Shall I have the Lariat procedure?

Hi All -

Had my 6 month post ablation TEE and visit with Natale two days ago. My history is one ablation in Feb which caused a 3 week hopitalization, another one in April which is successful so far. However, my LAA, where almost all the ablating was done, is now not pumping at a capacity that pleases Natale, so I am to continue on Coumadin forever, unless I have a procedure to block my LAA.

Currently Natale is doing the Lariat procedure. I'm wondering if anyone on this forum has researched it. I know that it is very new, and that less than 400 total procedures have been done in the entire world. Natale has done 40. He claims that this procedure, so far, is 95% successful. Just requires an overnight stay in the hospital.

His head nurse met with me immediately after the TEE and said that I would have to wait a year from the first ablation to have the Lariat done. Not sure why, but will ask. Natale said I could have it sometime in the next three months.

I will appreciate any help I can get weighing the benefits and dangers of going ahead with it.

I've been recovering from a fall which resulted in shoulder replacement and pelvic fracture, so haven't been able to type very well, so haven't been contributing much to the forum. I'm reading, though...

Thanks!

Cindy O

I'm consulting with Dr Vivek Reddy Oct 31 at Mt Sinai and he's doing those too. Being that I just had a TIA or mini stroke that will require longer than usual coagulation of up to a years after ablation it's something I've been think about. The watchman device does the same thing but if placed wrong would require open heart to remove.

Hi Cindy - Shannon is our research expert on the procedures to manage the LAA... I know he's out of town at the moment, so I'm sure he'll respond to your post when he gets back at his computer. He is very conversant on the potentials for both options as a result of his consults with Dr. Natale... so just stand by.

I am so sorry about your unfortunate accident and I do wish you a total and speedy recovery.
Best to you,
Jackie

Hi Cindy O,

Just back from Chicago last night. .... I know the feeling ... one more step required ... but for those of us with challenging AFIB/Flutter histories including persistent AFIB ... close to 30% wind up having to address the LAA in order to be free of the beast in the form of AFIB, or its equally unwelcomed twin Left Atrial Flutter, for the long haul.

So many EPs wont even go there (the LAA) and even wind up misinterpreting trigger signals as coming from elsewhere in the LA when in fact they originated in and around the mouth of the LAA all along! In the hands of such EPs, one is likely to be stuck on a merry-go-around of three, four or five or more ablations and still not getting the job done satisfactorily .. not a good protocol in my book.

But the flip side, if you are like me and you, who have no real choice but to address the LAA to really quiet the flutter or AFIB, then having to face anti-coag life long can become a real issue for roughly 50% of us,

I get my verdict in Feb, but my LAA was already 'delayed' a bit from the first ablation when Dr. Natale first started to work around the mouth of the LAA prior to him having to stop and cardiovert me to NSR at that time before finishing fully isolating my LAA, as previously described .. thus requiring the second ablation to finish LAA isolation last month for me.

The Lariet-II device definitely seems to be the preferred mechanical method of offering substantial stroke reduction risk for people like us, even to the point of allowing many of us to stop Coumadin/Xeralto or any such drug based blood thinners ( though I would always at least keep a strong protocol of round the clock Nattokinase, Omega 3s and other reliable blood thinning and likely clot-forming reducing supplements on board, as needed, to maintain an objectively verifiable low viscosity and clean blood flow .. even if some lower dose of the drugs are also needed to get the job done in addition to Nattokinase and other such more natural means.

But first the Lariet -II would likely be the wise choice as the major player in this stroke management protocol.

It has a significantly better track record so far than the Watchman for safety and lack of major side-effects such as needing to repair a placement gone wrong. Apparnetly it is a fairly simple and straight forward procedure.

With around 400 Lariet-IIs done so far, Dr. Natale has done about 10% of the tiotal installs and he knows our hearts well already so that is a plus!

If you want to get it done faster than a year from now, you will need to go to Texas and not San Fran. He is only doing them at St Davids in conjunction with Dr. Burkhardt there at this time.

Dr. N spends far more time there and since this procedure is not nearly so long and complicated as a full on ablation, it is a bit easier to schedule with both Dr Natale and Dr Burkhardt doing the procedure together there.

