update on On-X

[ks1490]

Hi,

I was diagnosed with aortic regurgitation a few years ago and am in the "waiting room". After my dianosis in 2005 I did alot of research on this and other sites about my condition and valve replacement. At that time, St. Jude appeared to be the mainstream valve that people were receiving. People mentioned the On-X valve but at the time I think it was still in testing to determine if people could indeed use it and only have to take aspirin, not coumadin. Does anyone know the outcome of these tests? How prevalent is the use of On-X valves now? Thanks.

 

[ALCapshaw2]

There has been a lengthy discussion that may be of interest to you in the thread entitled "I need to make a choice soon", also in the Valve Selection Forum.

Your questions indicate some confusion about the facts of the NO / LOW Anti-Coagulation Study which was approved by the FDA in 2006. The results of that study won't be complete until after 2015 (if I remember correctly...the specifics are on their study website which was referenced by "dtread" in the above thread.

The On-X Valves were introduced to the World Market in 1996 and approved by the FDA for use in the USA in 2001, with appropriate anti-coagulation, similar to all mechanical valves.

To date, around 70,000 On-X valves total have been implanted in 64 countries, including the USA. (I will double check those numbers, but they are close).

At the present time, only patients who agree to participate and are accepted in the No/Low AntiCoagulation study, AT one of the Participating Hospitals, are eligible to qualify for that type of (closely monitored) anti-coagulation protocol.

Any patient with an On-X valve who is NOT in the study needs to follow the standard anti-coagulation guidelines prescribed by their Doctor.

One Very Important point to note is that recipients will still benefit from the design improvements in the On-X valve which include 1) harder and smoother surfaces resulting from the improved and patented On-X Pyrolytic Carbon material, 2) reduced turbulence due to opening the valve leaflets a full 90 degrees (older designs are 75 to 85 degrees), 3) reduced damage to red blood cells (hemolysis) due to improved pivot design, 4) a barrier to prevent Pannus Tissue Growth from obstructing valve leaflet movement.

IF and WHEN the Anti-Coagulation Study Results affirm reduced anticoagulation is approved for the On-X valves, all recipients would presumably be able to change to that protocol assuming there are NO other risk factors.

 

[andrewg]

I received my On-X valve in June of 2007 and am a participant in the FDA study.

I was placed in the Plavix / Low Dose Aspirin group three months after my surgery.

So after just a little more than a year, I really don't have any apparent side effects or other problems.

I report to the study administrator every six months for a check-up & echo.

 

[Cooker]

I received my On-X valve in June of 2007 and am a participant in the FDA study.

I was placed in the Plavix / Low Dose Aspirin group three months after my surgery.

So after just a little more than a year, I really don't have any apparent side effects or other problems.

I report to the study administrator every six months for a check-up & echo.

Andrew ... You are not on any warfarin?

 

[Cooker]

I received my On-X valve in June of 2007 and am a participant in the FDA study.

I was placed in the Plavix / Low Dose Aspirin group three months after my surgery.

So after just a little more than a year, I really don't have any apparent side effects or other problems.

I report to the study administrator every six months for a check-up & echo.

Andrew I have a couple more questions ... Are you having any INR test? ... I am curious how anyone would know there was a problem unless a problem occurred?

Thanks,

 

[ALCapshaw2]

Here is a copy of the post from Dan Tread (aka dtread) in the "I need to make a choice soon" thread with links to the On-X website that describes the NO/Low AntiCoagulation Study.

I'm sure that a company representative would be glad to answer any Questions from Anyone who contacts them. Other On-X websites are www.onxvalves.com and www.heartvalvechoice.com

===============

Randomized On-X Anticoagulation Trial

--------------------------------------------------------------------------------

The FDA approved Clinical Trial called "Randomized On-X Anticoagulation Trial", Clinical Trials Identifier NCT00291525, found at: http://www.clinicaltrials.gov/ct2/sh...0291525&rank=1

Purpose: Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.

Detailed Description: This is a longitudinal, randomized (randomization to occur at the 3 month follow-up) study comparing the On-X valve on low dose anticoagulation (test group) to concomitant control groups of On-X valves receiving standard Coumadin/aspirin therapy, and also to FDA objective performance criteria (OPC) for heart valve replacement. It is a multicenter study consisting of 20 centers in the United States enrolling no more than 1200 patients (200 in each of 6 groups). There are three test arms of the study: low risk aortic valve replacement, high risk aortic valve replacement and mitral valve replacement. Each arm has an equivalent control. Test therapies are: low risk aortic valve replacement - aspirin/Plavix, high risk aortic valve replacement - Coumadin at INR of 1.5 to 2.0 plus aspirin, and mitral valve replacement - Coumadin at an INR of 2.0 to 2.5 plus aspirin. Follow-up will run for 5 years in each patient.

This is also described on On-X website, and there is an Adobe (PDF) file that you can link to with a brochure on the study at: http://www.onxlti.com/onxlti-hv-proact.html
Also more info at this website:
http://www.onxlti.com/onxlti-hvm-clinical-trial.html

They were granted approval for 40 centers, not 20 as stated on the FDA website (typo?). There are currently 29 centers showing on the Clinical Trial info on FDA website; it gets updated as more centers are added.

