FDA urges surgeons to avoid CryoLife valves

[John Cochran]

A story appeared today where the FDA urges surgeons to avoid CryoLife heart valves. Unlike other tissues, heart valve infections can hover for weeks or even months before manifesting. This story makes me feel SO GOOD (not) after having just gotten a CryoLife valve on June 5, 2002. I can't tell if the FDA is over-reacting or not. Sheesh.

http://www.startribune.com/stories/484/3180904.html

John

 

[Mara]

Hi John-
Scary indeed, but the article does not say that it's banning SynerGrafts. CryoLife makes "regular" valves too. SynerGrafts are treated and developed differently than the "regluar" cadaver valves.
Until I hear specifically that SynerGrafts are involved I am not panicking. But, I feel okay, my surgery was over a year ago.
I would say that if you were going to get ill you would be already.
Plus, you can't believe everything you read, right? I mean most of the article is a rehash of the problems with the soft tissue implants. and The FDA is suspect anyway. This is the group that made ibuprofen over-the-counter and gave approval to Claritin, IUD, thalidimide and a lot of other drugs that can kill you, so gimme a break, I take what the FDA says with a grain of salt.

I plan on asking my cardio and my surgeon about it.
Maybe a phone call to your docs is what you need. Just to put your mind at ease. But, it's certainly something to think about.

yer SynerGraft buddy,
Mara

 

[JJGo]

I think we shouldn't panic, YET!

I think we shouldn't panic, YET!

I posted this rather late on the previous thread so I'm not sure anyone saw it. I missed out on the beginning of the thread and just posted yesterday so I moved it here to the current thread:

Interestingly this was in the news while I was in the hospital getting my Synergraft and Dr. Zehr came into my room one morning and said, "I have to talk to you because I know you read a lot and I don't want you to be worried". Of course, I had already read about it but wasn't worried because I didn't think any infection could survive the Synergraft "washing" process. Dr. Zehr reassured me that at Mayo they test all the tissue they get themselves before implanting it. It seems to me any hospital should do that since you can't know for absolute certain what has happened to the tissue between point A and B.

From Dr. Zehr's point of view, he thought the media and government were treating Cryolife very unfairly. He thought the numbers of infections (was it a total of 27?) were in no way out of line given that huge amount of total tissue processed by Cryolife. Now I know if I was one of the few who got an infection or worse died, I would not be comforted by being one of a small number, but this goes back to how much responsibility does the hospital have in testing the tissue before implanting it. I also understand that Zehr has a personal stake in Cryolife not being put out of business as his cutting edge cardiology surgery and research relies on their research and product. The study I'm in will be null and void if Cryolife goes under which would be a shame. I am not however worried about my own health and well being. I'm still very happy with my Synergraft choice and don't feel at all that I have anything personally to worry about. (Of course, I could just be a fool, too!)

John, I'm also wondering why your surgeon went ahead and put in a graft that he thought didn't seem right? But that's a whole 'nother thing I guess.

We had an article in our paper saying the area that could be most affected by this is Pediatric Cardiology. Unlike the orthopedic tissue and adult heart valves that can be readily available from other companies or with other technology (mechanicals and porcine), the pediatric valves are much scarcer and having Cryolife out of business really has some pediactric heart surgeons worried.

http://www.startribune.com/stories/484/3167780.html

For the full article see URL above but here's an interesting snippet:

"A punitive action

"I would characterize this as a disaster for CryoLife," said Dr. Alex Arrow, who follows biotechnology stocks for the New York-based securities firm Ladenburg Thalmann & Co. "It is the most punitive action I have ever seen the FDA take against a medical device company."

CryoLife shares fell 63 pecent to $2.03, an all-time low for the company and the biggest percentage drop Thursday on the New York Stock Exchange.

Arrow said he does not believe that the company's products pose a threat. He said the FDA was taking the action to demonstrate that companies must follow its guidelines "and do so enthusiastically."

"There must have been some kind of personal antagonism for the FDA to take such a drastic step," he said."

