LAA Velocity check up

Hi, I had my LAA ablated in late July 2020 and am now scheduled to see Dr Natale on May 5th for a TEE to measure the velocity. He will also be advising me as to whether I will need a Watchman which he will put in on the following day. I have read that some people, even after the Watchman procedure, will have to stay on Eliquis for life. Has anyone from this forum not needed to have a Watchman after having the LAA ablated? I would love to hear from you about your experience and how you did afterwards.
Thanks much. Also, thank you Shannon and Carey. The new Afibbers Forum is great!

The official FDA protocol calls for people with a Watchman device to take a full-dose aspirin for life, but elsewhere in the world, that's not the case. It's standard in Europe for Watchman patients to take nothing at all after the first six weeks. Why the difference? It's just the FDA being super cautious and doctors feeling like they've got to do something.

Why the aspirin? Because there's a remote chance that your body won't fully endothelialize the device and some of the bare metal will remain exposed to blood flow, which could cause clots to form on the device. This isn't something that's actually seen in Europe, but the fear is it could happen in some individuals so aspirin is prescribed out of an abundance of caution.

But aspirin isn't a harmless drug and has its own side effects, with the big one being GI bleeds. And people with Watchman devices often have some degree of age-associated cardiovascular disease such as aortic plaque, which would warrant taking a daily aspirin whether they have a Watchman or not.

So one possible compromise is a half-dose of Eliquis or Xarelto instead of aspirin. It has a lower bleed risk than aspirin and is superior at preventing clots. So the choices I was offered after I'd had my Watchman for six months were:

1. Take nothing
2. Take low-dose aspirin
3. Take half-dose Eliquis

Natale's recommendation for me was #3. So I ran the question past both my PCP and my local EP without telling them Natale's opinion, and they both agreed #3 was the best choice. Do I need anything for the Watchman? No, probably not, but there's no denying that my last TEE showed "mild aortic plaque" and that presents an increased risk of clots forming on the plaque. (If you're over 60 it's virtually guaranteed that you have the same degree of plaque whether you know it or not.)

So instead of being totally drug-free like many people desire, I compromised with the Eliquis. I view it as a double benefit. I've got a Watchman that lowers my stroke risk to the same level as people who've never had afib, even if the afib returns, plus I've got better protection against other sources of clots without the GI bleed risk that aspirin creates. Plus, unlike virtually everyone else on the plane, I can take a 14-hour flight to New Zealand without concern for DVTs, and should I catch COVID I've already got protection against the clotting it causes.

As for what to do if I need to stop the Eliquis for something like a colonoscopy or surgery? Simple: I just stop. Unlike prior to the Watchman when taking Eliquis without any interruption whatsoever was vital, now I can safely stop it any time I want. Stopping it entirely is still a perfectly valid option for me, but it's my choice to continue it.

Carey, thank you for your most informative reply. Gives me a lot to think about and in the end I’ll probably go with Natale’s recommendation. One other thought, do you know of anyone that didn’t need the watchman after having the velocity test?
Thanks Victoria

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Cevetello
One other thought, do you know of anyone that didn’t need the watchman after having the velocity test?

Have a friend who had two Natale ablations, including LAA isolation. Initially he was just marginally on the need anticoagulation side, but after a period of time, his numbers amazingly improved enough that he no longer needed any anticoagulation (he's still doing very well). As an aside, I think there is a 40% chance those with LAA isolation can get off anticoagulation.

This is a note from my friend in March, 2018:

"Hi George and Shannon, I thought I’d share some good news with both you, leading up to saying a huge THANK YOU to both of you: ever since my second ablation with Dr. Natale 2 years ago I’ve been on the Eliquis blood thinner. The reason being that, a couple of months after the ablation I had a TEE done, and the emptying velocity ratio, or something like that, had to be at I think it was .42 or higher. I just missed the cutoff and was .03 points below the threshold. So for that reason Dr. Natale put me on a blood thinner.

I decided I wanted to try getting off of Eliquis again and wanted to get another TEE done. So for 2 weeks prior to the TEE I wore a holter monitor, to be sure that there wasn’t any ambient afib going on. There wasn’t - all clear! Then I did the TEE yesterday and my score was a .55 ! So it’s adios Eliquis for me!

So, again, THANK YOU both so much for leading me in the right direction with all of this!"



Edited 1 time(s). Last edit at 03/28/2021 03:48PM by GeorgeN.

George is right that about 40% of patients with an isolated LAA can come off anticoagulants, and I also know someone whose numbers didn't make the cut at first, but they did a year later. But I wouldn't expect sufficient improvement over time unless you were near the cutoff to begin with.

