On- X valve is superior to outdated one like st jude and ATS

[pellicle]

Found elsewhere :

Thanks, that makes more sense.

Silly me expecting the researchers had compiled something useful like quantitative analysis of the effects on INR.

👍

 

[pellicle]

I wonder if there's any study with regards to noise profile, which is a potentially sensitive issue for me

It's a good question, and important, but I think that from reading here over the years that the same valve gets different results in different people.

So it's a craps shoot in afraid.

Best Wishes

 

[Protimenow]

Thanks, that makes more sense.

Silly me expecting the researchers had compiled something useful like quantitative analysis of the effects on INR.

👍

If the paper was peer reviewed, it could have been handled by someone with a lack of knowledge (or who forgot the basics of) statistics - or the person who retyped it before printing had a bad day...

 

[Lisa from LJ]

The INR change was observed at a mean +/- SD of 6.7 +/- 3.3 days following the first dose of corticosteroid.​

The INR change was observed at a mean of 6.7 (and plus and minus isn't needed with SD so) SD of 3.3 in the days following the first dose of corticosteroid.

I believe 6.7 +/- 3.3 days means that 68% of people experience the effect anywhere from 3.4 days to 10 days.

 

[Lisa from LJ]

Do you recall what the PT was on Monday?

I'm surprised that your cardio was still using PT in 1998. I thought the industry had changed to INR in the mid-eighties.

I don't remember exactly, but know it was low because the doctor noted that we needed to remember that my body cleared the excess Warfarin really fast. I still drop like a rock when I hold a dose, and typically holding two doses will put me at 1.0, no matter how high I was.

I don't recall when it changed from PT to INR as far as my measurements, but think it was when I stopped going to the hospital lab and started going to the doctor's office for tests using their Coaguchek, maybe 6 months after surgery. My Cardiologist was about my age - 36 at the time of surgery - so it definitely wasn't because he was old and set in his ways!

 

[pellicle]

I believe 6.7 +/- 3.3 days means that 68% of people experience the effect anywhere from 3.4 days to 10 days.

its not how I'd phrase that, but yep.

 

[Protimenow]

I got my valve in August 1991. I was supposed to go in for testing every two weeks (I often went much longer).

Actually, thinking about it now, I think that they were testing INR, but am really not sure.

Later, in the early 2000s (or maybe earlier), it was definitely INR that was being tested.

I got an in office INR test in 2006 by a vendor selling the Protime meter - I happened to be in my doctor's office at the time. These things were new and expensive at that time. The strips required refrigeration. There probably weren't enough patients to test to make this meter worthwhile.

I got my first meter in 2009 and have been testing (and recording results) since then.

(I've used a LOT of meters - Protime (Classic), Protime 3, Coaguchek S, InRange (dangerous meter), Coaguchek XS (and Pro and Plus variants), CoagSense PT1 and CoagSense PT2).

Somewhere in my future - if I live long enough - there's an InRange with my name on it. Perhaps even further down the road the XS will be supplanted by something newer, with more glitter. Or, unexpectedly, there will be an expensive anticoagulant that does the same thing as a 10 or 20 cent dose of warfarin but doesn't require INR testing. (I have no problem with self testing and self managing and it may take a lot to convince me to stop)

 

[pellicle]

Actually, thinking about it now, I think that they were testing INR, but am really not sure.

I think about then ... but of course I'm a newcomer to this whole thing

https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/615966

 

[dick0236]

....... I still drop like a rock when I hold a dose, and typically holding two doses will put me at 1.0, no matter how high I was.

I also drop like a rock if I hold a full dose. It's been a long time since I held two doses, but I believe that took me uncomfortably close to 1.0 as well. I normally make any changes in 1/2 dose increments although I have occasionally held a full dose. Experience has taught me to make my changes slowly......to avoid the "roller-coaster" effect.

 

[Chuck C]

I still drop like a rock when I hold a dose, and typically holding two doses will put me at 1.0, no matter how high I was.

I also drop like a rock if I hold a full dose. It's been a long time since I held two doses, but I believe that took me uncomfortably close to 1.0 as well.

I am the same way. One day hold will drop my INR significantly. This underscores how completely insane, and dangerous, it is when hospitals have standard protocals which instruct patients to hold their warfarin for 7 days leading up to a procedure. This appears to often be done blindly without tracking INR. Sometimes this is even for minor procedures with low bleeding risk.

As noted before, I had a thyroid procedure for which they wanted my INR under 1.5. This was achieved by just tapering my dosage a little bit. I reduced my dosage by 40% two days then by 80% the day before surgery. The idea that some hospitals would have just instructed me to hold for 7 days blindly is nuts, but this is the instruction which so many folks get. As a result of they way my drop was handled, I spent one day, the day of the procedure, at about 1.4 INR. I was able to take a full dose a few hours after my procedure, once greenlighted by the physician. The day after the procedure I was at 1.9, and the following day 2.3. In my view, this involved significantly less risk than a 7 day hold.

The physician who did my procedure cited studies showing that for the vast majority of procedures, getting INR under 1.5 is sufficient. Of course, this would not be for procedures with a high risk of bleeding.

