On-X news

[Emma]

Hiya,
I was just looking on the On-X website for something and saw they had updated news. One bit was about a study into aspirin treatment only for On-X recipients, rather than warfarin. Sounds soooooo good if it gets anywhere!!
Here's the link if it's of any interest to anyone...

http://www.mcritx.com/news_aspirin_study.htm

Love Emma
xxx

 

[Emma]

as a side note

as a side note

i have been speaking to some people about the on-x article i posted about last night (see above) and someone pointed out to me that at the bottom of it it says the mitral on-x valve was not FDA approved until 2002. Chloe had her replacement in 2001!!!??
I don't know what the FDA is i'm afraid, but should i be concerned that her replacement was made before the valve was even approved for use??? I have somewhat of an obsession with this subject as i have still met no-one else in the UK with the valve type.

Love Emma
xxx

 

[catwoman]

Emma:

The FDA is the U.S. Food and Drug Administration, which must approve Rxes & medical devices, such as heart valves, used in the U.S.

 

[catwoman]

Emma --

What I saw at the company's website was dated last December, I think ...

BTW, I saw the company headquarters last November when I was in the Austin area for a cat show.

 

[Emma]

Thankyou for that Marsha! I had no idea what FDA stood for, except i assumed it must be something to do with the US. DUH!

Emma
xxx

 

[tobagotwo]

The Food and Drug Administration isn't the body of influence in the UK. Europe has its own version of the function, called the European Union (EU) Commission of the European Communities. I am not certain, but I believe the UK may be a part of that organization. Some prescription medicines and medical devices are approved by the FDA in the US, but not approved for use in Europe, and vice-versa.

So, approved by the FDA or not, it is entirely possible that the device was approved for use in the UK, or that you unknowingly signed a waiver to allow it to be implanted experimentally. If so, you got a jump on a valve that has gotten very high marks so far.

It would likely be my current personal choice, if I were in the market for a mechanical valve.

Best wishes,

 

[Dirk]

HI,

I also made some research on the ON-X-Valve.

They are doing an "aggressive" marketing on the valve , and the documented properties seem to be convincing.

So this valve is also one of my choice.

But you have to be carefull:


1. Other valves like the ATS and St. Jude valve already are proved to run safely on coumadin with a very low INR of appr. 2.0 (or sometimes 1.8).

2. One surgeon I talked about the ON-X said that it is a nice valve but that it is not true that it is haemodynamically superior compared to the others as claimed from MRCI. The ON-X is much larger from its dimension than the other valves, thus during implantation, the surgeon has to choose one size smaller to fit in, compared to the other valves. I.e. say a nominel size 25 from the On-X corresponds to a size of 27 from the other valves.

3. If you go to the website from Carbomedics to hear for the sounds of the valve, you can listen to the St. Jude. The sound of the On-X corresponds according to one study to that of the St. Jude.
ATS has been proven to be more quiet.

4. The study "Aspirin" only is of high risk, It is carried out in Germany, were the rules are not as strict for studies as in the USA (most valves are tested first in Europe, because it seems to be more easy to obtain official permission for that)

5. In this study the patients' valve sound is monitored using the "Thrombocheck" to find first signs for a thrombus.
http://www.cardiosignal.de/index_en.html

This maybe an interesting device, also for self monitoring other mechanical valves.


Greetings


Dirk

 

[tobagotwo]

Great info, Dirk, and interesting reading.

I liked the soft pivot aspect of the valve, which is intended to result in fewer mashed red blood cells. It's true, though, that many of the valve's features are shared with the other new valves. I had no idea of the downsizing requirement: that was entirely new to me.

Someone did post some time ago with a negative take on the ATS valve, but I don't recall if it was factual, or just one surgeon's opinion. I should look that up.

I am neither up nor down on St. Jude Medical. They have produced some outstanding products, but have probably also been responsible for more recalled valves than anyone else. And they weren't appropriate - in my mind - about handling their recalls early and fully, resulting in some people having a newly-implanted St. Jude valve recalled, undergoing a new St. Jude implantation, then having the freshly-implanted new valve be recalled as well. Because of that, and the neck-and-neck technical advances in the other available valves, they don't get the rating of Gold Standard from me, as I have occasionally read from others.

That doesn't mean their current products (Regent Series, or Masters Series for included aortic grafts, ets.) aren't great products, and well-tested. They are among the best, as far as I have found out, and very popular with surgeons. I just can't help but harbor indignation about the fellow valvies who endured multiple procedures - and some who didn't - for the St. Jude Silzone valves (and some earlier types) that did not keep their promise. There are still valve brothers and sistes who are waiting to find out if their personal valves will remain stable or not. In my mind, we may move on, but it is not good to forget that these things happen.

Silzone valves were very popular with the surgeons, too, so that illustrates the power of marketing more than the voices of experience.

Oh, the guy needs the Soap Box back. I guess I have to get off of it now...

