Edwards new valve ... Inspira Resilia

[DJM 18]

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

mrfox, I am not sure where you have seen the 20 year claims. In the articles I have read even Dr. Svensson at Cleveland who is quite bullish on this valve says in no uncertain terms:

“The results of open surgical AVR were uniformly excellent,” says Dr. Svensson, but he adds that longer follow-up will be needed to draw conclusions about the valve’s durability.

“At 10 years, we may not see a difference in durability between dry and wet technology,” he observes, “but I expect we will start to see a separation at 15 years. The long-term data in young patients will be interesting. A more durable valve would be a game changer.”

 

[Paleowoman]

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

Hi @​​​​​​mrfox ​Where did you see a 20 year claim ? The only claim I've seen is that it is supposed to be as durable as a mechanical valve....which exceeds 20 years. Best to ask the surgeon you are under at the Harefield. Royal Brompton and Harefield being one of the top British heart hospitals !

 

[pellicle]

Hi

Hi @​​​​​​mrfox ​Where did you see a 20 year claim ?

It's in the first post of the thread...

Also you yourself have written some enthusiastic posts about it (which you linked to in the post just under dicks)

From what I've read, the INSPIRIS valve will be out in the US in 2018. The INSPIRIS valve is tissue and is supossed to last as long as a mechanical valve and, as a result, they're planning to use them in younger people too. With the INSPIRIS you might not even need a redo at your age.

Here's something about the new valve on a UK heart valve website: https://heartvalvevoice.com/news/new...-performed-hea

 

[pellicle]

From the following site
https://cardiovascularnews.com/first...ve-take-place/

The longevity of the resilient valve is intended to reduce the chance of patients requiring additional operations in later years and could allow patients to remain or regain their active lifestyles, have children and go back to physical work.

Language is a bit odd... Allow patients to remain their active lifestyles...

, “This new device represents a huge step forward in the advancements of heart valve treatment providing surgeons and their active patients with an improved, longer lasting, treatment option.

So, better then than existing options....

Bahrami says, “As a specialist centre for patients with heart and lung disease, we want to offer the best treatments to our patients that give them the very best outcomes in the long term. We are very proud to pioneer this exciting development for young patients who need an aortic valve replacement.”

Not talking it down in the least...

Commenting on the procedure, Bahrami says, “We replaced the patient’s aortic valve through keyhole surgery, using just one small incision, in less than two hours. This technique is minimally invasive and avoided us having to perform major open heart surgery. The patient will be going home in just a few days.”

I'd sure like to know how that works

Bahrami continues, “Lasting three times longer and with a physiological design, where the valve’s ring moves with the heartbeat, if the Inspiris Resilia aortic valve continues to be successful it is going to change the whole concept for future treatment of heart valve patients.”

Three times longer (than what?) would make one feel that the 10 years one can conservatively expect from a tissue prosthetic would imply 20 years is a reasonable expectation ... Or it's all just spin doctoring

 

[DJM 18]

Articles on this valve are making the rounds but most tend to be more cautious with respect to durability claims despite the encouraging (and wildly confusing) headlines: [h=1]http://www.upmatters.com/news/healthwatch/new-heart-valve-replacement-changes-diagnosis-for-young-patients/1063970787
"New heart valve replacement changes diagnosis for young patients"[/h] "Dr. Svensson says it will likely take another 10 to 15 years before researchers know for sure if this valve will last as long as they think but so far it seems very durable."

 

[mrfox]

DJM 18 , Paleowoman - yes pellicle nailed it, 20+ years is in the first post of the thread here and I've seen many posts on this forum present this as having equivalent lifespan to a mechanical valve. No hard feelings or fingers pointed, I just wondered if there was a piece of research somewhere which supported these ideas as I am making valve decisions right now.

 

[mrfox]

Overall my assessment is that it seems like some clever design ideas which have shown equivalent safety and durability to current tissue valves in trials, over a 3 year period. The idea of a 'TAVI ready' valve is kind of cool, but only if you're of an age where one or two TAVI procedures will see you through to the end of your life. I wonder why they're so gung ho about it's longevity at the manufacturing company?

 

[DJM 18]

The fine print in the Edwards Resilia webpage states:

"*RESILIA tissue tested against tissue from commercially available pericardial valves from Edwards in a juvenile sheep model 1. No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients."

 

[DJM 18]

I wonder why they're so gung ho about it's longevity at the manufacturing company?

Marketing as these are after all companies looking to gain some form of edge so as to expand market share for a new product. It is no different then the claims that On-X makes regarding its valve with respect to reduced INR. Anything to stay a "step ahead" of the competition.

I am sure that there is very good science behind this product and millions of dollars in R&D. Hopefully, it will work as the expect but as Dr. Svensson says, it will take 10 to 15 years to have good data that could validate the superiority of this valve.

