Edwards new valve ... Inspira Resilia

[amarG]

Hi Folks,

Cleveland clinic called today to say the new valve will be available for use starting Jan 15th. And since my surgery is scheduled in late Feb, its an option they are offering. This is the tissue valve being marketed as having a 20+ yr life. I am torn.... there is really no longitudinal data on this valve. I will effectively be on of the early adopters. Risk taking is one thing, but being on a leading edge on such a mission critical part is scary. What do u folks think?

 

[dick0236]

When I had the surgery my surgeon said my valve was designed to last 50 years and it passed that milestone a few months ago.......to the astonishment of my current docs. It is also an Edwards valve that was new to the market......and the only valve, of any kind, on the market in the mid 1960s. This technology continues to rapidly advance which makes making a "forever" choice very difficult. All you can do is work with you docs who have a responsibility to "do no harm"........and make the decision that is right for you in the foreseeable future. I guarantee that the options will change in only a few short years.

 

[Paleowoman]

Risk taking is one thing, but being on a leading edge on such a mission critical part is scary. What do u folks think?

Have you read the other threads about this new valve ? It's being used in Europe already and in younger patients. Here's an article from Cardiovascular News: https://cardiovascularnews.com/firs...ces-inspiris-resilia-aortic-valve-take-place/ and here's a forum thread: http://www.valvereplacement.org/for...-resilia-valve-will-be-market-available-in-us There have been other mentions of the valve on forum - someone posted a thread about its use in Holland.

If I had been lucky enough to have been able to wait till now to have my BAV replaced I would have jumped at the chance to have this new valve, especially with top London cardiac surgeons using them.

But it's your choice. What does your surgeon advise ? I don't mean "offer" I mean "advise".

 

[Superman]

Not knowing how old you are, does 20 years mean you're unlikely to need a second surgery? What age will you be when the valve reaches that milestone?

I guess if you're planning on having a second surgery anyway - this valve should be fine, uncertainties and all.

If you are intent on avoiding another OHS, depending on your age, this may not work for you.

As most of us say, regardless, I'm sure it's better than the valve you have now.

 

[DJM 18]

There is some additional data here from the FDA on this trial which gives more specifics...

https://www.accessdata.fda.gov/cdrh_docs/pdf15/p150048b.pdf

 

[tom in MO]

From what I could tell, the 20-year lifespan is a guess and has not been clinically proven. It appears that it's been in use since 2013 in clinical trials; not even close to 20 years. Longest animal study appears to be 20 weeks. If the 20-year lifespan is your primary reason to chose this valve, I'd say there is insufficient objective evidence to support a choice for this valve.

 

[neil]

have another chat with your cardio and surgeon, there is no quarantee with it but then again theres no guarantee with any artificial valve, we make a choice whats best for us and go for it, I had a piggy 10 yrs ago and its still honking away, good luck

 

[cldlhd]

It is a very difficult choice. Obviously there is no crystal ball and each valve choice has it's own pluses and minuses.

 

[astle9]

From what i have been told by my surgeon if the valve fails in the future then a replacement through the groin will be the answer so no more OHS

 

[Paleowoman]

From what i have been told by my surgeon if the valve fails in the future then a replacement through the groin will be the answer so no more OHS

Hi astle9 - Valve in valve TAVR is already an option with the other Edwards valves like the Magna Ease BUT the valve has to be at least 23mm to take a valve through the groin. It will be the same with the new Inspiria Resilia - a person will have to have at least a 23mm one. The reason is that if you put a TAVR valve (the type threaded through the groin) inside an existing replacement valve the TAVR one will result in too small a valve area if the first replacement was 19 or 21mm. Not sure if I've explained that very well !

However, you're really lucky to be getting the new Inspiria Resilia as it's likely to last as long as a mech valve. They've already implanted them in much younger patients with the prospect that it may last their lifetimes - patients in their 20's I believe - at least one in their 20s in London and one in Holland from what I've read, and one in their 40's. Undoubtedly there have been more patients given them.

