Decellularized Allograft Heart Valve Approved

[Ross]

FDA has cleared for marketing the first allograft heart valve from which cells and cellular debris have been removed. It is called the CryoValve SynerGraft Pulmonary Heart Valve, and is manufactured by CryoLife, Inc.

Allograft valves are recovered from cadavers. Traditionally they are inspected, cleaned and decontaminated, but other than that, they are left unchanged. With the new valve, cells are removed during the manufacturing process. What's left is a scaffold of connective tissue that still functions like a human heart valve, but may be less likely to trigger an immune response and tissue rejection.

Clinical studies on the SynerGraft valve found that it performed at least as well as traditional CryoLife allograft valves with respect to mortality, re-operations, endocarditis, and blood clots.


Additional Information:

FDA Press Release. FDA Clears for Market First Decellularized Heart Valve. February 7, 2008.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01794.html

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[srwieland]

Hey Ross!

Maybe you remember me from years ago. I was possibly the first on this site (or near to the first, at least) to get a CryoLife SynerGraft homograft tissue valve.

I had also just recently heard from my surgeon this news about the reapproval of this valve. Unfortunately, after 7 years, mine is slowly failing and thus I am tentatively scheduled for a redo on June 3.

I still think that it is a very promising valve. Mine was a pulmonary (the only type available then and now) placed in the aortic position, so that may be why it has not lasted longer.

In any case, my case and, evidently, as I just discovered from Mary, that of John Cochran, should give everyone a bit of caution with going this route.

It may be more worth the risk for young patients facing further growth because it can grow with the child and they are otherwise facing a series of redoing the surgery anyway.

If anyone wants to know more about my experience with it, I'll be happy to share. One thing very positive about it in my case; it appears that, despite the increased leakage slowly over time, there has been zero calcification (i.e., rejection), which is what this valve was specially designed to reduce. Hence, for 7 years, no need for anti-coagulation, etc.

Thank you all. Even though I'm bummed about having to redo, it's still great to be back on VR.com.

 

[Ross]

Steve sorry to hear your having problems. You already know what happened to John I take it? I just post the new things that show up. I try not to be judgemental, but given cryolifes past, maybe I shouldn't have posted it?

 

[srwieland]

No, Ross, I think it is very very good that you brought this up, because CryoLife is a player and that valve is out there. So, unless we discuss the pros and cons of it here, how will anyone know its history, etc.?

Seems kind of interesting how I just happened to reappear on this site with my story right at the same time the FDA reapproved this and you posted about it!? Go figure! I assure you I am not part of any conspiracy (that I know of)!

Again, I think it is a promising valve and certainly a very delicate and sophisticated biotechnology to master. We do not want to be guinea pigs, even though I supposedly knew the risks going in (why do we always overestimate the positive, despite our experience with Murphy's Law?).

Bottom line, though, in terms of qualify of life for most of the last 7 years, my CryoLife valve was very good to me in every way except for longevity (probably the most important one, of course.)

For very young (because of their projected growth) and also very old (because of their increased risk with anti-coagulation) candidates for valve replacement, especially in the pulmonary position, I think this valve is still very worth considering. But, for the rest of us, it's probably better to wait until the bugs have been worked out of it!?

 

[sylviayasgur]

hi steve and ross!
steve, I remember way back when you had your surgery and got your cryolife synergraft valve. i also remember Mara had one. do you remember her?
i had heard some bad news back when and now good news again...
steve, i hope all goes well with you on june 3. please let us know, ok?
all the best,
sylvia

 

[Ross]

I wish Mara would have stayed in touch. I miss her. Of course I miss you too when your gone so long.

 

[srwieland]

Hi Sylvia!

Yes, I remember you and Mara very well.

Didn't Mara have a Ross procedure? (Ross, how did you ever get them to name that after you, anyway!?)

I guess no news really is good news! I think we all know, though, where to come back when we need.

By the way, I never heard how things turned out for John Cochran's redo. Could someone catch me up on that?

Thanks again!