Is it worth it to get the Watchman? And is there a better version coming out?

Hello all - . I am a 66 year young woman , who had vagal Afib for 10 years, from age 50-60, that got progressively more frequent over time. When I finally decided to get an ablation, I was getting Afib at least once/day, if not twice. I could always make it stop, but I couldn't keep it from coming back....When my husband was diagnosed with lung cancer, I decided I had to do something about it..and got my first ablation with Dr. Natale while he was in NYC. He needed to do an extensive LAA isolation to address my situation. All was well until the following Spring, when I went into Flutter after my Acupuncturist put a needle into my left shoulder - immediate flutter!

Dr. Natale was now back in Austin, Texas, so I followed him down there and got a flutter ablation almost one year after the initial Afib ablation. I don't think he was surprised that I needed a "touch up" ablation, as I had Afib so many times, two of my pulmonary veins self ablated themselves! That seemed to do the trick and it is now 5 years since that (hopefully) last ablation,

Since I had a LAA isolation, I've needed to be on Eliquis. I had 5 TEE's after that, hoping my numbers would be good enough to get off of Eliquis, and while on one or two of the tests it appeared "borderline", this last one did not. Unless I decide to get a device like the Watchman, it looks like I am on Eliquis for life. I don't have any obvious symptoms, but I don't' love being on a blood thinner for a few reasons:
I don't want to get older and forget to take a couple of doses in a row and jeopardize my health....what about needing surgery?... I want to be able to take fish oil for other benefits but don't want to make my blood TOO thin, and I definitely don't want to worry about falling and it being life threatening, due to bleeding more easily...that happened to my brother in law this past winter and he almost died.

I met with Dr. Larry Chinitz's son..who now works for my cardiologist here on Long Island, NY. Sounds like I would need to be on a couple of different blood thinners for a few months, and then I would need to be on a baby aspirin for life. Well what's the point of going through all of that when you still need to be on a blood thinner..and one that could give you a brain bleed or cause internal bleeding in your stomach, etc? My goal would be to get OFF blood thinners, not continue but with a different one.

Is this information correct? I've heard there is a newer/better Watchman in Europe that is supposed to be available in the U.S. sometime next year....but am not sure if that's true.

I am not in a hurry, but I do want to keep myself protected w/o trading one potential problem for another.

Thanks for "listening"....Barb

I’m in a clinical trial along with a couple others here, having had the Watchman FLX implanted in the summer of ‘18. I believe we all had our LAA’s electrically isolated by Dr. Natale. It’s been a very safe procedure and apparently effective too. I believe the complication rates so far show an improvement over the current Watchman being used in the states, which itself is very safe and effective. Yes, I now take a low-dose aspirin every day. I have no regrets having had this implanted - it was quick(under an hour), and I couldn’t tell anything had been done, other than the collagen plug in my groin. I think there is some under the table debate, if you will, over the necessity of a low dose aspirin.

I’m sure Carey can offer a more accurate assessment/evaluation. When done by experienced operators, I believe it to be a trivial experience for the vast majority.

If the FLX isn’t being used/approved yet in the states, it will be. Getting it covered by insurance is not easy for most, yet.

Quote
AB Page
I’m in a clinical trial along with a couple others here, having had the Watchman FLX implanted in the summer of ‘18. I believe we all had our LAA’s electrically isolated by Dr. Natale. It’s been a very safe procedure and apparently effective too. I believe the complication rates so far show an improvement over the current Watchman being used in the states, which itself is very safe and effective. Yes, I now take a low-dose aspirin every day. I have no regrets having had this implanted - it was quick(under an hour), and I couldn’t tell anything had been done, other than the collagen plug in my groin. I think there is some under the table debate, if you will, over the necessity of a low dose aspirin.

I’m sure Carey can offer a more accurate assessment/evaluation. When done by experienced operators, I believe it to be a trivial experience for the vast majority.

If the FLX isn’t being used/approved yet in the states, it will be. Getting it covered by insurance is not easy for most, yet.

How did you find out about a Clinical Trial with Dr. Natale? I cannot have a watchman installed because of stringent Medicare requirements. I absolutely despise anticoagulants because of bruising, skin being easy to tear etc.
IF a clinical trial comes up again I would love to know the inside lottery of knowing about it and being chosen.

Quote
smackman
How did you find out about a Clinical Trial with Dr. Natale?

My understanding is that the FLX clinical trial(s) that had been done up to the point in time this one started, LAAC trial, had a statistical weight towards females, so this one was organized and included only or mostly men. Because TCAI research/St. David's were/are a participating implant center, it came down to timing and luck. I was one year out from a Natale ablation that put my afib and flutter into remission, and my LAA isolated. And I met the inclusion criteria, barely. So when research asked if I was interested, I did what any of you would have done, though probably not as well, and I started learning about the Watchman. And i talked to Shannon a lot. And then I decided to participate. I believe that TCAI research may at any one time be participating in several trials. My last visit I was in a room that had a wall mounted document hangar, and it had information on about 12-15 trials, all apparently active or enrolling.

