Cryolife Suspends SynerGraft Processing

[John Cochran]

Today Cryolife announced that it was suspending the processing of its SynerGraft heart valves.

A handful of us here have received SynerGraft valves, and no one should be worried about this news. The reason for the suspension is simply that the FDA is trying to determine whether or not the SynerGraft process should be regulated as a medical device. Neither the safety or the efficacy of the SynerGraft valves has been questioned by the FDA.

I personally feel a bit of a moral victory in this. My own AVR surgery lasted 14 hours, with 10 hours on a heart/lung machine, due to the first SynerGraft valve leaking and then, according to my surgeon, actually tearing. Fortunately, I had insisted on a second back-up SynerGraft valve, which was then implanted successfully. 8 months post-op, in spite of nearly dying during this surgery, I am doing great physically as are the other SynerGraft recipients I know.

However, I was extremely upset that the first valve appeared to have problems. The seeming lack of quality control caused me to file with the FDA what had happened to me, and my concern that the SynerGraft process appeared to be unregulated. While I continue to believe that this technology is the future, and promises huge benefits for patients, regulation and monitoring of this process is probably a good idea. I am pleased to see that our federal government, when approached correctly, responds in a reasonable and timely manner.

The relevant part of this announcement is quoted below:

"The Company has advised the FDA that it will voluntarily suspend use of the SynerGraft technology in the processing of allograft heart valves and vascular tissue until the regulatory status of the CryoValve-SG and CryoVein- SG is resolved. The FDA has not suggested that these tissues be recalled. Until such time as the issues surrounding the SG tissue are resolved, the Company will employ its traditional processing methods on these tissues. Distribution of allograft heart valves and vascular tissue processed using the Company's traditional processing protocols will continue."


The link to the full press release follows:

http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=CRY&script=410&layout=9&item_id=385623


--John

 

[dano]

How did you know you had a SynerGraft valve? I had an allograft inserted as part of an aneursym repair in June of 2001. In October of 2002, I was informed that the valve was leaking severe enough for subsequent surgery. When it was removed, they told me it had developed holes in the leaflets. A St. Judes was used in January of 2003. Since we were unsure of why it failed, we went with the mechanical in an attempt to limit the number of future surgeries. I believe I had a Cyrolife allograft, but I'm not 100% sure and if it was, I'm not sure if it was the SynerGraft version. I'm thinking the surgeon should have that documented, but they didn't have the detail in my records.

 

[Ross]

John everytime I think of your surgery, my skin gets goosebumps and would like to run and hide. You certainly had someone high up on your side whether you know it or not.

Yeah, mine was a bad experience, in fact both surgeries were, but you still amaze the heck out of me.

 

[John Cochran]

dano,
It is highly unlikely that you received a CryoLife SynerGraft aortic valve, since there are only about 100 of us in the world. Also, there are only a couple of places (Mayo and Oklahoma) that you could have gotten one, and then only after they had thoroughly explained this option to you. Most likely you received a conventional homograft (also called an allograft) which, if provided by Cryolife, is referred to as a CryoValve.

Since these valves come from human donors, each one will be slightly different, unllike a manufactured valve. The big difference between the SynerGraft valve and a conventional homograft is that all the donor's cells have been removed, leaving behind a fully functional collagen matrix. This collagen matrix is readily accepted by the body, with virtually no rejection/inflammation response, which is thought to minimize calcification. Also, the recipient's own body slowly (over a year) repopulates the cells on the valve, which then becomes your own living tissue. That, at least, is the theory. Animal studies and the very few human valves that have been removed indicate that the repopulation really does occur. There is hope that this is a lifetime solution, with no replacement necessary. That is, of course, speculative. In the meantime, I have a heart that is as "normal" as possible after haviing a valve replaced, don't need any meds, and am back to running and lifting weights.

Ross, I am amazed my self how this turned out--definitely beats being dead! And yes, I think there has been something of a miracle!

--John

 

[sylviayasgur]

hi john and ross!
i agree, ross, when i think about what you two have been through, i am definitely convinced that somebody up there loves you two!!

ross, sorry i missed your birthday. wishing you a happy belated and many more happy and healthy ones to come. hope it was a special day for you and your family.

hope you are all well, sylvia

 

[LUVMyBirman]

Hi Dano,

Good to see you again. Wishing you a speedy recovery! How have you been doing with your Coumadin?

