Mechanical or tissue aortic valve?

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CE Valves

CE Valves

Calif. Jim:

In an effort to clear up your confusion about the traditional CE Perimount vs the new CE Perimount Magna valve I went looking in my "library" of this stuff. For sure the CE Perimount is a stented valve, as that is the way it is always described in the scientific literature. I cannot find anything in the Edwards literature that says if the Magna is stented or not, but the pictures of the two kinds of valves look very similar. There is no scientific literature on the Magna as yet because it is very new. The "Device Description for Patients," written by Edwards, of the Magna valve reads as follows.

"The Magna valve is supplied sterile. It has three valve leaflets made from bovine (cow) pericardium. The leaflets have been preserved and mounted on a flexible frame. Because the Magna valve is made from tissue, it is called a bioprosthesis, tissue valve, or pericardial valve."

Now, I'm not exactly sure what a stent is at this point, but if the Magna valve is stented I am guessing it is the "flexible frame" described above. Maybe someone else, possibly Phyllis, knows the answer to this one. In any event, I believe the model number for the aortic Magna valve is 3000 possibly with some letters as a suffix describing the tissue fixing process.

The thing that attracted me to the CE Perimount valve initially was the amount of scientific literature available on it that statistically evaluates the valve's longevity vs other valves, the patient's age at implant and other factors. The fact that the Cleveland Clinic seems to prefer this tissue valve cemented my opinion of it. There are no corresponding statistical studies on the Magna valve because it is so new. However, it does not look physically like a radical departure from the traditional CE Perimount valve. If I had to decide today, I'd probably go with the Magna valve and in another 20 years I'd be one more number in the next big statistical study on these valves.

In any event, you're not me and you have to make your own decision. But I don't think you can go too far wrong here. If you have any other thoughts, come back online. If not, good luck with the surgery and give us a yell when you're back up to it!

Good luck, Jurassic Cowboy
 
Jurrasic cowboy and Jim.
I believe you are right, the Magna valve is not stentless as tobago referred to it in the previous statement I quoted. The most important inovation about the Magna valve is that it is sewn around the outside of the annulus and therefore allows a larger opening. Dick's valve is the 3000 model, before they added the newest treatment that allows even more protection from calcification. Although Dick's valve has still been treated. The valve now is the 3000TFX. As I've said in another posting - if you wait a while after a new car comes out, you get the benefits of the improvements.
Here is a quote that describes it pretty well:

"Developed by Prof. Alain Carpentier, chairman of the Department of Cardiovascular Surgery at the Hopital Europeen Georges Pompidou in Paris, in collaboration with Edwards Lifesciences, the PERIMOUNT Magna valve is specifically created to optimize blood flow for the patient. The valve's unique design facilitates placement above the patient's native annulus, and its streamlined sewing ring maximizes the valve size that can be implanted - also known as "upsizing."

The valve is also treated with Edwards' proprietary XenoLogiX tissue treatment, a unique combination of surfactants and solvents designed to effectively remove phospholipids from the bovine pericardial tissue. The valve's patented design, when combined with new precision engineering processes that optimally match the tissue leaflets, is intended to further enhance the valve's overall performance and durability."

Here's hoping that Dick adds to the statistics and needs a replacement at age 90 at which time, we hope they will be doing it without opening the sternum!
 
Here's a picture of the Edwards stentless porcine valve and the Magna valve.
 
Valve Decision

Valve Decision

Cowboy,

Well, you've got a difficult decision ahead. I decided on a mechanical valve, however, I didn't make my final decision until a few weeks before surgery.

In summary, I was diagnosed with a bicuspid aortic valve about 4 years ago (surgery was July 6th, 2004). I had plenty of time to think about my options. The main reason I selected a mechanical valve was durability. First, I'm a long distance runner & swimmer. I was concerned about the life expectancy of a tissue valve in a active person (there's no long-term data available for the new tissue valves, although, I'm sure they've improved over existing models). Second, I had to endure regular 6 month echocardiograms that indicated the valve was slowly deteriorating (with increased regurgitation), causing the left-ventricle to enlarge. This will be the likely scenario for tissue valves at 15 - 20 years (or so); If a 2nd surgery isn't too troubling for you, than this scenario is O.K., but it weighed heavily on my mind. Third, being an engineer, I appreciate the technological hurdles (& testing) the valve manufacturers must endure to certify something like this for human use. Yes, the valve could fail prematurely, or you might need the valve replaced, but the odds are in your favor. Finally, I DON'T like to take Warafin, but I haven't had any hassles at 9 weeks. However, being relatively new to this type of therapy, I'll defer this topic to those with more experience.

