Aortic aneurism with bicuspid valve - options in 51 year old

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AndyW

Member
Joined
Apr 17, 2022
Messages
5
Hi, newbie here from NZ. Firstly thanks to the seasoned posters for your comments on others threads (chuck, pellicle, warick and others).

I have a recently discovered a 2-for-1 5.7cm ascending aortic aneurism and bucuspid valve combo. Ive got OHS pencilled in for mid July. Apparently my valve is ok with only mild regurgitation. My surgeon and second opinion surgeon are both recommending trying valve sparing aneurism repair first. If that is not possible on the day they will do a valve conduit combo (Bentalls).
Firstly, does anybody have comments on the valve sparing approach and longevity of bususpid valves? I read somewhere that 70% need replacing at some point. I have read a few posts and papers on this. Secondly, does anybody have intel on the durability of the inspira resilient valve post 5 years? Seems a bit of a leap of faith to hope for 20 years from it followed by a TAVR with another 20 years (takes me to 91), or is this a viable option to avoid warfaren? Not keen on a second OHS and the associated risks, but not keen on warfaren either. I have an active lifestyle with mt biking and skiing and kayaking.
 
Hi and more or less "welcome aboard"
I have a recently discovered a 2-for-1 5.7cm ascending aortic aneurism and bucuspid valve combo.

so 1) that's at a point where surgery to correct the aneurysm is a priority and 2) that means you won't have any valve replacement ruined by the arrival of an aneurysm without invitation.

... Apparently my valve is ok with only mild regurgitation.

... but it would make little sense to leave it in there and require a surgery for that in a few more years (say up to 10).

My surgeon and second opinion surgeon are both recommending trying valve sparing aneurism repair first. If that is not possible on the day they will do a valve conduit combo (Bentalls).

I personally do not see why they would say that, I mean the mean duration of a repair is not as good as a mechanical (end of story) and were you not having an aneurysm graft one might make the argument that repairing the valve made some sense in reduced bleeding.

https://pubmed.ncbi.nlm.nih.gov/30953445/
In-hospital and 1-year mortality was lower in repair cohort, although not reaching statistical significance (1.3% vs 3.6%, P = 0.12; 5.9% vs 9.3%, P = 0.77). Reoperation rate was higher in repair patients at 1 year (8.8% vs 3.7%, P = 0.03).​

so that's not encouraging ... and really one fhukken year ... like WTF? Seriously at 51 I'd be looking further down the track.

then

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3895061/
Two papers compared AV repair with aortic valve replacement (AVR) with a bioprosthetic valve and found that freedom from AV reoperation at 5 years was from 90 to 91% for the repair group and 94 to 98% for AVR. Freedom from AI (moderate or severe) at 5 years was 79% for the repair group and 94% for AVR.​

emphasis mine, and rest worth reading IMO

Firstly, does anybody have comments on the valve sparing approach and longevity of bususpid valves?

well speaking for myself (just as a person, not a scientist as that title has already been taken here) I would, with what I know, be seriously asking this: given that Bicuspid Aortic Valve (BAV) is well understood now as a connective tissue disorder, and given that you already have an aneurysm that frequently goes with that what would make you (asked of the surgeon) think that I'd be amenable to a repair which gives me a greater than 90% freedom from reoperation at 10 years?

I'd look them straight in the eye when asking that. Take notes.

Now, just going back to me for a minute, I had my last OHS (which was #3) surgery in 2011, I was 47; I had a mechanical. If I'd gone anything except mechanical I'd either be in SVD by now or not far from it. I can tell you with great clarity that at 58 now I would not be looking with a gleam in my eye towards another surgery. I would not be expecting I'd bounce back from that well either. I mean I'm fine now but I have a clear view of how health gets a bash on the head and requires hard work to regain when surgery is done at (nearly) 50, let alone at 60.

I think its safe to say you would be unlikely to be a candidate for a TAVR at re-operation and data suggests they last under 10 years, so I'll leave you to run the age numbers there.

I read somewhere that 70% need replacing at some point.

my view is that its more like 90% would require replacement, if you didn't die of other causes before that time, like if say you were 65 or more when you had the repair.

