AVR selection

[Jeri]

Again, I wish to thank each and everyone of you for sharing your thoughts and experiences for me. I read and re-read your posts many times to absorb, learn and even analyze what you are telling me. I want to make the right decision and you are all assisting me. I appreciate this so much. As I have always taught my girls, there are always two sides to every story and one must consider both sides objectively and I amtrying to do that. I will continue to read and study and by the time I see my surgeon again, I know I will have my mind made up. I also have the TAA that is only 3.8 cm to consider. I know it is small but the surgeon shared with my cardio that he is still concerned because I have a very small frame. I am 5'2" and weigh 100 lbs. He said the 5cm protocol is based on an average sized person and I am below average size. So I really don;t know what he has in mind for that, if anything. Again, thank you all and I will continue to monitor this forum nightly. My son-in-law is a software engineer for St. Jude Medical and I am hoping he brings me some info also. If he does, I will certainly share whatever he has.

Jeri

 

[normofthenorth]

I think it was Margaret who mentioned that we ultimately put our faith in our surgical team, and they may decide on a different valve -- even tissue vs. mechanical -- during the surgery. I'm sure this can happen (and I had a few things switched during my surgery), but switching from a tissue valve to a mechanical one, or vice versa, has got to be extremely rare. Certainly in the Aortic position, they're usually surgically interchangeable, so I can't think of a basis for that kind of switch, offhand.

So try to make peace with YOUR choice of the basic type of valve, because you're probably 99.99% likely to get the type you choose.

 

[Lily]

Jeri, I'm glad you have found the posts helpful. I have cringed at a few of them, especially when a member second guesses someone else's decision because they don't agree with it.

FWIW, I knew for most of my life I would need my valve replaced and knew what type of valve my doctors consistently recommended and knew what type of valve I and my husband thought would be best for me; and yet there were still members here who IRONICALLY and rudely argued with my decision over seven years ago when I first joined this site.

Anyway, it is only my opinion but, in most situations, which are unique to each person, there is not likely a wrong decision in regard to valve choice. Put another way, there may be no wrong choice, no matter what kind of valve you choose. The information you are accumulating is important but most of us here are just patients with opinions based on our own isolated experiences and limited viewpoints. Take our opinions with a grain of salt while realizing also that there may be some pushy members here whose motives may be suspect.

But we as individual patients can each take in information and sort and process it and consult with medical experts and eventually we know what we are comfortable with and why. And then we can make the best of our choice, no matter what it may be.

You have my continued best wishes

 

[Jeri]

Jeri, I'm glad you have found the posts helpful. I have cringed at a few of them, especially when a member second guesses someone else's decision because they don't agree with it.

FWIW, I knew for most of my life I would need my valve replaced and knew what type of valve my doctors consistently recommended and knew what type of valve I and my husband thought would be best for me; and yet there were still members here who IRONICALLY and rudely argued with my decision over seven years ago when I first joined this site.

Anyway, it is only my opinion but, in most situations, which are unique to each person, there is not likely a wrong decision in regard to valve choice. Put another way, there may be no wrong choice, no matter what kind of valve you choose. The information you are accumulating is important but most of us here are just patients with opinions based on our own isolated experiences and limited viewpoints. Take our opinions with a grain of salt while realizing also that there may be some pushy members here whose motives may be suspect.

But we as individual patients can each take in information and sort and process it and consult with medical experts and eventually we know what we are comfortable with and why. And then we can make the best of our choice, no matter what it may be.

You have my continued best wishes

Thanks so much Lily!! I understand what you are telling me. I appreciate your post as well as others. It is so appreciated. I will keep everyone updated.

 

[bdryer]

Jeri

Once your mind is made up, you are not allowed to hold your decision back regarding a MHV or biological choice. We are in suspense.

I excepted certain post surgery life time risks and pre made my mind up prior to the surgeons meeting, regarding AV composition. Considering my ascending aorta was 4.5 cms and required replacement, he agreed with my choice, as this is what they recommend. I only have a little over 3 mths from diagnosis to surgery, so I needed to get on it.