......end quote
_________________________________________________

I think there is so much we don't know yet about this. I for one do not necessarily trust the government to just do the right thing here (no, I'm not a conspiracy theorist). I don't think we have any where near the whole story yet. Although the "big business" side of medicine can be frustrating and hard to understand, the other side of it, is that is where the innovative technology is happening. It won't happen if someone doesn't get to make a profit off of it. It is a crazy balancing act that our country seems to thrive on in all areas. Even though some of us might prefer a little saner approach.

Well, I've gone on too long but will hope that we learn more soon.

www.caringbridge.com/mn/jymme

 

[John Cochran]

Here is my big concern: Even though the SynerGraft processing may get rid of infected tissue (no guarantee) it is possible that BEFORE processing the tissue may have been infected, resulting in diminished strength/integrity of the underlying collagen matrix that constitutes a SynerGraft valve. SOMETHING caused the first valve I received to have considerably less structural integrity. Unfortunately, simply looking at it intact didn't give my surgeon any cause for concern. It was only after it ripped during surgery that he could tell there was something wrong with it.

The other concern I have is that the FDA implies that infected heart tissue may not cause any problem immediately, but weeks or MONTHS later, an infection may arise.

The big question is, who do you believe? I think that the FDA is mightily pissed about CryoLife not heeding some directive(s) they gave them, and is responding punatively.

On the other hand, I also know the CryoLife technical rep walked out of my surgery before it was clear whether I would live or die. I was a CryoLife stockholder who had been in active correspondence with CryoLife executives about a number of issues, and after my nearly fatal surgery, I never heard one single word from them. Geez!

My surgeon also told me a story he'd heard about how long CryoLife sometimes takes to "harvest" tissue from cadavers...it was scary.

Anyhow, I'm not panicing about this, especially since I am doing so well, but I fear that we can trust NEITHER Uncle Sam NOR CryoLife in this mess.

Enough ranting. I just hope that Mara, JJGO, BrooksM, Steve Wieland and Jennie (our SynerGraft club) all continue to do well.

Best,
--John

 

[srwieland]

Thanks for the well wishes, John, and the same to you and the others in our club.

Wow! Do we really have to choose between whether to trust Big Government or Big Business more than the other? Damn, that makes me nervous! I prefer some balance of power between them, lest either gets too unrestrained in its power. And, lets not forget about the doctors and lawyers in that mix as well.

Interestingly, my surgeon a few days ago had an assistant leave a message for me that he had talked to everyone and everything was OK, no need to worry. Then, we now get this news about the FDA's message to him!

I find that the surgeons and the medical device and pharmaceutical suppliers are usually pretty much in 'cahoots' (that's one word that surely must have some strange etymology!). However, when I communicated with a CryoLife vice-president by email after first learning about my leak, he put the entire honus of the problem on the surgeon. If I were those surgeons, I would think twice about the extent to which I would defend my supplier who is so ready to post the blame on me.

Since I have genuinely suffered from a CryoLife implant which continues to leak, I have involved a lawyer friend of mind to investigate further, because I'm sure there is still a lot to this story that's behind the scenes.

It is also curious that when it was just a patient having a problem, namely me, my lawyer didn't think I had a case, but now that the corporate supplier has developed a problem (i.e., might be more vulnerable), he thinks maybe I do. Go figure!

Actually, all I want is just a valve that works!

 

[LUVMyBirman]

This may be a ridiculous question. Maybe I missed something in the translation.

If the FDA is urging the surgeons not to implant such valve, where is the mandatory recall of such? They are saying in a 'nutshell' that these valves may not be safe. What the h _ll are they waiting for??!!!!!!

For those of you that do have the valve.... and are far enough out. Hopefully, will not have to worry about initial infection.

Questions to the surgeon would be the following....

Would you suggest additional prophylactics for invasive procedures, i.e. IV antibiotics? Do you feel the Synegraft may be 'more susceptible' to secondary infections?

Please know that my intent is not to alarm anyone that has this particular valve. I do feel you all deserve a response for your future well being.

Maybe Cryolife should be contacted with a battery of questions? They could be posted here for all to see.

