Tissue Valve Durability data

[ks1490]

Hi all - is there a resource one can go to for data regarding the durability of various types of tissue valves, other than the manufacturers' own sites? The assumption here is that I have chosen tissue over mechanical, and would now like to choose among tissue valves based on durability. Obviously everyone's experience is different and there are no guarantees but I would just like to see what the trends have been.

Thanks!

 

[Bill B]

Carpenter Edwards has long-term published data on one supra-annular valve. Medtronics has 8 and 10 year follow-up published on the Freestyle, and some more data published a couple of years later. St Jude's has a large, long-term report published on the Biocor. One thing to note is that despite the relatively huge numbers of patients in some of these trials, very few patients made it out into the second decade. Most people died from other causes, and were excluded from the valve longevity analysis. So, the estimates of valve durability are based on actually very small numbers of patients. For example in the CE study of 1847 patients only 34 were alive at 18 years and only 2 made it 20 years. This is not the fault of the valve but is just a fact of life with these studies due to a high proportion of patients with underlying coronary artery disease or other illnesses.

[EDITORIAL COMMENT] I read about 50 original studies and analyses when TRYING to select my valve. Surgeon's often leave patients almost totally on their own to make what is a serious medical decision. They think they are doing the patient a favor by saying they will put in whatever the patient wants. I worked in medical-related fields and had decades of experience reading the medical literature and participating in clinical trials and thought I could sort this out, but the available literature mostly confused and disappointed me. Like many other things in medicine, despite major advances and complex technology, we only know so much with any certainty, and the data behind most medical device claims, like that behind the claims of in the pharmaceutical industry in which I worked, is incomplete, conflicting, biased and often, sadly, just plain faulty.[/EDITORIAL COMMENT]

Anyway, here is a collection of some relevant literature I read that you might enjoy. I only have studies on a few of the tissue valves because that's all that is published, as far as I know. I did include some bio vs. mechanical papers because they do include some good intermediate/long-term information on the bio valves. If you are looking for some definitive data in all this, you may be in for a struggle.

http://billsworkshop.com/Some_AVR_lit/

 

[neil]

hi there, well i went with a hancock 11 porcine,seems to have a good name and durabilty, to be honest most tissues are getting better and seem to have good durabilty,the borvine seems to be getting real good reports, but seeing as though i got my friend porky the pig at least am good for truffling ha ha ha

 

[Ross]

Bill would you mind if I posted your link in the must have references?

 

[Lynlw]

Bill, thanks for putting all that together in one place. I never thought (or would know how to be prefectly honest) of doing that. It works MUCH better than My system, which was to bookmark articles , which as you probably guessed I lost everything when that computer died.
I remeber when you frst joined it was one of the things that frustrated you, the fact there wasn't something like this and you said you would work on one, but Then I forgot about it.

 

[Bill B]

Ross: That would be fine. I am going to change it. I think even though as Lynn says having the literature there directly is better than links, MOST of the studies are available in full on the web - some are not free and require a subscription. All are copyrighted so I'm in violation of that. Still, go ahead and link for now and I will make that page more complete and legal soon enough.

And Lynn, I'm still working on spreadsheet that just gives basic information on the available valves. BUT it's never going to be a great help in decision-making. Making a choice between one biologic valve and another is fraught with ambiguity. Each has possible advantages and disadvantages. One of the over-riding frustrations is that the surgeons try to give you a huge say in the matter without providing key information that would favor one valve over another in your particular situation. I had to drag it out of my surgeon piecemeal. Sure, he stated his general preference early on, primarily based on my generally good health, but when I started getting into the nuances of selection and went one way or the other, he would dribble out stuff that turned out to be critical but is not spelled out in any studies and would be near impossible for a lay person to uncover. And his staff often gave information contrary to what the surgeon really preferred and did. It would be better if the surgeon gave a small range of choices for you to choose from unless it really doesn't matter what is used in your case. Ultimately I think it's best to just make a general choice between biologic and mechanical and let the surgeon choose the specific device. That might change depending on what is uncovered during surgery. My surgeon was willing to install whatever I wanted. What I didn't appreciate until a conversation the night before surgery was that had I gone with one of my choices, it would have completely changed the operative procedure and left me facing two operations.

