article on engineered tissue

[Lynlw]

thanks for the link RCB, it was pretty interesting, but I got a little confused and thought someone could help me, I always thought the risk for stroke w/ mechanical was about 1% a year (not cumulative, I know) but this says (I don't know how to copy it so hope i get the wording right)
even w/ anticoagulation, the risk of thromboembolismis between .5% and 3% per year for valves in the aortic position, and between .5% and 5% per year in the mitral position.'
so why is this higher than the 1% I thought, is it because it is any embolism and not just those causing strokes or major damage? would that take into account things like TIAs? Thanks Lyn

 

[geebee]

Lyn,
My understanding is the 1% figure is for major stroke with permanent damage or death. I do not believe it includes TIAs which are usually benign from a damage standpoint. A TIA is caused by a thromboembolism so it would be included in the stats you quoted.

 

[RCB]

Your not the only one!

Your not the only one!

thanks for the link RCB, it was pretty interesting, but I got a little confused and thought someone could help me, I always thought the risk for stroke w/ mechanical was about 1% a year (not cumulative, I know) but this says (I don't know how to copy it so hope i get the wording right)
even w/ anticoagulation, the risk of thromboembolismis between .5% and 3% per year for valves in the aortic position, and between .5% and 5% per year in the mitral position.'
so why is this higher than the 1% I thought, is it because it is any embolism and not just those causing strokes or major damage? would that take into account things like TIAs? Thanks Lyn

Lynn,
I was pretty confused about this myself, but after Tobagotwo and Al Lodwick took me to the woodshed, I soon learned that there is no one definition of these terms used in a study that compiles statistics. Different researcher can define their own terms and therefore come up with different results. The difference between 1% and 3% mathematically is 2%, but in real
terms, one is 300% larger than the other- that is huge! Another thing is again age. The young have relatively low rates, where the old have higher
rates of both problems, even with no mech. valve. In the early days('61-'67)
they took valve pts. off warfarin after a few months. I didn't have my first TIA
till Fall of '67, a month later my doctor put me back on warfarin. We didn't start using the INR system till the mid-'80s. With home testing and better valves, I think these figures will come down. My own feeling is that these test are still not that accurate. So please don't feel you are alone, we all need to hold hands tight and make our way through the night.

 

[OldManEmu]

A bit of clarification

A bit of clarification

My post which I should have clarified was in reference to patients in the 40+ year age bracket and AVRs only. These patients with today?s technology can reasonable expect to get 30+ years before a 3 surgery may be required. Many will have died by this time from both heart and non heart related problems as this is normal life expectancy, it is 77 years in the US. My point was the risks of 30+ years of ACT with the patients? normal life expectancy and 1 redo are similar. Obviously the average life expectancy is increasing over the next 30 years and most people think that they are going to live longer than average; however as every insurance company actuary has worked out we collectively do not statistically fall into a group that are likely to have an above average life expectancy.
I was never trying to say a tissue valve is a superior choice, just that the longer term risk is similar.

We all want to be like RCB, 45+ years since first VR.

GeeBee I agree with your statement in any given year the risk of ACT is less than a redo. I do understand that the risk is 1% per patient year. Year 10 doesn't carry a 10% risk however you have had a risk of 1% each year for 10 years.

By the way I like polls not sure how to start one or what to put in it perhaps you can provide some suggestions.

 

[Lynlw]

Lynn,
I was pretty confused about this myself, but after Tobagotwo and Al Lodwick took me to the woodshed, I soon learned that there is no one definition of these terms used in a study that compiles statistics. Different researcher can define their own terms and therefore come up with different results. The difference between 1% and 3% mathematically is 2%, but in real
terms, one is 300% larger than the other- that is huge! Another thing is again age. The young have relatively low rates, where the old have higher
rates of both problems, even with no mech. valve. In the early days('61-'67)
they took valve pts. off warfarin after a few months. I didn't have my first TIA
till Fall of '67, a month later my doctor put me back on warfarin. We didn't start using the INR system till the mid-'80s. With home testing and better valves, I think these figures will come down. My own feeling is that these test are still not that accurate. So please don't feel you are alone, we all need to hold hands tight and make our way through the night.

Thanks, they really must try to make it so confusing Lyn

 

[Andyrdj]

RCB and Geebee

RCB and Geebee

RCB, your link to http://www.ccjm.org/pdffiles/Thamilarasan902.pdfregarding the low freedom from structural deterioration in younger patients ties in with what Geebee said - that the tissue option is a gradual decline.