Best wishes,

 

[Emma]

Thankyou

Thankyou

Thankyou for your help with this! I am desperately trying not to stress over this valve thing although have started to look into it before now as well.
I think now though, Chloe is doing well and she's getting good reports back from her cardi's and i have more time to stop and actually 'think' about what the surgeon has put into her heart. Does that make sense??? So now I am starting to question his reasoning behing choosing On-X.
Don't get me wrong, i've researched it and am still convinced it's a good valve and am happy with it. What I'm not happy with is... (a) - not being told it wasn't approved in the US when Chloe had hers done as i may have questionned WHY it was approved here but not in the states!, (b) not being told she was the first UK child to have one (I found that out by accident afterwards) and (c) i wasn't told at the time of her replacement, that On-X had only been trialed for just over 4 years (not long enough in my book!). I think the EU tend to approve things too easily and quickly sometimes. I have also wondered about a comment above about the ON-X makers doing aggressive marketing and wondered if her surgeon fell foul of some of that marketing??! Could be waaaaay off but my mind tends to wander too much sometimes and i waffle - as you may be able to tell!!!
Ah well, i'll probably never get answers to most of my questions and as Chloe is well it's possibly irrelevant anyway!
I emailed MCRI last week about some of it but have had no reply.

Let it go Em! lol

Thankyou for all your input!!!
Love Emma
xxx

 

[tobagotwo]

A couple of thoughts...

- The Commission of the European Communites would take exception to being considered second-rate to, or an afterthought of the American FDA. And rightfully so. They've been right about issues that the FDA has missed about as often as it happens the other way. Thanks to the EUCEC, Europeans don't have mercury stuffed into their tooth cavities like many Americans still do. I am an American, and proud of what the FDA has accomplished, but am equally glad that there is an EUCEC that has a different perspective, and shares the burden of keeping health care as safe as possible.

- Four years is a long time. As the base materials are standard, it seems long enough. I can't help but agree that, if it were my son, even 20 years wouldn't seem like enough testing to me. However, the benefits of this "new" valve type over others available at that time are enticing to someone (such as your surgeon) who wants to have the best result for his/her patient. Should you continue with the older model, despite its known drawbacks, or seek the benefits of the new technology, developed with knowledge leveraged from the lessons of the old valve's shortcomings? In the end, I know I would want the newer valve for my son.

I don't believe your surgeon had any but the very best intentions, and I believe that he or she gave the matter extensive thought before proceeding. Whether she was the first or the 50th to receive the valve is irrelevent to the determined safety of using the valve, so long as it was approved, and procedures remain the same as they are for other valve implantations.

I agree with you - let it go, Em. Chloe is doing great, and that was what it was all for.


Best wishes,

 

[Dirk]

Well folks,

I would not say that the On-X valve is not a good valve, but there is some doubt to be taken into account that it is superior to others. And there is definitely an aggressive marketing.

Second:
I am German, and I can report that the standards in Europe ARE lower than in the US considering testing of new valves.
If you look into the publications, all the new valves first were implanted in Europe, and later the results of these trials were taken to get FDA approval.

This is valid for the ST. Jude Regent, for the ATS, for the On-X, for the Medtronic Advantage, for the Mosaic, and for the 3F Therapeutics valve (which seems to be a superior biological valve).

This does not necessarily mean that the requirements in Europe are too low. Maybe the FDA requirements are to strict.

"- The Commission of the European Communites would take exception to being considered second-rate to, or an afterthought of the American FDA. And rightfully so. They've been right about issues that the FDA has missed about as often as it happens the other way. Thanks to the EUCEC, Europeans don't have mercury stuffed into their tooth cavities like many Americans still do."
I am sorry, but this is not true. In fact I consider the European rules weaker than the FDA ones (however this is not necessarily a shortcoming). So far the Commission of the European Communities is say equivalent to the US Federal Government. However a lot of decisions are made on national level.
If a product is marked with "CE" or got the "CE" approval this only means that the distributor of the product guaranties that the product complies with alle applicable rules. If it does not, he or she is liable. But it does not mean that there was an official certification of such a produckt. I.e. if a valve manufacturer says he obtained CE approvel in Europe this only means that his European distributor officially declared compliance with all applicable rules.

It is also not true concerning the mercury in the teeth. This is still the standard cavity filling material (however, I do not get into my mouth). There is no law or regulation against it.

Furhter on, there is rumor in Europe from well recognized cardiologists against the Aspirin-only trials with On-X because of the risk for the patients.

This doese not mean that thant the On-X is not superior. But of course so far there is no evidence that it is.

This I just wanted to make clear.

One problem seems to be- according to one surgeon I talked to, who did implant the On-X, that the sizing is not equivalent to others. You might need a smaller one compared say to a St. Jude to get it implanted.
Also this does not mean that the On-X is not superior, but this does also not prove it that it is.

Best greetings

Dirk, from Germany, who did a lot of research on valves.......

 

[Mary]

Dirk,
Thanks for chiming in with your information. You sound knowledgable and neutral. That a good combination.
Mary

 

[gijanet]

Finally e-mailed Katie's surgeon..........

Finally e-mailed Katie's surgeon..........

but, of course, I piddled around so long that he was out of the office last week. Will let you know, Emma, what I find out when he gets back in town. I did specifically ask him about the On-X. Our surgeon tends to be pretty conservative, so I am anxious to see what he says. Whatever his opinion, please keep in mind what Bob said because he is so right - Chloe is doing well and that is all that matters.

