On-X and Brand Loyalty

[drivetopless]

It's like Chevy vs Ford . . . .

It's like Chevy vs Ford . . . .

You've touched on a subject that is very personal, so you trigger some hot buttons. Everyone wants to think their valve is the "best" so that's why you get such an adamant response in defense of what ever type of valve is being discussed.

I can imagine the prevalence of On-X promotion and loyalty is annoying, especially to those without On-X valves. I personally think we see so much about On-X because they are spending more on marketing/promotion at the patient level. They have to to get the word out about their product, much like the drug companies do with new drugs. If the patient asks the doctor about the product, it prompts more investigation/awareness from the doctor. It's a pull through marketing tactic and it works. If the On-X is a good product, then this is a good thing. It also builds patient loyalty and comfort level when the patient knows the data about the valve's performance.

I didn't hear much info/buzz on ATS valve during my research period, or it would have been more seriously considered based on today's comments.

St. Jude is the historical gold standard. Everyone knows about them and their reputation and their longevity and they have most of the market share, so they don't have to spend so much time on promotion/marketing.

I chose my valve before my surgeon. Then I selected a surgeon who had experience and good reputation with that valve. I think any valve will have issues if the surgeon implants it improperly. I also spoke to directly to people at ON-X for their input on my chosen surgeon and any unsettling/conflicting data I came across to get their response.

I was in the waiting room 13 years. When I was first diagnosed, I wanted a Ross procedure. As time went by, my valve replacement preferences changed with the latest technology options. If my surgery was 10 years from now, I would be open enough to consider something else. We make the best choice with the info we have in the moment and that is all we can do. Time will prove if that was a good choice or not.

Luckily, there is more than one good option in valve replacement. Best choice will vary depending on the patients situation. I'm happy with my On-X and there is a bit of pride in it. I got one of those carbon coated rings and a t-shirt and a $150 from On-X after my surgery, but I had chosen On-X before the survey was posted so that did not influence my choice. It just added a nice little bonus to a crappy situation. And it gave me bragging rights at cardiac rehab -- where I wore my "powered by On-X" t-shirt.

Sitting here 6 mos post op, the On-X valve works great and I feel good. But the clicking is pretty loud in a quiet environment. I don't mind it, but it is a little wierd at times. I won't be sneaking up on anyone any time soon.

 

[scott.eitman]

Finally, the right questions are being asked.

Some surgeons offer only One Mechanical and One Tissue Valve.

Some Hospitals (CC, Mayo) put their Valve Business up for Competitive Bid and pick 2 of each type.

So Yes, Choosing a Surgeon IS often tantamount to choosing the type of Valve you will receive.

It is good to have options. I visited a patient last night who needed to get the non-On-x valve due to fit considerations.

 

[scott.eitman]

I just hope the promises on-x has made are true. If so I will continue to disregard the fact that my on-x is too loud and be glad I forced my surgeon to use it for me against the hospitals policy (Mayo Clinic. They use the St Jude Masters series and the newer St Judes model. My surgeon is head of the cardiac dept and agreed to try the on-x for me)

I didn't have a choice of surgeons at Mayo, but I chose the hospital on reputation only and I believe all the surgeons there are great.

By the way, nobody ever told me this or any other mechanical valve would be queiter or better on any way than any other. In fact my Docs claimed they were all the same in general. I didn't believe that then or now and I dont believe they do either.

Doug, first I hope all is well with you. July 27th was a great day for surgery.

As for the the On-X being too loud. I met a patient last night with a louder valve. How would I know? I could hear his a couple feet away and his wife had to stand really close to me. Quiet is in the eye of the beholder. This makes me wonder how load Dick's 30+ year old valve is.

 

[ken taylor]

Funny thing, after being transferd to my local east texas cardiologist from St. Lukes the first thing he did was record the sound of my valve so his other doctors could hear how it sounded. And guess what they had never heard of the ONX valve and they have a fairly large practice.

 

[Bina]

My cardio recommended a surgeon who was chief of CT surgery....Met him, liked him.
Then we agreed on a St. Jude mech and I woke up with the newer St. Jude Regent. Yay. All good !!

 

[ElectLive]

...I also spoke to directly to people at ON-X for their input on my chosen surgeon and any unsettling/conflicting data I came across to get their response.

I was in the waiting room 13 years. When I was first diagnosed, I wanted a Ross procedure. As time went by, my valve replacement preferences changed with the latest technology options. If my surgery was 10 years from now, I would be open enough to consider something else. We make the best choice with the info we have in the moment and that is all we can do. Time will prove if that was a good choice or not.

