What are exact indication for a transcatheter AVR ?

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plsflgood

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Dec 27, 2011
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24
Location
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My mom was told to have an AVR awhile ago, but she was hesitant because of her kidney disease. Now her heart condition has deteriorated, and she needs to have an AVR. She asked about the transcatheter procedure (TAVR), and was told that it is reserved only for patients who are way more sick than she is. But we are not sure if this is the whole truth, because her hospital does not perform TAVRs, and they would have to send her to another hospital, so they might not be willing to do that.

So we would like to know: what are the formal guidelines for a transcatheter AVR ?
 
What is the reason she needs the AVR? If it's regurgitation, then as far as I know, it isn't approved for those cases. It is approved for aortic stenosis. Also, unless it's part of a study, it's only approved for patients who are too ill to survive traditional surgery. The complication rate for the valve is still higher for TAVR than regular surgery.

Here's a link to the FDA overview. I'm sure some other folks will be along soon to provide more details.
http://www.fda.gov/MedicalDevices/P...rances/Recently-ApprovedDevices/ucm280840.htm
 
My mom was told to have an AVR awhile ago, but she was hesitant because of her kidney disease. Now her heart condition has deteriorated, and she needs to have an AVR. She asked about the transcatheter procedure (TAVR), and was told that it is reserved only for patients who are way more sick than she is. But we are not sure if this is the whole truth, because her hospital does not perform TAVRs, and they would have to send her to another hospital, so they might not be willing to do that.

So we would like to know: what are the formal guidelines for a transcatheter AVR ?

Would it be worth your time to get a second opinion to give you peace of mind?
 
My mom was told to have an AVR awhile ago, but she was hesitant because of her kidney disease. Now her heart condition has deteriorated, and she needs to have an AVR. She asked about the transcatheter procedure (TAVR), and was told that it is reserved only for patients who are way more sick than she is. But we are not sure if this is the whole truth, because her hospital does not perform TAVRs, and they would have to send her to another hospital, so they might not be willing to do that.

So we would like to know: what are the formal guidelines for a transcatheter AVR ?

I would probably contact the closest center that is doing the various Sapien trials, They would be able to tell if your Mom qualifies just to get it based on who is approved from the FDA criteria right now, OR if not maybe she would qualify to take part in the trials for the intermeadiate risk patients http://clinicaltrials.gov/ct2/show/study/NCT00530894?term=sapien&rank=3&show_locs=Y#locn
all the centers taking part are , well should be, are at the bottom of the link IF she outright qualifies, I would go to one of he centers that took part in all he trials, since there is a learning curve and those doctors have been doing them for years now. the criteria for the trials on at that link too, who is included or excluded.

Medtroncs Corevalve was also just approved for higher risk patients if you want to go to one of the centers doing them again the link is to the trials http://clinicaltrials.gov/ct2/show/study/NCT01531374?term=corevalve+aortic&rank=3&show_locs=Y#locn but they should be able to say what your Mom would qualify for.
 
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