Secondly, does anybody have intel on the durability of the inspira resilient valve post 5 years? Seems a bit of a leap of faith to hope for 20 years from it followed by a TAVR with another 20 years (takes me to 91), or is this a viable option to avoid warfaren?

ok, let me bullet point these in order:
  • that they only promote the resilia to 5 years is rather telling to me, because (as has been mentioned here in the past) "even a 20 year old design pig valve would give you 5 with no expectation of problems" - so there's that.
  • leap of faith to hope for 20 years - submitted as understatement of the week
  • TAVR with another 20 years submitted for science fiction double feature award
  • everything I've ever read suggests that the number of people on warfarin with a tissue prosthetic goes up to over 30% as they progress in the years with that valve. So, to have chosen a tissue prosthetic simply to avoid warfarin must make the information that "you need warfarin now" even more bitter to swallow
Not keen on a second OHS and the associated risks, but not keen on warfaren either. I have an active lifestyle with mt biking and skiing and kayaking.

I suspect that, like everyone, you have a mistaken view of warfarin ... the risks and the onerous nature of it. However its actually important that you have the right attitude or it will be riskier. These attributes would include:
  • taking seriously compliance with the drug (take it, don't make mistakes)
  • taking control of blood testing with a POC device >regularly< (like weekly) and learning what's needed to actually self manage (do not rely on clinics)
Next, read through the many many posts here where people say "I thought it would be difficult, but after a year I realised it wasn't any issue at all". Why do we in the majority say this? Because Jantoven is paying us? Why also is the major resistance to warfarin from the crowd who took the opportunity to avoid it (pretty much at all costs).

Lastly I'll recommend this video for you to watch:



I'd really get a coffee and pay attention, take notes and especially at about 11:20, but its all good stuff.

Best Wishes
 
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I had a valve saving surgery I.e David’s procedure. Had a redo after 3 yrs and replaced the native valve with mechanical valve. I have been taken wafarin and I have been managing it ok.
If I could take time back I would have gone for a mechanical valve the first time and avoided the stress and risk of second OHS
This is only my opinion and hope it doesn’t add confusion. Finally you & your family needs to make a decision which will be right for you all. All the best
 
Globally there has yet to be any verified SVD failure of the Resilia Valve platform (a handful of reported fitment failures), the Commence trials and current hospital propriatory research support and indicate better than expected performance and a projected 15-25 year life. Understanding the warfarin bogeyman is not really a concern for many as detailed on this forum, but this is good for people who for personal reasons wish to avoid or have contra indications for blood thinners. These days they measure you up for the TVAR before they fit the Resilia and it's designed to fit 2/3 which at 51 would be beyond most people's lifespan. This aside the future is likely to be more the use of robotic surgery using portal access methods which is much more accurate than any human surgeon so in 15-20 years who knows and with some dark humour my surgeon said after 50 we are all on the actuarial downhill slope so something else may get you. Essentially either mechanical or the Resilia are good options IMO.
 
What the Resilia Valve,
yes, that one ... it was only approved by the FDA in 2017, so naturally we would not see any SVD at the clinical observation level yet. That's what I was calling into attention when you started shilling it up as no SVD yet. We would not expect to see SVD manifest in clinical observations for 10 years no matter what valve it was.

and a projected 15-25 year life

Lets try to keep it real here and not act like tribal fanbois over the TeamValve we've picked, its not NASCAR racing.

You may observe that I never "cheer leader" a valve, the most I'll say is something like the St Jude has a very long history of no known problems.

When you joined you decried a previous group as a "prayer group masquerading as a valve forum", so I had expected that meant you were rational and evidence based. A summary of the evidence to hand at 2020:
https://www.ahajournals.org/doi/10.1161/JAHA.120.018506

The durability of modern BHVs exceeds current standards for both stented and stentless models; for example, the Carpentier‐Edwards PERIMOUNT Magna Ease prosthesis retains its original hemodynamics even after 1 billion cycles, corresponding to 25 years of operation. Yet, most BHVs show failure signs significantly earlier, in particular in young patients. Thus, SVD development cannot be attributed solely to biomaterial fatigue and mechanical degeneration.​

Manufacturer claims are often all that we have until we have 15 years in the field.

Best Wishes
 
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G’day,

Tough situation, it’s hard when it’s not cut and dry. I think what @pellicle said about not barracking for your TeamValve is very useful to remember here, you'll hear/read a lot of anecdotal stories for each.