 

[srwieland]

Just found this: another reminder of the risk with all sorts of heart valves and valve replacement should never be taken lightly.

Heart valve recall ordered after patient's death
Apr 15 (Reuters Health Spain) - Spain's Ministry of Health and Consumption has ordered the withdrawal from the market of artificial heart valves made by a Brazilian company after Italian health officials reported that the device was tied to a patient's death, ministry sources confirmed to Reuters Health Spain.

The valves are made by Brazil-based TRI Technologies.

Last Thursday, Italian health authorities alerted European Community countries of the death of a patient in whom a TRI valve had been implanted, the Spanish ministry told Reuters Health Spain.

One day later, the General Directorate of Pharmacy and Health Products advised the regions of the event and ordered the product's withdrawal.

The notice warns that "the autopsy report of the deceased patient in Italy points to a defect in the mechanical aortic valve that was implanted in the patient 11 days earlier," although the problem is not specified, official sources indicated to Reuters Health Spain.

According to ministry sources, to date the valve has been implanted in 13 Spaniards in three medical centers. Representatives at these centers informed Reuters Health Spain that the 13 heart patients were enrolled in a clinical trial begun in 2001 by the manufacturing company. The trial has been halted.

The 13 implanted patients are being monitored by cardiologists, who will decide "if it is warranted to subject the patients to a new operation to replace the prosthesis," the Ministry said.

The valve in question has not been approved by the US Food and Drug Administration.

 

[John Cochran]

Gina,
Thanks for your concerned reply. Normal prophylactic doses of antibiotics are still recommended before dental procedures, surgeries, etc., but nothing extra.

Unfortunately, doctors and even surgeons are not scientists. Rather, they are pretty bright mechanics and drug prescribers. However, they have little to no training in scientific cause/effect relationships, nor are they very good at predicting the future outcomes of new technologies such as SynerGraft.

In spite of these recent worries, I wouldn't trade my SynerGraft valve for anything. At 12 weeks post op, I feel 100 percent back to normal. Other than my scar, I don't feel like anything happened to me except that I have more energy and feel better. Pretty miraculous for a guy who almost died during a 14 hour surgery!

This technology truly is the wave of the future; the problem is, non-scientist executives hungry for profits may cut corners, and over-zealous government beaureaucrats (sp?) may impede the ability for new technologies to fully develop.

Steve, my lawyer keeps sending me articles about CryoLife, even though at first he thought that since I wasn't dead and didn't have permanent injury (well, there IS my addled brain!) that there wasn't anything to pursue. Keep me posted on what yours thinks. What I hope, though, is that your valve continues to remodel and improve such that in a few months you have a "normal" aortic valve.

Best,
John

 

[srwieland]

Thanks John. As usual, you are a great source of information and wisdom.

Currently, my condition waxes and wanes, generally in correlation to my exertion and stress level. When well rested, I feel great and quite normal. When overextended, I have chest discomfort, arrhythmias, a sense of swelling in my left chest and under my left armpit, mild wooziness, and extreme fatigue. So, I don't think I'm anywhere near out of the woods; just stabilized on medication for the most part if I take it easy.

Hence, something went wrong with my valve; otherwise, even if the SynerGraft process didn't work, I would have at least 10-15 years without leakage or other symptoms like a normal homograft before experiencing what I am now. However, it actually appears that the SynerGraft process has worked, but that something else, more structural, is at fault.

My belief right now is that either the problem is due to a pulmonary valve being placed in the aortic position, which in my opinion would be the surgeon's fault and is clearly the stated opinion of the CryoLife vice-president I communicated with, or else it is due to some structural defect or deficiency in the valve, perhaps due to damage from an infection that either came with the valve or occured later, in which case I think the fault lies with CryoLife. The fact that the TEE I had recently shows leakage through only one leaflet seems to indicate this possibility. Otherwise, if it was just weakness due to being from a pulmonary source, it seems that the whole annulus would be stretched and not just cause leakage from one leaflet. it seems more likely that the one leaflet which is leaking has been damaged. But, what do I know?!

