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St. Jude Pig valve vs. Edwards Cow valve

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  • #16
    I agree that Lyn keeps up on the literature more than probably anybody else "here". But I still kind of disagree about your comment that surgeons wouldn't keep using a valve for decades unless it produced the best results. Maybe my attitude toward the scientific literacy and currency of surgeons has been permanently poisoned by my experience at www.achillesblog.com, but in that field, there are definitely lots of surgeons (including prominent ones) who keep doing what they do without reading or understanding all the new studies on the subject.

    Also, the studies that compare valve longevity (e.g., "freedom from structural valve deterioration" after 10, 15, & 20 years) DO seem to show differences between popular, well-established valve models. True, there are many confounding variables -- like one-center studies vs. multi-center studies, etc. -- but if a patient wants to do the research and has some choices, I'm all for doing it and choosing on that basis. (Maybe choosing a valve AND a surgeon on that basis.) Better to do it PRE-op than POST-op!

    On the mech-valve side, we've got some people who've worked very hard to get the On-X instead of one of its competitors, and I think there's also a good case for the ATF mech valve, which seems to be the quietest. And one of our bloggers here worked hard to get the new-fangled ATF horse (pericardial) valve, based on its early results. Why not? Taking some control over these decisions can also help with the "mental game". . .
    BAV, extended ARoot, some MV damage.
    68 y.o. (65 @OHS), keen active athlete until shortly pre-op, only symptomatic 1-2 months pre-op.
    AVR (Medtronics Hancock II) Dec. 1 2010 w/ Dr. C.M. Feindel at UHN aka Toronto General. Also a "tuck" on the Aortic root, and a (Dacron) Medtronics Simplici-T ring on my MV. I did ACT for 3 months for the ring, and Metoprolol (BB) for 3 months for A-fib.

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    • #17
      Originally posted by normofthenorth View Post
      I agree that Lyn keeps up on the literature more than probably anybody else "here". But I still kind of disagree about your comment that surgeons wouldn't keep using a valve for decades unless it produced the best results. Maybe my attitude toward the scientific literacy and currency of surgeons has been permanently poisoned by my experience at www.achillesblog.com, but in that field, there are definitely lots of surgeons (including prominent ones) who keep doing what they do without reading or understanding all the new studies on the subject.

      Also, the studies that compare valve longevity (e.g., "freedom from structural valve deterioration" after 10, 15, & 20 years) DO seem to show differences between popular, well-established valve models. True, there are many confounding variables -- like one-center studies vs. multi-center studies, etc. -- but if a patient wants to do the research and has some choices, I'm all for doing it and choosing on that basis. (Maybe choosing a valve AND a surgeon on that basis.) Better to do it PRE-op than POST-op!

      On the mech-valve side, we've got some people who've worked very hard to get the On-X instead of one of its competitors, and I think there's also a good case for the ATF mech valve, which seems to be the quietest. And one of our bloggers here worked hard to get the new-fangled ATF horse (pericardial) valve, based on its early results. Why not? Taking some control over these decisions can also help with the "mental game". . .
      You are probably right for alot of surgeons settling for what they know, so its always a good idea to talk to go to/ the centers and surgeons that usually are doing alot of the research and giving the talks at the various conferences and even writing the textbooks for a 2nd or 3rd opinion to get their thoughts and ideas and why I think it is important to get other opinions.

      I think choosing the surgeon is the most important part, but Justin's history is pretty complex, so its harder to find someone that has alot of (do a few a week) experience doing the surgery he needed. Heck a couple a month would be alot for his case.
      Luckily there are about 90,000 AVRs in the US each year so it is getting easier to find surgeons that have alot of experience with them.

      Also for many people the "best" valve is usually based on a combination of things and isn't based on 1 thing like which one may last a year or 2 longer for various age groups, but also how the valve functions, hemodynamics etc. and weigh everything together to decide what is best for them. Since HH was asking which tissue valve was the best between 2 valves after talking to one of the best surgeons I DO believe most people would be very happy and have great results with any of the valves most often used.

      I think it is pretty safe to say unless a valve was very good both in how long it last and how it functions they would not be very popular and still being used by the best centers 20-30 years later. They would simply go to the wayside like many other valves that didn't work as well or as long as they hoped.

