CryoLife On-X INR Claims

[Unicusp]

As some of you may recall, I had a On-X valve installed in the aortic position back in February, and passed the 10 week mark this past Friday. All is going well and I'm very happy with the result and performance to-date.

Today I received a brief letter from CryoLife regarding the "FDA Approved Safe lower INR levels" allowed with the On-X valve. I'll post a picture of that brief letter below.

We've all seen the graph that Pellicle has posted many times (shown below) indicating that the safest INR range is somewhere between 2.0 and 3.5 yet CryoLife is pushing for INR of 1.5 to 2.0 (of course with many disclaimers).

I've already "Bought" the valve. I'm baffled why they would push this with customers who already have the product. I understand marketing to potential new customers, but why to me?
Possibly relying upon word of mouth advertising on forums such as this. Well I'm certainly not supporting this, and will continue to target 2.5 to 3.0

One would think they would care most about the health and well being of the patients. Possibly not in today's society.

Thoughts / comments? I'm curious if any past On-X recipients are following the lower INR guidance. Thanks.

 

[pellicle]

Hi

firstly I love the line that says: this notification does not supersede advice you receive for anticoagulation therapy from your physician or health care professional.

Anyway, to answer this:

I'm baffled why they would push this with customers who already have the product. I understand marketing to potential new customers, but why to me?

I'd say:

1. keep the customers happy
2. they quite probably don't know you participate here and are just sending out a form letter.

you're not supposed to be one who seeks knowledge of your own volition.

For what its worth I think the valve is no less than any of the current crop, and if knowing what I know now I had got it (see here) then I would still be following the ACTherapy guidance of my surgeon and it would still be working as durably as my ATS is ...

 

[Warrick]

Hmm I have come across clueless onx recipiants on other sites that are on the low inr protocol but NO asprin, it was never even mentioned to them of the asprin requirement, I was quick to inform them of onx’s own recommendation.

Perhaps the mech valve manufacturers are scrambling to get as many out there as possible aided by word of mouth before the biopolymer valves currently in trials finally have their day in the sun.

 

[pellicle]

Hmm I have come across clueless onx recipiants on other sites that are on the low inr protocol but NO asprin, it was never even mentioned to them of the asprin requirement, I was quick to inform them of onx’s own recommendation.

Interesting that this doesn't mention aspirin either ...

 

[user 15848]

5 years on On-X, first year followed the plan of 1.5 -2 range and nothing bad happened, but after first year i decided to live worry free and changed my range to 2 - 2.5. And i do take the aspirin; did want to drop it, but my Cardiologist told me it was a good idea to take the 81mg ASA regardless; and so i do.

 

[Beach77]

I received the same notice and was baffled by why they even sent it out. At first, my clinic wanted me around 1.5 but I resisted and wanted it at 2.5 to 3. My doctor supported what I wanted and now the clinic goes by what I ask. I also take a daily aspirin.

 

[Mark M]

4 years with On-X, I maintain 1.5 - 2 INR range via Warfain, with 81 mg aspirin daily. Healthy lifestyle, no comorbidities. I have confidence in my team; the recommendations of the manufacturer, the FDA, my coag clinic, the surgeon who did the work, and my cardiologist. No problems. The valve itself is an engineering marvel, representing the state of the art. You can have confidence in your valve choice. With respect to modifying the range, I will not pretend to know more than the team. I won't give advice or add to the tempest in the teapot. Work with your team, and do what feels right for you. Peace!

 

[pellicle]

5 years on On-X, first year followed the plan of 1.5 -2 range and nothing bad happened,

For some nothing bad happens no matter what
https://www.valvereplacement.org/threads/how-long-can-you-go-without-it.887951/

 

[pellicle]

or add to the tempest in the teapot

Interesting choice of words for a very civil discussion

 

[user 15848]

With respect to modifying the range, I will not pretend to know more than the team. I won't give advice or add to the tempest in the teapot. Work with your team, and do what feels right for you. Peace!

We all have different teams, no team is better , enjoy !

 

[almost_hectic]

4 years with On-X, I maintain 1.5 - 2 INR range via Warfain, with 81 mg aspirin daily. Healthy lifestyle, no comorbidities. I have confidence in my team; the recommendations of the manufacturer, the FDA, my coag clinic, the surgeon who did the work, and my cardiologist. No problems. The valve itself is an engineering marvel, representing the state of the art. You can have confidence in your valve choice. With respect to modifying the range, I will not pretend to know more than the team. I won't give advice or add to the tempest in the teapot. Work with your team, and do what feels right for you. Peace!

