Perimount Magna and other questions

[jjputz]

Hi, I need some information ? and opinions. I?m a 44 year old male with a bicuspid valve (scarred and calcified) with severe aortic insufficiency, confirmed by TEE. Catheterization showed no heart disease.
My Aorta has enlarged to 5cm or larger.
Two Cardiologists have recommended mechanical valves ? but I?m not sure that?s what I want.
I was thinking about the Perimount Magna valve. However with my enlarged aorta I don?t know if that?s an option. I asked the cardiologist about a homograft but he said the infection or disease issues are high (so a pig?s valve is cleaner?)
I know with a tissue valve I?ll need a replacement later on but is the operation that bad?
I just do not want to deal with the coumadin or get a stroke.
I?m not that athletic and at 5?10? 210 lb overweight ? but strong. I?m clumsy and bruise easy as is. Also I was in a motorcycle accident and my leg swells up because of crushed veins from the accident.
I?m having the operation on January 17th 2005. I?m meeting with my surgeon at the Cleveland clinic on January 5th to decide what gets installed. I?m certain he will try to steer me towards a M.V. ? but I?m just not sure that?s my best option.

 

[JimL]

I was in the identical situation when I had my surgery at age 46. My aortic valve had calcified to the extent that it only opened a little, and the blood shot through under pressure caused a distended aorta.
My surgeon wouldn't even discuss a flesh valve with me, saying mechanical was the only way to go. I haven't regretted it at all, but have enjoyed life immensely ever since the surgery. But then I didn't bruise easy before surgery, and I sure don't now. I didn't bleed easily before surgery, and I don't now either. For me, coumadin has been a non-issue, although there are occasional questions, such as, Can I have a cyst removed while I stay on coumadin? Answer: Yes, if I find the right surgeon.
I wish you well on your upcoming surgery.

 

[tobagotwo]

Valve strategy

Valve strategy

You are headed to the Cleveland Clinic for surgery. That is certainly a good start. The lengthy prose that follows is my own, nonmedical opinion.

I have no idea where your cardiologist picked up the notion that infection or disease issues are high with a homograft. Based on everything I have read on the subject, I would have to say that it sounds like complete hogwash. Homografts are expensive and can be difficult to obtain, however, and there is reason to believe that (in the aortic position) a homograft no longer represents a significant advantage in longevity over xenografts.

I assume your cardiologist is just saying that to keep you in line, doing what he has decided will be best for you.

You realize it is not entirely his decision. It is your heart, your health, and your life. One of the themes you will see throughout this site is the notion that if you truly believe something and your cardiologist doesn't agree with you, then get rid of him and find one that does (and you can - their opinions are as widely diversified as ours on this site). Also, be aware that a second opinion from another cardiologist in the same group may not really qualify as a second opinion in some cases, due to the possible politics of the situation.

My advice would be that he is closed to your input: get someone else.

It also seems like the issue with your leg does not bode well for anticoagulation therapy (Coumadin/warfarin). I would want to know more about that issue from a different specialist before committing my heart's upkeep to lifelong ACT. As well, the easy bruising may indicate a problem. It may mean that you already have a slow clotting issue or vascular issue, which ACT might exacerbate.

Both of my cardiologists and my GP immediately said I should get a mechanical. (The GP later relented after I talked to him about my reasoning.) Fortunately for me, my surgeon was relieved that I wanted a biological valve, as he feels they are a better solution, and prefers to install them where applicable.

It is a frequent (and sometimes misguided) assumption that anyone younger than sixty five, other than childbearing-aged women, will automatically be better off with a mechanical valve. A mechanical valve is certainly not a bad choice, but statistics show that recipient longevity for either choice is about the same, when the daily risks of ACT are weighed against the cyclical risks of reoperations. And anticalcification and useful life of biological valves have improved. So the choice is now not nearly as clear as was assumed in the past.

The main reason for getting a mechanical valve is to avoid a later resurgery. If you don't avoid a resurgery, you reap the negative features of both valve types: the daily risks of Coumadin and the reoperation cycle of biological valves. Plus, reoperation while bridging for ACT (anticoagulation therapy) is more complex than without it, especially in the first 48 hours after surgery.

You have a bicuspid valve and an enlarging aorta, a not-uncommon combination. If the plan is not to do anything about the aorta right now, then it leaves the assumption that there will likely be a reoperation for the aorta later. How does that tie in with the strategy of a "permanent" mechanical valve that avoids reoperation? Your cardiologists should be able to tell you why that will work for you ten or fifteen years from now, when they decide to do something about the aorta. Or they should think it over again, a little harder this time.