We should throw a party when you make your mind up. LOL. Red vino will naturally be served.

Waiting for Jeri's announcement

 

[irel]

I doubt that my comments can be of much help but I had a tissue (bovine) aortic valve replacement at 69 some 9 mos ago, along with a double bypass. I am doing fine and although the valve will likely only last 10-15 yrs.; the future medical advances in this area will likely result in non-invasive surgery being the norm and recovery shuld be a snap in comparison to current open heart surger. I felt pretty good after 3 mos and although the sternum is not yet completely healed, it is hardly noticeable. They are also not using a super glue to close the sternum and have discovered an enzyme which can loosen a blocked artery, reducing the need for bypass surgery. Tissue or mechanical is a personal choice and it would appear that a tissue valve is less troublesome and more common. Good luck with your choice.

 

[ALCapshaw2]

Irel / Gord -

Can you tell us more about this "enzyme which can loosen a blocked artery"?

That's the first I have heard of this development. Do you know the name of this enzyme or where we could find more information on this?

 

[JUST-WAITING]

I know the feeling- I am 52 and have scheduled my surgery 17th and now am in a last minute situation - trying to decide- I am scared of comudin and leaves with a few options- My doctor has discussed the horse/ pig question .

 

[ALCapshaw2]

I know the feeling- I am 52 and have scheduled my surgery 17th and now am in a last minute situation - trying to decide- I am scared of comudin and leaves with a few options- My doctor has discussed the horse/ pig question .

What scares you about Coumadin?

Do you kNOW that whatever it is, is TRUE?

There are a Lot of Horror Stories and Myths about living with / on Coumadin.

Before 1990, there was considerable variation in reagents used to measure clotting time.
The International Normalized Ratio Testing method was developed in the early 1990's which greatly improved the accuracy and reliability of anticoagulation testing / monitoring / and management.

With Proper Management, most people are able to maintain a stable INR most of the time.
One of our members has been on Coumadin / Warfarin for 30-some years (or is it 40?).
His ONLY problem was when he went on a hunting trip and forgot to take his Coumadin with him.

EDIT: Member dick0236 has been on Coumadin / Warfarin since 1967 - 43 years and counting!

Have you read the "stickys" at the top of the Anti-Coagulation Forum?

That would be a good place to begin to learn the reality of living with / on anticoagulation.

'AL Capshaw'

 

[Jeri]

I keep leaning towards the tissue valve although I don't fear Coumadin the same way I did before I joined this forum and I thank everyone for that one. I know no matter what I choose or what the doc chooses, I will be OK. Thanks to all of you, the fear is gone. I see the surgeon in February and the cardio in Jan.

 

[normofthenorth]

Does anybody know whether the Plavix focus on the On-X is a reflection of the On-X's state-of-the-art lowest propensity to form clots, as opposed to a state-of-the-art eagerness on its manufacturer's part to push the envelope and study the acceptability of lower ACT approaches?

Put another way, is there independent evidence that the On-X is better than the competition in the factors that require ACT?

It seems like spiffy technology, and I've been "connecting the dots" to conclude that it was the best mechanical valve, but it's recently occurred to me that I'd never actually seen a study that established that -- just design-and-materials "reasons to believe" (from the manufacturer), and the PRESENCE of these tests. . .

I asked this question just before my OHS, and I think I've just "tripped" over the answer of ONE of On-X's competitors, at atsmedical.com/Physicians.aspx?id=2470 . On that page, ATS compares the clot-throwing experience -- including at LOWER INRs -- of its Open Pivot® valve, with the experience of the On-X valve with (what ATS calls) its "Magic Carbon"!! They've got some pretty impressive-looking numbers, and some Scanning Electron Microscope photos, too, indicating that there's nothing "magic" about the On-X, and that the good engineering of the pivots in the ATS valve may have even more significant benefits!

