Inspiris Resilia vs On-x, can't decide

Inspiris Resilia vs On-x, can't decide.



Hello



Looking further, for your opinions and thoughts, hopping not to be too redundant.

im a man and 45 years old with a bicuspid aortic valve, but with a healthy heart (except the aortic valve of course) which is pumping blood at good quantities but at high pressure (believe it’s called vertex), severe stenosis and regurgitation, I'm healthy from everything else.


My doctor told me that it’s time for surgery.

He offers me minimal invasive surgery; but he gives me two options... that’s On-X and Inspiris Resilia.

With On-X I'm scared to be too vulnerable to an accident or that warfarin may damage my body/organs at a long run.



With Inspiris Resilia I'm dismayed of how bad could be my second surgery (even with valve on valve tech), or how common this valve will fail at really early stages (1 to 3 years)?

Could I hope that advances in medicine offer me better options, not available today, for a second surgery 20 years from now?



My surgeon says my heart will be at 100% after the surgery regardless of the chosen valve.

And I like lifting weights at the gym.



I'll highly appreciate your opinions, experience or expertise.

Thank you.

You are too young for a tissue valve - get the mechanical (I would also consider a SJM).

Hi,

the only advice I can give you is please dont repeat my mistakes. I was 33 at first OHS and got a tissue valve made from equine material. The surgeon said that this material calicifies less and that he set it up for future valve in valve. Then in early 2022, now being 42, the valve failed but in a strange way. No calcification as promised, but one of the leaflets just tore off. I also though that there would be better technology. There wasnt. and because there was no calcium valve in valve wasnt an option. It wouldnt have been a good idea anyways because it is hard to get a TAVI back out at the following surgery. So with low surgical risk, the strong recommendation was to do surgery. My surgeon this time insisted a mech valve given my age. So I ended up with an OnX.

I have been on warfarin for a year now. Yes you can bleed longer when you cut yourself, but it is a small price to pay for the only chance to avoid future surgeries given your and my age.

For your own health (also mental health) it is better to minimise surgeries.

There are a lot of people on this website which have been on warfarin for decades without issues. As long as you take good care of yourself and manage your INR well you should be fine. That is what all the studies say.

As with regard to valve selection, the On-X and St-Jude are very similar. The major difference is that the St Jude has a 40 year track record in humans, but the ON-X has inbuilt Pannus protection, which means it is harder for your body to grow over the valve and stop it from working. The reduced INR requirement is not a good reason to choose the On-X, since the study that this was based on is not high quality from a statistics point of view. Regardless which valve you choose, On-X or St Jude when you go mechanical, it is best to keep your InR between 2-3 as recommended.

Good luck in your decision and valve replacement journey.

Groy said:

Inspiris Resilia vs On-x, can't decide.



Hello



Looking further, for your opinions and thoughts, hopping not to be too redundant.

im a man and 45 years old with a bicuspid aortic valve, but with a healthy heart (except the aortic valve of course) which is pumping blood at good quantities but at high pressure (believe it’s called vertex), severe stenosis and regurgitation, I'm healthy from everything else.


My doctor told me that it’s time for surgery.

He offers me minimal invasive surgery; but he gives me two options... that’s On-X and Inspiris Resilia.

With On-X I'm scared to be too vulnerable to an accident or that warfarin may damage my body/organs at a long run.



With Inspiris Resilia I'm dismayed of how bad could be my second surgery (even with valve on valve tech), or how common this valve will fail at really early stages (1 to 3 years)?

Could I hope that advances in medicine offer me better options, not available today, for a second surgery 20 years from now?



My surgeon says my heart will be at 100% after the surgery regardless of the chosen valve.

And I like lifting weights at the gym.



I'll highly appreciate your opinions, experience or expertise.

Thank you.

Click to expand...

Groy said:

Inspiris Resilia vs On-x, can't decide.



