TAVR for pure aortic regurgitation?

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Jeffrey Klein

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Joined
May 2, 2023
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1
I have moderate-severe pure aortic regurgitation and it has been stable for many years. No symptoms. I am 74 years old. In generally good health I am not considered high risk for surgery.
Of course I don't know how much longer I will remain stable, and of course I would prefer TAVR when the time comes. I know it is not yet recommended for someone in my situation, and I know that research and clinical trials have been taking place for quite a while. About how long will it be for TAVR to be the preferred method for someone like me?
 
Hi and welcome
and of course I would prefer TAVR when the time comes. I know it is not yet recommended for someone in my situation,

I'm not sure that in the USA its not already indicated just because of your age.

There are of course many things we don't know but here's a few points which you can add to your basket of questions and answers.

  • how long do you anticipate living for? (pick a valve that will last longer than that)
  • TAVR has been shown to give expectable durability in patients of something like 10 years
  • SAVR remains the gold standard if you're not 'contra-indicated'
  • as you age the necessity of needing "blood thinners" (referred to as Anti Coagulation Therapy or ACT) increases irrespective of valve surgery or not
  • Warfarin is the only ACT which actually can be (and should be) tuned to fit you, other ACT (like the Xabans) is "one size fits all" (because that helps the Dr's to not need to titrate a dose)
  • valve in valve TAVR is possible, but we don't yet have sufficient data on the durability of that. We do know its not a certainty that you can have that.
Take your time in this period of "surgery isn't needed yet" to read with leisure and become well informed.

Best Wishes
 
Hello,

You have Aortic regurgitation. At the moment, TAVR is only approved for Aortic Stenosis in the US, since you need some calcium in your old valve to anchor the new one.

Now, there is a new TAVR that can also be used for regurgitation already used in Europe since 2021. It is called the 'Jena Valve'. JenaValve Receives CE Mark for Trilogy™ - Jenavalve This valve features a paper clip type mechanism to clip onto your existing leaflefts. I was briefly considering this for a redo and spoke to the most experienced medical team in Germany with this type of valve. They said that this new mechanism allows the replacement valve to close all of the gaps, so it fits much better. In Europe this device was approved after a decade long trial with 10s of people in the trial.

Based on the small European trial, the FDA has now assigned 'break-through device status' to this new TAVR valve. This has allowed the manufacturer to start a trial in the US at Columbia university and Cedars Sinai: Enrollment ends for ALIGN-AR IDE Trial - Jenavalve . This means that in a couple of years this device will be available in the US.

However, despite these goods news, as with all new valves (and there are plenty of new valves which keep showing unintended side effects later on) there may well be unintended consequences later. In particular, we dont know some key questions:
- Does the new valve system raise the probability of pace maker? - TAVR already has this issue, but does the additional metal in the frame raise this risk?
- Does it raise the probability of endocarditis? - In pulmunary Valve TAVI they only found out after some time that endocarditis rates are high.
- Does it make TAVR valve in valve easier or harder later on? -
- Does it make surgical intervention easier or harder later on if necessary?
You should prob keep all these issues in mind when looking at this new technology. We will only know the answer to all these questions 7-10 years after the valve has been in commercial use.

However,
since you are only moderate to severe, you may still have some time, so hopefully there will be more information on these questions by the time you have to make your decision.

Good luck
 
You don't seem to need surgery yet per "I have moderate-severe pure aortic regurgitation and it has been stable for many years. No symptoms." If so, rest easy and don't even contemplate future decisions you may never need to make. You will be happier. There are lots of things that can happen at age 74 that may make a heart operation irrelevant.
 

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