Best method of LAA Closure

Is there a preferred, best method of LAA Closure? My Surgeon said they will use an Atria Clip or suture it closed, depending on what they deem is safer when they are at the site during Surgery. I know about the Watchman but being I am having robotic mitral valve repair surgery, I'd either have the LAA sewed or an Atria Clip inserted. My thoughts are I would prefer the sutures vs an Atria Clip as less foreign objects in my body the better. I've also read clots can form around some devices used for LAA Closure so I'm assuming the Atria Clip and Watchman would have possibility for
Clots to form around them? If so, wouldn't sewing the LAA from the inside be the best option?



Edited 1 time(s). Last edit at 03/07/2024 01:36AM by cornerbax.

Just a note: my cardiologist told me that the newest generation of the Watchman has a coating that is supposed to protect against clots—the Watchman Flex Pro. I don’t think that is is clinically available yet though.

Is the coating made from silicone?

Quote
Just a note: my cardiologist told me that the newest generation of the Watchman has a coating that is supposed to protect against clots—the Watchman Flex Pro. I don’t think that is is clinically available yet though

Wow, I did not know that but that Is awesome. Im sure the chances of getting a clot around a device are far less than getting a clot
In general but I'm curious what the chance is of getting a clot around the device? Also, I know an ablation and watchman are installed via catheter but because i'm having open heart surgery my doctor uses an Atria Clip or sews the LAA closed. I would think sewing the LAA would be the best option, no?



Edited 3 time(s). Last edit at 03/07/2024 01:37AM by cornerbax.

Quote
cornerbax
Are far less than getting a clot
In general but I'm curious what the
Chance is of getting a clot around
The device?

That is something they monitor closely in the TEEs that are done after implantation. They also have anticoagulation protocols in place for at least the first few months until it endothelializes. Here is Boston scientific’s explanation of the new type of coding: ( not silicone) [www.watchman.com]

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That is something they monitor closely in the TEEs that are done after implantation. They also have anticoagulation protocols in place for at least the first few months until it endothelializes. Here is Boston scientific’s explanation of the new type of coding: ( not silicone) [www.watchman.com]

This is great info and I'm surprised the first version of Watchman didn't do this. Glad to see technology constantly
evolving. I am probably MORE confused, however, now than when I made this post. The reason I say that is I
was researching best methods of LAA Occlusion and every single article I read and every video I watched ALL
SPECIFICALLY say these methods are for "NON-VALVULAR" AFIB. What I have has been deemed to be
"VALVULAR" AFIB directly as a result from my 50% or so Mitral Regurgitation. I am confused as to why every
article and video specifically states the Watchman or other LAA closure methods are for "NON" VALVULAR AFIB?

I do not understand. Is this saying that there's less chance of stroke with VALVULAR AFIB? I am completely
confused on this. Also, even with an LAA closure, (assuming everyone had this done) wouldn't sewing the LAA
closed with NO device added completely eliminate blood clotting from a "device" as there would be no device?

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cornerbax
I am confused as to why every
article and video specifically states the Watchman or other LAA closure methods are for "NON" VALVULAR AFIB?

They say the same thing for Eliquis. My understanding is that this is simply because there haven’t been trials with valvular Afib. My Afib may or may not have been valvular—I had had a mitral valve prolapse and some degree of regurgitation long before the Afib started, but I also have Dysautonomia and could also have been involved. BUT, Natale knew my mitral valve history very well and had no concerns about implanting a Watchman. Also none of my cardiologists or EPs ever had a problem with prescribing Eliquis for me.

Quote

The use of apixaban (Eliquis; Bristol-Myers Squibb) over rivaroxaban (Xarelto; Bayer/Janssen) in patients with atrial fibrillation (AF) and valvular heart disease is associated with better clinical outcomes and improved safety, according to a new observational study.

[www.tctmd.com]

Thanks again for the response. Interesting info but it still doesn't explain the WHY? Why would these device methods NOT be for Valvular Afib.
There has to be a reason. I've been on eliquis for nearly a year with no issues that I know of. I have no excessive bleeding or bruising and no side effects at all that I know of. But back to the original question and hopefully Carey can chime in when he gets the chance...but why would a watchman or any LAA device NOT be for Valvular Afib? There has to be a reason? On another note, Susan, are you getting the new
Watchman FLX to replace the non clot version of Watchman?