AP Page - why would you have the Watchman when you still need to be on a blood thinner...aspirin? I don't really get the point...I thought the whole idea of getting this was to get off of anticoagulants. While Eliquis is stronger than aspirin, they both thin the blood. Given that, I am not feeling motivated to go through all of that to trade one blood thinner for another. Perhaps you have another perspective?

Barb

I'm short of time to reply at length right now but a couple of brief comments....

I have a Watchman. I received it the same day Andy (AB Page) did and I'm not taking aspirin.

Aspirin is not an anticoagulant. It's an antiplatelet. The distinction is subtle but important.

The recommendation to take aspirin for life with a Watchman is the FDA's textbook recommendation. Not all EPs agree with that advice and it's not what you'd probably be told to do outside the US.

I'll comment more later but I think Andy is doing a great job answering questions on this.

Whether you take an anti-platelet, a NOAC like Eliquis, or opt for nothing post-Watchman, you still receive the benefit of the Watchman - to close off the LAA and thus prevent stagnant blood that can form a clot in the LAA from escaping and causing catastrophic damage. So many things in life are a trade-off. I accept the bleed risk associated with an aspirin over the risk of a clot originating in the LAA, as well as the additional risk from Eliquis. Relative peace of mind is a great pillow. And with an electrically isolated LAA, my at risk over a single missed dose of Eliquis was potentially life taking. That is a point emphasized here and from the great folks at TCAI.

Quote
smackman

How did you find out about a Clinical Trial with Dr. Natale? I cannot have a watchman installed because of stringent Medicare requirements. I absolutely despise anticoagulants because of bruising, skin being easy to tear etc.
IF a clinical trial comes up again I would love to know the inside lottery of knowing about it and being chosen.

There is a list of all clinical trials (for all illnesses) here: <[clinicaltrials.gov]

Quote
GeorgeN


How did you find out about a Clinical Trial with Dr. Natale? I cannot have a watchman installed because of stringent Medicare requirements. I absolutely despise anticoagulants because of bruising, skin being easy to tear etc.
IF a clinical trial comes up again I would love to know the inside lottery of knowing about it and being chosen.

There is a list of all clinical trials (for all illnesses) here: <[clinicaltrials.gov]

Thanks George but I do feel as with every day life experiences having a inside edge is absolutely paramount for situations like this. We are not talking about a small procedure here. Very expensive out of pocket. Having inside knowledge, help etc. is Life. I have had a inside edge before on employment opportunities so life goes on. It’s all good.😀 Just keeping it real.



Edited 1 time(s). Last edit at 10/14/2019 11:11AM by smackman.

Quote
AB Page
Whether you take an anti-platelet, a NOAC like Eliquis, or opt for nothing post-Watchman, you still receive the benefit of the Watchman - to close off the LAA and thus prevent stagnant blood that can form a clot in the LAA from escaping and causing catastrophic damage. So many things in life are a trade-off. I accept the bleed risk associated with an aspirin over the risk of a clot originating in the LAA, as well as the additional risk from Eliquis. Relative peace of mind is a great pillow. And with an electrically isolated LAA, my at risk over a single missed dose of Eliquis was potentially life taking. That is a point emphasized here and from the great folks at TCAI.

Exactly.

As I said earlier, I received a Watchman as part of the same trial Andy was in. However, my anticoagulation has followed a slightly different path. I followed the recommended course of 6 weeks of aspirin + Eliquis. After my TEE at 6 weeks showed it was properly seated, leak-free, and clot-free, I went to aspirin + 1/2 dose Eliquis instead of the aspirin + Plavix that the FDA recommends. At 6 months I was given the choice of following the FDA guidelines of daily aspirin for life, stopping the aspirin and continuing the 1/2 dose Eliquis, or just stopping everything. After lots of research and conversations with Natale, my local EP, and my PCP, I decided to continue on 1/2 dose Eliquis indefinitely. Do I need it for protection from clots on the device? Nope, very unlikely. My one-year TEE in July again showed no problems, so that means the Watchman is almost certainly fully endothelialized, meaning the aspirin isn't really necessary. And neither is the Eliquis, for that matter. But I decided to continue the Eliquis because it offers protection from strokes from other sources and DVTs, and it may offer some dementia protection (evidence exists but it's not conclusive). I watched my mother die of Alzheimer's in 2016. The last six months of her life, she didn't know who I was. She didn't know who anyone was. Every single memory she had after the age of 18 was erased. Nope, I'm not doing that gig, not if I can help it. So I'm continuing 1/2 dose Eliquis indefinitely. It helps that my insurance covers it at 100% as a preventative drug.

