MCRI Granted FDA Approval to Conduct Reduced Anticoagulation Clinical Trial of On-X

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The surgeon I spoke with said its the cuff they use to make it the larger size. That the valve itself is one size. That is what he didnt like about it for larger valve candidates and he said they dont advertise that detail.

I am sorry I should have been more clear about the feedback I got.
 
My honey got a 27mm On-x put in three weeks ago. The surgeon who is The heart surgeon in our area said that the fit was actually better than the St. Jude. He said that it seated perfectly with the aorta and the St. Jude sometime has slight openings around it that he has to adjust for most of the time.
 
Wondering?

Wondering?

Do you think they will talk to Randy about this?:confused:
 
More Info for the On-X folks

More Info for the On-X folks

It's been a while since I've checked in with the site and after reading this post I was very excited to say the least...

Then I spoke with the On-X folks today...

It is prospective enrollment and we are in discussions with Columbia, although I think our research interests are a bit divergent and we may not use this center due to their competing trials and such. In any case you would not be eligible for the study. We are looking into what can be done for patients that already have an On-X valve but FDA rules may limit our options here. One thing I will do is file your e-mail in a tickler file so that when we can come up with something we can contact you directly. You are not alone on this list so you will get our attention.

John L.Ely
Executive Vice President
Regulatory Affairs
Medical Carbon Research Institute, LLC


So then I asked:

Just as a final question, how long is the trial and if completed successfully, how long afterwards would the therapy be approved for all patients?

And they said:

The study lasts 5 years and roughly 1 year after that approval to change labeling could occur. That it takes this long is the unfortunately reality for anything new in heart valve therapy. The only way this could be accelerated is if the study results are extraordinarily good at about 3 years.

John L.Ely
Executive Vice President
Regulatory Affairs
Medical Carbon Research Institute, LLC


So not overly thrilling news for me, but to prospective patients it should be a huge step. And all things considered, I've been on Coumadin for about a year and a half and I don't see any huge issues other than shuttering when I see a sharp object. I still shave with a razor (only at night so I'm awake and coordinated though), drink alcohol very varied (some weeks none, some nights 8-10) and have tested weekly for over a year and have only been out of range (high) twice (3.5 and 4.8). Some of the side-effects of Plavix aren't too appealing and personally I think I'd rather wait for the aspirin-only. Anyway, just some info for the masses.

Rich
 
Actually, there is a difference in materials between the On-X and the St. Jude, as well as in hemodynamics. I'm surprised the surgeon brushed those issue off so readily.

Yes, both - in fact all of the best-known mechanical valves - are now pyrolytic carbon (thus the term "carbon valve"). However, the processes for creating that material are different. The pyrolytic carbon used in the manufacture of On-X valves is the only one at this time that is free of silicon, which is a part of the manufacturing process for other carbons. This makes its surface more slick than standard carbon materials and less permeable than the carbons used for other valves. It's even less brittle, although the value of that is moot, because all carbons used in valves are capable of outlasting their human hosts several times over.

The hemodynamic differences include shaping that creates flow points where momentary stagnations were previously possible, particularly around pivots, which reduce the blood's ability to clot. Along with the slicker surface and reduced permeability, it also interferes with the spontaneous growth of tissue on the valve.

The valve leaflets are also desiged to fall closed more gently, which causes less hemolysis (damage to blood cells - mostly red cells), reducing the chance and amount of anemia from that cause. This also means that fewer byproducts of broken blood cells are floating through the body. The body is set up to react to a significant presence of damaged blood cell components, and they can raise inflammation chemical levels and even cause enlargement of the spleen. Their very presence can form the base for blood clots or add to arterial plaque.

It may also mean less noise from the valve, but that's not important to function. I believe the amount of noise is dependent on body mass, body density, volume of the area inside the rib cage and above the diaphragm, conductive ("bone") hearing of the patient, volume of lungs, size of the heart, position of the heart, heart rate, and how hard the heart beats (pump stroke impact), and probably a few other things as well...

The current warfarin INR recommendations are really based mostly on years of experience with the St. Jude valve. It is by far the most common mechanical valve and has thus been the dominant valve in all carbon valve studies done over the last decade and a half. If the St. Jude could tolerate a lower INR profile, it would likely have surfaced in that time.

