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Thread: New medication for A-Fib is better at preventing stroke than Warfarin

  1. #1
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    Default New medication for A-Fib is better at preventing stroke than Warfarin

    I just found this paper - http://www.dukehealth.org/health_lib...paign=RSS_news.

    I don't know when this medication will be FDA approved, or will become available (or how much it will cost), but it's certainly a promising development for those with A-Fib who want a better alternative to warfarin.

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    I was just diagnosed with A-Fib. It comes at a time that I will need to have my aortic valve replaced (second time). I first had it replaced in 3/98 and chose a Homograft (human). It performed fairly well and it is close to the life they estimated at the time. I chose not to get a mechanical valve at the time, because being an active person, I did not want to go on cumadin. Now that I am 64, I believe a mechanical valve is the right way to go. I was put on Pradaxa during my recent bout with A-Fib. I seem to tolerate it very well and do not have to have blood tests. My question is will Pradaxa I be able to remain on Pradaxa after my aortic valve is replaced, or will I have to go on cumadin. Thanks for responses.

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    If you get a mechanical, you will be on warfarin, not Pradaxa. Pradaxa has not been approved for use with valvular a-fib or with mechanical valves.
    Marsha (7-28-50), MVP 1990/MVR (St. Jude) & ASD repair 6/24/03 Baylor University Medical Center, Dallas Texas. Hometesting since 11/03, first with ProTime 3, now with INRatio.
    John (3-13-46), MV repair 5/10/07, Dallas Presbyterian, port-access incision, Dr. William Ryan. Chordae ruptured 12/05 in car crash.

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    Quote Originally Posted by Protimenow View Post
    I just found this paper - http://www.dukehealth.org/health_lib...paign=RSS_news.

    I don't know when this medication will be FDA approved, or will become available (or how much it will cost), but it's certainly a promising development for those with A-Fib who want a better alternative to warfarin.
    Check out the NEJM. There have been several articles recently about other anticoagulants for use with non-valvular a-fib.
    Marsha (7-28-50), MVP 1990/MVR (St. Jude) & ASD repair 6/24/03 Baylor University Medical Center, Dallas Texas. Hometesting since 11/03, first with ProTime 3, now with INRatio.
    John (3-13-46), MV repair 5/10/07, Dallas Presbyterian, port-access incision, Dr. William Ryan. Chordae ruptured 12/05 in car crash.

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    It's a bit funny -- at 64, a lot of people choose tissue valves because they don't expect to outlive the valve. However, I do NOT disagree with your choice of a mechanical valve -- with lifespans for many people increasing, it would be nice to avoid having another valve replacement ten, twenty, or more years from now -- your mechanical should be clicking along until you get hit by some teenager driving a 2155 Buick Aerocar.

    I would not avoid a mechanical valve just because I'm scared of having to take coumadin/warfarin. It's really not that hard to manage it -- especially if you've got your own meter and dosing guides. Coumadin is not the dreaded 'rat poison' that some people may have you think. My dose of warfarin costs me about a dime or so a day -- from what I've heard, Pradaxa is about $8 a day. And, from some of the things I've read, it's not entirely foolproof and there's no way to reverse over anti-coagulation caused by Pradaxa.

    And, as Marsha noted, there are many new anticoagulant drugs being developed. Even if you have to take warfarin for a few years, it's not unlikely that you'll be able to take some other medication (at a steep price) that doesn't require any testing or frequent monitoring.

    Again -- I wouldn't avoid a mechanical valve just because of the coagulation issues. And, once you're on warfarin, consider getting your own meter and strips -- being able to test your INR is an empowering feeling.

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    I've been reading about Pradaxa. Is this medication (Apixaban) different from Pradaxa?
    Mitral valve repair & maze procedure - October 20, 2005 - Montreal Heart Institute
    A-Fib - August 2005
    Endocarditis - 2004

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    Apixaban is different from Pradaxa. It will be interesting to see what happens with both, or any others, over time. The Apixaban study seems to claim superiority to Warfarin in all 3 risk categories: stroke, bleeding, and mortality, while Pradaxa, I believe, only claims superiority to Warfarin in stroke risk. But, of course, all still very early, all still A-Fib only.
    "EL" - In the Barn | 1975 - BAV diagnosed at birth | 2010 - OHS: AVR and ascending aorta aneurysm (5.0 cm) graft | Valve: 27mm Carpentier-Edwards PERIMOUNT Magna Ease pericardial | Aorta: #30 Gelweave graft | Pacemaker: St. Jude Medical Accent Dual Chamber

