LAA Closure Device Options

Shannon – As time goes on after my LAA ablation, I’ve been more seriously contemplating one of the procedures but have questions.

Briefly, could you please explain away my concerns about the implantable LAA closure devices?
Also, has the LARIAT closure safety been improved since you had your stroke as a result of the leak after your procedure?

My concerns have been about anything ‘implantable’ left in the body that might cause problems over time.

So, does the Watchman’s “screening” capacity remain clear or does eventually fill with debris and naturally occlude the appendage? Does it become “integrated” as part of the surrounding tissue where placed at the opening of the LAA or can it become dislodged?

The Amplatzer (plug) device that you had after the Lariat failure seems best (to me) since eventually, it is completely engulfed by natural tissue which should make the plug permanent. Yes?

Are you aware of any reactions to the materials used in any of the devices? Has that been investigated?

Does anyone go for the surgical procedure to remove the LAA?

I’m certainly hoping that fairly quickly insurance will cover at least some of the costs for the LAA closure since the OACs are costly, but moreover, not the healthiest chemicals to be adding to one’s body forever….. at least mine, since I seem so reactive.

Thanks.

Be well,
Jackie

Hi Jackie,

It's bed time now for us so will try to get back to you in the next couple days with answers for your questions above.

Be well,
Shannon

Sorry Jackie for the delay in getting back to your and now others understandably wanting to know more about Watchman and LAA Closure in general.

Alas Magdalena are on the last days of a sort vacation for the two of us right now and are down in Tucson ... the timing of this vacation was partly triggered by my MacBook Pro laptop of 5 years age, finally giving top the ghost last Tuesday and Wednesday when my logic board failed entirely ... and this after the prior 6 weeks of computer hell in which it was thought (by our local Mac Clinic repair company) that my machine was suffering from a 'partition map corruption of the operations system' that led to two OS re-installs that only partially helped the matter for a short while before the same wheels started coming off the wagon again.

All this came to ahead week before this past one, when it was made obvious that the Mac repair folks had misdiagnosis my ailing laptop when it was a fatal infarct of the Logic Board that had been brewing all along and finally went Kaput! ... right when I was starting to write my reply on this important thread you started!

I had to rush order a brand new MacBook Pro, and they had just released a new. version of these computers the very day last Wednesday that my old MacBook died and thus it took more than a week for the new machine to arrive. It is now waiting for me to pick up ar our local Fed Ex hub when we return in a couple more days from our mini-vacation. here so please bare with me while I get the new machine reloaded and up to speed and I will be back in the saddle and first with addressing this thread, as I can see that a few more of our readers have been influenced by what I strongly consider to be Dr John's well-intentioned, but yet another mis-quided missive , this time on the Watchman. A topic we addressed in full here some six months ago on this forum too regarding the kind of errors in judgment Dr John made in his analysis of the very early RCT data on Watchman and thus drew some improper conclusions that is now misleading too many fine folks out there looking for insights in to this area.

Please read the excellent rebuttal of Dr John's mistaken assumptions about what the Watchman data suggests by Dr Vivek Reddy who is far more family with all the ins and outs of Watchman and LAA Closure research than is Dr John and he respectfully yet thoroughly yanks the rug on what I see as Dr John's backward looking and ill-informed anti-Watchman missive,

I will add a lot more to this issue when I get my new computer up and running and get myself back on the forum again after this mostly enforced Hiatus the last two weeks ... I can only type so much on my iPhone at the moment and this subject will require more explanation I can see from the reply above,

In the meantime I refer Barbara above, gmperf, Larry and Anton to the prior discussion of Dr John Mandrola's views on this subject, to Dr Reddy's outstanding and deeply informed and more enlightened analysis of where we stand as of this summer.

In the following post I have copy and pasted my post containing Dr Reddy's rebuttal on Dr Johns understanding of Watchman issue for those of you above showing interest in this topic can read before I can get back in the saddle by early next week I trust.

Thanks again for your patience Jackie and all above as I begin to recover from these technical snafus that have certainly tested my patience over the last 6 weeks and longer! I am sincerely hoping those days are shortly to be over!

Cheers!

Shannon

PS excuse any typos as I typed this on my iPhone's microscopic text.



Edited 2 time(s). Last edit at 06/15/2017 02:35AM by Shannon.

Hey there, J... and forum members.

You've likely read Dr. Mandrola's article from late last year. But I'm placing the link to it below in case you or others haven't. Within that article is another cite to an additional article.

Hoping everyone's doing well.

/L

[www.drjohnm.org]

Jackie, I had the same question regarding the Watchman as I was considering it. Research on the internet says it is made of Nitinol a nickel, titanium alloy for the expanding frame. This is problematic for me. About 20 years ago I developed extreme symptoms that were caused by some toxic reaction. I had nickel crowns, silver (mercury) fillings and a partial bridge made of chromium and cadmium. I went to several kinds of doctors. The only results were that some metals were high on the urine test. I immediately stopped wearing the partial bridge and replaced all my crowns and fillings. I started to get better.

