Inspiris Resilia vs On-x, can't decide

ATHENS1964 said:

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

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This is excellent news!

Important also to note, from the linked article regarding 7 year outcomes:

"The seven-year data from the COMMENCE aortic trial demonstrates strong clinical outcomes and excellent durability in a study of younger patients with a mean age of 65.1 years."

It comes back to what the public identifies as "young" vs what "young" means in the valve surgery world, very much like the meme Pellicle posted a few posts upstream. Yes, a person who is 65 is young in the valve surgery world. And, if a patient is under 50, well, that's basically a toddler.

I thank everyone for taking their time and contributing with their experience.

I carefully read each of your comments from day one.

Your opinions and experiences have made me see things I hadn't contemplated or confirmed like biological valve ruptures, life on warfarin.

I was honestly encouraged by how well you have coped with our condition.

although I am going to have a miniAVR I realize that a second surgery would most likely be a more dangerous full sternotomy and relying on inspiris resilia “25 years of endurance” it’s not a good bet.

I was relying on low INR of On-x, but as you guys told me, it's not safe

The Low-INR claim of the On-X is just marketing. There is no strong statistical evidence to support this. The numbers involved in the trial that supported this recommendation were small.

However the good news is that a large recent randomised control trial found that St Jude and On-X valves have basically the same event rates.
0.5% stroke risk per year and around 1% major bleed per year:

https://www.jtcvsopen.org/article/S2666-2736(22)00308-4/fulltext
These risk values are smaller than in many previous studies. We can only speculate why, but it is quite plausible that it is the significant improvement in INR control that occured in the late 1990s that is behind these lower event rates. There were two improvements: 1) We moved to the INR system vs Prothrombin measure before: Apparently INR is easier to manage. 2) The wide spread adoption of self-measurement/self-management of INR over time.

Good luck with your decision

tommyboy14 said:

The Low-INR claim of the On-X is just marketing. There is no strong statistical evidence to support this. The numbers involved in the trial that supported this recommendation were small.

However the good news is that a large recent randomised control trial found that St Jude and On-X valves have basically the same event rates.
0.5% stroke risk per year and around 1% major bleed per year:

https://www.jtcvsopen.org/article/S2666-2736(22)00308-4/fulltext
These risk values are smaller than in many previous studies. We can only speculate why, but it is quite plausible that it is the significant improvement in INR control that occured in the late 1990s that is behind these lower event rates. There were two improvements: 1) We moved to the INR system vs Prothrombin measure before: Apparently INR is easier to manage. 2) The wide spread adoption of self-measurement/self-management of INR over time.

Good luck with your decision

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Thankyou for the information and good wishes, I'll take a read at the article

Hi

Groy said:

I was relying on low INR of On-x, but as you guys told me, it's not safe

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there are actually instances here for anecdotal support to what is established in the literature

I'd look at my points here and note the reference to the other discussion (what I'm talking about there) for context (and how it relates to On-X and lowering INR marketing (to the ignorant hysterical):

https://www.valvereplacement.org/th...ial-on-x-lower-inr-target.888778/#post-920154

Next I'd cite this study (which IIRC includes On-X valves) of some thousands of participants (so yes, from a clinic) and in particular note the graph I've copied (and annotated) below from that study



URL for study
http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/415179

Also of importance is time in therapeutic range (TTR) the longer you are TTR the better and the more that you will have the age related issues of stroke or bleed (meaning what happens to every human who isn't on a mechanical valve or warfarin). An discussion of what those statistics mean is found here:

https://www.valvereplacement.org/threads/per-patient-year-question.888798/#post-920415

Its important to note that if you didn't yet watch (linked in my above blog post) the presentation by Dr Schaff I'll suggest you do it now



It is well worth paying attention to, and any dismissals of it being 2009 I would rebuff with:

• what subsequent studies have been done to counter or dismiss his points
• what has changed about human anatomy and biochemistry since then (hint; nothing)

The question is often asked "what makes a goo valve?" ... personally I think @nobog 's advice of "one that lasts 20 years is the best answer.

I began my surgical career (as meat) when I was 10 (with a repair). I had that repair replaced with a homograft at 28, then had that 2nd hand valve replaced at 48 with a mechanical. I'd thus class the homograft as a good valve.

So IFF you consider that another surgery will be in your future (because, say ... aneurysm) then a homograft may be a way to stretch that future surgery further down the path. I say may because "it depends". There are always factors to consider.