Edited 1 time(s). Last edit at 03/07/2024 01:38AM by cornerbax.

As I understand it, it isn’t that they AREN’T for valvular Afib, just that they can’t approve it unless there are trials and no one has done trials yet. I doubt if they have any suspicions that there would be a problem for valvular Afib patients.

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As I understand it, it isn’t that they AREN’T for valvular Afib, just that they can’t approve it unless there are trials and no one has done trials yet. I doubt if they have any suspicions that there would be a problem for valvular Afib patients.

I see... It would be nice if any of those articles or videos stated exactly that. All they would have to do is state Valvular AFIB isn't approved for such and such more studies are needed and it would make sense. To just specifically state for NON-VALVULAR Afib, it leads to a lot of questions. Are
you planning on getting an upgrade to the new and safer FLX Watchman when it's available?



Edited 1 time(s). Last edit at 03/07/2024 01:39AM by cornerbax.

I believe Daisy is right. It's just that they haven't run trials for valvular afib and they would have to do so in order to be able to claim it works for those people. Clinical trials are hugely expensive, many millions of dollars and years of work for hundreds of people. So they have to make a business decision weighing those costs against the expected market. The market of people with valvular afib is much smaller than the market for afib in general, so that's why they're not rushing into it.

For more examples of this, did you know that many of the antiarrhythmic drugs used to treat afib have never been approved for afib? Flecainide is the poster child for this. It was approved in 1984 and was specifically approved only for ventricular arrhythmias, nothing atrial. It began being used for afib by doctors willing to try it off label and now it's become routine. We might see this happen with valvular afib and drugs like Eliquis eventually, but it requires doctors brave enough to use a drug off label. It's a big legal/financial risk for them.

The Atriclip is applied to the outside of the heart, not the inside, so clots forming on the device aren't a concern. Any clots that did form would be irrelevant and harmless since they're outside the circulation. Since you're doing the valve surgery anyway, an Atriclip makes perfect sense for you. A Watchman makes no sense at all since it would require a second procedure. An Atriclip is also probably safer than suturing. Surgical removal and suturing can sometimes result in sutures too tight that restrict atrial wall movement. Not sure what you're talking about with suturing from the inside. That's not what they would do for you.

Quote
cornerbax
Are you planning on getting an upgrade
To the new and safer FLX Watchman
When it's available?

No, because mine should be endothelialized by now, or will be soon—so no exposed metal. The coating on the new Flex Pro helps with the process of endothelialization and also the inflammation that is there in the beginning, so at this stage (6 months for me) there would be no advantage in the newer model for me as I have passed those stages of healing. I will have one more TEE to check it in November.

Cornerbax: “ On another note Susan are you getting the new
Watchman FLX to replace the non clot version of
Watchman?”

My watchman hasn’t given me any problems. It’s been ok since 2-22. I had enough surgeries. I’m going to leave it be..especially since my watchman was difficult to insert because my vein from the groin to my heart was twisted, Dr Natale had to work his magic skills to guide it up. Plus my LAA wasn’t a regular shape and I had a large bent LAA shoulder. I don’t think anyone else could had been as gifted.

Carey would know if it’s worthwhile for patients to get their watchman replaced..or even if it’s possible. The watchman has metal hooks and by now there is heart tissue engulfing it so I speculate it would be difficult to remove annd replace —and what for? What’s the odds of getting a clot now after all this time? Zero?

Nah, I’m fine with my watchman as is. I’m very grateful I have it. I’m getting a colonoscopy in a week and that was my GI’s first concern-“you need to stop Eliquis for 2 days”. I just replied I have a watchman and can stop for 5 days and it isn’t an issue. I highly recommend anyone to get a watchman from Dr Natale as a first choice …or someone with his skills at TCAI.
[tcainstitute.com]

I follow Dr Rodney Horton from TCAI on Twitter. He repairs watchman’s that were not sealed and leaking. Take a look at his surgical videos. Ahh. His video is down :-(

[www.afibbers.org]

Check out TCAI team on Twitter (X) for doctors:
[twitter.com]



Edited 2 time(s). Last edit at 10/22/2023 02:12AM by susan.d.

