AR - I wouldn't spend too much time worrying about whether you got the right valve. There are no independent head-to-head trials and likely never will be. Device manufacturers almost never support such trials as they fear the chance that the outcome may not support their claims of superiority. I saw this firsthand when I worked for 4 major drug companies. So, what you see are attempts to support claims by statistical manipulations of existing data or unpublished data (data on file), with each manufacturer coming to their own disparate conclusions. Like your surgeon, mine, who has the credentials and experience to match any valve surgeon in the US if not the world, was very knowledgeable about all the valves but preferred what I got for me. Had I gone to the Cleveland Clinic, I'm sure one their equally qualified surgeons would have given me a different preference. I spent a long time trying to second-guess my surgeon, thinking he might just have an unfounded bias, but after reading all I could find, I came to the conclusion that there is no concrete way I could prove either of them right or wrong. My surgeon had 30 years of experience and study to back up his position and access to much more information than I could gather with Google, so I went with it, rather than to override him. Oh, but I did try.
On-X vs. St Jude Mechanical valve
- Thread starter edjspi
- Start date
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I'm with ya Bill. I did the same w/ my surgeon (questioned everything he told me, researched as much as I could, then questioned even more) and finally concluded he knew a lot more than I'd ever know on the topic. He's been doing this a long, long time and is personally involved or leading many studies himself. So in the end, I went with his professional recommendations (traditional sternotomy instead of minimally invasive, Regent instead of On-X, lower INR range than 'normal' - 1.8-2.2, etc.).
ALCapshaw2
Well-known member
It would be interesting and informative to know the Reasons your (very experienced) Surgeon prefers the older St. Jude Valve over the On-X Valve. Since the leaflets were designed in large part or totally by the Same Designer (Jack Bokros, Ph.D.) it's sort of like preferring a Model A Ford over a more modern Ford that represents the benefits of a long period of learning and development. I can't help but wonder if he has a specific concern about the valve or is it a bias for one manufacturer over another? (e.g. Ford vs. Chevy) I know of some Surgeons who only offer certain valve options and some Hospitals that offer only 2 choices, based on competitive bids (e.g. CC).
Does your surgeon have a similar bias against the newer Tissue Valves with anti-calcification treatments?
Would he prefer an untreated / unmodified Porcine Valve (straight from the Pig) which has a Known Low Durability (8 to 12 years) over the supposedly New and Improved Porcine (or Bovine) Tissue Valves?
'AL Capshaw'
Since Model A Fords haven't been produced since 1931, and St. Jude Master series valves are still in production today, I'm not sure the above is a good comparison.
From what I've seen, many surgeons like the proven track record of the St. Jude Master series vs. the relatively short track record of the newer valves (not that they're experimental or bad or anything, just don't have as long of a track record yet). That played a part in my surgeon's explanation of the reasons he prefers the Regent over the On-X for now. The Regent inherits the "good parts" of the Master Series design, which in his opinion means it inherits the long track record, but also incorporates many of the characteristics of the On-X (improved hemodynamics, etc. as Bina was pointing out). So it's kind of the best of both worlds (in his opinion). I don't know if he's right or wrong, but I do feel pretty comfortable putting my trust in him.
The Regent Series is not more technologically advnaced than the Masters Series, other than in its supraannular placement (positioning above, rather than within a ridge at the base of the aorta), which is a mounting option in use by many valves today.
The open pivots are the same design, the 85% leaflet openings are the same, the silicon-inpregnated pyrolytic carbon is the same. In fact, the writeups for the Regent valves are very careful to point out that they were not changed from the Masters Series, except in allowing for a larger-opening unit by changing the mount and the mounting position.
Technologically, the St. Jude Regent or Master Series and the On-X valves are distant cousins, and not at all twins. There are many innovations in the On-X valve that appear to add incremental improvements to hemodynamics, and to limit mechanical valve issues like clotting on the valve, hemolysis (mashed blood cells that can lead to anemia), pannus (scar tissue) growth, and leaflet vegetation caused by tissue encroachment.
That being said, it must be noted that no valve has saved or extended as many lives as the St. Jude mechanical valve. Nor are there as many implanted of any other brand of valve. Older technology or not, it is a thoroughly proven, highest-quality-level valve that is never a bad choice.
There are two possible replacements for Plavix coming down the home stretch in clinical trials, including one that will have outcomes for AFib usage later this year. And if these don't make it, there are others in the pipeline. Aspirin alone may not wind up being workable for On-X valves, but there is likely to be some kind of a mix available, should the aspirin/Plavix trial pan out.
Would I choose On-X, if I were to have a mechanical valve installed? Yes. Is it the only reasonable choice? No.
Best wishes,
The open pivots are the same design, the 85% leaflet openings are the same, the silicon-inpregnated pyrolytic carbon is the same. In fact, the writeups for the Regent valves are very careful to point out that they were not changed from the Masters Series, except in allowing for a larger-opening unit by changing the mount and the mounting position.
