Watchman procedure canceled

Since my two ablations with Dr Natale in 2013, I’ve been in NSR. Like others, during the ablations my LAA had to be zapped extensively to stop my afib. Because my LAA lacks velocity (is basically non-functioning), I need to stay on anti-coagulants for life. I take Eliquis, but want out. Don’t like the thought of being on it for life, and the unknowns re what it might do to liver, kidneys, brain, etc. I’m a very active 64-year-old, biking and hiking etc, despite being a fall risk due to equilibrium issues and nerve damage. I figured it would be best to get off of Eliquis as soon as I can to avoid bleeding to death if I fall and crack my head, and also to avoid future stomach bleeding issues. My father had serious bleeding issues on warfarin so I’m very sensitive to the bleeding risk. Enter the Watchman. I had a procedure scheduled in Seattle to implant the Watchman to occlude my LAA, but just canceled it, after learning that with the Watchman I would need to take aspirin for life (possibly just baby aspirin) to address a small risk of clots forming around (?) or behind the device even after tissue covers it. Studies show that the risk of bleeding from aspirin is comparable to the risk of bleeding from Eliquis. So now I’m waiting for a device to come to market that won’t require ongoing aspirin or anti-coagulant. Dr Natale initially suggested the atri-clip but later suggested the Watchman. I am not interested in the atri-clip now. I considered the Lariat but it won’t work for me (per one source, “chicken wing" LAAs (that’s me) can not be closed). So, for those considering the Watchman, remember that you still must take daily aspirin.



Edited 1 time(s). Last edit at 07/07/2017 01:10PM by tmac52.

I'm new at all this but isn't baby aspirin with a Zantac or something for your stomach vastly preferable to Eliquis? I'm on Eliquis also and looking forward to stopping it even if it's with aspirin for a period of time.

My doc has me on 81 mg aspirin (enteric coated) a day - not for anticoagulation but for the anti-inflammatory properties of salicylate. He also has me on 6g/day of fish oil for the same reason (we test for Omega 3 Index and he wants me above 10). I'm 62 and very active. I frequently rip skin off when rock climbing, many days in multiple places. I do notice that my clotting time is a bit slow, however it is not an issue. Last August, I took a swing while climbing and impacted on my hand, resulting in two deep gouges in my palm. Again not an issue. Did clot, just slowly. Of course everybody can react differently.

Bleeding risk on aspirin vs eliquis is about the same. Brain bleeds are a little higher on aspirin than on eliquis, but it's just the opposite for stomach bleeds. See these two studies: [stroke.ahajournals.org] and [www.ncbi.nlm.nih.gov]

Here's an excerpt from the first study: "The most frequent site of bleeding with both treatments was gastrointestinal (1.35%/year with apixaban and 1.25%/year with aspirin). The rates of site-speci c major or clini- cally relevant nonmajor bleeding were similar with the 2 antithrombotic treatments (Table 1). Of note the rates of intracranial hemorrhage were 0.41%/year with aspirin and 0.35%/year with apixaban (P=0.96). Of all fatal intracranial hemorrhages, 3 (0.1%/year) occurred in patients assigned to apixaban and 4 (0.13%/year) occurred in those assigned to aspirin."

According to the following link, if you take a PPI like Prilosec that can reduce stomach bleeds from daily aspirin use: [www.bmj.com] Though PPIs might reduce stomach bleeds, I wouldn't think that PPIs would reduce brain bleeds. Also, I wonder if there are any downsides to taking a daily PPI forever. With the Watchman device, my doctor advised me that you must take aspirin forever, not for a limited period of time. I have heard that some centers may take a different approach and not require aspirin forever. It seems that there should be a standard protocol for this.

Be aware that there are several reports on the negative aspects of PPIs and similar drugs.
Here's a link to one talking about PPIs and kidney disease.
[www.anh-usa.org]

This is so common. Take one drug to fix this; end up with other complications caused by
the initial drug.

Jackie

I am in a similar situation as you. I just had the Watchman approved by my insurance but decided to not have it done because of the life long aspirin requirement.

Dr Natale also first recommended the AtriClip but later recommended the Watchman. My understanding of the reason for his change in the recommendations is because he was concerned the AtriClip may form a small dimple like pocket that may increase risk of clot formation. This was never followed or studies. They were going to do a small study and see if there were any issues. I believe the study is done and there are no issues.

It is also my understanding that with the Watchman device, dual anti-platelet medications are used for a few months after implantation. Then, aspirin long term is recommended. But, they really don't know if aspirin is needed long term or not. It is more of a let us play it safe recommendation. In Germany, for patients that cant take these types of medication, thus the need for the Watchman, they are not having patients on these medications after the Watchman and they are fine. I also read that in Europe they are seeing a large number of clots forming on the Watchman. So what is the truth?


My impression is the Watchman may be what you and I are looking for. There are still a lot of "we don't know" with the Watchman. They start on the side of abundant caution, Warfarin, dual anti-platelets, etc. Then when they have patients that just can't take these medication, they see what the outcome is. Eventually they have enough data to develop a standard of care.
My position is to wait and see. Buyer beware. Better to wait.

I also remember Dr. Natale telling me to take a baby aspirin everyday after my first afib ablation. At that time I was 45 years old, CHADSVASC2 of 0. Why the recommendation when aspirin has been shown to not reduce afib stroke rates?
I have never been able to get an answer to this recommendation.

Thanks for your reply. I would imagine that there are many folks like us who want to get off of Eliquis or other anti-coagulant but aren't prepared just yet to have the Watchman device placed inside our heart to occlude the LAA. I will revisit the idea of occluding my LAA a few years from now. By then we'll have more data and studies, and possibly more FDA-approved devices on the market.

I'm lucky in that I don't currently have any noticeable side effects from Eliquis. I know things could change, as folks often do okay on a drug for a few years, then bad things start to happen. If I knew today that I could take Eliquis forever without experiencing any side effects or long-term adverse impacts on my liver etc., and that a proven reversal agent is available, then I would just stay on Eliquis and forget about occluding my LAA, despite Eliquis being quite expensive. Of course no one can predict with certainty what future effects the drug might have on one's body -- therein lies the problem.

I'm definitely on the fence as well about opting for LAA closure so I appreciate all the contributions. The additional recommendation of post-closure aspirin or such, would not be a choice for me but I would consider adding nattokinase or pycnogenol as a preventive measure after the closure. However, I doubt that would be formally sanctioned.

The effects of aspirin - both positive and negative - have obviously been studied the longest and perhaps, with time, we'll see similar observations with the new anticoagulants. Or, perhaps not, because they are far more profitable than ASA. I have a list of over a hundred studies looking at adverse effects of aspirin often due to various areas of damage to tissue or cells or as one study indicated "cytotoxicity of NSAID to erythrocytes" which identified aspirin as the NSAID. It will be interesting to see what begins to surface after these NOACs have been in use as time passes.

Meanwhile, it's wise to be informed that there is the potential in all NSAIDs including aspirin to cause a variety of problems in the body. Here's a few....

* Long-term low-dose aspirin therapy may not be effective in preventing cardiovascular disease and may double the risk of gastrointestinal bleeding

* Aspirin may inhibit lymphocyte function.

* Aspirin causes gastric mucosal cell injury in vitro by reducing intracellular pH

* The active ingredient in aspirin is sodium salicyclate which induces degeneration of cochlea spiral ganglion neurons. This may explain why aspirin use has been associated with Reye's syndrome, tinnitus and hearing loss.

* Aspirin with or without chronic oral anticoagulant treatment does not reduce mortality or reinfarction, reduces stroke, but is associated with significantly more major bleeding.

Jackie