To watchman or not

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 plus plavix. Plavix has a worse bleeding risk than eliquis and aspirin and eliquis seem about statistically even, so what does the watchman do for me, other than add the risk of device related thrombus to my already elevated stroke risk? Also, it seems that any leaks in watchman are risky, not just leaks over 5mm. Makes some sense to me since once the device is in, any blood inside the LAA will clot and any way out would be dangerous. Since many posters here have had a watchman, I was wondering what made you reach that decision. Thanks.

We've been over all this. Aspirin for life is not a requirement. It's only a recommendation by the FDA, and many EPs don't agree with it. That's also not the practice in Europe where they generally stop all anticoagulants and anti-platelets after 6 weeks.

Here are the protocols from the clinical trial I was in when I received my Watchman. I'm quoting them directly.

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You will stay in the hospital overnight. You will take a direct oral anticoagulant (DOAC) and aspirin (81-100mg) each day following your procedure until the 45 day visit.

If the 45 day TEE shows that the Device has closed the LAA and there is no clot on the Device, you can stop taking anticoagulation. You will remain on aspirin (81-100mg) and clopidogrel (75mg) until 6-months, after which you will be on aspirin alone.
If there is blood flow around the WATCHMAN FLX implant into your LAA or if there is a clot on your Device, you will continue anticoagulation and aspirin until the TEE is repeated at 6 months or until there is little or no blood flow around the Device implant into your LAA or the clot has dissolved. At the 6-month TEE, if there is a Device seal and no clot is present you will stop taking anticoagulation and remain on aspirin alone.

Note that this is not the protocol Natale had me actually follow. I was placed on aspirin and Eliquis for the first 6 weeks. I never took clopidogrel (Plavix) at all. At 6 weeks the TEE showed it was properly seated, leak free, and clot free. The aspirin was stopped at that point and I went from full-dose Eliquis to half-dose. At my discretion, I chose to remain on half-dose Eliquis indefinitely, but I had Natale's permission to stop it entirely if I desired. The bleed risk of half-dose Eliquis is extremely low, and yet it is still effective at preventing clots.

So the short answer is the chances of you having a leak or DRT are extremely low, and if there are none, you can stop all anticoagulants and anti-platelet drugs after 6 weeks if you choose.

[www.tctmd.com]

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.

I had a bad GI bleed and has a watchman and never took an aspirin and never will. . I take 1/2 dose (2.5 2/day) but if I need to I can go off if it for 5 days for a colonoscopy etc. if I had a fall I would completely go off if it until it was necessary became at my 6 months TEE, and my 45 day TEE, my watchman is sealed.

Yes, I've seen that data and it doesn't concern me. Do the math. Some 10% of Watchman recipients had leaks, and of that group, 68% were 3mm or smaller, which shouldn't be a concern, particularly since 86% had their leak stabilize or shrink in the following weeks. We're down to a very small number of patients who had leaks that would be a concern or that should be closed. (Roughly 3%.) Closing those leaks is a fairly quick, straightforward procedure. It's done by catheter, not surgery.

So we're looking at a very small percentage of patients who had leaks of any significance, and what that study didn't consider is operator experience. It included data from EPs who were brand new and EPs who'd done thousands, and I know from previous studies that breaking it down by experience level would point directly to the least experienced EPs as being responsible for the majority of the leaks. So for that reason I would choose an EP who has done at least a few hundred. It doesn't come close to requiring the skill levels that an ablation does, but as with all invasive procedures, you don't want to be the patient the brand new fellow is doing their first on, or even their 50th. For that reason, I wouldn't have a Watchman done in a teaching hospital unless the EP was willing to guarantee that they would be only person with a catheter in their hands.

As for me stopping anticoagulants, I wouldn't hesitate if I had a need or desire to do so. I know for a fact I have no leaks, never had a DRT, and should be fully endothelialized long ago. There's no foreign material in contact with blood flow in my heart, so what purpose would aspirin or an anticoagulant serve? With regard to the Watchman, none at all.

Now, what's the real benefit of a Watchman? The Watchman was designed for people who couldn't or shouldn't be on anticoagulants, and for people who had an ablation that isolated their LAA. It allows those people to come off anticoagulants and yet maintain the same stroke risk as someone who has never had afib. It's possible you fall into the category of people who shouldn't be on an anticoagulant due to your prior bleed, but you'll never know for sure since the bleed was due to trauma. Anyone can bleed in their brain from trauma. Remember, anticoagulants don't cause bleeding; they only prolong it.



Edited 1 time(s). Last edit at 08/20/2022 04:53PM by Carey.

