St. Jude Pig valve vs. Edwards Cow valve

[Hockey Heart]

Which of these valves is better?
Why do some hospitals use one over the other?

My understanding of the St. Jude Pig valve is that two pig valves are manufactured into one valve. Apparently a fully intact pig valve is not ideal because one of the three leaflets does not work great due to a thick muscle or thick tissue area. Therefore, good leaflets are harvested from two pig valves and manufactured into one valve.

My understanding of the Edwards Cow valve is that an actual cow valve isn't used at all. Rather, heart tissue from the cow is harvested and manufactured into a valve somehow.

Before meeting with two surgeons, I just assumed or envisioned that they would just take the actual intact cow or pig valves and use those to replace our valves. I was taken aback a bit to learn otherwise. So, which is better? It seems to me that there is more of a likelihood of something going wrong with a Cow Valve because an actual cow valve isn't even being used. Both surgeons I met with are of the opinion that both cow and pig valves perform nearly identically. One of the surgeons prefers Pig because technically it is easier for him to manipulate during the surgery. The other surgeon prefers Cow and I don't remember exactly what his basis was.

Do different surgeons use different valves based upon their preference or is their a contract between the manufacturer and the hospital?

 

[Lynlw]

It depends who you ask which of the 2 are the "best"
I don't know about which pig valve you are describing,(do you know the name of it?) but the CE bovine, (perimount) is made from the pericardial sac and its pretty tough/study tissue. I think many hospitals (like Cleveland) that use the Perimount use it because it has a pretty long track record (they've been using them in trials since around 82).

I personally wouldn't care as much which valve is "easier' for the surgeon to put in, I would be more concerned in how it will function and last the years it is in you. I "think" but not completely sure more people seem go use the bovine Perimount in the US at least.

Which valve does the surgeon you picked prefer? I'd probably go with that. but thats just me.

PS IF the pig is the biocore(but I'm pretty sure it is mixed cow/pig), it has been used in Europe as long as the Perimount has been used, but just recently been used in the US. (mainly because St Jude was promoting their mechanical valve and why they are better, but as more people were choosing tissue valves, they decided to get more behind their tissue valves

editted to add
looking at st judes site, it may be the Epic.. http://www.sjmprofessional.com/Products/US/Heart-Valve-Replacement/Epic-Stented-Tissue-Valve.aspx

 

[Hockey Heart]

The surgeon I picked (Pat McCarthy at Northwestern in Chicago) uses Bovine. The other surgeon I met with uses Pig. So, naturally I started wondering if one really was better than the other or if certain hospitals just had contracts with different manufacturers....the impression I got from both surgeons was that they were virtually identical as far as how long they will last and their function.

 

[Lynlw]

I added more to my post above about the different pig valves..I thought Mccarthey might be the one to use the Bovine since he was at CCF and they were 1 of the centers using them since the early 80s with much success.

As for why, its a little of both, depending on the hospital they might just offer 1 or 2 of each kind of valves they are contracted with, but other hospitals the surgeons get what they want and think it best for each patients

 

[kfay]

It depends who you ask which of the 2 are the "best"
I don't know about which pig valve you are describing,(do you know the name of it?) but the CE bovine, (perimount) is made from the pericardial sac and its pretty tough/study tissue. I think many hospitals (like Cleveland) that use the Perimount use it because it has a pretty long track record (they've been using them in trials since around 82).

I personally wouldn't care as much which valve is "easier' for the surgeon to put in, I would be more concerned in how it will function and last the years it is in you. I "think" but not completely sure more people seem go use the bovine Perimount in the US at least.

Which valve does the surgeon you picked prefer? I'd probably go with that. but thats just me.

PS IF the pig is the biocore(but I'm pretty sure it is mixed cow/pig), it has been used in Europe as long as the Perimount has been used, but just recently been used in the US. (mainly because St Jude was promoting their mechanical valve and why they are better, but as more people were choosing tissue valves, they decided to get more behind their tissue valves

editted to add
looking at st judes site, it may be the Epic.. http://www.sjmprofessional.com/Products/US/Heart-Valve-Replacement/Epic-Stented-Tissue-Valve.aspx

Lyn, I think you are right about the St. Judes valve. The Biocor is the valve I have and Bob (Tobago) has it too. I thought it was all pig until Bob told me it was a mix of pig and cow. Of course, he knows much, much more about it than I ever would pretend to know!

