Failed TEE

Well, I got the dreaded call; I failed the TEE after my last Ablstion where my LAA was isolated and Ablated. This means blood thinner for life. I am really having mixed emotions right now. I cannot stay on Eliquis; All the new blood thinners are expensive. Is Coumadin a really bad choice? I know it requires monthly labs but this would be covered by my Medicare supplement. Coumadin is cheap as far as drug price is concerned and MANY are on Coumadin.

Why us Coumadin such a bad choice? It has been around over 50 years. Someone please educate me.
I will be in the Medicare Part D loop hole every year using one of the newer blood thinners.

I can't answer your question about Coumadin.
I am in the same boat you are in with regards to the TEE.
I have been on Eliquis for over two years. At 52 years of age, hate the thought of being on this the rest of my life.
I guess that is just the way it is.

Don

Same boat too. Just switched to Eliquis about a month ago after almost two years on Xeralto. I'm going to explore any new developments of the watchman or atri-clip device next year perhaps in the spring. I'm 68, still working so I still have health insurance. Not sure how to figure out what my situation will be if I retire and go on medicare. I'll be watching these conversations carefully. Things are complicated by having some afib return recently after I overdid my workouts for a few weeks. Funny, when I feel good I feel really good, like I've beaten this thing. Then it comes back with a vengeance. Live and learn. Good luck smackman and Don, I'll be looking for your experiences as you relate them and will add anything I find.

Mike

I had no idea when I had this Ablation that there was a possibility I would be on blood thinners for life. I did know my LAA would probably have to to be isolated and ablated but I was never told or was it explained to me that I would l/could be on a blood thinner for life. I was told about the TEE upon discharge.
I do not know what difference it would have made but I wish I would have been informed about what could happen if my LAA WAS Ablated.
Is my heart permantly messed up for life?
I am disappointed I did not do more research. I guess I would have been on a blood thinner anyway. I am in NSR and thankful; Just disappointed in the blood thinner for life

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25 mg/hcr Fentanyl.patch changed every 2 days

1st ablation done Feb. 27, 2014 for Long term persistent AFIB Dr. Natale
2nd Ablation done June 16,2016 Dr. Natale LAA isolated



Edited 1 time(s). Last edit at 12/09/2016 10:40PM by smackman.

smackman,

The LAA can be permanently closed using a watchman or other devices via a catheter procedure or by an atriclip by surgery. Then after a period of time you can stop the anti-coagulant. It doesn't hurt to wait a little while they improve the devices and procedures, that's what I'm doing after asking Dr. Natale's office about all of the options. But failing a TEE isn't a life sentence. And having a poorly functioning LAA is a lot better than arrhythmia. If the LAA is the source, it has to be dealt with to have a chance at eventual peace of mind and a long life. In my opinion. Don't lose hope, they learn something new every day.

Smackman:

Sorry to hear that you may have to stay on a blood thinner always. You went through a lot so that you wouldn't have to be on blood thinners. I have been on this board for a number of years and have read about people getting ablations some have one and are great and no longer post, there are others that are not so lucky and have more than one, sometimes 3 and still have problems no matter what they do. Seems what works for some doesn't work for others.

Shannon went through a lot and is great now, there is always hope, just keep the faith.

Liz

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Edited 2 time(s). Last edit at 12/10/2016 09:09AM by daledint.

I don't look at your situation as being messed up at all. Being in NSR and not AF is a big benefit in terms of progression to heart failure and other potential health related issues. If you were still in AF, then blood thinners would be required for life as it is for my father in law. If you can't take the blood thinners, there is always the option of installing a LAA occlusion device. The latest generation Watchman is supposed to be much improved and there are other choices out there. Ask Natale for suggestions.

Smackman, You ask, "Why is Coumadin such a bad choice ? "

One of the things that you might take into consideration in regards to long term Coumadin use is that in "some men", Coumadin can contribute to bone loss. I have been on blood thinners for 11 years now, 7 of those were on Coumadin. I ask my Doctor for a bone density test while on Coumadin and it was found I have the beginning of osteoporosis. I can't say for sure, but Coumadin was likely the cause. A simple screening every few years with a bone density test would make it easy to find any problems in bone density due to the Coumadin. In my opinion, Eliquis is worth the extra cost.

One thing I notice Smackman on your daily drugs and supplements is that you don't include vit D or Calcium. You may get enough from your diet and the sun, but both are important when it comes to slowing bone loss that occurs as we age, as is weight bearing exercise.

I am in the same boat as you with a compromised LA. I am just very thankful that I was able to have the left appendage ablated as that was the final step in stopping the afib/flutter that I experienced over the years. If I need a blood thinner for life, I can accept that as a cost of a healthy and stress free (no afib) retirement.

