Tissue Quality

[Sammy1973]

First post. This forum is great. Very passionate discussions.

I'm 40 years old - had a heart murmur & aortic stenosis diagnosed when I was 14. Stress echo & Cath in the last few months have shown the regurtition is severe (stenosis mild) and along with shortness of breath & some chest pain it's time to get this valve repaired/replaced. Bicuspid valve.

1. The Cleveland Clinic & Univ. of Maryland sites state pretty clearly that advances in tissue valves have improved the past few decades. Cleve Clinic estimates "recent studies show these valves may last at least 17 years without a decline in function." Is there anyone on here that is 15+ years with a tissue?

2. We're seeing surgeons now and I really am liking what I read/hear about Cleveland Clinic. My question is, if I choose a tissue valve, would a nicer ($$$) hospital like Cleveland Clinic get "better quality" tissues than a random, not highly ranked hospital? You get a better cut of beef at a 5 star steakhouse than you do at Applebee's - why isn't the tissue quality the same?

I'm writing up pros/cons for surgeons/valve type/hospitals etc so I can make a sound decision and this is certainly something I've wondered about.

Thanks all!

 

[DebbyA]

Your choice of hospital will not determine the quality of valve you get, but it will be important in patient care. If possible, you're best with a hospital that offers dedicated cardiac surgical facilities and staff.

If you opt for tissue valve, you "may" have it 17 years, but should be mentally prepared for 6-7 (how do I know that?:frown2, especially at your age. What you want to know about any studies is the age at implantation for those valves. It's good you're doing all this research--you will find the best path for you.

 

[tom in MO]

Valves are like car parts, their quality depends upon the manufacturer not the mechanic or garage.

There is not a lot of data for people under 65. Most of the studies track everyone under 65 as a single group with the caveat the younger you are, the more likely you will need a replacement sooner. If you are older, the valves last longer due and in addition you are more likely to die from something else before your replacement valve craps out.

When I was making my decision at age 55, I was told I'd have one reoperation for sure if I went tissue. I would venture a guess, that at age 40, you'd have two reops before you die at age 90, being shot by a jealous husband

 

[neil]

hiya sammy and welcome, unfort we will not know for definate how long the new valves will work, but hopefully we should see them last many a year, the experts are saying really positive things about the modern tissue valve, because the new tissue valves have been modified the last few years we wont know how well they doing for another 10 years or so, listen to the experts and gather as much info as you can get, you will do just fine

 

[Eva]

Welcome aboard and good luck in your choice. I second Debby's and the others' thoughts.

 

[Lynlw]

First post. This forum is great. Very passionate discussions.

I'm 40 years old - had a heart murmur & aortic stenosis diagnosed when I was 14. Stress echo & Cath in the last few months have shown the regurtition is severe (stenosis mild) and along with shortness of breath & some chest pain it's time to get this valve repaired/replaced. Bicuspid valve.

1. The Cleveland Clinic & Univ. of Maryland sites state pretty clearly that advances in tissue valves have improved the past few decades. Cleve Clinic estimates "recent studies show these valves may last at least 17 years without a decline in function." Is there anyone on here that is 15+ years with a tissue?

2. We're seeing surgeons now and I really am liking what I read/hear about Cleveland Clinic. My question is, if I choose a tissue valve, would a nicer ($$$) hospital like Cleveland Clinic get "better quality" tissues than a random, not highly ranked hospital? You get a better cut of beef at a 5 star steakhouse than you do at Applebee's - why isn't the tissue quality the same?

I'm writing up pros/cons for surgeons/valve type/hospitals etc so I can make a sound decision and this is certainly something I've wondered about.

Thanks all!

Hi Sammy, first No! Better hospitals dont get different quality valves than any other hospitals. What ever brand they buy get the same valves any other hospital gets who buys the same kind.

Yes tissue valves are lasting longer, but some kinds and manufacturers, have track records of lasting better than other brands, for example the CE perimount (bovine) and a Hancock II, (porcine) have about 25 years worth of stats w/ good results. As for "why isn't the tissue quality the same" There are different types of tissue valves , for example pig valves,(Actually pig heart valve) Bovine (usually made from the pericardial sac of cows), Human (not used often) etc and different manufactures have different ways of treating the valves, anti calcium etc and manufacturer's have several kinds of valves, (always trying to improve things) . Some tissue valves look like they might not be doing as well as they hoped. I would definatly ask what valve they recommend and THAT valves track record.

For the most part CCF uses Perimount valves and for the past decade they have been using more tissue valves in younger patients , 40 and up usually. Thi is for a couple reasons, 1 the valves are lasting longer and IF the valve need replaced, already a first time REDO has as good stats as a first surgery..Not zero risk of course, Plus for someone getting a tissue valve now in their 40s there is a very good chance when it needs replaced it will be possible to replace it by cath. Actually "most" places, surgeons are using tissue valves for the majority of people, There was a HUGE shift in the amount of tissue valves compared to mech valves from 96-2006 , in 96 slightly more than 1/2 people got mech valves by 2006 about 80 percent were getting tissue, if Im remembering right. It (percentage of tissue valves used) has increased since then.