Here's some of the (aggressive) flavor:

MCRI On-X has contended that as a result of their non-silicon alloyed pyrolytic carbon and because of the shape and length of the orifice, there are inherent thromboembolic advantages to the On-X mechanical valve. The mid to long term studies of the On-X valve as presented in the journals summarized here do not support this. Collectively they show an acceptable, but unremarkable rate of complications at normal to historically higher INR levels. It really begs the question: Shouldn’t a valve touted as being likely suitable for low or no levels of anticoagulation have amazing results at regular INR levels?

The Truth About Non-silicone Carbon. . .

I'm sure some of this is y'r ordinary commercially motivated "negative advertising" -- but it does make me doubt that the On-X low-ACT trials are actually based on the superiority of the valve design and material.

Maybe I'm just a die-hard Medtronics loyalist, now that they own a piece of my heart . . . (Medtronics seems to own ATS, or some such. . .)

 

[ALCapshaw2]

Clots can be formed for several reasons. One possibility is due to Eddy Currents forming in the flow pattern.

On-X is the ONLY mechanical valve I am aware of where the leaflets open a full 90 degrees to prevent turbulence in the output flow pattern. They have a very clever solution to the 'how to close a valve that is open 90 degrees' challenge.

ATS, Carbomedics, and St. Jude Mechanical Valves open less than 90 degrees to catch the 'back-flow' at the end of the 'pumping cycle' to close the leaflets. The downside of this kind of design is Turbulence in the output flow.

EDIT - The ATS Valves only open to 75 degrees according to my contact 'in the biz'.

On-X has some supporting evidence of lower complication rates in non-compliant populations (in South Africa) where they reported lower complication rates than other mechanical valve manufacturers. One of the 'other' mechanical manufacturers tried a No Anticoagulation study in Europe many years ago. It was Terminated abruptly after several patients suffered Strokes. The FDA approved ON-X Low/NO anticoagulation study is still ongoing with (presumably) good results.

 

[ALCapshaw2]

NormoftheNorth wrote:

Here's some of the (aggressive) flavor (presumably from the ATS website):

MCRI On-X has contended that as a result of their non-silicon alloyed pyrolytic carbon and because of the shape and length of the orifice, there are inherent thromboembolic advantages to the On-X mechanical valve. The mid to long term studies of the On-X valve as presented in the journals summarized here do not support this. Collectively they show an acceptable, but unremarkable rate of complications at normal to historically higher INR levels. It really begs the question: Shouldn’t a valve touted as being likely suitable for low or no levels of anticoagulation have amazing results at regular INR levels?
The Truth About Non-silicone Carbon. . .

End of ATS Quote

I'm sure some of this is y'r ordinary commercially motivated "negative advertising" -- but it does make me doubt that the On-X low-ACT trials are actually based on the superiority of the valve design and material.

End Quote from NormoftheNorth

The ATS Ad uses a 'slight of hand' argument implying that the Valve has some influence on a co-morbidity most likely attributable to Higher Anti-Coagulation Levels.

IF there is a Bleeding Problem that is exacerbated by a Higher INR, that is Totally Independent of Valve Characteristics.

The VALVE Benefit is that with the ON-X Valve, a LOWER INR can be Safely Maintained to Lower the Bleeding Risk from anticoagulation.

With mechanical valves from other manufacturers, there is a Higher Risk of CLOT formation at Reduced INR Levels.

IF a patient has a Bleeding Problem at Higher INR levels, that problem is due to anticoagulation level and INDEPENDENT of Valve manufacturer.

You've got to keep your Apples and Oranges straight...

 

[Lynlw]

NormoftheNorth wrote:

Here's some of the (aggressive) flavor (presumably from the ATS website):

MCRI On-X has contended that as a result of their non-silicon alloyed pyrolytic carbon and because of the shape and length of the orifice, there are inherent thromboembolic advantages to the On-X mechanical valve. The mid to long term studies of the On-X valve as presented in the journals summarized here do not support this. Collectively they show an acceptable, but unremarkable rate of complications at normal to historically higher INR levels. It really begs the question: Shouldn’t a valve touted as being likely suitable for low or no levels of anticoagulation have amazing results at regular INR levels?
The Truth About Non-silicone Carbon. . .