Going forward, the cost of eliquis will most likely drop as new and better drugs come on the market, so Coumadin will probably not be in your life forever, no matter what your choice.

Good Luck Smackman.....ronH

I've been on Coumadin for 3 1/2 years now. Only thing that is problematic for me is I have a bad knee and Advil helps it, but I can't take Advil while on Coumadin. So that's annoying. Also have to watch supplements that act like blood thinners.
Nancy

I don't know that much about this, but it seems to me that it is projected that you need to be on Thinners permanently. Maybe down the road things could change.

I am wondering if the TEE may show changes with time.
It has been over two years for me. Maybe I should give Dr Natale a call and see what he says.

Im also thinking that with many more people having to deal with this issue, if the medical community will starting addressing the issue of all these people on blood thinners for life. I wonder how the insurance companies will address this large expense.



Edited 1 time(s). Last edit at 12/11/2016 12:06AM by gmperf.

Hi Smackman - I can appreciate your disappointment and frustration over continued use of anticoagulants; however, you undoubtedly had the same "informed consent" meeting with Dr. Natale and his team the day before your procedure as I did where they go over the details which include the potential for isolating the LAA, the use of anticoags and that also, it may mean you have to continue with those... if the TEE results don't prove to be adequate. You may have just tuned that out. I know I let that thought be in the background, rather than worry about it... thinking: one thing at a time. Still, when it becomes a reality, it's yet another thing we have to deal with.

It's a lot of info to process at the time and along with the anesthesia after-affects, it's easy to forget all that was said in the intro meeting. I know Shannon spent time with you prior to going to Austin explaining what might be the outcome since he has first hand experience as well and is kind enough to share with others and help with questions. He is so generous with his time and compassion we are fortunate to have him as our advocate.

I have to be on the anticoagulant, too, for life but I don't feel as if my heart is impaired. I'm loving the comfort of not having to think about my heart after 20+ years of having it front and center, 24/7. I hope you can relax and get to that place as well.

Kind regards,
Jackie

I had no consent meeting with Dr. Natale or his team before my surgery. Shannon probably explained it to me. I was a quick work in for this procedure and so thankful for it.
I just have to get a peace of mind about it. I have so much to be thankful for. The team in Austin is Fantastic! I want to get to a place where I do not worry about my Heart 24/7.
I would have had the Ablation done no matter what because I was on a blood thinner already and my only choice was to have the Ablation in my mind. I am glad I had it done and would do it again.

Jackie:

You have had three procedures why do you have to remain on a blood thinner? If one gets AF, that is why one is to be on blood thinners is what I have always understood. What happens when one has an ablation and no longer gets AF yet has to take a blood thinner.

Liz

Liz,

It has to do with what exactly gets ablated. In this case, the left atrial appendage is ablated, which eliminates the AF trigger but also makes the muscle less contractile (it doesn't "beat" along with the rest of the atrium). So blood can still pool up in it and form a clot. This is why the EPs do a TEE to check how blood is flowing in that area and if it is below a certain threshold then you still require anticoagulation. There are devices to "close up" the LAA that can offer relief from the blood thinners. I'm no expert on that, however.

Wolfpack:

Thank you for your reply, then why do some people not require a blood thinner, everyone that has an ablation doesn't require a blood thinner. I do get episodes of Af, they are not too long, but I cannot take a blood thinner, I have tried but I got bloodshot eyes, blood pooling in my fingers, I had to get off of the blood thinner (counadin), so having an ablation and requiring a blood thinner would solve nothing in my case, in fact it might make it worse.

Liz

Liz,

Outside my knowledge base, I'm afraid. The anticoagulation decision is between doctor and patient.

I have heard of studies using the new oral anticoagulants (Xarelto, Eliquis) as a pill-in-pocket (PIP) approach. Primarily it was done for folks in high-risk professions, such as law enforcement and fire fighting. I believe they showed positive results. Just take the thinner when you know you're in AF. Perhaps that's something you could discuss with your doctor?

Liz - When it's necessary to isolate the Left Atrial Appendage (LAA), the blood thinner requirement is mandatory until it's proven by the TEE... transesophageal echocardiogram... that the clearance velocity out of the appendage is in the optimal or safe range. The isolation procedure can result in lowered "clearance velocity" or efficacy from that appendage and when that happens, a clot can form there. Thus the anticoag requirement.

In my case, ablation #2 isolated the LAA. Then I had more AF activity so had a rush procedure... ablation #3 to clean up the stragglers. Typically, six months after the isolation, you have the TEE evaluation to determine the clearance velocity out of the LAA.

My first TEE was great at the time, but again... because of my age and to be very cautious, Dr. Natale had me wait another 6 months and repeat the TEE. I did. The results were borderline acceptable so the recommendation is to remain on Eliquis. If I were younger, I might consider the procedure to totally occlude the appendage so I could stop the blood thinner completely.