Hello



Looking further, for your opinions and thoughts, hopping not to be too redundant.

im a man and 45 years old with a bicuspid aortic valve, but with a healthy heart (except the aortic valve of course) which is pumping blood at good quantities but at high pressure (believe it’s called vertex), severe stenosis and regurgitation, I'm healthy from everything else.


My doctor told me that it’s time for surgery.

He offers me minimal invasive surgery; but he gives me two options... that’s On-X and Inspiris Resilia.

With On-X I'm scared to be too vulnerable to an accident or that warfarin may damage my body/organs at a long run.



With Inspiris Resilia I'm dismayed of how bad could be my second surgery (even with valve on valve tech), or how common this valve will fail at really early stages (1 to 3 years)?

Could I hope that advances in medicine offer me better options, not available today, for a second surgery 20 years from now?



My surgeon says my heart will be at 100% after the surgery regardless of the chosen valve.

And I like lifting weights at the gym.



I'll highly appreciate your opinions, experience or expertise.

Thank you.

Click to expand...

Worth thinking about Ross if you’re not going prosthetic, but you’d want to be real picky about finding an experienced surgeon etc.

Groy, sorry about your need for surgery but I commend you for arriving at the decision point that many of us have faced. Understand that there is no right answer - only what is right for you. It's all about what you value most. For me - I placed the highest value on the greatest potential for a 'one and done' surgery so I went On-X at age 52. Two years later, I am thrilled with how I am doing... skiing, trail running, mtn biking, weight lifting, volleyball - am back doing all I love and much stronger than when I was struggling before surgery. Have only had one bleeding incident and that was me being dumb and not talking to my cardiologist before having a nose polyp removed. Quite messy - but dumb/preventable. The Inspiris is a great valve and yeah, the potential for TAVR - and a more resilient TAVR - is there. Impossible to know. Wishing you the best but know that the mechanical valve option shouldn't hold you back too much.

I can’t tell you what you should do but I can give you my experience.

I went through your exact debate with myself almost 1 year ago when I had OHS to replace my severely stenotic bicuspid aortic valve. I was 51. I look back now and can’t believe I even debated it. I’m so happy - knowing what I know now - that I went mechanical. Truly, I never want to go through another open heart surgery again. It was one of the more difficult things I have done in my life. The doctors discuss it like it’s routine. I’m glad they think it is routine. That’s good. But it definitely isn’t routine for the patient.

The number of Open heart surgeries is linked to higher mortality. So, for me, decreasing the chances of another OHS was important. With that said, is heart patients I think always run the risk of another OHS. Maybe I will need another one in my life. But, I’ve set myself up to not need one.

With a bio valve at 45, it is basically guaranteed that you will eventually have another calcified and stenotic valve. Maybe 5 years. Likely 12 years. Best case 20 years. But you’ll need a fix in the future. Maybe you’ll qualify for a TAVR. But there is no guarantee that you will so don’t let a doctor tell you otherwise. TAVR qualification is determined when you need the replacement. Who knows what your insides will look like 5-20 years from now.

So I’m ultimately happy that I made the choice for a mechanical valve. If I was 65, I probably would have rolled the dice and went with a Resilia. But I’m not 65. I’m 51.

As far as Warfarin is concerned, I only have 2 complaints

1) I self manage and I’m particular about it. I test myself twice a week (no big deal when you consider that diabetics are testing way more frequently than that). But the cost for my self testing is annoying at $600-ish a year

2) I can’t just go get a colonoscopy. I have to figure out how to bring my INR down safely. For me I think that is an issue because I think I’m more prone to Transient Ischemic Attacks as compared to a normal person.

Other than the above, warfarin hasn’t changed my life at all. I do everything that I did before.

It is a hard decision between 2 types of valves but it's yours to make! At 64, I was choosing between the TAVR and On-X. I went with the On-X and turned 65 on the day they discharged me. Warfarin for the last 2 1/2 years hasn't been too difficult. I am active with hiking, yoga, weights and living! You will need to monitor your INR but once you get the hang of it, it's easy. (lots of advice about that on here!) Sometimes it's annoying being dependent on a few pills but I remind myself, it's better than another surgery! That's what helped me with my decision, a possible 2nd surgery. I was told TAVR has a good record for 5 to 10 years but after that, the data isn't there yet. The valve is still new. I am very happy with my decision and the On-X! Good luck with your surgery!