      Actually to make it more confusing, something that never gets mentioned but If I were trying to make a choice of a Tissue valve right NOW, another thing I personally would consider..not at the top of my priorities but would think about -especially if I hoped to outlive the valve, would be percutaneous valve replacements.
      IS this a valve that could be or has been easily be replaced by cath? We actually discussed that when Justin was getting his tissue valve and conduit in 2005. I wanted to make sure it could probably easily be replaced by the percutaneous valves in trials then. (It was)
      Chances are very high that companies that are developing percutaneous valves that have tissue valves in use today, are making their percutaneous valves to "fit" for lack of a better word Their tissue valve. Right now, today, there are a couple of companies that have percutaneous Aortic valves in trial in the US and one company that already had their Pulmonary percutaneous valve FDA approved, and work is being done for the other valves.
      So chances are 10-20 years from now those will be the companies that have the best data if the time comes a valve you get today, needs replaced and so you know your valve would most likely be able to replaced by cath. Tons of companies are coming up with percutaneous valves of their own now that they see they most likely will be money makers. So who knows what will be "the best" then, BUt IF some brands of valves already have been replaced by cath with good results, that would be something I would be interested in.
      Last edited by Lynlw; April 9th, 2011, 01:30 PM.
      Lyn
      Mom to Justin 25 TGA,VSDs, pulmonary atresia/stenosis ect, post/Rastelli, 5 OHS, pacer in and out ... and surgery w/muscle flap for post op infection (sternal osteomyelitis with mediastinitis) [url]www.caringbridge.org/nj/justinw[/url]

      Comment


      • #18
        Lyn, as usual, I find your comments thoughtful and well reasoned. But I disagree with maybe two of them:
        1) All the leading valves are "good", but the studies that most impress me show that they have pretty significant differences in their average longevity/durability. I disagree that a heart surgeon would get into trouble for choosing the second- or third-best for decades, nor do I think most surgeons would agitate to get their hospital to switch valves after (say) discovering that their valve came in second or third in the "Gold Standard" comparison. Heck, when my own world-class fancy surgeon discovered that HIS fave valve (the one he gave me!) came in second-best in a hemodynamic comparison (and in an article that my surgeon co-authored!), he told me he STILL doesn't believe the results! So I'd say that few surgeons are as open-minded about these comparisons as a pre-op AVR patient is!
        And if there really IS (as published) a several-year difference in average durability (at least in us fogeys) between even the TWO leading well-documented valves, then I'd say it's worth a few days of research and some surgeon-shopping to come out on the winning side of that difference.
        2) And speaking of hemodynamics: In principle, the more unimpeded flow an open AV can permit, the better. But in practice, I think the reported hemodynamic comparisons between valves are mostly "distinctions without difference", as the lawyers would say. UNLESS you have an unusually small AV (flirting with "valve-donor mismatch"), I don't think your effective AV area with any new valve is likely to affect your cardiovascular fitness. OTOH, if you can gain a few years of valve durability, you will DEFINITELY notice the difference for those few years. . .
        BAV, extended ARoot, some MV damage.
        68 y.o. (65 @OHS), keen active athlete until shortly pre-op, only symptomatic 1-2 months pre-op.
        AVR (Medtronics Hancock II) Dec. 1 2010 w/ Dr. C.M. Feindel at UHN aka Toronto General. Also a "tuck" on the Aortic root, and a (Dacron) Medtronics Simplici-T ring on my MV. I did ACT for 3 months for the ring, and Metoprolol (BB) for 3 months for A-fib.

        Comment


        • #19
          Tom - Which facility is the one you toured? I tried to google but it looks like there is more than one facility?
          1/2001 AVR 23mm Edwards Bovine Pericardial heart valve Model 2800
          Aortic Root Enlargement with Dr. Thomas Orszulak - Mayo Rochester MN (Awesome!)
          "Whoever said waiting for OHS was easy, must have had some good drugs..." :)