In your case with just occasional AF, it might give you peace of mind to know your levels of factors that influence the tendency to clot if your AF would be an extended bout in duration... ie, fibrinogen, CRP (for inflammatory marker), homocysteine. etc..... (see that post on preventing Sticky Thick Blood - the risk of stroke or MI) You also might consider using Cardiokinase regularly. That kept me safe for all those years when I had many events of long duration and I was unable to tolerate warfarin/coumadin and before the NOACs were available. Depending on what your markers for sticky blood are, you may also want to use other natural options.

Here's the link [www.afibbers.net]

Jackie

Smackman... I'm very surprised that you didn't have that meeting, but as you say, they may have relied upon Shannon's prep talk with you as sufficient especially with time constraints. However, as you say, you were already prepared for an ablation eventually and I'm glad you were able to take advantage of all that Austin has to offer.
You've had a successful ablation by the maestro, Dr. Natale. That's huge.

Your heart is calm now, right? So, now just focus on that very welcome peace and try to eliminate as much stress as possible. Ongoing, unremitting stress is very damaging and not just to your heart. It can take some doing but once you move beyond worrying about your heart, then a lot can change overall for the better. I speak from experience.

Since the New Year is coming up, it's a great chance to start looking forward to positive changes and overall improvements... I'm wishing that for you... in advance. You deserve it.

Best to you,
Jackie

Any studies comparing anticoagulated paroxysmal AF with anticoagulated LAA isolation from the viewpoint of stroke, myopathy,? Also, fraction of ablations which involve LAA isolation where subsequent TEE analysis requires anticoagulation?

As with many pharmaceuticals, the side effects of anticoagulants seem extensive, especially the post marketing experience. I am intolerant of most pharmaceuticals I have tried (and so-called natural supplements as well). If LAA isolation and anticoagulation are sufficiently likely, I would want to know as much as possible. I have read about it before on this site, but this has really piqued my interest.

researcher Wrote:
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> I don't look at your situation as being messed up at all. Being in NSR and not AF is a big benefit in terms of progression to heart failure and other potential health related issues. If you were still in AF, then blood thinners would be required for life as it is for my father in law. If you can't take the blood thinners, there is always the option of installing a LAA occlusion device. The latest generation Watchman is supposed to be much improved and there are other choices out there. Ask Natale for suggestions.<


Shannon: Well said researcher, I could not agree more!

And Smackman, I am truly sorry that you didn't win the lottery as we all wished that for you too. And I fully understand and realize how disappointed you must be from our prior talks and knowing how much you were counting on being on the lower odds side of this equation and thus able to stop OAC.

Also Smackman, while I also can certainly appreciate how so soon after hearing this news, how that disappointment might make you feel now that no one discussed this possibility with you of likely needing OAC long-term after LAA isolation.

However, I was very surprised to hear you say you had never been informed that having to stay on long-term OAC is a likely, though not absolute, outcome from LAA isolation. On the one hand, its is not uncommon at all for patients visiting a doctor prior to a significant procedure to forget or not really digest what all that they hear when meeting with someone like Dr Natale and/or his staff prior to such an ablation where LAA isolation could be required for the best long term outcome. Indeed, its easy for any of us to miss a lot when trying to take in all that is shared in such meetings. Hence, my strong recommendation constantly here on the forum, and when speaking to folks like you on the phone, urging everyone to record at least their initial meeting with Dr Natale prior to ablation so that one can re-listen to it later that evening and whenever after. I know from first hand experience that this I can very much help clarify key points you need to know and I also know that most folks are surprised when re-listenting to such recordings just how much they missed that really was shared.

Dr Natale and his staff make it a high priority, I know, from 2010 onward at least when LAA isolation came more to the forefront as a common requirement for many with persistent and and the vast majority of LSPAF cases. I would be highly surprised if neither Curry nor Dr Natale discussed this possibility with any patients in recent years who were facing a real possibility of him finding LAA isolation could be necessary in the upcoming procedure. So Smackman if you still feel you are 100% sure in your mind that no one at St Davids discussed this with you prior to your ablation, then you should take it up with Curry or Dr Natale as they would want to know if something this important was not mentioned to the patient whose case may have required LAA isolation during the upcoming procedure.

In any event, just for the record you and I have discussed this very issue on at least four occasions by phone over the last 2.5 years ... on two of our early phone calls going back between late Feb to early March 2014 just prior to your first ablation with Natale in Austin in 2014, and again twice more we discussed the odds of you needing an LAA isolation for your follow up ablation which I felt was a very high likelihood on ablation round two for you, especially with you having had LSPAF to begin with prior to the first ablation and since atypical left atrial flutter was your main recurrence arrhythmia at just over 2 years after your index ablation.

