there are too many morbid events in the trial, the trial would be stopped and we'd all have to wait for the next valve to come along.

I hope this isn't going to start a flame war. Bottom line is that if the On-X trials produce data that support the notion that Plavix/aspirin will work well, anyone with the valve who meets the appropriate criteria could be free to CHOOSE to go off Coumadin and use Plavix/aspirin. It is not mandatory to do so.

Let's wait for some data.

Fast Eddie

 

[RCB]

Let's wait for some data.

That is what I'm saying. I have been around long enough to see companies make all kinds of claims, only later to be totally discredited. If ON-X wants to make a claim that is contrary to the body of evidence- they better prove it with overwhelming evidence- that is the scientific method. The ON-X company shouldn't be treated any different.

 

[starfish11040]

they better prove it with overwhelming evidence

It's an FDA approved clinical trial. It will either be proven to the standard required by the FDA or it won't. Don't know what "overwhelming evidence" means.

 

[RCB]

It's an FDA approved clinical trial. It will either be proven to the standard required by the FDA or it won't. Don't know what "overwhelming evidence" means.

The FDA has standard protocols on data security, collection methodology,
privacy requirements, treatment of test subjects, etc., etc., which can be found in the CFR(Code of Federal Regulations). The CFR only details standards of the clinical testing. Standards of proof are not ?proven ? or it won?t?! You won?t find that phrase anywhere in the CFR.

If you want to know what overwhelming proof is you may study the Central Limit Theorem discussed in other thread here at VR.com. Try doing a search for it.

I?m sorry, but I?m not about to go in to the implication of what a FDA study is or is not. Perhaps Tobagotwo has more patience to explain
this to you. PM him. He is by far a better writer than I am and has the ability to wade through the CFR to detail the specific information you are seeking and integrating that information in to the Central Limit Theorem.

I apologize if my answer does not meet your expectations, maybe Tobagotwo?s will. Good luck.

 

[Bridgette]

"Brigette

It was the cardiologist who had never heard of it. I assume this means he has no patients with the On-X implanted. I'm not sure the population of a country really has or should have anything to do with whether a certain valve is used or not.

I (wrongly) once made an assumption about a cardiologist based on the country he was working in, only to be told that there are good and bad cardiologists everywhere, and their level of ability/professionalism might not nesessarily be reflected by the system they are operating under.

N. Ireland, incidently has a population of about 1.7 million."




I was merely trying to point out that I was surprised that medical professionals in "leading edge" countries like USA/UK, countries which are at the forefront of medical research and practice should never have heard of the On-x, or be reluctant to consider using it - it is not exactly 'new', having been in use for, what? ten years?...
I suppose what I was trying to say is that even in a little country at the bottom of the world which many people have never heard of (Yes, that is true!) the On-x is being used and has been for some time now...there have been several new members on this forum besides yourself who have shown interest in this valve, so sharing my experience may be useful as they gather information.

Bridgette

 

[ALCapshaw2]

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

For those who prefer to take the conservative approach, the undisputed champion in longevity is the Standard St. Jude Valve with a 30 year track record. NO other valve has that long of a record.

Carolyn Burnett (yes, of On-X) told me an interesting story about HOW St. Jude got it's foothold on the valve business. When the St. Jude Valve was in it's infancy, the 'standard of the day' was one of the 'Ball and Cage' designs (I forgot which) that was beginning to fail with increasing frequency. The St. Jude Valve showed promise and many surgeons began using it instead, IN SPITE of the fact that it was NOT YET approved by the FDA. One of our members even wrote how she? had to sign a waiver to receive a St. Jude valve back in the early days. That is "the rest of the story".

For those who are looking for an IMPROVED mechanical Valve, the On-X Valve 'seems' to address the weaknesses of previous designs, most of which were designed by the SAME PERSON who is NOW at On-X.

I am NOT willing to sit down and type out all of the information I have received (from On-X), BUT if YOU want to do further research, I suggest you get the information package from On-X, look at their data, and then CONFIRM the numbers from their competitors by whatever means YOU choose. Feel free to 'research your heart out' and report your findings back to us on VR.com.

'AL Capshaw' (AVR = St. Jude, future MVR - requested On-X)