Note: I looked at the Ross, Porcine valves, homografts, and the mechanical valve. It was still a difficult decision 3 weeks before surgery.

No matter what your decision, I think you'll be happy with your selection.
Wishing you the VERY best!
 
Hi Buzz

Hi Buzz

I have been on coumadin now, for 2 years..and almost 6 months. Never a problem... :) No bleeding or brusies..Age 64 and keep up with an age 12 year old Grandson every weekend..I can wear him out some weekends. :D Just remember..make coffee, throw the cat out and take a pill.. :D That's it..INR always in range.. :) Better taking one pill a day than thinking about another surgery in the future. :eek: I could never handle that..Bonnie
 
JC, What I'm trying to figure out now is where did I get the notion that you needed a mitral valve? Your initial post plainly states aortic stenosis and aortic valve...

Post-Traumatic Pumphead Syndrome. Here I thought I'd escaped it all this time...

I have spent most of my life fascinated by the fossils of the vanished seabeds of the Upper Ordovician (Cincinnatian), but haven't spent much time learning about the oil- and gas-bearing remains of the dinosaurs and their contemporaries.

I do admit to owning a few Canadian dinosaur bones, though, and will someday get to a good, legal spot to find some for myself. Here in Jersey, we have mostly footprints; and there's more gas in a Jersey pizza parlor than in any of the Triassic red shale we call lawn and garden soil.

Oh. Not a paleontology, paleobotany, nor geological site.

Okay...

Not that you really need to hear it from me, but I would agree with the choice of the Carpentier-Edwards Perimount series for your circumstance. I believe it would likely be superior even to the Mosaic in the mitral position, over time. My personal belief is that it is the most durable tissue valve series available at this time.

I am not a fan of any St. Judes goods until they've been thoroughly tested in someone else, so you won't find me on their experimental trial lists. From my readings, up to this point, their biological valves have been lackluster, and have been entirely outperformed by Medtronics and Edwards.

Remember that you're dealing with the mitral position, not the aortic, so I believe the Perimount series is fine. But the Magna referred to may not be one of the options for MVR, because of its peculiar configuration, intended to captialize on the way the aortic root is situated. I could be wrong, but have not yet found a mention of its use in that position.

As far as I know, the Magna has no benefit greater than the rest of the CEP series, other than its potential "upsizing" capability, when used in tha aortic position. All of the other CEP valves have the same treatments done to them as the Magna, so I would agree with your surgeon's statement as far as them each lasting as long as the others in the mitral position. Again, not that it is important that I agree with him.

As far as stents in general: the post quoted was a reply to someone who was told he may need an aortic graft as well as a valve, not entirely uncommon with bicuspid valve issues. The part of the Perimount series that includes the aortic graft is unstented.

As far as a stent in the Magna: Edwards Lifesciences has done considerable change and mutilation to their website, apparently to make things easier for uninformed patients, and to simply try the patience of everyone else. As such, I am not finding the original series of descriptions they attached to their valves. I did find a medical professionals access link, which is listed below. It is disappointing, inthat it stops just short of saying anything about the stent. I am certain I read the term "stentless" associated with the Magna. It was one of the thinking points when I was looking for my own valve.

Perhaps there is a difference of opinion between Edwards and their competitors about what "stentless" means, and there may have been flack about their flexible frame constituting a stent of sorts. That might make them reticent to say anything about stents in their literature.

To my understanding, CE does not consider the Magna to be stented, and you will see where it differentiates itself, "...it differs from a porcine (pig) stented valve..." in one of the posts. You will also note the stent mentioned in all the other CEP valve-only aortic replacements, but not with the Magna.

As far as articles, it is important to remember that the Magna is still quite new to the US, and an article even as recent as August, 2003, will include the stented Perimount series, but not the Magna. As such, most of the links to be found are "current" as far as the Perimount series, but not recent enough to reflect the Magna and its configuration, which is intended to be mounted and sewn over, rather than into the root.

