ON-X Valve?

[Elgato]

This company does a lot of advertising and I have seen references to it as the Mercedes of valves.

The most interesting aspect is the Reduced Anticoagulation trials. It is also supposed to be less destructive on the
blood cells.

Does anyone have experience or additional insight on this valve? Any chance it is quieter than the others? Any disadvantages?

Thanks

 

[Heart Of The Sunrise]

Tomorrow marks my 1 year anniversary with my ON-X Valve. My INR target is 2.0 to 2.5
I think it is quieter. I usually only hear it late at night if I wake up. Generally, I do not hear it.
I am very happy with my choice of valve.

 

[RobThatsMe]

I have my On-X aortic valve for going on 4 years now.
The main reason for my choice of this valve was that it is designed to help prevent/deflect panus development around the valve.

 

[chaconne]

I've had the largest On-X for the aortic position in me for 2.5 years now and it seems to be relatively quiet, which is notable for a large valve size. I only hear it in a quiet room and it sounds like a faint clock ticking or dripping faucet.

It's my understanding that the latest trials have demonstrated that the On-X can be safely used with a lower INR range (1.5-2.0). However the FDA has not approved it yet, so doctors won't recommendation that range right now. This doesn't mean that other heart valves are not safe in that range too, but might not have been tested (like ATS, St Jude, etc...).

It seems like lots of surgeons are willing to implant them and consider them as safe as St. Jude valves. If you feel good about using the On-X and think there might be some extra benefit to it, talk to your surgeon about it. Bear in mind, however, that there is no guarantee that you will be able to use the reduced INR range or that it will be quieter for you.

 

[river-wear]

I asked my surgeon about the On-X valve too. He didn't see a lot of difference in design between it and the St. Jude. I was a little surprised he was kind of dismissive of it (as he also pointed out they do a lot of advertising) because he seems quite progressive in many other ways. As far as I know, he doesn't have an affiliation with any valve manufacturers.

 

[Heart Of The Sunrise]

Michelle: As RobThatsMe stated:The main reason for my choice of this valve was that it is designed to help prevent/deflect panus development around the valve.
The design of the ON-X in my opinion is superior to the St Jude.

 

[RobThatsMe]

Michelle: As RobThatsMe stated:The main reason for my choice of this valve was that it is designed to help prevent/deflect panus development around the valve.
The design of the ON-X in my opinion is superior to the St Jude.

In my case, I originally had a St. Judes mech aortic valve for 10 yrs. But, panus tissue developed around the valve opening and was preventing it from functioning. I had to have another surgery to replace it. Since the On-X was designed differently, and had a deflective design to deflect and hopefully prevent panus from causing valve malfunction, I decided to give it a try. I already knew that the St Judes failed me once. They say if you are prone to Panus, then it is very likely to continue in the future. It was an easy choice for me to make, and Dr. Pettersson was also a big supporter of the On-X.

 

[pellicle]

something else to consider is this the thrombobosis potentials for a valve. It seems that not all mechanical valves are created equally in terms of potential for clot triggering. For instance:

Comparison of the Hemodynamic and Thrombogenic Performance of Two Bileaflet Mechanical Heart Valves Using a CFD/FSI Model
Journal of Biomechanical Engineering

As has been mentioned the ON-X valve has some design feature to reduce the effects of pannus growth, another issues (which few discuss) is the activation of platelets by pressures created by jet streams at opening and closing of the valves. This is Hemodynamics and is seldom discussed (even though it has significant influence). For instance:

However, for the regurgitant flow phase (Fig. 8(b)), the
SJM exhibits a stronger regurgitant jet, particularly in the hinges
region. Owing to its different open pivot hinge design for the ATS
valve, this jet is broken into two much weaker jets. Regurgitant
jets were previously implicated in mechanical heart valve hemolysis
and platelet activation.

Accordingly, fewer platelets are carried beyond the
activation threshold with the weaker leakage jets of the ATS
valve. This offers a viable explanation to the disparities observed
in the thrombogenic behavior of different types of bileaflet heart
valve designs. A similar explanation was offered when
comparing the hinge flow dynamics (measured with laser Doppler
velocimetry) of a CarboMedics bileaflet MHV to that of the SJM
Regent MHV used in our study and the Medtronic Parallel MHV.
...
Thus, a seemingly small difference may translate into a significant difference in the overall thrombogenic performance of these two valves. The difference between the two values reported here represents an almost
30% increase in the number of platelets reaching full activation during regurgitation in the SJM over the ATS valve.
...
it indicates that overall, the ATS valve may offer a lower thrombogenic potential owing to its different hinge mechanism design.

Some other readings from here are in this worthwhile thread:
http://www.valvereplacement.org/for...On-X-vs-ATS-open-pivot-The-Truth-is-Out-There

 

[jhebrink]

On-X, the way to go

On-X, the way to go

This company does a lot of advertising and I have seen references to it as the Mercedes of valves.

The most interesting aspect is the Reduced Anticoagulation trials. It is also supposed to be less destructive on the
blood cells.

Does anyone have experience or additional insight on this valve? Any chance it is quieter than the others? Any disadvantages?