 

[Emma]

I have spent a while now wondering whether to even reply again on the site but to put it quite diplomatically, I was really quite upset to read your message Bob and felt almost attacked by it - which i can assure you is not a term i ever use lightly.

Please don't take offence to what i would like to say. I am always very grateful for your help and advice and desperately don't want to argue, offend or insult anybody. I understand that i am a relative newcomer to the site and you have been here a long time, but feel i need to make myself clear as maybe it's my fault and i didn't do so before...

Not once did i say the Eu was 'second rate', and nor would i ever say that! - my comment that they tend to approve things too easily sometimes is justified and if you speak to a lot of English (or European) people, as i have done on this matter, then you will get the very same comment - as Dirk has illustrated too, with examples.

I know that my questions and worries will more than likely never be answered and maybe it's just reassurance that the worries are normal that i needed rather than concrete answers anyway. Especially when they are worries about my child's health - not my own.

I also need to make it clear, which i thought i had before, that i AM happy with On-X, i DO think it's a good valve and quite probably would have opted for it anyway, i have even recommended that others ask their surgeons about it, i just had some concerns too - things which have come more to the forefront of my mind now that the stress of her surgery is further behind us and i don't believe it is wrong to voice these concerns.

Finally I would like to also make it clear that Chloe's surgeon to me is God (again a term i would not use lightly!) He saved my baby's life more than once and i would let no-one else operate on her! I trust the man with her life. I would not like to suggest (and don't feel that i did!) that he ever had anything other than her best interests at heart. I simply wondered if his decision this time was added to by pressure by anyone at any point?!

As Chloe's mum, I feel it's up to me to ask these questions, rightly or wrongly and whether it would be productive or not! I may not ever get answers but it made me feel better to discuss my worries with people who i felt understood what i was talking about. Chloe is only 4 and will one day ask questions herself, but for now if i don't ask them and determine what is best for her then who is going to?!!

Again, i do not want to offend or upset anyone but felt i must get my point straight.

Thankyou for all help and advice while i have been a memeber of this site.
Emma
xxx

 

[tobagotwo]

Emma, I sincerely apologize. I had absolutely no unpleasant intent or feeling when I was writing it, and I did a very poor job of writing to have created that effect.

I was trying to look at the other side of the coin, and should obviously have kept my big mouth shut, as it came to no good end at all. Worse, it upset you, which could not be farther from my goal. I have seen a different perspective of the CEC, and know that pharmaceuticals are sometimes not allowed in Europe, although they may be in use here. I hypothesized that other medical items would be similarly situated, something you and Dirk have well corrected me about.

Again, I sincerely apologize, and assure you that I had no intention at all to impart a tone to the posting.


Very best wishes,

 

[Dirk]

Well, I think, all is said already.

I also did not want to citizise anything.

As I am waiting for sugery, I made a lot of studies to find the right valve for me, and you get lot of information. Not all information is without bias!

Concerning the On-X valve I would like to clarify that I do not think that it is not an excellent valve! I just wanted to comment that there is an aggressive marketing and that it is not proved that it is superior compared to the others.

Concerning the Aspirin only study I would be very, very carefull.
Studies like this were also tried with the St. Jude valve, which is also very excellent, and the outcome was disastrous. So let's wait what is coming out. However, if you are in such a study and once you got a stroke, it is too late.
Anyway, there is no real shortcoming with Warfarin, at least when you are doing home testing.

There have been a lot of studies which proved that valves like the ATS or St. Jude in aortic positin can safely by runned by an INR of 2.0, which ist quite low.
It is however mandatory, to carry out home testing of the INR, which is very easy using the Roche Coagucheck. In all studies, in which there was no home testing, the results were much more worse concering stroke and bleeding complications.
In Germany each patient gets the home testing and insurance has to pay for it.

Also I find it interesting, how we look to the other side of the Atlantic. The Europeans see their shortcomings and a lot of better things running in the USA, and from the USA it is vice versa.

Best greetings


Dirk

 

[tobagotwo]

By the way, credit for the information about amalgam fillings goes to my last two dentists, who informed me (incorrectly) that amalgam was no longer in use in Europe. I have a cleaning tonight, and will liven up the time by informing him that he is full of beans.

Fortunately, I now go to his partner, and her dental hygienist will be doing the cleaning, not his. He always stops by to say hello,, though, so I will likely get the opportunity.

Best wishes,

 

[Emma]

Bob,
Thankyou for the apology and it's very gratefully accepted, although i do accept i may have over-reacted so please accept my apologies too if i was too forceful in my reply.
Look forward to getting to know you on cheerier notes!
Emma
xxx

 

[Ross]

Bob,
Thankyou for the apology and it's very gratefully accepted, although i do accept i may have over-reacted so please accept my apologies too if i was too forceful in my reply.
Look forward to getting to know you on cheerier notes!
Emma
xxx

Just don't offer him any vacation time. He's used it all up for the next 2 years!

 

[tobagotwo]

Drat! I was this close, and he had to mention the vacation thing...