However, I note also this post containing data I lifted off Edwards' lifesciences website - see the actual "freedom from explant" statistics for the C/E Perimount valve http://www.valvereplacement.com/forums/showthread.php?t=15720. (first graph)

Note that even for those who received valves at age 20, the freedom from explant was over 60% at 15 years

This obviously doesn't take into account the freedom from structural valve deterioriation, which the graph below it addresses for differing valve types for 40 year olds. For those patients, 50% of pericardial valve users were free of SVD at 15 years.)

RCB, I can't recall whether this is for the Aortic or Mitral position. My own probelm valve is Aortic, so permit me to assume the slightly more optimistic approach.

The Anticalcification process used for the old Perimount was XenoLogic. Note that for Pericardial Valves, the majority of explants are due to calcification rather than mechanical failure (which can happen with Porcine valves)

Now consider here this description of the ThermaFix process
Disclaimer: you must evaluate this for yourself and read everyone else's opinions as well as mine

http://www.edwards.com/Europe/Products/HeartValves/ThermaFixBrochurePDF.htm

Note:

- the procedure adds an extra stage to the existing, proven XenoLogic treatment.

- the comparative reductions in calcification in 3 separate animals (particularly sheep, who calcify at an astonishing rate) are reduced by up to 75%, usually around 50%, compared to a proven sucessful process. Compare it to the old fashioned Glutaldehyde control, and the results are even more pronounced.

So here I am, like many of you, faced with a dilemma: Go with the proven, or take a risk?
Well, risks vary and grow less with time - the more people who go before you, the better. Follow up on the Magna is up to 3 years (v good so far). Its near competitor, the Mosaic, has 10 years follow up.

So those going for a tissue option have the choice: old and safe (e.g. perimount) medium age and risk (e.g. mosaic) or new and "most" risky (magna).

However, you do correspondingly take a different kind of risk when you play it safe - you risk missing out on something which has had over 20 years to improve on its predeccessor.

I've recently taken a similar risk in life - resigned from an old, safe job in order to pursue a newer one, which requires a reference from my old employers. If they don't like it, I could end up with no job. But looking at the opportunity I saw, and how unhappy I was with my old job, there is no way I could have "played it safe".

To respond to Geebee's I have not given up any quality of life for having a mechanical valve so please be a little cautious with that type of statement.
I think everyone should have a read of the Anticoagulation section, which is optimistically couched and which will read differently to everyone - i.e. it's a good guide to what's right for you.

I myself reading it could not help but think "this is so not for me". I'm baffled as to how Geebee could think what she does - but I anknowledge the fact that she does!

I have also spoken to a member who is having to attend hospital for blood draws at present. I asked how regularly, she said

How often am I tested? It varies, can be weekly if it is out of range, or two weekly, this time it was after four weeks, I am due to go this week. For me it involves going to the hospital and sitting in a queue (having taken a number like you do at a deli counter) and waiting anything from a few minutes to an all time high of almost two hours. They send my book back to me in the post, I receive it within two days maximum. If there is a drastic change they will phone with the new dosage, if I am well out of range. Then we will go back to weekly or two weekly testing. Eventually they hope to get it to three monthly - but we are already almost a year into it and no sign of that yet.

She, personally, would have preffered tissue with hindsight - to quote Having had one stroke I really don't want another, that is my fear, more than death itself. Had I known that it is so vital to stay within range, or not go much below, without risk of a stroke I would far rather face another surgery in 10 or so years time

Are her doctors being overcautious? I don't know.

This isn't a direct attack on mechanical - because the overall statistics quoted earlier contain all such stories like this, and the knife cuts both ways.

It's more to say "there are risks with playing it safe, there are risks with the newer stuff".

The one I find most acceptable is the risk associated with the new. Why? Because I can at least hope for the best, as opposed to "accepting my fate" (ah, how utterly alien to my personality that is!!). As far as I'm concerned, the odds and the game look good, and the risk is there to keep you from getting cocky. Let's go!

 

[Lynlw]

Note that even for those who received valves at age 20, the freedom from explant was over 60% at 50 years

I think you meant 15 not 50 altho i'd be thrilled if it was 50, Lyn

 

[RCB]

Sorry again

Sorry again

Andy, here is the link I posted:

http://www.ccjm.org/pdffiles/Thamilarasan902.pdf

Like lynn said, I think you have a miss type in your numbers.

Recheck, edit if you want and then we will discuss the premise of the study.

 

[geebee]

To respond to Geebee's I have not given up any quality of life for having a mechanical valve so please be a little cautious with that type of statement.
I think everyone should have a read of the Anticoagulation section, which is optimistically couched and which will read differently to everyone - i.e. it's a good guide to what's right for you.

I myself reading it could not help but think "this is so not for me". I'm baffled as to how Geebee could think what she does - but I anknowledge the fact that she does!