The problem is that I do not know which metal I have a reaction to. I think it is nickel, but it could be a combination of metals. So for the time, I will pass on the Watchman.

Barbara

Jackie, LarryG mentioned Dr Mandrola's article which was just recently quoted by Dr. Eric Topol (for those unfamiliar see Wikipedia). Essentially Dr Mandrola is questioning the (clinical trials) data. Watchman is not "better than Warfarin" in preventing strokes. It's not that simple but strokes may be caused by factors other than Watchman repaired LAA. He is afraid the current hype pro-Watchman ("irrational exuberance") is clouding the real stroke problem. His article is worth a read.

Regards, Anton [/size]

I got to see and handle an actual Watchman device.
Cool looking little umbrella. The part that has me concerned is the part that protrudes from the center.
It would seem to create a spot that might create turbulent flow and thus a clot formation point.
Just spectulation on my part.
Talking to different doctors it seems some think the Watchman is a good device in specific situations. Some think it isnt. Some think it is too new to know the long term benefits or risks.
How is a patient to know what to do!

Shannon [ PM ]
Dr Vivek Reddy: In Defense of LAA closure (Rebuttal of Dr Mandrola's comments and opinion on Watchman)-Medscape
December 01, 2016 02:30AM Admin
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In Defense of Left Atrial Appendage Closure - Dr. Vivek Reddy

(The above link, allows access to the article discussed below: In Defense of Left Atrial Appendage Closure by Dr Vivek Reddy, with only a simply free registration of your email address and username)


Hi All,
The above linked excellent article in Medscape by well-known and highly-regarded AFIB ablation EP and researcher Dr. Vivek Reddy at Mount Sinai Medical Center in New York City, provides a spot-on, well-needed tonic and corrective treatment to what, in my view and that of many front-line experts in the growing sub-field of LAA Closure research, was another well-intentioned yet shorted-sighted analysis of the state of LAA Closure for stroke and bleeding reduction reflected in Dr Mandrola's assessment of the Watchman device. As such, I feel Dr Mandrola used a too narrow view of the first two randomized clinical trials in PROTECT-AF and PREVAIL, mostly by looking at the data and drawing his negative conclusion about LAA Closure with the Watchman device too much in the rear-view mirror and while overlooking key points and insights that the collective experience with the Watchman and other LAA Closure systems now strongly suggest as of late 2016.

It is midnight as I write this note on my Iphone so I'm shutting off the light for dreamland now. When time allows I hope to finish my own look at the state of LAA Closure in light of the comments by Dr Mandrola in his Medscape column a few weeks ago, and posted in a thread below, that I want to share from an Afibbers patient perspective, especially with those on our forum for whom LAA may well be of relevant interest.

In the meantime, please read this super analysis by Dr Reddy whose timing in writing his article brought a smile to my face as it makes my summary of the same issues much easier and requiring less grunt work at the keyboard than it would have demanded before I read Dr Reddy's cogent reply to Dr Mandrola's controversial and dismissive LAA-Closure comments.

Last week I had a head's up that such a thorough reply would likely be forthcoming, allowing me to put my promised comments on the back burner until I had the chance to read this excellent technical clarification of the Watchman issue by Dr Reddy.

In my summary update, I will address some of the key patient-oriented questions around this issue of LAA Closure which will mainly be of interest to those who either cannont tolerate OAC drugs, and yet require anticaogulation for safety, or those who may have had ... or could be candidates in the near future for ... LAA isolation ablation which carries around a 60% chance of needing to either stay on OAC drugs indefinitely or go for an LAA Closure procedure. It is important to understand that, in any event, a large majority of afibbers will never have to address this issue one way or the other.

Cheers!
Shannon


Last edit at 12/20/2016 09:29AM by Shannon.
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Thank you Shannon for your replies to this post.
I can say as a patient, this is a frustrating and confusing topic.
The information available to patients is limited. The opinions of doctors seem to be all over the spectrum.
The research seems to not be clear as to benefit.

My understanding is after a Watchman implant, the patient must be on Aspirin life long.
My understanding is Aspirin has a similar bleeding risk profile as NOACs. NOACs' effect are short (12-24 hours), Aspirin bleed risk lasts about a week after the last dose.
How is having a Watchman, or similar device to close the LAA and being on Aspirin better than being on Warfarin or a NOAC?
My experience is I bleed easier and more on Aspirin than I do on Eliquis.
When you have the time, can you address this issue if you are able.

My opinion at this time:
LAA closure, if not complete, seems to actually increase the risk of stroke. My reading of studies and reports give me the feeling the whole "close the LAA" is not all that straight forward. Even the close/remove the LAA during valve replacement seems to show that there is little long term follow up with the standard "remove the LAA" during open chest heart procedures. 20% of patients end up with incomplete closure and an increase risk of stroke from these procedures. The Watchman may be being followed closer than the standard close the LAA procedure.