For someone in their 50s there is a chance they may not need another valve if they go tissue, How ever someone 40 I would plan on needing that valve replaced even if it last 15-20years you will prob sill outlive it.

One of the reasons I mention cath valves (percutaneous
, TAVI) is IF you choose tissue valve ONE thing I would ask about was what tissue valves would be the best chance of having a TAVI placed inside it. They already are implanting TAVI valves in older tissue valves and some valves are clearly easier -at this point in time at least- to place new valves in and some are much harder. I "believe" right now the Perimount is if not the easiest, than one of the easiest..I would definately not want one that so far isnt as easy. It would stink if the time came when this valve was failing, not to be a candidate to have it replaced in the cath lab, because of something about the valve you have.

When choosing hospitals, what side of Pa do you live in?

PS I wanted to add to the question " Is there anyone on here that is 15+ years with a tissue" this forum is a little younger that 15 years, sand since most people look for find places like this are because they have question or they need a valve surgery or just had one. So the people whose tissue valves are still doing well most likely would not be joining There have been a few people that have had human valves last 15+ years and some who had tissue valves on the right side (usually last longer) but I dont know off the top of my head anyone here with tissue 15 or so year

 

[Gail in Ca]

I have had a tissue valve and I can say that I expected the most years my surgeon told me it could last, and was devastated when it didn't last that long. Getting another surgery in 11 -12 yrs isn't what I had in mind when I got the tissue valve. Also, I posted my cardiologists opinion on valve life expectancy awhile ago. He was bothered by a couple of patients whose tissue valve lasted less than 4 yrs, one valve had little holes in the leaflets and another had a tear in his leaflet. This was recent, not years ago.
It seems that many surgeons aren't too concerned about scar tissue for subsequent surgeries, but it is a real issue, and was a major concern for my surgeon for my 2nd and 3rd surgeries. I would say to find out the average and do your best to hope you get many more years than that, but be aware that you may get less than average or just a yr or two beyond.
Also, my sister's friend is a cardiologist in his 60's. He only has one patient that has had a tissue valve for 20 years. So, some people do get the max out of them.

 

[epstns]

I think Lyn has hit most of the high points regarding longevity of tissue valves. The statistic you might want to seek is the "freedom from explantation" stat - the percentage of patients who still have their tissue valve at XX years. IIRC, Edwards Lifesciences publishes a statistic something like ". . . we expect 85% freedom from explantation at 15 years with our newest generation of valves." That means that they expect that 85% of their current valves will still be viable in 15 years. 15% would have been replaced already, but the other 85% will last that long or longer. They offer no estimate of maximum, but that probably doesn't matter unless you are the one achieving it. What I do not remember is the age range of the patients they expect to achieve these statistics. I remember that my age at surgery fell into the group range, as I was 63 at the time. I do not remember stats for younger patients, as I will never be that young again. . . although I have to admit that since surgery I definitely do not "feel my age."

 

[kpearse]

I just wanted to say good luck to ya. I had my aortic valve replaced when I was 50. I wasn't told, and didn't have the time to look if there was an option other then mechanical. If I was told, I was in another world trying to understand what happened to me. lol I had a check up at work, and they noticed something on my ekg. Long story short, I was operated on the next week. Everything happened so fast! It's good that your asking all these questions now, you be on warfarin for life with the mechanical.

 

[Lynlw]

I think Lyn has hit most of the high points regarding longevity of tissue valves. The statistic you might want to seek is the "freedom from explantation" stat - the percentage of patients who still have their tissue valve at XX years. IIRC, Edwards Lifesciences publishes a statistic something like ". . . we expect 85% freedom from explantation at 15 years with our newest generation of valves." That means that they expect that 85% of their current valves will still be viable in 15 years. 15% would have been replaced already, but the other 85% will last that long or longer. They offer no estimate of maximum, but that probably doesn't matter unless you are the one achieving it. What I do not remember is the age range of the patients they expect to achieve these statistics. I remember that my age at surgery fell into the group range, as I was 63 at the time. I do not remember stats for younger patients, as I will never be that young again. . . although I have to admit that since surgery I definitely do not "feel my age."

I believe that 85% was in groups 50 and up, BUT there is a newer study, not printed yet but presented at a conference specifically addressing under 60 and so far they showed 17 years later not only were the valves still in patients under 60 but the majority doing well. Since the paper has not been published yet, you cant see break downs by age etc.