Again, the good news is that TODAY young patients have a perfectly good option in mechanical valves if their intent is in selecting a valve that can last for 20+ years.

 

[Paleowoman]

Also you yourself have written some enthusiastic posts about it (which you linked to in the post just under dicks)

pellicle - I don’'t think you can have read the rest of what I wrote - which was that it is supposed to be as durable as a mechanical valve… which exceeds more than 20 years !

Maybe I was being too subtle in expressing some kind of 'dismay' at a claim of only 20 years for this valve which, from what I have read, should last longer than that if it is to be a viable option for younger people not wanting a mechanical valve.

 

[Paleowoman]

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients."

Well that's simply because they haven't been used for long. I don't think the valve I have has been used in the long term either. There is no clinical data for the long term impact for any of the newer valves, tissue or mechanical. Should we stick with valves that have only been in use for 30 or 40 years ?

 

[astle9]

why are people so hung up on this valve, i have it, i chose it, i take a calculated risk based on the companies findings, i will tell the world and his dog about this valve as an option but the final decision is theirs, if i was younger i would still have this valve and the chance of further operations because quite simply i do not want warfarin and testing as part of my life, i do not want to be reminded every day that i have had my valve replaced. You chose your valves and i am sure you had good reasons to chose them. My surgeon by the way explained in detail all of the pros and cons, the limited data, the fact the company is a world renowned and respected organisation that is not given to lying and hyperbole. In 15 or 20 years time i am sure we will have all the data you could want about this and other valves to follow but for me i will be too busy enjoying my life and the refreshed out look i have been given on life through the skills of my surgeon ( i live in the UK so my surgeon has no financial gain from my choice of valve) and the research and development of these valve companies. I also chose when in surgery to have a renal guard as an experiment to see if it would help prevent damage to kidneys in future during surgery but there is no data on that as well.

 

[DJM 18]

Paleowoman, Not at all, I am all for innovation and think it is fantastic that medicine has achieved over the course of the last 40 years. At issue is providing good data for someone trying to make a decision which is not entirely easy. I think there is VERY good science behind this valve which means there is some decent probability that it will last as long as they think it might, or perhaps longer. But the question that I thought was asked is if there is actual hard data to support the claims that this valve could last 20+ years in young patients.

As far as I am concerned, it could very well be a reasonable option but it is important to make a decision with eyes wide open. In that matter you are comfortable with whatever decision you have made (which is at the end of the day a highly personal matter) and accept the possibility that the valve may in fact only last 10 years or 15 years.

Perhaps what makes things so difficult today is the fact that we have VERY good options available. And as such, the hurdle is quite high for new developments. 50 years ago you would happily have them put in whatever they thought might work ;-)

 

[mrfox]

astle9 - I'm asking about it because I have to make a decision. No reflection on yours whatsoever - this can only ever be a very personal choice. May I ask how old you were when the valve was installed?

 

[DJM 18]

50 years ago you would happily have them put in whatever they thought might work ;-)

A great moment to reflect on a brave innovator whose courage and vision provides heart valve patients today with such great options for a beautiful life..

"In September 1952 Dr. Hufnagel, then director of the Georgetown University Medical Center's surgical research laboratory, implanted an aortic "assist" valve into the circulatory system of a 30-year-old woman. The valve consisted of a pea-size ball of plastic inside a chambered tube—an inch and a half long and an inch thick—that regulated blood flow through the heart. The manufactured valve compensated for the faulty original valve, but did not actually replace it, while ensuring that the heart was able to pump blood successfully into the body's circulatory system."

"The purpose of the aortic valve is to prevent blood from flowing backward into the heart. In the artificial valve the free-moving plastic pea in the tube was dislodged by the pulsing blood with each heartbeat, then fell back to close the tube between pulses.[SUP]"[/SUP]

"The first patient to receive the plastic implant had rheumatic fever, which had severely damaged her aortic valve to the point where she was given little chance to live. Shortly after the implant, she was able to resume a normal life and lived for almost a decade with the implanted valve before dying of unrelated causes. The valve itself, however, had some drawbacks, including the fact that it "clicked" loudly enough to be heard by others. Several hundred other patients subsequently received other "Hufnagel" valves.[SUP]"[/SUP]

 

[pellicle]

why are people so hung up on this valve, i have it, i chose it, i take a calculated risk based on the companies findings

my view is that this is a discussion about the valve based on 1) questions other people who are considering it asked 2) views of the claims being made.

As always there are other people making decisions (meaning the decision is not yet made), and for them asking questions and getting answers is important.

Myself I really don't care what valve others pick in the end, I have a valve that's working and I hope to not need surgery again (for it would likely be a drastic alteration on my life). I only try to examine logically and according to the evidence in an attempt to assist others to make their own choices.