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.

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jasams
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.

My decision to continue low-dose Eliquis had absolutely nothing to do with my Watchman. I consider the Watchman a done deal, water under the bridge that I never need to think about again.

I continued low-dose Eliquis for the same reasons that for many years doctors recommended that everyone in their 50s and above take low-dose aspirin. I used to for many years. After all, afib and the LAA aren't the only sources of clots in the body. The shine has rubbed off that advice but not because the goal was wrong, but rather because of the bleed risk aspirin presents. Low-dose Eliquis is just a much safer and more effective choice than aspirin. Natale recommended it, and I ran the decision past my PCP and my local EP and all three agreed they would do the same.

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 come along. There probably is no answer, like most things in medicine.



Edited 1 time(s). Last edit at 08/21/2022 01:56PM by jasams.

What if you get old and decrepit you forget your Eliquis? What if a caregiver does? The watchman gets completely covered with cardiac tissue so it won’t make a difference if you wait for the next version.

Plus what if you need immediate surgery? I did and was put into the icu until all half-life if Eliquis was eliminated from my body so I could get my pacemaker. He wanted me to not resume Eliquis for 5 days but with advice of my EP I started and had a hematoma the size of a large orange. It took a long time to get rid of it. Tooth surgery, colonoscopy etc you will have to wean off and bridge with a shorter half life drug before the procedure and maybe stop afterwards your Eliquis.

Plus many surgeons just want you to stop all together for 5 or so days. I wanted my gallbladder out and the surgeon refused to operate unless I stopped Eliquis.

Now with a watchman if I forget a dose I don’t worry and I went off 5 days after my colonoscopy.

Obviously you can wait but if you need any surgeries or procedures done there is an increase risk for a stroke. Probably small but do you want to chance it. My father has about 12-14 strokes (lost count) and was a prior professional baseball player who turned into a vegetable. It’s a decision you have to make that is regrets free.

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 days would be incredibly low, although not zero. It’s not zero with the watchman either.

The new watchman flx is safer than the original watchman 2.5 and it’s reasonable to assume future iterations will be even safer and more efficacious. Of course, given the FDA approval process, the availability of such devices could be years away.



Edited 2 time(s). Last edit at 08/21/2022 03:34PM by jasams.

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jasams
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 come along. There probably is no answer, like most things in medicine.

If you live as long as you hope, you will probably live to see afib cured. I think it's likely within 10-15 years. Care to gamble on waiting for that because of your concern over a 2-3% complication rate that extremely rarely leads to death or disability?

All you can do in life is bet on the odds, and the odds are in your favor with a Watchman implanted by an experienced operator vs years on an OAC. Susan made an excellent point about forgetting your Eliquis, care givers forgetting it, having to come off it for medical procedures, losing it while traveling, etc. You know darn well that in the next 20-30 years you will go without Eliquis for some periods of time. It's unavoidable. That was one of my driving reasons for going for the Watchman.

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.

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jasams
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 days would be incredibly low, although not zero. It’s not zero with the watchman either.

I think it is very important when discussing whether to get the Watchman to factor in whether your LAA has been isolated. If it has, and the circulation velocity in the LAA is not up to scratch, then you are at a very significant risk of a stroke if you miss doses of you anticoagulant or need to stop it for a medical procedure. If you LAA is NOT isolated, it is not such an issue. In the former case, getting a Watchman could be lifesaving.

If your LAA is not isolated then the discussion is very different, and you are right that missing a few days of your anticoagulant in order to get a medical procedure, is not such a big deal. And then there is the insurance issue: it will pay if your LAA is isolated or you are unable to take an anticoagulant for some reason. It probably won't (right now anyway) if you opt for a Watchman just for preference.

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.

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jasams
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

That is not true. Where are you getting your information?

That is not true. Where are you getting your information?


That’s what I was told by EP’s office.

I’m sure it’s possible but not ideal because the watchman could be covering a firing area (see second link)? But what do I know. I couldn’t find much info:
[www.ncbi.nlm.nih.gov]

A negative link:
[pubmed.ncbi.nlm.nih.gov]

“ Electrical isolation of the LAA could be difficult and when attempted can result in increased risk of short-term peri-device leak and recurrence of AT/AF in almost all patients.”
It probably depends on the EP’s skill

Isolating the LAA doesn't mean making burns in the LAA itself just as a PVI doesn't mean making burns in the pulmonary veins themselves. It means making burns around those structures, creating a fence that blocks errant signals from coming out of them. So the presence of a Watchman might complicate the procedure, but it doesn't make it impossible, as Susan's second link states.