Would be nice to be in that 40%. I have a better understanding now. I’ll keep you posted on my return.
Thank you, Victoria

My LAA velocity was 55-60%. Tall E waves were noted BUT no A waves are seen. I was left on a low dose of Eliquis for life. Low dose eliquis cost the same as regular dose which is a rip off.
I continue to take 2.5 mg of Eliquis 2x a day since Dec. 2016.

Smackman, was that a Natale decision? And, yes, the cost of Eliquis is outrageous.

Yes, It was Dr. Natales decision. I was not offered the watchman at that time nor was I one of the lucky recipients of the trial. I tried in I believe in late 2019 to see if I could get the watchman but was told it was very difficult to get approval after a couple of weeks of conversations with Austin with Medicare and a excellent supplement.
Anyway, Eliquis puts me in the donut hole every year.

Me too

You might want to look into it again. I'm hearing from more and more people who've been approved by Medicare for Watchman devices who would have been rejected a couple of years ago.

Smackman: Why not use a regular pill cutter and cut your 5 mg Eliquis tablet in half? I've done that with other pills for years with no problems.

I've been buying the 5 mg generic for Eliquis, Apixaban, from Canada for about $1.50/pill so that would mean your cost/day for half doses is about $1.50. That'll keep you out of the donut hole.

FWIW, I tried Phizer's discount pricing plan and for me on Medicare with Humana's supplement insurance it was no help.

For some reason we can't buy generic in the USA yet, probably because Phizer is paying the generic manufacturer to not produce it for a couple of years.

GGheld;

Are those pills scored? If not then each half doesn't hold the same amount of med when you cut them.

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Elizabeth
GGheld;

Are those pills scored? If not then each half doesn't hold the same amount of med when you cut them.

I actually discussed cutting 5 mg in half with the individual who I call to get refills for my Eliquis from Austin. He said he would ask Doctor and
They agreed to it!
That will cut my cost in half. I do agree that some pills not scored are not suppose to be divided but I also know that is not always the case For instance I use to take Klonopin 1 mg. One generic company scored the pill another generic company did not.
Xarelto makes there pills nearly impossible to score by the shape of the 20 mg. The Eliquis 5 mg is fairly simple with a little patience. Pills that are not meant to be scored are generally ER but some of them are even scored.
With Austin’s approval, cutting Eliquis saves me a bundle. Prescription Drugs are such a Racket. My pharmacist became upset over this Eliquis split. I had to change Pharmacist. I guess it cut into his profits since he had cut cheaper pills for me in the past because all he had was 2 mg and I needed 1 mg so he cut them for me.
Go figure....,,,,

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Carey
Why the aspirin? Because there's a remote chance that your body won't fully endothelialize the device and some of the bare metal will remain exposed to blood flow, which could cause clots to form on the device. This isn't something that's actually seen in Europe, but the fear is it could happen in some individuals so aspirin is prescribed out of an abundance of caution.

Carey, I know you had the Watchman fitted as part of a trial but did you ever consider the AtriClip which doesn't appear to have the endothelialization issue?



Edited 1 time(s). Last edit at 03/30/2021 12:21PM by scribbler.

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scribbler
Carey, I know you had the Watchman fitted as part of a trial but did you ever consider the AtriClip which doesn't appear to have the endothelialization issue?

Good question but I never really considered other devices because in 2017 that just wasn't a possibility. Medicare and insurance companies wouldn't pay for any type of LAA closure devices for someone like me. The Watchman FLX trial just happened to come along at that time, and the Watchman was as good or better than any other device available at the time, so I jumped on it. But if I were facing the same question today, I would definitely consider the AtriClip.

But it's hard to compare the Atriclip and Watchman since the AtriClip involves chest surgery with all the attendant risk and recovery time, while the Watchman is a 20-minute procedure with far lower procedural risk and virtually no recovery time. The AtriClip seems to be a very good device in the hands of an experienced operator. And, like you said, it avoids the endothelialization problem. So it's definitely something I would consider if I were facing the question today, but I think I'd probably end up going with a Watchman anyway. I haven't looked at data to compare the two in a while and this field is changing fast, but the last data I saw I think came down on the side of the Watchman for efficacy and safety.

I have a nickel and titanium allergy so I am concerned with getting the watchman. I wish I had a choice.

Carey,
Thanks for your answer, it helps to clarify my own thinking.

I take your point with regard to the risks associated with chest surgery. Another couple of points to consider in favour of the AtriClip is that fitting it doesn't require the puncturing of the septum, which may be permanent and the shape of the LAA doesn't seem to matter.

With regard to the LAA, apart from the Lariat device and the AtriClip, if there are any other devices coming along, please feel free to mention them!

