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Longevity of Tissue Valves

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Matt123

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Hello, I was wondering if people on this board could please provide data as to how long their tissue valves have lasted thus far and if they needed to have it replaced, what the time frame was. So far all data on the lab tested "20-year" tissue valve is great... however my understanding is no one who currently has these 2nd & 3rd generation tissue valves has actually had it for 20 years as it wasn't developed until after 1992 (20 years ago). Can people please comment...
 

Duffey

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I don't think 1992 is the correct year, but I'll leave it for someone else to give a definitive answer.

I've had a bovine since 2005; no problems so far.
 

Sarah_Louise

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I've had a tissue one in since April (couldn't tollerate anti-coagulants with the mechanical one) and already got regurgation on it and it's not even 9 months old!!
 

Mentu

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My surgery was performed at Oklahoma Heart Institu
I don't know a lot about other fabricators but, from what I have read, the first generation Carpentier-Edwards pericardial valve was created in 1981 but was not approved by the U.S. FDA until 1991. The third generation aortic valve was approved in 2003. So, while the first generation valves in the U.S. are just reaching 20 years, the oldest third generation valves in general use are not yet a decade old. My surgeon told me the present generation valves differ somewhat in architecture and in the preservation process that should render them less susceptible to calcification. Since I have only lived with mine for two years, I can only say that it is serving me well. My family doctor and cardiologist have both emphasized the need to treat bacterial infections promptly and to always use antibiotic prophylaxis for dental work to reduce the possibility of developing endocarditis but this is also true for those with mechanical valves. Tissue valves can suffer damage to the leaflets but all heart valve patients are at slightly elevated risk of infection around the area of the incisions and sutures.

Larry
 

Phil

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Hi,

I've had my human tissue valve for 10 years and it's suffering from wear and tear ... Words of my surgeon. I expect it will be replaced sometime this year.

Hope this helps.


Phil.
 

Matt123

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Interesting. Thanks all for your posts. I am undergoing surgery this Friday and not looking forward to it to say the least...
 

Matt123

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Ha.. thanks mate! I've always wanted to go to Australia. When I'm all patched up I'll be trying to get down there. This whole waiting process until 'the day' is just brutal.
 

Jkm7

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I've had my tissue mitral valve going on four years. My recent Echo showed it to be in fine shape and I know I feel well.

All best wishes to you Friday.
Truly, for most of us, the waiting is the worst part.
Please come back and let us know how you are doing.
 

Kathy McCain

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Hi Matt!

I have had my piggy valve for four yrs (Feb11) and my valve and heart according to my cardio are "doing great"!

Good luck on your surgery and take care!
 

yotphix

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Interesting. Thanks all for your posts. I am undergoing surgery this Friday and not looking forward to it to say the least...
It's true for sure. The wait is tough, and for me at least, became almost surreal as it got down to the last few days. What you don't know yet, but will cheerfully tell us next week, is that, like ripping off a bandaid, the anticipation is way out of proportion with the event. When the day comes, you don't really have to do anything but show up and go under. Your hard work will be finished (the waiting) and your surgical team (who are no doubt very skilled) and your loved ones (who owe it to you because the love you) will take over the hard work.

Don't forget to milk your recovery for all the sympathy and special treatment you can get!

Paul
 

normofthenorth

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Matt, I don't think there's a clear and unambiguous definition of "1st-gen" and "2nd-gen", much less "3rd-gen". It's not as if all the original (tissue) valves were classmates, invented simultaneously, then they all got improved exactly 10 or 12 years later. Each maker came to market when ready, and got approved ASAP, and came out with improvements whenever they could, etc.

And your reference to 'the lab tested "20-year" tissue valve' puzzles me. All heart valves are lab tested, but the data on durability usually comes from actual evidence from a bunch of human patients that received that valve, over the years - NOT from a lab. (Mechanical valves get some accelerated lab testing for mechanical durability, but the dominant mechanism of tissue-valve failure seems to have more to do with complex body chemistry than with mechanical wear and tear, so they're impossible to test like car-engine valves.)

