On- X valve is superior to outdated one like st jude and ATS

[Protimenow]

Whether or not the On-X results are correct, it's been well documented, AFAIK, that an INR below 2.0 for the St Jude valve (now Abbott) is dangerous. Let the On-X marketing folks continue using this irrelevant marketing message - if they feel that they have to - but I don't see why St. Jude (Abbott) would even care about pushing for approval of a range that's been historically unsafe.

Why sacrifice patient lives just to meet a competitor's claims, and increase your company's liability for adverse events?

 

[ChuckM]

I can't imagine that SJM would WANT to be FDA approved for a lower INR -- IT'S DANGEROUS. People (like me) would/could have strokes with an INR below 2.

There would be no competitive advantage to match a competitor's dangerous INR suggestions with a range that is KNOWN to be dangerous.

So - let the On-X marketing push a potentially unsafe range - it makes little difference to the person on anticoagulants with an INR of 2.5 versus an unsafe 1.5. It's just not worth the risk - or worth attempting approval to market it that way. Maybe the FDA can change its mind about On-X's safety claims and require INR above 2 - there are studies that show On-X's recommendations are unsafe for some people. And, as I've already said, it really doesn't have any effect on quality of life if On-X users maintain a higher INR.

I've been an outlier here since I first found this board. Not having it for reference prior to my surgery (things progressed pretty quickly), I took the surgeon's (who's expertise was well noted here in our smaller city) word for it. I was informed that I could have a tissue valve or a mechanical valve. Either procedure was going to be open heart because of my root aneurysm which had to be repaired as well. One would require warfarin, the other wouldn't. Because I was approaching 50, one would most likely need to be replaced before I caught the bus and the other would likely last a lifetime. My difference from what seems like everyone else on the board is that I have a MedTronic valve. My target INR is between 2.5 and 3.5, I usually am able to keep it around 3.0 with a steady diet and my coumadin nurse's dosing instructions. I don't self test, but I would like to have had it for reference when I had a colonoscopy. I was instructed to stop about 5 days before, was tested 2 days prior to the procedure and then immediately started Lovenox injections until I returned to my target INR.

I've spoken to my cardiologist a few times about self testing, but I'm not sure that my insurance would cover it. Currently he recommends the clinic which is covered by my insurance, and my nurse seems to do a good job of keeping things in check.

 

[Lisa from LJ]

Many of us who had replacement before the days of internet were in the dark and went completely with what our surgeons said. I knew the story of Lewis Grizzard and how multiple replacements led to his early death, but didn't really know what options I had. I was 36 when I had mine replaced and my surgeon said he'd see if the valve could be repaired when he got in there, but if not, he would replace with a St. Jude's mechanical. In other words, there were no options if he was going to do the surgery, but fortunately, knowing what I know now, I would have gone the same way.

Figuring out Warfarin took a lot of trial and error. In the beginning I was often on a roller coaster because I followed the advice of the nurse at the doctor's office. Finding the original group that existed before this website was a God send, although it was a few years before anyone self-tested. Al Capshaw was "the man" back then and explained things in layman's terms without a lot of statistics. My first degree is in Chemistry/Math, but I still appreciate clear English when it comes to my healthcare.

BTW, we lived in Lafayette for a few years - 1989-1991 - when my husband first started working at PHI. Loved the city and had my first child there. They offered him a transfer to Galveston so we decided to take it and be closer to family.

 

[SatoriFound]

Many of us who had replacement before the days of internet were in the dark and went completely with what our surgeons said. I knew the story of Lewis Grizzard and how multiple replacements led to his early death, but didn't really know what options I had. I was 36 when I had mine replaced and my surgeon said he'd see if the valve could be repaired when he got in there, but if not, he would replace with a St. Jude's mechanical. In other words, there were no options if he was going to do the surgery, but fortunately, knowing what I know now, I would have gone the same way.

Figuring out Warfarin took a lot of trial and error. In the beginning I was often on a roller coaster because I followed the advice of the nurse at the doctor's office. Finding the original group that existed before this website was a God send, although it was a few years before anyone self-tested. Al Capshaw was "the man" back then and explained things in layman's terms without a lot of statistics. My first degree is in Chemistry/Math, but I still appreciate clear English when it comes to my healthcare.

BTW, we lived in Lafayette for a few years - 1989-1991 - when my husband first started working at PHI. Loved the city and had my first child there. They offered him a transfer to Galveston so we decided to take it and be closer to family.

Hello neighbor!

 

[Lisa from LJ]

Hello neighbor!

Hello! When you decide which surgeon you're going with a have a date, let me know. If you'll be at Houston Methodist, I can ride the shuttle over from my office once you're ready for visitors!

 

[SatoriFound]

Hello! When you decide which surgeon you're going with a have a date, let me know. If you'll be at Houston Methodist, I can ride the shuttle over from my office once you're ready for visitors!

We are here now. Hubby is in the surgeon's very capable hands at this moment. I am feeling a bit anxious, hoping we don't fall into the bad statistics, even while knowing that the likelihood of that is small.

 

[Cris N]

We are here now. Hubby is in the surgeon's very capable hands at this moment. I am feeling a bit anxious, hoping we don't fall into the bad statistics, even while knowing that the likelihood of that is small.

Best wishes for a successful surgery.

 

[Chuck C]

We are here now. Hubby is in the surgeon's very capable hands at this moment. I am feeling a bit anxious, hoping we don't fall into the bad statistics, even while knowing that the likelihood of that is small.

He'll be fine. Best of luck and we will see the both of you on the other side

 

[tom in MO]

It seems like the literature that can be found online indicate both the SJM AND On-x have very similar performance despite important differences in design. Does anyone know why SJM is not seeking approval from FDA for lower dose warfarin despite loosing market share in the mechanical valve line of business? Obviously On-X marketing is using that to their advantage, but they are doing it because they can. I am sure SJM could probably get it too…but they may be worried if they fail? I think they are trying it in China for an INR of 1.5 to 2.5…if they get it it will be a big win even though it would probably only apply to some Chinese/Asian population but China is a huge market!

About 12 years ago, St Jude dropped my aortic valve’s range from 2-3 to 2-2.5, so they do make adjustments. I’ve dropped mu INR to 1.0 for several procedures (5 days w/o warfarin) w/o harm. My cardio calls it a “robust valve with a proven record.”

 

[Lisa from LJ]

About 12 years ago, St Jude dropped my aortic valve’s range from 2-3 to 2-2.5, so they do make adjustments.

That surprises me that they dropped it to a 0.5 range. When I had my surgery in 1998, the range for my St. Jude's mitral was 2-3. Fairly quickly it changed to 2.5-3.5, which is where it remains. I think it was standard practice then to start with a slightly lower range. I prefer to be in the upper part of my range as I have this theory that it's easier to stop a bleed than to dissolve clots, but it's such a relatively small difference that it doesn't really matter!