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    Please forgive a minor hijacking of this thread (which I started a few weeks ago).
    The pharmaceutical companies are highly motivated to develop a medication that will work for everyone needing a certain level of anticoagulation, work reliably, have no side effects or negative interactions or unwanted effects. As a person who's taken warfarin for twenty years, I certainly wouldn't mind taking a pill, one dose a day (or maybe one pill every week?), that prevents clot formation on or around my valve and doesn't cause my blood to get so extremely anticoagulated that this will cause a problem. In fact, a pill that works to prevent a clot on my valve, and doesn't require INR testing, or a somewhat close watch on diet and activities, would be great.

    However, I'm not sure I'd be willing (or able) to pay for such a miracle drug. (I've heard that Pradaxa is $8 a DAY)

    Sure, the pharmaceutical companies are spending quite a bit to develop drugs that do one or more of the things I listed above. Sure, it may cost millions of dollars to get the drug through FDA testing. Certainly, these companies deserve some kind of return on their investment in finding and developing a drug that does what many (if not all) of us who take warfarin would really like to use.

    HOWEVER, I'm not sure how many of us will be able to afford to pay for the drug (plus the pharmaceutical company's profits). Even with prescription drug coverage, some companies may balk at providing an expensive drug when warfarin is available and does almost the same thing.

    It's kind of like pain relievers. If any of us can remember back 30 or more years, the pain reliever in most common use was aspirin - plain old aspirin (sometimes with chemical buffers, sometimes with caffeine, and sometimes with other stuff that enabled a company to give it a new brand name and claim different benefits). Tylenol came along - with a different mode of action - and a premium price. The drug companies worked hard to develop other analgesics -- Ibuprofen, Naproxen, and others. While they still had the patents in force, the drugs were initially prescription only, and they could charge a LOT more than aspirin which, in general, did the same thing. Eventually, these medications were approved for over the counter use, the patents expired, and the price for these pain relievers plummeted.

    I can buy a bottle of 200 aspirin for 99 cents. The other OTC analgesics are somewhat more expensive.

    I may not be around to see it, but in 40 or 50 years, we'll probably see new drugs designed for people with AFib or mechanical valves. These drugs may essentially replace warfarin, and will be priced fairly low, once the patents expire and generic drug manufacturers get involved. They'll all be prescription only, and warfarin will probably still be around. These drugs may be needed by the remaining few who actually required mechanical valves -- before there was a simple surgery that repaired the valve or replaced the leaflets without adding the risk of clotting.

    Anyway -- we WILL probably be seeing new drugs aimed at people with AFib or mechanical valves. It would be nice if these medications are safe, effective, and not priced so high as to exclude people from their use.

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    Many, perhaps most, surgeons will recommend tissue valves for people over 60. Certainly if you prefer a mechanical, they will oblige (unless some reason to not). A mechanical valve will require coumadin but a tissue valve usually, at most, requires a 2 or 3 month course of coumadin until your tissue grows over the implant edges. Unless you developed a-fib post op, you would not require coumadin. Some surgeons do not require coumadin for even that short course after getting a tissue valve.

    You need to verify with your doctors about pradaxa for A-Fib if you have a tissue valve. They will know what you personally will require.

    Best wishes.

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    Absolutely, most surgeons will recommend tissue valves for people 60 or over. The theory is that these poor, weak, old people won't last longer than the 10-20 years (optimistically) that their tissue valves will last. The idea is that they won't have to worry about a repeat surgery to replace the tissue valve when it fails. Perhaps these people, as they age, will become incapable of taking their warfarin as needed. Perhaps the doctors think that these old people will go deaf, and the only thing they'll hear will be the incessant ticking of a valve -- and the ticking will drive them crazy. (I don't mean to disparage seniors -- I'm in that group -- but I sometimes wonder if going with a tissue valve is, in some ways, selling the idea of living past 70 or so somewhat short. A mechanical valve might be a BETTER choice, because it may be harder for a really old person to survive a heart surgery to replace or repair a tissue valve than it is for a younger person. If I was an old person and had a mechanical valve, the likelihood of having to undergo another major chest surgery would be reduced if not avoided entirely.)

    I'm not entirely sure that I'd agree with this thinking - unless the person has other health problems that suggest that survival longer than the tissue valve's useful period - is unlikely.

