Mechanical Valve leakage?

Help Support ValveReplacement.org:

RandomDude83

Member
Joined
Mar 7, 2014
Messages
11
Location
Evansville, IN USA
Hello All, has anyone encountered their mechanical valve 'springing a leak'?

I have an On-X (which Im keeping between 2.5-3 INR). Had an EKG followup for my 3yr anniversary last month, and they discovered a leak, which they initially thought was the sew-ring. After a TEE to further investigate, the leak is from the actual On-x valve itself. Cardiologist was glad its wasn't the sew-ring as that would been a big problem, but said he wasnt AS worried about this particular issue, but we'll need to continually monitor it. Which equates to more EKGs/TEEs IMO. But dangit, I chose a mechanical valve and a life of Coumadin so I could finally put this stuff in my rearview mirror. Cardiologist said there's nothing I can really do about it, that's Im doing everything right. This isn't a car part, ya know. I expected better quality from something that's should purpose is to keep me alive.

Guess Im semi-ranting here, but just looking see if others have had a similier situation and could give some more insight into what they've experienced with mechanical valves leaking early into their, uh, installation. And if On-X has a history with this sort of issue? TIA!
 

Lynn

VR.org Supporter
VR.org Supporter
Joined
Mar 24, 2021
Messages
63
Location
British Columbia
My On-x valve being less than 4 months old Random, I can’t offer any insights, but just wanted to say I’m sorry you are dealing with this. I understand what you mean when talking about hoping this was in your rear view mirror, and you must be pretty disappointed. I hope others with more experience on the board can offer you some insight and hope the problem never escalates for you. Keep us up to date.
 

tom in MO

Well-known member
Joined
Jan 17, 2012
Messages
1,709
Location
MO USA
You have every right to be disappointed and upset.

Yours is the first mechanical valve I've heard of that has a leak. In the past there have been a few people with sew ring problems (I think this can happen with any type of valve.) Things do happen, when I looked into the FDA records for my valve (StJude) I found 1 record of valve failure for my model. If I were you, I'd like to know what On-X says and if your additional treatment is covered by them.

Valves are medical devices and I believe problems are supposed to be reported to manufacturers who are required to pass the information on to the FDA. I also believe you or your doctor can report it to he FDA as well, but I have no concrete source of information.
 

nobog

Well-known member
Joined
Jun 14, 2019
Messages
142
ALL mechanical valves "leak". They have clearances. Your clinician should known the difference between a "normal" leak and say, if something was causing the leaflets not to close properly.
 

MdaPA

Well-known member
Joined
Jul 8, 2020
Messages
180
Had an EKG followup for my 3yr anniversary last month, and they discovered a leak
They discovered a leak from an EKG (electrocardiogram)? Or you mean an echo (echocardiogram)?

What is the degree of leakage (e.g. trace, mild, moderate, severe)?

And was there any degree of leakage present on prior tests post your heart valve surgery for comparison purposes? i.e. was it leaking to the same degree post-op or did it get worse?
 

Eva

Miracle Believer
VR.org Supporter
Joined
Aug 8, 2008
Messages
4,292
Location
Southern California
After three months of my surgery in 2008, echo showed a leak in the aortic mechanical valve and I was told it was not important! Of course, I was very disappointed! Then, another echo at a different clinic showed a leak in the mitral mechanical valve!! Cardios said that the shadow of the mechanical valve makes it hard on the echo technicians to interpret welll! I never had a TEE!
13 years later now, no deterioration in the leaks!
So, I learned not to let issues we have no control over affect me nor waste any energy!
Good luck and keep us posted.
 

pellicle

Professional Dingbat
Joined
Nov 4, 2012
Messages
8,821
Location
Queensland, OzTrayLeeYa
So, I learned not to let issues we have no control over affect me nor waste any energy!
wise.

to the @RandomDude83 I would say "wait till you have more information" ... it could be just an error or a misreading
1626475377532.png


One of the things you can do is to manage your INR well and make your life less anxious.

I see that you are following a narrow path of INR management, which may cause you some stress. Unless you've had some 'events' which have driven your INR requirement higher I'd be perfectly comfortable with an INR between 2.0 and 3.0

Even if it temporarily dips below 2 (and you correct that in your weekly testing) or above 3.0 (and again your correct that) you are in a good place.

Please do keep us posted.

Best Wishes
 

Warrick

Well-known member
Joined
Dec 27, 2015
Messages
695
Location
New Zealand
My last echo said trace aortic regurgitation, acceptable antegrade velocities.So thats a mechanical.

As I understand it a TEE is a pretty good view of things and quite definitive, and its a good thing its not paravalvular for sure so I guess it comes down to how much leakage are we talking??
 