Strategy is an important and oft-overlooked part of the decision for valve type. Based on my own interpretation of the valve types and their longevity, I would pick the Medtronics Mosaic for twenty years, the Carpentier-Edwards Perimount Magna for twenty-five years, and a mechanical valve for thirty years. All based on the assumption that there is no expected resurgery for other causes or other mishaps.

Longest is not necessarily best. I had my Mosaic put in at age 51. That means my likely resurgery will be around age 70 (still "young"). A CEPM would have been more likely to last to age 75 or more, which would make the resurgery significantly riskier and more difficult to get over.

A CEPM or mechanical at age 70 will probably survive the rest of me decisively. For that matter, imagine the improvements that may have been made by then. Meanwhile, I likely get these twenty years without critical daily drug dosing and constant testing.

As you're younger, you would be likely to calcify a biological valve earlier than its average expected lifespan, as the average age of biological valve recipients is closer to seventy, when calcification occurs much more slowly. The recipients average older for two reasons: people over seventy tend to have developed "senile calcification" (hate that term!), and biological valves are the overwhelming choice of surgeons for their over-seventy patients. I would guess that you would take five years off of either valve's expected life, as I have seen no long-term statistics for recipients in their forties.

But, if you're going to need resurgery for your aorta later anyway, I would seriously consider a xenograft. Fewer complications from ACT mean a less complicated resurgery. At that time, you can remake your decision, as you can stay biological or change over to a mechanical then, if that's what you wish.

By the way, my cardiologists never mention my choice anymore, even as they realize I don't need them for anything but a reference for echocardiograms for the next decade or two. I think they were shocked that someone would choose to have a valve that will require another OHS down the road. I think they also picked up a lot of information about valves that was never presented to them in such a personal manner before. I hope they're rethinking their adamant approach for the next person.

In short, it can be your decision if you want it to be. If so, base it on what you anticipate happening healthwise in your life (insofar as any of us can foretell), and base it on what you learn about valves, and on your gut feel about how your personality will deal with the outcome (OHS vs wafarin). If you have chosen for the best reasons you know, then the choice will be right for you, regardless.

Best wishes,

 

[tobagotwo]

Wow. The salesman must have just left when you got there...

It won't get you out of the hospital faster. I was walking the next day and out in three with my Mosaic. What gets you out of the hospital faster is being basically healthy and energetic other than the valve problem.

In my personal research, I found studies that it did better than AOA on an implantation under the skin of rats, not in sheep hearts. And that was when AOA was having its bad times, before the realization that larger batches of it were allowing recrystallization of the AOA in solution, which was almost impreceptibly roughening the surface of the Mosaic valves. The results from the original sheep studies were never published, for a variety of reasons.

Stentless valves are on a par with the Perimount magna, not second to it. One of the CEPM sales points is that its flow characteristics are comparable to a stentless valve. However, stentless valves like the Toronto are still catching up on anticalcification, which is their achilles heel.

The flow characteristics of the Mosaic and Freestyle are excellent, and there are numerous international studies lauding them for ventricular remodelling post-op. I assume that hemodynamics is being defined here strictly as flow, but the numbers should be viewed with caution, as the nominal aperture numbers don't match between the Edwards and Medtronics valves. If you take the labeled aperture size, rather than the measured (actual) size, you are causing a prosthesis-prosthesis mismatch for comparisons, in which the Medtronics will always be a smaller size than the Edwards, simply because of the difference in the labeling between the companies. Note that the CEPM does have slightly more flow, even with matched sizes, but its cumulative effect is marginal at best.

Is the CEPM a great xenograft valve? Absolutely. So is the Mosaic.

Best wishes,

 

[Bryan B]

What I'd like to know is why/how Adonis knew how to spell Perimount at the top of the paragraph but not at the bottom?

 

[tobagotwo]

Adonis67,

Apparently the investigator in the study he pointed you to did come across the mismatch in aperture labels, but still thought he was putting in "one size larger," rather than acknowledging that the companies use different size standards. As you point out (and I agreed above), there is a slight flow edge for the CEPM (but not the 20% they gave you), even with apples-to-apples valve sizes.

You should also look at the top of the study to see if it bears the Edwards Lifesciences name. I have run across two (older) studies that exploited the label issue, both from EL, and several independent studies noting that proper study conclusions should detail the company size standard differences appropriately to be accurate.

