need advice on "Epic valve"

[Enudely]

Hi guys
I went in for my pre-op today and they asked me if I want to participate in a study for a "new" (in the U.S) type of valve. It's made by St.Jude, is a pig valve with some special material coating it that is supposed to slow down calcification. They are trying to get it past the F.D.A in the U.S, though it has been successfully used in Europe and Canada for 15 years. It's proved to last 15 years and will probably last 20 or more. Sounds good to me! I signed the consent to accept it but can always change my mind. Surgery is Thursday. I just wondered if anyone has heard of this?? or has any advice???

 

[Nancy]

Elena-

This valve has not yet been approved by the FDA for use in the US, yet?

You'd better think twice and even three or four times before agreeing to put a "new" type of valve in your body that doesn't have a long track record. Others on the site have done that and it has not worked out as they were hoping.

You are young and have a long full life ahead of you. Take every precaution to assure that you will be able to enjoy it to the highest.

Remember there is a tremendous amount of hype with any new thing. Sales pitches abound.

Stay with the tried and true valves.

Just my opinion.

 

[Nancy]

Here's the press release on the first implantation.

http://biz.yahoo.com/bw/031202/25827_1.html

You will note that the first implantation was in December of 2003. Not much of a track record.

 

[bvdr]

Well Elena,

That is a tough one. I would be tempted to do it and hope it went really well. My husband on the other hand said absolutely not. What would tempt me would be the fact that a redo would be somewhere in the future anyhow and if the longevity lives up to the promise then maybe you would only have one more surgery and have the benefit of a possible lifetime without permament anti-coagulation therapy.

Whatever you do, once it is done don't second guess yourself. Think long and hard about it and then if you feel like you need to change your decision go ahead. Don't worry about disappointing your surgeon or anyone else.

Elena, I hope your surgery and recovery go very very smoothly and that you will be home and posting very soon. I will keep you in my prayers.

 

[ShezaGirlie]

You asked for advice...[edited post]

You asked for advice...[edited post]

Elena, you said -- "That "Silzone" stuff only had 5 years behind it. This one has 15. I think it's a totally different thing....."

Oh really? I'm most interested in exactly where you obtained this information. Please know that the valve you're going to get was only put in the first patient in December of 2003 -- not 15-17 years ago.

Know that five different valves have been discussed on this thread.

1. The Standard St. Jude Mechanical Valve is the 'GOLD STANDARD' of mechanical valves.

2. Made by St.Jude, is a pig valve with some special material coating it that is supposed to slow down calcification. [This is the SJM Epic(TM) or the Epic(TM) Supra valve -- which one are you getting?]

3. Thousands of people in Europe and Canada have had this valve for 15-17 years with NO ADDED COMPLICATIONS. [This is the SJM Biocor(TM) valve -- one that you are not getting.]

4. Dr. Alain Carpentier, a French surgeon, who pioneered the Carpentier-Edwards bovine valve. Dr. Carpentier was also a pioneer in mitral valve repair.

5. St. Jude Medical's Silzone valves.

Please know I do not intent to confuse you this late in the game. I merely want you to be informed in your decision. You've made it -- so go with it. I admire you agreeing to be an informed participant in this en vivo clinical trial as they are the most important trials in existance.



--------------------------------------------------------------------------------

 

[sylviayasgur]

i agree...

i agree...

hi elena!
i tend to agree with janie and nancy. i like the old "tried and true" valves.
however, it is a very personal decision and if this is what you feel most comfortable with, then this should be your choice.
i don't need to remind you to look at all the angles carefully before deciding.
this is a hard one, good luck!
either way, you will be making a wise choice in that you are having this done.
wishing you all the best. be well, sylvia

 

[Enudely]

I don't know, I'm confused because this valve has been used in Europe and Canada for fifteen years with positive results, they are just trying to get it into the U.S... Also, I would have more echo's and follow up exams than the regular O.H.S patient, which is a good thing. They said that there is no extra risk at all ...just the same risks associated with any open heart surgery. It's basically a bovine valve with a special kind of "anti-calcification" coating on it, and it might end up lasting a lot longer than the other ones! I guess I have to do more research on it, now you all have made me nervous!
I guess the only thing that is really knew in these valves is the protective coating....

 

[Christina L]

Elena,

I would say do what is right for you and your situation. Many on the board think having 2-3 operations is the worst thing that could happen to a person - I just had mitral valve repair 10 weeks ago and I agree that I do not want another operation any time soon - if ever - and God willing I will not have another surgery.

HOWEVER, that said, if I do have to have my mitral valve replaced, I still may go with a bovine valve, if I am not in atrial fibrillation and can be off of Coumadin.

I am hoping that by the time (if/when) I would need a replacement valve that they will have a tissue valve that will last quite a long time.

You are lucky in that your replacement will be in the aortic position as aortic replacement has a somewhat better long-term outcome than mitral replacement (from what I have read).

There are two schools of thought on this board - those who would NEVER want the risk of a repeat surgery and those who don't want the risks of taking Coumadin. It is a tough, tough decision, but you need to do what is right for you and your husband - he probably has a say in things too.

By the way, there have been posts on this board saying that mechanical valves can even run into problems and have to be replaced or reoperated on, so....

May God give you guidance and peace in whatever you decide to do -

P.S. I thought there IS a bovine aortic valve that has been used in the U.S. for many years. Have you checked into it?? It is supposed to last 15-20 years also. The Cleveland Clinic uses it extensively. Could you call them to find out what they use??