Lastly I'll say that (as Dr Schaff observes) many people on a tissue valve statistically will find that warfarin is needed eventually as they age. Indeed this is true of the general population (as I'm just now helping a person who's been introduced to warfarin because of a stroke history). Wouldn't it be pernicious to the mind to specifically chose a valve that will fail over a valve that will never fail to avoid what you find yourself on anyway? The wait for that failure will probably be more stressful.

IFF you go mechanical then soon after you make that choice and soon into recovery (when your INR is more or less well established) then reach out and I can give you a hand with managing INR. Or just keep an eye on my signature as my book on that subject is nearly finished at the proof reader (wow, very interesting) and I'll be publishing within a month or two I expect

Best Wishes

pellicle said:

Hi


there are actually instances here for anecdotal support to what is established in the literature

I'd look at my points here and note the reference to the other discussion (what I'm talking about there) for context (and how it relates to On-X and lowering INR marketing (to the ignorant hysterical):

https://www.valvereplacement.org/th...ial-on-x-lower-inr-target.888778/#post-920154

Next I'd cite this study (which IIRC includes On-X valves) of some thousands of participants (so yes, from a clinic) and in particular note the graph I've copied (and annotated) below from that study

View attachment 889245

URL for study
http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/415179

Also of importance is time in therapeutic range (TTR) the longer you are TTR the better and the more that you will have the age related issues of stroke or bleed (meaning what happens to every human who isn't on a mechanical valve or warfarin). An discussion of what those statistics mean is found here:

https://www.valvereplacement.org/threads/per-patient-year-question.888798/#post-920415

Its important to note that if you didn't yet watch (linked in my above blog post) the presentation by Dr Schaff I'll suggest you do it now



It is well worth paying attention to, and any dismissals of it being 2009 I would rebuff with:

• what subsequent studies have been done to counter or dismiss his points
• what has changed about human anatomy and biochemistry since then (hint; nothing)

The question is often asked "what makes a goo valve?" ... personally I think @nobog 's advice of "one that lasts 20 years is the best answer.

I began my surgical career (as meat) when I was 10 (with a repair). I had that repair replaced with a homograft at 28, then had that 2nd hand valve replaced at 48 with a mechanical. I'd thus class the homograft as a good valve.

So IFF you consider that another surgery will be in your future (because, say ... aneurysm) then a homograft may be a way to stretch that future surgery further down the path. I say may because "it depends". There are always factors to consider.

Lastly I'll say that (as Dr Schaff observes) many people on a tissue valve statistically will find that warfarin is needed eventually as they age. Indeed this is true of the general population (as I'm just now helping a person who's been introduced to warfarin because of a stroke history). Wouldn't it be pernicious to the mind to specifically chose a valve that will fail over a valve that will never fail to avoid what you find yourself on anyway? The wait for that failure will probably be more stressful.

IFF you go mechanical then soon after you make that choice and soon into recovery (when your INR is more or less well established) then reach out and I can give you a hand with managing INR. Or just keep an eye on my signature as my book on that subject is nearly finished at the proof reader (wow, very interesting) and I'll be publishing within a month or two I expect

Best Wishes

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Thank you very much for your help

I already saved and read the links of your blog you post in this thread. very helpfull

I'll definitley will buy your book

I keep asking myself is an over $200k surgery NOT once but twice worth not taking almost free rat poison that costs a few hundred dollars a month in monitoring?
These choices drive up costs and keep other patients outside healthcare and are the reason we spend so much money but have poorer outcomes.

Hi

Groy said:

I'll definitley will buy your book

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Well if you pick a tissue prosthesis it won't be much use

Ultimately you should make the decision based on the evidence and the circumstances unique to you. I have not aimed to sway you one way or another, but simply done my best to share what I know and have learned.

There will he impediments placed before you and responsibility upon you if you choose INR self management (or even something similar to that). The Americans here like Chuck and Timmay can advise you there better than I can.

There is nothing specifically wrong with selecting a valve like the Resilia, it just means you will have another intervention down the track. 2 surgeries isn't such a horrible thing (says the guy who's had 3), but each redo brings interesting and perhaps unforeseen risks.