New Data on Edwards PERIMOUNT Valves Demonstrate Long-Term Durability in Patients Aged 60 and Younger
MARSEILLE, FRANCE, June 17, 2013 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced unprecedented long-term durability results for bovine pericardial heart valves, based on a study of the Carpentier-Edwards PERIMOUNT aortic valve in a subset of patients aged 60 or younger at the time of operation. The study tracked patients over a nearly 25-year period, achieved follow-up of 3,299 valve years and determined that expected valve durability for this population was greater than 17 years. The data were presented Friday at the 66th Congress of the French Society for Thoracic and Cardiovascular Surgery by Thierry Bourguignon, M.D., from University Hospital of Tours, France...... http://www.edwards.com/de/newsroom/pages/ShowPR.aspx?PageGuid={2ab02bd3-d2f7-47ac-894c-dd79a101428f}

I have to disagree with you slightly, when you said "The statistic you might want to seek is the "freedom from explantation" stat" That is good, howeever some people might not have their valve explanted not because it is still doing well, but because they are ttoo high risk for surgery, (altho hopefully that will happen less and less since they can now help the highest risk patients w/ a valve in valve in he cath lab)
so anyway many people prefer freedom from structural failuer type data. For example on of the earliest Perimount studies showed "Hemodynamic stability during 17 years of the Carpentier - Edwards aortic pericardial bioprosthesis"

FWIW yes tissue valves last longer in "older" people but as far as "younger" people not lasting as long, there is a big difference in the chances of a tissue valve lasting long in a 40 year old compared to someone in their 20s.

 

[neil]

lyn a lot of positive stuff about tissue, i didnt know how popular tissue has become, thats amazing,

 

[Lynlw]

lyn a lot of positive stuff about tissue, i didnt know how popular tissue has become, thats amazing,

I thought it was pretty interesting too here is a study from 2006 (i cant believe that is now 8 years ago, but im not any older ) http://www.jtcvsonline.org/article/S0022-5223(08)01409-8/fulltext

Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: Changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database

It has alot of interesting facts and graphs, but the one that struck me was the graph of the change in valves used in that 10 years

http://www.jtcvsonline.org/article/...gr1&ishighres=false&allhighres=false&free=yes

Another thing I found interesting, was even tho the patients were older and sicker going into surgery, they had better stats for mortality AND morbidity

"Despite increases in comorbidity and predicted risk of death after AVR, the overall observed mortality and risk-adjusted mortality decreased (P < .01; Table 4 and Figure 2). Similarly, the incidence of stroke declined during the last 10 years (P < .05; Table 4 and Figure 3). Subgroup analysis (Table 5) demonstrated that mortality was higher for women than for men overall (not shown) and in the 1997 and 2006 populations (P < .01; Figure 4). Nonwhite patients had a higher mortality from AVR, which was not improved during the study period (Table 5). Age greater than 70 years, diabetes, peripheral vascular disease, ejection fraction less than 30%, and body mass index were all associated with higher mortality (Table 5). Mortality decreased more than 30% between 1997 and 2006 in the presence of diabetes, nonurgent cases, and renal failure and in the younger than 55 years, 55 to 60 years, 60 to 65 years, and older than 85 years age groups (Figure 5). In 2006 there were 2,431 patients who had undergone previous cardiac surgery and their associated mortality was 6.17%. By comparison, there were 12,966 patients with no prior heart surgery and the mortality was 2.35% (not shown). Stroke was reduced in the 55 to 60 years and the 65 to 70 years age groups (Figure 6). Overall stay was unchanged during the study period (not shown). Age older than 75 years, female sex, and ejection fraction less than 30% were associated with longer median stay (9.23 days vs 7.06 days, 7.80 days vs 7.40 days, and 9.53 days vs 7.67 days, respectively, P < .01 for all).


Along those lines the recent Aorta valve guidelines (US) http://www.sts.org/sites/default/fi...GuidelinesforManagementandQualityMeasures.pdf from 2013

table 2 talks about how many of each valve type were bought (from manufact) in the US in the year leading to june 2011 there were 17,000 all mech valve total and 76,000 all tissue valves combined. pg 6

BTW they mention that at 15 years, in patients under 40 almost 40 % have valve structural deteration, so a little over 60% of patients under 40 still doing well at 15 years, and that includes all under 40, including much younger, (page 26ish)

I also find it amazing how much both the US latest Aortic Valve guidelines and the latest EU/UK valve guidelines discuss the use of percutaneous valves for 1st and REDO surgeries. I believe they are here to stay.

 

[Sammy1973]

Thanks Lyn great information I live in Philly area so looking at docs UPENN and Lankenau in addition to Cleve clinic
Lol jealous husband Tom haha
Neil - makes sense. Thanks for replying
Thanks Debby and Eva
Thanks Gail definitely have heard of a fair share of 6-8 year old tissue life folks
Thanks Steve read a some of your posts in other threads good stuff

Ken - you seem to have Coumadin war stories - could you share some of those??

