Article in Chicago Trib's Tempo section today

[Mary]

Anyone know of this? Since I don't pay a lot of attention to tissue valve advancements, this could very well have been discussed here and I didn't read it. It sounds promising, but the big gap that wasn't discussed in regards to longevity performance was in the large age group between "child" and 80 year-olds.


New heart valve option
Still undergoing U.S. trials, device approved in Europe

By Terri Yablonsky Stat
Special to the Tribune
Published April 25, 2006


For people facing the breakdown of an aortic valve, the choice hasn't been pleasant: Replace it with an animal-tissue valve that itself may need replacing or with a manmade version that condemns the patient to a life of blood thinners and dietary restrictions. But a new heart valve still in clinical studies shows promise of being more biocompatible and mechanically durable than any tissue valve.

The SuperStentless Plus valve, manufactured by Shelhigh Inc., Millburn, N.J., is in Food and Drug Administration clinical trials at Central DuPage Hospital in Winfield. Made of cow pericardium and pig leaflets, the valve has been approved for use in Europe, where it has been used for nine years, and has been in U.S. trials for five years.

Patients who need a valve replacement have had to choose between a tissue valve or a mechanical version. Because mechanical valves make the blood clot, patients with these valves must take Coumadin, a blood thinner, the rest of their lives. That's why many patients prefer tissue, or biologic, valves from cows or pigs.

Tissue valves eventually wear out, however, and require replacement. "The younger you are, the faster it wears out," said Dr. Marc Gerdisch, director of cardiac surgery at Central DuPage Hospital. Typical tissue valves historically have failed because the body recognizes the valve as foreign matter, and the valve slowly deteriorates.

Though all other tissue valves deteriorate and calcify within a few years, no child or adult over age 80 has demonstrated tissue failure or calcification with the Shelhigh valve, according to Gerdisch. Babies usually have an accelerated calcification process, but those with the Shelhigh valve show no calcification, he said, adding, "The evidence is very strong that in an older person, the likelihood of valve deterioration is very low."

When Shelhigh valves have been removed, such as in a child who has outgrown one, the valves have been covered with a normal layer of endothelium, the material that lines the inside of blood vessels. That means the valve is being incorporated by the body, Gerdisch said. "No other valve grows normal endothelium, or normal cellular lining," he said.

Too, other valves commonly start failing within five years, Gerdisch explained. "I don't think there's ever been a tissue valve with the mechanical durability to withstand the continuous opening and closing of a valve," he said. Based on the science thus far, he expects the Shelhigh valve will outlast previous tissue valves.

The valve is implanted in a minimally invasive procedure using a very small incision. The breast bone is not divided, so the patient can return to normal activities sooner than with conventional valve replacement.

Gerdisch has implanted the valve in 35 patients so far with excellent results, he said. Because the valve is part of an FDA trial, he is limited to using it in people age 55 and over, but "I anticipate that age will lower."

The Shelhigh valve can be available for children up to 10 years of age in the U.S. through an FDA humanitarian device exemption, so the valve in small sizes can be implanted in the pediatric population.

Gerdisch recently implanted the valve in James Stade, 65, of Wheaton, who suffered congestive heart failure. "My aortic valve was calcified and wasn't opening properly," Stade said. "Three days after surgery, I came home from the hospital. I feel fine."

Stade's energy level has seen a boost since the surgery.

"I can now stay up late working on my patent drawings," said Stade, who owns a patent-illustration business in Chicago. "I'm not getting mentally fatigued like before."

If all continues to go well in trials, Gerdisch predicts FDA approval of the valve in about a year.

I am always glad to hear of any new developments with aortic valves. Thanks for posting the information.

 

[Karlynn]

The point they were trying to make to the general public was that there are known, non-trivial drawbacks with mech valves and that it is highly desirable to find an alternative.

Yes, using the words "CONDEMNED to a life" will get the point across. But the writer did not used the words "doomed to a life of risking death with each additional surgery" when refering to the drawbacks of tissue valves rather than the mild "Replace it with an animal-tissue valve that itself may need replacing". If the former had been written, our tissue valve members would most certainly have been pretty disturbed by it...and rightly so.