          Comment


          • #20
            Originally posted by normofthenorth View Post
            Lyn, as usual, I find your comments thoughtful and well reasoned. But I disagree with maybe two of them:
            1) All the leading valves are "good", but the studies that most impress me show that they have pretty significant differences in their average longevity/durability. I disagree that a heart surgeon would get into trouble for choosing the second- or third-best for decades, nor do I think most surgeons would agitate to get their hospital to switch valves after (say) discovering that their valve came in second or third in the "Gold Standard" comparison. Heck, when my own world-class fancy surgeon discovered that HIS fave valve (the one he gave me!) came in second-best in a hemodynamic comparison (and in an article that my surgeon co-authored!), he told me he STILL doesn't believe the results! So I'd say that few surgeons are as open-minded about these comparisons as a pre-op AVR patient is!
            And if there really IS (as published) a several-year difference in average durability (at least in us fogeys) between even the TWO leading well-documented valves, then I'd say it's worth a few days of research and some surgeon-shopping to come out on the winning side of that difference.
            2) And speaking of hemodynamics: In principle, the more unimpeded flow an open AV can permit, the better. But in practice, I think the reported hemodynamic comparisons between valves are mostly "distinctions without difference", as the lawyers would say. UNLESS you have an unusually small AV (flirting with "valve-donor mismatch"), I don't think your effective AV area with any new valve is likely to affect your cardiovascular fitness. OTOH, if you can gain a few years of valve durability, you will DEFINITELY notice the difference for those few years. . .
            Well we'll just have to disagee. When I said the leading valves were good, I was talking about the ones around over 25 years, the same ones I was talking about this entire thread. Also Maybe as you suggest some surgeons wouldn't agitate their hospital to carry different valves, but the leading ones at the leading centers usually don't have to ask their hospitals for much, they get what they want, and they WANT to do the best for THEIR patients. Because it makes them and their center look good. Maybe when you were interviewing a few surgeons in different hospitals, you found they weren't as open to discussing or trying new things, thats a shame if that's the case, but the Heart surgeons and cardiologists I have had many discussions with over the years, were not only up to date with all the data, but shared with me many interesting things that wouldn't be written about for several years. Maybe the important thing that came out of this is it is important to get several opinions. Maybe that is the difference in someone who is a heart surgeon and one that works on legs that you base alot on?
            I didn't say they would "get in trouble" I just don't believe they would still be the leading surgeons if they didn't use products that patients had very good results.

            As for the "gold standard study" that (I think they said they had good results for the oldest age group?) as I said earlier, beside reading a study with a few hundred people, they also look at their own data and know how their patients are doing with the different valves and I'm sure what their colleages have found when they run into them every few months at the various conferences that put in thousands of valves each year and the many many studies done on these valves over the years especially the valves used the most.

            Hemodynamics might not be as important for some people, or it might be very important. I was just pointing out that what makes one valve the "best' IF there IS one, would usually be based on a combinations of things and not just 1 or 2 studies on any function of the different valves. OF course who knows maybe the tissue valves that are the best hemodynamically will be the ones that would be able to be replaced easier by cath, which would probably come to play especially for the smaller sizes. THAT could make a HUGE difference in their life.

            Anyway I'm done here, I was simply trying to answer HH question and reassure him he would do great. The LAST thing I felt like was getting into 1 more back and forth on things people will NEVER agree on. As long as anyone is happy with the valve THEY got, that's what is important to me.
            Last edited by Lynlw; April 10th, 2011, 05:00 PM.
            Lyn
            Mom to Justin 25 TGA,VSDs, pulmonary atresia/stenosis ect, post/Rastelli, 5 OHS, pacer in and out ... and surgery w/muscle flap for post op infection (sternal osteomyelitis with mediastinitis) [url]www.caringbridge.org/nj/justinw[/url]

            Comment


            • #21
              The only Edwards facility I know of that gives a tour is the Irvine, CA. facility.
              Tom Price
              AVR and one CABG 1/25/07
              29mm model 3000 Bovine Pericardial Tissue valve

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              • #22
                Yes you can visit!!! And I highly recommend it...they are very gracious and it is very interesting. They have a giant display of all the valves they ever made, from the very early mechanicals to today's catheter. When you make arrangements, they ask for your serial number. If possible, you get to meet the employees who made your valve! It is very emotional, for both you and the workers.
                I can meet the people who made my valve? That is fabulous! I can't wait to plan that trip. (If I didn't have other plans, I'd go next month for the first anniversary of my surgery!)

                Thanks for letting us know about this!
                Born with BAV.
                AVR at Cleveland Clinic (Dr. Joseph Sabik) May 20, 2010.
                Carpentier-Edwards Bovine Tissue Valve - 23mm.