Replacing a Watchman would be major open heart surgery. No one's going to be doing that just to upgrade to the latest model. Besides, after a few months, a Watchman gets covered by your own endothelial tissue. (That's what Daisy meant when she said hers would be fully endothelialized by now.) It literally becomes completely encapsulated by your own heart tissue, and once that happens there is no risk of device-related clots forming.

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susan.d
I’m getting a colonoscopy in a week and that was my GI’s first concern-“you need to stop Eliquis for 2 days

I had a colonoscopy last Wednesday (I had been waiting until after my Watchman.) I had to stop Eliquis for 4 days—2 days before, the day of, and one day more because he removed a polyp and it bled enough that he had to put a clip on it—the clip just falls away and it eliminated. I only take 2.5 mg of Eliquis since the Watchman, so I was surprised by the bleeding and ever so thankful that I have a Watchman.

Just so you know, one difference is that with Watchman, low dose aspirin will be required for life to help prevent clots from forming on the Watchman Device itself. Low dose aspirin would not be required with Atriclip.

Jim

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endothelialized

I learn something new and informative every day here, and now I've learned a new word as well! That is excellent and i'm glad to know people who have current Watchman Devices more than that 6 month period of time you mentioned have had it endothelialized. This goes to answer the question for "Daisy" as well since she won't need any further surgery and should be endothelialized too.

Quote
Just so you know, one difference is that with Watchman, low dose aspirin will be required for life to help prevent clots from forming on the Watchman Device itself. Low dose aspirin would not be required with Atriclip.

If the device is "endothelialized" why would low dose aspirin be needed?


@ Carey, thank you very much once again. I did not know those facts on antiarrhythmic drugs, especially for AFIB, that is amazing. I do know with Flecainide and Propafenone I had my heart shoot up to about 200bpm and had the WORST dizziness/shortness of breath and sweating i've ever had. My Afib and Mitral Regurgitation are actually nearly Asymptomatic. I've only had 3 episodes the entire year and both were very short bouts. I'm sure the Diltiazem is helping, but even before medications it took some significant exertion
to ever get shortness of breath or dizzy. The Type 1C medications made me almost give up on medication completely. I'm glad I didn't, because in my case Diltiazem has helped even lessen the few episodes I already had. We know the Sotalol has done nothing
for me, but the Diltiazem definitely keeps my rate respectable. After the 2 week Zio my AVERAGE HR was 85BPM. That isn't resting, it just shows "AVERAGE" and while I didn't have many bad symptoms prior to Diltiazem, I know my heart rate was closer to 100-110
regularly, sometimes even higher, so I am very happy with Diltiazem for me and glad I am on it.



Edited 2 time(s). Last edit at 03/07/2024 01:40AM by cornerbax.

Quote
mjamesone
Just so you know, one difference is that with Watchman, low dose aspirin will be required for life to help prevent clots from forming on the Watchman Device itself. Low dose aspirin would not be required with Atriclip.
Jim

Perhaps some EPs recommend that though most don’t from what I have learned. I was not asked to take aspirin at all, rather 2.5 mg of Eliquis and that will be revisited after my 6 month TEE. At that point the choices will be—stop all anticoagulants, continue with 2.5 mg of Eliquis, or a baby aspirin every other day. Since tissue completely covers the Watchman after a few months, it will not attract clots any more than other heart tissue.

Quote
mjamesone
Just so you know, one difference is that with Watchman, low dose aspirin will be required for life to help prevent clots from forming on the Watchman Device itself.

Actually, that's controversial. It's what the FDA says, but many EPs disagree and Europe has always disagreed and it's been in use there longer than here. Two EP Watchman experts explained it to me as being more of a case of the FDA feeling they had to do something rather than basing it on actual data. Over a period of a few months following implantation, your own epithelial tissue grows over the Watchman and completely covers it, so once that's complete it's no longer exposed to blood flow and clots can't form on it. I'll believe aspirin is needed for life when I see data from Europe showing a higher incidence of stroke among Watchman recipients who aren't taking aspirin or an anticoagulant.