 

[Sammy1973]

Lyn this Edwards article from 2013 talks about mitral valves - does this apply to aortic valves? Is tissue life on mitral different than aortic?

 

[neil]

sammy no problem mate, lyn thats sum facts you have there, makes very good reading

 

[Lynlw]

Thanks Lyn great information I live in Philly area so looking at docs UPENN and Lankenau in addition to Cleve clinic
Lol jealous husband Tom haha
Neil - makes sense. Thanks for replying
Thanks Debby and Eva
Thanks Gail definitely have heard of a fair share of 6-8 year old tissue life folks
Thanks Steve read a some of your posts in other threads good stuff

Ken - you seem to have Coumadin war stories - could you share some of those??

We live in Camden County. Justin (25 year old son) Has had most of his heart surgery at CHOP, but many of his docs on on staff a both CHOP and Penn, they are very good.
Also I know there are some great heart surgeons at laukenau. Dr Samuels is one of the people I would trust to operate on myself or more importantly someone I love.

 

[Lynlw]

Lyn this Edwards article from 2013 talks about mitral valves - does this apply to aortic valves? Is tissue life on mitral different than aortic?

Is a little confusing , (article) since they mention 2 different studies, the beginning, is About Aortic
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced unprecedented long-term durability results for bovine pericardial heart valves, based on a study of the Carpentier-Edwards PERIMOUNT aortic valve in a subset of patients aged 60 or younger at the time of operation. The study tracked patients over a nearly 25-year period, achieved follow-up of 3,299 valve years and determined that expected valve durability for this population was greater than 17 years. The data were presented Friday at the 66th Congress of the French Society for Thoracic and Cardiovascular Surgery by Thierry Bourguignon, M.D., from University Hospital of Tours, France.

Then further down also good data on their Mitral valve

t the American Association for Thoracic Surgery (AATS) Mitral Conclave in May, Dr. Bourguignon also presented 25-year data on patients receiving mitral valve replacement with the Carpentier-Edwards PERIMOUNT valve, with follow-up of 3,258 valve years. The data similarly showed that the PERIMOUNT valve had an expected durability of more than 16 years in the mitral position, for the entire cohort and dependent on the patient's age. The study followed 404 consecutive patients with a mean age of 68 at the time of their mitral valve surgery, which took place between August 1984 and March 2011. Edwards has the only tissue valve specifically designed for the mitral position.

"More than 500,000 patients around the world have benefitted from valve replacement with Edwards' PERIMOUNT platform, and thousands more each year receive treatment with our market-leading surgical and transcatheter valves," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy. "These data offer yet another compelling, real-world experience to validate the excellent performance of the PERIMOUNT valve design for patients."

But yes it is different for Mitral than Aorta, I think they make one of the few tissue valves especially for the Mitral position, there are a lot more Aortic valves done each year, the stats are a little better for Aortic and right now mos of the cath lab valves being replaced are Aortic.

They tend to repair many more Mitral valves if possible and replace Aortic.

Thank you Neil, I have waaaay too much time on my hands, and get obsessed

 

[Agian]

Good for you Lyn. It's valuable having someone like you here. What are your thoughts on Cormatrix?

 

[epstns]

"Thank you Neil, I have waaaay too much time on my hands, and get obsessed"

Thank YOU, Lyn, as you help those of us who may be time-challenged by bringing out a lot of very good information.

I, for one, feel even better about my tissue valve impanted at age 63, after reading those excerpts.

 

[Lynlw]

Good for you Lyn. It's valuable having someone like you here. What are your thoughts on Cormatrix?

Thank you, I think the work Cormatrix is doing is wonderful. Just even a way to improve patches for holes in heart septums, is huge. FWIW Justin has a few dacron/gortex patches in the septums between both his ventricles (VSD) and atrium (ASD) he got them during his 2nd heart surgery when he was 18 months. They work ok as far as keeping blood where it belongs, but never have or will be as good as heart tissue. So the fact babies will be able to get patches from material that their own cels will take over so be like a heart that was born without holes is amazing. The other uses on surfaces of hearts and pericardial sacks is very promising.

For years, before Justin's 4th OHS to replace part of his pulmonary conduit and get a pulm valve, my hopes have been on tissue engineered valves, with the hopes that he (and other people like him who need their pulm valve replaced several times thru out their lives) could get valves and conduits made of their own cells that could possibly be the last one they would ever need. There have been a few centers working tissue engineered valves for the past decade or 2, so this matrix /scaffolding looks like it may be the answer to alot of prayers. The fact they already have valves made of it is very promising.

Just think maybe some day they might be able to implant tissue engineered valves like this by cath...the best of both worlds. But being able to get it by OHS is still wonderful. There are alot of really exciting things being worked on right now