Here are some interesting links for the CEP products. Be wary of the time of the article in the link, as many of the recent improvements to the valves occured after September of 2003, and even into this year. The earliest copyright date on an article is usually its publish date. As such, take most of them as information from before the latest improvements:

http://www.lifeisnow.com/MyHeart/EdwardsLifesciencesTissueValveProducts.aspx

http://www.vidyya.com/archives/0901_5.htm

http://www.ctsnet.org/edwards/product/699

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/02-02-2004/0002101107&EDATE=

Here is one for "medical professionals," that you used to be able to access from the Edwards Lifesciences site, although I don't see anything the general public couldn't understand or deal with in it. You can also click on the blue choices below each item for further information (includes things like: Press Release Product Brochure ECHO Videos Product Animation Contact an Edwards Representative ...all in blue type). Don't be concerned if it calls in outside programs, such as Adobe Reader or an MS product for animations.

http://www.edwards.com/MedicalProfe...?ItemId=304ABBA7-C9B8-4BA1-87E7-704BAF356F25+

Yes, the surgery is scary. If you're not frightened (or at least concerned), you're not paying attention. But the actual surgery really isn't all that bad for many of us. Many of the women on the site still rate childbirth as Number One: Most Painful. Of course, childbirth does cause a nearly continuous pain in the behind for at least twenty-one years, hard for any mere surgery to compete with...

My belief is that if you want to continue the type and nature of career that you now have, the CEP pericardial valve is a plainly enticing choice.

As well, with your other medical conditions, there will be a lot less worry for you and your physicians if you're not on Coumadin. It's not that it can't be handled, but it is undeniably easier to deal with if you have a tissue valve. A quick search for colonoscopy in the Coumadin forum can illuminate the issues for someone who must have to endure that procedure more often than most of us.

I wish you the best of outcomes, whatever your choice turns out to be. In the end, you can only take what you read, what you understand of the products and your own nature, and your own common sense to come to the answer that suits you best. And then hope you're right. ;)

You will be. It really does work out. There are an awful lot of us out here to tell you that it does.

Very best wishes,
 
Stokes with Mechanical

Stokes with Mechanical

Over in the Coumadin forum, Peter (Perimeno) asked the question:

"Recently, a question was discussed on this website concerning INR and the
likelihood of strokes following aortic valve replacements. In one reply,
reference was made to research which appeared to imply that after 10 years
upwards of 25 per cent of people with the St Jude mechanical valve had
suffered strokes -- despite the benefit of Warfarin. Is the inference drawn
correct? What is the long term likelihood of strokes for people with SORIN
or mechanical valves other than St Jude?"

Now, I understand that the study may be age dependent, but this would change the way I am thinking now! Does any one know more about this?

Jim
 
Bob:

I would say that the CE Perimount definetely is stented. It has the typical ring to which the leaflets are attached.

However, Edwards also has a stentless valve, which is nearly a complete porcine valve.

Jims:

The problem of strokes with a mechnical valve only occurs if the INR is not well maintained within its therapeutic range. Today, it is said to be mandatory to make a home testing using the Roche Coagucheck. This should give a very low rate on strokes.

See:

http://circ.ahajournals.org/cgi/content/full/108/10_suppl_1/II-75


http://www.ncbi.nlm.nih.gov/entrez/...ve&db=pubmed&dopt=Abstract&list_uids=15222277
 
Jims said:
Over in the Coumadin forum, Peter (Perimeno) asked the question:

"Recently, a question was discussed on this website concerning INR and the
likelihood of strokes following aortic valve replacements. In one reply,
reference was made to research which appeared to imply that after 10 years
upwards of 25 per cent of people with the St Jude mechanical valve had
suffered strokes -- despite the benefit of Warfarin. Is the inference drawn
correct? What is the long term likelihood of strokes for people with SORIN
or mechanical valves other than St Jude?"

Now, I understand that the study may be age dependent, but this would change the way I am thinking now! Does any one know more about this?

Jim
Click to expand...

Jim, I did some searches, but couldn't locate the original post - just Peter's post that you pulled the quote from.

Here is a study posted by Al Lodwick regarding stroke risk, and its associated thread and discussion: http://www.valvereplacement.com/forums/showthread.php?t=7782

Based on that, if one ignores the advent of mutiple strokes in one person, one might be able to fudge a 23% after 10 years in the mitral position, but not in the aortic. It would still be a gross misapplication of the statistics, though.

