Question on the Watchman device

What happens to the blood and any clots that form behind the Watchman device.

Liz

Quote
Elizabeth
What happens to the blood and any clots that form behind the Watchman device.

They just sit there and eventually get absorbed by the body. They can't escape, so they're harmless.

Quote
Carey

What happens to the blood and any clots that form behind the Watchman device.


They just sit there and eventually get absorbed by the body. They can't escape, so they're harmless.

Carey, What happens if you go into AFIB with the Watchman installed? I have had 2 Ablations with Dr. Natale the last in June 2016 and have been in NSR since. I was in persistent AFIB when I started this journey. I guess I had silent AFIB in the preceding years before my diagnosis of Persistent AFIB in late 2011.

Quote
smackman
Carey, What happens if you go into AFIB with the Watchman installed?

Nothing at all. Once a Watchman has been in place about six weeks, your heart endothelializes over it, meaning the same tissue that lines the inner surface of your atria grows over it. Once that happens it would be impossible for it to move or be dislodged. It's there for life. In the weeks prior to that, it's held in place by 12 anchors. There's a discussion and photos here comparing the original design and the newer Watchman FLX, which is what I received. As you can see, it's sort of a springy device with anchors that hold the device in place by exerting outward pressure against the walls of the LAA.

Did Natale isolate your LAA? That's often necessary with persistent afib.

Carey. Is there any benefit with the FLX over the Watchman once the atria grows over it in regards to stroke prevention ? Is the main advantage with the FLX being easier to install and remain in place better during healing ?

Quote
ron
Carey. Is there any benefit with the FLX over the Watchman once the atria grows over it in regards to stroke prevention ? Is the main advantage with the FLX being easier to install and remain in place better during healing ?

There are several advantages to the FLX over the original Watchman. Probably the biggest is it can be repositioned by the EP implanting it. My procedure report noted that the device was repositioned once, and that wouldn't have been possible with the original device.

Probably the next biggest improvement is that the attachment point where the catheter screws into it is recessed, so it's not out there in the blood flow attracting blood clots.

It also has a smaller profile so it fits more LAA sizes, and more attachment points so it's less likely to break free from where it should be.

Quote
Carey

Carey, What happens if you go into AFIB with the Watchman installed?

Nothing at all. Once a Watchman has been in place about six weeks, your heart endothelializes over it, meaning the same tissue that lines the inner surface of your atria grows over it. Once that happens it would be impossible for it to move or be dislodged. It's there for life. In the weeks prior to that, it's held in place by 12 anchors. There's a discussion and photos here comparing the original design and the newer Watchman FLX, which is what I received. As you can see, it's sort of a springy device with anchors that hold the device in place by exerting outward pressure against the walls of the LAA.

Did Natale isolate your LAA? That's often necessary with persistent afib.

Yes; my LAA was isolated on 2nd Ablation.

Carey, the one thing you didn't answer is if there is any difference in stroke protection between the FLX and original Watchman once they are in place and healed ?

Quote
Carey
It also has a smaller profile so it fits more LAA sizes, and more attachment points so it's less likely to break free from where it should be.

How serious is it and what intervention is required if the device breaks free? How common of an occurrence is the device (old and new) breaking free?

Quote
smackman
Yes; my LAA was isolated on 2nd Ablation.

Then you should consider one. I doubt your insurance company will pay for it now if you can tolerate anticoagulants, but I think that will change in the next few years.

Quote
ron
Carey, the one thing you didn't answer is if there is any difference in stroke protection between the FLX and original Watchman once they are in place and healed ?

No, I don't think there's much difference once they're in place and healed over. The differences are more in ease of placement, stability once placed, and resistance to device related clots forming in the early stages. Unlike the original, the FLX can be repositioned after it's been deployed, it has more anchor points, and the metal socket the catheter screws into is recessed so it's less likely to attract clots. It's also not as deep so it fits a wider range of LAA sizes.

Quote
mwcf
How serious is it and what intervention is required if the device breaks free? How common of an occurrence is the device (old and new) breaking free?

That's pretty serious because it has to be retrieved if that happens. It can usually be retrieved with a catheter, but if it goes somewhere a catheter can't get to it surgery would be required. Worst case would be it gets caught in a valve and interferes with the functioning of the valve. There was one case in an early trial of the original Watchman of it finding its way into the left ventricle, which ended up being fatal.

Fortunately, that's a very rare occurrence and was mainly an issue of operator experience. It's also far less likely with the FLX since it has more anchor points and can be repositioned if the EP doesn't get it just right on the first attempt. Now that there has been time for EPs to train and learn with the device, it's not something that should happen. Like an ablation, I would definitely seek someone who's done many of them.

Carey - have there been reports of the FLX breaking free? I would presume this would or could occur during the early stages and before the device is totally endothelized ??

Another question - have you seen data on what the materials are composed of? The reference you gave indicated metal screws and polyester fabric. Have you seen comments regarding tissue irritation or rejection because of those 'foreign' materials in the body in those who have general sensitivities?

Jackie

If I may piggyback on these questions, especially Jackie's second question, I was wondering if there were any concerns about the "for life" presence of the Watchman device, in terms of the metals, fabric: i.e., any potential toxicity?

Thanks, Carey, for tutoring us all on this. I'm scheduled for a Watchman FLX implant this coming Thursday, at Scripps Memorial, La Jolla, CA, by Dr. Douglas Gibson, superintended by Dr. Natale. Also part of the ongoing study.