Barb, if your TEE is clean, you can stop all anticoagulants at 6 months. No, that's not the FDA recommendation, but the FDA recommendation of aspirin for life is of dubious value. From what I've seen, the benefit does not outweigh the risk, and some EPs agree with that. Your body, your life, your choice. Aspirin or not the Watchman still reduces your stroke risk to the same level as people who don't have afib.

For anyone else with an isolated LAA, Medicare and some insurance carriers are already covering the Watchman, and I'm sure others will soon follow suit. Same if you're unable to tolerate anticoagulants, or if you've had serious bleeding issues. And I think the day will come very soon when Watchman is viewed as a viable alternative to anticoagulants for everyone with afib. Data already exists showing it's cheaper in the long run than anticoagulants, and insurance companies are all about cheaper. I think they'll be covering routine Watchman placement within the next few years.

To say Medicare covers the Watchman is “almost” a fallacy because the stringent requirements that must be met for approval is extreme. I worked with Austin to try and get Medicare to approve but it became such a cluster I gave up after around 3 month.
Without writing a book I can promise you it is not simple to get Medicare approval. I was told if I had a previous stroke, That would be to my advantage. 🙄
The cost of Eliquis or any of the new anticoagulant is absurd. I have Medicare Part D and because of Eliquis I am in the Donut hole every year..

I didn't say it was easy to get them to cover it but I've heard from a few who have been approved, and that never would have happened in their circumstances just a year or two ago. I think you'll see them gradually relax the standards in the coming year or two.

And I haven't checked the status of this recently but Pradaxa is coming off patent so hopefully there will be a cheap generic available soon. Also, doesn't the donut hole go away in 2020? I believe it does.

Bottom line:
Closing the donut hole will simply reduce costs in the Coverage Gap. Those who end up in that payment stage will still have to pay 25% of the cost of medications.

Last updated: 09-10-2019

Smackman, Insurance approve my Watchman because I had a gallbladder attack. The fact that I may have another gallbladder attack that may require emergency surgery while on Eliquis created a life threatening situation. The Insurance company approved the Watchman device because of that situation.
So far the gallbladder has been fine.
I was in a similar situation as you before the gallbladder issue.

I will be doing the second Watchman TEE tomorrow.
I have been on 1/2 Eliquis and a baby aspirin since the Watchman placement. Dr Natale did my Watchman. I am hoping tomorrow I can stop the Eliquis.
Either way, now stopping blood thinners or aspirin, for tests, surgery, etc, does not carry the high risks it did before the Watchman.

Quote
gmperf
I will be doing the second Watchman TEE tomorrow.
I have been on 1/2 Eliquis and a baby aspirin since the Watchman placement. Dr Natale did my Watchman. I am hoping tomorrow I can stop the Eliquis.
Either way, now stopping blood thinners or aspirin, for tests, surgery, etc, does not carry the high risks it did before the Watchman.

Good luck! But I'm sure it will be fine. I think the results are pretty clear that if the initial placement is good and there are no leaks, the device is probably good forever.

Have you considered stopping the aspirin and continuing the 1/2 dose Eliquis instead? That's the course that all three doctors I asked about this thought was the best course of action no matter what the FDA says. You might want to ask Natale about that.

Quote
Carey

I will be doing the second Watchman TEE tomorrow.
I have been on 1/2 Eliquis and a baby aspirin since the Watchman placement. Dr Natale did my Watchman. I am hoping tomorrow I can stop the Eliquis.
Either way, now stopping blood thinners or aspirin, for tests, surgery, etc, does not carry the high risks it did before the Watchman.

Good luck! But I'm sure it will be fine. I think the results are pretty clear that if the initial placement is good and there are no leaks, the device is probably good forever.

Have you considered stopping the aspirin and continuing the 1/2 dose Eliquis instead? That's the course that all three doctors I asked about this thought was the best course of action no matter what the FDA says. You might want to ask Natale about that.

Thanks Carey. The first TEE showed no leaks and it didn't move.

I had been on 1/2 dose Eliquis for a little over a year before the Watchman. The Eliquis gave me Tinnitus and made my head feel a bit off. That is why I went to the 1/2 dose. My Chads is 0. No afib for four years. I am 55 with no other (major) health problems and no medications. My only risk was the slowed LLA. I think aspirin is probably not needed.
I will do whatever Dr. Natale thinks is appropriate.

I do think I remember back when the Watchman was being researched, the Germans were not prescribing any medication post Watchman implant. The results showed post implant medicating provided no measurable benefits.