In those conversations prior to your follow-up ablation last summer we discussed again there was a rough 60% to 65% chance of requiring either ongoing OAC or LAA Closure after LAA isolation ... of course only should you require LAA isolation in your second ablation and only if your 6 month TEE showed inadequate LAA function. And we discussed that the odds of you possibility being able to avoid or stop the OAC issue entirely were roughly 35% to 40%, assuming you were one of the lucky one's who still retain enough LAA-mechanical function after LAA isolation to remain safe without OAC on board.

But the main point I emphasized at the time, and not only for you Smackman but that I stress for everyone I speak with when sharing my experiences with ablations and especially when LAA isolation might be in the cards while helping usher so many folks here through this process, and that I have also written about on many occasions over the last number of years here on the forum as well, is that there is no real choice here. If anyone has a significant trigger from the LAA and it is not addressed ... and this is most commonly found in folks with persistent AFIB and almost, though not absolutely, universal with LSPAF cases ... then for sure that person would never get off OAC drugs without at least undergoing LAA Closure in any event.

The very best odds that a person has of being able to stop OAC long term if they have documented active triggering from the LAA, IS to undergo full LAA isolation in addition to insuring any other PV or Non-PV sources in the left or right atria are also transmurally and durably ablated. And that assumes too that the persons CHADS2VASc score for systemic (non-AFIB related) stroke risk is 2 or under.

Keep in mind too, that neither Dr Natale nor any EP ablationist can control what condition our hearts are in when we arrive at their EP lab for ablation. They can only try to the best of their ability and knowledge to restore durable NSR in the least amount of total work required overall in an expert ablation process.

In any event, I detail all this Smackman as a learning experience for all of us, and again, I fully understand how easy it is to forget what we have and have not heard about our case, especially when some disappointing news occurs.

That is also why I urge for to let some time pass before getting too elated, or too upset, post ablation until the emotions and feelings of the moment have some time to mature and balance out and the periprocedural healing process has had time to play out and heal.

I know too that one can question, in the moment, when there is (for example) some initial mild to moderate transient pericarditis from the initial burning in the first 24 to 48 hours after an ablation, just what did we get ourselves into :-)? Only to realize it was one of the best decisions we have made anywhere from hours later to the end of the blanking period whenever blessed NSR sets in for the long haul and any residual mild to moderate discomfort is long gone.

I do know as well that one of the functions of Dr Natale having his patient's assigned Nurse Practitioner in every consult, is for them to document exactly what was discussed and I know too that each AFIB ablation patient who might require an LAA isolation depending on what he finds when inside their heart, is required to sign a document noting they have been informed of the risks, and possibly needing long term OAC as well. Most ablation signature forms also state the same things.

So, if you feel certain that you never were informed in person at St Davids about the OAC issue and never were given such a form to sign, then please do bring it up with your NP as they will want to know to make sure nothing fell through the cracks in your case ... And in spite of you and I discussing it too prior to both of your ablations. It is important you are informed about such potential outcomes, first and foremost, by the EPs and/or his NP, as I know is standard operating procedure at all of Natale's centers.

Regarding the high price of Eliquis and Coumandin; you can stick with Coumadin and do very well with it long term while knowing full well that both the costs will likely decline as more generic NOAC drugs come online, and new options for LAA Closure will be coming out all the time going forward for you to choose from. Indeed, advancements in LAA Closure have already been made and once I am back home from this 6 day functional and regenerative medicine conference here in Las Vegas where Magdalena and I have been since last Wednesday and where I have been working each day with my pal Dr Thierry Hertoghe with discussing his fellowship video training program and books with doctors of many specialties here. We are fixing to drive the 4 hours to home in Sedona leaving the hotel here within the hour, I really will prioritize finishing up the Watchman review Ive been working on in bits and pieces the last couple weeks that Im sure you will find reassuring in the long-run Smackman.

The key thing for very good outcome with Coumandin is weekly blood tests with a high quality home INR meter to insure you maintain your INR in your therapeutic range for a very consistent majority of the time you are on Warfarin. Taking Warfarin/Coumandin is a bit less convenient than NOACs, to be sure, but when cost is an object then, by all means, you will do just fine with this well-known and understood blood thinner for as long as you need to take it, in order for you to feel comfortable with the ongoing progress being made in the field of LAA closure such that you are ready to go for LAA Closure. Again, follow Dr Natale's advice on LAA Closure as he is the most conservative and careful Doc I know of who also fully understands the benefits too of LAA Closure, especially for our unique group of patients who have required LAA isolation.