Thanks

I got a mechanical On-X Aortic valve and aortic root in January this year, and my surgeon and cardiology team swear by the improved hemodynamics of this valve. I think it may even be a bit quieter then my previous St. Jude aortic valve which had to be replaced due to contracting endocarditis that turned septic. My surgeon, Dr. Kim Duncan at the Nebraska Medical Center is perhaps the most experienced and skilled in terms of treating adults with congenital heart disease within 400 miles of Omaha....just saying, I am alive today thanks to Dr. Duncan. :smile2:

 

[mcsf]

I am new to the On-X valve. I've been home a week now since having my surgery. My doctor and surgeon(s) like the On-X because of the better hemodynamics. I was told it would not be loud. Ha! It makes more noise than I expected. I can hear it now as I type. It sounds like a wrist watch. Friends and family can hear it in a quiet room. I'm 6' 2", 185 and they were able to use the largest size On-X valve they have. I forget the size. So far it I have no complaints.

 

[TheGymGuy]

You are going to get lots of On-X valve recepients respond here. There was a good post here somewhere by Bill W which talked about a study between ATS and On-X and hemodynamically they were basically same or very similar. I, too, have On-x and mainly cause their Marketing Machine won me over - lol.

 

[tom in MO]

My doctor was suprised I asked about the On-X and wanted to know where I got the information. He was also suprised to hear about their advertising, marketing and premiums to potential valve recipients. He told me he was familiar with the valve, but saw no distinct proven advantages over the valves he currently uses. He likes St. Jude with its dependable long term track record but would have installed an On-X if I wanted one. Since I assumed by surgeon knew more than I, I took the St. Jude.

My St. Jude was installed in 2012, the INR range is 2-2.5 which is smaller and lower than most (2-3 range). I was a little concerned about the tight range, I go low more than hight. I discussed it with my cardiologist and he indicated that the St. Jude is a robust valve and can tolerate INR levels less than 2 w/o problems.

 

[mcsf]

In my opinion the age of a surgeon may play a factor in what valve is used and is more likely to use a St. Jude. That is just my opinion. If you have an aorta root procedure with a valve replacement I think that will impact what valve a surgeon will use too. Again just my opinion. The St. Jude is much easier to use with an aorta root surgery because the St. Jude has a stent or something (I forget the term) that makes surgery a bit easier to use when doing an aorta root replacement. As my surgeon said post surgery, "I had to go old school to put the valve in place." I had a Onx-X valve. That said, a surgeon will use whatever you ask for in most cases.

 

[RobThatsMe]

In my opinion the age of a surgeon may play a factor in what valve is used and is more likely to use a St. Jude. That is just my opinion. If you have an aorta root procedure with a valve replacement I think that will impact what valve a surgeon will use too. Again just my opinion. The St. Jude is much easier to use with an aorta root surgery because the St. Jude has a stent or something (I forget the term) that makes surgery a bit easier to use when doing an aorta root replacement. As my surgeon said post surgery, "I had to go old school to put the valve in place." I had a Onx-X valve. That said, a surgeon will use whatever you ask for in most cases.

Well, my surgeon was old, and he was a solid St Judes guy. He advised strongly that I go with the On-X.

The On-X valve did not have the graft option,(not called a stent) when my second surgery was done 4 years ago, so my surgeon built his own graft for my valve. The On-X valve with graft was still in the final approval stages back in 2010, but was approved in 2011.
They now have the valve with graft available.
http://www.onxlti.com/product-divisions/heart-valve-products/ascending-aortic-prosthesis/

Not an opinion, just the facts for my actual surgery.

 

[river-wear]

Thanks for the discussion of the relative merits of the valves. It's always good to learn more while I can! (Or rather, while it still matters to me.)

 

[Elgato]

Has anyone seen anything new on the trials?
Could this really be the first mechanical that does not need Warfarin?

If approved, how significant would the lower INR range, 1.5-2.0, be?

 

[ElectLive]

Has anyone seen anything new on the trials?
Could this really be the first mechanical that does not need Warfarin?

If approved, how significant would the lower INR range, 1.5-2.0, be?

There's some discussion of this here: http://www.valvereplacement.org/forums/showthread.php?42468-On-X-CE-mark-and-%28unfortunately%29-1-5 and here: http://www.valvereplacement.org/forums/showthread.php?41634-Latest-on-ProAct-for-Reduced-Anticoagulation-with-On-X-valve.

 

[Lynlw]

Has anyone seen anything new on the trials?
Could this really be the first mechanical that does not need Warfarin?

If approved, how significant would the lower INR range, 1.5-2.0, be?

There's some discussion of this here: http://www.valvereplacement.org/foru...unately)-1-5 and here: http://www.valvereplacement.org/foru...ith-On-X-valve.

beside those threads, there was a thred the other day discussing it. http://www.valvereplacement.org/for...alve-produces-the-lowest-number-of-bloodclots

FWIW, IF it is approved, in some people w/ ON-X valves they MAY be ab;e to take Plavix and aspirin instead of Coumadin. Of course not everyone is a candidate for plavix and they just finally got enough people in the plavix arm, so will be several years before results are known.

 

[Elgato]

These stats are pretty impressive.

http://www.onxlti.com/low-anticoagulation-study/clinical-results/

 

[tom in MO]

Of course they are impressive, it's a marketing statement not scientific results.

There are anomalies in the data as well.

Why in one table is it thromboemelism but in another it is thrombosis? Why is valve related death only given for one table? They cite the same references but present different data in the tables for the similar events.

Why does only one table give the number of subjects?

I certainly don't know the answers, but I would counsel to not judge any medical product by the manufacturer's marketing statements. The largest government fines in the history of the US are levied against drug manufacturers and one of the biggest problems is false claims of effectiveness...yes I know, that's drugs these are valves, but they are both made by people.