It is a two part process all done at the same time with one doc threading a catheter through the femoral vein into the left atrium via a trans-septal puncture for a balloon only to then place it inside the LAA. The balloon is then inflated to better delineate the exact dimensions of the LAA and show exactly where the hilt or mouth of the LAA is where it opens to the inside of the Left atrium.

Simultaneously, the other doc makes a small 1/4" incision just under the breast bone near the sternum and threads two magnetic guide wires up through the chest cavity and makes a small puncture of the peri-cardial sack and threads these guide wires up to the outside of the LAA itself. This is all truly a minimally invasive epicardial procedure.

Once the balloon that is place on the inside of the LAA is fully inflated, a small wand-like instrument with a thin flexible neck that has a single pre-tied double-loop stitch in a 'Lariet' or lasso-like oval shape is then guided up to the outside tip of the LAA via the magnetic guide wires which they can see precisely on ICE imaging and fluoroscopy as needed,

Next, they put the Lasso-like loop stitch around the outside of the LAA and guide it all the way up and around the balloon-inflated LAA until they are sure they are at the very hilt of the Jalapeno-shaped LAA where it attaches to the outside wall of the left atrium. Once they confirm optimal positioning of the Lariet loop stitch at the very mouth of the LAA, they de-inflate the balloon and retract it back out of the femoral vein in the groin area ( or possibly jugular vein for all I know?) and then they synch down tightly and pull stitch closed so that is seals off the LAA at its very origin in the wall of the Left atrium so there is little to no remnant new cavity formed by the inside mouth of the LAA extending too far into the Ostium of the LAA which could still leave a small pocket for clots to possibly form if this wasn't done correctly.

This is one reason why the Lariet-II is a significantly better device than the other methods offered so far and brings far less risk of bleeding as is sometimes the case in surgical removal of the LAA during a MIni-maze for example which still also leaves the possiblily of a latent cavity at the mouth of what was the LAA as it is.

The LAA tissue now being starved for any blood supply then withers and gradually gets re-absorbed by the body as if you never had a LAA to begin with!

That is the goal and the procedure in a nut shell. Granted, we don't yet have many thousands of procedures to verify just how well it works, but in those 400+ done so far, apparently the results are highly encouraging and far better than the other methods on offer so far to mechanically close the LAA.

A repeat TEE test will be needed in about three months or so to confirm a tight, smooth and flat seal where the mouth of the LAA used to be and then if all goes as expected you can usually stop the blood thinner and hopefully also have the flippies behind you too and idealy we can truly put all these trials and tribulations behind us!?!

On another note, should you ever have any periodic AFIB/FLutter in the future after a confirmed successful Lariet procedure, your risk for stroke would likely not be any more than the general population going forward so that is also an added measure of reassurance ...

I'm hoping I dont have to go this route and I can jsut stop the Coumadin for good in February after my TEE, but with my LAA arleady delayed some from the first ablation and now having to have it fully isolated in August, as you did also Cindy last March, at least we can be thankful there are these Buck Rogers-like procedures that can address this issue and not necessarily have us stuck on blood thinners for the long haul!

I still would take 100mg of CardioKinase three times a day for life as well as Gingko, Resveratrol, Pycnogenol and at least 2 grams of DHA-based Omega 3 a day .. even after a successful Lariet-II install, since about 93 to 95% % of all strokes related to AFIB are from the LAA, that still leaves 5% to 7% from elsewhere. But as long as you are in NSR there should be no problem. However, these extra insurance policies in the form of the supplements will help your body in many other ways as well so the added stroke protection, whatever it may be, is just a bonus.

BTW, my neice who is chief attending physician in one of the largest Level 1 Trauma Centers in Texas in Houston is just finishing a large report comparing Coumadin and Pradaxa/Xeralto in the trauma setting..

The latest date shows that for people on either Coumadin/Aspirin/Plavix coming to the ER due to a bonefide 'trauma' with significant bleeding approximately 30% die as a result of excess bleeding.

That sounds like a lot, but consider 70% of those same degree of trauma patients who are on Pradaxa wind up dying!!! Mostly from bleeding out or related break down!! That really IS a lot!

So if you are taking Pradaxa/Xeralto and don't plan to live in an isolated padded cell, then based on these preliminary marketing date the Drug reps have been hawking to all the eager EPs and Cardios ... these new figures might give them some real pause for thought!>! Or at least I would hope so until they get a far better antidote.