I think this because I live it - why would that baffle you? Just because it is different from what you perceive to be the case doesn't mean it isn't true. I am not saying everyone has my experiences, I am merely sharing mine.

I have also spoken to a member who is having to attend hospital for blood draws at present. I asked how regularly, she said

How often am I tested? It varies, can be weekly if it is out of range, or two weekly, this time it was after four weeks, I am due to go this week. For me it involves going to the hospital and sitting in a queue (having taken a number like you do at a deli counter) and waiting anything from a few minutes to an all time high of almost two hours. They send my book back to me in the post, I receive it within two days maximum. If there is a drastic change they will phone with the new dosage, if I am well out of range. Then we will go back to weekly or two weekly testing. Eventually they hope to get it to three monthly - but we are already almost a year into it and no sign of that yet.

She, personally, would have preffered tissue with hindsight - to quote Having had one stroke I really don't want another, that is my fear, more than death itself. Had I known that it is so vital to stay within range, or not go much below, without risk of a stroke I would far rather face another surgery in 10 or so years time

This is another example of coumadin getting a bad rap because doctors do not inform their patients. Those of us who are informed know the dangers of too low an INR.

Andy - I am happy you have made a decision that will fit your lifestyle but please don't question my experiences because they are different from what you believe.

 

[ladyofthelake]

OK guys tissue / mechanical?? either way glad we are alive
(I tend to lean in the Andy tissue direction for me when I leave my long waiting room position unless I get a repair - replacement?? with a percutaneous or a stem cell option but will settle for a good old fashioned da Vi repair if I have to ) But I find this whole engineered tissue thing fasinating and I think I may have lucked out because at this point in time I choose Penn Health for my big performance and they are doing so much stuff actively with stem cell which includes an active cardiac surgical program that includes the use of stem cell bloodless surgery for those who prefer it. They also seem to be zooming ahead with Beating Heart procedures and I have a stange feeling that it wont be long before they impliment a Beating Heart Valve Repair option. They have a Dr. Woo heading off their minimally invasive cardiac surgery department and he is seems to be very focsed on tissue engineering. Along with all this new good stuff they were early with their Evalve approval so they have advanced to another phase with that. As long as I am not on my way in the next few hours through the surgery doors, I find this stuff so fasinating! I wish my local hospital which is also on the top 100 would step up to the plate like this!

 

[Andyrdj]

To Geebee

To Geebee

Ah, sorry, my intention misunderstood.

I meant it to illustrate that two people can have opposite opinions of the same phenomenon, can intellectually acknowledge (without malice) the fact of the other's opinion whilst utterly failing to understand it on an intuitive level.

In other words, I read the anticoagulation stories section and observed how you all support each other and thought "yes, for these people posting it is clearly a lifestyle they are content to adjust to". On that level, I can vigourously agree that it is a good thing that you had that option and weren't forced to go down my own route.

It's when I put myself in that position that the "this is so wrong for me" alarm bells start ringing.

That's why I think everyone choosing should read that section - it crystallised my own feelings for me, but I reckon would also help greatly the sort of person willing to live with ACT.

Also, have a chat with someone like AlLodwick (the ACT provider). He, by the way, has shown a very balanced opinion by being positive about ACT if you need it, and also optimistic about the newer tissue valves (based on the word on the grapevine he has heard from medical professionals)

 

[geebee]

Andy,
You know, if I were just starting all this today, I would also be very scared by all the negative information out there about coumadin. I might even be inclined to go tissue for fear of having to curtail my lifestyle based on that information. I can understand where you and others are coming from.
I am glad my problems started when there was virtually no decision. It was either a mechanical or a pig valve that only lasted 5 years. Back then most of the choices were made by the surgeon without any advance discussion.
Coumadin has been a non-issue for me because I did not let it be an issue. I have not changed one little thing about my life around being on coumadin. Back then, the info was simple: get tested once a month and go on with your life. There was little other information positive or negative.
Having been through 3 surgeries I know I would have preferred not to have experienced, I will always choose the path of non-surgery. However, I am a prime example of how getting a mechanical is not a guarantee of avoiding future surgeries. Stuff happens that we cannot predict. On that same note, having been through 3 surgeries gives me expertise that others do not have. I know, first hand, what the dangers are and that they increase each time.
I think we are all lucky in our own skins in our own ways. I truly wish you well in your research and decision making.

 

[Andyrdj]

Thanks for the smile!

Thanks for the smile!

So did you already have a diet that suited your ACT lifestyle, then? It just naturally happened that once you started you didn't really have to adjust your dose and keep watch on your diet, vitamin k etc?

I suspect you're not a big drinker (on the grounds that ladies are more moderate and look after themselves anyway).