 

[dornole]

I wouldn't go by that, factors that affect noise:
* aortic or mitral
* patient body type
* male or female
* blood pressure
* valve size (i.e 19mm or 31mm)

So are one or the other of these choice generally noisier? Just curious. I am getting a mechanical next week regardless and don't have any noise concerns.

 

[nobog]

So are one or the other of these choice generally noisier? Just curious. I am getting a mechanical next week regardless and don't have any noise concerns.

There is no final word on the subject but in general:
1) Initially you will hear something
2) it tends to get quieter over time - for most
3) some never get used to it
4) for others it is a comforting "tick"

JK

 

[Protimenow]

It's been 33 years for me. I'm not sure if the tick has gotten softer or not - I don't notice it unless I'm in a quiet place and try to hear it.

There are maneuvers I can make to make the click in my head louder.

For the most part, I don't hear it (and am not bothered by it) anymore -- actually, even when I first got it, it didn't really bother me.

 

[dick0236]

I have always been a smaller man....5'9", l56 lbs. After only a few months I could not consciously hear my valve and I don't think others could hear it either. I would think that my valve would actually generate more noise than the newer style. Mine is a little hard plastic ball that bounces around inside a Stainless Steel cage and I would think my valve should produce an audible ticking sound......but it doesn't. I would consider "ticking noise" to be a low-priority concern when choosing between tissue or mechanical valves......but these are my thoughts only and I have read where others have problems with noise(real or imagined). Unfortunately, we can't get a 30 trial(or send it back) of the valve we choose........but I think the various manufacturers have taken this in consideration when producing artificial mechanical valves.

 

[Lisa from LJ]

Not least because I don't think ti had an effect -3 days before first dose ...

What did you mean by this? That's the reason for my statement and I'm not sure how different phrasing would make it more clear.

 

[pellicle]

What did you mean by this?

I meant that the original authors writing looked so unclear it can only be the result of miswriting. What you wrote was clear.

Best Wishes

 

[pellicle]

Morning @dornole

So are one or the other of these choice generally noisier? Just curious. I am getting a mechanical next week regardless and don't have any noise concerns.

from some years here I can say that the entire spectrum of "can't hear it" through to "drives me bonkers" has been expressed for each and every valve

So I'd add that to the post by nobog

There is no final word on the subject but in general:
1) Initially you will hear something
2) it tends to get quieter over time - for most
3) some never get used to it
4) for others it is a comforting "tick"

Some time ago I posted this up, which may help to explain the issue.

https://www.valvereplacement.org/threads/mechanical-valves-but-what-about-the-ticking.889382/

I think so much is determined by things like how much scar tissue you have and where it is as much as by the valve design.

Myself I have an ATS valve and I can "perceive" its thump through my hearing organs

some things I've said in the past:

I can't hear any ticking; but I do "feel" acoustically the thump thump. I know its conducted through my body to my eardrum as earplugs don't alter it (actually they sort of enhance it).

I have the ATS and I think the noisyness of a valve is most influenced from the effects of scar tissue and how that conducts the sound through to the body. Scar tissue is not just visible on the surface, but at all layers of the opening and around the heart. Each subsequent surgery creates more.

A visit to a Dr recently had him observe soon after I walked into his office "Well, that's a real diesel you've got going in there"

I have had three surgeries though and last time I've had remarks from the surgeons that there was not of scar tissue to get through.

I still kinda hear it when stopped in quiet places (hallway and bathroom and my apartment here in Finland which is very insulated bring triple glazed). However when doing anything seldom do. What instrument do you play?

I myself hear a thump not a tick that others hear, as I hear it conducted internally more than via sound that reached my ears via the air Of that is understandable.

myself I can't advise you on valve choice other than to point at the data and say that it suggests that the On-X is all about claims and not about delivering on those claims. I'm seeing frequently in the literature that On-X is slightly more thrombogenic than St Jude and that their actual measurable claims do not match what people measure in implanted valves.

Are the claims about actually important stuff? Who knows, but if they believe their own marketing (if) then what they produce should match their claims.

Comb through this table here:
https://www.valvereplacement.org/threads/aortic-valve-choices.887840/page-2#post-902334

Best Wishes

 

[Windfinder]

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!

 

[Protimenow]

I've seen some resistance to the clicking by people evaluating which valve to get.

I've seen a lot more resistance because with mechanical valves, you'll need to take warfarin (as if it's such a bad, dangerous, terrible thing to have to test and self manage). Warfarin - rat poison - can kill you. Why would you want to take it. Your life will be over soon if you have to take that awful, dangerous stuff. (BTW - I read that there are some rats that are insensitive to warfarin).

The truth about warfarin is that, when properly managed, it's safe. It's easily managed. Effects are easily reversed. Unless you DON'T take it, or take far too much of the stuff (dosing is in .5 and 1 mg), you shouldn't have problems. And if you self test, having a good meter is essential. (I had an InRange that I trusted - 2.6 on an InRange was 1.7 in the hospital after I had a mild stroke. CoaguChek XS has a strong track record of accuracy

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!

The word is lose - not loose (a lot of people make this mistake).

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.

 

[pellicle]

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?

I don't know but if all of the analysis of the On-X study is correct they probably don't want to do it.

I would wonder how much they lost and how much it effects their bottom line (not much is my suspicion).