Watchman trial

Great news!

by AgentX86 - 2022-02-09 21:37:55

My LAA is clipped but my EP still laughed at me when I asked if I needed to stay on Eliquis.  He said that since I had permanent flutter that I was a lifer.  The LAA accounts for about 90% of the clots but there is still that 10%.

There is a huge insurance kerfufle with Eliquis now.  Many of the private insurance companies will no longer pay for it and everyone has to move to Pradaxa[*].  Medicare still allows Eliquis but only because the old farts (like me) threw up such a ruckus last year that they backed off.  What happens next year...  You've escaped all that.  Congratulations!

[*] There is an escape clause but no one knows what hoops there will be.

Eliquis

by howickgal - 2022-02-10 00:30:06

Thanks Agentx86.  Did not know all that about the eliquis but I do know it is expensive.  Glad to be off it and hopefully I am not in that 10%   I do feel more comfortable in that the PM has brought up my heart rate so that I can now tolerate betablockers and antiarrhmnics and I seem to have very few episodes of atrial fibrillation.  Hopefully that too will keep the clots at bay.   At some point would love to get off those meds as well.   I will be patient and see how things progress. 

Good to hear about your progress

by Gemita - 2022-02-10 07:49:01

howickgal, there are a few members I know who are considering the Watchman Device, so will be watching your progress with interest.  Would you care to share with us what was involved in placement of your device (if you weren't completely out of it) and your aftercare following your procedure?  I believe you will need to remain on ?Warfarin for some weeks followed by dual antiplatelet therapy like Aspirin and Clopidogrel if that is correct.  I did consider the Watchman at one time since I also have atrial fibrillation, but they found me a lower/therapeutic dose newer oral anticoagulant (Edoxaban 30 mg) instead which I am very happy with.

I am sure your Watchman, pacemaker and medication will protect you and keep you safe in the future and who knows in time, with a higher, stronger, steadier heart beat your arrhythmias may well be tamed.  Mine certainly are and considering they were awful before getting a pacemaker and receiving medication, I almost feel "cured".  I hope it will be the same for you too.  Good luck as you move forward

Watchman Insertion and aftercare

by howickgal - 2022-02-10 11:57:31

Thanks Gemita

I had been in excellent control after my abaltion in 2017 and decided to go ahead with the Watchman last fall.  The expense of the Eliquis and the potential side effects were my motivation. My EP was unwilling to let me stop anticoagulants because my Chads score was 3.

The insertion was supposed to be an outpatient procedure.   The insertion itself was simple and painless for me.  I was given sedation and really did not feel any pain.   It was inserted through the femoral vein and placed into the left atrial appendage through a small puncture in the septum.   Unfortunately I developed a relatively uncommon complication.   I went into atial fibrillation during the insertion and was cardioverted , by the time I got to recovery my atrial fib with a fast rate had returned.   I spent 4 hours in recovery ( poor Nurses) until I finally converted to sinus rhythmn ( with the help of multiple meds ).   I was kept overnight and stayed in sinus rhythm with my typlical bradycardia in the 40's.  

I was discharged the following morning with instructions to moniter my groin incision.   Recovery was slow at home.  I developed some mild chest pain and a little bit of shortness of breath.  I called the office and was told this was normal and sure enough after a few days I got better.  Decided I was able to get out of the house and started doing a few light errands.   Thats when my atrial fibrillation reared ugly head again.   The symptoms were getting much worse and I was started on flecanide.   My heart rate in between episodes was still low so I was not a candiate for beta blockers.   After about two weeks of increasing symptoms I was admitted to hospital to start Tikosyn .  On continuous heart monitering it  became apparent that my bradycardia had to be addressed.  My heart rate was in the low 30's at night when I was sleeping and truly I felt terrible.  The decision was made to put in a pacemaker.

I was truly annoyed.  I thought if I had just left well enough alone I could have avoided all this,   I was still on Eliquis ( protocol stated I had to stay on it for 3 months) and on ASA.  And now a pacemaker, tikosyn and metropolol.   And I was still feeling awful.

Well I got home and although I was sore my bouts of atrial fib became fewer and far between.  I have not had an episode that I could recognize for several months.   I am now 3 months out and feel better than I have in a very long time.   I did not realize that my bradycardia was a servere as it was.   I was coping but always tired with no motivation.  I don't like being on Tikoosyn ( always a bit lightheaded)  but I can't argue with success.   I feel good, I have energy and I am thankful.

I went from being angry about stirring up some atrial fib from the insertion of the Watchman to being extremely thankful that maybe this is what got the attention of my EP and getting the treatment I needed for the bradycardia so my arrhymnia could be more easily managed.   For most people insertion of Watchman is easy with little complication.    You have to stay on anticoagulants for 3 months ( in my setting. this may vary in other areas).  TEE is then done to veryify that the implant is in place and there is no leakage around it.   