If Dr Natale thinks I should still take aspirin after a year has gone by, I may see about trying the 1/2 Eliquis instead and see if I have a reaction again.

Oh, didn't know about the side effects. That would change things for me too. You can't go wrong with whatever Natale recommends so you'll be good to go. It would be nice if you reported back here later to tell us what he says.

Quote
gmperf
I will be doing the second Watchman TEE tomorrow.

Best to you on your results.

What's curious, and I will ask Dr. Natale about Monday, is the aspirin v eliquis thing. His NP claimed he was insistent that I go off the half dose Eliquis I was still on at the one year mark, and switch to low dose aspirin. This seems to conflict with the either/or it's your choice Carey was told. I've never compared the bleed risk between the 2, and I guess there could be other things in my or my family history for him to be insistent on aspirin over ld eliquis.

Quote
AB Page
His NP claimed he was insistent that I go off the half dose Eliquis I was still on at the one year mark, and switch to low dose aspirin. This seems to conflict with the either/or it's your choice Carey was told. I've never compared the bleed risk between the 2, and I guess there could be other things in my or my family history for him to be insistent on aspirin over ld eliquis.

I'll be interested to hear the answer. I suspect it is due to your history.

I am on 2.5 mg of Eliquis 2X a day. This decision was made after my Tee in Dec. 2016. My LAA was isolated in June of that same year. Everything on my TEE was good except no A waves on mistrial inflow.
2.5 mg of Eliquis is the same price as 5 mg tablet. I need to have injections for my back but I have to stop Eliquis for 3 days; No if ands or buts from this Pain Management Clinic.
I also acquired Tinnitus after starting the new anticoagulants in 2012. It was Pradaxa back then and it has never left me.Buzzing 24/7.



Edited 1 time(s). Last edit at 10/15/2019 02:49PM by smackman.

Quote
smackman
I am on 2.5 mg of Eliquis 2X a day. This decision was made after my Tee in Dec. 2016. My LAA was isolated in June of that same year. Everything on my TEE was good except no A waves on mistrial inflow.
2.5 mg of Eliquis is the same price as 5 mg tablet. I need to have injections for my back but I have to stop Eliquis for 3 days; No if ands or buts from this Pain Management Clinic.
I also acquired Tinnitus after starting the new anticoagulants in 2012. It was Pradaxa back then and it has never left me.Buzzing 24/7.

I have had similar experiences with healthcare providers during the time I have been on Eliquis. Perhaps not every provider needs to know about the Eliquis.
I even had a dentist refuse a teeth cleaning because of Eliquis.

I have a prescription for 5 mg Eliquis that I cut in half. Why pay for 2.5 mg tablets if they cost the same as 5 mg.

Quote
gmperf


I have had similar experiences with healthcare providers during the time I have been on Eliquis. Perhaps not every provider needs to know about the Eliquis.
I even had a dentist refuse a teeth cleaning because of Eliquis.

I have a prescription for 5 mg Eliquis that I cut in half. Why pay for 2.5 mg tablets if they cost the same as 5 mg.

That dentist was either unskilled at dental prophylaxis or certainly overly cautious. A routine dental 'cleaning' should not cause concern about bleeding risk when on Eliquis, unless, of course a) the skill factor is involved
and b) severely inflamed gingival tissue with significant 'pocketing' from periodontal disease exists. Obviously, if a treatment involves deep cleaning (subgingival debridement) of pocketed areas, then the Eliquis or other OAC should be paused.

Jackie

Quote
Carey

His NP claimed he was insistent that I go off the half dose Eliquis I was still on at the one year mark, and switch to low dose aspirin. This seems to conflict with the either/or it's your choice Carey was told. I've never compared the bleed risk between the 2, and I guess there could be other things in my or my family history for him to be insistent on aspirin over ld eliquis.

I'll be interested to hear the answer. I suspect it is due to your history.

The TEE went well. The results were good. Dr. Natale came down to take a look at the results shortly after the TEE was performed.
He gave me the OK to stop the Eliquis. We talked about aspirin versus 1/2 Eliquis. He said he thought the 1/2 Eliquis was better than the baby aspirin.

As we all know guidelines are just guidelines. They are based on the patient population used in the guideline formation. These guidelines are for a relatively new device. No doubt they will change over time. A good doctor will treat the patient rather than the guidelines. That is the situation here with me. I am 3 months post implant. I really appreciate Dr. Natale treating me as an individual. That is so rare these days.

I decided to do the aspirin for a month and see if the side effects I attribute to the Eliquis go away. If they don't, I will go back to the 1/2 Eliquis. I plan at the 1 year mark to look at stopping all medication related to the Watchman.

