CryoLife On-X INR Claims

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Keithl

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The problem with the FDA is reliance on the data provided by the drug companies themselves with very little risk of bad repercussions. If companies became more fiscally responsible via bonds and insurance I would have more faith. Add to that the lack of true accountability and there is little incentive for anyone not to game, scam or push the limits of the system. Somewhat related below:

 

Unicusp

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My faith in the FDA has been shaken over the last year. The drug aducanamab ADUHELM, the New Treatment for Alzheimer's and Dementia | Infusion For Health
was okayed by the FDA for Alzheimers. This was done despite any evidence for clinical effectiveness. A number of the people on the panel reviewing the drug resigned in protest.
Like many things in our society money can corrupt institutions that we would assume were incorruptible. The way officials can bounce between government and private industry and back is worrisome. This issue has been seen in the military when it comes to deciding on weapon systems. But I think it is creeping in at the FDA.
To my eyes the ONYX data was not compelling about using low INR for their valves but the FDA cleared it. Personally to me the downside of an embolism is much worse then extra bleeding at an INR of 3 vs 2. Since it has been mentioned many times if you aim for 1.5 you could easily hit 1.2.
Agreed. I also do not have much trust in the FDA. Have seen this trend with too much coziness and links between Pharma execs & Congress with the FDA. It has been going on for over 30 years and just getting worse.
I do not trust the PROACT Xa trial with Apixaban (Eliquis) either. I declined participating in the trial. Not worth the risk in my opinion. The side effects of Eliquis are scary as opposed to the the long proven safety of Warfarin.
All in the name of profit. No real benefits to the patients.
 

slipkid

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Yeah, there is a lot of shady stuff about agencies like the FDA (& CDC & NIH), like what the FDA does with rating generics is almost criminal (long story)....

I have an On-x and aim for 2 to 2.5. I take comfort in not freaking out if I dip down a little below 2.0 occasionally but want to stay in the 2's.

What's that Yes song - Aim High Shoot Low? Has no bearing on INRs but this made me think of it!
 

slipkid

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P.S. I worked in big pharma for 20 years. It is a VERY profitable business. Those $$$ get spread around & money talks. Adverse effects are routinely minimized and even covered up. Drugs get approved anyway. People get sick/die. A public flashlight gets shined on it eventually then it takes the FDA like 10 years in some cases to do anything about it.

Remember seldane? That took years to get taken off the market and the FDA didn't even do it, the manufacturer did.

And Reglan? Can cause permanent nerve damage yet all the FDA will do is put a black box warning on it. I had a Dr who tried to put me on that crap and he was 100% clueless as to that issue/risk, and didn't even bother to recommend a safer (and much better alternative) - I had to do that for him.

Not to get off the track of the FDA comments but man I effing HATE Drs. Anyone who blindly trusts their Drs without asking pointed questions and doing some investigation themselves is really risking their lives or health quite severely (sometimes we are incapacitated and have no choice but still....man I could go on and on and on about this with tons of real world examples that have happened to myself, family members, friends etc due to AVOIDABLE medical mistakes as opposed to the things just didn't work out situations)...
 

jlcsn2015

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During first year, i focused to keep my OnX INR between 1.5 - 2; at the end, and with learning curve; came to conclusion i would have a happier life if raised my lower level to 2.0, and that is my target, low 2 , high keep it below 2.4; this way, IF goes below 2.0 , i have time to move it up, and IF it goes up to 3, all is fine; BUT yes, during year ONE, i was most of the time at 1.7, but i rather use 2 as my target; almost 6 years, all good
 

Chuck C

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I agree, higher INR, but too late. Now, I have permanent heart damage, and more meds from having a heart attack from the blood clot. They need to do more research with a larger trial. Or just move it to higher 2-2.5.
Thanks for sharing this Bob. Really sorry to hear about the heart attack. There are others who have shared that the low INR, which the manufacturer claims is ok for the On-X valve, has led to clotting and damage. I sure hope that others listen when you share this. Even the small trial, which they use to support the claim that the lower end target for INR can be 1.5, found that there were more clots and strokes in the study group with the lower INR.
 
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slipkid

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Yeah, someone up here once said (& I would bet it was Pellicle) "I'd rather lose blood cells than brain cells". Blood cells from bleed are replaceable. Dead brain cells from a clot/stroke not so ez. Aim High....Shoot High...
 

Critter

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Well I can’t do much above INR of 2.5 without having episodes of anal/rectal bleeding. I am glad I decided to have a colon and an egd a couple of weeks prior to surgery to make sure the pipe was clean of polyps or ulcers in stomach. Glad I did it. I aim for 2.0 and I take the 81mg asa. I have no issues with it at this level and feel comfortable at that level. My fitness level now jogging 2.5 miles at a 15 minute/mile clip and I am not an athlete. I think I am on the bottom rung of “normal” based upon my VO2 max number which has increased gradually since surgery. I was also asked to participate in Apixaban study, factor XA inhibitor and I decided I would wait to see what the results are in about 5 years. Not interested in being a test subject.
 

Critter

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My faith in the FDA has been shaken over the last year. The drug aducanamab ADUHELM, the New Treatment for Alzheimer's and Dementia | Infusion For Health
was okayed by the FDA for Alzheimers. This was done despite any evidence for clinical effectiveness. A number of the people on the panel reviewing the drug resigned in protest.
Like many things in our society money can corrupt institutions that we would assume were incorruptible. The way officials can bounce between government and private industry and back is worrisome. This issue has been seen in the military when it comes to deciding on weapon systems. But I think it is creeping in at the FDA.
To my eyes the ONYX data was not compelling about using low INR for their valves but the FDA cleared it. Personally to me the downside of an embolism is much worse then extra bleeding at an INR of 3 vs 2. Since it has been mentioned many times if you aim for 1.5 you could easily hit 1.2.
There has not been a new drug for Alzheimer’s in 20 years and this drug getting approved did not have good data as vitdoc has said. I lost a lot of faith in the cdc while trump was in office with the recommendations that were made for Covid prevention and treatment. The disinformation involving things like HCQ, Ivermectin, macrolide antibiotics all of which have no indication to be used or being promoted without scientific evidence. What a huge cluster.
 

jlcsn2015

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2.0 works just fine, so my range is that 2 - 2.5 , no need to go higher with an OnX;
and the few times i have gone above 2.5 i had some bleeding events, so, "For Me" , 2.0 -- 2.5 is just Perfect, for others including Pellicle, could be different, Difference is what makes us special !, and yes, i also take a 81mg asa.
 

pellicle

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@slipkid
I'll happily attribute this quote to here
Many of our members prefer to be on the High Side of their Range and deal with a possible Bleed vs. deal with a STROKE.
One of our Favorite Sayings is: "It's easier to replace Blood Cells than it is to replace Brain Cells". Tell that to your Doc!
The *usual* recommendation for a Mechanical Aortic Valve is 2.0 to 3.0 (higher with additional risk factors for clotting / stroke).
As others have indicated it is Very Hard to remain within a 0.5 range if for no other reason than the normal Variation in the Measurement / Test Strip.
 

slipkid

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2.0 works just fine, so my range is that 2 - 2.5 , no need to go higher with an OnX;
and the few times i have gone above 2.5 i had some bleeding events, so, "For Me" , 2.0 -- 2.5 is just Perfect, for others including Pellicle, could be different, Difference is what makes us special !, and yes, i also take a 81mg asa.
Ditto for me.

And I'm having a bleed event right now (just look at my hand in my avatar). No biggie.
 
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