Take care......

 

[dano]

John, thanks for the info. I'm curious what happens when they have to replace a valve in less than 18 months. Wondering if there is any analysis done on what went wrong.

Gina, doing pretty well. Still a little chest pain, but back at work and doing ok. Coumadin still a battle. Was supposed to have a two week check today, but we're pretty icy down here, so it is Friday. Been taking 7.5 Mg a day for these two weeks, so I guess we'll see. I don't think I'm having any adverse reaction to the drug, unless it causes itchy skin.

 

[LUVMyBirman]

Ahhhh, yes Dano. I miss those TN ice storms
I hear Memphis received a few inches of the 'white stuff' yesterday.

Hang in there with the Coumadin. It takes awhile to level off. The more your dose is tweaked........higher level of fluctuation.

Keep us posted.
Take care.

 

[srwieland]

Thanks, John, as usual, you're on top of things.

I'm still having minor symptoms with my SynerGraft. I seem to be on the edge of normal and every once in a while slip over it, but still hanging on nonetheless!

I too am glad CryoLife is getting lots of scrutiny. The SynerGraft is a great idea and scientific breakthrough, but requires great care to pull it off. Unfortunately, due to some defect in the one I got, I'm pretty much in the same boat I was with my native valve for so many years before I finally needed to replace it. I hope this one can last at least as much as the other one while leaking (25 years), but still don't like having symptoms after going through replacement surgery, even when they're minor.

Seems like you got all of your bad karma in one shot, though, and now you're home free!

I guess we'll always be linked as brother guinea pigs, hopefully for a long time to come! Good luck with it.

By the way, I recently checked my medical records and had another bubble popped! All along, I thought I got some 20 year old's valve, but actually my new valve came from a 48-year old, only 2 years younger than me at the time of my surgery. Here I thought I gained about 30 years on those parts and I only gained 2! Oh well, I guess I'm still pretty darn lucky, so I won't need to invite you to my pity party!

 

[Jennie]

Hi John! (and Steve!)

Thanks for the info here. How do you find all these SynerGraft articles? Are you on some kind of mailing list or something? If so, I would like to know.

Everytime you post an article, my heart almost stops, until I read it and see, no, all is still well in the universe. I am all for the FDA taking a better look at the situation, and I just want to thank you for taking measures to roll some heads at the FDA and CryoLife. Someone's gotta do it, and who better than you after what you went through.

I still haven't fully digested your email about the aspirin, but I will get back to you soon on that. I am still in the dark on this whole aspirin subject. Is it good, is it not good....

Next week I see my cardio in DC, I haven't seen him since September. I still have questions regarding the ACE Inhib, and I would like to try to get off the happy pills, but not at the expense of the mental and emotional sanity that I've been enjoying for the past few months. I'm waiting to hear when I will be scheduled for my one-year at Mayo. I am just a tad bit on edge, wanting to hear about my LV size, my EF, my MITRAL leakage (which was upgraded from "trivial" to "moderate" at my four-month), and what they think about my wires....

I haven't been doing so well on the treadmill (I'm trying, though!), but the weights are going well. Ladies and Gentlemen, for the first time in my life, I am a "WEIGHT LIFTER"! Ugh, Grunt, move over Ahnold! I'm up to five pound dumbbells (for a total of ten ), and seven pound ankleweights. Boy, am I gonna look good when summer comes!! Good days, some not so good days, but certainly making progress in the right direction. Just taking it nice and easy....

Pleeze keep me posted on the SG scene. thanks!!

-Jennie
p.s. like my new avatar? didn't recognize me, did you!

 

[Johnny Stephens]

Hey John, that's interesting reading. You sure went through the grinder with that one...I remember it well! I'm so glad there was a backup plan in place for you, which begs the question of how often is such a fallback necessary in any type of surgery.

I'm glad to see all the due care and caution being taken here to ensure future recipients' safety. We should all be thankful that there are people like yourself that willingly take on the role of "early adopters."

 

[lcwhitney]

When you had your surgery you should have been give an ID card with a serial number, the company's name,your name your doctors name, date of implant, and the hospital's name. My pulmonary valve came from cryolife and is not working properly and will have to be replaced. It has just been 18mos the 21st of Feb. Personally I hope they get sued from every direction and have to go out of business.

 

[Mara]

thanks a lot for your post John.
please keep us posted of any further developments you find.

-Mara