End of ATS Quote

I'm sure some of this is y'r ordinary commercially motivated "negative advertising" -- but it does make me doubt that the On-X low-ACT trials are actually based on the superiority of the valve design and material.

End Quote from NormoftheNorth

The ATS Ad uses a 'slight of hand' argument implying that the Valve has some influence on a co-morbidity most likely attributable to Higher Anti-Coagulation Levels.

IF there is a Bleeding Problem that is exacerbated by a Higher INR, that is Totally Independent of Valve Characteristics.

The VALVE Benefit is that with the ON-X Valve, a LOWER INR can be Safely Maintained to Lower the Bleeding Risk from anticoagulation.

With mechanical valves from other manufacturers, there is a Higher Risk of CLOT formation at Reduced INR Levels.

IF a patient has a Bleeding Problem at Higher INR levels, that problem is due to anticoagulation level and INDEPENDENT of Valve manufacturer.

You've got to keep your Apples and Oranges straight...

I'm a little confused (at first I thought this was something you passed on from catherine) When you are talking about co-morbidity are you talking about the risk of bleeding because your on Coumadin or something else entirely, (I never heard people call bleeding a co-morbidity here)?
The other part that confuses me, is are you saying that hopefully if the trials go well AND On-X patients can have a lower INR THEN there will be less than the 1-2% risk of a major bleed that there is NOW or are you saying right now you have a lower chance of a major bleed with the On-X compared to the other mechanical valves on the market today?

I get that the risk of bleed has nothing to do with the valve itself, it is just fact you need to take coumadin that increases your risk over someone not on Coumadin (as we just went over and over) and even people in range are at a risk for a major bleed, and it goes up w/ each .5-1 INR point so of course lowering the INR would lower the risk of a bleed. But are you saying there are studies now showing it is safer right now and not what they hope will happen IF they can lower the INR? Because it looks you are saying that is how it is right now, "The VALVE Benefit is that with the ON-X Valve, a LOWER INR can be Safely Maintained to Lower the Bleeding Risk from anticoagulation"
and I'm not sure that is correct.

 

[Jeri]

I have been reading all these posts and I am really confused....maybe I just need to re-read them. But I am moving along with the surgery.....I have lots of pre-op tests this month and my cath in feb....I see the surgeon towards the end of Feb for a valve replacement in March sometime. I am still leaning towards a tissue valve although this On-X is interesting. So confusing......I will discuss with my surgeon. I wanted to put everything off because my Mom who is 94 just had another MI last Tues and a CVA on Wed......she is still with us, Thank God!!.....But I really want to be there for her with her therapy. She has a lot of damage and deficit from CVA. I have been praying alot. I am blessed that she has survived all this.

 

[normofthenorth]

NormoftheNorth wrote:

Here's some of the (aggressive) flavor (YES INDEED from the ATS website):

MCRI On-X has contended that as a result of their non-silicon alloyed pyrolytic carbon and because of the shape and length of the orifice, there are inherent thromboembolic advantages to the On-X mechanical valve. The mid to long term studies of the On-X valve as presented in the journals summarized here do not support this. Collectively they show an acceptable, but unremarkable rate of complications at normal to historically higher INR levels. It really begs the question: Shouldn’t a valve touted as being likely suitable for low or no levels of anticoagulation have amazing results at regular INR levels?
The Truth About Non-silicone Carbon. . .

End of ATS Quote

I'm sure some of this is y'r ordinary commercially motivated "negative advertising" -- but it does make me doubt that the On-X low-ACT trials are actually based on the superiority of the valve design and material.

End Quote from NormoftheNorth

The ATS Ad uses a 'slight of hand' argument implying that the Valve has some influence on a co-morbidity most likely attributable to Higher Anti-Coagulation Levels.

IF there is a Bleeding Problem that is exacerbated by a Higher INR, that is Totally Independent of Valve Characteristics.

