ats vs on-x

[westie]

.
i have an on-x mitral valve, i am very happy with it. my health is great.

factors in my selection of the on-x valve were my own reseach and also a lot of favourable comments on vr.com.

recently i have come across the following site http://www.myheartvalvechoice.com/ which suggests the ats is by far the best mechanical valve in terms of lower complications and suitability for reduced warfarin doseage. if all this is true, then i do not have the best mechanical valve like i thought.
also, one would expect the competing mechanical valve companies to be jumping up and down in protest if all of this was fiction?

what do you guys think? especially, it would be interesting to hear al clapshaws comments

 

[Philip B]

What's best?

What's best?

Congrats on finding a website sponsored by ATS. Do you think there might be a motive behind the representation that ATS valves are the best available?

The quick look I did at the comparison chart ATS provides showed some pretty decent data on several of the valves listed. Frankly, the On-X fared pretty well as some of the studies produced better numbers than ATS.

The numbers provided in the chart on the ATS are simply there to provide a quick comparision. The website even notes that the data provided is not comprehensive.

ATS undoubtedly produces a fine product. This is not to say that ATS products are better than others. Visit the On-X website and you'll see a lot of information which indicates that the On-X is a great valve choice. I can personally vouch for the quality of my St. Jude valve.

While we certainly want to make good decisions which are based upon high quality information when valve choices are made, I think it is rather silly to have the attitude that one particular manfacturer's valve is the best choice. There are a lot of variables which must be factored into the decision an individual makes regarding valve choice.

There is a reason valve manufacturers play the "my valve is better than your valve game." It's called marketing.

-Philip

 

[westie]

phillip, the operative phrase was "if"

phillip, the operative phrase was "if"

.
if all this is true, then i do not have the best mechanical valve like i thought.

also, one would expect the competing mechanical valve companies to be jumping up and down in protest if all of this was fiction?

stone the crows mate, are you a school teacher or something??

thanks for your post phillip; but the operative word is "IF" . indeed, i use "IF" twice. the sum total of test results suggests the ats is best, so 'IF" the test results reported are correct, then "PERHAPS" the ats is best.

so "IF" you had paid attention to my post, you might have inferred correctly

 

[Jeanie]

I provided more info in another thread in this area, but it appears that, as On-X and its low-dose anticoagulation protocols are still in clinical trial stage that may be why ATS Medical http://www.atsmedical.com/ states their valves are better, as they've already completed 10 year low dose anti coagulation studes, and they continually upgrade the features of the valves. Speaking as myself, a 'one rat experiment', I am just thrilled with the way my energy level and ejection fraction rebounded once my AP360 ATS valve was implanted. http://www.atsmedical.com/Products.aspx?id=836

 

[Ross]

I'm not one to sit and study valve dynamics. As far as I'm concerned, all a valve has to do is correct your problem and that's good enough for me. Which is the best? The one that allows you to live your life. I guess that means they're all the best.

 

[Philip B]

Dear Westie,

If's or no if's, I think it's silly to question whether or not your valve is the best based upon information provided by a particular valve company. Like it or not your post asks a question. You can play with prepositions like "if" all you want. Marketing is marketing; we see it all the time with all kinds of products.

With regards to your comment about my profession, yes indeed, I've enjoyed a career as an educator (secondary and college). Thanks to teachers, people like you learned to read and write. Of course, I might simply be misreading your inference. If that's the case, pardon me.

Geez, lighten-up already.

-Philip

 

[dick0236]

.
i have an on-x mitral valve, i am very happy with it. my health is great........but ???????

Are you having a little "buyers remorse" ? What would you think competing manufacturers would say when comparing their product to others ?

Recently, I had some contact with my valve manufacturer, Edwards Lifesciences. While they acknowledge my valve as one of their longest still performing valves, they are not interested in my "patient story"......probably due to the fact that they have left the mechanical valve market in favor of other valve designs.

Fortunately for me, there was only one commercially available valve when I had the surgery. That made my decision easy and I have lived a long, successful, time with it. I doubt that there is any "one" best valve, and if so, it will not stay #1 because of technology. Long term success depends on a lot more variables than valve design.......including a little luck. Like my docs tell me...you will die of something, but it probably won't be the "ping pong ball" valve in your chest.

Personal research, coupled with the input of your cardiac professionals, will guide you to yourbest decision.....and then NEVER second guess your decision.