...the clicking is pretty loud in a quiet environment. I don't mind it, but it is a little wierd at times. I won't be sneaking up on anyone any time soon.

Interesting. I probably come at it most naturally from a ask a surgeon about a valve perspective, never even considered that valve manufacturers could/would give advice about surgeons.

I guess in theory I was in the waiting room since birth, having yearly echos from the beginning. Nobody even mentioned surgery as something that might happen to me until about 5 years ago, though, and at that time, it was forecast for 15 years or so later. I didn't give it much thought, I'm an optimist and live in the moment, so figured I'd worry about it when there was actually something worth worrying about. Then, lo and behold, an echo 1 year ago turned up an aneurysm needing surgery very soon (the valve was still fine). The aneursym size had progressed dramatically, it literally came out of nowhere, wasn't even on anyone's radar, especially mine. So, full scale research efforts were not possible. In some ways, I'm glad though. Clarity is pretty elusive it seems, no matter how much time you have.

I notice you are Atlanta also...did you interview any other surgeons? I didn't have much time, but certainly would have found a way to find time for more "browsing" had I thought it necessary. But once I met Dr. Guyton at Emory, after researching prior, my decision was made.

I've always been curious about the clicking. Do other people hear it just as much (assuming they're next to you obviously) or does self-awareness just make it seem loud to a patient. I can't stop noticing my perfectly quiet tissue valve'd heart sometimes too, things just feel different. But I never noticed a thing about my heart until I found out I had an aneurysm, and the next day I couldn't stop noticing things that felt off.

Yeah, I was thinking Chevy - Ford was a good analogy too.

 

[ElectLive]

I got one of those carbon coated rings and a t-shirt and a $150 from On-X after my surgery, but I had chosen On-X before the survey was posted so that did not influence my choice. It just added a nice little bonus to a crappy situation. And it gave me bragging rights at cardiac rehab -- where I wore my "powered by On-X" t-shirt.

See, I knew it! Everyone loves free t-shirts. On-X geniuses.

I'm thinking of pulling out my valve wallet card and making a call to recommend a framed photo of the donor cow for all future patients. I wish I had one...would put it above my mantle.

 

[normofthenorth]

Forget the photos, I could have saved a lot of time if they'd chosen a pig that could already ski and bicycle!

 

[New Guy]

Thanks Scott, I'd recommend Jul 27th to anyone needing the surgery too. I'd also like to know how loud Dick's ol ball 'n cage is too. I just hope mine lasts so long. I can hear my valve sometimes and my kids can always hear it but no stranger has asked me if I have a loud watch yet. Still waiting for that.

Glad to see you're feeling strong, I am too, and keep up the good works.

Doug

Doug, first I hope all is well with you. July 27th was a great day for surgery.

As for the the On-X being too loud. I met a patient last night with a louder valve. How would I know? I could hear his a couple feet away and his wife had to stand really close to me. Quiet is in the eye of the beholder. This makes me wonder how load Dick's 30+ year old valve is.

 

[lance]

New Guy,
You make an excellent point about valves in general and Mayo Clinic's preference for St. Jude.
How much, if any, testing has been done on the new SJM Model?
My experience with SJM causes suspician as to why the Mayo Clinic is using it. Actually I'm suspicious of SJM. Other manufacturers may deserve better but I lack personal experience with them.

NormoftheNorth
You are very fortunate to have dealt with Tor. Gen'l and Dr. Tirone David. Had my surgeon had his smarts I wouldn't have the recalled SJM valve.

Discussions like this are only one reason why this site is so valuable.

 

[ElectLive]

Had my surgeon had his smarts I wouldn't have the recalled SJM valve.

Discussions like this are only one reason why this site is so valuable.

Recalled? My goodness. I knew there existed some possibility this could happen, just never heard anyone say it had. Wow. Dare I ask what that means for patients with a recalled valve?

This has turned out to be a great discussion, thanks to everyone who has shared.

 

[Julian]

Recalled? My goodness. I knew there existed some possibility this could happen, just never heard anyone say it had. Wow. Dare I ask what that means for patients with a recalled valve?

This has turned out to be a great discussion, thanks to everyone who has shared.

Here is a link to St. Jude recall:

http://www.recalledproduct.com/medical.html

And added link discussion on forum:

http://www.valvereplacement.org/forums/showthread.php?2097-St.-Jude-Aortic-Valve-With-Silizone-Seal

 

[Duff Man]

To answer the question posed by OP, your hypothetical is impossible. I can not consider the surgeon without also considering his/her valve selection and the hospital and the cost and the proximity to my home and even my family's opinion of these variables. Sorry.

