FDA approves TAVR for more than high risk patients

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DDT77

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from the link: At an average of 15-17 months follow-up, the results of both studies suggested intervention with TAVR was just as successful as intervention with open-heart surgery, proving the safety and efficacy of the less-invasive approach.

Don't we already know that TAVR is ok for relatively short timescales (<5 yrs)? It is the longer times in which valve degradation is an issue. Also, what is successful?
 

Duffey

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The statement says that intervention with TAVR is as successful as intervention with Open Heart surgery. I believe that defines successful.
 

Protimenow

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The follow-up for the two studies was '15 to 17' months. The FDA wants follow-up for ten years.

The patients in the study were all 75 years old or older, with significant aortic stenosis.

In the approval release, it was said that severe aortic stenosis occurs in Seniors.

Nothing was said about approval for patients with congenital valve problems. I don't know if TAVR has been used to replace diseased or congenitally defective valves.

The TAVR uses either magnesium, titanium, or both.

If I live long enough, it would be interesting to learn how long these valves last. I wouldn't be surprised if these weren't used for 'off label' implantation in patients with other valve issues.

I don't know enough about TAVR to have any opinion about it. The studies appeared to only look at survival rates (from the actual surgical procedure, and follow up for up to 17 months). Tissue valves in most people would last at least 19 months.

I understand why a manufacturer would want to bring a product like the TAVR to market as soon as possible, but it would be good to know whether or not the TAVR valve replacement lasts longer than a tissue valve.

Sure, a minimally invasive procedure would be preferrred over OHS, but long term survival - and not having to replace the TAVR sooner that you would a tissue valve - may make the choice of valves a bit more difficult -- unless the patient is in a high risk situation and probably wouldn't survive an OHS.
 
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rich01

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I believe the higher risk of stroke was with the earlier versions of the TAVR valve. With the newer valves, the incidence of stroke seems to be lower with TAVR than SAVR, at least within the 1st year.
A randomized controlled trial led by Dr. M.J. Mack, published in the New England Journal of Medicine, showed that in patients with severe aortic stenosis and a low surgical risk, treatment with transcatheter aortic valve replacement (TAVR) with a balloon expandable valve was associated with a lower risk of stroke, death or rehospitalization by 1 year when compared to surgery.
 

nobog

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I understand why a manufacturer would want to bring a product like the TAVR to market as soon as possible, but it would be good to know whether or not the TAVR valve replacement lasts longer than a tissue valve.
The answer is that it can - invitro (so far), however there is an unlimited geometric possibilities that the valve needs to be designed for which would affect the ultimate life - a simple example would be round vs oval, or expanded to diameter X or diameter Y (final implant geometry). Thus it is difficult to compare stented tissue valves to TAVRs in-vivo.

JK
 

Keithl

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I believe the higher risk of stroke was with the earlier versions of the TAVR valve. With the newer valves, the incidence of stroke seems to be lower with TAVR than SAVR, at least within the 1st year.
The real question (being 58) is how is the TAVR holding up in 20 years, or even 10. What happens when theta valve needs to be replaced, how do they get that valve out? Can they just keep putting valve over vale without risk or impacting your blood flow?
 

rich01

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The real question (being 58) is how is the TAVR holding up in 20 years, or even 10. What happens when theta valve needs to be replaced, how do they get that valve out? Can they just keep putting valve over vale without risk or impacting your blood flow?
My cardiologist, who is chief of cardiovascular medicine at Wake Forest Baptist. a interventional cardiologist, and performs TAVR, told me that TAVR in TAVR is the preferred way to replace a TAVR valve. I didn't think to ask, how often in real life is it possible and how often is open heart surgery required.

Based on his experience, he thought I would get 10-15 years with a Medtronics tavr valve. I'm currently 70 and don't expect to see 90, so if everything goes as hoped for, I may not need a replacement valve or possibly just 1 replacement.
 

Duffey

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The follow-up for the two studies was '15 to 17' months. The FDA wants follow-up for ten years.

The patients in the study were all 75 years old or older, with significant aortic stenosis.

In the approval release, it was said that severe aortic stenosis occurs in Seniors.

Nothing was said about approval for patients with congenital valve problems. I don't know if TAVR has been used to replace diseased or congenitally defective valves.

The TAVR uses either magnesium, titanium, or both.

If I live long enough, it would be interesting to learn how long these valves last. I wouldn't be surprised if these weren't used for 'off label' implantation in patients with other valve issues.