 

[catwoman]

While we certainly want to make good decisions which are based upon high quality information when valve choices are made, I think it is rather silly to have the attitude that one particular manfacturer's valve is the best choice. There are a lot of variables which must be factored into the decision an individual makes regarding valve choice.

There is a reason valve manufacturers play the "my valve is better than your valve game." It's called marketing.

-Philip

Philip:
Excellent points!! And very nicely worded, too.

 

[ALCapshaw2]

Westie -

I've read your post and some of the links.
I'll get back with you later.

 

[terryj]

My husband has the ATS aortic valve because that is the one his doctor recommended. He has had it for nearly nine years now with no problems. We are happy with our decision but I had some doubts when i started hearing about On-x trials. But, he certainly would not go through surgery again to remove one and have the other one put in.

 

[kpearse]

I'm not one to sit and study valve dynamics. As far as I'm concerned, all a valve has to do is correct your problem and that's good enough for me. Which is the best? The one that allows you to live your life. I guess that means they're all the best.

I agree with Ross!

 

[dtread]

Westie, if ATS is so good, how come they don't have a Clinical Trial ongoing for reduced anticoagulation? One would think that they would certainly echo the steps taken by On-X to gain authorization from FDA to conduct a Clinical Trial for reduced anticoagulation. I think you're beating yourself up for no good purpose whatsoever. You sure as hell aren't going to have another surgery just to replace your On-X with an ATS because you think it might be better. Like you (and a lot of other folks), I did a lot of research on the valve options before my surgery. Right or wrong, I chose On-X because I felt it was the best option for me. I still think I made the right choice. I quantify that choice every time I go to the gym or get on my bicycle and get the heart pumping and put the On-X to the test. At three years post-op it has not disappointed me yet. And I do a lot of cardiovascular exercise.

When I was in high school prior to taking the Scholastic Aptitude Test (SAT), one of my teachers indicated that studies had been done showing that more often that not when a person is answering a question on the SAT their first selection is usually the right one. They found that when a person went back and tried to "correct" an answer, or rework a question, that they frequently answered it wrong.

 

[Bill B]

I'm happy that ATS is so convinced they have the best valve. I hope all the valve manufacturers feel this way. Some are just a bit more direct about making claims. I find areas of their corporate website where ATS makes rather direct attacks on On-X with rather casual, unverified allegations. Strikes me as a bit below the belt. It may be true, but that is not how science and health care should be conducted.

Also, you need to read their studies carefully. ATS used low-intensity warfarin in SELECTED low-risk patients. This was not a blinded, randomized trial. And although I cannot find the full text, a follow-up indicates they used low-dose aspirin in addition. You could probably do that successfully with many valves. In fact, that is what my surgeon recommended I do (INR 1.5-2.5 + 80mg ASA). As much as I respect him, I'm a skeptical kind of guy who spent decades working inside the pharmaceutical industry and saw a lot of poor study design and misleading results get published. I need to see better executed proof to accept low-intensity anticoag. In the end, I decided to compromise and am targeting 2.0-3.0.

Anyway, I would not let ATS's somewhat aggressive claims upset any choice I made to the contrary. Their valve is fine but at this point there is no substantial proof it is superior. And the aggressiveness of their promotional material rubs me the wrong way.

Bill

 

[ALCapshaw2]

The ATS Low Anticoagulation Claim is based on studies of patients with an INR Target Range of 1.5 to 2.5
In the USA, Mechanical Aortic Valve Recipients with NO additional Risk Factors are advised to maintain an INR between 2.0 and 3.0
The ones who maintained an INR of 2.0 to 2.5 could be classified as Low Normal.
It would be interesting to know how many of the Study Patients had an INR Below 2.0

The only FDA Approved studies of Low INR that I am aware of are the ongoing studies of the On-X valves.

Another interesting source of information on manufacturer claims is the FDA Submission Data from the manufacturers.
Some manufacturers have a comparison chart showing the numbers and reference sources which they will send on request.

 

[kpearse]

As luck would have it, I didn't know I had any other choice. It all happened so fast, all in one week. I'm glad others have found this site before their surgery's so they could make a choice. Now I feel like I've been cheated somehow. lol But I will say I'm happy with it so far!

 

[Jeanie]

On the question 'Westie, if ATS is so good, how come they don't have a Clinical Trial ongoing for reduced anticoagulation?' - the answer is it has already been done. Personally, I do not give a rat's posterior whether something like that is 'FDA approved' or not. FDA approval process is quite often a revolving door kickback farcical arrangement; just look at the way aspartame was approved. (Use search engine to research that travesty.)