Be well Smackman and remember, while its natural to feel a bit of initial disappointment that the OAC issue is one you will have to deal with, it truly is something your will adapt too fully and can thrive in your life enjoying the many blessing of durable NSR. And keep in mind you were totally destined to be on Blood thinner for life with your LSPAF AND still be in 24/7 ongoing AFIB for life too, had you not had the great good fortune to find this website and your wisdom to hook your wagon to Dr Natale's star as one of the relatively few EPs on earth who can so consistently restore durable NSR via an expert ablation process for patients like you and so many other of us who had persistent or
LSPAF to begin with, and now almost miraculously do not suffer from Arrhythmia any longer! This fact is far and away the most important reality in this whole equation.

Cheers!
Shannon

(PS please excuse any typos I had to write this on the fly while packing up to leave our hotel this morning)



Edited 2 time(s). Last edit at 12/15/2016 11:40AM by Shannon.

Thanks Shannon. I was just hoping to " beat the odds" but.....
I was probably told and forgot. St. Davids had always been good to me and always so professional in everything they do. I will be fine.

Interesting - I received a letter today from Scripps La Jolla.
Letter says Re: Consultation regarding WATCHMAN left atrial appendage closure.
"per Dr Natale, you are currently maintained on a blood thinner for stroke prevention, since your ablation procedure."
In summary the letter goes on to invite me to make an appointment for a consultation. It says when making an appointment to inform them I am be referred for a consultation by Dr. Natale.

When I spoke with Dr. Natale last January, he said to wait for the next generation Watchman device. He though it was much better than the current version. I had heard it had some problems that delayed its release.
Also, his NP indicated that at that time, private insurance was not approving the procedure for patient who were electing for the Watchman due to not wanting to take blood thinners.

What has changed? Anyone have any insight? Shannon maybe?
Perhaps this is just a marketing letter for Scripps.I plan to call later this week and see what I can find out.

Don

gmperf - Thanks for posting your latest news. I'm sure Shannon will respond as soon as he is available.

However, on the insurance not covering the Watchman (and probably any other closure method).... that's really not surprising considering the the considerable cost of the new OACs.... Big Pharma would be reluctant to give that up as they have us captive.

If you learn the total cost of the Watchman (out of pocket) or similar, please share with the forum.

Thanks.

Jackie

I would also like to know the cost of the Watchman or similar procedure cost. The cost of Eliquis,Xarelto etc is way to much especially for senior citizens.

I will let you know what I find out. I think I heard the cost was about 40,000.

40K is way out of my price range. Hopefully, Insurance will cover this procedure one day. Also the pricing of Eliquis, Xarelto is way out of hand. You can actually buy Eliquis or Xarelto for under half the US price at many Canadian pharmacies. Check it out sometime. I know individuals who use Canadian pharmacies for expensive prescription drugs with good results.

Smackman, LAA closure systems will almost certainly be covered by insurance as the comparative e vetting process continues to show its advantage for a fair number of AFIB patients going forward.

The most recent results from the latest and cumulative Watchman studies, improved Lariat experience the last two years and Amplatzer Amulet prospective studies from Eurooe, Canada and Asia/Austrailia/NZ have all shown very significant reduction in periprocedural complication rates too, over the very early learning curve phase to be expected within the first few years of any all new cardiac procedure.

A very important point that Dr Mandrola completely missed in what in my view was his very limited 'rear view mirror' assessment of the first two RCTs on early generation Watchman device plus the early procedural techniques for installing Watchman, and that have all been significantly improved since then, is that he ignored the reality that nearly 100% of the risk for the Watchman occurs upfront during, and shortly after, the procedure itself (i.e. during the periprocedural phase extending out around 2 months post procedure).

While in contrast, the on-going risk incurred by the comparative arms using Warfarin ... instead of Watchman ... in these two RCT trials, the risks of bleeding in particular but also a small yet steadily increasing risk for LAA-based clot formation and thrombo-embolic events (TE), continues to increase in an almost (but not quite) linear fashion over time for as long as the person takes an OAC drug ... in this case for life.

These two studies were structured as follows; PROTECT-AF a total of 707 AFIB patients assigned in a randomized fashion, 2:1 to Watchman device vs. Warfarin arms, and for PREVAIL a total of 470 patients were also randomized 2:1 in similar Watchman device vs. Warfarin comparison arms. While Dr Mandrola mostly referred to the earlier 2009 phase of PROTECT-AF data spanning only 1.5 years (we have since had further data points at 2.3 and 3.8 years with the final 5 year conclusions to PROTECT-AF due out this summer 2017). Dr Reddy's more thorough analysis of the current state of LAA Closure evolution includes the full 3.8 years of PROTECT-AF and for the more recent PREVAIL trial we have 18 months of data that have so far been fully vetted.

Since a systemic blood thinner will always win out in a narrow comparison of, say, Warfarin vs an LAA closure system, when looking at overall clot/stroke/TIA reduction, especially over such short time frames and with comparatively so few patients over so short a time, the picture increasingly changes to favor Watchman/LAA Closure the greater the number of patients followed and over longer time frames.