This is where combining something like a Lariet-II procedure with the best quality blood thinning supplements and even small as possible doses of anti-coagt drugs, if still needed, makes better sense than stayiing on either Coumadin or Pradaxa/Xeralto/Eliquis indefinitely .. all these drugs are definitely a a big role of the dice and an even bigger one for these newer agents at least until a real world antidote is universally available.

More later, its time for bed. Best of luck Cindy and keep us posted.

Take care, Shannon

Cindy and Shannon, I have the same issues and I thank you, Shannon, for posting this information. It has been two years since my ablation by Dr. Natale at St. David's which included isolation of the LAA. I also had a TIA on the second day following the procedure. As a consequence, I am on life-long warfarin therapy--not my favorite thing. At one point, I was switched to Pradaxa but the GI side effects were horrendous, even with a PPI, and I went back on warfarin. After reading your analysis, Shannon, being on warfarin would appear to be the better/safer choice anyway and I know my primary care doctor prefers that I be on warfarin as well. I have not asked Dr. N whether the Lariat procedure would be a consideration for me but perhaps it is something I should look into. Again, thank you for sharing your experiences and knowledge.

Be well,

Laura

Shannon,
Fantastic information good to know we may have a way to avoid blood thinners long term.
Question how common is LAA ablation....50%? How important is the LAA to heart function/capacity?

You are welcome Laura and McHale.

I'll try to address your pertinent questions below McHale.

LAA isolation ablation is now becoming more common, largely due to Natale's group of EP's and the Bordeaux group which, until recently, has tended to ablate around and focally within the LAA but not full isolation unless necessary. That is pretty much what Natale does as well. He only isolates the LAA when it is clear that is the primary and often Only source of AFIB/Flutter and to not address it would amount to spinning your wheels leading to more repeat ablations trying to address outlier triggers while avoiding the real elephant in the room all along.

Many EPs want to avoid working on and around the LAA due to the delicate nature of this appendage as it is easier to puncture through the thinner LAA walls and thus possibly cause a cardiac tamponade. That is where having very skilled and experienced hands doing the LAA isolation comes in real handy. Also, they want to avoid the possibility of the person having to deal with anti-coag for life should the velocity of blood in and out of the fully isolated LAA drops below 0.4meters per second and there is a consistent A-wave at the Mitral inflow as shown on doppler imaging in the Trans-esophageal echocardiography test.

But when you step back and look at what we are trying to do here in the big picture of AFIB ..we want to achieve as robust and consistent amount of NSR time as possible. With this view in mind, for those relatively few of us whose main issue is around and in the LAA, then dealing with it directly is the best chance of achieving long term freedom from (or at least greatest reduction of) active arrhythmia.

Natale's stats show approximately 27% of those people requiring a second or third follow up procedure after breakthroughs following the first ablation, do have either some or all of their triggers located in the LAA. A much larger percentage of those repeat ablations required on people with persistent AFIB prior to the first ablation, wind up having the LAA as the main culprit... including yours truly.

But the total figure is far less than 50% of all ablations, though no doubt a large number of people who are not given the option to isolate the LAA even if that is the sole source of the problem, should have that option clearly explained to them .. and then if the EP isn't confident in his/her own skills in getting the job done safely, then they should refer the patient upstream to one of the maestros who can handle the job, rather than simply dismissing it as unnecessary or too difficult because it is a bit more challenging than a run of the mill PVI.

The chance to really put this beast in the rearview mirror is worth the approximately 50% risk that one who requires a full LAA isolation might have to deal with the continuously evolving world of anti-coagulation for life in one way or another ... and fortunately we are slowly but surely getting better options in any event and that will continue to expand in the years ahead as well. At least that is my conclusion after weighing this issue from as many angles as possible.

Your second question McHale on the function and benefit of the LAA has a two part answer. First of all, there is considerable debate as to how much, if any, significant benefit having an LAA provides a grown person in life? Its not unlike the appendix in which whatever benefits in might once have provided.. and maybe still to some degree continues too... is greatly overshadowed by the downsides of having this marginally functional 'appendage' hanging off both the left and right atriums ( yes there is a right atrial appendage too but its not much of an issue for this discussion).