I wrote an email to the author of the article and pointed out that it appears she has poor information on what life on Coumadin is like. I refered her here and to Al's site if she wished to learn a little more. I mentioned that statistically tissue and mechanical have generally the same level of risk factor, but that the risk factors for the individual could be completely different for each valve type. To point out that the valve choice issue is not as unbalanced as her words made it seem, I told her that we recently have had two members, (young, assumed healthy over all with exception of the valve), that had extremely difficult occurances with their first surgeries. I wrote that, while this is more the exception than the rule, what did she think these members would rather do if they had known their surgeries were going to be so difficult - take Coumadin or face another surgery? I also thanked her for presenting the exciting possibilities of this new valve and told her that I hope that it continues to perform so well as it would mean a huge leap forward for valve replacement surgeries.

When misinformation is continually imparted, would it not be irresponsible of us not to point out the "myths of anticoagulation"? As Ross said, new people come on this board every day. Yes we've discussed the myths at length, but new people don't necessarily go back and read old posts. I didn't right away when I joined. Not to mention that many guests just pop on for a quick read and they're off. If having a little fun with the misinformation causes someone to understand that "condemned" was not the correct word to use, then so be it. Plus, what's wrong with just having fun? There was nothing malicious about it and if someone reads maliciousness into it, then maybe they are being too defensive.

I think the information in the article is exciting. Pointing out that the writer had incorrect information on what life on Coumadin is like does not detract from the information the rest of the article provides. I wish this new valve was not lacking in data for an age group that will be needing the vast majority of valve replacements. When I first read the article I was happily waiting to read some data for that range. When I read they only had data for children and those 80 and above, my thought was "Darn, and who wouldn't recommend a tissue valve for an 80 year old person?" I do think the fact that there is good data for children is WONDERFUL!

 

[RCB]

Look who is getting defensive!

Look who is getting defensive!

Don't let's make this post one of those "mech valvers get defensive" ones. For one thing, the authors of the article won't be reading this forum.

The point they were trying to make to the general public was that there are known, non-trivial drawbacks with mech valves and that it is highly desirable to find an alternative.

I'd really like to hear more about this valve. The fact that it was absorbed into the body and shows now calcification makes it truly fascinating



So come on folks, let's gather information and keep on topic. It ever we encounter some misinformation like this again, it should be easy for Ross to post a link to one of the "Truth about anticoagulation" posts.

Sounds to me like your points are being defensive, Andyrdj. I think the points
made were valid criticisms of the article. If you believe that are false, then state your arguments on why they are false. It is getting to the point on this form where we can’t even give our opinion about an article without some accusing others of being "defensive".

My take on this newspaper article this is nothing more then a PR article. If these people truly had a break through, they should publish their data in a peer reviewed medical journal! The reporter has some obvious biases in his statements and some omissions the facts.

It seem to me that a double standard is developing on the forum by which
Mech. valve studies are to be examined under a microscope, while every PR piece that has the slightest chance of becoming a reality is to be heralded as the next coming of Christ and if you dare doubt its veracity then you must be a heretic
or rude- probably both!

Let just argue the article- point, counter point, and not argue the argument!

Sign me, Condemed to live for the last 46 years!

 

[Mary]

As Karlynn states, "When misinformation is continually imparted, would it not be irresponsible of us not to point out the "myths of anticoagulation"?
I agree completely Karlynn.
The offending opening paragraph was written by a reporter who needs to be set straight on the facts.
Is it possible, since you read it in the Tribune, and posted it, that you could address the inaccuracies in an email to the section editor? Until the information is corrected at the source, it will continue to make its way into the published literature.
Thanks,
Mary

 

[Karlynn]

Is it possible, since you read it in the Tribune, and posted it, that you could address the inaccuracies in an email to the section editor? Until the information is corrected at the source, it will continue to make its way into the published literature.
Thanks,
Mary

Yes, that's what I did, maybe others will as well. I referred the writer to this site and Al's, not only to address the information, but so she might actually see what a big community we have.

Has anyone read about this valve in a medical journal yet. Maybe Tobagotwo knows. If it has been in a journal, maybe it will contain more information that would be intersting to read.

 

[Dustin]

Very encouraging, but I never heard of this valve even though it appears to have been used for nine years in Europe. I'll ask my cardio when I see him on May 19th, perhaps he can shed some light on this tissue valve. If this valve guarantees 20+ years of freedom from structural failure, then I'l seriously consider this option.