In any case, someone is at fault and its not me! Although, if the fault was due to the SynerGraft processing, I do believe that I would share in the fault since that risk I knowingly took. I did not knowingly take the risk of place a pulmonary valve in the aortic position nor have any idea that some of the tissue being provided by CryoLife might be contaminated.

I will keep you guys posted. Please do the same.

 

[srwieland]

Indeed, Gina, my cardiologist has put me on a standing order of antibiotics for any sign of the slightest infection, even a small cut. They are very concerned about infection finding its way to the one leaflet through which my leak is occurring, which must have been damaged after 8 months of working fine either due to structural weakness or infection. I think taking such precautionary measures in my cases is clear indication that something is seriously wrong!

I also just had an atypical mole removed yesterday, leaving me with 4 stitches, and had to take prophylactic antiobiotics just like for a dental procedure.

 

[Jennie]

CryoLife recall / My four-month update

CryoLife recall / My four-month update

Hi everyone,

I've been semi-following the discussions here, just not really sure what to say to all of this. I found an article sometime before my surgery (actually threw it out a couple weeks ago, I think) about the CDC reporting some (non-valve) tissues that had been infected, and I figured it was a remote possibility that it would be an issue I would have to deal with. I had also done a search and found four or six valves (i.e. two or three donors) whose donated CryoLife valves had been recalled. Anyway, I am not thrilled to hear this news, but am not panicing either. Just a bit of an unsettling feeling, I suppose. I guess my question is, if recently donated valves are recalled, what does this mean to those of us carrying them? Is an explant in order, or just a "watch closely for signs of illness," or a massive blast of antibiotics, or is there some way to test? Along with this is my thinking (possibly misled) that antibiotics are not to be indulged in heavily with tissue valves, plus the statements from the FDA that it could take months before an infected valve manifests itself. Just don't know what to think. I read your post, JJGo, regarding Zehr's comments back a few weeks when you had your surgery, so it was nice to hear what he had to say about it (prior to recent events, anyway).

Anyway. I had my four-month checkup this week at Mayo Clinic, a round of tests etc. The doc there, a good guy to be sure, tends to whiz through like a whirlwind, so I came away from our brief consult with a somewhat fuzzy assessment of my situation. I plan to discuss things more in-depth with my "steady-eddie" cardio here in DC in early September. BUT, it looks like my arrythmia has seriously settled down - only 17 bad beats in some 21 hours of monitoring, with only one run of 6 bad beats - as opposed to MANY per minute before my surgery. I certainly noticed a big difference beginning about the tenth day after my surgery. I think my heart is a lot happier now that its load has been decreased to normal. Size-wise, it sounds like my LV may be back to "normal", but I'm not clear on that, and I'll wait until I get my copy of the echo and my chat with my cardio before I believe it. The Mayo doc wants me to come off the ACE Inhibitor since LV is supposedly no longer enlarged, but they took me off it right after my surgery, and two months later my cardio here put me back on, saying "why did they take you off??!!" A little difference of opinion there, I think! And lastly, it seems that my mitral has "mild to moderate" leakage, another thing to discuss. I was hoping that would go away - now that the LV is not bursting at the seams any longer and essentially popping out the "back door" mitral valve - but the doc is saying it's probably due to my "marfanOID" situation (surgeon says I am NOT "marfan"). So, like I say, I am not clear on a lot of this, not sure where I stand with the details. But, certainly, things were positive overall, no big worries or anything. So, a thumbs up, I would say!

In general, my energy kicked in a few weeks ago, and I've been spring cleaning up a storm! I also caught a round of pink eye/laryngitis/sinusitis/bronchitis from my cute little nieces and nephews, so I'm struggling back from that. I also recently noticed that the top of my scar has a bony little bump there - for an inch or so down the scar. Not sure what to make of that....

Anyway, those are my gory little details, for those of you who are still reading this! I certainly hope that all of us CryoPals are set up with some good valves. And that means you, too, Steve.

all for now, and thanks for the info here.

