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Most of the statistics regarding the watchman are clearly arbitrary. For whatever reason, in the USA, it was determined that leaks up to 5mm could be ignored. Europe, being socialists used a more conservative 3mm limit. Most top EP’S will now tell you than the tolerance is zero leaks, which makes perfect sense and why I cancelled a watchman several years ago. All current LAAO devices are metaby jasams - AFIBBERS FORUM
If the pumping action is reduced to the point that requires lifelong anticoagulation or a laao device, then clinically speaking, it’s not pumping. Also, the fact that Boston scientific is developing and is now testing a new generation of the watchman should lead to the conclusion that the leak problems of the previous generations are not merely theoretical.by jasams - AFIBBERS FORUM
Sorry, my answer could be clearer. First, it’s not well understood why the leaks lead to clots. Is blood collecting in the leak space and clotting because the laa is not moving? Or is the clots formed in the laa after it’s covered escaping from the leaks? I don’t think they know, but some eps are. Concerned with the pooling and clotting. Also, I think the laa is like an appendix; it’s not fuby jasams - AFIBBERS FORUM
The first 3 generations of the watchman are rigid. They are round devices out in an oval opening. The belief was any remodeling of the heart perioperative would have the heart close any leaks. It turned out that the rigid nature of the device resulted in the opposite affect. That’s why a 4th generation device, watchman flx pro ng, is currently in trial. Its frame is more flexible and the hopby jasams - AFIBBERS FORUM
I have been struggling with this very issue, but not because of persistent afib. I had 2 ablations, the last over 4 years ago. Since the end of the blanking period, I have had 3 episodes lasting a total of 14 hours. That means my afib burden is 0.04%. It’s well established that the lower the afib burden, the less likely the incidence of stroke. A couple of years ago I had a bad fall. I fracby jasams - AFIBBERS FORUM
Hi and thanks for replying. I know that many here are happy with the watchman and I don't want to say anyone should not be. I have 2 main concerns. The first is that I believe an occlusion device should have no leaks and that small leaks are not OK. Once the device is implanted, the blood left in the LAA coagulates and any size leak will allow a piece of that clot to dislodge. The US orby jasams - AFIBBERS FORUM
I've had 2 ablations for afib. The first in August of 2021 and the second on 2/22/22. I had a few episodes during the blanking period after the second ablation, the last being on 5/25/22, just at the end of the 3 month blanking period. I then contacted EP about whether another ablation was warranted, but told to wait a while and see what happened. I was afib free until 6/6/23, just overby jasams - AFIBBERS FORUM
This is very disappointing.by jasams - AFIBBERS FORUM
QuoteCarey What are the long term side effects of taking Eliquis or other DOAC? None are known. One side effect of any DOAC is a brain hemorrhage -- leading to severe disability or death. The longer one stays on a DOAC, the more likely this side effect will happen. Carey, you are convinced that your watchman obviates your need for any anticoagulant, yet you still take one. Of course,by jasams - AFIBBERS FORUM
QuoteCarey And I have a Watchman which puts me at the same risk level as someone who's never had afib. I'd like to know where you get that information. A watchman is supposedly, at best, as effective as a DOAC at preventing stroke. A DOAC reduces one's risk by 60-70%. So, if an AFib sufferer has 5-8X the risk of stoke of someone whose never had AFib, how can reducing that riskby jasams - AFIBBERS FORUM
Actually, Boston Scientific recommends a minimum of one year of aspirin in the UK. My French isn’t good enough to look up the recommendation there.by jasams - AFIBBERS FORUM
As I understand this, the FDA is not being conservative or liberal. The FDA approves or declines to approve drugs/devices based upon clinical trials designed and conducted by the drug company/manufacturer. In this case, the FDA can not on its own decide that no post implantation anticoagulation is needed. If the manufacturer was confident such a protocol would pass, I’d think it would be testedby jasams - AFIBBERS FORUM
JakeL “You could infer that Boston Scientific believes that "you can suspend all anticoagulants permanently" with the Watchman since the Champion AF Clinical Trial will determine if the Watchman FLX is a reasonable alternative for D/NOACs. Report date is December 2027.” As I understand it, the Champion-AF trial compares the watchman flx to long-term DOAC. Those in the watchmanby jasams - AFIBBERS FORUM
All good points, Casey, but since, as you noted, doctors are already instructing patients that they can use dual antiplatelets for the first six weeks and then indefinite aspirin, why is BS applying to change the FDA recommendation of warfarin plus aspirin for the first six weeks? The obvious answer is because the Amulet doesn’t need warfarin per the FDA. and that’s the competition. If Watchmanby jasams - AFIBBERS FORUM