Edited 1 time(s). Last edit at 10/22/2023 02:07PM by Carey.

Some say…

“Apixaban (Eliquis) was the safest, followed by edoxaban (Savaysa), dabigatran (Pradaxa), warfarin (Coumadin) and then rivaroxaban (Xarelto); the Watchman device ranked last. The Watchman device has been advertised heavily, both to the public, in medical journals, and at medical conferences.Jul 4, 2019”
[www.inquirer.com] › health

Quote
susan.d
Some say…

“Apixaban (Eliquis) was the safest, followed by edoxaban (Savaysa), dabigatran (Pradaxa), warfarin (Coumadin) and then rivaroxaban (Xarelto); the Watchman device ranked last. The Watchman device has been advertised heavily, both to the public, in medical journals, and at medical conferences.Jul 4, 2019”
[www.inquirer.com] › health

I can't find whatever article that came from, but I'd like to see it. The link just goes to the main page, the health section has a zillion articles, and the search feature doesn't work.

I found it here.
[www.inquirer.com]
Sketchy or not?

I like this peer opinion —however published in 2015- not new enough-where are the newer further independent studies done (not from watchman site)?
[pubmed.ncbi.nlm.nih.gov]

“ Conclusions: NOAC therapy was superior to warfarin for multiple outcomes while Watchman reduced hemorrhagic stroke. Further studies are needed to assess Watchman versus NOAC to optimize therapy for stroke prevention in AF patients.”

The current study from 2021:
[www.nmhs.net]

Curious on the results.

The trouble with these kinds of studies is that anticoagulants prevent clots from forming everywhere in the body while a Watchman (and other LAA closure techniques) only prevents them in the LAA. The LAA is the source of 90% of all afib-related clots, but there's still that 10% that form elsewhere in everyone, even those without afib. So doing direct comparisons between LAA closure devices and anticoagulants is always going to favor the anticoagulants since they have a 10% advantage.

That final article you linked to briefly alludes to the other side of the coin, which is hemorrhagic strokes. Anticoagulants increase the risk of hemorrhagic strokes but LAA closure devices do not. So to really do a meaningful side-by-side comparison, bleed risks have to be included. And not just hemorrhagic strokes, but GI and other types of bleeds as well. I've never seen a study that looked directly at both sides of the coin.

And there's also a third side of the coin: compliance. If you look at studies on compliance with anticoagulants, the numbers are terrible. Something like 40% of all people who should be on them eventually either stop taking them altogether or just become so spotty about taking them that they're ineffective. A study lasting a year or two isn't going to catch those problems. That needs a longitudinal study lasting many years or even decades, and those are expensive as hell and don't produce results for years, so they're hard to justify. After all, will Eliquis and Watchman devices even be relevant 20 years from now?

This is a pretty good basic link (09/05/2023) explaining which DOAC is more effective and which supplements that may interact.

“ Direct oral anticoagulants, or DOACs, have been found to be safer than warfarin for patients with atrial fibrillation. A new study published in November 2022 in Annals of Internal Medicine found apibaxan to be the safest blood thinner among DOACs, including dabigatran, edoxaban and rivaroxaban. ”

[www.drugwatch.com].

I’m an eliquis fan and Carey also posted his preference as well. I have no problem remaining on 2.5mg BiD.

We should know by December 2027 if the Watchman is a reasonable alternative to NOACs.
Prior Discussion Link

This is all excellent info. With all of this said, why would someone not want to take eliquis or an anticoagulant all of their lives vs. getting a watchman implanted? I'm guessing that some have bad reactions to anticoagulants or maybe at
some point in time they may not be able to get the anticoagulants and a watchman is permanent? The thing is, Carey said that the Watchman only prevents blood clots coming from the LAA, where 90% of clots from AFIB related clots, but the other 10% come from elsewhere.
While Anticoagulants eliminate blood clots from ALL areas. Again, with this known, wouldn't it be best for most people to take Eliquis for life vs. having a Watchman implanted?