My piggy valve has been around for almost 30 years now, and its track record over more than 25 years of implantation here in Toronto is nicely documented in an article entitled "Hancock II Bioprosthesis for Aortic Valve Replacement: The Gold Standard of Bioprosthetic Valves Durability?" by Tirone E. David, MD, Susan Armstrong, MS, Manjula Maganti, MS, in Ann Thorac Surg 2010;90:775-781, abstract at ats.ctsnetjournals.org/cgi/content/abstract/90/3/775? . Unfortunately, the fulltext is still restricted (~$30), though I have a faxed copy that I've typed several excerpts from in posts here. The last several pages of the article compare their results with all the other published tissue-valve longevity results the authors could find. That section forms the basis of the cheeky "Gold Standard" claim in the title.

The Hancock II is obviously the "2nd-gen" version of Medtronic's Hancock porcine valve, but I think we make comparisons among "classmate" valves at our peril. They're all approved, and they're all way better than a failing native valve. Some seem to last longer than others on average, and any of them can last unusually long or fail early in an individual, no guarantees. Better-than-average surgeons and better-than-average centers probably get better-than-average results, on average, though the data are scanty. The age of the patient is the biggest determinant of average durability (duration of "freedom from Structural Valve Deterioration", in the biz), older patients getting much better longevity than younger ones.

It's not inconceivable that some of the newest-fangled 3rd (or even 4th?) gen valves will turn out to be less durable than earlier ones, despite the best efforts of all inolved. (I'm sure we've all had experiences like that with commercial products, or software, cars, drugs, whatever.) And you've hit on one of the central paradoxes in this important and R&D-intensive field: Everybody wants the most durable valve, but we can only get solid proof of impressive durability for a model of valve that's been in use for a long time. Meanwhile, many providers have come out with newer-fangled models. They don't have a long track record yet, but many of them have features (and vendors) that SUGGEST that they will perform better and/or last even longer. The choice (for those of us who have a choice) is not simple.

Good luck on Friday, and post again as soon as you can!
 
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Superbob

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On February 16, I will celebrate the seventh anniversary (valversary) of my porcine tissue valve -- the Medtronic Freestyle. My surgeon has kindly reviewed all tapes of echoes and CT-scans in recent years and has confirmed that it is working fine. It could be the only one I ever need or I could at some point need a re-op; it depends on how long my journey continues on this earth. Have no crystal ball. But in general, I believe the stats show that tissue valves usually last longer in older folks than in younger ones -- the reason having something to do with body chemistry.
 

Lynlw

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Matt, I don't think there's a clear and unambiguous definition of "1st-gen" and "2nd-gen", much less "3rd-gen". It's not as if all the original (tissue) valves were classmates, invented simultaneously, then they all got improved exactly 10 or 12 years later. Each maker came to market when ready, and got approved ASAP, and came out with improvements whenever they could, etc.

And your reference to 'the lab tested "20-year" tissue valve' puzzles me. All heart valves are lab tested, but the data on durability usually comes from actual evidence from a bunch of human patients that received that valve, over the years - NOT from a lab. (Mechanical valves get some accelerated lab testing for mechanical durability, but the dominant mechanism of tissue-valve failure seems to have more to do with complex body chemistry than with mechanical wear and tear, so they're impossible to test like car-engine valves.)

My piggy valve has been around for almost 30 years now, and its track record over more than 25 years of implantation here in Toronto is nicely documented in an article entitled "Hancock II Bioprosthesis for Aortic Valve Replacement: The Gold Standard of Bioprosthetic Valves Durability?" by Tirone E. David, MD, Susan Armstrong, MS, Manjula Maganti, MS, in Ann Thorac Surg 2010;90:775-781, abstract at ats.ctsnetjournals.org/cgi/content/abstract/90/3/775? . Unfortunately, the fulltext is still restricted (~$30), though I have a faxed copy that I've typed several excerpts from in posts here. The last several pages of the article compare their results with all the other published tissue-valve longevity results the authors could find. That section forms the basis of the cheeky "Gold Standard" claim in the title.

The Hancock II is obviously the "2nd-gen" version of Medtronic's Hancock porcine valve, but I think we make comparisons among "classmate" valves at our peril. They're all approved, and they're all way better than a failing native valve. Some seem to last longer than others on average, and any of them can last unusually long or fail early in an individual, no guarantees. Better-than-average surgeons and better-than-average centers probably get better-than-average results, on average, though the data are scanty. The age of the patient is the biggest determinant of average durability (duration of "freedom from Structural Valve Deterioration", in the biz), older patients getting much better longevity than younger ones.