Christina L.

 

[ALCapshaw2]

Elena,

In your first post on this topic you said it was a PIG Valve.
In your second post on this topic you said it was a BOVINE valve.
Which is it?

The St. Jude SILZONE Mechanical valve had a 'special coating' that caused SEVERE problems, including several DEATHS.

The Standard St. Jude Mechanical Valve is the 'GOLD STANDARD' of mechanical valves.

IF you are interested in a Long Lasting TISSUE Valve, why not go with the Carpentier Edwards Bovine Pericardial Valve which is made from the pericardium of a COW's Heart and shaped like a human valve. This is the 'Valve of Choice' at the Cleveland Clinic and has a 90% durability rating at 15 years and some early recipients are pushing 20 years (in the U.S.)

'AL'

 

[Harpoon]

Find accounts in Canada and Europe about the valve in question....



While I'm all for medical research and the idea of trying something "new" that might offer a better option of treatment or better results, there are limits and an experimental heart valve would be one.

There are other options available and they have proven track records.

Do you really need to have this new, experimental valve? Is there some thing that precludes you from other options?

If you wanna be "different" get a tattoo or piercing before you start in on coumadin therapy. Don't be a "beta-tester" for some new heart valve....


That's just me. =)

 

[mamsram]

pig? cow?

pig? cow?

At first I got mixed up on these two Its porcine(pig) and bovine(cow)

As for choises of valves, my surgeon, one of the leading valve surgeons in the country, also a Harvard professor, had to have his aortic valve replaced. It was done by Dr.Calvin at Cleavland.

This mans choice of valves was the Carpentier Edwards Bovine pericardial valve. Now if this Dr. chose this valve, wouldn't one be tempted to accept his knowledge and judgement and access to research and studies to conclude that his choice after all may be the best choice, at least at the time. (which was not too long ago)

For what its worth-------

 

[Marge]

I can't take a position on whether it is a good idea or not to accept this valve.

Would, however, like to point out a few things:

1. FDA approval is NOT a guarantee of anything. The St. Jude "Silzone" valve, mentioned upthread, later recalled & the subject of the current lawsuits (Billy McCombe of this board is one of the plaintiffs) was FDA-approved.

2. There have been many advances in heart surgery outside the US. Many proved techniques and devices were pioneered and widely and successfully used in other countries before our cumbersome FDA approval system OK'd them for this country. Possibly the top valve guy in the world is Dr. Alain Carpentier, a French surgeon, who pioneered the Carpentier-Edwards bovine valve. Dr. Carpentier was also a pioneer in mitral valve repair ("the French coRRection").

So if I were offered a "new" type of valve, and told that it had been developed outside the US, I wouldn't necessarily reject it out of hand; I'd ask to know some more about the European trials, and their outcome.

Easy for me to talk about this, not being a couple of days away from surgery. This is a tough decision, Elena -- right on the verge of having the surgery, and they throw this at you! I think if they did this to me a few days before the operation, I'd freak out. You're being remarkably calm.

 

[Enudely]

The thing with this valve is this... Thousands of people in Europe and Canada have had this valve for 15-17 years with NO ADDED COMPLICATIONS and none of them have had to be replaced yet! There are no extra risks than those associated with any heart surgery. My boyfriends father is a chemist and he said there is no way that this substance could break off the valve and cause problems or anything like that. To be truthful, I am convinced and think I'm going to go for it. Maybe it will last 25 or even 30 years!? Don't know unless we try. At some point, somone had to be the 100th person in America to get the bovine pericardial valve...... This valve has been a great success so far and could help millions of people if we can get it past the F.D.A ..... also, there will be more, free Echo's coming to me and extra monitering. I think it's a good idea.
Also, my surgeon is one of the best in Northern California and he wants me to go for it. That "Silzone" stuff only had 5 years behind it. This one has 15. I think it's a totally different thing.....

 

[Christina L]

Elena,

I think you have made a wise, educated choice on the type of valve you want to use. I think it sounds great!

Can I be snoopy and ask who your surgeon is?? I almost used a surgeon from San Francisco (Sequoia Hospital) before I decided on Cosgrove in Cleveland.

You can PM me, if you don't want to say who your surgeon is on the regular posts.

You will be in our thoughts and prayers - best wishes on a successful surgery and speedy recovery, AND that the new valve will last a long, long, long time for you!!

Christina L.

 

[Nancy]

Elena-

Best wishes for a terrific surgery tomorrow.

Bon Voyage and smooth sailing. I hope someone will post and let us all know.

Talk to you later.

 

[Enudely]

Cristina, my surgeons name is Dr. Flaschbart at Kaiser San Fransisco. He's done 6-7 THOUSAND open heart surgeries and 7-8 HUNDRED aortic valve replacements!!!

 

[Karlynn]

Elena,
You have to go with your best judgement and gut (Spirit?) feeling.

Best wishes. If a positive attitude has impact on the outcome - your outcome will be great.

 

[ShezaGirlie]

Elena

Elena

Please see my edited post above. Good luck to you..

 

[Christina L]

Elena,

The surgeon I was checking into was Vincent Gaudiani, in Redwood City, Sequoia Hospital, who is a mitral valve specialist. He was my #2 choice after Dr. Cosgrove.

Your surgeon sounds very schooled and experienced.

We will be waiting to hear from you when you get to the other side of the mountain! Hold only good thoughts in your mind and you will be just fine.

God speed!

Christina L.