The difference in flow between the Mosaic, which is a half-width stent, and the top-hat mounted Magnum is negligible when viewed as valve pressure gradients and in regard to ventricular remodelling within a few months of implantation, per international studies. These would be the measurements that matter to your heart.

Please understand that I'm not knocking the CEPM at all. It was originally my go-to valve. If I had been between 40 and 48, I would certainly have gone with it, as my surgeon likewise would have implanted whichever one I wanted. Based on my opinion and personal research, it, or its descendent, may well be my next valve.

But I was 51, and the strategy I mention in the earlier post makes sense to me (having the next surgery at around 70, rather than 75). Since my surgeon had implanted as many Mosaics as any surgeon alive at the time, it was (and still is) reasonable that I went with his strong suit and my age timeframe. I didn't get cheated or take second best. I have a top-of-the-line valve that will work best for me and my situation, all things being equal.

Best wishes,

 

[Les]

Adonis,
You misinterpreted Bryan's post. VR.com has been infested lately with valve sales representatives and he was merely raising an eyebrow. Your post appeared to be the same "bait" that a "few" of us jump on everytime. If you are in fact not a sales rep, then welcome to this informative, non-commercial site.

 

[Ross]

Yes your welcome so long as this doesn't turn into a salesfest for Edwards valves. The posting sure does take on that distinct sound to it huh?

 

[Bryan B]

Adonis,

I was just being my normal sarcastic, smartass self...and I tend to notice weird small details that most overlook. I was pointing out that you spelled Perimount correctly without questioning yourself near the beginning of your post and later misspelled it with the "(sp?)" notation (I found that odd is all). And Les is correct...I admit that your post in general raised my suspicion that you might be pushing a product for other than personal reasons, but by no means was I attempting to act as the spelling police.

If you're not affiliated with CE then welcome aboard. If you are...welcome aboard but be upfront with us.

 

[jjputz]

Thanks for the feedback

Thanks for the feedback

In the copy of the letter I got it says my Aorta has enlarged to 5cm or larger.
Is this a problem? Will I be able to get a tissue valve with this large of an aorta? Or will they have to replace that to. What do you think? And it looks like the Magna makes sense - right?

 

[tobagotwo]

Therein lies the issue, JJ. Unfortunately, there is not a simple answer.

In my nonprofessional opinion, I believe the sizing would not be a problem.

If the surgeon and cardiologists truly believe that the aortic enlargement will not continue, and you will not need further surgery later, then the advantage of the mechanical is that it has a longer useful life, due to your age. However, functionally, either valve type will provide excellent service.

If your aorta is enlarging and will continue to enlarge, then a tissue valve might have an advantage over a mechanical valve. This would be because you would eventually need an OHS to repair/replace the enlarged part of the aorta and probably the aortic root. The advantage of the mechanical (avoiding reoperations) would be lost. Plus, the reoperation with a xenograft would not have to deal with ACT (warfarin) bridging issues. At the time of reoperation for the aorta, the valve can be replaced as a part of the procedure, either with a new tissue valve, or with a mechanical, whichever is decided on at that time.

There is one more thing that can affect the choice. The remaining question is whether you have BAV (bicuspid aortic valve) pathology, which is evident in as many as 33% of bicuspid valve owners. Its importance in individual cases is determined by the surgeon during the procedure, as it requires direct observation. This is because even when it is present, it develops at different rates in different people, and may not have any real effect on treatment or surgery throughout the patient's life.

BAV pathology involves tissue changes that sometimes allow the aorta and the aortic root to continue to enlarge, sometimes to dissection proportions, and can sometimes cause myxomatous tissue changes to the original valve and to the tissue that the new valve would be sewn into. The myxomatous tissue (tissue that becomes expanded with fibers or even gel-like) does not hold as well when being sewn into during reops. So, if the tissue at the site is fibrous or otherwise myxomatous on inspection, the surgeon may decide that a mechanical will avoid reusing the sewing site longer and is preferable for that reason.

Sorry that it gets so complicated.

You can spend some time determining how you feel you would do on Coumadin (warfarin) by looking through the Coumadin Forum, and searching history there. Many people do extraordinarily well on Coumadin. Most seem to deal with it as only a minor annoyance. Some are not so thrilled with it. The large majority of warfarin users do not consider it as damaging to their quality of life. Whatever your own conclusion, there is no question that life with warfarin is preferable to slowly dying of valve disease.

Again, in your particular case, you would probably want an opinion regarding any ramifications for your vascular leg injury and from your bruising before committing to a mechanical valve and ACT, if that is the surgeon's recommendation. If it is an issue for ACT, the surgeon should be aware of it before the OHS.