The purpose of this place (among other things) is to assist people who are trying to navigate the mountain of knowledge and make a choice. They ask questions ... perhaps you did once too.

Why are you "hung up" about that?

 

[pellicle]

... I don’'t think you can have read the rest of what I wrote - which was that it is supposed to be as durable as a mechanical valve… which exceeds more than 20 years !

Maybe I was being too subtle in expressing some kind of 'dismay' at a claim of only 20 years for this valve which, from what I have read, should last longer than that if it is to be a viable option for younger people not wanting a mechanical valve.

its entirely possible ... actually I'm not entirely sure I understand what you are saying now ... but questions were asked and I chose to answer. I personally don't mind if you are a protagonist of this valve or a champion of it. I certainly have no evidence to make any decision about it. I can have my views of historical performance of almost indistinguishably different valves (which I often cite) but who knows what "magic" they've worked ... certainly they'd keep that "intellectual property" close to their chests (as would any good card game player). Eventually their actual hand will be known, but that's at the end of the game for the current round of betters.

 

[mrfox]

One thing I've noticed is a lot of 'kick it down the line' thinking when medics advise on valve choice. Now that peri-operative safety is pretty damn good a lot of cardiologists seem to feel like having several OHS is totally fine, and technology will always be better 'in ten years' - whatever that means.

To be frank it seems like the basic principles behind valve choice have been the same for a while so until some of this new 'grow it with your cels' stuff comes through the decision is still very much about balancing the perceived risk of warfarin dependency against the perceived risk of multiple valve deteriorations and surgeries.

In my shoes if an inspiris valve buys me 20 years then I'm 51 when it comes time for another surgery. Maybe TAVI has proven itself to be totally amazing by then but I don't like what I'm reading about it right now - seems like you're basically stenosing your own valve? It's a gamble, regardless.

To end positively - it is amazing to have choices regardless so I'm certainly grateful for that.

 

[pellicle]

Hi

One thing I've noticed is a lot of 'kick it down the line' thinking when medics advise on valve choice.

There is, but there are reasons for it ... for a starter people are often in different situations (which changes the balance point of the equation) , are often in shock and can't think straight, so what appears to be "minimizing risk" may actually be minimizing an insignificant factor.

Still (for instance) there have been strides in some areas (such as AC therapy management) which can benefit many ( but not all ).

Now that peri-operative safety is pretty damn good a lot of cardiologists seem to feel like having several OHS is totally fine, and technology will always be better 'in ten years' - whatever that means.

I spent last week in England with some friends, my friends wife is a pediatric surgeon , we had an interesting discussion about the tensions which exist between cardiac surgeons and cardiologists who specialise in trans catheter stuff ... which in her mind was stents ... she hadn't given much thought to valves (because its not the most common driver of adult cardiac surgery).

To be frank it seems like the basic principles behind valve choice have been the same for a while

correct ... but it takes any given person an amount of time to work through that ... and many simply just believe what ever the priest in white gown says ... unquestioningly.

... the decision is still very much about balancing the perceived risk of warfarin dependency against the perceived risk of multiple valve deteriorations and surgeries.

it is exactly that and it is worded that way in surgical guidelines ...

It's a gamble, regardless.

it is always a gamble ... things can drive the need for another surgery, for instance an aneurysm ... I happened to be "lucky" that my aneurysm was discovered at about the time my (homograft) valve needed replacement. Pannus can also effect the valve (causing obstruction) which can drive a replacement surgery too ... as far as I know both tissue and mechanical prosthetic are equally effected in that area. (risk factors are: female, small diameter oriface , and aortic valve in about that order)

To end positively - it is amazing to have choices regardless so I'm certainly grateful for that.

we are and we are certainly better off then when I had my first or second surgeries ...

 

[DJM 18]

And while all the attention is on the TAVR revolution, there are some potentially interesting improvements to anti-coagulation therapy that could make the mechanical valve option even better.

Evolution in AC therapy:

- Improved data analytics which will create improved algorithms for people self testing. This is an application that lends itself well to big data and as the software learns more it can actually tell you when to test and how to modify dosages;

- Customization of AC therapy based on a analysis of your own genetic make up.

Revolution in AC therapy:

- An implantable sensor that when you scan provides you with an INR reading, as is already the case in diabetes

- A new AC drug to replace Warfarin outright

- Next generation mechanical heart valves coated with newer super-hydrophobic materials

But the point being that even without the above this an excellent option with excellent outcomes. In fact, as I have read through literature I am struck by the fact that in some studies (with optimal INR self testing) the stroke risk seems to be fairly close to the so called background stroke risk of the age adjusted general population.

Again, amazing the options that are TODAY available.