Keep in mind that most EPs don't have the training necessary to perform LAA isolations in the first place. It's a relatively new approach so it's not surprising that most EPs don't have this training and experience.

“So the presence of a Watchman might complicate the procedure, but it doesn't make it impossible“

That’s why I wrote not ideal —but a lot of choices in life are not perfectly ideal but compromises are made for the overall good. One makes the best of the situation and uses a highly skilled EP.

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Carey
Isolating the LAA doesn't mean making burns in the LAA itself just as a PVI doesn't mean making burns in the pulmonary veins themselves. It means making burns around those structures, creating a fence that blocks errant signals from coming out of them.

So indulge me while I ask a basic question: If you get a Watchman without having your LAA isolated, wouldn't the Watchman itself prevent any errant signals from coming out of the LAA, eliminating the need for it to be isolated through ablation?



Edited 1 time(s). Last edit at 08/22/2022 08:04PM by Daisy.

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Daisy
So indulge me while I ask a basic question: If you get a Watchman without having your LAA isolated, wouldn't the Watchman itself prevent any errant signals from coming out of the LAA, eliminating the need for it to be isolated through ablation?

Nope; a Watchman just sits in the opening of the LAA with tiny wires that extend maybe a millimeter or two into the tissue to hold it in place. There's nothing there that stops electrical activity.

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 the initial 6 weeks from warfarin and aspirin to a dual antiplatelet. I also think that Carey’s point of taking low dose Eliquis rather than aspirin makes sense, if the bleeding risk is indeed better or the same as aspirin. Eliquis has a reversal agent and aspirin does not.



Edited 1 time(s). Last edit at 08/23/2022 10:38AM by jasams.

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jasams
I don’t think you can suspend all anticoagulants permanently or the company would be pushing for approval of that instead of merely switching the initial 6 weeks from warfarin and aspirin to a dual antiplatelet.

It's done in Europe routinely. Where do you get the idea that dual antiplatelet drugs are required? That's true only for the first six months, and only in the official recommendations. In practice, that's rarely done, and never beyond six months.

As for pushing for FDA approval of no anticoagulants, that's not how FDA approvals work. The FDA establishes recommended usages when a drug or device is first approved. Those recommendations generally don't change even if reality does. For example, flecainide, which received FDA approval 38 years ago, still isn't recommended for use in atrial fibrillation, and yet it's a mainstay of treatment for it today and has been for years. Why? Because the FDA recommendations written in 1984 have never been changed. Even when it was still under patent the manufacturer never sought that change. Why? Because the FDA would require all new clinical trials specifically to prove if it was safe and effective for afib, which would cost millions of dollars, and that would be of no benefit to the company because doctors are free to use the drug as they see fit no matter what the FDA said in 1984. So for the same reason, Boston Scientific has no reason to seek a change in the FDA recommendations for the Watchman. Doctors are already seeing that those recommendations are overly conservative and modifying them to fit reality.

So you really shouldn't go by what the FDA said several years ago when they first approved the device. You should go by what leading doctors are actually doing in real practice. For the majority that probably means OAC + aspirin for 6 weeks, followed by aspirin indefinitely. For the leaders, it means OAC + aspirin for 6 weeks followed by either nothing or low-dose OAC indefinitely depending on the patient's particulars.

This is such a great group. I am sure I will embarrass myself with this question, but here it goes! I just bought a Philips Sonicare toothbrush. I am reading the instructions and it says, “ if you have a pacemaker or other implanted device, contact your physician or the device manufacturer prior to use”. So, here I am taking everything literally. How does a watchman, which is implanted, relate to this?

Please don’t laugh at this one……..

By the way, I probably should have posted this as a new topic. Hope it does not get lost in this string.



Edited 2 time(s). Last edit at 08/23/2022 12:58PM by Pixie.

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 Watchman needed no anticoagulation after 6 weeks or 6 months, that would be a clear competitive advantage. Agree that docs are free to prescribe off label, but not all are willing to do so.

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Pixie
This is such a great group. I am sure I will embarrass myself with this question, but here it goes! I just bought a Philips Sonicare toothbrush. I am reading the instructions and it says, “ if you have a pacemaker or other implanted device, contact your physician or the device manufacturer prior to use”. So, here I am taking everything literally. How does a watchman, which is implanted, relate to this?

Please don’t laugh at this one……..

By the way, I probably should have posted this as a new topic. Hope it does not get lost in this string.