-JEnnie

 

[srwieland]

Thanks Jennie! Sounds like you got one of the good ones. You should go to Vegas. Not sure that I should, though!

Take care and keep us posted.

 

[John Cochran]

Jennie,
Good to hear you are doing well, and I was especially pleased to hear that your arrythmias have settled down. Sounds like your LV is getting whipped in to shape, too. Which brings up something I've encountered about major differences in philosophies about ACE inhibitors and beta blockers.

Seems as though the Mayo philosophy is, once the symptoms (like LV dilation, arrythmias, etc.) have settled down, that's it for the meds. On the other hand, your DC cardiologist sounds like what I'm hearing, although when I asked how long I need to take these, the answer was "for life." When I asked why I'd do that once my LV returns to normal, and since I don't have hypertension, the answer I got was "because it is good for your heart." When I mentioned that the Mayo folks experienced with this valve were 180 degrees different in this, I got a very stony and silent look, sort of like I shouldn't really know that, and screw me for daring to bring it up.

Regarding the Las Vegas reunion--I'd like to go but I'm so overwhelmed with getting my company back on track after my "vacation" that I don't think I can I really do hope in the not too distant future there is another one where our "SynerGraft Club" can all get together.

Best,
--John

 

[Mara]

Hello SynerGrafters!
Well, my one year check up was good. "Scarily normal" was how the cardio described my condition. He has been my parents neightbor for years, so I know him pretty well, he's funny.

He had not heard anything about CryoLife, but said that any infections etc., would show in the first month, even sneaky fungus. Plus he made an interesting comparison that we all have so much bacteria in our bodies, i.e. rectum, that we are inundated by bacteria at all times. He said that a lot of people that get infections from transplanted tissues have compromised immune systems to begin with. I wonder if that was the case with the folks who had bad cryolife outcomes. No newspaper articles ever said that, as far as I read.
He said that the SynerGrafts are so de-populated that he feels confident there's no germs on them. He did say that sometimes the tissue valves get roughed up and that is how one's own body might infect the valve.

I guess the point is, if any of us was going to get ill from the valve we'd already be ill.
I do think that CyroLife has to answer for it, but that's not up to me. We could all express our concern to them, but will they really listen to us? They don't seem to care about the FDA.

I will ask the surgeon next week if he has more info. I know his group gets all the "new" valves before other docs in Indy.

So, dear friends, let's keep postive and believe that we are all okay.

Jennie- great news from Mayo. Wahoo!

By the way, my echo was great. aortic valve, no leaks, functioning normally, small leak on pulmonic (the SynerGraft), but not uncommon or unexpected, and not a worry at all. Hypertrophy of the heart reduced so there were no indications of hypertrophy on the EKG!
I guess I'm not a "heart patient" anymore.

John- I, too read the CyroLife harvests valves and tissues from cadavers. There was something about a suicide victim who's body was found 19 hours later and CryoLife harvested tissue. Ughh. That's just sloppy. They need to get in trouble for that.

Steve- I wish that things would turn around for you. You have struggled so much with that valve.

 

[Jennie]

Hi again!

The reunion? My next project here is to do another round of calls to get my surgery bill straightened out. The insurance company sent me a letter saying they would pay for "all" of it, but they haven't actually done so yet, if you know what I mean. So, it looks like my little vacation to Minnesota in April will be costing me a good chunk of change, and I'm not so sure I want to shell out another pile of dough to come to Las Vegas, as much as I would LOVE to see you all...! We'll figure something out!

