On-x Valve Failure after 10 years?

[Gator Chief]

There has been a lot of discussion lately about lowered INR range and strokes because of it. After 10 yrs with my On-x valve I suddenly have been experiencing a lot of the symptoms that caused the replacement of my Bicuspid aortic valve. It’s very complicated at this point and I don’t know if todays medicine is still sympathetic to the cardiovascular community as they were 10 yrs ago, with Covid-19 taking center stage at the majority of medical institutions and hospitals now.
It started with some shortness of breath about 6 months ago, but only when working out hard at the gym. (Decline press 140 x15 and 400 lbs leg press x20) I walked 2- 4 miles most every night after supper. Than I noticed that I was breathing a little heavier while walking after a big supper until I burped several times and then everything was back to normal,( I do have IBS). This went on for several months until the slight chest pains turned into sharp prolonged pains after eating fatty foods. So a trip to the Gastro Dr and colonoscopy and endoscopy. Whoops, I said chest pains and he said that’s not Gastro, that’s heart! I can’t do those procedures unless you have cardiac clearance. Off to my cardiologist for echo, tread mill, and heart cath. All negative ( but he was concerned about a bad chest pain I had for several hours two weeks prior and thought he saw a small infarct on the scope after the tread mill) but the heart cath Dr saw no evidence of MI and RCA artery were only at 30 - 40% plaque.
Back to the Gastro for the GI test. Everything normal scheduled a gall bladder scan that was negative.
All this time the shortness of breath stays about the same, but the bending over and standing up got progressively worse with severe nausea almost to the point of fainting at times. The only time the symptoms aren’t cropping up now is when I’m at rest. I saw a post on the thread of a member that started the On-x and strokes discussion. I can’t find the post where he stated that On-x valves have a propensity to build up clots on the back side of the valve at lowered INR which is very difficult to detect without a TEE. I’ve never had one and I can’t help but wonder with all the surgeries I’ve had and as many times I’ve held Coumadin and been at 2.0 or less in 10yrs that is could be the issue. To top it off, I didn’t take aspirin with my Coumadin as most of the time I was at (75-85 %) 2.5 to 3.0 and it didn’t effect my INR when I tested. It would be hard to go through another OHS at 72 because the first one was no cake walk, but feeling like this as we all know, is really bad.

 

[Protimenow]

I hope this all resolves completely and rapidly. I'm about your age, and am jealous of how active you are. I'm kind of lazy and haven't done enough to stay in shape.

I take one 81mg aspirin each day. These are coated pills that I buy at Costco for about a penny each.

The effect of Aspirin will not show up in your INR - aspirin works differently than warfarin.

Are you self testing? If so, how often do you test?
If not, why not?

If you go to a clinic or lab, how often to you get tested there?

Have you seen a pulmonologist (lung specialist)? Perhaps the issue isn't your heart.

Please keep us informed when you can.

 

[Chuck C]

Hi.

Sorry that you are having so many issues.

Decline press 140 x15 and 400 lbs leg press x20)

I'm curious if your cardiologist has given you the green light to leg press 400 pounds. Although you are doing high reps, that is a lot of weight. I would be concerned that you might be spiking your blood pressure. Anyway, hopefully you've gotten the green light from him.

To top it off, I didn’t take aspirin with my Coumadin as most of the time I was at (75-85 %) 2.5 to 3.0 and it didn’t effect my INR when I tested

Apirin was done in the PROACT trial when INR range was brought to 1.5-2.0. If people are using that range due to the PROACT outcome, then to be consistent with PROACT protocal they should be on low dose aspirin, under the guidance from their cardiologist. If your range is 2.5 to 3.0, some cardiologists will have you on aspirin and some won't. Also, aspirin does not affect your INR.

 

[Gator Chief]

This is not a brag just my lifestyle. I have been going to the gym for most of my life and I mention the gym routine to my cardiologist often. The tread mill test was a little disappointing ( 9 min 45 sec 144 hr ) but I don’t do enough cardio except walking I tell myself. The point I’m trying to make is this decline in my health is very concerning and I believe it points to the heart. I remember a recent post by a member about a clot on the back side of his On-x valve and was experiencing many unexplained symptoms. He was afraid he would have to go through another OHS but a surgeon used Tissue Plasminogen Activator to dissolve the clot and he did t have to have another VR. Does anyone remember that post?