For those reading this, you may think what good is the Watchman if you need to be on medication still.
The medication is to prevent thrombus from forming on the device. This seems to be a rare occurrence. When it does happen the thrombus usually stays on the device. This is still a relatively new device and longer term data is just now coming in. It appears to me the data is trending toward less medication post implant.
My opinion is because they (FDA) don't know who will have device related thrombus form, it is simply better to have guidelines specify medicate everyone who can tolerate the medication until they have more data.

Device related thrombus is not the same as an LAA clots. Therefore if you stop the medication you take because of the Watchman, your risk of device related thrombus is quite low. (I believe the problem with device related thrombus is only an issue when the device is not fully endothelialized. There is no way to now if it is endothelialized at this time.)
Your risk of a stroke from a clot in the LAA no longer exist with a properly placed, sealed, Watchman. If you need to stop the (Watchman) medication for a procedure for a few days or weeks, it isnt much or any risk.
If your LAA is open and slowed, stopping medication for a day or two can be quite a high risk.

Stopping Eliquis this morning feels very strange. I have taken it religiously for almost 5 years. It will take a few days to get used to this new normal.

Quote
gmperf

Stopping Eliquis this morning feels very strange. I have taken it religiously for almost 5 years. It will take a few days to get used to this new normal.

Glad to hear your news was good.

I echo the strange feeling of stopping a med that you previously were told missing one dose could have catastrophic consequences. I felt the same, and definitely took more than a few days to feel ok about it.

Quote
Jackie




That dentist was either unskilled at dental prophylaxis or certainly overly cautious. A routine dental 'cleaning' should not cause concern about bleeding risk when on Eliquis, unless, of course a) the skill factor is involved
and b) severely inflamed gingival tissue with significant 'pocketing' from periodontal disease exists. Obviously, if a treatment involves deep cleaning (subgingival debridement) of pocketed areas, then the Eliquis or other OAC should be paused.

Jackie

Hi Jackie, Glad to see you still active on the forum.

It was a simple cleaning. I think the reaction to blood thinner's is over blown by many providers. I do understand the liability issues they think they face.

I bleed much more and longer on aspirin than on Eliquis. Eliquis seems to just delay the clotting for an extra minute or two.

I have an old back/shoulder injury. Every 2 or 3 years it flares up. I went to my doctor who treated this for the last 30 years for a trigger point injection. When he found out I was on Eliquis he wouldn't do the injection.

I found a pain management doctor who wanted to do needling into the muscle. I didn't tell him I was on Eliquis. I figured I needed the treatment. He didn't know I was on Eliquis because if he did, he wouldn't treat me. I was willing to accept the risk. He wasn't responsible for what he didn't know. Not an ideal situation.
He did about 20 injection into the muscle. Went back for a second treatment 2 weeks later. It was the most effective treatment I ever had. No excessive bleeding. No issues what so ever.

Lots of interesting discussion here. I'm inclined to wait a bit on the Watchman, as the improved version is supposed to be heading to the U.S. sometime next year. Less complications sounds good to me.

Why are some saying that even missing one dose of Eliquis could be catastrophic? I was told that isn't true by my cardiologist. And if it were true, how would anyone on Eliquis ever be able to get off for a medical procedure, such as surgery?

Barb

Quote
tobherd
Why are some saying that even missing one dose of Eliquis could be catastrophic? I was told that isn't true by my cardiologist. And if it were true, how would anyone on Eliquis ever be able to get off for a medical procedure, such as surgery?

That's true only for people who've had their left atrial appendage (LAA) isolated during an ablation and now have inadequate blood flow within the LAA. In that case, clots can form within the LAA after missing just one or two doses of Eliquis (or whatever they're taking). Aside from myself, I believe there are at least two others here who fit this description.

For people in that situation, if they have to stop Eliquis (or whatever) for a medical procedure they use what's known as a bridging protocol. A bridging protocol replaces the Eliquis with heparin several days before the procedure. Unlike warfarin and the NOACs, heparin has a very short half-life, so the heparin can be continued right up until just before the procedure. This reduces the time off an anticoagulant to the bare minimum.

Clearly, people in this situation would benefit hugely by receiving a Watchman because it seals your LAA and eliminates the need for anticoagulants completely.

Quote
tobherd
Lots of interesting discussion here. I'm inclined to wait a bit on the Watchman, as the improved version is supposed to be heading to the U.S. sometime next year. Less complications sounds good to me.

Why are some saying that even missing one dose of Eliquis could be catastrophic? I was told that isn't true by my cardiologist. And if it were true, how would anyone on Eliquis ever be able to get off for a medical procedure, such as surgery?

Barb

My situation was the surgeon wanted me off Eliquis post surgery for gallbladder removal for 2-3 days. Dr Natale would not approve this. The surgeon refused to do the surgery.
Dr Natale and the surgeon talked and decided the Watchman was the best option.
Now I have a Watchman.