Thanks to all who’ve replied. After reading all the replies and reading what I could find, it seems that the one advantage of the watchman is the ability to suspend any anticoagulant for a period if surgery is needed, while still having some protection. I don’t think you can suspend all anticoagulants permanently or the company would be pushing for approval of that instead of merely switching tby jasams - AFIBBERS FORUM
That is not true. Where are you getting your information? That’s what I was told by EP’s office.by jasams - AFIBBERS FORUM
My LAA has not been ablated, which is another issue. If I get a watchman now, there would be no way to ablate it in the future, although I’m not presently inclined to have another. I don’t believe ablation is the benign procedure many make it out to be.by jasams - AFIBBERS FORUM
I hope you’re right about a cure, Carey. That would be wonderful. Of course, predictions often turn out to be elusive, or I’d be able to head off to Austin in my flying car by now! Your other points are well taken. I’m just overwhelmed at the moment by this journey. Thanks for replying.by jasams - AFIBBERS FORUM
Thanks Susan. Sorry to hear about your father. That’s a terrible fate we all want to avoid. Eliquis has a reversal agent, so emergency surgery would not be delayed. I was given the reversal agent when I fell so they could operate on my fractured bone. You do make a good point about needing to spend time off the anticoagulant for medical procedures. I think the percentage risk for a few daby jasams - AFIBBERS FORUM
Thanks Carey, So I guess put another way, you feel that a watchman plus OAC is better than either alone. That’s certainly possible. My concern right now is that at age 65, if I’m lucky, I could live another 20-30 years. The watchman is permanent choice and there isn’t any long-term data about how it will perform over time. Why not stay on OAC until I’m older. Perhaps better treatments will cby jasams - AFIBBERS FORUM
Thanks Carey. You make some good points; especially about having a procedure at a teaching hospital. Im sure that fellows worked on me during my 2 ablations. While I don’t understand your reasoning for taking eliquis if a watchman puts you at the same risk as someone who never had afib, I respect your decision.by jasams - AFIBBERS FORUM
I don’t know if you’ve seen this, but I don’t know that I’d be comfortable discontinuing all anticoagulation after watchman, which takes me back to the original question, which is what’s the real benefit.by jasams - AFIBBERS FORUM
I am trying to reach a decision about whether to have a watchman implant. A few months ago I suffered a fall, which resulted in some mild brain bleeds. I was on eliquis at the time. I went off eliquis for 8 weeks and then resumed. Originally, I thought the watchman would allow me to avoid all anticoagulation, but now see it will require indefinite aspirin, not to mention 6 months of aspirin pby jasams - AFIBBERS FORUM
Carey, First, thanks again for your replies. As you can see, I’m struggling with this decision. Unfortunately, it’s my nature. I know that all the choices we’re considering are based upon statistics and statistics are meaningless in a population of one. Of course you’re right when you say a watchman with no anticoagulant or anti platelet would be my favored route, but I’ve found nothingby jasams - AFIBBERS FORUM
Carey, I did read your posts, but perhaps I misunderstand. You’ve said: 1. A watchman reduces an afib patient’s chance of stroke to that of someone who never had Afib. 2. After endothelialization, no anticoagulant or anti platelet is needed. 3. You have a fully endothelialized watchman, but still take Eliquis because you’re 66 years old, have hypertension and like all westerners youby jasams - AFIBBERS FORUM
Aspirin is supposed to help avoid device related thrombi.by jasams - AFIBBERS FORUM
I haven’t found anything saying that half dose eliquis is safer than low dose aspirin for intracranial bleeding. Certainly eliquis has a better risk-benefit profile than aspirin for afib, since aspirin has very little effect in reducing afib related stroke. The watchman duplicates or betters the ischemic stroke prevention of eliquis, so it’s only the risk of bleeding between eliquis and low dosby jasams - AFIBBERS FORUM
If one could take no anticoagulant or anti platelet at all, I don’t know why one would chose to take eliquis. It certainly has a non-zero chance of causing a major bleed, including intracranial bleeding. I did read the article you linked. The problem with all of these articles is that they raise as many questions as they answer. Not sure I agree that one device is as good as another after enby jasams - AFIBBERS FORUM
Carey, I’m on the fence because a watchman is permanent. Whose to say that in a few years there won’t be a better device; just like the watchman flx is better than the original 2.5? Plus, since the watchman requires a lifetime of aspirin, that’s a bleeding risk that the general population doesn’t have. I should add that I had a fall which resulted in some minor brain bleeding while on elby jasams - AFIBBERS FORUM
Carey, I’ve never seen a study saying that a watchman reduces to chance of a stroke to the same as the non-AFIB population, but rather that it’s non-inferior to oral anti coagulation. Is there a study supporting what you wrote. I’m currently scheduled for a watchman in 2 weeks but sort of on the fence about it. Thanks.by jasams - AFIBBERS FORUM