Second Surgery 20 Years Later

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Survived03

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Hello all,
I will be 63 yo this year and I had a valve sparing ascending aortic aneurysm repair almost 20 years ago (2 months shy). I am scheduled for open heart surgery on May 26 for aortic valve replacement due to severe aortic stenosis, and yes, I do have a bicuspid aortic valve. I am returning to the same institution that did my initial procedure. In fact, the surgeon I am using sat in on my initial aortic repair so he has already seen under the hood, so to speak.

Twenty years ago when I had my aorta replaced with Dacron I opted for the valve sparing approach. To be honest, I believe I was so stressed about the aneurysm (5.5-6.0cm) that I did not give as much thought regarding valve selection at the time. At the time they only had seven years of data showing the success rates of the valve sparing approach. The surgeon said "I can quote 7 years success but it could possibly go for 10, 15 years or perhaps your lifetime". I also asked a few additional cardiologists and primary care physicians their opinions regarding mechanical valve vs. valve sparing. For the most part they all liked the idea of valve sparing and felt that cardiology was continuing to improve and in the future years there could be less invasive approaches to a new valve if needed. They were correct.

At this time I have no regrets with my initial approach taking the path of repairing and utilizing my native valve when I had the aneurysm repaired. Twenty years was somewhat remarkable. However, given the condition of my stenotic valve, my age and my health goals we are requesting a bio valve for my upcoming redo and its going to be open heart surgery again. Only if, and I stressed this point with my surgeon, there is enough room for a good size bio valve that can manage a valve-in-valve replacement via TAVR in the future if required. I requested that if there were any doubts about future valves via TAVR then proceed with mechanical. My surgeon actually mentioned the goal of placing a valve large enough for ViV and the possibility of ViV a second time. That possibility was news to me.

So how did I get here? I have been having yearly echos for 20 years. We watched the stenosis and gradient across the valve increase to the point of cross-over into severe late November of 2022. For the most part I did not have any symptoms at that time. Day to day activities were not impeded in any way but I did feel a unique heaviness in my legs and arms about 10-15 minutes into a routine workout on elliptical machine starting prior to November echo results. It would last less than a minute and I could complete my exercise and then jump on the stationary bike and then on to weight training. I was never tired per say, no chest pains nor did I become dizzy. The surgeon and primary care physicians were all recommending a watch and wait on a three month basis. My cardiologist on the other hand felt like I should not wait. As many of you have mentioned and quoted papers on, the earlier the surgery in the severe stenosis stage the better the outcomes. So the next steps were to conduct a stress echo for added information and guidance on when I should have surgery. The stress echo showed no damage to the heart wall muscle and mild LV hypertrophy which I have had for many years. During the stress echo I did experience a normal increase in bp and then a sudden drop right around the 10 minute mark. This was probably what I had been feeling during my normal workout and contributing to the short period of "heaviness". That was the first "ahah" moment that I was looking for in order to push me along to surgery sooner. The second "ahah" moment was during my annual physical my labs came back mildly anemic. I researched anemia along with stenosis (I'm still searching for the publication to share with you all) and if memory serves me, the publication mentioned that approximately 40% of the time aortic stenosis will cause some for of anemia but they can't explain why. At this point I scheduled the surgery.

I also had a 36 gene panel focused on genetic mutations related to aortic aneurysms and connective tissue abnormalities. Surprisingly they all came back negative. I say surprisingly because I had conflicting data from an earlier study about 15 years ago that was probably not as robust and did not have all the fully validated genetic mutations available at that time. This new information did very little for my decision but it does help with managing sibling expectations and downstream management of the offspring of my children. If I had been positive this would have been a third "ahah" moment for me driving me to surgery sooner rather than later.

So to summarize for others with bicuspid valves with or without aortic aneurysms, you may want to consider the following:
1. Yearly echos
2. Stress echo once you approach the severe stenosis stage
3. If there is any sign of a moderate aneurysm, have everything replaced at once if feasible. You can still take a decision regarding mechanical, bio, or just repair regardless.
3. Genetic testing just for extra information that may help guide you and your decisions plus provide family risk data
4. Obvious, but capture multiple opinions regarding the surgical approach. My two surgeons had significant differences to their approach.

I will include and edit my post with a few publications that were useful for me once I can track them down. I want to thank everyone on this forum for their generous offering of useful information. See you on the other side of surgery.
 
You seem to be a great candidate for the Inspiris Resilia if going with a bio valve. Not only should that bio valve last longer … but it is also designed with TAVR in mind and can be expanded in place to accept a TAVR.
 
Nobody can predict the future or the amount of change to your body (e.g. scar tissue) with the implantation of a new biological valve. Nobody knows how long your new tissue valve will last particularly at age 63. Per your decision rule "any doubts about future valves via TAVR then proceed with mechanical"...I would posit there are doubts now before your surgery.