There's at least one other device similar to the Watchman, but its name escapes me at the moment. I don't know of any advantage it has over the Watchman. I think the Lariat and AtriClip are the only external devices, but there's also just plain old sutures. Heart surgeons have been routinely closing off the LAA during surgery for other reasons by simply suturing it closed.

OK and thanks again, Carey.

Hey Carey,

The other similar device to the Watchman series I believe you are thinking of is the Amplatzer Amulet LAA Occluder.

It has been around as long as the original Watchman, perhaps even a bit longer, and it has gone through a number of improved iterations as well over the years.
The Amulet has been more commonly used and approved outside of the US in past years ... and I'm not exactly sure what its full FDA status is these days, but I'm pretty sure it is being used in some US centers occasionally too. I am just not sure it that use is under trial use authorization or full FDA approval as yet?

And in any event, the Watchman FLX advances have made it the most popular device for endocardial-only LAA occlusion. And no doubt, Watchman FLX is far more popular compared to the more invasive devices for full ligation of the LAA, such as The Atriclip and updated LARIAT-Plus ... as Carey noted above.

These latter two Ligation systems can be very useful for different scenarios in which full ligation might be preferred. With, again, emphasizing the noted caveat that both ligation methods require notably more invasive procedures ... thus some degree of added risk relative to a simpler, roughly 20 to 30 minute endocardial Watchman FLX install.

The added advantage of full LAA ligation is essentially to dramatically minimize, or even eliminate, both LAA/AFIB-related embolic risk, as well as eliminating future LAA-based arrhythmo-genesis as well. Thus, when such epicardial ligations like with the Atriclip, or with the LARIAT-Plus endo-epicardial approach, for the very same targeted outcome of full LAA ligation, then one can kill two birds with one stone and greatly minimize both embolic events (and any further atrial arrhythmia's that may spring from LAA sources ...

Another similar and simple Watchman-like device called the Wavecrest LAA Occluder that I believe is still moving toward FDA approval (though I need to confirm this as I have lost track with this devices approval process during the pandemic). In any event, the Wavecrest has its own added advantages as well from where it stood one abd a half years ago when I last checked it out at an EP conference.

I'll check back in the next few days and let you all know where the Wavecrest stands with the approval authorities ... again, though, the Watchman-FLX is currently the king of the hill of endocardial LAA occlusion devices, from all reports I've seen, and with it's impressive safety, consistency and efficacy that we have seen too from an ncreasing numbers of our own Afibbers who are now enjoying its benefits.

Cheers!
Shannon

Shannon- any without nickel or titanium? The alloy used for the watchman contains nickel.

Shannon, thanks for that.

Shannon, thanks for that information. I’ll be looking for your additional messsge.

Wavecrest is the other one I was thinking of.

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Carey
Wavecrest is the other one I was thinking of.

I couldn’t find the alloys used. Do you know?

[patents.google.com]

Neat diagram of its patent

Sorry....

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6302034/

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The WaveCrest 1.3 device consists of a self-expanding nitinol frame with 20 anchoring points, covered by an expanded polytetrafluoroethylene (ePTFE; also known as Gore-Tex) fabric. It comes in three sizes (22, 27, and 32 mm), as shown in Figure 1.

I think you're going to find nitinol in almost all implanted devices that depend on spring pressure holding them in place, so that rules out all the "plug" type LAA devices for you. You would need an AtriClip, LARIAT, or surgical closure.

Nitinol is used in all the "plug" type devices because it's unique in that it can be formed into almost any shape and then it will always return to that shape. It also doesn't corrode, it's non-magnetic so it's safe in MRIs, it's fairly benign about causing inflammation and clots, and (not counting you) it's fairly hypoallergenic. So it makes the perfect metal for implanted devices that have to retain their shape and springiness inside you for decades.



Edited 1 time(s). Last edit at 04/01/2021 08:51PM by Carey.

Good Friday morning all,
Circling back to our discussion above on LAA occluder/ligation devices from above,

The Wavecrest LAA Occluder is now on hold and at a recent review board meeting it seems that the consensus is that the design is so similar to a Watchman design and due to the excellent results over the last couple of years with the new Watchman-FLX that there now simply may not be any real incentive to move forward with this device by Johnson & Johnson who, it is my understanding, had invested in the Wavecrest.

As for the Atriclip, it certainly has a good role to play, but mainly, at this point and in light again of the really great real-world success of the Watchman-FLX in high volume in-plant centers, there is less demand for this very significantly more invasive surgical procedure .