The research I read says the assumption is remove the LAA and stroke risk is reduced. However I fail to find much research that make this conclusion a 100% FACT, or even close to that. I find most research references one or two small studies that seem to indicate a stroke reduction. Then when you read the study limitations, they indicate the studies are not all that conclusive.
90% of clots are formed in the LAA. That is what I read all the time. But the reference to that number seems to come from one or two small studies that are referenced over and over again in other studies.

I may be all wrong. I am not a doctor or medical research professional. I am a frustrated and confused patient.
If the medical establishment doesn't know, I wish they would PLEASE just give us patients the facts and then their opinions.
Is LAA closure for stroke risk reduction, like Aspirin? Everyone should be on a baby Aspirin as a preventative. Now its no, only a specific patient population should be on Aspirin as a preventative. Or is it, "... we closed your LAA and now you have a whole new set of problems".

What to think about the Watchan device? If you follow some of the top doctors (names left out intentionally) on Twitter, you see the opinions are more like it is "probably better than nothing" if you can't take Warfarin or a NOAC. If you visit the Watchman installers, they will tell you it the best thing since sliced bread.

I believe the majority of patients want their doctors to make the hard decisions for them. Then there are us that want the facts, the doctors opinion, and the ability to know which are which.



Edited 1 time(s). Last edit at 06/15/2017 02:56PM by gmperf.

Thank you, Shannon, for taking the time to help provide reading material for investigation of this topic. I appreciate your effort, given all the computer problems and such...plus, you do have (or should have) time for a personal life as well.

As you explained to me in our phone conversation, the Watchman device does become endothelized into the opening so that creates a natural (tissue) plug which I assume has been found (so far) to be a total 'seal' and not have microscopic pores or leak areas. Then, after 6 weeks, one is able to stop using Eliquis. That doesn't address material sensitivity issues of the patient so those with known sensitivity issues might benefit from a compatibility assessment if that is even available.

I have not yet had the time to read the referenced reports offered but plan to do so soon... and with an open mind, but after reading these other responses, it sounds as if there are a lot of uncertainties...not the least of which would be the advice (if true) that one would still have to take a daily aspirin... whether it's full or low dose.... that's not an acceptable option as there are so many detrimental effects with aspirin, I'd almost prefer Eliquis but we don't really know (yet) its long-term use history especially in the senior population.

Lots of points to consider overall and then based on what's the best option for the individual including the almost- guaranteed cost increases for Eliquis and similar.

Perhaps, the surgical removal of the appendage makes the best sense overall but then there is undoubtedly the factor of need-versus-elective option issue insofar as insurance coverage goes.

I appreciate others chiming in with thoughts and references. If you find more, please share.

Jackie

Here are a few links on the downside of continual aspirin use... I have many

[www.ncbi.nlm.nih.gov]
[www.ncbi.nlm.nih.gov]
[www.spiritofhealthkc.com]
Mercola's report: FDA on daily aspirin and side effects
[articles.mercola.com]





:

Hi Shannon!

I couldn't resist "dipping my toe in the water" on this subject. Thank you for the reference to Dr Reddy article which I have now read quite a bit of... I surrender already! By his admission it is lengthy and filled with statistics, some of which I really glazed over! He is a prime partner for and compensated for his input as he mentions.

But generally his article is in agreement with Dr Mendrola! Watchman is not "better than Warfarin" in preventing strokes. (as I mentioned it isn't that simple)

He defends the bleeding aspect in a 2015 article: "LAAC resulted in improved rates of hemorrhagic stroke, cardiovascular/unexplained death, and nonprocedural bleeding compared to warfarin". If so that's a great point albeit a little surprising. His statistics are "silly" comparing apples & oranges but here I glaze over...

Will we ever compare NOACs to Warfarin? Seems only fair and it would be a good study. Gmperf asks about aspirin for life but it is my impression that was only for the study and not a future recommendation at all. Hooray for Mandrola for starting this conversation.

I'm tired now, Anton

PS: Shannon I have sent a PM



Edited 2 time(s). Last edit at 06/17/2017 05:00PM by Anton.

To All,

In my first note I was talking about the metals I was familiar with, but titanium could be a problem. I remember reading about Dick Van Dyke having dental implants and eventually getting constant migraines. His dental implants were titanium. His doctors finally recommended removing the dental implants. He did have them removed and replaced with super hard ceramic implants made of zirconium oxide. His migraines stopped.

When I asked my dentist to remove my nickel crowns (porcelain covered) he was reluctant because the gum tissue was not inflamed. But research indicated that reaction could be "extra oral" or out of mouth.

How would the Watchman be removed if one has a reaction to nickel or titanium. Possibly open heart surgery.

Barbara