 

[Ross]

Being what may, I do see a glimmer of hope in this valve. I'd like to hear more and see more studies when it's possible.

 

[Andyrdj]

To bob H and others

To bob H and others

Sounds to me like your points are being defensive, Andyrdj. I think the points
made were valid criticisms of the article. If you believe that are false, then state your arguments on why they are false. It is getting to the point on this form where we can?t even give our opinion about an article without some accusing others of being "defensive".

Aaargh! Still not got my point across! The points are indeed valid, but I've seen so many occasions where they get posted and overwhelm the main topic. As, ironically, have my answers to people who are getting cross at me here!

Perhaps, Ross, you could compile a standard post with links to the articles debunking Mech valve myths. This post could have a nice bright graphic saying "READ THIS", a quick sentance such as "Mech valves are not as bad as they're made out to be - if you're worried, follow these links, and add your comments here rather than this post". Then add links to the long and involved debates we've all had in the past. Whole thing will be one post.

Then, hopefully, the rest of us will refrain from repeating this, and the post will remain specific to the original point. I suppose it's my computer programmer mind being fussy - i.e. saying "information needs to be stored in a central location rather than duplicated"

Now, I'm not going to waste any more of your time with this bit of nit picking. I look forward to hearing more about this interesting new development.

 

[RCB]

Who is getting cross!

Who is getting cross!

As, ironically, have my answers to people who are getting cross at me here!

How dare you accuse people of getting CROSS!! I'm NOT getting cross! Just joking, but I think we need to undertand that as
new discoveries come along, our discussions here will not affect the eventual
outcomes of these devices. If they truly work, they will be available in the future, if they don't, they won't. That is the way it goes.

 

[MikeHeim]

I completely agree with Andyrdj's posts above. It's sad that some people have to gravitate to the one line of an article that has absolutely nothing to due with the subject of the article instead of taking out the information that was intended. If the title of the article was "Doom and Gloom for those on Coumadin", I would have expected to see many of the posts above. However (I just checked again), the article actually seems to be about a new valve that has a very long life and doesn't require anticoagulation. Shouldn't that be something we all would wish for?

 

[Andyrdj]

Indeed!

Indeed!

Thanks for that, Mike - very positive!

I think we need to undertand that as
new discoveries come along, our discussions here will not affect the eventual
outcomes of these devices. If they truly work, they will be available in the future, if they don't, they won't. That is the way it goes

That's true, but one of the reasons I'm most thankful for having found this board are those advancements that are a little less new, and which I may be after for myself

(in my case, an understanding of the preservation processes used in the C/E magna valve, I'm going to push hard for the most up-to-date)

Checked on the Web - try searching for "shelhigh" with one l - you'll find more results. The valve has been around a bit, the company claim several of their valves aquire human tissue.

 

[RCB]

I completely agree with Andyrdj's posts above. It's sad that some people have to gravitate to the one line of an article that has absolutely nothing to due with the subject of the article instead of taking out the information that was intended. ..... seems to be about a new valve that has a very long life and doesn't require anticoagulation. Shouldn't that be something we all would wish for?

The sad thing is the way you choose to characterize as "gravitate(ing) to the one line of an article" There were plenty of things that were wrong with the newspaper article. However, I didn't see you leading the cheering section
when ON-X annouced clinical trials that if successful would prove to be " a new valve that has a very long life and doesn't require anticoagulation."

Sorry for being so rude Mike!

 

[Karlynn]

Just an FYI, and since I'm the originator of this thread I feel I'm allowed to do this, of the first 10 posts, 7 of them had nothing to say about the Coumadin issue. 5 of the next 6 were just having a little fun bantering back and forth with no talk of the original complaint in any serious way. Humor is always good, it is the way I got through and get through, the very serious situations in my life. It didn't get serious until someone posted about mechanical valvers and their defensiveness getting things off topic- when really there was not much defensiveness we were just having some fun. Had that not been brought up - this thread would probably be heading towards history. I'm sure many have read the initial post of the article and moved on.

Mike - I don't think anyone said they weren't wishing for a great new tissue valve to be developed that would get rid of the need for mechanicals and Coumadin all together. That would be like saying a diabetic doesn't want a good pancreatic transplant option to be perfected in order that no diabetic needs to be on insulin anymore. I have a mechanical valve and I'm the one that posted the article!!!