At 45 you can expect two more surgeries using your 20 year life of the Inspirus valve......one at 65 and one more at 85. I am 87 and still have my first mechanical valve 56 years later.

Your statements regarding warfarin seem to be based on "old wives' tales" and what it was like in the olden days. I was around during those "olden days" and some of the old horror stories were, in fact, kinda true. Today, with the new testing technologies and a much better understanding of correctly managing warfarin, if you can walk and chew gum at the same time you can handle ACT (anti-coagulation therapy).

Save yourself a lot of second-guessing down the road........get a valve that will probably last your lifetime........not one that assures future surgeries in your "senior" years.

Welcome to the forum.

A lot of us have faced the same choice that you now have before you. I was 53 when my bicuspid aortic valve was replaced. Originally, I planned to go with the Resilia valve, but after a good deal of due diligence and several consultations, I ultimately decided to go with a mechanical valve. I wanted to be one and done, and at 53, I was assured of future procedures down the road if I went with a tissue valve. Two of the leading valve surgeons in the country told me the same thing, that at the young age of 53, I should expect a tissue valve to last about 10 years. Some get lucky and it lasts a few years longer. Some get unlucky and it lasts a lot less than that, but on average to expect about 10 years.

So, doing the math, at 53 it did not look good for future procedures. That would have meant another procedure at about 63. It could be TAVR, if I qualified, but there is no certainty that anyone will qualify for TAVR. And honestly, TAVR at 63 is probably not a good idea. It would be expected to last 5 to 10 years and the surgery following TAVR is a very high risk one. Some will say that you might be able to do TAVR in TAVR at that point, but consults with my cardiologist convinced me that this would just be a bandaid for a few years and not a good one. With TAVR in TAVR there is so much junk in that valve that you have a very low cardio output, and probably can't do much more than walk and still face a very high risk surgery on the next round, which will probably be just around the corner.

At 45 you are 8 years younger than I was. Every guideline in every country indicates that a patient your age should get a mechanical valve, to have the best chance at a normal life expectancy, assuming that there are no contraindications to warfarin. Timmay indicated that he would probably go with Resilia if he was 65. That is about how I feel. I think that Resilia has a lot of promise and I would likely go that route if I was about 65, an age at which a tissue valve is expected to last longer and also an age at which we have less life expectancy remaining, increasing the odds that the valve will take you to the end.

Life on warfarin is just like life before warfarin. I run, bike, do Brazilian Jiu Jitsu, hike and swim. Don't let anyone tell you that you can't live an active life on warfarin- that is nonsense. I self manage and find it very easy to do and stay in range.

I was deciding between On-X and St Jude mechanical valves. My surgeon was willing to go with whichever I chose. But, he indicated that if I go with On-X, I would be on the proven INR range of 2 to 3, not the range tested in the PROACT Trial. He had some very negative things to say about the PROACT Trial and indicated that patients at INR of 1.5 to 2 are are high risk of blood clots- stroke. Ultimately, I chose to go with St. Jude.

So, there is no perfect valve. One choice means anti-coagulation for life. The other choice, at age 45, means future procedures and a lower life expectancy. But, as others will say, the only wrong choice is to not get the procedure. The choice is yours and yours alone to make. No one else will be the one who has to live with the consequences of your decision.

Best of luck in your decision and best of luck with your procedure, whichever valve you choose. It does not matter if you choose a valve different than what we would have chosen- we will all be here to support you no matter what.

Hi and welcome

lots of good answers above.

Groy said:

With On-X I'm scared to be too vulnerable to an accident or that warfarin may damage my body/organs at a long run.