    I realize that this topic has morphed into one that may be better positioned in the Valve Selection forum.

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    Most surgeons are suggesting tissue valves implanted in a 60 year old are likely to last upwards to 20 years....... and they aren't sure if even more.

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    For the sake of the older people getting tissue valves, I hope this is true. On this forum, we've seen many with tissue valves that didn't last more than 7 years or so. Perhaps the valves have been improved enough to deliver 20 or more years. (But even for an 80 year old whose tissue valve lasted for 20 years and is facing repair or replacement, the prospect of another open heart surgery could be pretty daunting. I'm hoping that by 2030 or so, medical technology would be at a state that a minimally invasive repair of valve leaflets - perhaps by robotic control of surgical devices - would make this almost as simple as outpatient surgery).

  13. #13

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    Quote Originally Posted by Jkm7 View Post
    Most surgeons are suggesting tissue valves implanted in a 60 year old are likely to last upwards to 20 years....... and they aren't sure if even more.
    Several tissue valves, perimount, Biocore, hanncock II already have a PROVEN track record, of lasting 20+ years in the majority (in around 85% or higher) of patients over 60-65 and of course longer in patients even older.

    I supposed a few doctors, might base their reccomendations on as PTN says,"Absolutely, most surgeons will recommend tissue valves for people 60 or over. The theory is that these poor, weak, old people won't last longer than the 10-20 years (optimistically) that their tissue valves will last. The idea is that they won't have to worry about a repeat surgery to replace the tissue valve when it fails."
    BUT the majority of surgeons in the leading centers who are reccomending tissue valves for patients 60 and younger has nothing to do with that, but has to do with the fact that tissue valves ARE lasting longer as well as the improved stats for first time REDOs and even multiple REDOS in experienced hands. BUt the main reason is the chance that any 60 year old getting a tissue valve NOW most likely will be abl to have that valve replaced when it is time by cath. So the odds are pretty high they will be able to avoid repeat OHS and coumadin.
    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) www.caringbridge.org/nj/justinw

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    In my last posting, I speculated that repairs of tissue valves 20 years from now could be done as a minimally invasive repair. It's good to hear from Lyn that there are now tissue valves with 20+ year track records. It should be safer for us old people to not have to worry about INRs and anticoagulation when we hit our 70s or higher age ranges.

    I'll back off my cynical view that some doctors put in valves with shorter anticipated useful lives than those for mechanical valves, and hope that the future proves this less cynical view to be well placed.

    (And returning to the original subject of this thread - there are medications being developed that seem to do a better job than warfarin -- lets just hope that these are developed soon, by a company whose only motivation isn't pure profit, and the cost could approach that of warfarin)

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    Quote Originally Posted by Protimenow View Post
    In my last posting, I speculated that repairs of tissue valves 20 years from now could be done as a minimally invasive repair. It's good to hear from Lyn that there are now tissue valves with 20+ year track records. It should be safer for us old people to not have to worry about INRs and anticoagulation when we hit our 70s or higher age ranges.

    I'll back off my cynical view that some doctors put in valves with shorter anticipated useful lives than those for mechanical valves, and hope that the future proves this less cynical view to be well placed.

    (And returning to the original subject of this thread - there are medications being developed that seem to do a better job than warfarin -- lets just hope that these are developed soon, by a company whose only motivation isn't pure profit, and the cost could approach that of warfarin)
    You can be as cynical as you want, doesn't bother me ..I just wanted to make sure others know, things you HOPE happen or specualte MIGHT happen, or possiby happen in 20 or more years already either exist and have for years, like the tissue valves they started using in the early 80s and have already proven record of over 20 years in the majority of patients over 65, or how they will need replaced and have been talked about/with links quite often here, for longer than I was a member.