I had a valve sparing procedure with aortic root aneurysm repaired. From my perspective, my surgeon and I discussed best case scenario options for the day of surgery - 1, 2 and 3. They were spare the valve, bio valve and mech valve. I was lucky to have a surgeon who tried to view the decision through my eyes rather than his. He told me that there are certain characteristics they assess for once you're opened up. If your native valve meets these characteristics/requirements then it would be preferred (in my case) that it was spared. It's about commissure length and the condition of the connective tissue (I think). If it is spared and the repair is within certain limits, you could join the ranks of some patients at centres of excellence in Canada and the US have data pushing out to 20 years (and counting) with no re-op.

My opinion after hearing all the info and evidence was that my lifestyle would benefit from my own valve. But if you want a one and done, then go for mech. It appears that the mech is the most tried and tested. Pretty much bomb proof these days with the new ones.
 
They were spare the valve, bio valve and mech valve. I was lucky to have a surgeon who tried to view the decision through my eyes rather than his. He told me that there are certain characteristics they assess for once you're opened up. If your native valve meets these characteristics/requirements then it would be preferred (in my case) that it was spared.
Indeed, I've read of this a few times and I think I've heard my own surgeon (one of them maybe) say this too. Either way this relies on the experience of the surgeon and the work done. I've read (reported here) cases of a repair not lasting >5 years and that would have to be rather devestating. IIRC @cldlhd had a valve sparing surgery done and I understood he'd done some due diligence researching that to some extent too.

If you (meaning @AndyW ) have not read this post:
https://www.valvereplacement.org/threads/bicuspid-valve-aneurysm-and-complication.888125/post-907836
I would begin there, Cld's views are pretty consistently repeated throughout his many posts here and (having mentioned him above) he may drop on by eventually to explain his views again.

Anyway, Andy, I think its important to remember a few things
  1. these things are described statistically, not prescribed as your outcome: meaning that wining or not is a bit like a casino.
  2. having one surgery is better than having no surgery, having a second is less desirable but in the main not bad
  3. having a third is less desirable in terms of "externalities" (as the economists would say, meaning things accessory to but not the actual surgery) and I did my best to plan to avoid a 4th
  4. planning anything based on what technology might be in the future is foolhardy.

I've had a finger in a few options and can speak about my own experiences, however (for instance) my repair at 10 years of age, that lasted 18 years may not be what you experience.

On the subject of bomb proof, I helped one lady with her INR management who had gone through chemo for (I assumed breast) cancer (but my memory may have filled in that detail). Worthy of note was that after she was in remission she said that her doctors said that if she'd not had a mechanical valve that chemo would have ruined her tissue prosthesis. Nobody wants cancer and planning for it is bonkers, but as we age all sorts of things are possible but I usually only hear people talk about how problematic managing INR is around procedures. So, Andy, I'd say that on that note this is worth reading
my fist publication on the subject:
https://cjeastwd.blogspot.com/2017/12/perioperative-management-of-inr.html
a collaboration project with @Chuck C (where in the main I analyse his outcomes where he extended mine):
http://cjeastwd.blogspot.com/2022/05/rapid-dust-off-inr-management.html
Best wishes with a complex decision
 
Hi Andy, where abouts in NZ are you?
I'm guessing perhaps Auckland as I had my OHS in Chch and I think there's only 3 surgeons here that all work out of the same pool for public and do private as well.
My 2 cents on warfarin is it is easier to manage it yourself here, I see a pool of doctors at my GP and they all seem to come and go with the international doctor exchange so none of them have ever "managed" me. It is not easy early on but not hard to become an expert self manager if you are motivated that way.
You may have seen me post my father had a mechanical valve for 30+ yrs and passed from unrelated issues, so when he had the St Jude valve in the early 80s there wasn't years of data either to say it would last for x amount of years, and there had been several previous mechanical valve incarnations that had mixed results in longevity. But now we know they do what it says on the tin.

The long slow degradation of a tissue valve and a lot of ailments is and can be attributed to your immune system sticking calcium in places it shouldn't, so perhaps the Resilia Valve might be on the track.
 
the Commence trials and current hospital propriatory research support and indicate better than expected performance and a projected 15-25 year life.