The problem with all blood thinners is their nagging tendency to cause significant bleeding risk over time. If Warfarin caused no bleeding risk at all we would all adding Warfarin/Eliquis to our morning Cheerios. Indeed, looking ONLY at combined LAA-based, plus systemic ischemic clot/stroke/TIA risk, alone and not accounting for bleeding risk, you could do a similar comparative Warfarin RCT comparing a large group of perfectly healthy 35 year olds without any AFIB history and not taking Warfarin or any blood thinner at all versus an equally well-matched healthy group of 35 year old subjects taking warfarin, and this warfarin group of healthy adults with zero AFIB history will show at least slightly less clotting and overall systemic ischemic embolism/TEs over time versus the healthy 35 year olds who did not take Warfarin.

Alas, all blood thinners do carry a significant bleeding risk that slowly, but surely, increases over time. This reality is where complete durable closure of the LAA in folks with ongoing persistent AFIB, or poorly-controlled paroxysmal AFIB, will inevitably catch up to and surpass the 'non-inferior' risk stats compared to Warfarin, and indeed is almost certain to do so with NOACs over time as well.

Even in these two, so far, short time frame and very small patient sample-size RCTs on Watchman, the Watchman already achieved statistical non-inferiority to Warfarin in PROTECT-AF ... and just barely missed achieving non-inferiority in the shorter 1.5 year follow-up time frame so far reported in PREVAIL. And the only reason Watchman did not achieve straight-up non-inferiority vs Warfarin in PREVAIL was because the relatively small Warfarin group showed a surprisingly low number of bleeding event rates in this study compared to the average bleeding event rates in the vast majority of prior Warfarin RCTs seen overall when looking back at far more than a decade of Warfarin clinical trials.

When adjusting the stats by taking out the relatively few strokes/TIAs caused by installation/periprocedural mistakes during the first 7 days from Watchman installation, the Watchman easily met non-inferiority with Warfarin in PREVAIL too, even with these smaller 470 total patients and over just 18 months follow up ... the larger the numbers and longer the follow up the better the efficacy and lower the risks for Watchman versus an ongoing systemic blood thinner. And thus the case for Watchman are bound to look increasingly better and better he longer out we look, and at some point should achieve full superiority for LAA Closure in either those with persistent AFIB or poorly-controlled frequent paroxysmal AFIB, or for those of us who no longer suffer from any atrial arrhythmia, often courtesy of an extended expert ablation process that includes successful LAA-isolation, but that also results in a reduced LAA mechanical function to a degree that requires one to stay on life long OAC drugs. In such a case, we have to protect ourselves from a persistent risk of an ischemic thrombo-embolic event even when in NSR, with either indefinite OAC therapy, or with an LAA-Closure system ... i.e. via Occlusion - Watchman/Amulet/Wavecrest ... or Ligation - LARIAT PLUS/Atriclip.

Dr. John presumes we should not remove those initial strokes/TIAs from the analysis that are caused largely by operator error during Watchman install, but several subsequent studies using much improved installation technique and with experienced operators only installing Watchman, have unequivocally proven that Watchman can, indeed, be installed with consistent safety showing major reduction is embolic events during the procedure down from 1.4% to ~0.1% ... less than the already very low rates of stroke/TIA that occur in most AFIB ablations studies.

This is important, since the overall installation risks, including installation error-caused TEs, that were higher in PROTECT-AF, and to a less extent in PREVAIL, collectively have been dramatically lowered to a very small level now after the initial lessons from the early Watchman 'learning curve' period during the first few years of experience with the device had been digested and applied by very experienced EPs and Interventional Cardiologists very familar with transeptal puncture access to the LA.

By almost eliminating installation mistake-caused stroke risks, reducing it to a very low level of acceptable risk, we already see clear non-inferiority in the actual real-world benefit of Watchman/LAA Closure vs Warfarin, even over such relative short time frames and with so few people studied so far in these first two RCTs alone. Common sense extrapolation of these early results compared to much larger and longer period OAC/NOAC comparative drug trials strongly suggests a very favorable long term outcome for Watchman patients that insist on a highly-experienced Watchman installation team.

Consider too, that for the NOACs to achieve basic 'non-inferiority' to Warfarin in a more apples to apples comparison of blood thinner vs blood thinner, they had to recruit huge numbers of patients who were followed over a minimum of 5 years ... 20,000 to 30,000 and more patients in some studies ... just to show 'noninferiority' of say Eliquis or Xeralto over Warfarin.