K

 

[tprice54]

I was fortunate enough to get a tour of the Edwards facility, which they offer to any of their valve recipients. Their bovine valve is made from the pericardial tissue. The tissue is cut to be flattened out, measured for specific thickness, cut into exact sizes for leaflets. Each of the 3 leaflets in each valve is exactly the same thickness. The valves are sewn into a valve cuff by hand. Each step of the process has quality inspections. They have moved away from porcine valves, as they feel they can make a more prefect valve by hand. Hope this helps.............

 

[neil]

hi from what ive heard, read etc, there both exellent valves, depends if you wanna honk or moo ,

 

[Jkm7]

I have CE bovine perimount. I left the choice of which tissue to my Mass General Surgeon once we agreed I would be getting a tissue valve. I am three years out from having it implanted and will see my cardio next week. Hopefully, another good report from him...... fingers crossed.

 

[Hockey Heart]

You can tour the Edwards Facility to see how the valves are made?! I'm gonna add that to my bucket list. Or maybe it will just freak me out? Hmmmm....

 

[tprice54]

Yes you can visit!!! And I highly recommend it...they are very gracious and it is very interesting. They have a giant display of all the valves they ever made, from the very early mechanicals to today's catheter. When you make arrangements, they ask for your serial number. If possible, you get to meet the employees who made your valve! It is very emotional, for both you and the workers.

 

[normofthenorth]

I'm not familiar with the St. Jude's pig valve, though I got a different pig valve (see my Signature). Based on the latest studies I've seen on the durability of the oldest, most established valves -- the ones that have been used and studies long enough to have 15-year and 20-year follow-up -- I think the Edwards (or "CE) Perimount "cow" valve looks like the second best one, second only to "my" pig valve! The newest and most complete study is entitled "Hancock II Bioprosthesis for Aortic Valve Replacement: The Gold Standard of Bioprosthetic Valves Durability?" by Tirone E. David, MD, Susan Armstrong, MS, Manjula Maganti, MS, in Ann Thorac Surg 2010;90:775-781, abstract at ats.ctsnetjournals.org/cgi/content/abstract/90/3/775? . You've got to pay some bucks to get the whole study, including the part where they compare their results to those of other studies, including studies on the CE Perimount. But the abstract, with the summarized results, is free at that link.

Of course, many good-looking valves have come along within the last 10 or 15 years, and they can't possibly compete on the basis of proven or demonstrated durability, even though they may end up lasting longer.

My impression is that my pig valve came from a single pig, and was then treated in a number of ways. The "pericardial" valves, including all valves made from cows and horses, are manufactured out of the tough tissue that surrounds these animals' hearts. (I bet it's hard to find a cow or horse's heart valve that's small enough for most humans.) It's tempting to conclude that one approach MUST be better, but that kind of "obvious logic" is often proven wrong in medical studies.

I place a bit more value on choosing a valve that my surgeon is comfortable with, than Lyn and several others here. I don't mind making my Doctors squirm when I'm meeting with them or talking with them on the phone, but I'd really rather they did NOT squirm while they have my heart in their hands!

 

[Lynlw]

The St.Jude Biocore, CE Perimount and Hanncock II, have all been in use roughly the same amount of time, they first were used in the early 80s, so have been around close to 30 years now.

Studies are very good, but I also go by what different doctors experiences are.
For example even tho they may not write up their experience in an official study, many centers have been using these valves for a couple decades, so have about 10 years worth of patients who got their valves 20 years ago..(meaning by 2002 patients that got one in 82 had their surgery 20 years earlier and in 2009 patients that got their valves in 89 had theirs 20 years ago and everyone in between) even patients who had their valves in the early 90s are coming up to the 20 year mark.