Best Wishes

Mister_James said:

These choices drive up costs and keep other patients outside healthcare and are the reason we spend

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Very ethically slanted point. That's probably why Norway (and Australia) does mechanical in selected under 60yo's

And

Chuck C said:

The seven-year data from

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Personally I find it a bit disingenuous that they do studies on "long term durability" and call 7 years sufficient to start projecting out further, when we know it's not linear in progression of SVD.

Groy,
I wish you well in whatever you choose. I had my first valve replacement, for a bicuspid aortic valve, at 37 and I went with a homograft that lasted 21 years and would have kept going but for the ascending aortic aneurysm I had to replace. My cardiologist never told me that ascending aneurysms can be common for individuals with bicuspid valves. So, at 58, I had OHS last year due to the aneurysm. The homograft was replaced as an age precaution although it was still functioning well. I went with the Inspiris Resilia because I am used to that type of normal in my life. I would simply suggest that you inquire about your risks for an ascending aneurysm, because that may require a future surgery regardless of the valve you have. The advances in medicine are significant and I personally do not want to be on blood thinners for the rest of my life - my personal choice. I have fortunately had no complications following two OHS and the option for a TAVR - possibly - was enough of a selling point for me despite me being below the European recommended age. Best wishes in whatever you decide!

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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US is different.
The doctor signs you up to a monitoring group that you call your results into and they tell you "you are in range" (for a fee and supplies)and they send results to your doc who then reviews and charges a fee and the doc calls you to say stay the same.
Then the monitoring group cuts a check to your doctor a referral fee.

Mister_James said:

US is different.

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indeed, well known; but Timmay and Chuck are in the USA one in California the other in NY area ... and they both self manage

Challenge them on this not me, for they (like I said) know how it is in the US

Mister_James said:

US is different.
The doctor signs you up to a monitoring group that you call your results into and they tell you "you are in range" (for a fee and supplies)and they send results to your doc who then reviews and charges a fee and the doc calls you to say stay the same.
Then the monitoring group cuts a check to your doctor a referral fee.

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I don't have to do any of that. Part of this is that my insurance company does not cover self testing supplies. So, I am out of pocket about $260/year for strips ($5 x 52). And for that price I have total independence. I may end up switching carriers at some point. If my new carrier covers self testing supplies, but requires me to jump through hoops, I'll choose to pay the $260/year to remain independent.

My cardiologist is involved, to the extent that I contact him through the patient portal and sometimes ask him to put an INR test in for me at Quest, so that I can test the accuracy of my meter. He know that I'm in range 90% + of the time.

Mister_James said:

US is different.
The doctor signs you up to a monitoring group that you call your results into and they tell you "you are in range" (for a fee and supplies)and they send results to your doc who then reviews and charges a fee and the doc calls you to say stay the same.
Then the monitoring group cuts a check to your doctor a referral fee.

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Or, alternatively, you convince your doc that you’ll do a better job than anyone else. In that case, you make it like YOU like it. Nobody will manage me better than me.

Like Chuck, my insurance will not cover self-testing supplies - and I have REALLY good insurance that covers everything. I honestly don’t know of any health insurance here in the states that will cover your supplies UNLESS you are part of a self-monitoring service. Being part of a self-monitoring service changes the game. But I don’t want to allow someone else to manage me. I want to self-monitor AND self-manage.

Dano64 said:

Groy,
I wish you well in whatever you choose. I had my first valve replacement, for a bicuspid aortic valve, at 37 and I went with a homograft that lasted 21 years and would have kept going but for the ascending aortic aneurysm I had to replace. My cardiologist never told me that ascending aneurysms can be common for individuals with bicuspid valves. So, at 58, I had OHS last year due to the aneurysm. The homograft was replaced as an age precaution although it was still functioning well. I went with the Inspiris Resilia because I am used to that type of normal in my life. I would simply suggest that you inquire about your risks for an ascending aneurysm, because that may require a future surgery regardless of the valve you have. The advances in medicine are significant and I personally do not want to be on blood thinners for the rest of my life - my personal choice. I have fortunately had no complications following two OHS and the option for a TAVR - possibly - was enough of a selling point for me despite me being below the European recommended age. Best wishes in whatever you decide!

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I appreciate your best wishes and info, Thank you.

an ascending aortic aneurysm was something I was not aware of.

May I ask, your ascending aortic aneurysm was discovered at the time of the homograft valve surgery? Or time after the surgery? or you developed that aneurysm time after the first surgery?.

Hi Gory

Groy said:

an ascending aortic aneurysm was something I was not aware of.

