Edwards ThermaFix and Valve Testing

[ElectLive]

I happened upon an exhaustive explanation today of the ThermaFix treatment used in the Edwards Magna valves, including a case study in valve testing, so just thought I'd post, in case anyone else is interested. For what it's worth, depending on your personality or perspective, this may either be fascinating or utterly boring. In any case, the best part for me was not actually any particular revelation that these guys are geniuses and this will actually work (I've still got fingers crossed for that one), but more just generally impressed by how thorough the pre-human research phase actually is:

http://ht.edwards.com/sci/edwards/sitecollectionimages/hveducation/ar01316.pdf

Also hitting home, I should spend a little less time honoring my bovine donor species, and a little more time honoring the other animals who make bioprosthetic valve advancement possible.

 

[Lynlw]

Not really that related, but have you ever stumbled upon the different webcasts from the CT surgical society conferences? there are some pretty interesting sessions, usually easy to undrestand and a great way IMO to learn about what they are working on and how thigs are going. Some of them also have q&A spot at the end of the sessions where the audience (other doc usually residents etc) get to ask questions so you learn alot in them even. Even the US ones usually have leading doctors from all over the world as guest lectuers. I Believe that this is part of the way doctors who aren't taking part in the different trials learn how things are going, what is coming up etc

Speaking of the cows who lived good lives ate well didnt smoke lol so we could live longer,better lives, have you ever read anything about the pulmonary contegra conduit? its pretty interesting and is a cows valve, just NOT a heart one

 

[ElectLive]

Lyn - No, I have not seen those webcasts, but they do sound very interesting. Do you have a link? I did find on the CTSNet.org site today a "Giants of Cardiothoracic Surgery" video interview series that includes several of the well known surgeons who have operated on members here. I had not read about the Contegra either...a trileaflet jugular vein, wow.

 

[dsaf2001]

Going in two weeks for replacement of the aortic.doing it at nyu with dr Galloway. All surgeons I have meet with allstro g recommend this cave vs. Mechanical
I'm 52fit and very active and not sure is this the wY to go vs mechanical.
The thought of reop in 20 years seems daunting

 

[dsaf2001]

The big question before surgery is valve selection the two major surgeons I spoke to all feel strongly about the benefits of the new tissue carpentier Edwards third generation cow vs. Mechanical
Seems the reop risk is less that 25 plus years on blood thinner drugs.
Ceetaintly welcome others thoughts
I have been told I need to replace aortic and I have no other health issue. I was very lucky this was caught from a regular physical as I feel great with no symptoms and been very physically active
Thanks and really have found this site very helpful

 

[ElectLive]

dsaf2001 - Welcome to the community. You may want to start a new thread in the valve selection forum (Forum - Valve Selection - Post New Thread (upper left - under the big On-X ad)) to help bring attention to your situation and questions, particular those who have faced the valve decision at a similar age. I generally don't encourage or discourage either way, so I'll just point out instead that both are very good options. Best wishes.

 

[Lynlw]

Lyn - No, I have not seen those webcasts, but they do sound very interesting. Do you have a link? I did find on the CTSNet.org site today a "Giants of Cardiothoracic Surgery" video interview series that includes several of the well known surgeons who have operated on members here. I had not read about the Contegra either...a trileaflet jugular vein, wow.

There used to be some links in the "reference forum" some might have changed, but I just checked the 2008 one and it works http://www.aats.org/2008webcast/
or if you search here for webcast or aats a few links will come up like this one to the 2110 aortic symposium http://www.streamingmeeting.com/webmeeting/rillahan/aats/2010/toc.html#
You usually can find the different ones from the different orgs websites you might need like this one I found at AATS has links to all their past meeting http://www.aats.org/annualmeeting/Program-Books/index.html by year.. there are tons of them and I think it's the best way to keep up on everything in trials etc whats happening and the various doctors opinions on things, from all over the world who is the leaders in that feild or procedure etc
Just need LOTS of time it can be addciting. I pick and choose things that I might need to know about and it helps i've watched then for a few years alredy so not as oer whelming lol

 

[enkaynj]

Thanks for sharing this paper paper on Thermafix; However, it did not clearly state what the expected life of a thermafixed valve is. Also, is it safe to assume that all 3rd gen Edwards Carpentier valves use the thermafix process ? Can anyone infer this from this article ?
Thanks

 

[dsaf2001]

I'm slated to go in two weeks and meet with two world class surgeons and both recomended this Edwards third generation valve with great confidence. It does have the new treatment

 

[ElectLive]

Lyn - Thanks for the links. Yes, finding time will be a challenge, but eager to try and do so.