Technologically, the St. Jude Regent or Master Series and the On-X valves are distant cousins, and not at all twins. There are many innovations in the On-X valve that appear to add incremental improvements to hemodynamics, and to limit mechanical valve issues like clotting on the valve, hemolysis (mashed blood cells that can lead to anemia), pannus (scar tissue) growth, and leaflet vegetation caused by tissue encroachment.
That being said, it must be noted that no valve has saved or extended as many lives as the St. Jude mechanical valve. Nor are there as many implanted of any other brand of valve. Older technology or not, it is a thoroughly proven, highest-quality-level valve that is never a bad choice.
There are two possible replacements for Plavix coming down the home stretch in clinical trials, including one that will have outcomes for AFib usage later this year. And if these don't make it, there are others in the pipeline. Aspirin alone may not wind up being workable for On-X valves, but there is likely to be some kind of a mix available, should the aspirin/Plavix trial pan out.
Would I choose On-X, if I were to have a mechanical valve installed? Yes. Is it the only reasonable choice? No.
Best wishes,
ALCapshaw2
Well-known member
Yeah, maybe the Model A analogy was a stretch.
A better one would have been a late 1970's vintage vehicle (St. Jude Master's Series Valve was designed in the late 1970's) vs. a 1996 vintage vehicle (when the On-X Valves were introduced).
Typically, the way a GOOD Product becomes a GREAT Product is through a series of 'incremental improvements' as 'issues' are addressed and improved upon. I expect that Jack Bokros, Ph.D., who was consulted for or designed the major Bi-Leaflet Valves produced in the USA, looked at the 'issues' that were seen in some (small) percentage of Mechanical Valve Recipients such as Hemolysis (damage to Red Blood Cells), Clot Formation (due to Turbulance from leaflets that did NOT open to a full 90 degrees, or due to 'surface irregularities' caused by the strengthening agents in the early forms of Pyrolytic Carbon), and Pannus Tissue Growth impingement of the Valve Leaflet motion and set out to see what he could do to reduce the incidence of those 'issues'. He founded Medical Carbon Research Institute (now On-X Life Technologies) to produce his 'latest and greatest' design.
'AL Capshaw'
A better one would have been a late 1970's vintage vehicle (St. Jude Master's Series Valve was designed in the late 1970's) vs. a 1996 vintage vehicle (when the On-X Valves were introduced).
Typically, the way a GOOD Product becomes a GREAT Product is through a series of 'incremental improvements' as 'issues' are addressed and improved upon. I expect that Jack Bokros, Ph.D., who was consulted for or designed the major Bi-Leaflet Valves produced in the USA, looked at the 'issues' that were seen in some (small) percentage of Mechanical Valve Recipients such as Hemolysis (damage to Red Blood Cells), Clot Formation (due to Turbulance from leaflets that did NOT open to a full 90 degrees, or due to 'surface irregularities' caused by the strengthening agents in the early forms of Pyrolytic Carbon), and Pannus Tissue Growth impingement of the Valve Leaflet motion and set out to see what he could do to reduce the incidence of those 'issues'. He founded Medical Carbon Research Institute (now On-X Life Technologies) to produce his 'latest and greatest' design.
'AL Capshaw'
I read all the information provided by On-X on their website, including every referenced paper and made notes on them when I was doing my due diligence last September. Give me a day or so and I'll get my notes origanized and up on my website.
mitchner9g
Active member
Well put, Bob - And not just because I arrived at the same conclusion as you (-:
Facing my 4th reconstruction in 11 years (3rd re-op following my orig. Ross procedure in 1999). After some poor luck with biologic valves, I'm knuckling down with a mechanical aortic valve and the one I'm opting for is the ON-X based on a lot of sleuthing over the past few months. But given the strong track record, if I wake up post-op and doc said for some reason he had to fit me up with a St. Jude, I won't be disappointed given such a good track record.
Suerte, amigos
jtludwig
Member
I chose a St. Jude Masters valve for my aortic valve replacement. My surgeon, Dr. Vlahakis at Mass General Hospital in Boston said it was the only one he used. During one of our earlier meetings I asked about having the latest/greatest valve, and he stopped me and said you want the one with the long track record, not the latest/newest one on the market.
ALCapshaw2
Well-known member
There are a number of Doctors who share that philosophy.
Unfortunately, you can't have BOTH the Latest Technology and the Longest Track Record.
There is another way to look at this dilemma. Since ALL of the Mechanical Valves made in the USA were designed at least in part by the SAME person, i.e. Jack Bokros, Ph.D. who is attributed with discovering the pyrolytic carbon used for all Leaflets in the modern Bi-Leaflet Valves, would you want to use his FIRST Design (i.e. the one with the Long Track Record) or his Latest and Greatest Design reflecting all that he has learned in over 20 years (now 30) designing Heart Valves?
Another interesting Question for your Surgeon would be:
How many of the Newer Valves would you want to know were successfully implanted in patients before YOU would convert to the Latest Technology?
FYI, the On-X Valves were introduced to the World Market in 1996.
Their Aortic Valve was approved by the FDA for use in the USA in 2001.
Their Mitral Valve was approved by the FDA for use in the USA in 2002.