Both paths have merit, tissue or mechanical, rest easy that there really isn't a wrong choice especially when the true options are life vs. sudden death from a native failed valve.

When it comes to your genetics and BAV, your children should be screened. Both my cardiologist and their personal physicians agreed on this point. Both had an echo, covered by insurance, and were free of BAV.
 
Survived03,
Best wishes for you with your surgery. At 58, I had the Inspiris Resilia put in last year, along with my new Dacron aorta. I was given similar information about the future and I knew that this valve had arrived just a few years earlier. Please give us your updates on the other side if you are up for it.
 
Nobody can predict the future or the amount of change to your body (e.g. scar tissue) with the implantation of a new biological valve. Nobody knows how long your new tissue valve will last particularly at age 63. Per your decision rule "any doubts about future valves via TAVR then proceed with mechanical"...I would posit there are doubts now before your surgery.

Both paths have merit, tissue or mechanical, rest easy that there really isn't a wrong choice especially when the true options are life vs. sudden death from a native failed valve.

When it comes to your genetics and BAV, your children should be screened. Both my cardiologist and their personal physicians agreed on this point. Both had an echo, covered by insurance, and were free of BAV.
All my siblings, their children and my children have been screened via echo's. Once the grandchildren are older they will be too.
 
Just reading your post here, it's somewhat similar to what I went through. I'm 56. I had a bicuspid aortic valve (two cusps fused together), very severe regurgitation, with a moderate mid-ascending aortic aneurysm, 20 years ago, at age 35. They did some genetic evaluations (no gene testing, as that was too expensive, they said the problem can show up in multiple places along the DNA), because Marfan Syndrome was a possibility, as I have long legs, long fingers, heart valve disease. But the surgeon ruled that out once he was in there. He didn't know what happened to my valve, probably due to a childhood virus. I was hoping for a repair, got a second opinion, but once he got in there, the valve just disintegrated in his hands, and he replaced it with the brand new CryoLife Synergraft (tissue value, human donor, cryo-preserved and washed of its donor cells, for hopefully long-lasting tissue, minimal "rejection"). That got pulled from the market a few months later, however, as the FDA didn't like the idea that it wasn't sterilized (yes, or you'll damage it!) and people were getting serious, sometimes fatal, fungal infections from donor tissues (knee cartilage etc). At the time, they believed that the aneurysm was due to blood hitting the valve and shooting off at an angle, hitting the aorta wall, and causing the bulge. So I got the tissue valve plus some Dacron to replace the aortic root and part of the aorta. I was wanting a tissue in hopes of avoiding warfarin, in hopes of having kids. My current cardiologist believed I had made the right decision, years ago, to go with the tissue. So much less risk of stroke for those almost 20 years.

Life was good. Value was leaking again, but we were watching it. February 2021 I had an echo, and besides the regurgitation, the value was also stenotic. More watch and wait. In October 2021, I suddenly couldn't breathe and heard fluid near my lungs. Could hardly walk a short distance. I thought I had pneumonia, and wandered around looking for help. 10 days later I got in to see my cardiologist. Turns out, due to all the calcium buildup and hardening (stenosis), the valve blew a hole, and put me into full-blown Congestive Heart Failure.

There was a team at the hospital that talked about a TAVR, and they were doing tests to measure how much room they had in there, whether they could fit a valve on top of all the mess. My tissue replacement in 2002 was 22mm, so things were tight with all the calcification, but a TAVR was a possibility. My personal worry was that if I got the TAVR, that might last 8-10 years, but what else would break in the meantime, with all that calcification? And would a chunk of calcium hit my bloodstream and cause a stroke? Could I do a serious re-op (mechanical) when I was yet another 10 years older? For a mechanical valve, there was 10-15% chance of mortality. They were worried about slicing open the sternum again, and possibly breaking the calcified aorta that was very close underneath the sternum. My new surgeon had been colleagues with my first surgeon (which is how I got hooked up with my cardiologist), and between the three of them (all top dudes at a top US hospital), plus myself, we decided on the mechanical for longevity, and I received an On-X with the aorta conduit. They sliced me open using a "clamshell" incision to avoid the sternum area. And really, I don't know if I could go through another massive surgery ever again.

My new mechanical value is 19mm, so, it's small. The surgeon did quite a lot of cleaning out and fixing of various things while he was in there, and I think he had to tighten up the root area. So I really don't think there would have been much room for a ViV, or even more than one. I was going for longevity, and to not have to worry about some calcification breaking.

My cardiologist has since retired, and another cardiologist commented to me that the theory about the aortic aneurysm being from the force of the hemodynamics is outdated. He says they've since come to believe in a genetic/hereditary "aortic dilation" disease, as you seem to be aware. This was news to me. One of my brother's got checked and is fine. The other brother, I don't think he's done so yet.

