3f Aortic Bioprosthesis - Does anyone have experience with this?

[Matt123]

Hello,

I am a 34 year old male from NYC. Four years ago I was taken to Lenox Hill Hospital after experiencing excruciating pain in my chest as I was having a type A aortic Dissection; I was very lucky to live. Anyway they replaced my upper aorta and arch but left the aortic root. Needless to say the root has now expanded to 5cm and I need to go back in for a second surgery. I am going to go with the valve sparing. However in the event that it does not work I have chosen the 3f Aortic Bioprosthesis.

Does anyone have experience with this choice? I know that the first implants were in 2001, which would mean there should be 10 years of solid clinical data however I am unable to find anything. Could anyonw opine on this?

Many thanks,

Matt

 

[markp66]

From what I've read this valve compares satisfactory to many bovine valves. The main drawback is that follow up data is limited whereas many bovine valves have great long records. This is made from equine tissue from what I remember?

Good luck, hopefully they can save the valve anyway!

 

[Lynlw]

From what i know it was only FDA approved in the US in 08 thats probably why you arent finding alot of info on it. I know of 2 people here who have it, Just waiting, and I forget the other person, he didnt know until after surgery he was getting it. when i remeber who i'll add it, he is doing fine and happy with his valve, . Just waiting had problems and had to have his replaced, but i'm not sure if it was valve related or something with the sutures,or his tissue, but they did put in a different kind of valve.
ps I remebered it is Bean Counter who has the 3f horse

 

[ElectLive]

Matt - I know very little about the 3f, but I remember reading a comment a year or so ago from a well known surgeon, Dr. Gillinov at the Cleveland Clinic, about its unique design, and he said that he would normally recommend a standard bioprosthetic valve with a stent instead, since that would provide the best "landing zone" for the potential of a future percutaneous valve "replacement". It's only one of many things to consider, but may be worth discussing this specific issue further with your surgeon.

Now, the relatively recent approval would seem to me to drastically limit the ability to forecast long-term longevity data with any degree of accuracy. Of course, longevity forecasts in all tissue valves are somewhat hit and miss, especially in our age group, but at least with some of the more "standard" tissue valve models out there, there is significantly more long-term evidence. The 2001 date you mention appears to have been the original clinical trial of 405 patients, 8 of which were in your age group. ATS/Medtronic may have 10 year results of this group on file, but it appears that the FDA submission only incuded 4 years.

Anyway, merely my thoughts. Obviously, every great "standard" valve out there now had its unknown origin at some point in time, nothing new ever hits the valve market with 20 years of successful data. Oh, and by the way, here's the FDA info I found that includes the trial data, in case you don't have:

http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060025b.pdf

Best wishes to you moving forward. I cannot imagine what experiencing an aortic dissection must be like...thank goodness for your good fortune and glad to have you join us.

 

[Matt123]

Thank you all for your support and advice. I hate going through this for a second time. Lyn: is "Bean Counter' the screen name of the person who has this on this site? I was having trouble locating him/her...

Many thanks again all.

 

[Lynlw]

Thank you all for your support and advice. I hate going through this for a second time. Lyn: is "Bean Counter' the screen name of the person who has this on this site? I was having trouble locating him/her...

Many thanks again all.

yes im pretty sure its (2 words) his name here. Did you look at the member list (under the community dropdown above?) they are alphabetical "just waiting" is also the members name lol

 

[kfay]

My cardio (EP) told me the last time I saw him that this is the valve he chose for himself. He seemed very excited about it and told me I should consider it the next time I need mine replaced. He was at Duke years ago and developed the EP program there and was one of the pioneering Dr.s of ablations of rhythm issues.

Kim

 

[Matt123]

Lyn: Thanks so much... found him and just emailed him some questions. Hopefully he will get back to me (sigh). Does anyone have any opinion as to when the existing non-invasive aortic valves would be made public to the general population and not merely the elderly? 10 years, 20 years? That would really be something.

 

[Matt123]

Electlive... thanks for this link! good stuff.

 

[ottagal]

Lyn: Thanks so much... found him and just emailed him some questions. Hopefully he will get back to me (sigh). Does anyone have any opinion as to when the existing non-invasive aortic valves would be made public to the general population and not merely the elderly? 10 years, 20 years? That would really be something.

I can only tell you what MY surgeon said: As I am in the 'under 50' age category, statistically he gave my bioprosthetic valve an approximate 10 year lifespan. When I asked if there was a possibility that the replacement would be done endovascularly in 10 year's time, he told me not to bank on it especially if I wasn't high risk or had any co-morbidities. I guess that is the million dollar question and no one has a crystal ball (however it would be nice!). It will depend on a number of factors such as how far this advances, how quickly they perfect the procedure (along with reducing the complication rate to an acceptable range), how long the percutaneous implanted valve will last once implanted etc.

I recall in another thread discussing this topic that it may be difficult to get long term data on these patients who have received the percutaneous valve as many of them are elderly with co-morbidities; hence, they will 'naturally' not live longer than possibly a 2-10 year lifespan so that will scew outcomes/results. The most recent patient to undergo this procedure at our hospital was 90 years of age.
You may want to do a search as there have been a number of discussions on this topic.
Good luck

 

[Lynlw]

Lyn: Thanks so much... found him and just emailed him some questions. Hopefully he will get back to me (sigh). Does anyone have any opinion as to when the existing non-invasive aortic valves would be made public to the general population and not merely the elderly? 10 years, 20 years? That would really be something.

My guess, and it is just a guess, would be closer to 10 years than 20, based on how long it took for the pulmonary valves here (US) and how fast they started being used commonly in Europe.

 

[ElectLive]

Does anyone have any opinion as to when the existing non-invasive aortic valves would be made public to the general population and not merely the elderly? 10 years, 20 years?

The million dollar question indeed. In reality, it may not be a question of will the surgeons have the technology and be able to do it in a reasonably safe manner, but the bigger question, will they be able to do it as safe as, or better than traditional surgery. Supposedly my valve, particularly at its size, is a good candidate for percutaneous replacement. I guess it's good knowing that, but it's not something I'm counting on either.

Surgeons are giving this issue consideration nowadays, though. But like I said before, just one of many things to factor in. It was just the only clinical comment I'd happened to have heard about the 3f. Even if what I read is true about the 3f, there might be far more important advantages to base a decision on, rather than the somewhat unknown future of percutaneous surgery.

If you'd like to hear actual surgeons talking about percutaneous replacement, here's some more info:

http://www.valvereplacement.org/forums/showthread.php?39306-Q-amp-A-with-Dr-Bruce-Lytle-Cleveland-Clinic-webchat

http://my.clevelandclinic.org/heart/webchat/1233_percutaneous-valve-treatments.aspx