 

[Gator Chief]

I hope this all resolves completely and rapidly. I'm about your age, and am jealous of how active you are. I'm kind of lazy and haven't done enough to stay in shape.

I take one 81mg aspirin each day. These are coated pills that I buy at Costco for about a penny each.

The effect of Aspirin will not show up in your INR - aspirin works differently than warfarin.

Are you self testing? If so, how often do you test?
If not, why not?

If you go to a clinic or lab, how often to you get tested there?

Have you seen a pulmonologist (lung specialist)? Perhaps the issue isn't your heart.

Please keep us informed when you can.

It’s spending 26 yrs in the military and fitness requirements for service. I did have a pulmonary function / sleep study test 2 yrs ago that was negative. It seems that the daily symptoms are lasting longer now. Cardiologist appt next Thursday, luckily I had it scheduled as a follow up from the Heart Cath otherwise it’s 4 to 6 weeks wait for an appointment with him now and it’s with every doctor’s office. It seems that the medical community is using the ER to triage their patients now I may have to go there to get a test soon.

 

[pellicle]

Hi Gator

sorry to read about your difficulties. However I'm not entirely sure that this is a valve failure, indeed from your first post they are conducting investigations into what you are actually experiencing and are in my view doing the right thing in not making assumptions and investigating all options as if starting blind.

its good that you go to the gym and that you've been building muscle strength, but the situation appears to be a limitation of the ability to oxygenate not the ability of muscles (including the cardiac one) to function. So I think you should continue to follow the investigative pathway.

you mentioned this earlier when you said :

I saw a post on the thread of a member that started the On-x and strokes discussion. I can’t find the post where he stated that On-x valves have a propensity to build up clots on the back side of the valve at lowered INR which is very difficult to detect without a TEE.

and to be honest I don't recall that post (which is something I'm pretty sure I'd have noticed.

I remember a recent post by a member about a clot on the back side of his On-x valve and was experiencing many unexplained symptoms

I think at this stage the issue doest not sound like thrombosis nor thrombosis related obstruction (or the Echo would have fingered that clearly).

I suspect that something else is at work here and we need to have tests to gather data to clarify what the actual cause is. I don't see how valve obstruction wouldn't show up in either gradients or leakage.

Both Chuck and Protime have rightly pointed out that aspirin is nothing to do with INR as its a platelet not a thrombic actor (meaning to give it a military context, it hunts platelets not the chain of thrombosis command which is what warfarin attacks). The reasons for being on aspirin are that it reduces thrombo-geneisis caused by platelet activations due to valve action (impacts) and pressure (from jets). These present as TIA's or mini-strokes.

https://pubmed.ncbi.nlm.nih.gov/17655477/

Platelet stress accumulation during forward flow indicated that no platelets experienced a stress accumulation higher than 35 dyne x s/cm2, the threshold for platelet activation (Hellums criterion).​

Best Wishes and keep us posted

 

[ValveAdmin]

Welcome to the forum.

 

[Keithl]

Sorry about your issue, but have they confirms it is,the valve? I get short of breath more now as I ate and they found small nodules on my lungs. I do cardio workouts at least 4x a week. Some of it is I am getting older. I keep my INR range between 2-3 shooting for 2.5-3.0. I take a baby aspirin every day and a lot of fish oil as I have high triglycerides as well as garlic powder every day. The aspirin, fish oil and garlic all actually make clotting less likely, but I do them for other reasons. I have never bought into the 1.5-2.0 as I have had swing of .5-1 so I would rather run higher INR than lower. What is doctor saying?

 

[Gator Chief]

Sorry about your issue, but have they confirms it is,the valve? I get short of breath more now as I ate and they found small nodules on my lungs. I do cardio workouts at least 4x a week. Some of it is I am getting older. I keep my INR range between 2-3 shooting for 2.5-3.0. I take a baby aspirin every day and a lot of fish oil as I have high triglycerides as well as garlic powder every day. The aspirin, fish oil and garlic all actually make clotting less likely, but I do them for other reasons. I have never bought into the 1.5-2.0 as I have had swing of .5-1 so I would rather run higher INR than lower. What is doctor saying?