The bottom-line when comparing LAA Closure systems like Watchman, Amulet, LARIAT or Atriclip is that even with such relatively short duration/lower patient numbers in these comparisons with a systemic blood thinner, an LAA Closure system that even just approaches, but does not quite yet achieve full 'non-inferiority' to a given comparison systemic blood thinner, already IS proof of efficacy for the LAA Closure concept when factoring in the inevitable advantage of the LAA Closure systems elimination of added long term blood thinner bleeding risk and what the embolic TE reduction seen in the cumulatively Watchman data so far shows as basic non-inferiority with Warfarin so far. We will have to await longer term larger RCTs for absolute confirmation of the long term overall safety/efficacy benefit from LAA Closure over NOACs, but even more recent non-randomized, yet very well-structured studies only support this strong likelihood of a positive outcome comparing LAA Closure vs NOACs over the long haul going forward.

We can thus see, even from a proper and fair analysis of just these first two RCTs on Watchman, that already 'non-inferiority' can be practically achieved with Watchman in spite of the larger % of operator error and inexperience as shown in PROTECT-AF ... and to a lessor degree as seen in PREVAIL ... both of which did not benefit fully from more recent improved techniques used now for Watchman installation and by insuring only very experienced operators are doing the installations.

An interesting Cost-Benefit Analysis of the combined PROTECT-AF and PREVAIL randomized controlled trial data show that when factoring in costs, complication risks/safety and procedure efficacy ... it takes approximately up to year 5 before Watchman reaches above the break even line showing a superior cost/Benefit versus Warfarin. And Watchman is expected to achieve above break-even from non-inferior cost/benefit line compared to NOACs by year 8 (note: this longer time frame for NOACs to achieve a positive cost/benefit over Warfarin is almost entirely due to the higher price for NOACs vs generic Warfarin).

Again, this still very favorable long term cost/benefit analysis that Dr Vivek Reddy refers to in his recent Medscape article gives an insightful and thorough counter-point to Dr Mandrola's more limited Watchman assessment. And that is true even when restricting the analysis to just these first two early Watchman RCTs that do not reflect the real-world improvements in technique and understanding of Watchman (and other LAA Closure approaches) that have been realized over the last couple of years. It also reflects cost of Watchman installation vs warfarin generic cost. And once the NOACs become available as genetics the cost-benefit break-even point is likely to be much closer, if not superior to, the 5 year estimate time frame for Watchman/Warfarin cost-benefit superiority over long term brand-name NOAC therapy as well.

The above very important points, also shared in Dr. Reddy's cogent analysis of Dr Mandrola's Watchman dismissal, are just a few of the reasons I found Dr Mandrola's well-intentioned missive on LAA Closure to be inadvertently misleading. Those of you with a real interest in this issue please read carefully Dr Reddy's article and I will finish as soon as I can, a more complete layman's summary of Dr Reddy's perspective as well as address a few extra points of interest to those in our group who have either had LAA isolation, or may be candidates for LAA isolation in the future.

Shannon



Edited 4 time(s). Last edit at 12/15/2016 01:33PM by Shannon.

Shannon,

Excellent analysis and information as usual. Since a picture is worth a thousand words I thought the attached charts comparing watchman and warfarin costs that you cite from Dr Reddy would help some of those on this forum.

Watchman vs Warfarin Costs

Also please note that under certain circumstances Medicare will reimburse for the watchman.

See Medicare

Alan

Quote
Alan
Shannon,

Excellent analysis and information as usual. Since a picture is worth a thousand words I thought the attached charts comparing watchman and warfarin costs that you cite from Dr Reddy would help some of those on this forum.

Watchman vs Warfarin Costs

Also please note that under certain circumstances Medicare will reimburse for the watchman.

See Medicare

Alan

Many thanks Alan for sharing this outstanding poster of Dr Reddy's Cost-Benefit Analysis of the Watchman vs Warfarin study. I'm sure this will help give a visual confirmation of the points I was trying to spell out above on the topic to many of our readers!

Be well,
Shannon

Quote
gmperf
Interesting - I received a letter today from Scripps La Jolla.
Letter says Re: Consultation regarding WATCHMAN left atrial appendage closure.
"per Dr Natale, you are currently maintained on a blood thinner for stroke prevention, since your ablation procedure."
In summary the letter goes on to invite me to make an appointment for a consultation. It says when making an appointment to inform them I am be referred for a consultation by Dr. Natale.

When I spoke with Dr. Natale last January, he said to wait for the next generation Watchman device. He though it was much better than the current version. I had heard it had some problems that delayed its release.
Also, his NP indicated that at that time, private insurance was not approving the procedure for patient who were electing for the Watchman due to not wanting to take blood thinners.

What has changed? Anyone have any insight? Shannon maybe?
Perhaps this is just a marketing letter for Scripps.I plan to call later this week and see what I can find out.