So even with the complications I had , I feel that for me this is a good choice.  Obviously my hearts electrical system was comprimised and I was probably on the brink of decompensation , the watchman triggered that.  But this prompted quick care and treatment of some intrinsic problems.   I am no longer angry and in fact I am thankful . I do look forward to more improvement and hope I can come off some of my meds .  I see my EP next week and will see what he says about that. 

Watchman Questions, Eliquis

by Marybird - 2022-02-10 14:01:31

Howickgal, after what you've gone through with your arrhythmias and Watchman placement, I bet you're thrilled to be on your way to recovery and a healthy life! Glad to see your update with the good report. 

My question with the Watchman has to do with the anticoagulation protocol afterwards. As I understand it, the protocol is to take the anticoagulant for 45 days following placement, if a followup TEE shows the Watchman is well (?anchored) and there is no leakage around it. Then the anticoagulant is replaced by a prescription antiplatelet drug ( clopidigrel), plus aspirin, for another 45 days, after which aspirin is continued for an indefinite period, maybe for life. In any case this was the protocol my sister, who was to have undergone a Watchman placement last October, postponed to November ( non-emergency surgeries delayed due to covid) said her protocol would be. She died suddenly and unexpectedly in November, so never had the Watchman placement. 

I see this anticoagulation-antiplatelet-aspirin regimen was set up early in fhe Watchman game, and it still looks to be recommended widely, but my impression also is that at least the last part- aspririn for life, is being changed and the anticoagulation-antiplatelet regimen may be modified depending on individual patients' conditions, experiences, etc. So just wondering if your regimen includes aspirin indefinitely once you have stopped the anticoagulation and other antiplatelet therapy? 

As for the Eliquis exclusion from the CVS Caremark Pharmacy Benefits Manager formulary (at least here in the US)  that Agent mentioned, that kerfluffle looks to be ongoing. There are numerous medical organizations ( American Heart Association,,American Society of Hematology, to name two) other organizations and patient advocate groups taking CVS PBM to task for "practicing medicine without a license by forcing patients" to replace a medication with which they've had good success and which has proven to be safe, for another drug (Xarelto, the only direct acting anticoagulant left in their formulary, looks as though Predaxa has been excluded for a while now). CVS also claimed that something like only 0.95% of their patients taking Eliquis would be affected bythis exclusion. 

I worried when I read this, as our prescription drug plan is a commercial one, covered by the FEPBlue insurance we have secondary to our medicare. And this plan is administered through Caremark, with the mail order program directly through Caremark. I looked through both our retail pharmacy and mail order formularies for 2022, and saw Eliquis listed as a Tier 2 drug (brand name preferred) as it had been in previous years. I also called the FEPB Pharmacy customer service people to ask if they knew of any upcoming plans to exclude Eliquis from the formulary. They didn't know ( they said), of any such exclusion, and reassured me that Eliquis was still available through their formulary, at least through 2022. After that, well, it's anyone's guess. 

I also, just for the heck of it, looked up a number of both medicare part D and non-medicare plan formularies for 2022, to see if Eliquis was excluded, and saw that it was still in their formularies as covered drugs. In fact, the only place I saw the drug excluded was in the 2022 CVS caremark formularies- those without anyone else's name attached. Guess we will have to stay tuned for this one! 

Think I will make my comments on getting off/staying on maintenance prescription meds in another post. 

Anticoagulation after watchman

by howickgal - 2022-02-10 16:16:08

Marybird you are correct about the watchman protocol.  45 days and then TEE if all good can stop Eliquis (or equivalent) then antiplatlet drug for up to 6 months and baby aspirin.  I think that is pretty standard   I am in a clinical trial with a slightly different protocol.   90 days then stop eliquis and continue aspirin.  Antiplatlet drug was optional depending on patient and I did not get it.   Supposed to stay on ASA indefinitely but that may change

watchman

by new to pace.... - 2022-02-10 18:56:29

when i first saw the EP for a pacemaker.   He suggested the Watchman .  Reminded me of when i first saw the ear doctor to get a hearing aid.  he had me watch a videio of a Cochlear implant.  I thought at that time only needed a hearing aid.

The thought of not having to take any medications was a good way to go.  Unfortunately he did say would need to be on them after the Watchman was implanted.  If i had to would just go without the watchman.  Also understand a clot can form in another place.

Also i cannot tolerate aspirin uncoated or coated.

Now Watchman has a forum just like this one.  Where many seem to be on the fence about the watchman.  Also the website mentions only 150,000 done.  Which to me is not many.

new to pace

Getting Offa Meds

by Marybird - 2022-02-10 19:44:11

Howickgal, sounded like that to me, ie, aspirin indefinitely, though as you mention the protocols may change over time. Sounds as though you're in one of the clinical trials comparing after Watchman anticoagulation protocols using the direct anticoagulants ( Eliquis, Xarelto)- the earlier studies were done using warfarin as the anticoagulant. Be interesting to see how they turn out.

As for the hopes that we will, sooner or later, be able to get off our meds, and go medication free, it's a dream, but I wonder how often it actually happens, especially as we get older and the comorbidities pile on, so to speak.