Keep in mind too, that the original 'purpose' (as far as we now know) of the LAA was to serve as a temporary vestigial Left atrium itself during the first or third trimester (cant remember which?) of fetal development while our permanent and real Left atrium was still forming from the bundle of Pulmonary vein branches that was taking place at that point in the gestation of the fetus. Once the real left atrium also took shape and started to function as such, the role of the LAA was severely diminished in any event.

There is some evidence that there may be some hemodynamic benefit to having this side chamber to act as a kind of pressure relief valve or engine governor in the event of extreme cardiac mechanical stress ... think competitive marathon racing or ultra-marathoning for example, or any intense sustained physical stress that might put significant stress on the heart. But even assuming the best case scenario for assigning such a benefit for the LAA, most researchers suspect the advantage is rather minor at best. And it is something people our age are far less likely to ever really need or run into in real life.

The second part of this answer deals with the second possible compromise when the LAA is removed or shut off and re-absorbed as with the Lariet-II device, is the possible loss of added ANP ( Atrial Natriuretic Peptide) hormone production from the pacing cells lining the inside walls of not only the small thumb-sized LAA but also throughout both the right and left atriums and the lining within the right atrial appendage as well.

ANP is a key hormone for regulating sodium and potassium balance and I know first hand what it is like to suddenly lose a significant amount of my ANP production. This happened due to the very long burn time my first ablation required of almost 2 hours (117 minutes) compared to 35 to 40 minutes of typical burn time in the average first time AFIB ablation. Because such a large percentage of my ANP producing pacing cells were ablated to stop my very symptomatic 24/7 persistent AFIB/Flutter at the time .. and with the concomitant use of the first generation Thermocool catheter during my first ablation with its double the volume of water dumped into the heart compared with the current generation of Thermocool catheter with half the amount of water used .....I developed a temporary four day bout with ablation-induced Congestive Heart Failure and wound up with a 5 day hospitalization then rather than checking out the next day at noon, post-ablation, as is then norm.

This manifest in me by my body swelling up dramatically gaining 16 to 18 pounds of water/fluids and requiring IV Lasix and Potassium around the clock for the next four days in the hospital while those ANP-producing pacing cells regrew enough to re-establish my electrolyte balance on its own.

However, removing the LAA should not have anything close to that kind of significant edema.. if any at all?! We still would have a far larger surface area inside the left and right atrium and within the RAA too to make plenty of ANP ... the heart might well adapt and compensate over time for the modest loss in ANP production from the missing LAA function in any event? ... Nevertheless, even if there is some minor edema that should be pretty easy to control with insuring proper potassium intake and making sure you have good hydration .. Just drink extra hydrating water each day .. and that should more than compensate, in the unlikely event there is any noticable issue at all. Again this is unlikely to be a significant concern as it is based on the collective experience of quite a few maze and mini-maze patient who, in most cases, have lost both their left and right atrial appendages and still manage very well.

Whether they find some unexpected consequence from not having an LAA in the future is any one's guess? But at this point in the collective experience and research knowledge base, the beneficial impact of having an LAA, and any possible negative consequence of suddenly not having one, seems minimal on both accounts!

It certainly pales in comparison to the HUGE potential benefit of eliminating the single largest source of strokes associated with AFIB/FLutter with most reliable estimates of around 90% to 95% of all strokes originating within the LAA.'

I hope that gives you a better idea of the landscape here for decision making purposes. Its all still a work in progress, but this is all about making the best of a not ideal situation to begin with. None of us asked for this beast to enter our lives and most or our decision will involve a balance of compromises. At the end of the day it is up to each of us to find our best way through it all.

And for this quest, knowledge really is our best ally.

Shannon

Shannon great details but now I'm perplexed
about something. Can persistent or permanent
Afib really be emanating from the LAA and EPs
Were targeting areas other than the source?
Is remodeling both structural and electrical a
Result of substrate changes or from LAA or both?
Seems like the top EPs are able to eliminate permanent
Afib by ablating LAA? Just thinking out loud don't
Know if I'm even making valid points.......

Hi McHale,

Its not that all persistent AFIB has its origins in the LAA alone. The majority of persistent Afibbers have triggers sites and areas all through the left and right atrium at many of the usual suspect focal points and the ostium of the PVs as well.