I don't know enough about TAVR to have any opinion about it. The studies appeared to only look at survival rates (from the actual surgical procedure, and follow up for up to 17 months). Tissue valves in most people would last at least 19 months.

I understand why a manufacturer would want to bring a product like the TAVR to market as soon as possible, but it would be good to know whether or not the TAVR valve replacement lasts longer than a tissue valve.

Sure, a minimally invasive procedure would be preferrred over OHS, but long term survival - and not having to replace the TAVR sooner that you would a tissue valve - may make the choice of valves a bit more difficult -- unless the patient is in a high risk situation and probably wouldn't survive an OHS.
Tobagotwo underwent TAVR in late May. His porcine valve was replaced with an Edwards after radiation treatment destroyed it. In his situation, the TAVR allows his heart to function normally again while he battles cancer. His initial preference was open heart replacement, but the doctors recommended that valve surgery take a back seat to the cancer treatment. So yes, a damaged tissue valve can be replaced via this method.
 

OldManEmu

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At my latest cardio visit this year when discussing my tissue valve life span she mentioned that TAVR now has less risk in placement than conventional AVR and was going to be used as the standard replacement option for all patients over 75 not just high risk patients. She sits on numerous government advisory panels regarding cardiology.
Duffey I have thought a number of times what Tobagotwo was up to as he was a regular contributor with detailed information in my early years here, I hope all goes well for him with his cancer challenge. Thanks for the update on Tobagotwo.
 

rich01

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I just received new info on TAVR.
On Friday we received an email from Medtronic, our sponsor for this research study. The TAVR procedure has been FDA approved for Low Risk patients. With that being said, they would like for us to remove all of our current patients from the study that have not yet been implanted.
I will still have TAVR as scheduled and Medicare will pay for it. The main difference is I won't be in the group that is followed up on for 10 years. I hope the information I received is correct and I won't have to wait until the next medicare year for coverage.

I'm guessing that means the results from the study have been extremely positive.
 
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Duffey

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At my latest cardio visit this year when discussing my tissue valve life span she mentioned that TAVR now has less risk in placement than conventional AVR and was going to be used as the standard replacement option for all patients over 75 not just high risk patients. She sits on numerous government advisory panels regarding cardiology.
Duffey I have thought a number of times what Tobagotwo was up to as he was a regular contributor with detailed information in my early years here, I hope all goes well for him with his cancer challenge. Thanks for the update on Tobagotwo.
You’re very welcome, OME. I only wish that my update were more positive. I hoped that he might return to VR after the change of ownership and the recent upgrade to the system, but his attention is now focused on cancer rather than valve disease. He is literally engaged in a fight for his life.
 

ottagal

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You’re very welcome, OME. I only wish that my update were more positive. I hoped that he might return to VR after the change of ownership and the recent upgrade to the system, but his attention is now focused on cancer rather than valve disease. He is literally engaged in a fight for his life.
Duffey, please give Tobagotwo my very best wishes. I am sorry to hear this news and will keep him in prayer and positive thoughts. He is sorely missed on this forum, but as you said, needs to focus his attention on taking care of his own health crisis. Thinking of him.
 

jlcsn2015

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Before i choose the type of valve for my AVR, 4 years ago, I had the opportunity to meet a very nice lady that had a tissue valve for 7 years and then went thorugh a TAVR procedure, all went well, but that implant only worked for 4 years, so yes, how long they work for "IS" an issue, Industry is always trying to sale new products, that we all know; i also know a lady with a ball cage valve since 1980 and still ticking..... warfarin... yes, but... in the age of GMO and so many other things... i dont think Warfa is the boogieman , babayega or John Wick 4 , just a thought
 

Beekind

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My cardiologist has told me last year, while I am in the waiting room, that I can not have a TAVR because of my BCV. Should I assume that is still true?
 

rich01

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Before i choose the type of valve for my AVR, 4 years ago, I had the opportunity to meet a very nice lady that had a tissue valve for 7 years and then went thorugh a TAVR procedure, all went well, but that implant only worked for 4 years, so yes, how long they work for "IS" an issue, Industry is always trying to sale new products, that we all know;
Sounds like that was a 1st generation valve. Big difference between 1st and 2nd generation TAVR valves.
 

jlcsn2015

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Sounds like that was a 1st generation valve. Big difference between 1st and 2nd generation TAVR valves.
Research of anything takes 10 years...., 2015 is not long time ago, BUT everything changes, agreed,
but... when we see real cases of TAVR lasting more than 5 years, then it would be a sign of change, opinions are good
but not facts
 
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