 

[astle9]

Hi astle9 - Valve in valve TAVR is already an option with the other Edwards valves like the Magna Ease BUT the valve has to be at least 23mm to take a valve through the groin. It will be the same with the new Inspiria Resilia - a person will have to have at least a 23mm one. The reason is that if you put a TAVR valve (the type threaded through the groin) inside an existing replacement valve the TAVR one will result in too small a valve area if the first replacement was 19 or 21mm. Not sure if I've explained that very well !

However, you're really lucky to be getting the new Inspiria Resilia as it's likely to last as long as a mech valve. They've already implanted them in much younger patients with the prospect that it may last their lifetimes - patients in their 20's I believe - at least one in their 20s in London and one in Holland from what I've read, and one in their 40's. Undoubtedly there have been more patients given them.

I am not very much up on the technical stuff but my surgeon basically said i would be able to have a TAVR if this fails in the future and it was one of the selling points for the valve, i still have the option to go for a mechanical valve as nothing is set in stone, all i have signed is the paperwork to agree to have the valve replaced within the next 3 months. He has done 4 of these valves in people around my age 50 and slightly younger, the data clearly does not exist yet on the valve but he seemed very positive. Dental clearance to get and the standard MRSA and blood checks and i will be good to go.

 

[Nocturne]

Actually, this is really good news for me.

I will be keeping my eye on this valve. I’ll probably need my replacement done around age 50, and considering the state the rest of my heart is in, another 20 years after that ought to do me just fine. The option for TAVR if/when it starts to go bad is just gravy. And it would keep me off the Warfarin, which IN MY CASE might be a good idea because my coronary arteries are so calcified already.

Thanks for the info!

 

[amarG]

My Cardiologist at Stanford thinks its too early for me to go with this new valve. Not enough test data. The surgeon at Cleveland thinks the risk is manageable. Its a tough call, but I trust my Stanford doctors and I think I'll just go with their advice. If I could have waited a year for the surgery, maybe I'd go the other way. But things are what they are....

 

[amarG]

My Cardiologist at Stanford thinks its too early for me to go with this new valve. Not enough test data. The surgeon at Cleveland thinks the risk is manageable. Its a tough call, but I trust my Stanford doctors and I think I'll just go with their advice. If I could have waited a year for the surgery, maybe I'd go the other way. But things are what they are....

 

[carolinemc]

amarG, you go with your gut feeling. As long as the doctors are keeping you up to speed, then going with their advice might be a wiser choice and risk. You do what you feel is right. Good Luck, hugs for today.

 

[ozsky]

you are one of few lucky patients who have chance to try the latest medical technology of the whole world, and you said you scary? shouldn't you be exciting?
btw. i know a female patient from facebook who replaced with this valve

 

[DJM 18]

amarG, Stanford is an impressive team and their advice seems most sound. Sadly, as they concluded there is at present not sufficient test data. This article just came out but it is mostly anecdotal and from the daily mail so not at all scientific. It also relates to a 64 year old patient so going with a tissue valve such as the Resilia Valve was a most reasonable option.

http://www.dailymail.co.uk/health/article-5272821/Heart-valve-cow-tissue-avoids-lifetime-pills.html

Good luck to you

 

[Paleowoman]

So here’s a article from Cardiovascular News about valve replacement done with the new Inspiris Resilia valve on a 27 year old patient and a 44 year old patient at Kings College Hospital and the Royal Brompton Hospital: https://cardiovascularnews.com/firs...ces-inspiris-resilia-aortic-valve-take-place/

 

[mrfox]

I just can't see any data anywhere which justifies the 20 year claim regarding this valve - where does this claim come from?

 

[pellicle]

I just can't see any data anywhere which justifies the 20 year claim regarding this valve - where does this claim come from?

The company marketing division ... I wonder if they'd put that in writing as a grantee "... or your money back"