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you know, I nearly added that in my original post to you and didn't. My 3rd OHS was driven by aneurysm. If you have BAV then you have a strong likelihood of aneurysm (it can be ascending or descending, although in the main it begins with a dialated root.

you should very much discuss this exact point as a priority with your team. For example you'll find (if you start searching here) that people who have OHS to replace a valve because it was BAV often have aneurysms drive a replacement. In my case the homograft valve was the one which was kicked out because its easier to just plug in a new valve and a pre-attached artery-replacement. Such as B below



time saved in surgery is time not spent on the cross clamp and time in surgery is the biggest predictor of infections and post-surgical complications. Its not joke to say they pace this like a F1 race.

So do have that conversation with your team.

To answer when its found, its often found on an Echo, if its major they'll refer you to a CT immediately and if that's worrying they'll refer you to an angiogram (personal experience).

Best Wishes

Timmay said:

...I honestly don’t know of any health insurance here in the states that will cover your supplies UNLESS you are part of a self-monitoring service....

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I have US blue cross and blue shield and self monitor and self manage. My cardiologist's practice doesn't like it, they want you to go to the coumadin clinic. However my cardiologist allows it, thus his practice allows it as well.

Hi Groy, and welcome!

If you go back through my previous posts, you'll find my husband's story. He went with the Inspiris Reslia and promptly had it replaced 10 months later. I'll spare you the details because it was a bit of a rollercoaster and not the typical experience with that valve, but he ultimately ended up with the On-X.

His last surgery was August 9th, 2019 and he's doing great. He's been opened up a few times now, and has lived to tell the tale! Warfarin is no biggie (I think the only people that make it a big deal are those that aren't on it), self-testing is no biggie (once we got everyone to respect his wishes of a 2.0-3.0 INR range...that was an epic battle spanning years. Ridiculous.), and he's still just as active as he was going in. Still rides his dirtbike, captains our little boat, drinks alcohol, uses cannabis, works a physical job, we are DIYing a complete gut and remodel on our house, he still does heavy lifting...nothing is different for him except the scar, the warfarin, and the fact that we keep a special first aid kit for him for when he gets bumped, bruised, and scratched. Which has still definitely happened just as much as in the past! He's a stubborn guy with the will to do just about anything

All this is to say, I guess, that we can go into these things with an amazing support system, all of our t's crossed and i's dotted, thinking we have all of the ducks in a row, and yet things can still turn upside down on us. Which is not to scare you, but to encourage you that many of these fine folks here have had plans go arwy and have lived lives after, just as full as before. You are in the right place, and doing your due diligence to research for yourself and make an informed decisions, which is the best thing you can do. Keep asking questions, and keep hanging around! This is a good group of people to help you through this.

All the best to you!
Jill (wife to Mathias, OHS 3x over 10 months).

Oh! I should edit to add, Mathias had AVR and ascending aortic aneurysm fixed at 25 years old. The aneurysm fix is still holding strong from his first surgery, and his last surgery placed the On-X in the aortic position. He just got his yearly echo results back last week "Everything is pumping along just fine!" per his new cardio. Even a couple of years later and we still celebrate when his echo comes back peachy.

pellicle said:

Hi Gory



you know, I nearly added that in my original post to you and didn't. My 3rd OHS was driven by aneurysm. If you have BAV then you have a strong likelihood of aneurysm (it can be ascending or descending, although in the main it begins with a dialated root.

you should very much discuss this exact point as a priority with your team. For example you'll find (if you start searching here) that people who have OHS to replace a valve because it was BAV often have aneurysms drive a replacement. In my case the homograft valve was the one which was kicked out because its easier to just plug in a new valve and a pre-attached artery-replacement. Such as B below

View attachment 889248

time saved in surgery is time not spent on the cross clamp and time in surgery is the biggest predictor of infections and post-surgical complications. Its not joke to say they pace this like a F1 race.

So do have that conversation with your team.

To answer when its found, its often found on an Echo, if its major they'll refer you to a CT immediately and if that's worrying they'll refer you to an angiogram (personal experience).

Best Wishes

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Thanks’ again for the info.

This is a nightmare!

I must say I have several Echocardiograms across 4 different cardiologists and none of them mention an aneurysm. Absolutely I’m gonna talk with my cardiologist about it.

I’ll probably go with On-x and will do my best to take care of me and my new valve hoping no reintervention