I am NOT saying anyone HAD their valve that many years, or even that they are still alive (especially if they were in their 70s or 80 in the early 80s) Just that the surgeons have all that information about how long valves seem to be lasting for their patients as well as other studies.

Since all 3 tissue valves are still in use close to 30 years later, to ME that means they must be showing great results or not many surgeons still be using them, they would be using another valve, either one of the older ones or a newer hopefully "improved" one.

Also I don't ever want a surgeon to squirm when they are working on me or a loved one, which is why I said I'd go with the valve the surgeon prefers. I just probably wouldn't go to a surgeon who choose one valve over another mainly because it was easier for them to put in.

 

[Jkm7]

Since all 3 tissue valves are still in use close to 30 years later, to ME that means they must be showing great results or not many surgeons still be using them, they would be using another valve, either one of the older ones or a newer hopefully "improved" one.

Also I don't ever want a surgeon to squirm when they are working on me or a loved one, which is why I said I'd go with the valve the surgeon prefers. I just probably wouldn't go to a surgeon who choose one valve over another mainly because it was easier for them to put in.

Exactly.
My thoughts,too, Lyn.

 

[Hockey Heart]

Thanks for all the great feedback guys! Lyn, are you secretly a cardiologist because you always have such great things to say and really are such a source of great knowledge!

 

[Lynlw]

Thanks for all the great feedback guys! Lyn, are you secretly a cardiologist because you always have such great things to say and really are such a source of great knowledge!

No, Thank you tho. I've just been doing this for a while. Justin will be 23 next week and we found out about his heart defects the next day. He had his first heart surgery at 10 days and we knew he'd need at least 1 more between the ages of 18 months and 3 YO, depending how he grew, since he needed to be big enough to have a good chance of surving all the work they had to do. (it ended up 18 months - he was a good eater, even THEN his heart was about the size between a walnut and small plum when his surgeon had to pretty much rebuild his heart and reroute the blood paths that weren't much bigger than the size of lead in a pencil..it still amazes me to think of that).
So much was out of my control, the one thing I knew I could do was learn as much as I could about hearts and Justin's heart, so I could hopefully make the best choices. I have to say that became much easier with the internet, before that I had to go to medical libraries and read books He's had a couple surgeries without much notice, so I try to keep on top of whats going on and who is working on what, incase we have to make quick decisions.

 

[normofthenorth]

I agree that Lyn keeps up on the literature more than probably anybody else "here". But I still kind of disagree about your comment that surgeons wouldn't keep using a valve for decades unless it produced the best results. Maybe my attitude toward the scientific literacy and currency of surgeons has been permanently poisoned by my experience at www.achillesblog.com, but in that field, there are definitely lots of surgeons (including prominent ones) who keep doing what they do without reading or understanding all the new studies on the subject.

Also, the studies that compare valve longevity (e.g., "freedom from structural valve deterioration" after 10, 15, & 20 years) DO seem to show differences between popular, well-established valve models. True, there are many confounding variables -- like one-center studies vs. multi-center studies, etc. -- but if a patient wants to do the research and has some choices, I'm all for doing it and choosing on that basis. (Maybe choosing a valve AND a surgeon on that basis.) Better to do it PRE-op than POST-op!

On the mech-valve side, we've got some people who've worked very hard to get the On-X instead of one of its competitors, and I think there's also a good case for the ATF mech valve, which seems to be the quietest. And one of our bloggers here worked hard to get the new-fangled ATF horse (pericardial) valve, based on its early results. Why not? Taking some control over these decisions can also help with the "mental game". . .

 

[Lynlw]

I agree that Lyn keeps up on the literature more than probably anybody else "here". But I still kind of disagree about your comment that surgeons wouldn't keep using a valve for decades unless it produced the best results. Maybe my attitude toward the scientific literacy and currency of surgeons has been permanently poisoned by my experience at www.achillesblog.com, but in that field, there are definitely lots of surgeons (including prominent ones) who keep doing what they do without reading or understanding all the new studies on the subject.