I'm still waiting for Tobagotwo's review of the article.

 

[MikeHeim]

The sad thing is the way you choose to characterize as "gravitate(ing) to the one line of an article" There were plenty of things that were wrong with the newspaper article. However, I didn't see you leading the cheering section
when ON-X annouced clinical trials that if successful would prove to be " a new valve that has a very long life and doesn't require anticoagulation."

Sorry for being so rude Mike!

Feel free to point out the other things that were wrong with the newspaper article. I just read it again, and it seems pretty good to me. It doesn't exactly read like a Tobagotwo post, but I would say that it wasn't too bad for someone who probably had absolutely no knowledge of valve disease prior to the article.

I didn't know there was a "cheering section" for the ON-X aspirin clinical trials. If so, I would certainly be in it. I have been following it very closely, I don't know why you felt the need to insinuate that I wasn't.

 

[Randy & Robyn]

This thread has turned into one of the primary reasons I have been slowly gravitating away from this site. I don't feel the posts in question, mine included, were "pro mechanical" in the slightest sense. They were intended to add a bit of much needed levity and also served to correct a statement that is blatantly false. Where was the harm in that? Is camaraderie suddenly a felony?

Too many times we end up defending ourselves when their is no reason to have to do so. Too many times we end up at each other's proverbial throats, even though we insist it is all in good humor. I, for one, do not need the aggravation. Admittedly, I have a very low boiling point and zero tolerance for arrogance and false accusations.

But I have nothing but respect and admiration for those who continue to deal with these situations every day here on this site and continue to provide information, consolation and inspiration to those desperately in need of it.

Randy

 

[geebee]

Good grief. I find it unbelievably unacceptable that we are now no longer permitted to have some fun now and then. I do not understand how chuckling about a really ignorant statement is construed as a "pro-mechanical" stance. I am all for advances in valve types be it tissue or mechanical. You can bet your bottom dollar that if there were a tissue valve that would last a lifetime, I would be shouting about it from the rooftops.
Lighten up.

 

[Ross]

O.K. I think we have that all out, so lets get on with the original topic. Excuse me from vering it off course.

 

[RCB]

Hey Sailor!

Hey Sailor!

O.K. I think we have that all out, so lets get on with the original topic. Excuse me from vering it off course.

What is the course this ship is tacking in to? If an article is posted here, do not the members have a right to question the assertions made by the author? Or do we just accept the announcement of whatever is the claim, "hook, line and sinker!" If someone is saying a Ford has a great new
car, that will end the need for those clucker chevys and cheap rice-burner
Hondas- I think people have a right to question the casting of the other cars
in such a bad light. This particularly true of any PR release. Why don't these drs. put out some data and release their findings. Do these drs. have any financial interests in this valve- CCF got in to some hot water for this very problem!

What we need here is some kind of police force, which will be able to control both the direction and scope of any article discussed here. If you make a joke or question some of the author?s assertions- even comments about the style in which it
is written, that should be grounds for a severe Billy-clubbing about the head! That will surely make these discussions more orderly and law abiding!

 

[Der Biermeister]

whoa ..... Whoa ...... WHOA ..... everybody


(Starting to sound like some of the motorcycle BBs I frequent. )

I think anything that is cutting edge technology should be brought forward and looked at, and not as the "be all, end all" -- but at least to show that advances are ongoing.

Anyway, that's my 2 cents - I am not going to take sides here as ALL OF YOU have helped me tremendously in the last few months. Besides ..... I stir up enough trouble elsewhere.

 

[Andyrdj]

Taking new advancements into account

Taking new advancements into account

Given all this info, it leads me to make the following choice.

I'm looking at my second surgery within 4 years. If I had it tomorrow, it would be the C/E magna valve. I reckon given data on its predecessor I can get 15 years out of it, possibly more until my thrid op.

By that time, many of this emerging stuff should be mature technology.
If there's a zero anticoagulation/asprin only Mech valve, a Tissue which could last 40 years, or a biologically grown valve, I'd go with them.

Worst comes to worst, I'd probably go with the best mech valve with lowest anticoagulation.

So this new tech makes me hope for the best, and prepared for the worst. You can't base your entire plan on it, but I'm prepared to gamble a little.