As for the implication that proponents of on-x are brainwashed... I don't necessarily buy it. I think the facts present a persuasive argument in favor of the valve. I think if the other valve manufacturers were so confident about their valves' ability to tolerate lower INR and especially NO ACT then they would also design a controlled study to prove it - but they haven't. From what I've seen so far, the On-x valve is the only manufacturer that's actually designed a study to test what happens when someone is on no ACT.

I have on a few occasions put it out there that if the mechanical valve choice were made, I myself would look harder at a valve that requires a lower INR. And I've also stated in the next "breath" that it appears the On-x valve has the best chance of operating with the lowest therapeutic INR. I don't work for on-x, but from what i've read in preparation for my surgery, I am leaning in that valve's direction.

If you can point out a study form a different manufacturer on the same order and magnitude as the on-x valve's design that specifically tests the results of no ACT or low act for patients, then maybe there is bias. But it just seems like I would've read about it by now. Someone here should've.

The studies I have read dealing with reduced INR were retrospective and not designed from the beginning to test a certain threshold. They looked at data and compiled it to draw conclusions passively in hindsight.

 

[ElectLive]

Julian - Thanks.

Duff - It is a not so easy question, I admit, everyone wants the best of everything. Plus, the real life decisions we all face are hard enough as it is, nothing definitive. Posing a hypothetical question on top of all of that only makes it worse.

I think the reactions and thoughts are proving much more useful than the poll. Simple math tells you that there are more world-class surgeons than there are world-class valves. Finding comfort with a 2nd place surgeon should theoretically be easier than finding comfort with a 2nd place valve. But again, it's not always so easy. And is there really a 1st and 2nd place, or just 1A and 1B. Much like everything discussed on this site, I don't think there's a right answer, it is different for everyone.

If the poll doesn't work, it doesn't work, that's ok. I've already gotten plenty of valuable insight into the valve/surgeon issue.

By the way, glad you responded. I saw your poll when it was first posted, but I wasn't a member then, so didn't have a chance to respond.

 

[lance]

I hope the situation re Silzone is as innocuous at the previous thread on VR refers to.
The SJM Master Series valve patent was about to run out in 6 months time so Silzone was attached to the sewing cuff to ward off endocarditis a rare occurence. Silzone is composed of 3 metals--elemental silver. palladium and sorry I forget the third. All are toxic to mammals which is why I'm interested in the new model SJM--how and if it was tested. Silzone was never tested and the FDA never approved it so SJM released it worldwide. Dr. T. David encountered problems, returned the unused valves to SJM. The surgeon/hospital I attended weren't that smart and even when the valve was recalled told me they (the surgeon's office) didn't know whether mine was Silzone or not. Mums the word. I found out on my own. One learns to live with things and make the best of everything.
Cheers

Here is a link to St. Jude recall:

http://www.recalledproduct.com/medical.html

And added link discussion on forum:

http://www.valvereplacement.org/forums/showthread.php?2097-St.-Jude-Aortic-Valve-With-Silizone-Seal

 

[dtread]

On the mech-valve side, it's pretty clear that On-X has developed a very good valve, and have also been very energetic and aggressive in promoting it -- including helping to fund this forum, for which I'm very grateful! They were also gracious enough to stop using a banner her that many of us thought went TOO far, into the range of tasteless and misleading, for which I'm also grateful.

According to On-X and their supporters (including most of their end-use customers), the advantages of their valve are clear and obvious:

• A superior carbon construction material, which they claim resists thromboembolic effects and attachments;
• A wide-opening mechanism, which is claimed to decrease turbulence and damage to blood cells;
• Some evidence, from a group of badly-anticoagulated patients, that it might work OK with lower -- or maybe conceivably NO -- levels of ACT;
• Permission from the US government to pursue (and continue) a trial with one or two less intense ACT regimes (NOT including Aspirin only, though that claim is often repeated, maybe even once by me!);
• The On-X valve expressly incorporates features designed to discourage the growth of pannus, which is apparently one of the leading causes of re-ops for mech-valve recipients -- and it seems to be the only mech valve that does!
• It's too new to have directly demonstrated durability, but I think most of us accept the claims based on accelerated life-cycle tests, that show that virtually all current mechanical valves should physically last longer than a full human lifetime -- i.e., "forever".

That's obviously a lot to like!

I was part of the On-X Glee Club myself, until I dug up some competitive information from ATS (now part of Medtronics), the manufacturer of the mechanical valve that is virtually always found to be the QUIETEST mech valve in comparative studies. Their web-site has a couple of separate sections that just kind of sit there, quietly buried in their own web-site, undermining a number of On-X's impressive claims.