Also, the studies that compare valve longevity (e.g., "freedom from structural valve deterioration" after 10, 15, & 20 years) DO seem to show differences between popular, well-established valve models. True, there are many confounding variables -- like one-center studies vs. multi-center studies, etc. -- but if a patient wants to do the research and has some choices, I'm all for doing it and choosing on that basis. (Maybe choosing a valve AND a surgeon on that basis.) Better to do it PRE-op than POST-op!

On the mech-valve side, we've got some people who've worked very hard to get the On-X instead of one of its competitors, and I think there's also a good case for the ATF mech valve, which seems to be the quietest. And one of our bloggers here worked hard to get the new-fangled ATF horse (pericardial) valve, based on its early results. Why not? Taking some control over these decisions can also help with the "mental game". . .

You are probably right for alot of surgeons settling for what they know, so its always a good idea to talk to go to/ the centers and surgeons that usually are doing alot of the research and giving the talks at the various conferences and even writing the textbooks for a 2nd or 3rd opinion to get their thoughts and ideas and why I think it is important to get other opinions.

I think choosing the surgeon is the most important part, but Justin's history is pretty complex, so its harder to find someone that has alot of (do a few a week) experience doing the surgery he needed. Heck a couple a month would be alot for his case.
Luckily there are about 90,000 AVRs in the US each year so it is getting easier to find surgeons that have alot of experience with them.

Also for many people the "best" valve is usually based on a combination of things and isn't based on 1 thing like which one may last a year or 2 longer for various age groups, but also how the valve functions, hemodynamics etc. and weigh everything together to decide what is best for them. Since HH was asking which tissue valve was the best between 2 valves after talking to one of the best surgeons I DO believe most people would be very happy and have great results with any of the valves most often used.

I think it is pretty safe to say unless a valve was very good both in how long it last and how it functions they would not be very popular and still being used by the best centers 20-30 years later. They would simply go to the wayside like many other valves that didn't work as well or as long as they hoped.

Actually to make it more confusing, something that never gets mentioned but If I were trying to make a choice of a Tissue valve right NOW, another thing I personally would consider..not at the top of my priorities but would think about -especially if I hoped to outlive the valve, would be percutaneous valve replacements.
IS this a valve that could be or has been easily be replaced by cath? We actually discussed that when Justin was getting his tissue valve and conduit in 2005. I wanted to make sure it could probably easily be replaced by the percutaneous valves in trials then. (It was)
Chances are very high that companies that are developing percutaneous valves that have tissue valves in use today, are making their percutaneous valves to "fit" for lack of a better word Their tissue valve. Right now, today, there are a couple of companies that have percutaneous Aortic valves in trial in the US and one company that already had their Pulmonary percutaneous valve FDA approved, and work is being done for the other valves.
So chances are 10-20 years from now those will be the companies that have the best data if the time comes a valve you get today, needs replaced and so you know your valve would most likely be able to replaced by cath. Tons of companies are coming up with percutaneous valves of their own now that they see they most likely will be money makers. So who knows what will be "the best" then, BUt IF some brands of valves already have been replaced by cath with good results, that would be something I would be interested in.

 

[normofthenorth]

Lyn, as usual, I find your comments thoughtful and well reasoned. But I disagree with maybe two of them:
1) All the leading valves are "good", but the studies that most impress me show that they have pretty significant differences in their average longevity/durability. I disagree that a heart surgeon would get into trouble for choosing the second- or third-best for decades, nor do I think most surgeons would agitate to get their hospital to switch valves after (say) discovering that their valve came in second or third in the "Gold Standard" comparison. Heck, when my own world-class fancy surgeon discovered that HIS fave valve (the one he gave me!) came in second-best in a hemodynamic comparison (and in an article that my surgeon co-authored!), he told me he STILL doesn't believe the results! So I'd say that few surgeons are as open-minded about these comparisons as a pre-op AVR patient is!
And if there really IS (as published) a several-year difference in average durability (at least in us fogeys) between even the TWO leading well-documented valves, then I'd say it's worth a few days of research and some surgeon-shopping to come out on the winning side of that difference.
2) And speaking of hemodynamics: In principle, the more unimpeded flow an open AV can permit, the better. But in practice, I think the reported hemodynamic comparisons between valves are mostly "distinctions without difference", as the lawyers would say. UNLESS you have an unusually small AV (flirting with "valve-donor mismatch"), I don't think your effective AV area with any new valve is likely to affect your cardiovascular fitness. OTOH, if you can gain a few years of valve durability, you will DEFINITELY notice the difference for those few years. . .