The VALVE Benefit is that with the ON-X Valve, a LOWER INR can be Safely Maintained to Lower the Bleeding Risk from anticoagulation. [Al, this is the part that's being TESTED now, with studies that are still under way, right? -notn]

With mechanical valves from other manufacturers, there is a Higher Risk of CLOT formation at Reduced INR Levels. [And THAT's what ATS has presented comparative data on, right on the page I linked! See discussion below. -notn]

IF a patient has a Bleeding Problem at Higher INR levels, that problem is due to anticoagulation level and INDEPENDENT of Valve manufacturer.

You've got to keep your Apples and Oranges straight...

Al, the ATS website I linked compares the rate of THROMBOEMBOLIC EVENTS (not just "Bleeding Problems") in a number of studies, with the ATS valve at LOWER INRs, and with the On-X at REGULAR INRs. And they do that for the Aortic position and the Mitral position, equally. Apples and apples, right? And lower INR would tend to INCREASE the rate of THROMBOEMBOLIC EVENTS (= TE =~ "thrown clots"), right?

But the Linearized Rate of TE for the ATS valve with LOWER INRs (in Aortic position) is 0.7% and 1.1% in the two listed studies, while the Linearized Rate of TE for the On-X valve with REGULAR INRs is 1.5%, 0.9%, and 1.3% in the three listed studies. The On-X had a slightly HIGHER rate of clot-throwing than the ATS, with HIGHER INR! That suggests to me, as the ATS folks suggest, that On-X's "magic carbon" may NOT be preventing thromboembolic events, or it might not be doing it as effectively as the clever design of the ATS valve's hinges.

If you look a little lower on the ATS page I linked, you can see the results for the MITRAL position, where the ATS valve knocks the On-X completely out of the water:
ATS: 0.4%, 0.45%, & 1.1% linearized rate of TE,
On-X: 1.6%, 1.6%, & 1.7%!!
Again, the ATS results are with LOWER INR, and the vastly inferior On-X results -- almost THREE TIMES as many clotting events!! -- are with REGULAR INR!!

It seems only logical to assume that the ATS would have had even BETTER TE-rate results with REGULAR INR than it did with LOWER INR, so it also seems logical to conclude that -- assuming that most or all of these study results are true and representative and replicable -- the ATS Open Pivot valve is MUCH less prone to throw a clot (= cause a ThromboEmbolic event) than the much-vaunted On-X valve, especially in the (somewhat more clot-prone) Mitral position.

Al, do you find any Oranges in that apple sauce?

 

[Lynlw]

I'm sorry to hear about your Mom. AS for posts being confusing, some times the threads tend to get away from the origonal question and just back and forth between members, over little details, or studies that really noone knows how things will turn out. I know a few of my post here have been about the ON-X but like my last post It was questioning claims made that I've never heard, or to answer questions from what I read altho I'm certainly not an expert on mech valves.

IF you are leaning tissue, I would think about why you want tissue or better yet what you want to avoid as far as a mechanical valve (just like if someone was leaning mech they would be trying to avoid reops from a tissue valve) IS the On-X MUCH better than any other mechanical valve? Maybe, but maybe not enough to make that much of a difference in living day to day life.. meaning you most likely will still need to take Coumadin maybe just a smaller amount. There are also studies comparing the On-X valve to 2 other valves in patients that didn't have stable INR (South Africa) that didn't show much difference between the valves (I think a link to it is in one of my other posts in this thread) and the one 5 year study I saw (I think it may be in this thread too), didn't look that much different than what I see for other valves.
Only you know what would be best for you. BUt at least now when you talk to your surgeon you will have alot of information to be able to have a good conversation.

 

[ALCapshaw2]

Lyn -

I wrote a response but decided that I want to verify my answer before posting.
My comments above were mine alone.