Best wishes,

 

[Ross]

As a reminder to all reading this thread, these are opinions and opinions only. None of the participants are Medical Doctors and are only reflecting on material they've read. Leave the decisions up to your physicians, but become educated in what those decisions will be.

Guys, I do not want a new member coming in here and taking all this to be Medical Gospel, so add disclaimers to your statements or whatever it takes to make sure that these statements cannot be misunderstood.

 

[tobagotwo]

Adonis69,

My take on it is that because the pressure gradients are a function of each, individual heart, and are resultant from volume and valve orifice size, as well as a variety of other variable cardiac dynamics, they actually best match the actual amount of labor any particular heart requires to pump blood through the valve within its unique circumstances and demands. The EOA is already "wired in" to the pressure gradient for every heart.

Also, you'll note that when Dr. Kon's study implanted a one-size-larger valve, it was a Freestyle, rather than a Mosaic. The Mosaic is the new valve of that series. It is the only one with the half-width stent that increases the flow. The study would have been apples-to-apples had he used the Mosaic, rather than the Freestyle model, as they're not the same flow design.

(For the benefit of those who get a Freestyle valve at some point, especially for those requiring root replacement, the Freestyle is an excellent valve, with very good flow characteristics, and does include the anticalcification treatment. Adonis69 and I are in the stratosphere discussing minute variations on a theme, not critical flaws.)

However, your mention of the increased stress capabilities of the bovine pericardium in the manufactured valve over the natural porcine valve material is well-taken. In fact, I'm counting on it...

Best wishes,

 

[tobagotwo]

jjputz: In response to your question, which was specifically about the Carpentier Edwards Perimount Magna, my personal belief as an enthusiastic amateur is that it is an appropriate choice for a biological valve, if that's the road you decide to take, particularly for your situation and age level. It would probably require only one reoperation during your life, depending on the stability (or timing) of your aorta and aortic root, and under the assumption that it at least reaches its average useful life expectancy, minus five years for your age.

If the determination is that your aortic root should be dealt with now, and you wish to stay biological, the Medtronics Freestyle is one good candidate for that task.

Adonis67: You have a good point about the Mosaic flexible stent. As a third-generation valve, the stent is thinner than a first generation stent: http://www.medtronic.com/cardsurgery/products/mosaic_flow.html , but Hancock II is a second-generation valve, with a similar stent. I apologize: this was not plain to me in previous versions of the Medtronics web page. Both valves allow positioning for sewing so that the valve stent is out of the flow path (positioned in a supra-extra-annular manner). This also allows for a larger size valve to be used. Both the Mosaic and the Hancock II have this feature, but the Hancock II has a better illustration of it: http://www.medtronic.com/cardsurgery/products/han2_hemospra.html

Nonetheless, the pressure gradients between the Mosaic and the Magna do level within a few months of implantation, so the effects of the very nominal flow difference appear to be negligible in terms of the heart's practical effectiveness and burden level.

Freestyle is really more for root-inclusive surgeries, as far as I can see, and would probably rarely be used in cases where a less complete replacement can be implanted. Nice to know it's there, though, should your aortic root enlarge to replacement level. More info: http://www.medtronic.com/cardsurgery/products/free_index.html

Best wishes,

 

[Ross]

I'm really beginning to think your both Valve Reps for Edwards. Might have to ban you all. Ooopps, did I say that?

 

[d-mac]

Great thread guys

Great thread guys

Hi jjputz

What a wicked thread. Great reading on all responses. JJ, you are in the right place - you will learn enough here to put intelligent questions to your doctors (does not guarantee intelligent answers always) and enough to understand the gobbledegook they give you back. Bob (tobagotwo - what is that?), I always love reading your stuff as it is so informative - thanks.

JJ, I am 36yo and had my bicuspid aortic valve replaced 8 weeks ago or so. Like you, I had an ascending aortic anuerysm which had dilated to 55mm. I was informed that surgeons generally indicate repair/replacement in the 50mm and above area. The higher it is the quicker the surgery. The 38yo next to me had also had a bicuspid valve and an anuerysm that had reached 85mm and he went in to surgery within 3 weeks of being diagnosed - I waited 3 months at 55mm. In my limited exposure to this topic I have not yet heard of anything greater than 50mm being left alone when they are actually opening you up for the AVR - although I could be very quickly corrected on this. This is especially so for bicuspids and is more and more becoming recognized as bicuspid aortic valve disease.