I don't believe that that Commence Trial makes this 15-25 year claim. Do you have a source for this? There is only 5 years of published data for the Resilia valve. The Resilia valve has not been in the field even close to this long, so it would be very optimistic to project it to last this long, especially for a 51 year old patient, which is young in the valve surgery world.

Like its predecessor, the Resilia valve did well in the 1 billion cycle test, meant to represent 25 years of physical use. The results were published November, 2021.

https://www.jtcvsopen.org/article/S2666-2736(21)00416-2/fulltext
This is certainly good news, but important to note this comment, the bold is mine:
" Overall, our data show that in the absence of thrombosis and calcification, the Inspiris Resilia aortic valve is durable through 25 years. "

One would not expect valve failure due to SVD at 5 years, so a 5-year study is limited in that it can't really project valve life in a clinical setting, other than to say that it should last 5 years. The real test is how the valve holds up to 10, 15, 20+ years in the human body, subject to the biological factors which lead to calcification.

Even though the enrollment number is low (220 patients), RESILIANCE will track young patients (<65) for up to 11 years. It basically picks up where the other studies stop. This is expected to be completed in 2027, although typically it takes a year or more for publication. Hopefully this will give us better data on the performance of the Resilia beyond 5 years. Although it should be noted that this is a non-randomized, single-arm, observational trial, and thus, this is considered a much lower level of evidence compared to a RCT trial.

Until the valve has actually been in patients (in vivo) for longer periods of time, it is speculation on whether the Resilia represents an improvement on valve life over the Magna Ease. Hopefully by 2027-2029, with the publication of RESILIANCE, we will have better data. Even then it will probably be premature to say that it should last 15-25 years for a 51 year old patient.

Info on RESILIA:

https://clinicaltrials.gov/ct2/show/NCT03680040
I hope that your comment of 15-25 years ends up being correct for the Resilia. We've heard other unsupported claims here that it will last 25-30+ years and even that it will last 2x to 3x as long as the previous generation. It would be very exciting if the Resilia ends up lasting 30+ years. But, for those who are looking to make their decision based on the available evidence, we just don't have it yet to make any of those claims.

And to be clear, I do not believe that it is wrong to make valve choice based on "hope" that it will last longer than normally expected for tissue valves. But, one is taking on some risk that it will not live up to the hope and face earlier need for replacement than hoped for. The idea is that one makes the choice with open eyes knowing the difference between hope and actual data.
 
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I had a valve sparing ascending and partial root aortic aneurysm repair 9 years ago. My BAV was well functioning prior to the procedure. After it had trivial regurgitation, then over the next year it progressed to mild, then moderate regurgitation. But it stabilized there. My latest ultrasound indicated mild to moderate regurgitation. Once it started leaking I thought I would never get 10 years, but now that looks very likely.
 
Pellicle is on the money so I’ll make my reply short.

Replace the valve. Trust us, you don’t want to have multiple open heart surgeries. You already know your bicuspid valve is going to fail. Do it now.

Inspiris Resilia valve? You’re not old enough to make it worth it. Maybe … maybe the resilia will last until you’re 65. Maybe. Maybe only 60. Maybe 70. Who knows. Also remember, tissue valves don’t last as long in younger patients. Whatcha going to do at 65-ish? TAVR IS NOT A GUARANTEE. You can hope and pray for TAVR but you need to be evaluated at that point of your life and be a candidate.

The best bet is a one piece prosthetic mechanical (bentall) if you’re trying to minimize open heart surgeries … because having one at 70+ won’t be easy.

And if you go mechanical, then ya gotta make a choice there too. Different mechanical valves, etc.
 
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I do not believe that it is wrong to make valve choice based on "hope"
well I've got friends who are addicted to gambling, to me "hope" (depending on what you hope for) leads to disappointment. If your hopes are realistic then they are not wrong. If you are hoping for the longer end of the claims by marketing then there is a very good chance you'll be disappointed. You can be sure there is no money back guarantee on valves by the makers. If it does not achieve your hopes then you'll still be suffering another surgery. (*unless Superman is on the money with a lifetime guarantee, then no more surgery will be needed)
 
A few thoughts this morning from me,

If we all waited 25+ years for data, where is this data coming from? All the best valves were either chosen (or chosen for) patients. Therefore I wouldn’t suggest you to be a fool for choosing the resilia.