HI Carey - which number(s) on the TEE indicate inadequate blood flow? And do you know what the numbers need to be to have less of a concern? I've had over 5 TEE's, so I can look that info up for my own situation....

That's the one problem with working with an EP who is long distance and not someone you can set an appt with easily....I don't trust the local EP's nearly as much as I do Dr. Natale, but I can never talk to him unless I want to make an appt and fly to Austin....not too practicable. Of course,if I were getting a procedure done, that's different.

Thanks for any info you have ~ Barb

The measurement they look at is the LAA emptying velocity, but that's not something you'll find on most TEE reports. They have to be specifically looking for it. It needs to be at least 45 cm/sec. (Mine was 30 cm/sec so not even close.) They also look at the E:A ratio and the presence of "smoke" in the left atrium, which are also things you won't likely find in a standard TEE report.

Was your LAA isolated? If so, did they do a TEE later looking at these things specifically?

Cary, what is the E:A ratio ?

Yes, I had an LAA isolation ablation back in 2013, with a "touch up" ablation for Flutter in 2014.

My left emptying velocity has been all over the map, which is one reason I went for multiple TEE's. It's been 28.8, 41.4, 32, 40, and 58.5. All except for one were done at Montefiore hospital. Not sure if my numbers really vary that much or if the determination is that difficult to make.... frustrating. But my last one was the lowest....28.8. NO smoke detected on any of them. I'm not sure what the E:A ration is...?

Dr. Natale got the results for all of these. My cardiologist knows I want to have Dr. Natale as my "go to" doctor for anything Afib related, so she defers to him in general for that. However, going back to my original post here, I did meet with the EP on her staff about the Watchman, and the talk of having to be on an aspirin is what got this discussion started...my question being what's the point of trading one blood thinner for another?

Barb

Quote
ron
Cary, what is the E:A ratio ?

It's a measure of the blood flow from the left atrium to the left ventricle. The E wave is the passive flow of blood from gravity in between each beat, and the A wave is the flow from the atrial contraction. Normal is E > A. But as the number gets larger that means your atrium isn't contracting as forcefully. I don't recall what the number is they're looking for but in general you want a good strong atrial contraction, therefore a low E:A ratio.

Quote
tobherd
My left emptying velocity has been all over the map, which is one reason I went for multiple TEE's. It's been 28.8, 41.4, 32, 40, and 58.5.

That 58.5 number is the only one that meets the minimum of 45. Not sure what Natale would say about those numbers but he'd probably want to do another TEE and go by that. He'd also want to see the E:A ratio, which it sounds like your TEEs didn't report.

Quote

I did meet with the EP on her staff about the Watchman, and the talk of having to be on an aspirin is what got this discussion started...my question being what's the point of trading one blood thinner for another?

Two things. First, aspirin isn't a blood thinner. It's an anti-platelet drug. Similar but definitely not the same things at all. Second, the requirement for aspirin for life is the FDA protocol, but not everyone agrees with it. When you consider how a Watchman works, you have to ask why they would impose that requirement. The device should be completely endothelialized by about six weeks, so what's the aspirin protecting you from? Good question. The FDA put that in place out of an abundance of caution with a relatively new device and a general sense of "we've got to do something." In Europe it's not the protocol and patients are typically told to stop all anticoagulants and aspirin afterwards. That's also done in the US when patients are need urgent surgery, are intolerant to anticoagulants or aspirin, etc.

I'm not taking aspirin and have no intention of taking it. So far I've continued a half-dose of Eliquis but not because of the Watchman. That's an entirely separate decision for me based on other benefits Eliquis may have. I wouldn't hesitate to stop everything if I needed to do so, or simply decide it's not to my advantage. That might get to be the case when I'm older, for example. My personal evaluation of the data and recommendations from EPs knowledgeable of the Watchman is that aspirin just isn't necessary and the risks probably outweigh any benefit.

Barb,

As Carey noted above, the temporary ‘requirement’ for Watchman recipients to stay on an aspirin a day will not last indefinitely. As Carey also noted, aspirin is not used long term, post Watchman, in most other parts of the world and as more of the larger scale RCTs in the AuS, Europe and Asia are published over the coming few years, the consensus thinking among those EPs and Cardiologist who are at the forefront of LAA-based therapy, is that a daily aspirin will not remain a required drug indefinitely once the current evidence from the waves of well-vetted studies in process are published and disseminated throughout the field’s of cardiology and neurology.

If you want to wait until that near certainty manifests before too much longer, or you can go for it and start to benefit sooner.

Either way, I strongly suggest you go for LAAClosure in your circumstance so you simply don’t have to ever be concerned that you might start missing some doses of Eliquis down the line.