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its the very reason why I wrote this blog post; to put proper context on the wildy inaccurate and frequently wrongly presented basic facts

https://cjeastwd.blogspot.com/2014/01/heart-valve-information-for-choices.html
Then this post to dispel the also wrongly presented facts about warfarin

https://cjeastwd.blogspot.com/2014/09/managing-my-inr.html
so, to back that up there's my entire series about INR related topics here

https://cjeastwd.blogspot.com/search/label/INR
Lastly remember that facts are facts but people write about interpretations to guide you into something which perhaps suits them. Do your research on proper sources

https://cjeastwd.blogspot.com/2021/07/done-my-research.html
I encourage you to read all of that carefully (you know, like as if your actual life outcomes depend on this choice).

Oh and the most common argument against a mechanical valve is "but I'm active". Are you more active than this?

https://www.newsweek.com/my-turn-climbing-everest-bionic-heart-99749
Lastly one more tip always question what a qualitative word like "younger" means in quantitative ways



Best Wishes

PS; its worth asking your surgeon why arguably the worlds best valve (the St Jude) wasn't on your list of choices? There are few reasons to choose the On-X over the St Jude. For example, there's marketing claims and then there's independent measurements:

https://www.valvereplacement.org/threads/aortic-valve-choices.887840/page-2#post-902334

BCAVR said:

Worth thinking about Ross if you’re not going prosthetic, but you’d want to be real picky about finding an experienced surgeon etc.

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word

Chuck C said:

At 45 you are 8 years younger than I was. Every guideline in every country indicates that a patient your age should get a mechanical valve,

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worth restating

Timmay

Timmay said:

But the cost for my self testing is annoying at $600-ish a year

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Three tubes of 24 strips at @$100 each would adequately cover 52 weeks of self testing and a bunch of adhoc testing, either you should confess your habit or hobby or explain to the poor gentleman why is it so.

Myself I never use 3 tubes per year...

pellicle said:

Timmay



Three tubes of 24 strips at @$100 each would adequately cover 52 weeks of self testing and a bunch of adhoc testing, either you should confess your habit or hobby or explain to the poor gentleman why is it so.

Myself I never use 3 tubes per year...

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Point taken. I DID say I test twice a week - but I left out the frame of reference. Most self testers test only once a week. Stated in a better way: I am abnormal in my testing procedures and don’t follow the standard of once a week testing. This choice of mine differs from the norm and is costing me extra money. My complaint of cost really doesn’t have a bearing on anyone but me. Ultimately, it’s immaterial and I probably shouldn’t have brought it up.

The choice - in 2014 I was facing my second open heart surgery OHS to replace my bicuspid aortic valve. I was pretty adamant about avoiding Warfarin and planning on TAVR replacement in 10-15 years, so I decided bio valve. Surgeon first tried the bovine, but wasn’t pleased with results so switched to porcine. I slept through it all.
Last year, 2022, actually this weekend, I had the tommyboy14 experience- the bio valve leaflet tore. “Flailed” was the tech term. I was telling the doctors I was going for a TAVR- haha - but when I went to my original surgeon, he too was planning the mechanical valve.
At the time the Eliquis study was still active so they were pushing On-X and I did not know to research options, i.e. St Jude. (Eliquis study was cancelled the week I was planning to start…)
I got the On-X last June and now take two Warfarin tabs daily, test with the home monitor kit weekly, and otherwise cycling, skiing, running- staying as active as I want. Not playing soccer - bruises just stay around for a long time and I’m chalking that up to blood thinner - but at 55 I’m ok with that.
My experience - your choice.
With hindsight and my current experience, I would have gone mechanical in 2014.

Morning

Timmay said:

My complaint of cost really doesn’t have a bearing on anyone but me

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I only mentioned it because out of pocket charges and medical insurance is discussed a lot...

I missed that you test twice weekly in my skim (sorry) but for which I can't see a valid reason for; but equally I'm not going to tell anyone to test less. Its just that with a new person wanted to make (possibly hidden) assumptions plain. Beginnings are a delicate time and wrong ideas can be hard to shift.