The question id be asking myself is not about the longevity of the various valves, id be asking:

-Am aware that the risks increase with a reoperation?
-Does the prospect of reoperation down the line scare you?
- Will anything about my life be hampered by a mech valve/long term INR testing etc (relax everyone this is just my thought process, not gospel)

For me, If the answers are: Yes, no and yes/maybe I’d be going for a bio valve. If your aortic valve wasn’t already bicuspid I’d go valve sparring first.

Standing by for friendly pushback, bring it on! This isn’t an echo chamber, and it’s important we see all views.

Have a great day everyone, it’s bloody cold down in southern NSW, Aus.
 
If we all waited 25+ years for data, where is this data coming from?
exactly ... and it comes from the bleeding edge.

This is a reasonably well studied psychology:
1655760582621.png


However if you are an early adopter you want to make sure you know why you are.

I'd say however that the last 50 years of tissue valve development shows that the boundaries of durability in the younger patients are in a diminishing return curve, not on a growth curve. That this is reality is also evidenced by the choice to make the resilia study only 5 years (not say 19 years).

I would request that you find me a study by a tissue valve maker (or a 3rd party) which is as rigorous as this

https://pubmed.ncbi.nlm.nih.gov/11380096/
which btw is where I have had my surgeries done. I would call that place a centre of excellence.

I'll suggest you won't find such because:
  1. tissue prosthetic valve makers know that 15 years is on average enough durability for a 68yo
  2. diminishing financial benefits exist when you can clearly show 5 years data and project out to non critical thinking patients (IE most)
  3. mechanical valves exist for younger patients (even children although that is a fraught area)

So, from articles I discuss on my blog:

1655761067926.png


allograft = homograft

to me, a critical thinker would ask questions like: why isn't reoperation at X years a common thing, why is it always survival (think about the psychology there)

next there is this interesting pair:

1655761267893.png


Pericardial tissue did pretty well but isn't it interesting that
  • once you get to a bunch of late survivors they actually do really well
  • those same late survivors tapered off to nothing at pericardial (probably why nobody uses it now)
  • porcine did well all the way out to nearly 15 years (making patients in their 90's) ... even that old style porcine valve
  • mechanical started to show better results (and may be anticoagulation was introduced to porcine valvers in that late phase).
Lots of questions that are literally never asked by "believers" here. Yet lots of actual data exists if you dig for it.

Best Wishes

PS:
it’s bloody cold down in southern NSW, Aus.

was an acceptable winters 3.3C here (southern Queensland), but as the sun comes out to blue skies its likely to hit 18C around the arvo
 
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If we all waited 25+ years for data, where is this data coming from?

Good point. As I said, I am not against people making a choice based on hope, only that they are aware that the data isn't there yet and that it may not last as long as is hoped for. As it is based on the same platform as the Magna Ease, I think that it will most likely do at least as well as the Magna Ease. Is there some risk that it will not match the Magna Ease in performance and they will all start to fail at year 8? Yes, but I would say that it is a very low risk. In choosing the Resilia over the Magna Ease, I think that there is a pretty good potential reward vs risk. So far, the 5 year data seems to support that it is as good as the Magna Ease at the 5 year point. I expect this to continue. Will it be superior? We won't know for some time.

Also, it is not as though we need to wait 25 years to know if it is better. There are a number of young patients (< 65 years) being studied with the Resilia. At some point, maybe 12, 13, 14 years out, it should be pretty clear how the Resilia compares against the Magna Ease, and answer the question as to whether it is equal to or better. The reason is that tissue valves don't last this long for young patients on average in previous tissue valves. By then we won't yet be able to say 30+ years, but equal to or better is going to be plenty enough for most to make this choice, if choosing tissue.

I don't think we will have ever have a situation where everyone is waitng for 15-25 years data and have no volunteers for a hopeful new valve. The hope that it will be an improved valve will always be enough for a large segment of the market to make this choice. In time, we will know whether the hope was warranted.

It's is a little bit like the stock market. Some are going to always stick with the blue chip stocks for lower risk, given long term performance. Others will always gravitate towards new start ups, which offer the hope of huge returns but have not yet withstood the test of time and have associated risk. There are takers for both choices.
 
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