Edited 1 time(s). Last edit at 03/07/2024 01:40AM by cornerbax.

Quote
cornerbax
with this known,
wouldn't it be best for most people to take Eliquis for life vs. having a Watchman implanted?

A couple of things play in here—a significant issue for some of us is that you have to stop your anticoagulant for most surgical procedures and some dental procedures. I just had to stop Eliquis for 4 days for a colonoscopy. If your stroke risk is low this okay, but if, for instance, you have had your LAA isolated as was necessary to stop my arrhythmias, you cannot stop your anticoagulant safely for even a day. Isolating the LAA reduces the circulation there and increases the likelihood of clots forming. So I had to wait until my Watchman was in place for 3 months before my colonoscopy. I and others here, will continue on a half dose of Eliquis indefinitely to cover the 10% of clots not coming from the LAA. Even without LAA isolation, some have a high ChadVASc score and it could be risky to stop anticoagulants for medical procedures.

Quote
for instance, you have had your LAA isolated as was necessary to stop my arrhythmias, you cannot stop your anticoagulant safely for even a day. Isolating the LAA reduces the circulation there and increases the likelihood of clots forming

So closing/isolating the LAA "REDUCES" circulation and "INCREASES" chances of Clots Forming? If that
is the case, wouldn't it be better to NOT close off/isolate the LAA to begin with? In my case my Chadsvasc
score is 1, due to slightly elevated blood pressure which is no longer the case so it may actually be 0 right
now. Regardless, my EP said because i'm "PERSISTENT" to continue to take Eliquis 2x a day at 5mg each
dose.

I spoke with my Doctor/Surgeon who would do my Mitral Repair and when I asked about the LAA they said they
either use a Clip, which I assume is the AtriClip or I am pretty sure they said almost this exactly "IF THEY CAN GET
TO IT FROM THE INSIDE THEY WILL SEW IT." I know Carey mentioned he was unsure about this but I am
pretty certain that is exactly what they said. And then they said there are PROS AND CONS to both and I didn't
ask any additional questions on the LAA at that point but I can definitely clarify.

With that said, would an AtriClip from the OUTSIDE still restrict that circulation and increase the chance of clots in the
LAA as you stated with the Watchman?

Quote
cornerbax
With that said, would an AtriClip from the OUTSIDE still restrict that circulation and increase the chance of clots in the
LAA as you stated with the Watchman?

No, you're not understanding the point that the Watchman and Atriclip both completely seal off the LAA. There won't be blood flowing inside it at all so there's no way for clots to form. No doubt the blood that's in there when they seal it will turn to clot, but so what? It can't go anywhere because the LAA is completely sealed. This short video will help you visualize what's going on.

Why would people not choose to remain on Eliquis for life? Because of bleed risk, which increases with age, and because of what Daisy said about having to stop it for procedures. When my LAA was isolated, blood flow in my LAA was poor enough that I was instructed to remain on Eliquis for life and never to miss a single dose. Well, what are the odds I can go the next 20 years without once forgetting a dose or losing my meds or needing surgery or being injured or whatever? I put those odds at exactly zero. A year after my ablation I had the opportunity to join a Watchman FLX clinical trial so I jumped at it. The result is last week I had a colonoscopy and I simply stopped the Eliquis for 5 days like they wanted. I didn't need to contact Natale and arrange a bridging procedure or anything of the sort. I have standing permission to stop the Eliquis for as long as I wish any time I wish, or even just stop it altogether. That wouldn't be possible without the Watchman.

Quote
cornerbax
So closing/isolating the LAA "REDUCES" circulation and "INCREASES" chances of Clots Forming? If that
is the case, wouldn't it be better to NOT close off/isolate the LAA to begin with?

Isolating the LAA and closing it are two different things. Isolating it is simply creating an ablation line around the mouth of the LAA—it is still open. This is only done in order to stop arrhythmias coming from this area, not to prevent clots. To close the LAA you need a separate procedure, either the implantation of a Watchman, which plugs and seals the LAA, or an AtriClip or suturing (which can only be done during open heart surgery). As Carey said, in your case clipping the LAA would prevent clots by sealing off the LAA.