For example, one page deals with what ATS/Medtronics calls On-X's "magic carbon", and its associated claims that it's less thrombogenic, and therefore should be fine with lower levels of ACT/INR/Warfarin/Coumadin. The page reports the results of several studies showing the level of thromboembolic events (clots) in On-X and ATS patients on NORMAL levels of ACT/INR. Logically, if the On-X is more resistant to clot-formation, that advantage should appear at ALL levels of ACT/INR, not just at extra-low levels. But it doesn't. As I recall the data, the On-X patient's rate of clots seemed to be HIGHER than the ATS patients', not lower. The page also shows some photographs of ATS and On-X leaflets after they were exposed to possible clotting, and the photos SEEM to show that there's just as much clot-like stuff sticking to the "magic carbon" as to the ATS carbon (though they're pretty small photos).

In addition, when our BAV colleague 'pem' "drilled down" into the data, including direct communication with reps from On-X and Medtronics, he turned up enough evidence to convince him to choose an ATS/Medtronics Open Pivot mech valve instead of an On-X valve for his own heart. (His surgery is coming up very soon, so wish him well, since none of these statistics come with a guarantee!)

Most of that discussion is here. The charts showing the actual well-being of On-X and ATS patients at 1, 2, & 3 years post-AVR (as submitted to the US FDA using their reporting protocols) are especially striking, IMHO. Pannus schmannus, it seems that the ATS patients were a bit LESS healthy/fit/well off going INTO the AVR surgery, but were very significantly MORE healthy/fit/well off afterwards! (Details, details!)

Based on all that information, I think the best mech valve available now is probably the ATS/Medtronics, and I've joined their "Glee Club".

FYI: here is a Clinical Comparison of FDA Approved Studies for Heart Valves, broken out by valve type (i.e., aortic, tissue, mitral) comparing complications and mortality for the various valves. Note that On-X has the lowest mortality rate as well as the lowest composite complication rate in each category: http://www.onxlti.com/heart-valves/.../clinical-comparison-of-fda-approval-studies/
The FDA approval mortality statistics On-X vs ATS: For the On-X out of 184 patients there were 7 deaths, with 2 of those being valve related (.0108695%). For the ATS out of 965 patients there were 56 deaths, with 20 of them being valve related (.0207253%).

Also: here is a news release about the release of four Clinical Trials related to the On-X: http://www.onxlti.com/2011/06/four-...eart-valves-exceptional-clinical-performance/

 

[RobThatsMe]

In my case, I had a St Judes mechanical. It only lasted ten years due to pannus.
Due to my dissection, a tissue valve is out of the question.
If you are prone to pannus, then you will get it again.
So, install another St Judes, or a new type of mech valve that claims it can also slow, or even stop pannus development around the valve?
My decision was easy. I chose On-x.
Only time will tell if it was the right choice.

Rob

 

[ElectLive]

I don't remember ever seeing a percentage, but I haven't really been looking for it either...how common is this pannus issue with mechanical valves?

 

[RobThatsMe]

I suggest you start to do some searches on "pannus"

 

[normofthenorth]

Dtread, I'm having trouble reconciling the data in that On-X page you linked -- http://www.onxlti.com/heart-valves/.../clinical-comparison-of-fda-approval-studies/ -- with the charts that pem and I found in the actual FDA Summaries of Safety and Effectiveness (SSEs) for each valve. I posted those charts at http://www.valvereplacement.org/for...On-X-vs-ATS-open-pivot-The-Truth-is-Out-There , and they say what they say -- that the ATS patients came out of their surgery with way better results (e.g., way higher percentages in NYHA Class I) than the On-X patients did.

Do you know the nature of the document that your link points to? I.e., what is it? It doesn't seem to be a study that was published in a real (= peer-reviewed) journal, and I don't even see an author listed, do you? It LOOKS like a published article, but I can't see any other indication that is. Any idea? Is it just On-X's own compilation of data (partly from the FDA documents) that they want us to see?

Anyway, the two charts that I posted in the other thread are "raw", cut and pasted exactly as they appear in the two FDA SSEs. I haven't gone back to those documents to look for the data that On-X reproduced, and I'm certainly puzzled if one group had way fewer complications, but the OTHER group was way more likely to be playing sports without CV symptoms, and more likely to be out of the worst NYHA classifications.

Must sleep now, or I'd probably drill down to scratch that puzzle itch. Feel free to beat me to it, if you want to.