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  • TAVR vs AVR

    Article in Science Daily June 2011, discussing TAVR vs. AVR

    http://www.sciencedaily.com/releases...0605123244.htm
    Diagnosed with rhematoid arthritis 2010. Aortic valve repacement April 29, 2011 (Moo) due to native valve infective endocaritis (P.acne)

  • #2
    This is an interesting report. The group that could possibly benefit from this procedure are those with aortic stenosis. Many of us -- myself included -- were born with a congenital valve defect, or had valve damage from Rheumatic Fever, bacterial endocarditis, or other valve damaging process. Other studies report that TAVR may actually work for those in this other group.

    The results of future trials will certainly be interesting.

    It would also be interesting to see if these tissue valves are sites of clotting risk -- it would be great for future patients who've had TAVI valves implanted don't need to take anticoagulants or monitor their INRs.

    Comment


    • #3
      From my reading of this report and from what my cardiologist has told me, the TAVR procedure is only for patients who either cannot undergo OHS or have high risk of mortality with it. My cardio implied it was not for 'active' patients....implication is that it's for very elderly people who mostly sit around and not challenge their hearts.

      But I'm hopeful that over the next few years TAVR will become better and become suitable for all ages and activity levels as it's obviously much better to not have OHS when you can have a valve implanted via TAVR.

      Anne
      Anne - Congenital bicuspid aortic valve. AVR 6th January 2014 CE Perimount bovine Magna Ease Aortic valve - 19 mm. St Anthony's Hospital, anaesthetist Dr JP van Besouw, surgeon Prof Jahangiri. Also atypical Type 2 diabetes, osteoporosis, small airways disease.

      Comment


      • #4
        Originally posted by Protimenow View Post
        It would also be interesting to see if these tissue valves are sites of clotting risk -- it would be great for future patients who've had TAVI valves implanted don't need to take anticoagulants or monitor their INRs.
        Funny you should mention this...concern about stroke in the TAVI PARTNER trial and recommendation for a mandatory anticoagulation protocol came up in the Edwards Sapien FDA advisory committee meeting back in July:

        "There was a significant increase in the neurological event risk in the SAPIEN arm compared to Control, noting that the majority of Controls had BAV, in both the acute periprocedural period and the longer-term follow-up phase of the PARTNER trial. While interpretation of the increased late event rate is complicated because of the higher mortality rate in the Control group, neurological adverse events remain an important safety consideration for this device and impact the overall risk-benefit profile of the SAPIEN THV.

        The identification of stroke in the current study depended on recognition of symptoms by the cardiovascular team. Because of the elevated neurological event rate in this study and with consideration of the papers mentioned above, future FDA-regulated studies of transcatheter valve implantation will require more intense neurological evaluations.

        The cause of neurological injury with transcatheter valve implantation is multifactorial. One important consideration is management of coagulation and platelet aggregation. The PARTNER trial did not require patients to be on a protocolized anticoagulation or antiplatelet regimen. In light of this, as well as the increased neurological event risk discussed above, the sponsor has proposed a protocolized anticoagulation/antiplatelet regimen to be used in the proposed post-approval study. While this may aid in reducing the neurological event risk for patients receiving the SAPIEN, other risk mitigation measures may also need to be taken into account."


        In the PARTNER trial, the anticoagulation strategy that was recommended was limited to Aspirin (for life) in combination with Plavix for 6 months.
        "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

        Comment


        • #5
          If anyone is interested there are quite a few threads about Sapien Valve or percutaneous valves in general. heres a couple of the most recent http://www.valvereplacement.org/foru...cutaneous-Info and http://www.valvereplacement.org/foru...t-Valve-in-U.S.

          FWIW yes right now in the US trials they are for "High Risk" patients, (which isn't really that "high" like 15% chance of not making it, I thought your odds would have to be worse) the "too high risk for surgery patients, in the newest trial,corevalve) can get the valve and don't have to be divided into the valve or best medical treatment, like the sapien arm did since they did SO much better, it was felt it wouldn't be fair to make some patients be treated medically when they would do so much better with the valve.

          Usually for trials, they start with higher risk patients when it is to replace something like OHS that has pretty good//great stats, but right NOW at the latest Europen conference they said "In 2011, one out of two cases of biological aortic heart valve replacement in Europe is taking place via transcatheter procedure."
          so chances are pretty high IF you choose to get a tissue valve NOW it can be replaced by cath when it needs replaced.