 

[Lynlw]

Ross: That would be fine. I am going to change it. I think even though Lynn says having the literature there directly is better than links, MOST of the studies are available in full on the web - some are not and require a subscription. All are copywrited so I'm in violation of that. Still, go ahead and link for now and I will make that page more complete and legal soon enough.

I am computer impaired, so if you just had a list with all the links and not articles, would that take care of the copyright issues? If so even that would be helpful. When I had all the links in my bookmark that worked much better than searching for them when I wanted to reread them. but since that only was on 1 computer, I lost them. I realize you couln't see all the articles just the free ones, but it would be legal and still helpful

 

[Superbob]

I selected the Medtronics Freestyle for a variety of reasons, none of them exactly scientific. But I am happy to see from Bill's compendium of studies that it is associated with "excellent clinical outcomes after 12 years." The research is still early for this baby, but so far so good. By no means do I recommend it for everybody; there may be better choices for other folks, but this study is about as far as I care to look right now, since no cardio or surgeon has told me it needs replacing yet.

 

[Mentu]

Mechanical-Tissue Survival Rates

Mechanical-Tissue Survival Rates

http://jtcs.ctsnetjournals.org/cgi/content/full/122/2/257

This link connects to a study published in The Journal of Thoracic and Cardiovascular Surgery in 2001 and does compare several valves over 20 years. Here is the Conclusions statement:

"Tissue and mechanical valve recipients have similar survival over 20 years of follow-up. The primary tradeoff is an increased risk of hemorrhage in patients receiving mechanical aortic valve replacements and an increased risk of late reoperation in all patients receiving tissue valve replacements. The risk of tissue valve reoperation increases progressively with time."

The paper does not, of course, discuss the newer generation valves but if the propaganda can be believed both the newer mechanical and tissue should be better than those followed in the study.

 

[ALCapshaw2]

http://jtcs.ctsnetjournals.org/cgi/content/full/122/2/257

This link connects to a study published in The Journal of Thoracic and Cardiovascular Surgery in 2001 and does compare several valves over 20 years. Here is the Conclusions statement:

"Tissue and mechanical valve recipients have similar survival over 20 years of follow-up. The primary tradeoff is an increased risk of hemorrhage in patients receiving mechanical aortic valve replacements and an increased risk of late reoperation in all patients receiving tissue valve replacements. The risk of tissue valve reoperation increases progressively with time."

The paper does not, of course, discuss the newer generation valves but if the propaganda can be believed both the newer mechanical and tissue should be better than those followed in the study.

Another factor which has helped lower the incidence of anticoagulation "issues" for mechanical valve recipients was the development of the INR method of monitoring anticoagulation levels in the early 90's. Training (or ReTraining) Medical Providers in the Newer / Better / Proper ways to Manage Anticoagulation seems to be a Long and SLOW process.

'AL Capshaw'

 

[fischje]

My live tissue (Bovine) valves only lasted less than seven years. My surgeon said that was pretty much the norm.

 

[ALCapshaw2]

My live tissue (Bovine) valves only lasted less than seven years. My surgeon said that was pretty much the norm.

I have seen Low Durability numbers reported by *some* Porcine Tissue Valve recipients (under 10 years) but most Bovine Pericardial Tissue Valve Recipients get over 10 years (if received in their 20's to 40's) and often 20 years if received in their 60's. Less than 10 years from a Bovine Pericardial Tissue Valve seems unusually short-lived from what I have read on this site.

I don't recall anyone reporting a "live tissue" valve before. Please elaborate on what that means.
Did you receive a "Valve Card" from the manufacturer of your valve? It would help to know how it is described by the manufacturer. It would also be useful to know at what age you received your "live tissue" valve.

'AL Capshaw'

 

[fischje]

I guess I should have just said Bovine Tissue Valves. The manufacturer was Carpentier Edwards ( 21mm aortic and 25mm mitral . I was 27 years old when I received the tissue valves.

 

[Ross]

Another factor which has helped lower the incidence of anticoagulation "issues" for mechanical valve recipients was the development of the INR method of monitoring anticoagulation levels in the early 90's. Training (or ReTraining) Medical Providers in the Newer / Better / Proper ways to Manage Anticoagulation seems to be a Long and SLOW process.

'AL Capshaw'

Yes and it shouldn't be. I'm more then positive that if all providers were on the same page, that huge <2.9% risk of hemorrhage would be much less.