Bob referred to the 30-40% chance bicuspids (mostly males) have of developing an anuerysm. There is some study beginning on bicuspid aortic valve disease also affecting the nearby aorta. I found a good website once that was helpful (something like www.bicuspid aortic valve disease foundation or similar).

Anyway, that fellow next to me received a mechanical valve and I opted for a homograft. The homograft comes with a fair piece of aorta and in my case they still needed a bit of dacron hose at the end of it under the aortic arch as the anuerysm extended underneath it. The other fellow and I are both doing well. Your journey will be the same - you will make the decision based upon your circumstances in consultation with your surgeon and the result will save your life. Your choice will be different to others in the same circumstances.

If your aortic root is distended (beyond at least 31mm I think) a surgeon may have trouble pulling the heat tissue back in to accommodate a tissue valve. There is a problem sometimes with large dilations at the root due to the stress the surrounding heart tissue would put on the tissue valve (maybe pulling it out of shape) and this may lead to a mechanical valve being put in by your surgeon regardless of your decision pre-surgery. They sometimes make decisions on the run in the OR.

 

[tobagotwo]

Fair enough, Ross. Sometimes, statements just come out too bald. The response was to a direct question about the CEPM, so it had dealt solely with that. jjputz has also repeatedly declared his interest in biological valves, which has guided my responses toward further information about the xenografts.

The MAEF (Morning After Editing Fairy) came during the wee hours, and did some cleanup. Hopefully, that will ameloirate the one post's perceived Edwardsian 'tude, as well as vividly notate my nonprofessional status.

D-mac: My wife and I honeymooned on the island of Tobago years ago. We are thus the "Tobago Two."

 

[Ross]

Just want you all to remember that there are new folks who are not versed in these matters. I do not want them taking anything said here as Medical Gospel. Inform, educate, etc, but don't make particular recommendations. Leave that for their minds and their Doctors to decide upon.

That is all.

*Turns attention toward another fire*

 

[inlaguna]

Valve Choice

Valve Choice

I am a 41 year old male who just had my Aortic Valve replaced 1 month ago. I chose a Edwards Magna Tissue Valve knowing I would have to go back to get it done again. I also had a Dacron tube placed in my ascending aorta as there was some evidence or enlargement. This was my second surgery in my life and my experiences ( both times) were relatively uneventful. Other than the nuisance, some pain (quite frankly the IV's gave me more problems than anything) and a 6 week recovery time it was no problem. I walked three miles yesterday and felt better than I have in years.

I chose the tissue valve because I would rather go through 6 to 8 weeks of this again in 10-20 years than be tied to coumadin. I talked to many who are taking it and most have no issues. All expressed displeasure in the disruption of their lives ( to get blood work done etc) and many stretched the rules in terms of activity.......skinging etc......

My doctors gave me different advice. The surgeon said he would go with a mechanical ( he stressed reoperation but did indicated that risk only goes up minimally the second time around). My cardiologist said he would do a tissue valve. The decision was mine ultimately and it was a hard one. Now that I am on the other side of it I am glad I made the choice I did. Interestingly, one of my cardiologist said they had done a poll at a conference asking what valve the doctors would choose if they had to have the procedure. The majority chose tissue. Don't have any reference on that. Also read that the Cleveland Clinic is about 85% tissue now.

I also considered medical advancement in 10-20 years. I am playing the odds that either anti-coagulation therapy or tissue valves will be much better than they are today and my next valve will go the distance with little trade off. Consider this, the valve in my chest has been around for about 12 years ( I actually have a newer version approved in '04) so medical science does not stop.

You will tolerate both valves well so it comes down to 6 weeks of discomfort (tissue)vs some lifestyle changes and incovenience(mechanical). I would be happy to answer other questions if you have them.

Good luck with everything.

 

[Ross]

Hello inlaguna and welcome

With each subsequent surgery the risk is higher, so you really have to weigh these things out. We've had members that didn't make it through their very first surgery, so I'm not going to tell anyone that this is something that can be done repeatedly. Once is enough, twice is dicey and it just gets worse. In my own circumstance, both of my 2 surgeries were nearly my end and I ended up in the hospital for months, not days. For me, the choice was obvious-Mechanical and hope that I never have to do it again.

Sorry if I seem like I'm coming on strong, but there are those that have a rough time from the get go, so I don't want to give them the false hope of being able to go through repeated surgeries. This surgery is far from ordinary and is not like a simple tonsillectomy, so the risks need to be carefully analyzed.

Again welcome aboard.