The numbers may all be for St. Jude because it was an apples-to-apples study, and St. Jude has more artificial AVs implanted than anyone else, making them easier to follow. From what's here, I don't know why this would make Sorin's (or ATS', or On-X's, etc.) numbers any better than St. Jude's, as their numbers are simply not included at all.

However, there is a lot of sway available in the numbers in either case. What constitutes a stroke to the surveryors? And may the numbers change, now that weekly INR self-testing is more generally available?

Most importantly: Were the strokes resultant from normal living, or from ignorant health professionals insisting that people stop their Coumadin for a few days to get a tooth pulled, hangnail removed, or routine colonoscopy performed without bridge therapy? I would guess that many of the strokes not caused by other aging factors fall into this preventable category.

I know. Doesn't help. Doesn't simplify or quantify. Still, it's food for thought.


Best wishes,
 
Last edited:
Bryan B: Thanks for the definition of a stent. I think we are dealing with a nominclature problem with the Magna valve. The "flexible frame" is not the same thing as a stent in a natural porcine valve, but in fact it serves the same purpose in a manufactured tissue valve.

Buzz: There is one critical difference between your situation and mine if a read your birth date correctly. Namely, you are nearly 47 and I am nearly 62. Given your age, I think you did the right thing in getting a mechanical valve for two reasons. First, at your age a tissue valve will almost certainly wear out on you in a normal lifespan. Second, there is good statistical evidence that the younger you are at implant of a tissue valve, the faster it will calcify and wear out. This might be because younger people are more active, but in fact there is no statistical evidence to demonstrate that's the cause of the calcification. Might be that and other factors. BTW, I had a good friend who died of cancer at 59. He had a mechanical valve inplanted at 50 and he ran marathons and 50 km races. So your mechanical valve should not affect your running, other than probably making you faster!

Bob H: Glad to hear you have an appreciation for geology, a difficult thing to keep up in New Jersey. Personally, I do geological oceanography, mostly in the south and western Pacific where the oceanic crust is Cretaceous or Jurassic in age. I acquired the "Jurassic Cowboy" label from a Texas drilling crew and the fact that I am also very bowlegged! BTW, I believe you were incorrect in referring to Jims's problem being the need for a new mitral valve. In his first post he said he has a biscuspid aortic valve and needed an AVR. As such, the Magna 3000 should be a good one.

That's all for now,
Jurassic Cowboy
 
statistics and other mysteries

statistics and other mysteries

Jim and Bob:

For sure I am no statistician, but I think that simply adding up annual averages of a stroke or anything else to estimate the chance of it happening to an individual in, say 10 years, is incorrect and overestimates the 10 year likelyhood. If each year is treated as an independent event, and that's a critcial assumption I am not sure of in this case, then the total percentage is substantially less than the sum of the annual averages. The simplist example of this is to consider flipping a coin. The odds of it coming up heads on one flip is 50%, obviously. But the odds of it coming up heads on EITHER of two consecutive flips is not 100%, but 75%, because there are four possible outcomes to the two flips, HH, HT, TH and TT and only three of them contain a H. The answer for a longer set of independent events is buried in something called a "probibility density function," and that's where my statistical knowledge ends. But the main point is that the long term chance of something happening to you, if it is considered an independent event each year, is more than the annual probability but less than the sum of that annual probability over the total number of years, I think.

J. Cowboy
 
JC,

The reference to the mitral position was just to figure any angle that would get Al Lodwick's numbers close to the 25% that was in Peter's post from the Coumadin forum, and wasn't intended to reflect Jim's problem. The mitral carries a higher incidence of strokes, due to the slower flow in the area, so its percentages were the pick to try to get to the elusive 25%. The aortic position is naturally lower than that, and wouldn't have hit nearly 25% in ten years.

However, in an earlier post, I did seem to mix up your aortic requirements with a mitral need. One of the hazards of responding while jumping between threads, I guess...OK...could be dementia...

As far as twisting the odds to get there, note the phrase, "...it would be a gross misapplication of the statistics, though." I have reordered the sentences to make that clearer in the original post.

I totally agree on the Magna 3000. However, I don't know the genesis of Peter's numbers, and I don't think they should weigh down Jim's decision to go mechanical without some closer study. I suspect that they are old numbers, and that Jim should be leery of letting them influence him. While I prefer the xenograft valves, there are many people on the site who are quite content with their mechanicals, and I would want Jim to have the best possible information to make his decision.