 

[ElectLive]

Thanks for sharing this paper paper on Thermafix; However, it did not clearly state what the expected life of a thermafixed valve is. Also, is it safe to assume that all 3rd gen Edwards Carpentier valves use the thermafix process ? Can anyone infer this from this article ?
Thanks

ThermaFix was approved by the FDA in 2004, and according to an Edwards press release was launched in the US on the Perimount Magna valve series in January of 2005. The Magna valve series was approved by the FDA in 2003, though, so it would appear (my guess only) that in the beginning, Magna valves hit the market prior to ThermaFix. The current numbering system - your valve and mine are the same - seems to only use a "TFX" if the ThermaFix is used. For instance, the "3000TFX" and the "3300TFX" have it, but there is a "3000" model that does not.

To my knowledge, they have not directly predicted longevity. But indirectly, they reference the longevity data of the Perimount valve (2003 data claimed around 90% odds of 20 year lifespan for 60 year old and up), and then reference the lab results of the ThermaFix of up to 44% reduction of calcification compared to and beyond the treatment that was used on the Perimount.

 

[Lynlw]

Thanks for sharing this paper paper on Thermafix; However, it did not clearly state what the expected life of a thermafixed valve is. Also, is it safe to assume that all 3rd gen Edwards Carpentier valves use the thermafix process ? Can anyone infer this from this article ?
Thanks

This chart might help you http://www.edwards.com/products/heartvalves/pages/pericardialaorticmodels.aspx?PERIMOUNTAortic=1
from your sig it looks like you have the magna with thermafix.
as far as longevity of the thermafixed ones , they dont know yet, but it is supposed to be improved over the first Perimount over half a MILLION have been implanted so there is plenty of data on as far as long term hemodynmics and longevity.

 

[enkaynj]

EL & Lyn,
Thanks for pointing out the TFX suffix on my valve number. Never paid attention to it until now.

 

[normofthenorth]

EL, what's the source for your "Perimount valve (2003 data claimed around 90% odds of 20 year lifespan for 60 year old and up)"? That sounds longer than the numbers in the study that was referenced in Tyrone David's 2010 "Gold Standard" article.

 

[ElectLive]

EL, what's the source for your "Perimount valve (2003 data claimed around 90% odds of 20 year lifespan for 60 year old and up)"? That sounds longer than the numbers in the study that was referenced in Tyrone David's 2010 "Gold Standard" article.

You know, Edwards seems to use the same trusted source and credit for nearly all of their valve data numbers: "Data on file at Edwards Lifesciences." :rolleyes2:

Whenever I read that citation, I picture a nondescript building bunkered into a hillside with no windows, a single door, multiple security checkpoints, and no means of reproduction allowed. It turns out, though, to Edwards credit, they are more forward with their information than their published citations imply. In fact, only a few days ago, I spoke with someone at Edwards who is supposed to be sending me interim results of ThermaFix valves.

Meanwhile, specific to your question, my point is that Edwards cites (similar to above) 20 year results for the Perimount in nearly every document they publish, but they oddly never publish the actual data. If I recall, Tyrone David even commented on this in his article. But, those 60 year old, 90% numbers are seen very often in their press releases, as was the case when ThermaFix was launched: http://www.edwards.com/newsroom/Pages/nr20040202.aspx

So, I used the word "claimed" above purposefully, as I did with even more skepticism in the somewhat parallel thread: http://www.valvereplacement.org/forums/showthread.php?39460-Longevity-of-Tissue-Valves&p=511433&highlight=#post511433

Back to the data, though, when there is a will, there is a way, and I do believe I have found at least a portion of the 20 year data here: http://ht.edwards.com/resourcegallery/products/heartvalves/pdfs/clinicalcommuniqueaortic.pdf You may want to immediately save to your computer in case someone realizes this information is out there for the general public and immediately removes.

I've never done a side by side comparison with Tyrone David's Hancock numbers, but would welcome any volunteers (hint, hint). I know you've shown a predilection in the past for valve data analysis, Norm, so will look forward to any comments you may have. At a certain stage, I just sort of surrender to the inconclusiveness and/or irrelevance of it all, but perhaps that is more my own laziness on the topic than a data problem!