          Already the percutaneous Pulmonary valve, the Melody (that a few members here have gotten) are used mainly in chilren and young adults who are VERY active.

          You already do NOT need to be on long term Coumadin with the percutaneous valves in use today.
          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


          • #6
            Originally posted by Lynlw View Post

            but right NOW at the latest Europen conference they said "In 2011, one out of two cases of biological aortic heart valve replacement in Europe is taking place via transcatheter procedure." so chances are pretty high IF you choose to get a tissue valve NOW it can be replaced by cath when it needs replaced.
            But you have to remember that most AVRs are not for congenital heart disease like bicuspid valve but for elderly people with degenerative heart disease, often these people are already in their 80's and 90's ! These are not 'active' people ! As I explained in my message above, with info from my cardio (I live in the UK), I would not be offered this procedure - I am going for tissue valve and I am 58, but like you say, maybe in 15 to 20 years time when that needs replacing TAVR will be a viable option.

            From what was explained to me, the TAVR valve is not sewn in place - it is 'sprung' into place once in position...so you see why it might not be suitable for active people who challenge their hearts ! I guess that TAVR must also increase the risk of stroke - I watched a little video of AVR on YouTube and one of the things the surgeon does is to very carefully remove all the calcification in the area so that nothing is left loose to cause stroke - with TAVR the new valve is sprung into place on top of the 'old' valve so there must be more danger of any calcification breaking loose since no one is removing it.

            Anne
            Anne - Congenital bicuspid aortic valve. AVR 6th January 2014 CE Perimount bovine Magna Ease Aortic valve - 19 mm. St Anthony's Hospital, anaesthetist Dr JP van Besouw, surgeon Prof Jahangiri. Also atypical Type 2 diabetes, osteoporosis, small airways disease.

            Comment


            • #7
              Originally posted by Paleogirl View Post
              But you have to remember that most AVRs are not for congenital heart disease like bicuspid valve but for elderly people with degenerative heart disease, often these people are already in their 80's and 90's ! These are not 'active' people ! As I explained in my message above, with info from my cardio (I live in the UK), I would not be offered this procedure - I am going for tissue valve and I am 58, but like you say, maybe in 15 to 20 years time when that needs replacing TAVR will be a viable option.

              From what was explained to me, the TAVR valve is not sewn in place - it is 'sprung' into place once in position...so you see why it might not be suitable for active people who challenge their hearts ! I guess that TAVR must also increase the risk of stroke - I watched a little video of AVR on YouTube and one of the things the surgeon does is to very carefully remove all the calcification in the area so that nothing is left loose to cause stroke - with TAVR the new valve is sprung into place on top of the 'old' valve so there must be more danger of any calcification breaking loose since no one is removing it.

              Anne
              The reason I mentioned the fact that in 2011 in Europe Half the patients having tissue AVRs ARE having them by cath already, is because I believe many of the people interested in whats going on with percutaneous valves, and threads like this one about the PARTNER trials, are probably not thinking it would be an option for them right now if they need surgery soon, but are probably taking that into some considerration when they are making a choice on what kind of valve they want now. When they are trying to decide wether they want to get a tissue valve and the chance depending on their age, it will probably need replaced and hopefully avoiding Coumadin, OR wether they rather get a mechanical valve and need to take Coumadin and hopefully avoid REDOs or maybe in the future some other anticoagulant would be available and all the other things they might consider when choosing their valve.

              When someone is trying to figure out what the chances are that IF they get a tissue valve now will they be able to avoid OHS and have this one replaced by cath, I think it probably helps to know that right now in Europe half the people getting tissue valves are getting percutaneous valves, or 40,000 TAVI have been done so far world wide or how the different trials are going as well as what is going on with the other percutaneous valves and how long it took them to be approved etc. or even if they've already done valve in valve replacements.