Cheers!
Shannon

Hello All,
I had my second ablation in Austin on March 1 , 2016 with Shannon at my side, he fed me a red popsicle in recovery....

My LAA was fully isolated at the last minute when on the wayout the Dr Natale injected me with isoproterenol to make sure he ablated all triggers and boom there was a spike in electrical activity! My follow-up TEE's were pathetic, wondering if two years later my velocity has improved?

I've been on Xarelto since with no problems whatsoever, I've banged myself hard, had deep cuts, deep scaling scraping of my gums with no problems of uncontrolled bleeding or bruising. But I've always wondered God forbid I had to stop the Xarelto......

With that said I received a call from Natale's nurse inquiring about my intentions of my dead Linq monitor and I ended up talking about my concerns with stopping NOAC's. I inquired about the Watchman X, which Natale highly recommends, so she put me on the waiting list with approval expected early 2020.

According to Shannon I should easily qualify due to my TIA 5 years ago, I'll be 63 next month, have excellent private insurance so this I'm guessing is my last step in putting this beast to rest.

During my recent cardiologist visit he had no problems with this but he cautioned me we don't know the long term effects and leaks could eventually develops if the watchman somewhere collapses .....?
I countered with once a thin layer of tissue will grow over the surface of the WATCHMAN Implant we should be good....? any thoughts on this and whether my poor velocity has improved years later.....

Also don't like the thought of aspirin for life but I see there are different protocols here included low dose eliquis which is reassuring.


McHale



Edited 1 time(s). Last edit at 10/27/2019 01:20PM by McHale.

I am appreciating hearing from all of you as I know you have far more knowledge on this than I do, and in many cases, then the local
EP seems to have. My cardiologist hired Dr. Larry Chin's son, who is now the local EP under that practice. He made it sound like staying on aspirin indefinitely was the protocol that he recommends. I bucked it a bit, as i also take a supplement that does the same thing basically, but w/o the side effects...AND because I know that aspirin can cause brain bleeds....doesn't sound like a good trade off to me.

If the newest Watchman is coming here to the U.S. in 2020, do we know if it's been out for awhile and has shown that it doesn't leak, or have concerns too?

I am in the research phase of all of this....doing fine on the Eliquis, but I like to plan and prepare...and I am 66, so I feel that's a good thing to do.

Barb

The new Watchman you're talking about is the Watchman FLX. I have one and so does Andy (AB Page). We got them the same day in August 2018 as part of the Watchman FLX trial, and they've been perfectly fine and leak free for both of us.

The FLX is only an iterative improvement on the original design, not a completely new device. It has more anchor points to prevent it from slipping out of place, a recessed nut the catheter attaches to that makes it less likely to attract clots, it's a little thinner, and it's redeployable so the EP can retract it and redeploy it if the initial placement isn't perfect.

The Watchman has been in use in the US since 2015 and having one collapse or develop leaks later is unheard of. Within about six weeks after placement your own endothelial tissue grows over it and once that happens it's never going anywhere and can't develop leaks.

There are three lines of thinking about post-implant anticoagulation. The FDA says a daily aspirin for life. Natale doesn't think that's necessary but still recommends a half-dose of Eliquis for certain patients, and others don't think anything at all is needed. Not using any type of anticoagulation afterwards is very common in Europe. I wrote about the hows and whys of this earlier in the thread.

McCale, sorry man, but it's extremely unlikely your flow velocity has improved enough to stop anticoagulants if your numbers were pathetic after the procedure. It could improve some, but probably not a lot. The only way to know is with another TEE, which they have to do before an implant anyway.

Carey says:

The Watchman has been in use in the US since 2015 and having one collapse or develop leaks later is unheard of. Within about six weeks after placement your own endothelial tissue grows over it and once that happens it's never going anywhere and can't develop leaks.

Sorry not true, I had to respond. Shannon has posted about his TIA because of a leak.

Quote
Elizabeth
Sorry not true, I had to respond. Shannon has posted about his TIA because of a leak.

Shannon doesn't have a Watchman. He has a completely different device that works differently.

I stand corrected:

Shannon said:

As Carey noted above my stroke was from a very different mechanism 11 months after my LARIAT LAA Ligation procedure, back before Watchman was FDA approved ( and thus I do not have Watchman device) but I did have both a LARIAT procedure, plus I had an Amplatzer Duct Occluder-2 vascular plug installed to plug the central ‘pucker’ very late leak in my LARIAT procedure, even though my three initial 2D B&W TEE scans had seemingly confirmed that my LAA was entirely sealed with no sign of any leaks over the first 2.5 months post LARIAT

Is the LARIAT still being performed? It sounds much simpler than the Watchman, it doesn't have anything added in the closure of the LAA like the Watchman does?

