Standard protocol following Watchman procedure.

Is there a standard protocol followed by most EPs in terms of follow-on appointments and procedures post-Watchman procedure? I’m interested in knowing the timing of such events and what to expect. TEE a certain number of weeks following the Watchman procedure , etc….

Does the Watchman cause irritation? Other side effects?

I believe there is a 45 day TEE, a 6 month TEE and a final 12 month TEE. Perhaps it’s EP to EP’s discretion how often. I had Dr. Natale implant mine and his CA office told me the three above. Perhaps his Austin office differs. I don’t know.

I didn’t feel anything different after my watchman. I even was not admitted overnight and was discharged a few hours after the anesthesia wore off. My only glitch was my artery he inserted the watchman up had a curved bend which required a few attempts to thread it up. I had a temporary hematoma and pain but that may not occur to anyone else. It’s my unique anatomy which differs from everyone else. I had no problems with three ablation catheters finding their way up to my heart…maybe my size watchman was a snug fit for my artery. They come in different sizes and mine was 24mm-midsize.



Edited 1 time(s). Last edit at 05/04/2022 02:16PM by susan.d.

The catheter used to insert a Watchman is much larger than the catheters used in ablations. That's true even if you get the smallest size.

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Chuck Connors
Is there a standard protocol followed by most EPs in terms of follow-on appointments and procedures post-Watchman procedure?

Does the Watchman cause irritation? Other side effects?

Here is the protocol used in the 2017 Watchman FLX clinical trial I was in. Since this was a clinical trial, they followed us for a full 2 years, but there wouldn't be a follow-up for you after the 1-year mark, and some EPs don't do the 1-year follow-up.

This is the official FDA protocol, but EPs aren't required to follow it. For example, after 45 days Natale stopped the aspirin entirely and cut my Eliquis to a half-dose. After 6 months, I was given the choice of aspirin for life, half-dose Eliquis for life, or nothing. Natale's advice was the Eliquis and both my local EP and PCP agreed, so that's what I did.

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Does the Watchman cause irritation? Other side effects?

No, you won't even know it's there.

Just to comment that everyone is different and Natale customizes his protocol on a per patient basis. You had the option to drop aspirin at 45 days and reduce the Eliquis to a half dose. I never started aspirin after the implant and stayed on full dose Eliquis for only 24 hours after the watchman implant and immediately went half dose because I was hemorrhaging somewhere in my intestines. I don’t think there is a set protocol in general—maybe average % of patients but not carved in stone. Having Natale as my EP, I felt comfortable he is the most experienced and knew how to correctly guide me on my blood thinners dosing.

Dr. Natale's post Watchman protocol for me, effective 2/15/22, was halving my daily dose of Xarelto to 10mg and adding one 81mg aspirin. He switched me from Pradaxa to Xarelto in 2016 prior to my first ablation. I had my six week TEE 3/29 and will have my six month one in mid-August. After the six month TEE I will follow the regimen Dr. N prescribes for anticoagulant. I hope it's at most 10mg Xarelto as I'd prefer to be off aspirin.

I had my 45 day TEE last week.
The report said “ Watchman left atrial appendage occluder device implanted, well seated.
The Watchman device has a prominent shoulder along the Mitral annulus. There is a trace
leak <3mm. No thrombus seen.”
Is that concerning?
I haven’t heard from Natale yet. But they did schedule me for an echocardiogram next week, which seems unusual.

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Mac
Is that concerning?
I haven’t heard from Natale yet. But they did schedule me for an echocardiogram next week, which seems unusual.

It's under 5 mm so I don't think it's concerning, but it's something they'll want to watch, which is probably why they're doing another echo. They probably want to verify the previous echo. What they'll hope for is that endothelial tissue will grow over that leak and seal it.

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Carey
It's under 5 mm so I don't think it's concerning, but it's something they'll want to watch, which is probably why they're doing another echo. They probably want to verify the previous echo. What they'll hope for is that endothelial tissue will grow over that leak and seal it.


I am curious to know what is done if tissue does not grow over the leak and seal it. Is there then surgical intervention?



Edited 1 time(s). Last edit at 05/10/2022 12:31PM by Pixie.

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Carey

Is that concerning?
I haven’t heard from Natale yet. But they did schedule me for an echocardiogram next week, which seems unusual.

It's under 5 mm so I don't think it's concerning, but it's something they'll want to watch, which is probably why they're doing another echo. They probably want to verify the previous echo. What they'll hope for is that endothelial tissue will grow over that leak and seal it.

Thanks Carey.
It seems a little odd to me, because what are they going to see in a regular echocardiogram that they didn’t see in the TEE?
And yes, what if the tissue doesn’t end up blocking it?

Carey, I had sent a prior post related to Mac’s. If the tissue does not grow over the leak and seal it, is there surgical intervention?

I will be having a watchman and this topic remains on the top of my list.

Sherry

Yes, there are procedures available to seal the leak if they think it's necessary. But at this point the standard of care is that leaks smaller than 5 mm don't need to be sealed. They're considered harmless. But if they believe it does need to be sealed, they can do that with another procedure using catheters (not surgery). There are small screw-like devices specifically designed to be plugged into vascular leaks. They would go in the same way they went in to implant the Watchman and screw one of these small devices into the leak, sealing it.

So if they confirm the leak is still there and they confirm the size at 3 mm, I doubt they'll want to do anything. But if they do, they have options available.

You're both good. :-)