On-X Valve Study - Updated (sorry if its been posted already)

[pgammo]

http://www.onxlti.com/2012/10/on-x-...ation-indication-for-on-x-aortic-heart-valve/

 

[Heart Of The Sunrise]

pgammo: Thanks for posting. I get my ON-X Valve on 3/18/2013. So the approval of the results of this study by the FDA means alot to me, you and all ON-X valve recipients.

 

[Scott]

Wow thanks for the post. I stay at 2.0 -2.2 inr most of the time. I have worried that it might be safer for me to keep my inr higher but it seems to fluctuate a lot more when I try to keep it in the mid 2's. Often going above 3. It would be great to safely stay at 2.

 

[bradvo]

I think the study ends in a couple years, could be wrong tho. My visit to my surgeon last Oct he felt we would all be off the warfarin and on alternative thinners. At least that is the way the study is leading.
I've been with that study group for just 15 months but ended up in the warfarin group, it's still a win win being I home test for free thru the study.

 

[babshappy]

does it include on-x valves from 2009??I had my surgery in dec 2009

 

[RobThatsMe]

The PROACT results, the IFU modification (when approved), and the accompanying benefit of reduced bleeding events for patients receiving the On-X aortic valve are extremely meaningful for patients needing prosthetic valves,” said Clyde Baker, On-X Life Technologies CEO. “Younger aortic heart valve replacement patients — those 65 years and under — now have a much safer and permanent resolution to this common cardiac condition. They can now make a choice for low complications and not be faced with the trauma of a likely future cardiac reoperation.”

Ummmm.... and what about those 65 and older? Geezzzzzzzz....

 

[dtread]

RobThatsMe, what Clyde is saying really applies to anyone, not just those 65 and younger. In the past there was an unwritten dividing line; i.e., for those over a certain age (it has usually been expressed as 65) the general preference was for tissue and for those that were younger the general preference was for mechanical (due to the reoperations that tissue valves require). So Clyde is saying that now younger folks have a safer alternative because they can get a mechanical valve with lowered INRs and thus, reduced bleeding events. But this is really true for anyone getting a mechanical valve at any age. Clyde is just referring back to the historical perspectives related to heart valve selection.

Babshappy, the ongoing Clinical Trial is for any On-X heart valve in the aortic or mitral position, regardless of year of implantation. This would include your valve implanted in 2009. FYI, the Clinical Trial is found here: http://www.clinicaltrials.gov/ct2/show/NCT00291525

 

[RobThatsMe]

Thanks for clearing that up Dan.

I have an On-X, nice to know that the new IFU could be 1.5 - 2.0.
I'd use that as a safety factor personally, as I'd really feel more comfortable with my INR around 2.5
I don't buy into the the line we valvers hear so often, that your mechanical valve will last your life time.
In some cases they may, but there are many others here, including myself that required a re-op due to Pannus, or some other condition that promoted the re-op. Hopefully, the On-X design helps fight off pannus growth. That was my main reason for selecting it.