John, I hope you had a nice anniversary celebration! And yes, it seems that Mayo was quick to take me off the ACE Inhibitor. I was quite surprised, but then again, surgery tends to drastically change the situation, so maybe this was normal? I don't think they were terribly opposed to the idea of my being back on, but it didn't seem to occur to them to put me back on themselves. On this last visit I managed to snag the echo results from the week after my surgery, and from my little look at the numbers, it seems that my LV was within range! But the surgeon said it would take six months to a year for it to return to normal size, so this is why I am confused as to their thinking on this - has it been enlarged these past few months or not? My DC cardio seemed to think it was still enlarged as well, though he gave me a copy of everything the Mayo doc sent him, and it did NOT include the actual echo results, just a writeup of the actual surgery by the surgeon and my discharge summary. I am curious to see what he thinks when he sees the actual echo. His policy is to be on the meds until it's no longer enlarged, IF and when that happens, and if it never happens, then I would remain on them indefinitely. I don't think he would agree with your guy's "for life despite normal heart" med prescription. Maybe it would help the heart, I don't know. Beta blockers, from what I hear, have not-so-fun side effects, so I wouldn't think they'd want people on them unless necessary. The Mayo doc did say that I'd probably have more energy once I'm off the ACE Inhibitor, as low blood pressure tends to make you feel fatigued. Anyway, I'll let you know what I find out in September.

Jennie

 

[Jennie]

Me again.

Mara, GREAT to hear your news! "No longer a heart patient"...? That's pushing it a little, don't you think?!

I think it's sick about the 19-hour wait for harvesting. Doesn't seem like it would be in top condition.....

Interesting what your cardio had to say, but from what I've been reading in these articles, it says it could take months before an infection in a heart valve manifests itself. I'm not sure why this would take so long versus the other types of tissue....

I popped off an email to my surgeon last night, just to hear his thoughts on the matter. I'll let you know what he might have to say.

A little more to add on my deal: The post-surgical echo says "LV normal size" but also "Mild concentric LV hypertrophy". I guess I thought enlargement and hypertrophy were the same thing. Can anyone explain this to me? It also said "Abnormal ventricular septal motion" - what is this?

thanks!
Jennie

 

[John Cochran]

Mara,
I was delighted to hear how well you're doing! I've heard of some RP patients who, a couple of years post op, have echos that are virtually indistinguishable from a normal heart that has never been through surgery. I'm hoping the people who've had the aortic Synergraft get the same results. Anyhow, way to GOOOOOO!!

Jennie,

The ventricular septal movement would relate to the wall that separates the left and right ventricles. I suspect that on your report they simply noted that yours moves a little differently, which in the absence of pathology is probably no big deal. Let us know what you find out about that.

I'm liking this good news about our "club" members' progress...helps offset the negative press about CryoLife.

--John

 

[Mara]

John- Thanks a lot for your kind words
I am hoping that your SynerGraft does better than mine and has no leaks! Still, it's interesting to know that my EKG looks so normal after so many years of goofy aortic stenosis stuff. Amazing healing powers of the body I guess.

Try to keep postive about the outcome of your valve. I sincerely hope that there are no troubles with yours or anyone else's in our little SynerGraft club.

-mara

 

[Jennie]

I heard back from my surgeon. The main argument between the FDA and CryoLife is concerning the numerical parameters of the standards of sterilization of the tissue/valves. The FDA wants higher numbers to ensure sterilization in the classical sense, but tissue processed to those standards tends to degrade and become unusable. Instead, the tissue is cultured and quarantined for a while, to ensure that no infections are present. My surgeon also takes a small culture from the conduit during surgery, and has yet to come across any positive cultures in his career. Of course, any valve can become infected during its lifetime, but homografts supposedly have the lowest rate at less than 1 in 100. Reassuring news as far as I am concerned....

Jennie

 

[BrooksM]

Hello all

Hello all

Just wanted to let everyone know I'm still doing very well. I think we are all a little on edge, my friends and family keep seeing Cryolife in the news and asking if that is the valve that I have. I came down with Pericarditis a couple weeks ago, but they did not find any reason to believe it was infection. I think I just overdid it playing basketball on a 90 deg. day. I'm still in here checking on everyone almost daily.
It definitely sounds like Cryolife has some quality control issues but at the same time the govt. may be overreacting. It seems to me that most of the issues would be easily correctable, they just need to err on the side of caution and not worry about the bottom line. I'm sure at this point they fully understand how costly their mistakes are.
This is definitely a setback for this technology, I'm sure patients and surgeons will be less likely to choose the Synergraft until it is much more proven and the Cryolife corporate image improves.

Take care everyone.