                Comment


                • #23
                  Lyn, I'm not sure why you wrote
                  When I said the leading valves were good, I was talking about the ones around over 25 years, the same ones I was talking about this entire thread.
                  Those are also the ones I'm talking about. And I think the biggest and best studies show that some of those good valves last longer than others. It used to be "standard wisdom" that cow valves lasted longer than pig valves, even though both were "good" and in common use for decades. I believe the newest and best studies (including the "Gold Standard" study on my valve from my hospital) shows the opposite, that the Hancock II has been lasting quite a bit longer than the CEP.

                  You also wrote
                  As for the "gold standard study" that (I think they said they had good results for the oldest age group?) as I said earlier, beside reading a study with a few hundred people, . . .
                  I think you know that the "Gold Standard" study (details above) documented 1134 patients, all of whom got the Hancock II. That's not "a few hundred people" where I come from, but maybe we'll have to agree to disagree on that, too. Many of the other studies discussed in that article, mostly on the Hancock II and the CEP valves, also dealt with >1000 patients receiving identical valves. The comparisons are pretty strong statistically, as you can see from the "+/-" numbers, which represent the bounds of the 95% confidence intervals -- which also suggests that the studies don't suffer from small sample sizes.

                  Here's one sample comparison:
                  McClure and colleagues [16] recently published the long-term outcomes of 1000 patients who had AVR with the CEP. . . . According to Figure 2 in their article, . . . they reported a freedom from reoperation due to SVD at 15 years of 34.7% in patients younger than 65 years and 89.4% in patients aged 65 to 75. The freedom from SVD with the Hancock II at 15 years was 80.7% +/- 2.6% for patients younger than 65 and 99.0% +/- 4.2% for patients aged 65 and older.[emphasis added]
                  "[16]" refers to a 2010 Ann. Thorac. Surg article entitled "Late outcomes for aortic valve replacment with the Carpentier-Edwards peicardial bioprosthesis: up to 17-year follow-up in 1,000 patents."

                  As I've discussed before, freedom from REOPERATION for significant valve deterioration (SVD) is always higher than freedom from SVD, because the former misleadingly includes patients who HAVE SVD, but aren't fit candidates for surgery. So this large advantage of the HII over the CEP is in fact UNDER-stated, by that difference.

                  While the authors only claim "Gold Standard" status in patients 60 and over (you refer to "the oldest age group", as if the other results were unimpressive), they may be too modest, since their 80.7% freedom from SVD after 15 years in the <65 age group seems heads and shoulders above the CEP's 34.7% freedom from reoperation due to SVD at 15 years in the same age group. Again, nobody is denying that the CEP is a good tissue valve, and a long-time standard in the US. But I don't think we should be denigrating any of our fellow patients who do decide to exert some effort to try to join an 80.7%-odds group instead of a less-than-34.7% group, or to try for 99% odds instead of 89.4%.

                  The other studies cited in the "Gold Standard" study, on those two valves and a few others, seem to fall into about the same pattern.
                  Last edited by normofthenorth; April 21st, 2011, 02:00 PM.
                  BAV, extended ARoot, some MV damage.
                  68 y.o. (65 @OHS), keen active athlete until shortly pre-op, only symptomatic 1-2 months pre-op.
                  AVR (Medtronics Hancock II) Dec. 1 2010 w/ Dr. C.M. Feindel at UHN aka Toronto General. Also a "tuck" on the Aortic root, and a (Dacron) Medtronics Simplici-T ring on my MV. I did ACT for 3 months for the ring, and Metoprolol (BB) for 3 months for A-fib.

                  Comment


                  • #24
                    Back to the tours: make sure you write or call ahead. Make sure you bring tissues....I can tell you, it's emotional. The thing is, the workers who make the valve wil ltell you they vhave the best job in the company, not those office people. What they do at work everyday saves someone's life.
                    Tom Price
                    AVR and one CABG 1/25/07
                    29mm model 3000 Bovine Pericardial Tissue valve

                    Comment


                    • #25
                      I went into surgery April 14th, giving my Surgeon permission, 5 minutes before my surgery, to deviate from my "pig" valve choice, if upon examination ...he felt another, would be a better fit, for me. I came out of surgery with a Edwards " Magna" Bovine tissue valve.... so guess, this Moooooo's for me
                      Renee

                      Go Team 2011 !!!!!

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