Quote
Elizabeth
Is the LARIAT still being performed? It sounds much simpler than the Watchman, it doesn't have anything added in the closure of the LAA like the Watchman does?

The LARIAT is a vastly different device, it's considerably more invasive than the Watchman, and not simpler at all. Here's a pretty good explanation of how it works with diagrams. Unlike the Watchman, it requires both a catheter to be inserted into the heart and a surgical opening through the chest. The Watchman requires only the catheter. The LARIAT can also be used by surgeons doing open heart surgery, but I believe most of them prefer using the AtriClip or simply suturing the LAA closed.

Not sure what you mean about nothing being added in the closure. There's definitely a device left inside you after the procedure with a LARIAT.

The problem in Shannon's case was that the device didn't close off his LAA completely. There was a small leak left and that was the source of his TIA. They closed that leak with a vascular "plug" that sealed it off much like sticking your finger in a hole in a dam.

Not sure if the LARIAT is still being used these days the way Shannon received it. I think it's fallen out of favor now, but I believe surgeons are still using it in open heart surgery, and there's also this.

All good information - thanks all. Next question is....would you only allow someone like Dr. Natale to put the Watchman in? He's in Austin and I'm in New York, but I did fly down there to have him do a "touch up" flutter ablation after he did my initial ablation (while he was in NYC). I totally trust him...not sure if I would trust anyone else for such a procedure.
Also...do most insurance companies cover this? I'm on Medicare and Tricare for Life (military).

Thanks ~ Barb

I would only allow someone who's done hundreds of Watchman implants to do it. Natale is an obvious good choice but there also Rodney Horton at TCAI and he's done far more than Natale. Being in NYC I would expect there are several EPs with a lot of Watchman experience in the city. You might want to have a look around this page. Check out the "See if Watchman is right for you" link. https://www.watchman.com/en-us/watchman-device-procedure.html

Carey:

Thank you for your explanation.

l

Hi Barb,

To be sure, for a straight up Watchman-only procedure there are a good many more well trained EPs at doing Watchman’s to make ones job easier to pick a high volume experienced Watchman installer that can do a good job. Typically, such an experienced Watchman installer would be found around a larger metropolitan area, with some exceptions, that can also do a solid reliable job.

However, when you need a Watchman subsequent to having required an LAA Isolation, plus having had a more typical AFIB ablation, I would narrow my list down considerably to the St Davids elites or long time protégés of Dr Natale who themselves are experienced in both LAA-Iso and Watchman. Primarily because of their greater familiarity with all the nuances of LAA-Iso touch-up as well, than would be the case with a Watchmsn installed who likely had never don’t an LAA-Isolation.

Even when you feel good that your LAA-Iso is holding up strong, once Natale or Horton are in there for the WatchmanFLX install, they well most certainly do a thorough left and right atria evaluation while they are in the LAA area to take advantage of this golden opportunity for one final ‘button-down’ of any possible remnant mildly loose ends in or around the LAA ostium or in the Coronary Sinus. I would certainly want to take full advantage of such an only-as-needed opportunity to reinsure a likely full lifetime of freedom from all AT.

A more typical ablation/Watchman qualified EP, who might be more limited to doing mainly just a standard PVI ablation before adding the Watchman, may indeed do a decent job at both those two tasks, but I would feel much less confident having such an operator being able to both detect and track down and reliably eliminate a potentially challenging left atypical flutter circuit in the LAA, in particular.

And Barb with your extensive history with Dr Natale, I would want to stay with the tried and true as much as possible.

Best wishes,
Shan

Question: once the Watchman flex is approved (March-ish?) and hopefully Medicare criteria for installation are eased, will Dr. Natale be doing ablations and Watchman installations in one procedure? I ask because I have not yet had an index ablation (I’m steady on flecainide so far) but when I do, it would be nice to have a Watchman installed at the same time unless there are contraindications to doing them together.

I also have a Watchman FLX as part of the trial. At my late September one-year follow-up (passed TEE with flying colors!) Dr. Natale's nurse practitioner told me that the word was that the Watchman FLX will be generally available in May 2020.

Best to all,

--Lance

Quote
Daisy
Question: once the Watchman flex is approved (March-ish?) and hopefully Medicare criteria for installation are eased, will Dr. Natale be doing ablations and Watchman installations in one procedure? I ask because I have not yet had an index ablation (I’m steady on flecainide so far) but when I do, it would be nice to have a Watchman installed at the same time unless there are contraindications to doing them together.

That's a big question I can't answer and I doubt Shannon can either. I think the Medicare criteria for Watchman will begin to ease, but I think doing a Watchman and ablation in the same procedure is a distant goal at this point, probably at least 2-3 years off.