On-X and Brand Loyalty

[dtread]

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.

The figures are taken directly from the applicable FDA Approval Documents. For ATS its Table 1 on pages 5 & 6 from their FDA Approval Document. The nature of the On-X Clinical Comparison document is that its a summary showing the exact figures for each manufacturer's valve for when they applied for and gained approval with FDA to market their valve. Its not a Clinical Trial that would be "peer reviewed". The author is On-X Life Technologies, Inc. The figures are right there in black and white in the FDA approval documents. Nothing is fabricated or manipulated. The reason you have difficulty reconciling the figures is that the NYHA classifications are subjective whereas the FDA approval figures are objective and factual.

 

[normofthenorth]

Still busy with other things, Dan, but I appreciate your response. As I recall, the Doctors of the ATS patients rated their condition WORSE pre-op than the Docs of the On-X patients rated theirs, then rated them BETTER post-op, at several intervals. And the differences were very large, even spanning more than just the immediately-adjacent NYHA classifications, too. To me, it seemed way past the normal bounds of subjective variation. OTOH, if the On-X patients came out better on a bunch of undeniable characteristics (like survival), then that's very persuasive. I'll try to get to it soon.

I think I recall pem writing (maybe just in an e-mail to me) that the "purely objective" markers in the two FDA applications seemed ambivalent -- some favoring ATS, some favoring On-X -- but that the two charts comparing post-op well-being were strikingly and significantly different. If the former are really ambivalent, but the On-X summary presents only On-X-favorable data comparisons, then the difference between a peer-reviewed paper and a piece of corporate communication may yet turn out to be important.

Your last comment distinguishing between "the NYHA classifications" and "the FDA approval figures" seems disingenuous and misleading, since (a) the NYHA classification data COMES FROM the FDA approval documents, and (b) FDA REQUIRES that applicants (manufacturers/vendors) provide pre-op and post-op NYHA classification data for their patients, presumably because FDA considers them important and meaningful -- as do I.

 

[chaconne]

New member, first post.

As an engineer, I must say that I am intrigued with the On-X, given it's many design features that supposedly give it advantages over others. It makes sense from a fluid dynamics point of view that these things could make it better.

My surgeon has done over 6000 Valve surgeries and doesn't think there are any significant differences in the valves (On-X, St. Jude, ATS) except for the Ox-X pannus growth inhibitor. Unfortunately all the bi-leaflet mechanical valves are not ideal because the blood is, at least, split up by the leaflet and causes some drag/turbulence.

I wonder if the period of time when a mechanical valve is opening and closing causes the most turbulence and therefore the greatest potential to form clots, as opposed to when it is open. Has anybody else looked into the differences in opening and closing time between brands?

-Steve

 

[normofthenorth]

Steve, some of the articles that documented the fact that the ATS is generally quieter than the other two have suggested that it's probably because it doesn't open as far as the others (esp. the On-X). On the one hand, it sounds great to have a valve whose leaflets open so far that they're invisible (parallel) to the blood flow. On the other hand, if that makes them take longer to fully open and (especially) longer (with reverse flow) to fully close, then that doesn't sound so great.

But I still think the discussion Dan and I are having will produce the "bottom line" and all these theoretical engineering ideas should be considered logically subordinate. E.g., if pem and I are right and the ATS produces way more symptom-free healthy people than the On-X does -- OR if Dan and On-X are right, and "On-X has the lowest mortality rate as well as the lowest composite complication rate in each category" -- then I'd want to go with the winner in that competition, whatever the REASON that valve produced better results, wouldn't you?

I remember years ago being intrigued by the hydropneumatic self-levelling suspension in the Citroen DS sedan. As a piece of engineering, it was way niftier than anything else in automotive engineering -- and also way niftier than On-X's anti-pannus features, or the ATS "open pivots". But the Citroen DS CAR, taken as a whole, didn't seem anywhere near as impressive as its most intriguing engineering feature. When we're shopping for a car, we want something that does the WHOLE job well, and ditto with a heart valve, where the whole job is, I think, (1) allowing us to be fit and active, (2) avoiding medical symptoms, complications, health risks, and restrictions/nuisances, and (3) lasting a long time, preferably forever. If one valve can demonstrate that it DOES that better than the others -- or best among the tissue valves, or best among the mech valves -- then I'd want to declare it the best (and choose it for myself) FIRST, and investigate WHY it's the best SECOND.