Thanks Carey,

I understand now. I took isolating the LAA as the same as CLOSURE of the LAA, which is not the case
as Daisy explained. I am going to watch that video when I get off of work because I do want to fully
understand the process and the LAA. I also agree that it's at 0 or close to 0% that in your case all of
those things would happen for 20 years. It's also good to know you can stop Eliquis with no issues
whenever you need. That is awesome!

In my case, if my LAA is completely closed with the AtriClip or Suturing, and my ChadsVasc score is either
0 or 1, would it be fine to discontinue Eliquis at some point? I would think with a complete closure of the LAA
and a 0 or 1 ChadsVasc score I could?

Quote
cornerbax
In my case, if my LAA is completely closed with the AtriClip or Suturing, and my ChadsVasc score is either
0 or 1, would it be fine to discontinue Eliquis at some point? I would think with a complete closure of the LAA
and a 0 or 1 ChadsVasc score I could?

Yes.

I was part of a study 16 years ago at Emory University during a mini maze procedure, the LA was clipped shut - not removed or sewed. My cardiologist wanted to see if it was still closed and any leaks during a latest discussion should I be on an anti-coagulant. My cardiac CT scan revealed that after all these years, it is still closed off and no leaks. They sent this report to the EP's on staff. I was told I did not need to take Eliquis or any other blood thinner. I can take a low dose aspirin if I wish. I was also told that the ChadVasc score is somewhat arbitrary - for example, being a female - getting dinged for that is not a factor. I was also told that there is still not enough data regarding long term requirement use of these drugs after having any type of LAA closure procedure including the Watchman. Time will tell at some point.

Quote
cornerbax

In my case, if my LAA is completely closed with the AtriClip or Suturing, and my ChadsVasc score is either
0 or 1, would it be fine to discontinue Eliquis at some point? I would think with a complete closure of the LAA
and a 0 or 1 ChadsVasc score I could?

With a score of O or 1, you would generally not need to take a thinner, even without any type of LAA Closure, or
am I missing something here?

Jim

Quote
mjamesone
With a score of O or 1, you would generally not need to take a thinner, even without any type of LAA Closure, or
am I missing something here?

With an isolated LAA you may need to remain on an anticoagulant even if you're a zero. It depends on how well your LAA continues to pump after the isolation. They generally do a TEE at six months to assess LAA function and if you don't meet the criteria, it's either anticoagulants for life or an LAA closure device.

Quote
With a score of O or 1, you would generally not need to take a thinner, even without any type of LAA Closure, or
am I missing something here?

My blood pressure 6 months ago was slightly elevated (Diastolic upper 80's or 90-92) so they gave me a score of 1. My blood pressure has been within normal range mostly since so I believe I am 0 right now. Either way, my EP said because I am PERSISTENT, he suggests remaining on Eliquis even at 0 or 1 on the chadsvasc scale. You don't agree with this?



Edited 1 time(s). Last edit at 03/07/2024 01:41AM by cornerbax.

Thanks. I was assuming it would be closed per previous statements.

Jim

Makes sense to take thinners if you're in persistent. However, once in normal rhythm, in general would not make sense at 0 or 1.

As to whether you're a 0 or 1, that might be open to interpretation as the the parameters of high bp have changed since the
CHADS score was introduced. At that time above 140/90 was considered "high". However, your doctor may be calling anything
over 130/80 high, per newer guidelines.

Interesting article on that here:

[www.medscape.com]


Jim

Quote
Makes sense to take thinners if you're in persistent. However, once in normal rhythm,

I don't believe I've been in NSR for at least a year probably longer. I just finished with the Zio Monitor for 14 days and it says 100% AFIB burden. My EP was very clear on taking Eliquis due to Persistent or Long-Standing Persistent AFIB, regardless of Chadsvasc score at 0 or 1.Thanks for your response and info on this as well as Blood Pressure guidelines.



Edited 1 time(s). Last edit at 03/07/2024 01:41AM by cornerbax.