With respect to discussion I should say to @Groy that once one is established weekly testing is pretty much sufficient. Myself back when I started I only tested weekly and confined my more frequent testing to specific objectives on learning or observation.

Best Wishes

Groy said:

Inspiris Resilia vs On-x, can't decide.



Hello



Looking further, for your opinions and thoughts, hopping not to be too redundant.

im a man and 45 years old with a bicuspid aortic valve, but with a healthy heart (except the aortic valve of course) which is pumping blood at good quantities but at high pressure (believe it’s called vertex), severe stenosis and regurgitation, I'm healthy from everything else.


My doctor told me that it’s time for surgery.

He offers me minimal invasive surgery; but he gives me two options... that’s On-X and Inspiris Resilia.

With On-X I'm scared to be too vulnerable to an accident or that warfarin may damage my body/organs at a long run.



With Inspiris Resilia I'm dismayed of how bad could be my second surgery (even with valve on valve tech), or how common this valve will fail at really early stages (1 to 3 years)?

Could I hope that advances in medicine offer me better options, not available today, for a second surgery 20 years from now?



My surgeon says my heart will be at 100% after the surgery regardless of the chosen valve.

And I like lifting weights at the gym.



I'll highly appreciate your opinions, experience or expertise.

Thank you.

Click to expand...

I don't know what the latest data is on the Resilia valve. What is the latest data on how many make 5 years, 10 years, 15 years etc.. How is this data influenced by patient type? Sex, age etc.. So at 45 you could be facing a new valve from anywhere from 5-15 years and on a good day maybe longer.
I don't think we should make decisions on what may be available medically in 15-20 years. Total guess-hope. So you could be buying yourself at best two procedures or maybe three or even four if you go the tissue approach at this time.
Having a mechanical valve gives you a chance for one procedure. I have been on warfarin for 40 years. It is annoying but not a huge issue. I have had some significant bleeds from trauma in my leg twice. Painful but I got better. As the years go by it may be a bigger issue as I may face more medical procedures that may require fiddling with the dose or with bridging. But having to have multiple heart procedures whether open or vascular like TAVR each have their own risks and for the open a bit of misery. So there is no free lunch but probably in 2023 given your age a mechanical would be preferred.

Finally as far as which valve I would consider the St. Jude. Longer time in the wild than the ON-X and less misleading information about the low INR suggested by the company that makes the ON-X. I don't like misleading information to try to gain market share and also makes me wonder about potentially other aspects of the company and their data.
Good luck on whatever you do.

Groy said:

My doctor told me that it’s time for surgery.

He offers me minimal invasive surgery; but he gives me two options... that’s On-X and Inspiris Resilia.

Click to expand...

I dont think the options he offered you are nearly equivalent. You may find this article helpful to your decision...

Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry

An excerpt:
"The risk/benefit profile of mechanical versus bioprosthetic valves has led to both American and European guidelines on valvular heart disease recommending the use of mechanical valves in patients younger than 50 years [14, 15] with the European version extending this recommendation to patients up to 60 years (class IIa, level C) and the American guidelines considering both mechanical and bioprosthetic valves in patients between 50 and 70 years of age (class IIa, level B, no RCT data). Despite these recommendations, the use of bioprosthetic valves has significantly increased over the last few decades across all age groups [26]. Currently bioprosthetic valves are being developed that avoid the risk of valve required anticoagulation while reducing the reoperation rates seen with earlier generation bioprosthetic valves."

Despite the point that this "registry study" is funded by Edwards (the manufacturer of Inspiris Resilia), the guidelines quoted are unambiguous for patients under 50.

Full disclosure: I received an Inspiris Resilia aortic valve in 2022 at 70 yo. I'm praying that my valve lasts 20 years and that I die from something else.

Wishing you the best outcome with your pending surgery.

Thanks for posting this. These numbers are impressive. I think that the issue is that the average age of the trial participant is 65. And we know that tissue valves wear out faster in younger people...

ATHENS1964 said:

https://www.dicardiology.com/conten...rable-durability-safety-and-efficacy-outcomes

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