Don

Hi Don,

I discussed this letter from Scripps with Dr Natale today and he and his NP Linda Couts wrote that note to send to only his former Scripps patients who have had an LAA isolation just to be sure they were in the loop with Dr Douglas Gibson at Scripps and that they could follow up with him if they desired so as to insure none of you who had your LAA isolation at Scripps while Dr Natale was still practicing there would possibly fall through the cracks and not be properly followed up with.

Some of you may not have heard, but since Scripps opened up their new Hospital wing where Dr Natale was to do ablations too, Dr Natale found the set up quality with the new Hospital not up to his standards and so has stopped seeing patients and doing ablations at Scripps Green Hospital as if the last two months. His excellent NP Linda Couts and assistant Dorie both have new jobs as well, with Linda working in a stroke program at a different Medical Center now.

Ideally, I would recommend any of Dr Natale's LAA-Isolation patients from Scripps to go seek him out when needed for follow-up at either CPMC in San Francisco, or at Dr. Natale's main office in Austin at St Davids. If travel is out of the question for any southern California patients of Dr Natale, then he recommends you see Dr Douglas Gibson who is a highly trained ablationist and very highly trained in Watchman installation as he has done as many, if not more, Watchman installs that just about anyone else in the US at this point. Dr Gibson has trained for a number of years under Dr Natale and has learned how to do LAA Isolation which he performs too, so he is very familar with the issues around LAA isolation/LAA Closure.

Dr Gibson is a very nice man and a very competent EP and ablationist and I can certainly recommend him as well for Watchman installation as he is a real expert with Watchman for sure.

I'm sure, though, that many of you who have sought out Dr Natale's unique skill and expertise for your hearts care might well want to travel to see him for making such decisions about LAA Closure and such, and he told me today he would be most happy to see any of his Scripps patients again should they wish to follow up with him elsewhere.

Dr Natale did say that if the issues with the new Hospital facility at Scripps were resolved satisfactorily he might well return to doing his practice there periodically as before, but there is no word yet whether the issue(s) in question are yet resolved in that way so stay tuned, I will update here when and if that situation changes.

Take care,
Shannon



Edited 3 time(s). Last edit at 12/15/2016 01:42PM by Shannon.

Thanks very much Shannon.
This is sad news for us that have had Dr. Natale and his staff available out of Scripps in California. I have been with Dr. Natale and Linda since my afib first started 7 years ago. Having Linda available for an occasional question or some guidance was a real help. Nothing lasts forever.
Linda gave me a 12 month prescription for Eliquis that has 1 refill left. I guess I will have to figure out what to do. Local EP sees no reason for Eliquis with no afib and a chadsvasc2 of 0.
I think I will make an appointment with Dr Gibson and see what I can find out about dealing with this LAA issue.

Thanks again Shannon. As usual, you have been very helpful.

Hi Don,

If your local prescribing EP sees no need for an Eliquis script when you had an LAA isolation and your TEE detected LAA funtion was not robust enough to warrant stopping OAC, have him call and ask for Barbara Thomas , head of the EP program at Texas Cardiac Arrhythmia Institute at St Davids Med Center in Austin, and she will explain why you need OAC or an LAA Closure.

I'd be happy to speak with him as well. Bottomline, since your LAA emptying velocity is under the required 40cm/sec flow rate you will remain at a similar risk for embolic events like a stroke or TIA, as in ongoing AFIB, even when in NSR. And thus the need to address this risk without fail.

I realize you know this Don, but for any new folks reading this issue for the first time, if your LAA had remained in the safe parameters on your TEE showing good and safe mechanical function, then his assessment would be correct and there would be no need for ongoing OAC. Around 35% - 40% of those who have had successful LAA-isolation are able to stop OAC drugs in spite of the LAA being electrically isolated, but for the 60-65% of us for whom that is not the case, we have to address this one last issue to put a period to our sentence ... and hopefully once and for all ... as the well-worth-it-price for freedom from the beast.

Why don't you show your EP a copy of your 6th month TEE and he should get the message, and print out a copy of this reply here if you wish and I'm sure he will refill your Eliquis.

Cheers!
Shannon



Edited 1 time(s). Last edit at 12/24/2016 07:52AM by Shannon.

Shannon,

Been meaning to write back and say thank you. I appreciate your help and will take you up on the phone call offer in the next few months.
I have an appointment with my local EP and they say they will refill my Eliquis.
I have a referral from Dr Natale for the Dr at Scripps that does the Watchman. I will see him in February.
I will post what I find out for others facing this LAA issue.

Don

Thanks Shannon for your help. I posted a reply a while back from my phone and I guess it didn't post.
My EP says he will prescribe Eliquis and I can come by for some samples since I will run out before my appointment with him.
I hate the idea of needing a pill to stay alive! O'well it could be worse.
Hoping at some point LAA closure will be an option.

Don