    Min invasive repairs/replacements that involve much smaller incisions or robotics, have been in use for probably close to a decade- but even better percutaneous valve replacement, that beside only needing a small incision for the cath, also do NOT need the heart/lung machine Already have been APPROVED and done daily in the US, for pulmonary valves (for the most part in children or young adults who are very active). I'm sure anyone who has been a member here for even a few months also is aware that the trials for Percutaneous Aortic valves already have been going on, with great results for edwards sapien valve and most likely WILL be aproved in the US the beginning of 2012 if not earlir. Medtronics corevalve trials have also started in the US and according to one of the latest european conferences almost HALF of the Aortic tissue valv e implanted in Europe this year have been done by Cath. (links somewhere here ill look for them later)So chances are pretty good the " 80 year old whose tissue valve lasted for 20 years and is facing repair or replacement, the prospect of another open heart surgery could be pretty daunting". most likley ill be able to have it replaced in the cathlab and be home in a day or so, like people with stents are, without the long recovery OHS involves. Actually chances are pretty good a person who is 60 now and chooses a tissue valve, not only can have this valve replaced by cath in 10-20 years, but already they are replacing cath valves with new cath valves, so he'd probably be pretty safe. They are working on percutaneous valves for the other valves too, but pulmonary and aortic are much further along

    There are very good reasons MANY of the leading surgeons are reccomending tissue valves in patients 60 and up NOW with the hope they will live a long and happy life and when THIS valve needs replaced in 10-20 years they will most like have a cath, day surgery. Of course some people won't be able to avoid OHS, depending why they need another surgery.

    Thats without even taking into considerations coumadin and ANY anticoagulants DO have risks, and the risks go up even more in the "elderly" especially if they have other comorbidities that being on anticoagulents can, not will complicate, or fall etc (when most studies show elderly people who are on coumadin IN RANGE do the worst, even in something as small as a fall from standing.) not to mention other things like bone density that involve Vit K, that Coumadin can (of course not always) make worse. The fact is the % of valve patients getting tissue valves is increasing quite a bit in the last 5-10 years

    YES some tissue valves can and Do last much shorter than hoped for or the average, especially in younger (less than 40) either because of the valve being calcified or poor stitching, panus, BE etc . but like you remember the short lasting tissue valves, I remeber quite a few of the older members whohad their mech valve over 20 years, were on their 2nd mech valve or needed another surgery to repair of clean up their origonal one..just like Justin's dacron conduit that SHOULD have lasted "forever" needed replaced in less than 2 yars..thing happen. Even if the valve didn't malfunction, from our experience id doesn't matter why you need the extra surgery, just the fact you do.

    but yes it is great they are working on so many new things, better meds that dont need testing and aren't related to vit K, so food doesn't matter as well as better surgeical techniques and valves. MY big hope for the future is tissu egineered valves, that they will be able to make from the person's own cells, so SHOULD not only last long, but even better grow with children if they get them so they dont need extra surgery because they outgrew their valve.
    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) www.caringbridge.org/nj/justinw

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    Just curious.....is it possible to have a mechanical valve replaced with a tissue valve through a cath procedure....or only tissue to tissue???

    S.
    Congenital: Cleft MV, BAV, ASD. First OHS 8-3-11: MVR, TVR: Edwards MC3/4900 AS, ASD (2), MAZE, AVR: St. Jude. Dr. James Tweddell/Herma Heart Team and Wisconsin Adult Congenital Heart (WAtCH) Disease Program, Dr. Earing and Bartz, Children's and Froedtert of WI...YAY!

  17. #17
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    Quote Originally Posted by Optimus View Post
    Just curious.....is it possible to have a mechanical valve replaced with a tissue valve through a cath procedure....or only tissue to tissue???

    S.
    I'm pretty sure I have read that to replace a mech with either another mech, or a new tissue valve, requires
    another open heart surgery.
    BAV-Aortic Stenosis...AVR Oct 11, 2005 / St.Jude Regent mechanical 21mm
    INR Home testing since 2007 with Coaguchek XS...Self-Dosing

    "Caution: I may have been in contact with Nuts"

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    Thanks, Lyn. Good stuff. I was commenting on what is still considered 'experimental' versus what is now done in common practice.

    The concept of tissue engineered valves - perhaps taken from a person's own stem cells and somehow (they still haven't mastered this part) grown in a lab (my guess is that, using a cath, they can harvest a few of the bad valve cells and use these to program the stem cells), and then rebuild an entire valve. There may be the choice of whether to just replace diseased or missing valve leaflets with newly grown ones, or doing OHS and replacing the entire valve with the one a person SHOULD have been born with.

    Whichever way it goes, the future looks promising for a future generation - if they can figure out how to make these new miracles actually happen (and if the healthcare system allows the common person to afford it).

    As far as replacing a mechanical valve with a tissue valve, I'm with Bina - it is probably an oepn heart procedure because you wouldn't be able to get the mechanical valve out any other way.

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