RandomDude83

Member
Joined
Mar 7, 2014
Messages
11
Location
Evansville, IN USA
Sorry meant Echo.

The gist from my TEE
Mild regurg on mitral
Mild aortic insufficiency, No pervalvular leak tho
Trivial regurg on tricuspid
Mild hypertrophy on my left ventrical, prob from high blood pressure
 

Deepak khanka

Active member
Joined
Jun 24, 2021
Messages
38
After three months of my surgery in 2008, echo showed a leak in the aortic mechanical valve and I was told it was not important! Of course, I was very disappointed! Then, another echo at a different clinic showed a leak in the mitral mechanical valve!! Cardios said that the shadow of the mechanical valve makes it hard on the echo technicians to interpret welll! I never had a TEE!
13 years later now, no deterioration in the leaks!
So, I learned not to let issues we have no control over affect me nor waste any energy!
Good luck and keep us posted.
Excellent this is reassuring 🙏🏽
 

Deepak khanka

Active member
Joined
Jun 24, 2021
Messages
38
Hello All, has anyone encountered their mechanical valve 'springing a leak'?

I have an On-X (which Im keeping between 2.5-3 INR). Had an EKG followup for my 3yr anniversary last month, and they discovered a leak, which they initially thought was the sew-ring. After a TEE to further investigate, the leak is from the actual On-x valve itself. Cardiologist was glad its wasn't the sew-ring as that would been a big problem, but said he wasnt AS worried about this particular issue, but we'll need to continually monitor it. Which equates to more EKGs/TEEs IMO. But dangit, I chose a mechanical valve and a life of Coumadin so I could finally put this stuff in my rearview mirror. Cardiologist said there's nothing I can really do about it, that's Im doing everything right. This isn't a car part, ya know. I expected better quality from something that's should purpose is to keep me alive.

Guess Im semi-ranting here, but just looking see if others have had a similier situation and could give some more insight into what they've experienced with mechanical valves leaking early into their, uh, installation. And if On-X has a history with this sort of issue? TIA!
So sorry to hear about the leakage. I can’t comment much. I am due a surgery myself . However how is your on x been . Sound wise and compared with St judes will you need less warfarin. What size on x was put for you.
 

Chuck C

Well-known member
Joined
Dec 5, 2020
Messages
1,024
Sound wise and compared with St judes will you need less warfarin.
If you go with the On-X, I would encourage you to fully research as to whether it is truly wise to go as low as 1.5 with INR, as they claim. There was a woman on these boards who went with the low INR range with her On-x valve and she got into serious complications with clot formation.

During my second consultation with my surgeon, one of the main things that we were discussing is whether to go with a mechanical St. Jude or an On-X. He was willing to go with either valve, my choice, but cautioned me that if I go On-X that I should not use the lower INR target. He indicated that he and many of his colleagues were not convinced that this range was safe and that the study, sponsored by the valve manufacturer, was flawed. Ultimately I chose the St. Jude. Most sound satisfied with their On-X, but I would think long and hard about whether to let your INR go down to 1.5, as a low end target. I see no gain in going from 2.0 to 1.5, in terms of risk of events, and potentially a lot to lose by going so low.
 
Last edited:

dick0236

Eat the elephant one bite at a time
VR.org Supporter
Joined
Feb 10, 2007
Messages
3,258
Location
louisville, KY USA
I would agree that I don't see any advantage in going to a 1.5 INR.(17 second clotting time). The clotting time for the "normal" non-warfarin user is 1.0 INR (12 seconds clotting time) and that gives you very little margin of error (5 seconds). As a frame of reference, I have been on warfarin probably longer than anyone in history......54 years and have used the INR system since it was first developed in the 1980s (I think)......probably about 40 years. I have one of the first valves ever implanted and my INR target range for this old valve is 2.5-3.5 (26-34 second clotting time. During these 40 years I have had NO issues with clots, cuts, bruising or bleeding (internally or externally). I did experience one stroke but it was before the INR system was introduced when I think my PT (prothrombin time) was allowed to get too close to 12 seconds........but, again, that was back in the 1970s when nobody knew a hell of a lot about managing mechanical valves. Take the low INR time with a grain of salt. Believe me, you don't want a stroke due to low INR....it ain't worth the risk.
 