On-X has now produced over 100,000 valves. Is that enough?
I would also be interested in hearing comments from such Old School Surgeons on Tissue Valves.
Would they opt for the Latest Tissue Valve with anti-calcification treatments,
or Straight From the Pig Porcine Valves which are KNOWN to Wear Out in 8 to 12 years in older patients?
Bottom Line: As your experience confirms, selecting a Surgeon Often results in Selecting (or Limiting) your Valve Choice(s). If you (the patient) desire a particular Valve or Procedure, it is best to find a Surgeon who has Experience using that valve or performing that procedure.
'AL Capshaw'
Al,
Have you found any mention of the silzone coated valve from St. Jude regarding morbidity?
I agree most emphatically with your surgeon's philosophy about track records. Without much testing St. Jude launched its silzone coated masters/Regent on the market. The coating had been lab tested. Ten sheep received the coated valve resulting in 50% death rate then the valve was sold on the market to unsuspecting recipients of which I'm only one. Then the valve was recalled. Long track record? Absolutely.
Don't I wish my surgeon/hospital shared the same philosophy as yours. You bet.
ALCapshaw2
Well-known member
Its been a while since I looked at anything regarding the St. Jude Silzone Valves.
You can find Many Links to that valve by doing a Google Search for "Silzone".
'AL C'
Hi Al,
There are thousands of sites on Google about Silzone. My specific question regards the statistics about morbidity referred above for other manufacturers/valves. I suppose where Silzone is concerned it's heavily censored because I haven't seen any.
Sandra
There are thousands of sites on Google about Silzone. My specific question regards the statistics about morbidity referred above for other manufacturers/valves. I suppose where Silzone is concerned it's heavily censored because I haven't seen any.
Sandra
jtludwig
Member
You're right..there is no right or wrong answer. All I can say is that Dr. Vlahakes is the chief of cardiac surgery at one of the best heart hospitals in the country, so I considered it unwise to disagree with his recommendations.
Your surgeon's reasoning appeals to me also.
LeeDavies
New member
Hello, My name is Lee and I have a mechanical st Jude Conduit Valve (they also replaced my aortic root). I am 43 years old and had my surgery (I had an ascending aortic anneurism that was dilated by 8.3cm) on 19 April 2010, I do not in any way pretend i'm an expert but all I will do is let you know of my thoughts of my mechanical valve.
I was given the option and talked through the reasons why I shouldn't have a bovine valve (I wouldn't want to go through all that again) so I went for a mechanical valve. I know it's fairly early days but I have recovered very well and all seems to be working well. When it was first fitted you can soooo hear it at night clicking away and it simply kept me awake all night and panics you as you've just returned home and are on your own (no nurses etc) and it makes your heart beat sound so fast. However, you slowly get used to it, I ended up wearing ear plugs for a while and that helped sleep.
I manage my own INR by testing at home (i've bought a coaguchek xs) and all I'll say is that I have absolutely no problems with my st jude and I am sure yours will be likewise. The fact that it will last me lifelong (touch wood) makes the decision all worth while to me.
I wish you well with your forthcoming surgery. I had mine at Kings College Hospital in London and my surgeon Dr J Desai has done an amazing job and the staff were just fantastic throughout my stay in High Dependancy. I even went back to work on July 19 and all subsequent CT's, Echos and checks all seem well, I wish the same for you.
I was given the option and talked through the reasons why I shouldn't have a bovine valve (I wouldn't want to go through all that again) so I went for a mechanical valve. I know it's fairly early days but I have recovered very well and all seems to be working well. When it was first fitted you can soooo hear it at night clicking away and it simply kept me awake all night and panics you as you've just returned home and are on your own (no nurses etc) and it makes your heart beat sound so fast. However, you slowly get used to it, I ended up wearing ear plugs for a while and that helped sleep.
I manage my own INR by testing at home (i've bought a coaguchek xs) and all I'll say is that I have absolutely no problems with my st jude and I am sure yours will be likewise. The fact that it will last me lifelong (touch wood) makes the decision all worth while to me.
I wish you well with your forthcoming surgery. I had mine at Kings College Hospital in London and my surgeon Dr J Desai has done an amazing job and the staff were just fantastic throughout my stay in High Dependancy. I even went back to work on July 19 and all subsequent CT's, Echos and checks all seem well, I wish the same for you.
edjspi
Active member
Thanks Lee. I got the On-X valve and am now 12 days post-op. Everything seems to be going exceptionally well, but I DO hear it a LOT like you said. Hoping it will decrease over the next few months. Still working to get my INR correct, other than that I'm noticiably improving each day now.
Thanks!
Eddie
Thanks!
Eddie
ALCapshaw2
Well-known member
dl_mooney
Well-known member
I too have a OnX valve (Mitral),Did a lot of research on the net & thats the one I chose.Surgeon wanted a INR of 2-3,Do home check with CougaChek.Take daily dose of Warfarin of 4 Mgs.Do sometimes hear it.But its not as bad as it was at first.Would choose it if i had to do it over.