I spent fifth and sixth grades in Cincinnati's suburbs, and spent all of my free time tracking down the limestone creek beds in search of trilobites, brachiopods, and cephalopods. I understand it's not legal to do that anymore. What a shame for the children.

My wife and I took a vacation before my valve work, and we followed the Coal Heritage Trail in West Virginia, and out into Appalachia, Virginia. We found some fascinating plant fossils in layers next to the coal seams. Even found a pine tip fossil near the top of Black Bear Mountain, the highest point in Kentucky. Go figure.

Best wishes,
 
Bob:

I am a bit confused on the CE Pericard valves.

There is the standard CE Pericard and the Magna.

Are now both treated with the newest anticalcification process or is this applied only to the Magna?

Which is the series of both types with the newest technology?
The CE Website ist not really informative on this.

Greetings


Dirk
 
Dirk,
This should answer your question as to which valves are treated and their model numbers. It is from the FDA website.
P860057/S022

1/26/04

180-Day
Carpentier-Edwards® Perimount® Pericardial Bioprosthesis, Models 2700, 2800 (Perimount® RSR), 6900P (Perimount Plus®), and 3000 (Perimount Magna®)
Edwards Lifesciences LLC

Irvine, CA

92614
Approval for the addition of a post-fixation tissue heat treatment step solution prior to the Edwards XenoLogiX® tissue valve processing steps. The devices, as modified, will be marketed with the reference to ThermaFix? as the trademark/brand name for the tissue processing method and will be identified according to the following modified model numbers: Models 2700 TFX, 2800TFX, 6900TFX, and 3000TFX.
 
mechanical valves and coumadin

mechanical valves and coumadin

Buzz and Granbonny: I appreciate both your information to me, and your reasons for going with a mechancial valve and coumadin. From the many opinions of coumadin I have read so far, people seem to fall into two distinct camps. On the one side are people who don't mind taking it and have no problem in keeping their INR in range and on the other side are the people who hate taking it and have all sorts of problems with their INR.

The thing I am trying to balance is the necessity to take coumadin and the associated hassle of that with a mechanical valve, versus the increased probability of a second operation in ~15 years if a tissue valve wears out. I think there is a lot of truth to the old saying that we fear the most that which we know the least about. In my case I've already had several operations for other things, so I'm no stranger to ORs! Admittedly, I've not yet had my chest opened up and my heart plumbing operated on, so this is clearly a new level of technology for my experience. However, at this point I feel that I would be less worried about a second operation for a worn out tissue valve than I would be about screwing up my INR and dying suddenly of a stroke with a mechanical valve. This is clearly in the realm of personal opinions and everyone has their own combination of these things.

In any event, thanks for sharing your information and feelings with me.

J. Cowboy
 
Burair:

Thanks for the tip. I managed to save all viewgraphs and to make a powerpoint presentation and PDF from them.

They are quite interesting. They show that the superiority of the SPV Toronto valve claimed from Tirone David is not believed by Cosgrove who got results that show the opposite. Question: What is true here? David has interest in the SPV as he developed it. Is it the same for Cosgrove for the CEP?
Second, the last viewgraphs show that the freedom from failure is not superior of Homografts and Autografts compared to the CEP.
Also interesting!

Bob, Phyllis and Dick:

Thanks for the additional information.
However, I do not not know whether I would want a CEP Valve with the newest anticalcification process unless the manufacturer does not release any information. And from were do I know that the additional post-fixation tissue heat treatment improves the performance?
At least I would like to see results of in vitro and of animal testing were evidence is that the valves have less calcificaiton compared to the earlier ones. In fact FDA - as I read - only approves new tissue valves if they are superior to one other already approved valve. Of course I would like to know again which one the new ones were compared with. For example if you look on the FDA safety sheets for the Medtronic Mosaic and Hancock II you will find these data. I assume that they also exist for the Edwards, but for reasons not to understood they are not published on the FDA site.
In this terms I am disappointed from the website from Edwards as they do supply few information, no real literatur references, which other valve makers have. And they also have not a complete listing of the available valves describing the different treatments.

Has anybody an idea how to get the information from Edwards?


Greetings


Dirk
 
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