Put another way, if valve "X" seems to have the most elegant or spiffy design, but patients DO better with valve "Y", then I think it's wrong/silly/unproductive/irrational to prefer valve "X".

 

[chaconne]

Norm,

Yes, the operation of the valve is the bottom line, as opposed to it's apparent design advantages. However, the thing that makes it difficult is the lack of data. Many of these studies comparing the pros and cons of different heart valves seem to have too few participants and too many variables to decide whether or not one is better than the other (at least according to my surgeon). I suppose time will tell.

- Discovered BAV in 1995
- Replacement surgery for AR and Aneurysm possible late 2011
- Active at age 41

 

[ElectLive]

I hope I'm wrong, but I don't think the too many variables problem will be solved anytime soon, it's the nature of the patient population. For example, the majority of the studies out there involve(d) patients 50 or 60 and above. It seems to me that a study on 30 to 40 year olds might be more productive. The medical variables would be a lot more controlled since age related complication factors like increased stroke and hemorrage risk would not be prevalent. I guess there aren't as many candidates at that age group in comparison, but there's got to be enough to expand the data field in a significant way.

Trusting and using the data is another issue, though. Let's say for example that a new patient is considering an On-X valve, and he or she finds a persuasive study comparison like that posted earlier in this thread: http://www.onxlti.com/heart-valves/medical-professionals/clinical-comparison-of-fda-approval-studies/ I have actually seen another version of this that's even more bold: http://www.reidhealthcare.com.au/wp-content/uploads/2010/07/clinical-update-no-31.pdf So, it's pretty convincing, even taking on tissue valves as well. After reading this, why would anyone consider tissue?

But wait, let's look closer at just one part, the mean age of the On-X numbers is 60 while the mean age of all but one of the tissue numbers is 70. Anybody, even a non valve recipient, is more suceptible to many of those complications at 70 than they are at 60. Passing it off so innocently - “While age tends to be higher in patients with tissue prostheses, it is not always substantially higher” - seems quite a stretch, particularly when combined with a low patient year number too.

Now, it's not just On-X, I'm sure all the manufacturers, mechanical and tissue, do this to a degree, it's called marketing - arrange the data in the best way to sell your product. But my point is that the data process begins with flawed studies (too many variables), then is often compounded with biased reporting. Finally, let's assume for a second that these two issues could be solved, and a reliable data set might one day be available for patients everywhere. As soon as the data is available, the next generation valve is out, and nobody even cares about the data anymore.

Hold on, though, I'm probably sounding much more negative than I intend to...not at all my point. This is actually my roundabout way of saying that many of the discussions here, like the posts above, are great tools to help us all try and make the best of bad data. Will any of us be able to definitively say that this valve or that valve is the best valve in the end? Probably not. But thanks to folks like those posting above, I do think we can make informed decisions based much deeper than simply the information available.

 

[pem]

Like I said, I to have been in sells all my life, I know you sell the sizzle not the steak. Most everything about all valves ,for me were taken with a grain of salt. Except one thing ONX was built to retard panus growth and they have never had one valve reported to have this proublem. For me that was enough to get my business

1) a surgeon at Cleveland Clinic, who I've come to respect very much, is a proponent of the OnX valve

2) as far as I know there are no studies reporting pannus in the ATS, but if someone can dig one up, please let us know

The mechanical valve options today are great. It seems that some of the difference of opinion are more religious than factual, which is human nature. The fact that we have two pyrolitic carbon valves to pick from will only ensure continued competition and improvements in the industry.

To OnXers and ATSers alike: Cheers! We're all very fortunate and in good company. I propose we call ourselves "the black diamond club"

Pem

 

[neil]

just wanted to say i got a packet of pork scratchings when i got my piggy valve :thumbup:

 

[pem]

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/

I now recall the study regarding valve-related mortality. The 2% vs 1% difference gave me pause at first, but I think the lower number of subjects in the OnX study, which appeared to be a single site study, and the fact that the ATS study was multisite suggested that the reported difference wasn't necessarily related to the valves. And trust me, I'm as squeamish as the next person about little things like mortality rates, and for me this was not a show-stopper.