However, what Natale's group has found is that once the condition progresses to a persistent/permanent AFIB state, by then a substantial percentage of people will have developed a lot of triggering involvement in and around the mouth of the LAA itself .. which is another good reason not to procrastinate too long about getting an ablation by the best EP you can find once you have tried all the supplemental strategies and meds and still are having too many episodes.

Indeed, Dr. N told me that a fairly large number of those people who were persistent Afibbers prior to their first ablation do wind up needing more than one ablation, In fact, it seems that the vast majority of persistent Afibbers do need more than one to get it fully done.But for these folks, on detailed examination by his large group of EPs in Texas, Ohio, California, Florida and Italy have found that a significant percentage of these folks presently for a second or third follow-up ablation do indeed either have the majority of their on-going triggers in the LAA or, as in my case it is the ONLY source of continuing trouble.

He also said it can be very challenging, especially for less experienced ablationist, to discriminate accurately between triggering signals that have an echo-like appearance elsewhere in the left atrium and SVC region that appears at first to be the origin of those triggers, when in fact it is more like a reflection from the real source in or around the LAA! Thus a lot of repeat work winds up focusing on areas that might also need some additional work, but that masks .. in a sense... the real on-going culprit in the LAA where these triggering energies are initiated and that often isn't even addressed at all .. leading to even more ablations being necessary.

To Dr. Natale that isn't a valid 'less is more' philosophy as the added risks, expense and personal distress resulting from almost insuring on-going AFIB/Flutter by ignoring or overlooking the LAA when it is a significant issue due to lack of skill or confidence, and thus also insuring a less than satisfactory outcome and therefore the need for even more repeat ablations than should be necessary. Its a bit like robbing Peter to continue paying Paul. It's a false conservatism borne of being too cautious for the good of the patient and can often wind up exposing them to far more risks in the long run than doing the job right by going after the real source of the problem, whenever and if, it is found to be in the LAA.

The guys like our Blogger Dr. friend who often has some interesting articles on this field, but who is not a very experienced ablationist himself, are inherently more prone to treading lightly in more progressive cutting-edge areas of ablation where they instinctively feel out of their depth. As such such docs will dismiss even thinking of addressing the LAA and instead will wind up screening their patients to try and minimize the numbers that make it to their table that might have more a more challenging case such as persistent Afibbers. Instead. they will tell the patient simply that they are not a good candidate for ablation and must learn 'to live with it'.

That is just one of the vast differences between the average even decent EP that is still climbing the lower rungs of this rather steep experience curve of cutting-edge ablation docs and the real maestros who do their best to solve the issue as satisfactorily as possible within the real of acceptable risk.

Is it more 'risky' to take the 50% chance of needing to deal with the whole anti-coag issue for life even it it meant a lifetime of freedom from the beast, or is it more risky to accept, as I would have had too without Dr. Natales help, a life of requiring ECV very 6 weeks or so until something really bad went wrong?! I can tell you that after 13 ECVs in 15 months it was a no brainer that even if I had to adjust to life long Coumadin it was far better odds for me than having to live across the street from the nearest ER no matter where I was!

OF course you first do everything possible to control AFIB/FLutter, with life style, the Strategy, enzymes, Iodine and meds, but when that all proves not enough, you're left with making the best of a challenging situation. The funny thing is at a certain point when you really have done your best to sort this out for yourself and you find yourself still faced with this choice, it was really easy to make at long last.

No way getting having to get shocked 10 times a year is a recipe for good long term health. Bring on the Lariet-II, if need be, if that was the alternative as in my case.

Anyway,back to your last question, yes remodeling has an electrical and substrate component both. and that substrate and electrical remodeling issue extends from the left and right atriums proper into the LAA as well. But with the LAA, due to its thin walled nature with a bit less blood velocity than the rest of the LA, it can make for a trickier procedure to properly address and turn off the triggering results of those electrical and substrate changes that occur as well in other parts of the left and right atriums, but that are now taking place around the mouth and within the LAA.

No one wants to have to take a blood thinner for life, and Dr. Natale is very cautious about going there unless, and only if, he finds that there is no other choice to get the job done. At least, with hopefully better antidotes coming soon for the newer class of anti-coags and continued refinement of systems like the Lariet-II, it offers real hope that the future for those of us who might have to stay focused on anti-coagualtion will get a lot easier and safer than it otherwise would have been in years past.