 

[JulieS]

Tom - Which facility is the one you toured? I tried to google but it looks like there is more than one facility?

 

[Lynlw]

Lyn, as usual, I find your comments thoughtful and well reasoned. But I disagree with maybe two of them:
1) All the leading valves are "good", but the studies that most impress me show that they have pretty significant differences in their average longevity/durability. I disagree that a heart surgeon would get into trouble for choosing the second- or third-best for decades, nor do I think most surgeons would agitate to get their hospital to switch valves after (say) discovering that their valve came in second or third in the "Gold Standard" comparison. Heck, when my own world-class fancy surgeon discovered that HIS fave valve (the one he gave me!) came in second-best in a hemodynamic comparison (and in an article that my surgeon co-authored!), he told me he STILL doesn't believe the results! So I'd say that few surgeons are as open-minded about these comparisons as a pre-op AVR patient is!
And if there really IS (as published) a several-year difference in average durability (at least in us fogeys) between even the TWO leading well-documented valves, then I'd say it's worth a few days of research and some surgeon-shopping to come out on the winning side of that difference.
2) And speaking of hemodynamics: In principle, the more unimpeded flow an open AV can permit, the better. But in practice, I think the reported hemodynamic comparisons between valves are mostly "distinctions without difference", as the lawyers would say. UNLESS you have an unusually small AV (flirting with "valve-donor mismatch"), I don't think your effective AV area with any new valve is likely to affect your cardiovascular fitness. OTOH, if you can gain a few years of valve durability, you will DEFINITELY notice the difference for those few years. . .

Well we'll just have to disagee. When I said the leading valves were good, I was talking about the ones around over 25 years, the same ones I was talking about this entire thread. Also Maybe as you suggest some surgeons wouldn't agitate their hospital to carry different valves, but the leading ones at the leading centers usually don't have to ask their hospitals for much, they get what they want, and they WANT to do the best for THEIR patients. Because it makes them and their center look good. Maybe when you were interviewing a few surgeons in different hospitals, you found they weren't as open to discussing or trying new things, thats a shame if that's the case, but the Heart surgeons and cardiologists I have had many discussions with over the years, were not only up to date with all the data, but shared with me many interesting things that wouldn't be written about for several years. Maybe the important thing that came out of this is it is important to get several opinions. Maybe that is the difference in someone who is a heart surgeon and one that works on legs that you base alot on?
I didn't say they would "get in trouble" I just don't believe they would still be the leading surgeons if they didn't use products that patients had very good results.

As for the "gold standard study" that (I think they said they had good results for the oldest age group?) as I said earlier, beside reading a study with a few hundred people, they also look at their own data and know how their patients are doing with the different valves and I'm sure what their colleages have found when they run into them every few months at the various conferences that put in thousands of valves each year and the many many studies done on these valves over the years especially the valves used the most.

Hemodynamics might not be as important for some people, or it might be very important. I was just pointing out that what makes one valve the "best' IF there IS one, would usually be based on a combinations of things and not just 1 or 2 studies on any function of the different valves. OF course who knows maybe the tissue valves that are the best hemodynamically will be the ones that would be able to be replaced easier by cath, which would probably come to play especially for the smaller sizes. THAT could make a HUGE difference in their life.

Anyway I'm done here, I was simply trying to answer HH question and reassure him he would do great. The LAST thing I felt like was getting into 1 more back and forth on things people will NEVER agree on. As long as anyone is happy with the valve THEY got, that's what is important to me.