Sorry for pasting in the whole message above. I'm still only about 10 days out from surgery so I have to use this lightweight iPod instead of my 10 lbs behemoth of a laptop. Can't figure out how to cut and paste inside the forum text boxes on this thing.

Pem

 

[djteako]

I've been studying and researching my next valve for the last 2 years . Of everything I encountered , the ON-X came out on top .

Here in canada we don't really have a choice in surgeons , or brands for thsat matter , but as it lucks out , my surgeon is one of the top rated in the world , and he uses ON-X valves !!!!! Lucky me .

oh , and as for the loud question , My 25 year old bjoirk shilley can be heard across the room , no problems !!!

 

[bdryer]

Good day

Lucky for you to have joined this forum and found yours truly! I have paved the way for you in cow town to receive an On-x valve! I was the first recipient to have the implant in the aortic position at the Foothills. Like you, I did my research and found On-x to be head and shoulders above the rest in leading edge MHV technology. I worked with my cardio, surgeon, and both the American and Canadian On-X reps to make the implant a reality. The surgeons at Calgary Foothills and the Maz in Edmonton are trained on the On-x procedure!

In Alberta, if you want a specific surgeon, or specific valve, you get it period! Have your Cardio send a referral to your choice of surgeon. Call the surgeons and see if they are familiar with the On-x procedure, if they are, have your cardio or family Doc fax a referral. Dr Kidd did my implant and like I said, we were the first in cow town to link up and make it a reality. The valves are in stock at the Foothills and the Maz up in the chuck.

Send me a PM and we can get further into details.

 

[ElectLive]

I have paved the way for you in cow town to receive an On-x valve!

First of all, forgive me, but I assume you must referring to an area of Canada, and not to those of us with cow valves? Just wanted to clarify...

I admire your determination and efforts to get the valve you wanted...wow.

 

[bdryer]

Indeed we are speaking of geography, not valve type.

 

[yagernc]

I'm coming up on my 1 year anniversary. I am 37 so my choice for a long term solution was focused on mechanical, life-time type valves. As a computer engineer and avid gear head it was only natural for me to research what was available on the market. I spent weeks, several hours a bay obsessing over the options. I had no dog in the race at that point, only to look out for myself. I don't see this as a drink the cool-aid type of thing. I read every pro/con discussion here and anywhere else, with the same level of skepticism. I made several pro/cons lists for each, evaluated those options for me. I researched any technical facts or claims to my fullest ability.

Its my opinion that the SJ valve was an almost incumbent, de-facto type reputation in many hospitals. And rightfully so there was little risk and choosing them. It also seemed from my reading that many hospitals 'suggested' them when asked for recommendations (again not a bad option in anyway). I think medical studies are ok to a point. Fact is I think more people need to participate in studies/research/ and fairly answer questions asked of them about their conditions. I find it hard to understand how you can mathematically account for so many variables in a person and their lifestyle and activities, then correlate that back to a single medical device then draw a definitive conclusion.

Anyway my Dr. seemed happily surprised when I wanted to talk about valves in great detail. He agreed with my choice for the On-X valve but also clearly stated he would support other options I may have chosen. We moved forward with a possible valve repair/reconstruction option going in, with a replace w/ On-X as plan B. I woke with the 25mm aortic. At 6months my flow numbers were great and pressures were lower than I has expected.

I look at all this way... They (On-x) are the new kids on the block with the shinny new bike that looks a little different and made of 'stuff' others didn't think about using. I had to educate myself not only on their 'advertised features' but the mechanics or their claims. I have no doubt that in 5,10,20 years there will be another new design made of unobtanium that will surpass our current valves. I truly hope so. I also closely follow the stint type valves that can be popped into place.. Made w tissue but potentially easy(er) to replace. Almost best of both worlds.

At this point I really feel left out of the On-X club as I didn't get a t-shirt

Maybe there is a secret wave, hi sign, or gang hand signals I don't know about (yet)..

 

[ken taylor]

If you want a tee shirt call cathren burnett 888-339-8000 x 265 you can even get a ring with your valve serial number on it, nothing magical there always there for EVERYONE , THERE GREAT FOLKS!!!!!!!!!