Deepak khanka

Active member
Joined
Jun 24, 2021
Messages
38
Thank you for the advise. My knowledge about INR and warfarin is very limited. What I can understand from above is that warfarin brings the INR close to range and that might expose me to clotting risk. On the other hand ST Jude keeps it between 2.5 and 3.5 giving me more tolerance.
Definitely I will pick this up with my surgeon
Many thanks guys 🙏🏽
 
  • Like
Reactions: Eva

pellicle

Professional Dingbat
Joined
Nov 4, 2012
Messages
8,821
Location
Queensland, OzTrayLeeYa
My knowledge about INR and warfarin is very limited. What I can understand from above is that warfarin brings the INR close to range and that might expose me to clotting risk.
to try to simplify this:
Warfarin alters your blood clotting ability. You seek to have a therapeutic range (see this post which increases in complexity as you dive in) which is now defined in a simple number called an INR. Evidence from robust research in the last 20 years has shown that keeping INR between 2 and 3 (for Aortic valve, 2.5 ~ 3.5 for mitral) puts you within the minimal risk range. Risk is a statistical thing. If you look at your phone and attempt to text while driving you may or may not have an accident; do it regularly and it becomes a certainty.

A simple graph from that blog post
1626560212414.png


This can be charted as follows



If you are in India its unlikely you'll get Warfarin and instead one of those with a much shorter half life. This makes management a sine wave not a line within the course of a day.

Hope that helps
 

sharky7

Active member
Joined
Mar 18, 2015
Messages
28
Location
miami, fla.
to try to simplify this:
Warfarin alters your blood clotting ability. You seek to have a therapeutic range (see this post which increases in complexity as you dive in) which is now defined in a simple number called an INR. Evidence from robust research in the last 20 years has shown that keeping INR between 2 and 3 (for Aortic valve, 2.5 ~ 3.5 for mitral) puts you within the minimal risk range. Risk is a statistical thing. If you look at your phone and attempt to text while driving you may or may not have an accident; do it regularly and it becomes a certainty.

A simple graph from that blog post
View attachment 887960

This can be charted as follows



If you are in India its unlikely you'll get Warfarin and instead one of those with a much shorter half life. This makes management a sine wave not a line within the course of a day.

Hope that helps
PLEASE, i would love to read much more, do you or anyone here know the links to those graphs/etc., that you posted, they are awesome, but without more i dont understand the way i think that they were meant to be, call be stupid, but at least i am trying to learn. thank you for posting them!!!
 

pellicle

Professional Dingbat
Joined
Nov 4, 2012
Messages
8,821
Location
Queensland, OzTrayLeeYa
that you posted, they are awesome, but without more i dont understand the way i think that they were meant to be,
What specifically don't you understand?

The last graph is from "Optimal level of oral anticoagulant therapy for the prevention of arterial thrombosis in patients with mechanical heart valve prostheses, atrial fibrillation, or myocardial infarction: a prospective study of 4202 patients."

but again, what needs explaining in that graph?

here is a question: can you drive a car? if yes then can you do complex geometery to prove the steering mechanism is suitable for driving? If no does it matter as long as you can steer and avoid accidents?
 

Al3x

Member
Joined
Jun 18, 2021
Messages
23
PLEASE, i would love to read much more, do you or anyone here know the links to those graphs/etc., that you posted, they are awesome, but without more i dont understand the way i think that they were meant to be, call be stupid, but at least i am trying to learn. thank you for posting them!!!
If you're confused by the dashed lines (like I was the first time I saw this graph), they represent the 95% confidence intervals.
 

Deepak khanka

Active member
Joined
Jun 24, 2021
Messages
38
to try to simplify this:
Warfarin alters your blood clotting ability. You seek to have a therapeutic range (see this post which increases in complexity as you dive in) which is now defined in a simple number called an INR. Evidence from robust research in the last 20 years has shown that keeping INR between 2 and 3 (for Aortic valve, 2.5 ~ 3.5 for mitral) puts you within the minimal risk range. Risk is a statistical thing. If you look at your phone and attempt to text while driving you may or may not have an accident; do it regularly and it becomes a certainty.

A simple graph from that blog post
View attachment 887960

This can be charted as follows



If you are in India its unlikely you'll get Warfarin and instead one of those with a much shorter half life. This makes management a sine wave not a line within the course of a day.

Hope that helps
Thank you . I am Speaking to surgeons tomorrow. I am UK based and the hospital that I am getting operated is Harefield Greater London. Surgeon Mr Bahrami. In my previous surgery I had an injury to my coronary artery while doing a David’s procedure. Then they clipped my left main and did a CABG. Now after 2 years my LV is 6.7cm and second surgery is a must. After my surgery my BAV prolapsed and I had a regurgitation. Now the surgeon needs to be very careful when he enters not to injure the CABG I.e by pass then reach the ascending aorta which was replaced during David’s the make a cut on it reach the BAV then remove the prolapsed BAV and then put a new valve mechanical . Has anyone in the group has had such a procedure
Mortality 3 to 5%
Injury to by pass is the same
 

Deepak khanka

Active member
Joined
Jun 24, 2021
Messages
38
What questions can I have for the surgeon tomorrow. I have a list of questions but any other input will be very much appreciated 🙏🏽
 
Top