Mechanical Valve - No Coumadin?

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J

JCDavis81

Hey all,

You all seem to be so much more in the know about these things than me, I thought I'd post this question and see if anyone knew anything.

When I was discussing valve options with my surgeon, he mentioned that there is a valve that is currently in trials in europe whose manufacturer believes will not require anticoagulants. This valve has been implanted in patients in the united states (I know they've used them at boston children's) WITH coumadin followup, with doctors hoping that the FDA will eventually approve (years down the line) of it's use without coumadin.

Has anyone heard of this valve, and if so, have any more information on it?

Thanks,
Joe
 
WOW - that was fast!

WOW - that was fast!

Thanks Ross.

So my next question is (forgive me if all these have been asked before) if you had to have a mechanical valve, why would anyone choose the St. Jude over the On-X.

Is the St. Jude just the known quantity?

Joe
 
JCDavis81 said:
Thanks Ross.

So my next question is (forgive me if all these have been asked before) if you had to have a mechanical valve, why would anyone choose the St. Jude over the On-X.

Is the St. Jude just the known quantity?

Joe
Click to expand...
On-X is the "new kid on the block" when it comes to mechanicals. It was not available when I had my St. Jude implanted in 1994. I might consider it if I were having sugery tomorrow but I am conservative enough to probably go with the "known entity - St. Jude". I do not believe any mechanical will NOT require coumadin in my lifetime so I would go with the valve with the most history of success.
This, of course, is just my opinion. Many people who are a little more trusting of advances will disagree.
Also, I have been on coumadin for 25 years so I think of it as no big deal, another opinion that is hotly debated.
 
Really, some people have no choice and in other cases, it's the surgeons choice, not so much the patient. In my case, my surgeon wanted to use the Ox-X valve, but they don't have a model with a grafting sleeve attached and he needed that since my Aorta was already grafted before. The next choice was a St. Jude CAVG 404 valve.

If you have your heart dead set on On-X, talk with your surgeon and be sure he can put it in. Some places do not have them and have to order them special which could stink if your open on the table. ;) Obviously as it stands, you still need to take Coumadin, but should that study ever become a standard, you'd be one step ahead of the game.
 
Ross said:
Really, some people have no choice and in other cases, it's the surgeons choice, not so much the patient. In my case, my surgeon wanted to use the Ox-X valve, but they don't have a model with a grafting sleeve attached and he needed that since my Aorta was already grafted before. The next choice was a St. Jude CAVG 404 valve.
.
Click to expand...

Interesting Ross -- so does your post mean that if you've having a dialated aorta fixed as well, the On-X is not an option? They're going to try sparing the valve by just putting in the dacron graft, but if valve doesn't reorient itself, the surgeon is going to have to replace the valve as well.

Joe
 
JCDavis81 said:
Interesting Ross -- so does your post mean that if you've having a dialated aorta fixed as well, the On-X is not an option? They're going to try sparing the valve by just putting in the dacron graft, but if valve doesn't reorient itself, the surgeon is going to have to replace the valve as well.

Joe
Click to expand...
Honestly, if it's a first time for you, you should ask the surgeon. I don't think so, but hey, that was 3 years ago for me. Mine had to cut out more and replace with even more Dacron. I honestly don't know.
 
Joe as Ross said the On-X doesn't come with the option of a Dacron grafting to replace the Aorta in a Bentall procedure. On-X valves have been around for about 10 years I am not sure how long they have been approved for use in the USA by the FDA. ATS is another new generation mechanical valve that has been designed using fluid dynamics like the On-X and does come with an Aortic graft. It isn't however being trialled with aspirin only anticoagulation. The ATS web site makes some vague statements about may require lower INR level however this hasn't been approved so may just be marketing spin. :rolleyes: I take it from your post that you have an Aortic aneurysm? I am interest to know as I was scheduled for a Ross procedure last year. My condition deteriorated and I finished up with a tissue valve. I will still be in the age group for a Ross when the tissue gives up (10+ years) so I am interested to hear from people that have had Ross's that have gone bad in a relatively short time (8 years). :(
 
Ross

Ross

Hey OME,

Thanks for the info, doesn't sound like the best news for someone like me however.

Yes, i had the Ross procedure about 8 years ago when I was 16. Everything seems to have gone well and I've had very few problems with calcification of my pulmonary valve. The aortic is another story. About 4 years ago the docs noticed that my aortic root had dialated to about 5.1cm. My root has been about stable since then, but the dialation has caused my AV to become extremely insufficient.