I followed the On-X guidelines for the first 4 years. Then my cardiologist decided he wasnt comfortable with the 1.5-2.0 range and upped me to 2.0-2.5 I would have been fine to stay at the range I was in, but I upped my range to accommodate my doctors concern based on something he said he had read. Why go against your doctors advice I figure. Things just seem to work better when we are in the same camp and he knows I trust him. I just bruise a lot easier now. Im literally never without some kind of bruises somewhere ALL THE TIME

 

[tom in MO]

Bruising gets worse as you get older...and when a new younger dog enters the house I want to be safe from clots and also bruise free. Normal clotting time for a human is INR 1.0. The difference in 1.5 and 3 INR is it takes twice as long to stop bleeding for you and at 3 it's 3 times longer than a normal human. This would have been significant for my friend's brother who turned his grain truck over, slid 45 yards, and removed a lot of his face. Personally, I know with a TURP surgery, the INR difference effects healing in a direct way you can see...blood in your urine. For that surgery, due to my valve which can handle lower INRs, I did not need to bridge...another plus for lower INR valves.

I don't have an On-X but my St. Jude INR range dropped from 2-3 to 2.0-2.5 soon after I got it. I knew it changed thanks to this forum. My surgeon didn't know when I asked him, he told me ask the cardio. My cardio did know about the change. I have no difficulty with the narrower and lower range. I think On-X is just trying to educate patients about the realities of their valve. Some cardiologists are not up-to-date and if On-X literature sparks a conversation between patient and cardio, this is a good thing. Maybe someone can avoid bridging. One size does not fit all, the treatment guidelines are for most people, not everybody.

 

[Chuck C]

My doctor supported what I wanted and now the clinic goes by what I ask.

I also target 2.5-3.0 with my St Jude mechanical. Like you, my clinic has been very supportive of how I want to proceed and has always done what I ask. They gladly gave me one year's worth of 1mg warfarin prescriptions when I asked. At this point, I give them my numbers weekly and basically tell them my own plan for dosing. No push back and always supportive- the fact that I am always in range probably helps with this. It baffles me when I hear stories from others whose Clinics act tyrannical, not allowing for any patient input.

 

[almost_hectic]

It baffles me when I hear stories from others whose Clinics act tyrannical, not allowing for any patient input.

I would imagine, most people aren't good at managing their own dosing and so forth. Or haven't educated themself enough on the topic to really know what they are doing and end up in a yo-yo effect with INR swings up and down.

 

[bob124]

As some of you may recall, I had a On-X valve installed in the aortic position back in February, and passed the 10 week mark this past Friday. All is going well and I'm very happy with the result and performance to-date.

Today I received a brief letter from CryoLife regarding the "FDA Approved Safe lower INR levels" allowed with the On-X valve. I'll post a picture of that brief letter below.

We've all seen the graph that Pellicle has posted many times (shown below) indicating that the safest INR range is somewhere between 2.0 and 3.5 yet CryoLife is pushing for INR of 1.5 to 2.0 (of course with many disclaimers).

I've already "Bought" the valve. I'm baffled why they would push this with customers who already have the product. I understand marketing to potential new customers, but why to me?
Possibly relying upon word of mouth advertising on forums such as this. Well I'm certainly not supporting this, and will continue to target 2.5 to 3.0

One would think they would care most about the health and well being of the patients. Possibly not in today's society.

Thoughts / comments? I'm curious if any past On-X recipients are following the lower INR guidance. Thanks.


View attachment 887797View attachment 887798Wondering if anyone else has had a heart attack from a blood clot while on INR protocol of 1.5-2. or other blots, stroke? Had valve replaced in 2017, had heart attack in 2019 due to blood clot blocking 100% of my LAD, aka widow maker.

 

[bob124]

Wondering if anyone else has had a heart attack from a blood clot while on INR protocol of 1.5-2. or other blots, stroke? Had valve replaced in 2017, had heart attack in 2019 due to blood clot blocking 100% of my LAD, aka widow maker.

 

[pellicle]

Hey Bob

...had heart attack in 2019 due to blood clot blocking 100% of my LAD, aka widow maker.

sorry to read of that, but what's a LAD?

as to samples, we are a relatively small subset of the actual "installed base" of valves, but if you are asking about the On-X then there is also this post
https://www.valvereplacement.org/threads/failure-of-onx-valve-and-problems-with-lowering-inr.878615/
unlike the title suggests, it wasn't a failure of the valve but a failure of the effectiveness of the Lower INR protocol for that person.

We are all sufficiently different for you to need to evaluate performance of the valve for yourself.

 

[almost_hectic]

LAD left anterior descending artery—when that artery is blocked it can stop the heartbeat completely

 

[Keithl]

I just buy into the 1.5-2 even with 81mg Aspirin with the On-X. I got an On-X just over 2 years ago and after reading this forum and other articles decided 2.5-3 was where I wanted to be and try to maintain every since. I treat my INR like my car tire pressure, over is better than under. I have ahead a few readings in the 3.1-3.4 range at times, but otherwise in my sweet spot. When I get a low reading like 2.3 I do a full dose of warfarin on my next half pill day. I don't remember the sample size they used to get that 1.5-2 approval, but if I recall it was very low, not enough to convince me. I still take the daily 81mg aspirin as well as pure garlic powder pills.

 

[vitdoc]

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.