I hope that gives some additional insights that help in sorting through all this McHale. Its a lot to chew on for sure. But with your TIA that thankfully wasn't too serious, it is a wake up call to examine all this thoroughly as gladly I can see you are doing. Besides the odds are still very good that you will not even have to have the LAA isolated as it is, when you get your ablation ... Best thing I can tell you is to saddle up with Dr, Natale or at least someone in his neck of the high-end ablation woods and go from there. Don't compromise with anyone else, unless you have really researched their track record and are fully confident in their skill and experience level.

Take care,
Shannon

Hi Shannon -

Thanks so much for all the information! Extremely helpful. I realize that the materials given me by Natale adequately describe the procedure, and it sounds quite reasonable and even easy. You have now answered my question about the role of the LAA and the known effects of losing it. Sounds like presently there aren't any significant ones.

As a side note - last month my healthy and active cousin died from a brain bleed no doubt caused by the Coumadin he was put on after being diagnosed with afib earlier in the year. Two weeks before he died, he suffered a nose bleed that was very difficult to stop in the hospital.

I'm taking Coumadin, as I know the dangers of Pradaxa/Xeralto and wonder why any one would consider taking them knowing those dangers. Coumadin seems the lesser of the evils, but I am definitely not interested in taking it life long. As an ED of a nonprofit clinic group, I saw so many bad outcomes from Coumadin therapy that sometimes I marvel to myself that I have agreed to take it. Makes good sense, though, in this case. Natale said that I could go off Coumadin 45 days after my Lariat procedure.

I'm wondering if you have any idea why Deb (Natale's chief nurse practitioner) met with me and told me I would have to wait a year from my last ablation to have the Lariat procedure. I've called to ask for the reasoning behind this but she hasn't yet been available. I need to decide soon if I want to do it this year since the end of the year is fast approaching, and I have travel plans to work around.

Sorry I didn't get to meet you that day at CPMC. Where will you go for the Lariat if you decide to have the procedure? They offered me Austin or San Diego (Scripps). I'll probably opt for Austin.

So many thanks! Be well -

Cindy O

Shannon,
I appreciate the wonderful insight you have provided it's lots of info to process but I have the uncanny ability to store this information and then propagate at the right time when I need to. My stroke or TIA was so tiny as to be of no consequence and wonder if they put stroke that on the formal diagnosis as to fluff up my stay and to justify that to my insurance. The scary part is the 2 other tiny ones that they never mentioned in the official medical MRI but just dotted down in doctor gibberish on my release form. I wonder how many people on this forum have the same silent TIA's or strokes and don't know it unless they have n MRI? The head neurologist told me on the day of my release he see's these all the time in people our age most likely cause paroxysmal afib! So anyone getting a run of pac's/pvc's for a day or two might be blowing this off as no Afib but the reality is the only way to know is with an EKG? Interesting how inexperienced EP's might be ablating other areas because of resonance and the tendency of afib from the LAA to oscillate to those areas from I understand from your post.

Cindy,
I'm more comfortable with Xarelto than I would ever be with coumadin as so far as brain bleeds from what I've been reading. The danger is with blunt trauma is where you would get in trouble with Pradaxa/Xarelto but due to the rapid offset of these drugs it might not be a problem in most cases. I would have to see more concrete studies than from empirical evidence from preliminary reports from a resident with all due respect. I think the jury is out on this and hopefully we will have a reversal agent in the near future.

I see Dr Chinitz of NYU on Oct 18 and Dr Vivek Reddy of Mt Sinai Oct 31. Dr Reddy is also doing FIRM ablations so I'll be intrigued into what he has to say. Both are rated highly skilled ablation EP's.

Hi McHale,

Silent TIA like events are a lot more common than most people think and most resolve without incident or lasting damage (or so the story goes). When they get to a certain size and or number there is some indication of possible increase in dementia which would make since once there is a fair number of these that don't resolve.

Getting older is a real crap shoot, no?!

Regarding less experienced EPs ablating other areas rather than the real source when, and if, it happens to be coming from the LAA ...you have the right view of the overall issue. The one point of clarification I might add is that it isn't that there is no reason to ablate these other 'echo' focal points or regions when the main source is radiating out from the LAA, but to address only these areas that are getting triggered themselves from an original driver in the LAA without address the LAA is not enough to get the job done in most cases.