However, for folks with AFIB who are also undergoing open heart surgery, say, for a non-TAVR valve replacement, or for a full-on open heart procedure using CABG surgery (coronary artery bypass graft), in which case adding an Atriclip to seal off the LAA through ligation makes a lot of sense in being able to potentially kill two birds with one stone once your Cardiac surgeon is already inside your heart. Those are potentially great applications for an Atriclip!

Also, I learned yesterday that the Amplatzer Amulet LAA Occluder is nearing FDA approval in the coming months, so it looks like Amulet will join the Watchman-FLX.

However, it is my understanding that there has been no significant upgrades to the Amulet over that last number of years since seeking FDA approval, though it has had a few updates or tweaks a longer time ago, but the Watchman FLX appears to be the current champ for most folks trying to get off a blood thinner and/or having had LAA isolation.

Cheers, . and happy Holidays!
Shannon



Edited 2 time(s). Last edit at 04/04/2021 12:54PM by Shannon.

Shannon- what is the alloy used for the Amplatzer Amulet LAA Occluder? Nitinol? I wish they can gold plate it.

This post is mostly for those of you who might well benefit greatly from LAA Occlusion/Ligation, keep in mind that the Atriclip spring also is based on nitinol, and as Carey noted above, nitinol is 'nearly' ideal for the vast majority of folks who could potentially benefit from LAA Occlusion/Ligation.

And in fact, I had a direct experience with what to me seemed to be a possible allergic reaction to nickel that initially we had to rule out roughly 5 months or so after I had a tiny 'Amplatzer Duct Occluder II' vascular plug device (ADO2 from now on) that was installed to seal off a central 5mm diameter leak in the center of what we had all assumed was a fully sealed and ligated LARIAT procedure back in 2014.

And anyone interested in reading more about the full saga of my LARIAT procedure back in the early years of the LARIAT, can read or download The AFIB Report issue 133 August/September 2014. This issue can be found under our 'Learn' section ... within the 'Past Issues' sub-heading ... and the subsequent embolic event I had 11 months after that first generation LARIAT was install.

And please keep in mind the significant upgrades to the now much improved LARIAT-PLUS with its overall enhanced procedural efficacy and safety in recent years. My experience was with an early first gen. LARIAT back in the day.

But back to nickel allergy issues, it is possible for implanted cardiac devices containing nickel to be associated with, or even less often directly the cause of an allergic reaction ... however as Carey noted above, it's quite rare to see significant and confirmed nickel allergy with what typically in these cases are usually small amounts of nickel that often are found to not be deal-breakers after-all when further testing is done.

The key point for any of you who may have tested positive for nickel sensitivity on typical allergic skin testing by a dermatologist in the past , and if you also might benefit greatly from an implantable cardiac device that contains some nitinol, then please don't automatically rule out your potential ability to tolerate the usually small amount of nitinol that often has a surface coating.

Granted, it is not that uncommon for patients to inform their EP or Cardio that they have previously tested positive for nickel allergy. However, before just ruling out such an important implantable device, when the makers of these devices have all gone to such great lengths to minimize reactivity of their implanted products.

So at least explore with your EP/cardiologist and a dermatologist too, about undergoing further testing with more advanced skin testing methods and/or by having your Doc tape a similarly small representative amount of nitinol in strategic places on ones skin for up to several days, and see if you might get a passing grade after all without showing any significant reactions?

In my own experience with this issue, in 2014 I had a tiny all nitinol vascular plug called an: 'Amplatzer Duct Occluder Il (ADO2)' installed in the center of my previously LARIAT-ligated LAA. This added ADO2 plug was required to finish sealing what had gradually become a 5mm diameter leak in the very center of what turned out to be a very small partial and very late reopening leak from my LAA at the 11 months mark after what had seemed to be a fully-sealed initial LARIAT LAA ligation. Instead, we discovered that this leak had caused a modest embolic event.

In any event, after getting unequivocal confirmation that with the addition of the ADO2 vascular plug my ligation would be finished for certain, I was all in on the fix ... and indeed I got the green light that I was good to go after the plug device was installed.

And BTW, the ADO2 looks, and performs very much like, a 'mini-Watchman' that had been added to finish plunging that small LARIAT leak ...

Then, a number of months later I noticed a small urticaria-like rash on both of my calves and knees. This was during warm weather season in Arizona which demands only short-sleeved shirts and shorts for pants during that time of year. The rash began to morph and spread, migrating to my arms and hands with me soon developing scary looking blisters on and between my fingers and knuckles on both hands and elbows too.