You really ought to consider posting this separately in a new thread. Yes, it's relevant, especially to you, but it is also informative for onlookers who may have the same concerns. It's an education forum after all, where we share experiences and try to help others to make sense of what they're about to experience or what they're currently experiencing.

However, the watchman is an inert metal cage not very dissimilar to cervical protection diaphragm. It gets placed in the left atrial appendage and is left there. The reason we take anticoagulants is chiefly because of the risk of thrombosis in the LAA. The Watchman device is hoped, with accumulated empirical evidence, to be able to obviate anticoagulants.



Edited 1 time(s). Last edit at 08/23/2022 01:32PM by gloaming.

Carey,
Thanks for posting this information about post-Watchman protocol. I am glad to hear I can remain on Eliquis and do not have to switch to another anti-coagulant. Please explain why short-term aspirin is required. I recently had an ablation by Dr. Santangeli at Penn Medicine and he recommended a Watchman. He said I could remain on Eliquis also. This double protection protocol I learned about from Shannon and this forum. Jill

Now, I am really confused about the post-Watchman aspirin protocol.

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jasams
I don’t think you can suspend all anticoagulants permanently or the company would be pushing for approval of that instead of merely switching the initial 6 weeks from warfarin and aspirin to a dual antiplatelet.

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.

Champion AF Clinical Trial

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 watchman arm will take either a DOAC or dual anti platelet therapy for 3 months and then switch to aspirin indefinitely.

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gloaming
You really ought to consider posting this separately in a new thread. Yes, it's relevant, especially to you, but it is also informative for onlookers who may have the same concerns. It's an education forum after all, where we share experiences and try to help others to make sense of what they're about to experience or what they're currently experiencing.

However, the watchman is an inert metal cage not very dissimilar to cervical protection diaphragm. It gets placed in the left atrial appendage and is left there. The reason we take anticoagulants is chiefly because of the risk of thrombosis in the LAA. The Watchman device is hoped, with accumulated empirical evidence, to be able to obviate

Thank you for your reply. I will try to post this as a new topic.

This is such a great group. I am sure I will embarrass myself with this question, but here it goes! I just bought a Philips Sonicare toothbrush. I am reading the instructions and it says, “ if you have a pacemaker or other implanted device, contact your physician or the device manufacturer prior to use”. So, here I am taking everything literally. How does a watchman, which is implanted, relate to this?

Please don’t laugh at this one……..

By the way, I probably should have posted this as a new topic. Hope it does not get lost in this string.



Edited 1 time(s). Last edit at 08/23/2022 06:23PM by Pixie.

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Cookie24
Carey,
Please explain why short-term aspirin is required.

When the Watchman is first placed you have a foreign object made of metal and fabric that's in direct contact with the blood flowing in your heart. Blood tends to coagulate on foreign objects and form clots, so you need something to prevent that from happening. Within 6 weeks, the endothelial tissue that lines the inner surfaces of your heart will grow over the device, completely enveloping it. This is called endothelialization. Once that happens, the Watchman is no longer exposed to blood so it can't form clots.

Why does the FDA recommend lifelong aspirin? Frankly, it's mostly out of a compulsion to "do something." They envision a rare scenario where the endothelialization is incomplete, so they recommend aspirin to guard against that possibility. They apparently think the risk of that is higher than the risk that aspirin presents. I'm unaware of any data supporting that notion, and I am aware of a number of experts in the field who disagree.

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 tested and submitted for approval. If my understanding is wrong, I’d appreciate someone correcting me.

The FDA imposes its own limitations and requirements all the time. They're not limited to strictly what the manufacturer ran trials for, and in fact they often dictate how those trials must be run. Note that Boston Scientific does not recommend lifelong aspirin for the Watchman in Europe. Their recommendations actually leave it up to the doctor. They recommend anticoagulation, dual-antiplatelet, or NOAC plus aspirin for at least three months. But they leave the door open to the doctor to make whatever decision they see fit, including no NOAC or aspirin at all. So clearly the lifelong aspirin recommendation was added by the FDA, not BS.

[www.watchman.com]

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.

Well, you get the point that their recommendations are shaped by the governments they're dealing with, right? The lifelong aspirin thing, which is unique to the US, is not based on evidence.

After my third ablation and Warthman implant on 2/15, Dr. Natale reduced my Xarelto dose from 20 mg 1x/day to 10 mg 1X/day and added one 81 mg aspirin 1X/day. After my six-month post Watchman implant TEE, he took me off the 10 mg Xarelto and prescribed one 81 mg aspirin every other day at evening meal as the Xarelto has always been. We're all different and if I felt any better I wouldn't be able to stand myself.