Anyway. I hope this is of interest/help to you! I will be praying for you this week. Please keep us posted!

Jennie

BTW, my new cardiologist says hey, you have an On-X, we can reduce your INR! But I talked him into 1.5-2.5 rather than 1.0-2.0 range. I prefer to stay higher.
 
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Hi
BTW, my new cardiologist says hey, you have an On-X, we can reduce your INR! But I talked him into 1.5-2.5 rather than 1.0-2.0 range. I prefer to stay higher.
wait, what?! Your Cardio said "un-anticoagulated" (which is what 1 means) to the bottom end of "in range" ... WTAF

and you have the right idea, but I'd stay between 2.0 and 3.0 because the lower end of the scale is just marketing hype based on very shakey reasoning.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6472691/
Ninety days after surgery, 425 patients were enrolled and 375 patients meeting the inclusion criteria were finally randomized in one of two study arms: (1) a targeted INR between 1.5 and 2 (test group) and (2) a targeted INR between 2 and 3 (control group). Concomitantly, all patients received aspirin 80 mg and were monitored using home INR testing. Any patient who experienced a TE event in the study group was crossed over to the standard INR group
Primary endpoints were rates of TE events, thrombosis, bleeding and all-cause mortality. An interim non-inferiority analysis was performed for a composite of all primary endpoints, with an absolute margin of 1.5%.

so basically if you aren't being monitored like that then DO NOT risk 1.5 as a lower end point.

And people wonder why I advocate self management. Sure the patient is stupid they suffer the consequences, but being directed to do something stupid and then potentially being threatened or coerced by someone who is clearly stupid (because they are unaware of the standards let alone even the product guidelines) is worse. Its worse because a professional has a duty of care which they are obliged to provide.
 
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@Jennie

Please please be careful with a low INR range. Strokes are no joke. Pellicle above pointed out some information that I would heavily recommend that you read and come to understand.

I have an On-X valve too. My surgeon recommended the highly marketed 1.5-2.0 range that Artivion (the makers of the On-X valve) recommend to their users. That said, my Cardiologist and I target 2.7-ish.

Never ever ever would I personally go less than 2.0 with any mechanical aortic valve (just my humble opinion)
 
I don't have a On-X valve, but have been down to 1.0 INR for awhile for medical procedures. My range is 2-2.5, but drops to less than 2 are not considered emergencies.
 
@pellicle @Timmay @tom in MO

So, hmm, maybe my memory is incorrect. Maybe he wanted a range of 1.5 to 2.0 for me?? I'll have to go back and look that up. I do know that the upper value was 2.0.

But I absolutely agree about the INR range. I have read a lot of posts from @pellicle. I feel like artvion (formerly cryolife), for the On-X valves, was using the lower INR as a marketing ploy. Very cute, but yes, I absolutely do not want a stroke.

I got a new cardiologist last year, as my fabulous guy retired. I wanted to home monitor, I don't have time to run around to labs and poke up my veins all the time and wait for results. My home meter company requires that I be monitored by a doctor. The cardiologist hooked me up with the Coumadin Clinic to do the monitoring. He had to submit a doctor's order for me, and put the range as having the top value of 2.0. He basically quoted that study to me, saying that since I have the On-X, I could lower my INR. So, if I were to go above 2.0, that would flag me as being out of range, and they will want to adjust meds, etc.

This was causing me to lose sleep. I have read this study, and read lots of posts here. I am not comfortable being below 2.0. So I called him and sweet-talked him into revising the order to be 1.5 to 2.5. It took some convincing to do that. Especially as I am new to warfarin, new to him, and here I am telling him what I think my INR should be. But, he revised the order to be 1.5 to 2.5.

Secretly, I am aiming to be in the 2.0 to 2.5 range. This way, I can sleep, and I don't get flagged.

Thanks for the reminder, though. I have been drifting lower than 2.0, and I need to back off the spinach.
 
There is actually a randomised trial (LIMIT trial): Low INR to Minimize Bleeding With Mechanical Valves Trial - Full Text View - ClinicalTrials.gov
going on right now, with 2000+ participants that randomises people between 2-3 and 1.5-2.5 INR. Given the large number of participants, this trial should be able to shed more light on whether 15.-2.5 is as safe a 2-3.
Importantly, this is a trial run by several hospitals and not sponsored by Artivion.

So we will need to wait until 2026 to know the answer ( we may know earlier if they need to stop the trial early because there is more adverse events in one versus the other). In the mean time, like everyone said, best to ignore On-X marketing claims for now.



@pellicle @Timmay @tom in MO

So, hmm, maybe my memory is incorrect. Maybe he wanted a range of 1.5 to 2.0 for me?? I'll have to go back and look that up. I do know that the upper value was 2.0.

