Failure of Onx valve and problems with lowering INR

[Protimenow]

Agreed. The others can fend for themselves. Actually, the one on the left would probably provide adequate ballast, if I had a sidecar. The guy on top can get on his unicycle, once he gets back on the ground, and pedal away.

 

[vitdoc]

Let me make something clear. When a drug or device is authorized for use in the US the studies that are done are done by the manufacturer. If the manufacturer feels the data looks good it is forwarded to the FDA where it is analyzed and voted on by committees concerned the appropriate drug or device.
ON-X did the study and the FDA reviewed it. I can’t quite understand how the low dose protocol was approved. The study was small and oddly done. Also as mentioned ASA was used. Normally with warfarin ASA is not required.
Also the FDA is supposed to do post release surveillance. I doubt this always is followed up.
So having a low INR almost undoubtedly caused the valve clot and all your other miseries.
Hopefully keeping the INR higher will avoid what you went through. I am curious why the removed the valve. They could have just removed the clot.
Maybe they were being ultra cautious fearing some valve defect.
If the valve was removed it should have been looked at for some flaws.
You might want to ask about that.

 

[Keithl]

I thought I read somewhere that if you get a clot on the valve they will replace it, although they can try and dissolve it first.

 

[pellicle]

I thought I read somewhere that if you get a clot on the valve they will replace it, although they can try and dissolve it first.

yes, that is the ultimate solution to the problem of contestive valve failure. I have this case mentioned on my blog:

I don't know (can't recall the results) if this was successfully treated with tPA (not warfarin or heparins, they are not successful) administered by PICC line

I know of one case here when a member was successful in reversing the thrombosis blockage of the valve with this
https://www.valvereplacement.org/threads/st-judes-valve-repair-or-replace.850001/post-850389

 

[drivetopless]

Hi, Cherie! I remember you. I got an On-x in 2011. thanks for sharing your story. I ttied to maintain INR at 1.5 to 2 and found it very difficult. I asked doc to expand the range to 2,5 years ago and maintain on the higher end with he aspirin therapy. This is great info you shared. I’m glad you survived. Take care.

 

[Humboldtgrrl]

old but perhaps interesting
DEFINE_ME

Thanks - if I follow this 2002 article correctly, the data was collected from 96 to 2001, the AVR folks were on 2.5-3.5 anticoagulant in that era & the 5 yr data on them was favorable. The authors then suggest at the end of the article that a future study of On-X at a lower dose anticoagulant would be helpful.

 

[user 15848]

I tried to work on the 1.5 -2 inr first 2 years, and found it hard to manage, so i set myself a target level of 2-2.5, and wao worry free, even if it goes below 2 at times i know i am covered, and if it goes above 2.5 no big deal; "for me" , this is my best approach, no re operation, and worry free inr management; "for me" , rather manage inr than worry about "when" i need second op., just "my" perspective...., no rights or wrongs

 

[pellicle]

even if it goes below 2 at times i know i am covered, and if it goes above 2.5

This is essentially my view too, even with my valve.