It's not inconceivable that some of the newest-fangled 3rd (or even 4th?) gen valves will turn out to be less durable than earlier ones, despite the best efforts of all inolved. (I'm sure we've all had experiences like that with commercial products, or software, cars, drugs, whatever.) And you've hit on one of the central paradoxes in this important and R&D-intensive field: Everybody wants the most durable valve, but we can only get solid proof of impressive durability for a model of valve that's been in use for a long time. Meanwhile, many providers have come out with newer-fangled models. They don't have a long track record yet, but many of them have features (and vendors) that SUGGEST that they will perform better and/or last even longer. The choice (for those of us who have a choice) is not simple.

Good luck on Friday, and post again as soon as you can!
Hi Matt, (I have a brother Matt so like that name ) As Norm mentioned it isn't quite as cut and dry as your questions, but along with the Hancock II (treated pig valve), Edwards Perimount (bovine made from treated pericardial tissue not actually a cow valve) does have proven track record, in patients since the early 80s (81?) in the US even tho it wasn't approved until the 90s , which makes it a little confusing. So patients did have it placed about 30 years ago. Now I am NOT saying anyone has had it 30 years, just that it has been in use that long. Unfortunatly like the Hancock II study since most patients getting them are in their 60s-70s many have died by 25, even 20 years after their surgery but lived long happy lives just were old. There is a paper that just followed that first group of about 250 patients and didnt add in ALL the patients who got that valve so it is a little easier to read and understand, FOR ME, compared to the paper Norm mentioned that groups all ( alittle over 1000 if I remember right) patients who got the Hancock 2 at one center from 84-2004 so even tho only 2 (?) patients were alive at 25 years after their surgery for that valve implant, and about 30 alive at 20 years post op, it could be just that most of the people only got it 5-10 years earlier and are still doing well, since I never saw it broke down by years (or even decades) implanted or patients age ect. They''ll probably update it ever 5 or 10 years as they have more data

FWIW I would guess the Perimount valves and the "improved' Perimount valves are PROBABLY the most used tissue valves in the US (for example half a MILLION Perimounts have been used) so there is info about them and many centers know how their patients with them are doing, and to make things more confusing Norm mentioned the Hancock II is the 2nd generation of the Hancock, but medtronics Mosaic is touted basically as the new improved Hancock, and it seems that many people get the Mosaic. Will it turn out to be even better than the hancock II? It "should" but who knows, but at this time I'm not sure I would feel comfortable choosing that if I (or family member) wanted a pig valve or tissue valve in general, but thats just based on a small group of VR.com patients- hardly a scientific study. but sometimes you pretty much just go with your gut and hope for the best no matter what valve you choose.

ps
Oops forgot to answer your other question, Justin got a perimount aortic valve BUT it is in the pulmonary position, he was 17 when he got it in 2005. It is doing well (knock on wood) BUT at the same time he got 2 dacron conduits (grafts) on either side of the valve that "should" have pretty much lasted forever, 1 of his conduits needed replaced in less than 2 years. When they had him open the tissue valved looked perfect so they left it alone and just replaced the 1 conduit. The really surprising thing is from past surgeries we knew Justin is great at building scar tissue and calcifying implanted parts , he had a conduit made from his own heart/pericardial tissue that was stenosised 2 years after it was patched with more of his own tissue, luckily they could help him with stents to buy time and let him grow as much as possible before replacing it. So since they couldn't get a good look by echo or MRI, until they saw the problem was in his conduit during the cath everyone thought it was probably the tissue valve, so were quite surprised.
so it just goes to show anything can happen
 
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ElectLive

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My piggy valve has been around for almost 30 years now, and its track record over more than 25 years of implantation here in Toronto is nicely documented in an article entitled "Hancock II Bioprosthesis for Aortic Valve Replacement: The Gold Standard of Bioprosthetic Valves Durability?" by Tirone E. David, MD, Susan Armstrong, MS, Manjula Maganti, MS, in Ann Thorac Surg 2010;90:775-781, abstract at ats.ctsnetjournals.org/cgi/content/abstract/90/3/775? . Unfortunately, the fulltext is still restricted (~$30), though I have a faxed copy that I've typed several excerpts from in posts here. The last several pages of the article compare their results with all the other published tissue-valve longevity results the authors could find. That section forms the basis of the cheeky "Gold Standard" claim in the title.