The Clinical Trial has come up several times before. Previously there were VR.com members that chimed in that they would not be interested in participating, but there were also members that indicated that they would be interested in participating. Also discussion about the pros and cons of Plavix, etc.

When it is said that you would not have to use Warfarin that is true, but you would still have to use Plavix/aspirin; i.e., you would not be completely free of any medication like with a biological. However, note that the amount of Warfarin that you have to take could also possibly be reduced, if you chose to stay with Warfarin.

For those persons desiring to get into the Clinical Trial it is a requirement that you get your On-X implanted at one of the study centers. Personally, I could not work that out so I could not get into the Clinical Trial (but I would have been willing to do so if I could have).
__________________
Dan
AVR 06/05/07, On-X 21mm Aortic Valve, Dr. Ammar S. Bafi, Washington Hospital Center, Wash, DC. And Medtronic Model ADDR01 Pacemaker.
Pre-Op: http://www.youtube.com/watch?v=-vlrn7mVqrw
Surgery: http://www.youtube.com/watch?v=7RQSHbqGsTI
Post-Op (hospital):http://www.youtube.com/watch?v=tHw9b4BBV9Y
Post-Op (out of hospital): http://www.youtube.com/watch?v=HJ8mQ...eature=related
Recovered: http://www.youtube.com/watch?v=49iQut6K0qE

 

[Roger Frank]

I received my On-X valve in June of 2007 and am a participant in the FDA study.

I was placed in the Plavix / Low Dose Aspirin group three months after my surgery.

So after just a little more than a year, I really don't have any apparent side effects or other problems.

I report to the study administrator every six months for a check-up & echo.

Andrew...your my hero!

 

[ks1490]

THat's great, thank you so much for your help.

Here is a copy of the post from Dan Tread (aka dtread) in the "I need to make a choice soon" thread with links to the On-X website that describes the NO/Low AntiCoagulation Study.

I'm sure that a company representative would be glad to answer any Questions from Anyone who contacts them. Other On-X websites are www.onxvalves.com and www.heartvalvechoice.com

===============

Randomized On-X Anticoagulation Trial

--------------------------------------------------------------------------------

The FDA approved Clinical Trial called "Randomized On-X Anticoagulation Trial", Clinical Trials Identifier NCT00291525, found at: http://www.clinicaltrials.gov/ct2/sh...0291525&rank=1

Purpose: Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.

Detailed Description: This is a longitudinal, randomized (randomization to occur at the 3 month follow-up) study comparing the On-X valve on low dose anticoagulation (test group) to concomitant control groups of On-X valves receiving standard Coumadin/aspirin therapy, and also to FDA objective performance criteria (OPC) for heart valve replacement. It is a multicenter study consisting of 20 centers in the United States enrolling no more than 1200 patients (200 in each of 6 groups). There are three test arms of the study: low risk aortic valve replacement, high risk aortic valve replacement and mitral valve replacement. Each arm has an equivalent control. Test therapies are: low risk aortic valve replacement - aspirin/Plavix, high risk aortic valve replacement - Coumadin at INR of 1.5 to 2.0 plus aspirin, and mitral valve replacement - Coumadin at an INR of 2.0 to 2.5 plus aspirin. Follow-up will run for 5 years in each patient.

This is also described on On-X website, and there is an Adobe (PDF) file that you can link to with a brochure on the study at: http://www.onxlti.com/onxlti-hv-proact.html
Also more info at this website:
http://www.onxlti.com/onxlti-hvm-clinical-trial.html

They were granted approval for 40 centers, not 20 as stated on the FDA website (typo?). There are currently 29 centers showing on the Clinical Trial info on FDA website; it gets updated as more centers are added.

The Clinical Trial has come up several times before. Previously there were VR.com members that chimed in that they would not be interested in participating, but there were also members that indicated that they would be interested in participating. Also discussion about the pros and cons of Plavix, etc.

When it is said that you would not have to use Warfarin that is true, but you would still have to use Plavix/aspirin; i.e., you would not be completely free of any medication like with a biological. However, note that the amount of Warfarin that you have to take could also possibly be reduced, if you chose to stay with Warfarin.

For those persons desiring to get into the Clinical Trial it is a requirement that you get your On-X implanted at one of the study centers. Personally, I could not work that out so I could not get into the Clinical Trial (but I would have been willing to do so if I could have).
__________________
Dan
AVR 06/05/07, On-X 21mm Aortic Valve, Dr. Ammar S. Bafi, Washington Hospital Center, Wash, DC. And Medtronic Model ADDR01 Pacemaker.
Pre-Op: http://www.youtube.com/watch?v=-vlrn7mVqrw
Surgery: http://www.youtube.com/watch?v=7RQSHbqGsTI
Post-Op (hospital):http://www.youtube.com/watch?v=tHw9b4BBV9Y
Post-Op (out of hospital): http://www.youtube.com/watch?v=HJ8mQ...eature=related
Recovered: http://www.youtube.com/watch?v=49iQut6K0qE

 

[andrewg]

I do not take any wafarin, and do not have to take any INR tests.

Evidently, Plavix works differently than wafarin.

Before the valve replacement, I was on a daily aspirin regimen (adult).

I seemed to have more nosebleeds, slow coagululating cuts, etc. on that therapy than I do now..