Anyway, now its time to fix the root and the valve. My surgeon gives me about a 75% chance of being able to spare my valve and just replace the root. I have to choose a replacement in the case that I end up being in that other 25 percent. Tissue or Mechanical is a tough choice for a 24 year old.

Wish I could give you a little more info about the Ross but there are much better educated people on VR.com for that. All I know is my personal experience. It's unfortunate what happened and I had hoped that this valve would last me for a few more years, unfortunately I just had a little bit of bad luck.

Good luck with your decision.
 
My daughter has a 25mm On-X valve, she was the first (surviving) child in the UK to recieve one. She was 18 months old at the time - June 2001.
I believe it was approved by the FDA in 2002 for use over in the USA but had been used in parts of Europe for a few years prior to that. It is supposedly very good and is that only valve I know of at the moment that has a possibility of being warfarin free some time in the furture.
To be 100% honest with you, had I have been given a choice for our daughter between ON-X and St Judes at the time of surgery, I propably would have chosen St Judes just on the fact it has been around and worked for so long. But over here its very much the surgeons choice, in our case in was anyway, and he told us he was implanting On-X (althouth didnt tell us it hadnt been used before in children!).
Now, i am completely happy with the choice, Chloe is doing very well and so is her valve.
I can understand your concerns at going on warfarin/coumadin for life but having lived with a small child on it for almost 5 years now, I can tell you its not anywhere near as bad as it's made out to be.
Hope you reach a descision thats right for you and you're happy with!

Love Emma
xxx
 
Note about St. Jude's valve

Note about St. Jude's valve

My surgeon called the St. Jude's valve the "gold standard" - the valve has the best long-term performance and a proven design. It's not just used frequently because it's been around a long time, it's been around so long because it works. Also there's over 25 years of clinical data to support its use, see
http://www.ncbi.nlm.nih.gov/entrez/...d&dopt=Abstract&list_uids=15734375&query_hl=7

That said, I received a St. Jude's "clone", designed by the same guy!

The On-X valve was approved in May, 2001 by the FDA for use with anticoagulants. Clinical studies are currently underway in the US for use of the valve with aspirin only. http://www.onxvalves.com/Med_Clinical_Issues.asp

They also claim the valve is less destructive towards red blood cells (hemolytic), and has superior biocompatibility. It looks like it could work with aspirin only, but since the clinical data from the US study is a ways off, I was more comfortable going with the proven technology. But it sure looks promising - the advantages of a mechanical valve w/o the coumadin.

Patty
 
afraidofsurgery said:
The On-X valve was approved in May, 2001 by the FDA for use with anticoagulants. Clinical studies are currently underway in the US for use of the valve with aspirin only. http://www.onxvalves.com/Med_Clinical_Issues.asp

They also claim the valve is less destructive towards red blood cells (hemolytic), and has superior biocompatibility. It looks like it could work with aspirin only, but since the clinical data from the US study is a ways off, I was more comfortable going with the proven technology. But it sure looks promising - the advantages of a mechanical valve w/o the coumadin.

Patty
Click to expand...

By "in the US" are you saying testing is being done in the within US borders, ie. on US pts.?

One has to be very careful to read wording on these company website. They
are carefully written by lawyers to make "puffing" statements, but fall short of actually making a claim. Also, when they compare their latest valve spec.
to that of their competitor, they will often use the competitor's older generation of valve. There is a lot of trickery going on in these website. Just like the soap companies that claim "NEW and IMproved."
 
RCB said:
By "in the US" are you saying testing is being done in the within US borders, ie. on US pts.?

One has to be very careful to read wording on these company website. They
are carefully written by lawyers to make "puffing" statements, but fall short of actually making a claim. Also, when they compare their latest valve spec.
to that of their competitor, they will often use the competitor's older generation of valve. There is a lot of trickery going on in these website. Just like the soap companies that claim "NEW and IMproved."
Click to expand...

My surgeon Dr. Ed Lefrak the founding chief of heart surgery at Inova Fairfax has been a valve man going back almost to the beginning. He wrote his first book on mechanical valves in the early 70's. When I asked him about the ON-X, he said such claims have come up frequently in past years and are nothing new. He uses all St.Jude but if he did put in an On-X he would aso put the patient on anticoagulants.
 
Aspirin study

Aspirin study

RCB said:
By "in the US" are you saying testing is being done in the within US borders, ie. on US pts.?

One has to be very careful to read wording on these company website. They
are carefully written by lawyers to make "puffing" statements, but fall short of actually making a claim. Also, when they compare their latest valve spec.
to that of their competitor, they will often use the competitor's older generation of valve. There is a lot of trickery going on in these website. Just like the soap companies that claim "NEW and IMproved."
Click to expand...