To get back on topic, I agree with Ross, as he said 'The one that allows you to live your life. I guess that means they're all the best.' Since surgeons have their own preferences it is wise to trust the surgeon's judgment, IMO.

 

[Kathy McCain]

Westie,

I think you just need to relax a bit. Yes, lighten up. Like my surgeon said forget about your heart, and live your life! I mean, I don't believe in too much obsessing about it. You sound like your're doing really well. Most likely you will die from something else, not even heart related!

This comment was meant with good intentions. Please take it as such.

 

[dtread]

Regarding quote by Jeanie: "On the question 'Westie, if ATS is so good, how come they don't have a Clinical Trial ongoing for reduced anticoagulation?' - the answer is it has already been done."

I checked Clinicaltrials.gov database and I'm sorry I cannot find that ATS completed a Clinical Trial that would allow for approval for reduced anticoagulation by U.S. patients that have the ATS heart valve implanted in them. I did find where a study was conducted in Belgium between Jan 1993 and June 1999 with two groups in the aortic position for 286 patients that was reported in the Journal of Heart Valve Disease in 2003. The complete reference is: Van Nooten G., et al., Lower Intensity Anticoagulation for Mechanical Heart Valves: A New Concept with the ATS Bileaflet Aortic Valve, Journal of Heart Valve Disease, 2003 12:495-502. The group that was given the reduced anticoagulation were all patients with no complications. While your opinion of FDA may have some merit they are the approving agency for medical devices in the U.S. If the device has not completed an FDA sponsored Clinical Trial for reduced anticoagulation, then the INR dosing with the ATS heart valve is the same as for any other manufacturer's bileaflet heart valve.

 

[Bill B]

Regarding quote by Jeanie: "On the question 'Westie, if ATS is so good, how come they don't have a Clinical Trial ongoing for reduced anticoagulation?' - the answer is it has already been done."

I checked Clinicaltrials.gov database and I'm sorry I cannot find that ATS completed a Clinical Trial that would allow for approval for reduced anticoagulation by U.S. patients that have the ATS heart valve implanted in them. I did find where a study was conducted in Belgium between Jan 1993 and June 1999 with two groups in the aortic position for 286 patients that was reported in the Journal of Heart Valve Disease in 2003. The complete reference is: Van Nooten G., et al., Lower Intensity Anticoagulation for Mechanical Heart Valves: A New Concept with the ATS Bileaflet Aortic Valve, Journal of Heart Valve Disease, 2003 12:495-502. The group that was given the reduced anticoagulation were all patients with no complications. While your opinion of FDA may have some merit they are the approving agency for medical devices in the U.S. If the device has not completed an FDA sponsored Clinical Trial for reduced anticoagulation, then the INR dosing with the ATS heart valve is the same as for any other manufacturer's bileaflet heart valve.

Yes, I agree. Whether FDA approved or not, I would want a more rigorous trial. I mentioned earlier that ATS's low intensity anticoag trial was not blinded, randomized or open to all comers. The ATS trial is what I would consider a preliminary report. My surgeon maintains that you can do the same lower intensity anticoag with other valves in selected patients. Regardless, there isn't much good data on this. What we've got is a lot of very good valves that work very well, with each company trying like heck to capture more of the market.

 

[Jeanie]

Very interesting, dtread. I personally have much greater confidence in the degree of scientific rigor shown in Europe than anything that has the FDA stamp of approval. Whether studies themselves were of US or European origin, the statistics of the patients followed in the studies are impressive. Edited to add, those who pointed out that the types of patients studied were selected for being low risk made a good point. A low turbulence mechanical valve plus absence of arrythmias or other co-morbidities such as diabetes, chronic smoker, high blood pressure, yadda yadda = low risk patient. I am one of those low risk patients, and am very blessed to be such. FYI my target INR is 2 - 2.5 anyway, but it is reassuring to me that, because of the studies previously done with the ATS recipients INR levels, that I do not need to panic if ever I have a sporadic drop below 2.0.

The bottom line, IMO, is for a surgeon to use whichever valve he or she thinks is the best choice for the individual patient, which of course will be affected by more factors than just a post-op INR range.
Edited to add, http://www.atsmedical.com/Company.aspx?id=992 states the FDA gave approval for use of the ATS Open Pivot valve in October of 2000. As the company has an active R&D program, I am sure all enhancements to the products and additions to the product line are also reviewed by FDA.