'AL'

 

[normofthenorth]

I have been reading all these posts and I am really confused....maybe I just need to re-read them. But I am moving along with the surgery.....I have lots of pre-op tests this month and my cath in feb....I see the surgeon towards the end of Feb for a valve replacement in March sometime. I am still leaning towards a tissue valve although this On-X is interesting. So confusing......I will discuss with my surgeon. I wanted to put everything off because my Mom who is 94 just had another MI last Tues and a CVA on Wed......she is still with us, Thank God!!.....But I really want to be there for her with her therapy. She has a lot of damage and deficit from CVA. I have been praying alot. I am blessed that she has survived all this.

Jeri, at 58, the choice between a mech valve and a tissue valve is in your hands. As Al says (paraphrasing), your preference will depend on which things you especially want to AVOID. Each choice brings its own different risks, but they seem to be about the same total SIZE, in terms of life expectancy or risks of bad outcomes. And one of them brings the routine nuisance of ACT, while the other brings the looming of specter of the strong likelihood -- almost a sure thing if you live a long life -- that you'll have to go through OHS & HVR all over again. Hopefully just once, and POSSIBLY through stent-like catheter implacement rather than having your "wishbone cracked" again. ACT brings risks as well as nuisance, and re-op also brings risks as well as "Yee-Yikes!", but the two sets of risks seem to be about the same size for a 58-year-old.

So it's a choice, and it's your choice. Some people here acknowledge that it's a tough and highly personal choice, and some seem to think that it's an obvious "no-brainer" in the direction of their OWN choice(!). Learn what you can, consult your own feelings and values and concerns and preferences and fears, get used to the sad fact that NONE of the options comes with a guarantee, talk to your health professionals and any other experts you can find, and make the best (or "least bad"?) decision FOR YOU, and hopefully find peace with that decision.

If you're still leaning toward a tissue valve and skipping the ACT, then you really don't have to get to the bottom of the discussion between Al and me about the two competing mechanical valves. Neither one holds much promise of avoiding ACT altogether, so all the mech valves still mean lifetime ACT -- which some people find a bloody nuisance and some people find a walk in the park, and which statistically brings risks that seem comparable to the tissue-valve risks (which are mostly from re-ops).

As far as delaying your operation so you can be there for your Mom, I don't think you've posted many of your specific test results, so I don't think we're in a position to "play doctor" to advise you on that. My impression is that you could probably wait a couple of months without much risk, but that you'd be at increasing risk of a number of bad outcomes, especially if it dragged on longer. One of the concerns is that your elective surgery could become emergency surgery. Another concern is that the surgery gets "bigger", or that your heart function ends up permanently compromised, because of the cardiac compensation and damage that's going on now in response to the specific damage they're planning to fix. Without details on your condition, we can't give you a busybody layman's "second opinion" about how urgent or important any of those considerations are today, or how important a month or two is.

One other consideration: it MAY make sense to delay the cath/angio and some of the other tests if you're planning to delay the surgery. The surgeons often want to do a lot of those tests pretty close to the time of the surgery, so if you go for them soon and then delay the OHS, you may end up having to have a second round of tests, which would be an extra bother and an extra expense for somebody. (I personally found the cath/angio unpleasant enough that I'd make a few phone calls to avoid a second one, though other's mileage varied. . .)

I hope that helps. Good luck to you and your mother!

 

[Lynlw]

Lyn -

I wrote a response but decided that I want to verify my answer before posting.
My comments above were mine alone.

'AL'

I'm still a little confused, but think you are saying the "comments above" that were your own was post 72 and 73 was partly yours and partly Catherines?

Do you know the answers to the questions I had about post 73. Or could you please ask Catherine? I THINK she is talking about the hopes for the future IF the INR is lowerred, but I could be wrong and maybe she is talking about right now.

"When you are talking about co-morbidity are you talking about the risk of bleeding because your on Coumadin or something else entirely, (I never heard people call bleeding a co-morbidity here)?

The other part that confuses me, is are you saying that hopefully if the trials go well AND On-X patients can have a lower INR THEN there will be less than the 1-2% risk of a major bleed that there is NOW or are you saying right now you have a lower chance of a major bleed with the On-X compared to the other mechanical valves on the market today?"

(BTW by right now, I mean following the guidelines and not people in the On-X trial)

Thanks