The On-X aspirin study is being conducted in Germany, but data from the study will/can be used for an application w/ the US FDA for aspirin-only indication. Many FDA approvals are based at least in part on european data.

The claims about less hemolytic activity of the valve are based on a single clinical studies analyzing the blood of patients w/ the On-X valve before and after surgery
http://www.ncbi.nlm.nih.gov/entrez/...d&dopt=Abstract&list_uids=10678387&query_hl=3

but since the trial didn't involve patients w/ other types of mechanical valves, it is a bit of a stretch to make claims comparing On-X valves to others on the market.

BTW, lawyers rarely, if ever, write any marketing or FDA-approved materials for pharmaceutical companies. These are written by marketing and medical personnel, based on clinical data - usually w/ a tug of war between these groups for making an attractive claim vs representing fact. Lawyers may examine or approve statements written by these groups, however.

Patty
 
On-X info

On-X info

Since I am once again in the valve market due to my failed valve repair a month ago, I have recently been in contact with the company that makes the On-X.

They assured me the aspirin trial in Europe is still going well. There will be an update published at the beginning of the year.

They also divulged that the FDA has just approved a study in the U.S. for lowered anti-coagulation with the On-X valve. It will be starting this next year.

Considering how fastidious the FDA is in regard to studies of this kind ( and for good reason ) this is definitely good news.

Randy
 
Thats good news Randy. Will have to try and find out more about that lowered INR with ON-X. Wonder if they will trial that over here too? Always hope for the future while they are conducting all these trials.

Emma
xxx
 
Hi everyone, there's another member who lives in Brazil and up to a few days ago, she was considering having her second AVR here with this surgeon called Dr. Enio Buffolo who according to her, claims that she'd be able to get a mech without having to take warfarin afterwards. Has anyone else ever heard about this valve or the surgeon? I'm Brazilian, but my problem is the mitral valve so, I'm not very familiar with what can be done to the aortic one, but I must say that got me quite curious though!???Here's part of her post:

I live in São Paulo which has the biggest and best heart hospital in South America. I feel confident about the surgeons and medical staff there. The surgeon's opinion is to put in a metal valve with no coumadin therapy afterward. He says that in Brazil they have been doing this for some time with AVR, with excellent results. I have heard good things about the surgeon, and I felt very comfortable with him, but I am not 100% sure of his skills and he is against the Ross.
 
Debora,

The mitral valve traditionally throws more bloodclots than the aortic, because of the less turbid conditions just those couple of inches away. I wouldn't recommend anyone with a mechanical aortic valve to go without anticoagulation therapy, although I could see how someone might try to talk himself or herself into it, because of the foreign trials.

However, even if they are successful, I would still absolutely not recommend it to someone with a mechanical mitral valve. I don't believe there are any mitral trials out there for this.

Don't forget, there are different attitudes in play in different countries. Where poverty is an accepted fact of life, some people do not have the funds to afford ACT. Some are ignorant. Some feel that it's all borrowed time. They often aren't given the same push and patient education that American patients receive. They are even less likely to have prescription insurance.

In the US, if 20% of patients didn't make it two years post surgery, we'd be horrified. In some countries, they would say, "Four out of five people make it for two years. Your chances are good."

It's not that other countries can't do it or have less gifted surgeons. It's that the care, particularly the after-care, across some countries is so variable.

Best wishes,
 
For a mechanincal mitral valve to not need warfarin anticoagulation, it would have to have no flow restrictions or eddy currents in the hemodynamics. All the studies I read have show asprin to be about 1/3 at best at reducing stroke risk as compared to warfarin. Granted the On-X has very good hemodynamics and low gradient (I think I remember it being the 2-4 mmHg range), I still think it would be wise to stay with coumadin because even it if lowers the risk from 2% to 1%, the medication is cheap enough for a 50% reduction in stroke rate. We tend to be rather litiguous here in the states and even though there's always some risk, if we're the statistic, we know its someone elses fault. Fortunately, I didn't get a choice of what type of mechanical valve, otherwise I'd be constantly thinking "I shouda' got the other one". One more thing to worry about.:rolleyes:
 
Aspirin Trial

Aspirin Trial

This is encouraging news. I had a tissue valve implanted in January, and hope to get 15 years out of it. I will probably go with a mechanical the next time to hopefully limit my number of surgeries to two. I wish everyone well that is taking part in this trial. It would take some mighty big cohones to be a guinea pig with so much on the line.
 
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