Lance

--Lance

The Watchman FLX frame is composed of nitinol, part titanium and part nickel. It’s properties are such that it compresses very well and returns to it’s original shape nicely. The cover is a PET fabric, a permeable polyester. The permeability doesn’t matter once the device endothelialises. I fully expect mine to last longer and in place longer than I will.

Quote

The Watchman FLX device is a self-expanding nitinol frame structure with fixation anchors and a permeable polyester (PET) fabric cover facing the LAA. The proximal face is flat with a reduced, minimal area of metal screw facing the left atrium to encourage endothelialisation and reduce post-implant thrombus formation. The nitinol 18-strut frame (compared to the 10-strut frame in the previous version) provides 80% more contact points at the LAA ostium and radially expands to maintain a proper position in the LAA. Atraumatic closed distal end has a fluoroscopic marker which enhances procedural visibility. Twelve “J” shaped fixation anchors in two rows create a proximal and distal line to aid in device stabilization in different anatomies of the LAA (10 in one row in the previous version).

[www.ncbi.nlm.nih.gov]



Edited 1 time(s). Last edit at 09/22/2018 05:29PM by AB Page.

Quote
Jackie
Carey - have there been reports of the FLX breaking free? I would presume this would or could occur during the early stages and before the device is totally endothelized ??

Another question - have you seen data on what the materials are composed of? The reference you gave indicated metal screws and polyester fabric. Have you seen comments regarding tissue irritation or rejection because of those 'foreign' materials in the body in those who have general sensitivities?

I'm unaware of any reports of the FLX breaking free. That's rather unlikely since the FLX was redesigned to prevent exactly that, and also because only top centers already experienced placing Watchman devices were selected to participate in the trial.

The metal basket is nitinol, which is an alloy made of nickle and titanium that's long been used in implanted devices. Although some people are sensitive to nickle, the nitinol undergoes an electropolishing process that forms a barrier on the surface that prevents nickle from leaching out. This is the same stuff stents and other implanted devices are made from, so there's a lot of experience with it and sensitivity reactions are very rare. The polyester fabric is also something that's widely used in implantable devices and particularly vascular repair applications. It's very biologically neutral and I've never heard of anyone experiencing a reaction to it. If someone did have a reaction to the Watchman, I would expect that would show up fairly quickly, so the device could be easily retrieved by catheter.

Quote
ln108
If I may piggyback on these questions, especially Jackie's second question, I was wondering if there were any concerns about the "for life" presence of the Watchman device, in terms of the metals, fabric: i.e., any potential toxicity?

Thanks, Carey, for tutoring us all on this. I'm scheduled for a Watchman FLX implant this coming Thursday, at Scripps Memorial, La Jolla, CA, by Dr. Douglas Gibson, superintended by Dr. Natale. Also part of the ongoing study.

There are no known toxicity issues. As I said in my previous post, the materials have been used in other implanted devices for decades so their behavior is well known.

Good luck! It's a breeze of a procedure. I was up walking around 2 hours later and eating dinner shortly after that. It's nothing at all like an ablation other than the fact that you'll have a groin insertion site like an ablation (but just one, not two).

Quote
Carey


Good luck! It's a breeze of a procedure. I was up walking around 2 hours later and eating dinner shortly after that. It's nothing at all like an ablation other than the fact that you'll have a groin insertion site like an ablation (but just one, not two).

Carey, I am assuming that you has your LAA ablated. When did that happen? Did it take care of all of your arrhythmias?

Thanks Carey - Once you mentioned the nitinol, I did a search on the percentages of nickel and learned that in some, there are concerns about reactivity for some patients if they have nickel sensitivity... they also talked about that concern in stenting. It's good to know reactivity is not common or a serious concern.

Jackie

Quote
MissSunshine
Carey, I am assuming that you has your LAA ablated. When did that happen? Did it take care of all of your arrhythmias?

Yes, in August 2017 by Dr. Natale. I've been 100% in NSR since. A Holter monitor for 8 days last March showed absolutely nothing, not even a stray PAC or PVC. That comes after 5 previous failed ablations over the course of 7 years that left me with multiple flutter circuits, including one that produced rates of 250 bpm.

Quote
Jackie
Thanks Carey - Once you mentioned the nitinol, I did a search on the percentages of nickel and learned that in some, there are concerns about reactivity for some patients if they have nickel sensitivity... they also talked about that concern in stenting. It's good to know reactivity is not common or a serious concern.

There's an interesting discussion about those concerns here. I found this comment compelling:

Quote

A third cardiologist from the Mayo Clinic added, “I, too, have generally ignored this in the past. Since there is a relatively high rate of Ni allergy in community, I would assume any signal of problem in the 1.5 million patients who get stents in U.S. annually would have been seen by now.”

I suspect the reason they don't see issues is because of the electropolishing they do that locks the nickle in.

Quote
Carey

Thanks Carey - Once you mentioned the nitinol, I did a search on the percentages of nickel and learned that in some, there are concerns about reactivity for some patients if they have nickel sensitivity... they also talked about that concern in stenting. It's good to know reactivity is not common or a serious concern.

There's an interesting discussion about those concerns here. I found this comment compelling:

A third cardiologist from the Mayo Clinic added, “I, too, have generally ignored this in the past. Since there is a relatively high rate of Ni allergy in community, I would assume any signal of problem in the 1.5 million patients who get stents in U.S. annually would have been seen by now.”

I suspect the reason they don't see issues is because of the electropolishing they do that locks the nickle in.

Boston Scientific had major recall due to problems with their stents, but for other reasons. Hope the Watchman works out better over the long term.