I went to the head honcho Doc at a large Dermatology group in AZ who was very surprised at the severity of the rash and immediately ordered a battery of skin tests and subsequently prescribed a heavy-duty topical steroid cream called Clobetasol Proprionate for short term use. This was also after I had informed him my 'bionic' implanted hardware that includes my dual chamber pacer, the LARIAT and the little ADO2 LAA plug on board.

The Dermatologist said that it didn't look particularly like a nickel reaction, but he did all the tests anyway, and on first review a nickel allergy was still not yet ruled in, or out.

So repeat tests were done including two other more targeted tests that seemed to rule out nickel allergy, and that last two test did rule in a likely causal relationship from several desert plants that are known to cause such rashes and hives that can get out if hand if irritated further and compounded by the skin scratches. That all made all the more sense with the multiple fine skin scratches I had on my lower legs, arms and hands.

Dr Natale was very skeptical that such a nasty rash was caused by the relatively small amount of nitinol from the ADO2 plug, and all the mire so due to where it was installed . And as was a highly respected interventional cardiologist who, at the time, was one of the most experienced early Watchman and LARIAT installers in the U.S., and who Dr Natale had referred me too at Scripps in La Jolla to install my ADO2 in order to plug my LARIAT leak once and for all. This Doc also was sure this was no nickel allergy and proclaimed that: "...he would eat a ten gallon hat right in front of me if this allergy was at all related to the ADO2 or nitinol." He still has an intact ten gallon hat somewhere :-)!

I have never again had such a florid rash since that late summer of 2014 and, not surprisingly, I have been careful to avoid scratching plants on my arms and legs since then.

In addition, I did get a single sample of an ADO2 plug from one of the kind reps from the original company (Amplatzer products are now owned by Abbott) when I was at an EP conference on the last day of the conference when the reps were busy packing up their exhibits, and subsequently I several times taped the tiny nitinol device to the side of my chest, and on my inner forearm, and I have never seen a reaction of any kind from that experiment.

The bottomline here for those who might benefit from a nitinol containing cardiac device, and especially if you have a documented history of confirmed nickel/titanium allergy, then by all means make sure you carefully confirm through your EP and a Dermatologist too, if you actually show frank reactivity not only from a typical skin test panel, but also from having your physician try prolonged direct skin contact with a nitinol containing device ..: similar to the device in question ... and see if both the cardiologist and dermatologist agree that it should be safe for you after all.

Of course, if the verdict from the experts and various tests is that you are too reactive from these evaluations, then definitely avoid such implants!
I just would hate to see folks inadvertently ruling themselves off the list as possible good candidates for what, for them, could well be a beneficial life-altering implantable device if the consensus of their experts deem it safe to recommend such a device onboard after all!

I sure am glad I had such good advice when I was faced with a similar go, or no go, assessment!

Shannon

Thanks Shannon. All I know is all my titanium had to be removed from my body because they balled up to large globs of scar tissue with decades of pain until I had them removed. I wouldn’t want that in my heart.

The watchman rep for Dr N told me to wear a nickel coin taped to my leg for a few days. A nickel coin only contains 25% nickel and 75% copper so it’s not apples to apples. It left a black circle. Then I went to Dr N office and had an actual watchman taped to my thigh for 30-45 minutes. No redness or discoloration but it was a short test. The watchman is sharp and all the test showed was shallow subdermal puncture mark scratches. My GP suggested I get a component of the watchman inserted under my skin and see what happens. I’m game but I don’t think Medicare will cover it and how will I get hold of a watchman? Plus I’m allergic to stitches and tapes so it would be tricky to determine the origin of an infection if it occurs.

So without any scratch tests I may be allergic. Skin metal allergies don’t concern me. It’s internal that concerns me. Nickel based 14k white gold turned my earrings black and I had a pus infection in my ear lobe. I had over the years pierced my ears 3 times. I now only use yellow 18k gold without nickel. Rings turned my skin black along with discoloration of the metal.

So there is a possibility I’m allergic. I googled it and there are people with true nickel allergies. So what do you do if it gets infected? Open heart to remove it? Or live with a NOAC with a 4 Chad score and a family history of strokes and personal dvt history? Tough decision.

If you can't prove you can tolerate the device then it would be insane to have it implanted. Surgical removal would be major surgery if it had been in long enough to become fully or partially endothelialized.

The LARIAT or AtriClip would be more appropriate choices.

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Carey
The LARIAT or AtriClip would be more appropriate choices.

Still has nickel.

Susan, the LARIAT is gold plated, so the nitinol is never in contact with you. The current version of the AtriClip does not contain nickel. If you're just going to do shallow searches on these devices and refuse to consider anything that contains (or used to contain) nickel, then just plan on a life on anticoagulants. Aside from surgery to suture your LAA closed, there aren't any other options.