But I absolutely agree about the INR range. I have read a lot of posts from @pellicle. I feel like artvion (formerly cryolife), for the On-X valves, was using the lower INR as a marketing ploy. Very cute, but yes, I absolutely do not want a stroke.

I got a new cardiologist last year, as my fabulous guy retired. I wanted to home monitor, I don't have time to run around to labs and poke up my veins all the time and wait for results. My home meter company requires that I be monitored by a doctor. The cardiologist hooked me up with the Coumadin Clinic to do the monitoring. He had to submit a doctor's order for me, and put the range as having the top value of 2.0. He basically quoted that study to me, saying that since I have the On-X, I could lower my INR. So, if I were to go above 2.0, that would flag me as being out of range, and they will want to adjust meds, etc.

This was causing me to lose sleep. I have read this study, and read lots of posts here. I am not comfortable being below 2.0. So I called him and sweet-talked him into revising the order to be 1.5 to 2.5. It took some convincing to do that. Especially as I am new to warfarin, new to him, and here I am telling him what I think my INR should be. But, he revised the order to be 1.5 to 2.5.

Secretly, I am aiming to be in the 2.0 to 2.5 range. This way, I can sleep, and I don't get flagged.

Thanks for the reminder, though. I have been drifting lower than 2.0, and I need to back off the spinach.
 
There is actually a randomised trial (LIMIT trial): Low INR to Minimize Bleeding With Mechanical Valves Trial - Full Text View - ClinicalTrials.gov
going on right now, with 2000+ participants that randomises people between 2-3 and 1.5-2.5 INR. Given the large number of participants, this trial should be able to shed more light on whether 15.-2.5 is as safe a 2-3.
Importantly, this is a trial run by several hospitals and not sponsored by Artivion.

So we will need to wait until 2026 to know the answer ( we may know earlier if they need to stop the trial early because there is more adverse events in one versus the other). In the mean time, like everyone said, best to ignore On-X marketing claims for now.

That's fabulous. Thanks for the info! I will be watching this, for sure.
 

Interesting read. I’m making an assumption here in that where they say “Exclusion criteria:
Lower boundary of planned INR range is less than 2.0”
They mean for those in the comparison group, not the study group.

I’ve got a valve in the mitral position so the study isn’t relevant to me, but still interesting.

I view INR ranges like driving on a 2 lane road. Cross over the center line and you could have a head on collision (that would be too low). Go too far off the shoulder and you could wind up in a ditch (that would be too high). I try to stay in the middle, but worry less if I’m hanging into the shoulder a bit, vs. driving right on the center line. (Especially if there’s a tractor coming the other way.)
 
Hi

But I absolutely agree about the INR range. I have read a lot of posts from @pellicle. I feel like artvion (formerly cryolife), for the On-X valves, was using the lower INR as a marketing ploy. Very cute, but yes, I absolutely do not want a stroke.

I'm not sure if this is going to be difficult to convey, but the problem with the above trial that's used by On-X to get that certification is that its based on a failure to grasp stats. So again, from that study

The mean follow-up was 3.8 years and was 98% complete.​

that is just long enough to avoid the stroke that's coming based on stats. So if they'd done a mean follow up of 5 years then they'd have seen more strokes.

Of course if you're on warfarin because of a mech valve you'll be on it for more than 5 years right? This sort of stuff is what we call "cooking the books".

I urge you to target what the actual guidelines say (which is 2.0 ~ 3.0 ... Not only will that necessitate less changes in dose it will be safer

which I encourage you to read and to discuss here to better understand it.

So, if I were to go above 2.0, that would flag me as being out of range, and they will want to adjust meds, etc.
which is vexing for sure
Secretly, I am aiming to be in the 2.0 to 2.5 range. This way, I can sleep, and I don't get flagged.

as mentioned above the actual surgical guidelines stipulate 2.0 ~ 3.0 this was done for reasons of evidence based on research
from this image you can see the doi and look this up yourself

1684961636040.png


there is insufficient data on the On-X which to me classifies it as type c above

using doi is simple:
1684962048171.png

link here.


and I need to back off the spinach.
you do not, you should dose the diet. You need a healthy Vitamin K rich diet for good health.

If you are not self managing and you are capable of it then you should ... empowerment is better than being enslaved by a machine that doesn't care about you.

a blog post of mine expressing my views on "the machine" of bureaucracy in the Nanny State of Australia.

http://cjeastwd.blogspot.com/2009/10/does-machine-make-good-parent.html
If you will self manage then reach out and I'll show you how, otherwise soon enough it'll be in my book.

Best Wishes
 
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its a pretty good analogy but a bit sharper in delineation than is actually the case statistically.

I was just making an easy to grasp mental analogy. Some folks don’t mentalize charts and graphs well. But, yep, we’re on the same page (there’s another mental analogy).
 
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