On-X

[Smedly]

Hi all,

First time posting. My wife Helena goes to CC for pre-op the 30th, surgery for valve and root on Aug. 3rd.

I've read a bit about On-X, talked to Catheran, now I'm looking for any details.
Why would a surgeon not use?
What is the worst thing about it?
If you want to private email me please do, and I can give you my cell number.

Thanks,
Bob

 

[Blanche]

Bob:
Welcome. You have come to the right place for info on On-X. There have been tons of threads here going back all the way to 2002. While you are waiting for others to respond, you might want to check out past posts, which can be found by clicking on the search feature at the top of the page. Enter "on-X" and you will find much background material.

Also, you might want to check out this post too. http://www.valvereplacement.com/forums/showthread.php?t=20851&highlight=On-X

Kind regards,
Blanche

 

[geebee]

Welcome Bob,

I wish your wife all the best for her surgery and will be thinking of you as well. You are very nice to be gathering information for her.

As far as your question as to why someone would not use an On-X. It is kind of like why would someone choose a Mercedes over a BMW or a Porsche over a Maserati. All are great cars with good features but some folks might think one is less of a gamble than the other or one has a better/longer track record than the other.

There are a number of mechanical valves out there today but the two that seem to be used the most these days is the St. Jude and the On-X. Many of us are not gamblers (or have been "bitten" by the "new kid on the block" valve in the past) so we tend towards the tried and true St. Jude. The On-X is newer on the market and, although it has a wonderful track record so far, it does not have the history of the St. Jude. If we were 10 years down the road, the story might be different but we are here in good old 2007.

The On-X is also hoping for less or no ACT in the future. Again, that is/might be in the future. The decisions need to be made based on what is, not what might be - IN MY OPINION.

I truly believe either valve would be great for your wife and the ulitmate decision will be hers and the surgeons as to which valve to choose.

 

[ALCapshaw2]

Over 55,000 On-X Valves have been implanted in the World Market over the past 10 years. On-X received FDA approval for use in the USA about 5 years ago.

To my mind the MAIN advantage (regardless of the outcome of the NO vs. Less Anti-Coagulation Studies currently underway) is that On-X reports the LOWEST incidence of Morbid Event Failures of ANY Mechanical Valve on the Market today. This is the REAL Benefit and is available TODAY.

The Gold Standard for Longevity is still the STANDARD St. Jude Mechanical Valve with a 30 year track record.

The New St. Jude REGENT Valve was developed to compete with the On-X valve. So far they have only developed one for the Aortic Position.

I would urge every patient to research and ask their surgeons about the history and design features of ANY valve(s) they are considering.

'AL Capshaw'

 

[Lynlw]

Al, I'm curious since you seem to be the ON-X expert,maybe you know this.

To my mind the MAIN advantage (regardless of the outcome of the NO vs. Less Anti-Coagulation Studies currently underway) is that On-X reports the LOWEST incidence of Morbid Event Failures of ANY Mechanical Valve on the Market today. This is the REAL Benefit and is available TODAY.

I was wonderring do you knw where we can find a graph type of info to see the comparison, or see how the incidence of mortality (so far) relates to the more common tissue valves?
Since Justin just had his 5th,OHS and we never know when he will need his next, since his last conduit was just replaced 2 years ago, I try to keep up.Thanks Lyn

 

[ALCapshaw2]

Al, I'm curious since you seem to be the ON-X expert,maybe you know this.

To my mind the MAIN advantage (regardless of the outcome of the NO vs. Less Anti-Coagulation Studies currently underway) is that On-X reports the LOWEST incidence of Morbid Event Failures of ANY Mechanical Valve on the Market today. This is the REAL Benefit and is available TODAY.

I was wonderring do you knw where we can find a graph type of info to see the comparison, or see how the incidence of mortality (so far) relates to the more common tissue valves?
Since Justin just had his 5th,OHS and we never know when he will need his next, since his last conduit was just replaced 2 years ago, I try to keep up.Thanks Lyn

Catheran Burnett, Education and Information Manager of Ox-X sent me an *extensive* information package that included a booklet discussing Valve Disease and descriptions of ALL types of artificial valves.

She also included several "Clinical Update" sheets on various topics including sheets entitled "Morbid Event Rates Comparison", one for the Aortic Position and one for the Mitral Position. These sheets listed data from On-X, SJM (St. Jude), CMI (Carbo-Medics), ATS, and MH (I forgot the full names) along with footnotes citing the references from which the data was obtained.

I'm sure that Catheran would be happy to supply a similar information package to anyone who wishes to receive one. She can be contacted at [email protected] or 888-339-8000 ext. 265

'AL Capshaw'

 

[Lynlw]

Catheran Burnett, Education and Information Manager of Ox-X sent me an *extensive* information package that included a booklet discussing Valve Disease and descriptions of ALL types of artificial valves.

She also included several "Clinical Update" sheets on various topics including sheets entitled "Morbid Event Rates Comparison", one for the Aortic Position and one for the Mitral Position. These sheets listed data from On-X, SJM (St. Jude), CMI (Carbo-Medics), ATS, and MH (I forgot the full names) along with footnotes citing the references from which the data was obtained.

I'm sure that Catheran would be happy to supply a similar information package to anyone who wishes to receive one. She can be contacted at [email protected] or 888-339-8000 ext. 265

'AL Capshaw'

thanks,
ps.Wow i didn't know you couldn't just type "thanks", or the message was "too short" I'm always learning things.

 

[dtread]

On-X

Why would a surgeon not use? A surgeon would not use because they are already familiar (i.e., comfortable) using another valve. In my case, the facility where I was to have my valve implanted used the St Jude. However, after researching the options, I decided that the On-X would be a better choice for me. I met with the surgeon prior to the surgery, and he was initially reluctant to consider the On-X. After I persisted, he indicated that he would research it but would not guarantee that he would use the On-X. I had contacted On-X and they interceded on my behalf (with my blessings) and worked with the surgeon to ensure that the various valves, sizing instruments, etc. would be available during the surgery. On-X even sent a representative in that was present during the surgery to help with the valve sizing. In the end I got the first On-X implanted at that facility.

What is the worst thing about it? Anticoagulation - which you are going to have with any mechanical valve. However, with the On-X valve there is the ongoing FDA ?Randomized On-X Anticoagulation Trial? for reduced anticoagulation of patients with the On-X valve: http://www.clinicaltrials.gov/ct/show/NCT00291525

The purpose of this Clinical Trial is to investigate whether various patients with the On-X Valve can be maintained safely on lower doses of blood thinner (Coumadin) or on antiplatelet drugs (aspirin/Plavix) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.

To participate in the Clinical Trial you have to meet certain criteria, have your valve implanted at one of the centers participating in the Trial, and have follow up visits at the same center. The Clinical Trial is not expected to be complete for a number of years (around 2015). However, it does provide some hope for reduced anticoagulation somewhere down the road, if you are not in the Trial itself.

The above is strictly personal opinion and is not to be considered either legal or medical opinion or advice.

 

[Smedly]

On-x

On-x

I appreciate the information Dan.
Bob

 

[ALCapshaw2]

I have been told that "some" hospitals put their Valve Business out for competitive bids, taking the 2 Lowest Bids. Surgeons who do not wish to 'rock the boat' presumably offer only valves "from the company store".

Bidding bottom dollar makes it very hard for smaller and / or newer companies to compete, not to mention having to overcome development costs for 'new and improved' models.

'AL Capshaw'