The Hancock II is obviously the "2nd-gen" version of Medtronic's Hancock porcine valve, but I think we make comparisons among "classmate" valves at our peril. They're all approved, and they're all way better than a failing native valve. Some seem to last longer than others on average, and any of them can last unusually long or fail early in an individual, no guarantees. Better-than-average surgeons and better-than-average centers probably get better-than-average results, on average, though the data are scanty. The age of the patient is the biggest determinant of average durability (duration of "freedom from Structural Valve Deterioration", in the biz), older patients getting much better longevity than younger ones.

It's not inconceivable that some of the newest-fangled 3rd (or even 4th?) gen valves will turn out to be less durable than earlier ones, despite the best efforts of all inolved. (I'm sure we've all had experiences like that with commercial products, or software, cars, drugs, whatever.) And you've hit on one of the central paradoxes in this important and R&D-intensive field: Everybody wants the most durable valve, but we can only get solid proof of impressive durability for a model of valve that's been in use for a long time. Meanwhile, many providers have come out with newer-fangled models. They don't have a long track record yet, but many of them have features (and vendors) that SUGGEST that they will perform better and/or last even longer. The choice (for those of us who have a choice) is not simple.
Norm - The Gold Standard article does not seem to be restricted anymore. I'm curious...did your valve decision process ever include consideration of the updated model (Mosaic)? As you say, newer models aren't necessarily better, and there have certainly been a few bad outcomes mentioned here regarding the Mosaic, not that they are statistically relevant, but it's enough to give anyone pause. So, just wondering if you went through a Hancock vs Mosaic discussion process, any worries from your surgeon about the 3rd generation changes (Mosaic) or just going with the proven veteran, so to speak?

Matt - My surgeon gave me two tissue valve options - the Edwards Magna that I have and the Medtronic Mosaic. As was said, it seems that these are the most common choices here in the US in recent times, and neither around long enough in their totality of current design to be fully "proven". Not that it much matters, but I think the Edwards Magna, approved in 2003, did not get a key treatment component - ThermaFix - until a year later. The "current" Medtronic Mosaic was approved in 2000, so a few additional years of evidence.

So, at best, only 12 years or so of evidence exists. For 70 year olds, that wouldn't necessarily be that useful, given the track record of the previous generation. But, for patients in their 30's, you know what, 10 years of evidence sounds a lot more useful. But, of course, far fewer patients go with tissue in their 30's so study documentation is tough to find. Now, my normal instinct is to completely ignore any valve longevity forecasts that are produced by the manufacturers themselves. But, in the interest of your question, and the limited time frame for these current models, here's what they have to say:

"...data released in 2003 [http://ht.edwards.com/resourcegallery/products/heartvalves/pdfs/clinicalcommuniqueaortic.pdf ]indicate that patients 60 years and older who receive Edwards' original Carpentier-Edwards PERIMOUNT aortic valve will have a greater than 90 percent chance of not needing a new valve for 20 years. ""While we are confident in the excellent performance of our existing tissue processes, the addition of the ThermaFix process has been shown in laboratory studies to reduce calcification up to 44 percent beyond Edwards' current tissue treatment alone,"" ..."

"...The Mosaic valve was evaluated in patients who had aortic valve replacement (AVR) and mitral valve replacement (MVR), and with 12 years of follow-up, the study revealed a freedom from structural valve deterioration of 93.3 percent of AVR patients 60 years and older and in 95.3 percent of MVR patients 70 years and older. In addition, hemodynamic performance data showed stability up to 10 years, indicating durability of the Mosaic bioprosthesis over time..."

Straight off their literature, and no background on these studies, so again, bear that in mind. Now, if memory serves, you are actually hoping for valve sparing on Friday anyway, just working on Plan B here, so hope everything works out for the best!
 
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Matt123

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Wow. A lot of good information here. Thank you very much for everyone's response. I will be sure to fill you in once I get back from the hospital as I am going in on Friday. Many thanks again to everyone... -Matt
 

Jkm7

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Don't be depressed, Matt. First off it does no good and secondly, it looks worse than it is.

Can you give a link to the video you watched? I've yet to find one of opening....... most I've watched the chest is already open.

Thanks if you can provide the link.

You'll do FINE....... give yourself over the professionals. They really are excellent at what they do. You've been through the worst part which, IMO, is the waiting.

ALL BEST WISHES.
 

Matt123

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All - I had my operation at Columbiua Presbyterian on Jan 14 and was released 5 days later. I just wanted to sincerely thank all of you for your support and kind words. Everything went perfect. This is a wonderful site and I hope I can be of help in the future for anyone who ever has a question or would like to contact me. Many thanks to you all again.

-Matt
 

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