The St. Jude is a fine valve that has probably saved more lives than any other single valve of any type from any manufacturer. But the St. Jude and the On-X are not the same valve, and in no way would I agree that the results of the study under discussion would be interchangeable between them.

Best wishes,
 
Don't worried Randy!

Don't worried Randy!

Your valve will last till at least 2016;) :p :D
 
ON-X heart valve

ON-X heart valve

I am going to have my AVR Thursday May 11th, by Dr Marvin Peyton at OU Medical Center in OKC, OK. After a lot of research, I have decided on the ON-X valve by MCRI. Dr Jack Bokros created the first pyrolitic carbon material about 30 years ago, has made parts for the St. Jude valve, helped create the Carbomedics valve and then started the MCRI ON-X valve. He has been in the big middle of the mechanical heart valves for 30 years. My gut tells me this is a superior valve. Dr. Bokros has created a yet stronger carbon material and reshaped the mechanical heart valve to try to duplicate the natural valves contours, which cuts down on blood damage and noise. I like the possibiltiy of reduced INR levels or maybe asprin and Plavix. Would liek to hear from anyone who has a an ON-X valve.
 
I don't usually follow this forum but I think an important question to ask is, "Will it be a different ON-X valve that will be tested or will it be the ones already implanted."

Another consideration is that nobody knows the effects of long-term Plavix. Instead of taking a well-studied drug (warfarin) you will be a lab rat for long-term Plavix.
 
More info regarding Plavix wanted

More info regarding Plavix wanted

I've heard vague stuff about it. How will it work, in comparison to Warfarin? Fewer side effects? More specific?
 
It works on the platlet clotting system. This is involved with clots in high pressure, high shear force situations like heart attacks. Warfarin is involved with the fibrin clotting system which has to do more with blood that stagnates such as in the leg, when you have atrial fibrillation or a mechanical valve that causes a change in how the blood flows around the heart chambers.

We have absolutely no idea what the 20 - 30 - 40 year toxicity of Plavix might be. Not even a guess. We will not know until thousands of people have taken it for these long periods of time. That is why I say that taking it will turn one into a lab rat.

We know about warfarin causing bleeding. But because it has been around since the 1950's, we have good knowledge of its 25-year toxicity -- extremely low.
 
All I know is, when I took Plavix, it made me have bleeding exacerbations in my lungs. Coumadin does not. I also didn't care for the diarrhea that came with Plavix. If you ask me, Plavix gets a firm thumbs down.
 
Hmmm!

Hmmm!

From what allodwick has said, it actually sounds like Plavix is less suitable for the purpose anyway - either for A/Fib or mecha valves!
 
I now read that long term aspirin may increase the risk of pancreatic cancer while other publications argue a reduced risk of colorectal cancer. It's frustrating to be exchanging complications, for the On-X may turn out to be safe with aspirin/plavix yet you end up with a cancer or a toxified liver.

Sometimes you just want to bang your head.... :mad:
 
I believe I have already stated this in another post somewhere but I will reiterate.

I chose a mechanical valve because I was terrified of another surgery. But, despite all of the reassurance everyone gave me here on this forum that coumadin was no big deal, I was also very worried that I would be one of the few to have difficulty with it. That is why I wanted the On-X. Because it offered the possibility that I could be off coumadin within a few years.

But now that I am on coumadin and have experienced no problems I seriously doubt I would even consider switching to plavix, even if this study succeeds.
If I am living a perfectly normal life, eating what I want, doing what I want, and with no negative side effects then why mess with what is obviously working?

This past weekend, my wife and I built a deck on the front of our house. Never one to take the precautions that I should, I dropped a 2x10 on my sandalled foot, received numerous splinters that I had to dig out, and just generally banged myself up. I have not one bruise to show for it and no more bleeding than I would have expected from the splinter extrications.

I realize age plays an important factor in the risk of complications with coumadin but I am very hopeful that by the time I reach that point, there will almost assuredly be a safer form of ACT. In thirty years, OHS might even have minimal risks and they can pop in a tissue engineered valve that will last the rest of my life.

Randy
 
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