As an example where I differ - I don't always drink, but at a dinner party with a long multi course meal I would probably consume about 4 pints of beer, 3 or 4 glasses of wine, a couple of Ruby port and a couple of whisky chasers over the cause of the night.

I suspect that might cause a need to re-evaluate the daily dose, and I also wouldn't think you personally would be prone to such excesses!

Don't get me wrong - I do have my clean living days and weeks, but the people who wrote this page below would have a nightmare if I was on ACT!

http://shop.safeway.com/corporate/safeway/wellness/healthnotes.asp?org=safeway&ContentID=2095502

How accurate is this, by the way?

 

[geebee]

So did you already have a diet that suited your ACT lifestyle, then? It just naturally happened that once you started you didn't really have to adjust your dose and keep watch on your diet, vitamin k etc?

I suspect you're not a big drinker (on the grounds that ladies are more moderate and look after themselves anyway).

As an example where I differ - I don't always drink, but at a dinner party with a long multi course meal I would probably consume about 4 pints of beer, 3 or 4 glasses of wine, a couple of Ruby port and a couple of whisky chasers over the cause of the night.

I suspect that might cause a need to re-evaluate the daily dose, and I also wouldn't think you personally would be prone to such excesses!

Don't get me wrong - I do have my clean living days and weeks, but the people who wrote this page below would have a nightmare if I was on ACT!

http://shop.safeway.com/corporate/safeway/wellness/healthnotes.asp?org=safeway&ContentID=2095502

How accurate is this, by the way?

I usually drink once a week or so and then have a couple of glasses of wine. I occasionally have a Bailey's after a tough day so I do drink but not heavily. I have had times when I drank more than I should but have had no INR issues because of it.
My diet is fairly consistent but I do not really concern myself with it. I eat what sounds good to me and do not look at lists to decide.
There are a lot of true statements in the link you sent but, keep in mind, that all drugs sound this scary if you read the inserts. The cranberry thing is questionable as I consume cranberry juice on occasion with no problem. I think the list of drug interactions is a bit excessive and I have had many injections into muscle over the years without incident.
I don't want to imply that you should ignore all coumadin inserts but, if we read every insert for every drug and expected each of the interactions or side effects to apply to us, we would never take any medication. The drug companies are required to list every little thing that could possibly go wrong.

 

[RCB]

but the people who wrote this page below would have a nightmare if I was on ACT!

http://shop.safeway.com/corporate/safeway/wellness/healthnotes.asp?org=safeway&ContentID=2095502

How accurate is this, by the way?

Oh it is pretty accurate, particularly this part contained in the above reference:

"Notes
Do not share this medication with others."

Looks like Andy won't be going up to some hot chick after a long night of drinking and whispering in her ear "Hey baby, want a hit of my warfarin"?
Too bad, it always worked for me.

 

[ladyofthelake]

Looks like Andy won't be going up to some hot chick after a long night of drinking and whispering in her ear "Hey baby, want a hit of my warfarin"?
Too bad, it always worked for me .

I know, way off original topic but? that is just way too funny in a visual!

Bob, are you hangin out in those Goth Clubs again?

 

[RCB]

Hey Lady

Hey Lady

I know, way off original topic but? that is just way too funny in a visual!

Bob, are you hangin out in those Goth Clubs again?

I wish! They always check ID?s and turn me away. The bouncer mumbles something about me being too old and scary! Can you believe that, I mean, I?m not that old????.

Maybe you could smuggle me in, under your cape. Now there is a visual I could go for!

 

[ladyofthelake]

"Old Goths Don't Die, They Just Need Less Makeup"

"Old Goths Don't Die, They Just Need Less Makeup"

Maybe you could smuggle me in, under your cape. Now there is a visual I could go for!

I do see how that would work well. Being the ~ Lady of the Lake ~ I do happen to own a beautiful black flowing triple velvet Cloak straight from Scotland and we do happen to sell the theatrical vamp fangs in my little part time shop, so if you were too tall in this scheme I could just steal the witch heels from my sister, (that the house fell on). Just promise, once you get in there you only let them have a few ozs because some of us know how bad dehydration can be for us.

 

[Ross]

"Avoid eating cranberries or drinking cranberry juice while being treated with this medication unless your doctor instructs you otherwise. Cranberry juice can increase the effect of this medication. Consult your doctor or pharmacist for more details."

This has recently proved to be nonsense also. There is no definitative proof of cranberries interacting with Warfarin.

 

[Andyrdj]

Probably mostly the booze!

Probably mostly the booze!

I know alcohol is the one that is the main problem with ACT - the most excessive mech boozer I've heard of so far(friend of my dad's) has something like 2 pints of beer in a session.