No doubt a case could be made for abating as many overly-sensitive trigger spots as one can find to help lessen the likelihood of an atrium-wide episode of chaotic flutter or afib, once these areas are triggered from a tachycardia or flutter that is driven first from the LAA. But to make that hte prime focus while ignoring the LAA if it is active is tantamount to working backwards in my view. Ideally, all the most sensitive trigger spots will be addressed AND a thorough isoproterenol challenge to the LAA will be given on all ablations to rule in, or out, whether or not that structure is a prime candidate for starting a lot of the mischief .. and if it is found to be so ...then doing whatever is necessary to eliminate or at least greatly lessen its unwanted contribution to creating ongoing misery and frustration in one's life.

Dr Natale makes a judgment call when doing a first AFIB ablation, if the person is paroxysmal he wil often address all the main triggers that are active as well as all four PVs and SVC/CS etc. and will do focal ablation around and at targeted spots within the LAA is it is also active and then usually leave it at that and see how well the patient does over the coming next year or two. If no AFIB recurs but atypical left flutter arises that is a tip off that the LAA is more likely the remaining culprit still driving the show and if that is comfirmed during the EP study portion at the beginning of the follow-up ablation, he will then go ahead and fully isolate the LAA to end hopefully finish the job altogether.

For persisent afibbers he will more often ( but not always) go for the full LAA isolation in the first ablation if the LAA is a major active area, and will do so even with paroxysmal afibbers in the first ablation when the LAA is found to be either the prime or only driver of their arrhythmia.

I spoke with my new local EP in Scottsdale on Wednesday (after relocating there 8 months ago) and he is a very nice guy and very competent. Dr. Natale's office referred me to him for a local EP to follow me as well who knows and does ablations and who he respects, and this new EP said he, as yet, hasn't ventured inside the LAA nor done LAA isolation, but is starting to zap those hot spots around the outside of the LAA.

He has done around 500 or so ablations so far and, as such, its no doubt appropriate for him not to jump in too far too soon while he is developing his technique and experience level. He also commented that in the EP community Dr. Natale is widely regarded as among the top two or three ablationist in the world (Haissaguerre and Jais likely the other two) and the best, bar none, in the US.

I have heard good things too about both Dr. Chinitz and Dr. Reddy as well, so it sounds like you will be in good hands there in any event if you wind up feeling really good about either of them. Best of luck on getting it all sorted out and settled for the long haul!

Shannon

PS McHale,

You are correct that the main issues with the new Anti-coag's versus Warfarin are with true traumas in the ER, from whatever source, but a significant brain bleed is indeed a problem as well for all anti-coagulation drugs and demands quick reversal to prevent often irreversible brain damage.

Also FYI, my niece isn't a greenhorn resident simply conveying a few local anecdotal experiences, she is Chief Attending Physician at the largest level 1 trauma center in Houston .. runs the whole show there. The report she and a host of her Trauma doc colleagues at many centers across the US have been compiling, and of which she was elected to put it all together for publication, is far from a few anecdotal reports. This data is from the total combined documented clinical experience with these new agents reported from the front lines of every trauma center in the US over the last year and a half or however long it has been since Pradaxa first hit the streets ... by far most of the reports are with Pradaxa which is easily the most dangerous of the two..but also with Xeralto.

Bottomline, its a choice of compromises that fact that 30% of geniune trauma patients on either warfarin/aspirin therapy/plavix die in the ER or hospital after admittance from a significant bleeding trauma from whatever cause, is pause enough! But keep in mind that a good number of those would likely have died from the severity of their injuries regardless if they were on warfarin/aspirin/plavix or not.

However, the relevant stat here from the total combined experience across US ERs and hospitals so far is that 70% of people using Pradaxa/Xeralto that come into the trauma center with a similar grade of traumtic bleeding as those in the warfarin/aspirin/plavix group wound up leaving via the morgue! That is a 40% increase of dead patients using Pradaxa/Xeralto over the warfarin/aspiring/plavix group considering and comparing the same general level of trauma and expected recovery rates.