              But my point about the pulmonary Melody valve already mainly being used in Children and young adults who are VERY active and often are playing sports and challenging their hearts quite a bit, is because The basic deployment is the same for all the percutaneous valves right now. Yes they are "sprung" into place, because they are sewn onto stents, (instead of sewn into the frames with sewing cuffs that are sewn into the tissue) and work like other stents that even If it is possible for them to dislodge, that is relatively rare especially after the first few Months when the persons cells grow thru the spaces in the stents, and even in the beginning the sharp little points really grab on to the tissue. Since the leaflets are sewn right onto stents instead of thicker frames and sewing rings is why you can actually have a larger opening with a perctuaneous valve than with a valve that is sewn in.

              I suppose anything is possible, but I personally dont really see it being a big concern that it might not be suitable for active people who challenge their hearts because its on a stent and not sewn to the persons tissue, since I know of quite a few people who've had stents and are VERY active. For example we chose to try and open a section of Justin's pulmonary conduit with stents to hopefully avoid another surgery, instead of having that section cut out and replaced like it was 2 years early when the stents he could have used weren't approved in the US yet. He was 12 at the time and while he had the stents, he was VERY active, played competive sports (baseball, soccer, basketball and also skate and snowboarded) it was never a concern they weren't sewn in. So I imagine all the young people like him with stents like his and all the people who had stents placed in the coronary arteries instead of OHS, (and of course the melody valve), should be a good sign for other valves placed with stents.


              As for strokes, yes in this group of patients the rate of a stroke during the procedure/first month was about 4% compared to about 2% who had open heart surgery, but as was discussed in earlier threads, alot had to do with how sick this group of patients were, with other comorbidities, already had history of strokes etc. AND of course I'm sure the learning curve played some role in it, since many of the doctors had only done a couple if any TAVI before the trial started compared to these were some of the best surgeons with decades of experience doing the surgeries, and these were first genration valves with bigger sheaths than they have even now. So it will be interesting how the stroke rate goes as they start doing the procedures on healthier people with improved and smaller sheaths and valves with the better nose cones, filters to catch clots and the staff have more experience, since in most studies the rates of stroke went down further into the trials..
              Last edited by Lynlw; October 31st, 2011, 06:51 AM.
              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


              • #8
                The Sapien valve that the article is about was approved by the FDA for inoperable aortic valve patients today. Hopefully this will improve many people's quality of life.
                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


                • #9
                  That's good news. Now, I wonder how many surgeons will jump into learning how to place these valves, so we can quickly build up a pool of surgeons who can do the procedures when/if these valves get broader approval for candidates with more options than the 'inoperable' patients. It'll be nice to see some statistics generated in the United States for this valve.

                  Comment


                  • #10
                    Originally posted by Protimenow View Post
                    That's good news. Now, I wonder how many surgeons will jump into learning how to place these valves, so we can quickly build up a pool of surgeons who can do the procedures when/if these valves get broader approval for candidates with more options than the 'inoperable' patients. It'll be nice to see some statistics generated in the United States for this valve.
                    Well according to the clinical trial site 25 centers in The US(22) and Canada (3) took place in the Sapien trails and the Corevave Trial that started this year has 41 centers (most if not all different than the sapien) so far so It looks like a lot more places will be doing them in the beginning than alot of other new things. And even better it seems they are spread out all over the country so anyone interested most likely wouldn't have to travel very far.
                    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


                    • #11
                      I've read as much I could regarding percutaneous TAVIs. I was hoping someone could help me answer these questions that I had:

                      1. In the Phase 3 Partner II trial, BAV patients were excluded and only symptomatic patients were included. Europe appears to be doing many of these procedures, more so than in North America. If this is so, I was wondering if anyone on this forum had had an Edwards Sapien transcatheter valve? who also had BAV? Is so, were you asymptomatic or symptomatic? Are there not enough studies yet to determine the efficacy of this procedure?

                      In Canada, a study was done at the hospital my husband is monitored at:

                      http://www.ncbi.nlm.nih.gov/pubmed/21087746

                      2. I could find no information regarding the longevity of the Edwards Sapien trancathether valve. Does anyone know?

                      3. How common is it for someone with BAV and severe aortic stenosis to have no symptoms and great exercise tolerance prior to surgery? I could only find one gentleman on this site with that experience. I believe he is a marathon runner.

                      Thanks in advance for the help.

                      Comment


                      • #12
                        The asymmetric nature of a bicuspid valve somewhat compromises the expansion of the TAVR device, making regurgitation a higher risk, and that's one of the reasons why BAVs were excluded. Limited "off-label" cases have been done, as you said, but I'm not aware of any active members here who have had this done, with or without BAV. I do remember someone posting about a parent who had it done at Emory here in Atlanta, but I don't remember any additional posts since then, maybe someone else will speak up...