He read the original On-x FDA approval and said great! This should reduce bleeding events significantly. The data sheets included from the trail only recommended 81 mg aspirin on the last page in the Q&A section. Neither of us caught that at the time. Now that the controversy has arrived I do see that recommended in the Q&A on the last page. I will lobby him to change the range from 1.5 - 2.0 back to 2.0 - 3.0.

 

[Keithl]

My surgeon recommend the 1.5-2.0 and 81mg aspirin and I said "fine" then went to my cardio and told them I want 2-3 and they agreed. The stats show minimal risk in 2.5-3.0 range so that is what I shoot for. If I get to 3.0-3.4 I don't panic, maybe have a little more vitamin K, if I am low 2.0 rang I may pop an extra 1mg warfarin for a day or 2 (my daily dose is 8.5mg.

 

[Timmay]

My first thought is what pellicle already said above. You've had both an Echo AND a Heart Cath. I find it very hard to accept that both of those tests wouldn't have showed the issue. Both of those can determine the pressure differential between each side of the valve. Example: Prior to my bicuspid aortic valve replacement with the On-X, I was 60-70mmHg (Heart Cath said 60, Echo said 70). A follow-up echo after my On-X valve shows that I am now at ~12mmHg. Huge difference.

What was your pressure differential?

 

[pellicle]

Hey Gator, I just wondered:

Off to my cardiologist for echo, tread mill, and heart cath. All negative ( but he was concerned about a bad chest pain I had for several hours two weeks prior and thought he saw a small infarct on the scope after the tread mill) but the heart cath Dr saw no evidence of MI and RCA artery were only at 30 - 40% plaque.

why not put the data here for the echo and cath because while I don't know the good and bad data without looking it up, some members here are pretty Au fait (naturally spoken with an outrageous French Accent) with that data and could maybe point to something.

Best Wishes

 

[Gator Chief]

My first thought is what pellicle already said above. You've had both an Echo AND a Heart Cath. I find it very hard to accept that both of those tests wouldn't have showed the issue. Both of those can determine the pressure differential between each side of the valve. Example: Prior to my bicuspid aortic valve replacement with the On-X, I was 60-70mmHg (Heart Cath said 60, Echo said 70). A follow-up echo after my On-X valve shows that I am now at ~12mmHg. Huge difference.

What was your pressure differential?

Mine was 15.95 mmhg mean and 25.67 mmhg max

 

[Timmay]

Mine was 15.95 mmhg mean and 25.67 mmhg max

That’s really not that bad at all. Would you mind sharing the rest of your data from the echo?

 

[user 15848]

I manage my OnX with target range of 2.0 -2.2 for 6 years, all good, Did 1.6 -2.0 first year but ran into several 1.5 levels and was always worried about it, so now, 2.0 is my number and it stays between 2 and 2.2 when i test every 12 days and all good, my diet is VERY consistent so only random factors make the inr fluctuate around 2.0,

 

[Protimenow]

I've occasionally let my testing frequency drift away from weekly (which is preferable because you will be able to detect major changes in your INR before you develop clots or have an INR spike) to as much as two weeks - if I get really forgetful.
The recommended interval is one week. I encourage you (and me) to test weekly.

 

[user 15848]

12 Days works for me, weekly so far not needed as everything is very much the same. 'for me', we are all different, there is not one rule for all, but my doctor recommends test every 2 weeks....., so lots of people different thoughts, as well as the gang of doctors in my family, all same the same, 10 to 15 is ok for "most" people with an Onx

 

[Protimenow]

I'm just going by what the Duke Clinic wrote a few years ago - a clot can form in as little as ten days when your INR is below 2.0. We aren't all THAT different when it comes to clot formation.

That said, I try to keep my INR pretty consistent. In theory, unless something happens (new medications, infections, grapefruit, or other things that may cause my INR to change), it's probably okay to go for longer than weekly. But it's still safest to test weekly and, what's the big deal about a finger prick every week?

And if you're really concerned about the cost of strips, at $5 or less a strip, if you usually test every other week, changing to a weekly test will cost you about $130 a year. Is it worth it to NOT invest that money on yourself?