I've had battles with tachyarrhthmias (including a-fib) over the years, along with hard to control ( genetic) hypertension, which are pretty well controlled at present ( with breakthroughs, occasionally) with fairly high doses of rate control meds ( metoprolol- 150mg/day, and diltiazem-360mg/day). These meds overlap, with two other meds, to control my blood pressure. But sad experience has showed me what happens when I don't take those meds- the tachy goes out of control, and the blood pressure, when I can even get a good measurement, is ridiculously high. I feel as though I'm lucky that those meds do such a good job in controlling those issues, and I feel few, if any side effects, and generally feel good. The pacemaker has helped as well, in ensuring my heart rate doesn't circle the drain from taking these meds.

The thing is, it may be the medications that are controlling your afib and other tachycardias, and making you feel much better than having to fight them without the meds. Just something to think about, and a conversation to have with your EP/cardiologist depending on what goes as time goes on.

As for the Eliquis, I started taking it after my remote pacer monitor reports showed a couple of hours' long afib episodes last year. I had dreaded having to take it for years, but this time  I was informed a CHADS2 score of 3 ( will be 4 when I turn 75 in August) with the afib put me at an unacceptable risk of stroke, hence the Eliquis.

Thankfully, I have had no issues with Eliquis- not even any extra bruising. So as the corollary of Murphy's Law ( or something) would have it, my next two 90 day monitoring reports showed no afib- other than perhaps a quickie few beats here and there-insignificant. So, at my recent cardiologist appointment (actually saw his PA this time), the question came up: if THIS is all the afib I ever have, do I need the Eliquis? Or would I be able to get off it entirely after a long period showing no afib? I mean, there MUST be some advantage to seeing those remote reports of my heart activity and knowing exactly what the afib activity, or lack thereof had been.

The PA said, at first, that possibly after a looong period showing no afib activity, we "could have a conversation" about it, but then reminded me of my stroke risks, the inability of the monitor reports to predict future afib, and how devastating strokes can be. I've read the literature out there, looked in the mirror ( at the old lady looking back), and seen the devastating effects of strokes- some in my own family, so as much as I'd like to lose the Eliquis, I couldn't disagree with the guy. When I asked, he said yes, most likely I will be taking Eliquis the rest of my life. He mentioned the Watchman as an alternative, but I don't want that at this point ( if ever), though it does, over the long haul, hopefully, provide a good alternative to anticoagulation.

New To Pace

by Marybird - 2022-02-10 20:18:30

Just wondered, are you having problems with your anticoagulation ( Eliquis, Xarelto, warfarin) and for that reason your doctor suggested a Watchman for you? Or is it that the cardiology world is beginning to suggest the Watchman as an alternative to anticoagulation ( blood thinners) to anyone with afib ( barring contraindications, of course), trying to encourage people to do so to generate the numbers and experience among the docs in performing this procedure?

The Watchman is still fairly new (maybe 5 yrs old?), at this point,  and hasn't  become the "gold standard" for prevention of atrial fibrillation thrombosis and stroke, though in time, who knows, it may get there. When we were discussing my taking Eliquis at my last cardiology visit, he asked me if I'd ever consider a Watchman as an alternative. MY response was a resounding NO. I said I didn't want any more hardware inside me, and was leery of the side effects. And like you, I have had problems with GI bleeding, (ulcers) and excess bruising with regular aspirin use.

It may be down the road, that the Watchman will become the standard, and part of an afib protocol to control the thrombotic stroke risks with afib. At that time, I'm sure you will see a lot more people sign up for it.

marybird

by new to pace.... - 2022-02-10 22:35:15

to answer your comment.  When i had my first appointment with the EP is when he mentioned Watchman.  That even before we discussed  why i needed a pacemaker.

 Had seen the cardiologist who had me take a stress test, wear a holter and echogram. Something was seen on the holter.  But i had know for a couple of years i had a slow heartbeat.  Nothing was done for that. 

I beleive now if i had had the pacemaker implanted about 4 years ago i never would have kept falling.  i kept saying my right leg would stop and then the left one would flail.  Sometimes nothing fractured other times did.

  Not on any anticoagulation as some are coated in lactose am lactose intolerant.  Causies  major bloating.   As had that problem when i took Fosamax in the late 90's.

The cardio say my taking a Turmeric supplement was better than nothing.

new to pace

Watchman

by AgentX86 - 2022-02-11 15:09:46

If I had the opportunity, particularly if it woud get me off an anticoagulant, I'd jump at a Watchman. I jumped at the Atri-clip when offered. While I've had no problem with Eliquis, there is a risk of brain bleeds. Anticoagulation is a trade-off beteen ischemic stroke and hemorrhagic stroke. The watchman eliminates 90% of the ischemic side of the equation. Removing the anticoagulant removes the chance of a brain bleed.  It's really then a choice between 10% of the probability of stroke due to a clot and the chance of a brain bleed. The Watchman seems to be a good thing to me.

In the seven years the Watchman has been around 150,000 have been placed.  Of course there is a risk but there is also a risk of brain bleeds.