                        The new Consensus Guidelines in the US (http://content.onlinejacc.org/cgi/re...59/13/1200.pdf) are a good resource for everything, including longevity. Longevity of Sapien is still TBD since they have been in use (5-6 years at most in an official Registry) less than the anticipated lifespan. In use thus far, pretty limited of course, there haven't been reports of structural valve deterioration, though. But, they are also being put in the best case patient group for longevity (80+) so hard to draw conclusions. Back to BAV, the Guidelines also included references to the limited # of BAV cases which should include that Canada center.

                        Symptoms vary a lot patient to patient, some are asymptomatic and some really struggle. I had great exercise tolerance myself, but am not the best example, since my BAV while at the severe threshold was still replaced early due to an aneurysm.
                        "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

                        Comment


                        • #13
                          Wow! Thanks so much for all of that info ElectLive. Very informative. It'll take me awhile to sort through all of the info on the excellent link you posted.

                          At present, this forum for me is a lifeline to some semblance of my own sanity. (and I'm not even the person with the stenotic BAV!).

                          Did you have concurrent severe/critical AS along with your aneurysm? or an aneurysm alone?

                          Comment


                          • #14
                            Originally posted by BicuspidBuddy View Post
                            I've read as much I could regarding percutaneous TAVIs. I was hoping someone could help me answer these questions that I had:

                            1. In the Phase 3 Partner II trial, BAV patients were excluded and only symptomatic patients were included. Europe appears to be doing many of these procedures, more so than in North America. If this is so, I was wondering if anyone on this forum had had an Edwards Sapien transcatheter valve? who also had BAV? Is so, were you asymptomatic or symptomatic? Are there not enough studies yet to determine the efficacy of this procedure?

                            In Canada, a study was done at the hospital my husband is monitored at:

                            http://www.ncbi.nlm.nih.gov/pubmed/21087746

                            2. I could find no information regarding the longevity of the Edwards Sapien trancathether valve. Does anyone know?

                            3. How common is it for someone with BAV and severe aortic stenosis to have no symptoms and great exercise tolerance prior to surgery? I could only find one gentleman on this site with that experience. I believe he is a marathon runner.

                            Thanks in advance for the help.
                            BiCuspid Buddy - If we're thinking of the same person, he is a cyclist, who happens to have recently competed in an Ironman since his surgery. My situation may not interest you because I had no stenosis; however, prior to my surgery, I had a BAV with severe regurgitation/insufficiency and no symptoms and was highly athletic (cyclist). The only symptoms I developed occurred within a few months of my surgery: A-Fib. That was due to my left ventricle enlarging to the point where my heart simply was beginning to fail. Until that time, I had monitored it for years and watched it change rather dramatically while it amazingly managed to compensate and allow me to ride at a very high level. My diagnosis was at least moderate to severe insufficiency for several years. I suspect, but have no proof, that well conditioned athletes have respiratory and cardiovascular systems that help an also well conditioned heart efficiently pump blood and oxygen with each stroke throughout the body to where it's needed until things just start breaking down. At that point, it's a rapid decline that requires immediate surgery. I would guess that the with less conditioning, there is a greater likelihood that other symptoms (i.e., shortness of breath, dizziness, etc.) will surface earlier in the heart's decline cycle. But what do I know?

                            I just hope that we do indeed continue to see advances in TAVR procedures. While I am quite prepared to face another full sternotomy when it's time for my next surgery, wouldn't it be great if we could receive our next valve without it and still keep up with our activities?

                            Thanks for the great thread.
                            AVR - Medtronics 29mm
                            porcine valve and partial Maze
                            9/12/08 at Fairfax Hospital/Dr. Alan Speir[SIZE="2"][/SIZE]

                            Comment


                            • #15
                              Thanks JeffM. Your information was also helpful.

                              Yes it would be great to receive a re-op via TAVR some day.

                              My husband hasn't had any surgery yet. I'm crossing my fingers that by the time surgery is recommended for him, that TAVR will be available, done with great efficacy and safety, and not be done off-label for patients with BAVs.

                              Comment

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