Now, I realize the drug reps try to paint the relatively modest level of reduction in primary bleeds from the drugs themselves with Pradaxa or Xeralto ( and its my understanding that the data on Eliquis (Apixiban) now due for FDA approval in March 2013 is even better than the first two new anti-coags) as a compensating factor for not having a readily available practical real-world antidote yet.

But I would be highly surprised, to say the least, of any data that implied anything close to the 40% negative ratio in the trauma setting between the new agents and warfarin?!

I guess at least for now, when using either Pradaxa or Xeralto one should jsut exercise extreme caution with engaging in any activities that might land you in the ER with a bleeding problem.

Its instructive too to see the very different story on this issue you will get from the EPs/Cardio's who have been waiting with baited breath for a true warfarin messiah for the longest time, and the front line Trauma/ER docs who have to deal with the real world consequences every day of these new drugs once they move from the relatively narrow experience of drug trials designed to promote the drugs and insure their approval and many more people come pouring through their ER doors with these kind of life or death problems.

I can tell you, most trauma do NOT like these new drugs at all, at least not without an effective reasonably quick reversal agent that is widely available and all personnel are trained to use it in ERs across the country and world.

By way example, when I met with my new Arizona EP on Wednesday we discussed these drugs in relation to my LAA isolation issue and he told me he was dead set against Pradaxa because 'it didn't have an antidote', but then he said: "Xeralto should be okay since it has a reversal agent now in Prothrombin Complex Concentrate". When I relayed to him what my neice said and that all trauma people are so concerned about, that at this time that is a false promise and misleading to feel any kind of comfort should you find yourself in an urgent situation needed to stop bleeding as no ER in the US currently stocks PCC which requires refrigeration and special handling, nor are any ER docs trained in using PCC for this application.

He was unaware of, and quite disturbed, to learn of this practical real world 'wrinkle' in the story he had gotten from colleagues and the Janssen Pharmaceutical reps who all had reassured him that there was now a ready and workable antidote available for Xeralto! That is the kind of differences you too often hear about not too long after the approval and release of many new drugs when listening solely to the specialist who prescribe it (some of whom may well have had a hand in the early studies with a vested interest in seeing it approved) in the beginning days of a new drug release, compared to what you will hear from the ER docs who see the actual consequences pretty quickly coming through their doors.. that sometimes paint a starkly different story than the rosy glow from the slick adds and the initial hype frankly too many of the new wonder drugs.

I'm sure they will come to some workable solution at some point down the road ... I sure hope so! I would much prefer taking Xeralto or Eliguis than Warfarin if I didn't feel like I had to wear a Formula 1 helmet and fire suit every time I turned on my Audi for a drive to the grocery store .


Shannon

Hi Cindy,

I'm glad you found the overview of the Lariet-II procedure helpful! We are all in this together and learn from each other that's for sure.

I'm very sorry too to hear of all your trials and tribulations of late with your difficult time getting this beast under control, which thankfully seems well on the way to being so now, and your fall and injuries, followed on top of it all by the death of your cousin from what sounds like a related issue with Coumadin/AFIB and a brain bleed!

You have sure had more than your share of woe and hopefully its all clearer skies for you for a long time to come!

I'm not sure now Cindy after re-reading your last post why Debra said you would have to wait a year?? My first hunch for the long delay was that I assumed she was inferring it would be a year before Dr. N started doing them in San Fran at CMPC. But I see now they are talking about a year also in either Austin or Scripps. You will have to get in contact with Deb to find out the details of which I am most interested too. I'm sure she will get back to you soon and you can always ring again for a reminder, or ask for Joan if Deb is too tied up with ablation patients that week. Joan handles most of the post-ablation after care issues at CPMC while Deb mainly handles the patients in the beginning and through the ablation itself.

I'm still keeping my fingers crossed I wont have to cross that bridge and can jsut stop Coumadin and go my merry way, but if I do have to deal with it life long (which I think is likely considering my LAA was already delayed some by the first ablation) I'll be right behind you in Austin for the Lariet-II. Definitely go to Austin if its either there or Scripps, as Dr. N is there the most time and he works closely with Dr, Burkhardt there to and they both do the Lariet-II procedure as a team and they have done nearly all of them together as I understand it so that is the place to go and they have a very professional team there at St. Davids in Austin as well.

Best of Luck and keep us posted!
Shannon

P.S. Cindy,
Yes its a shame I just missed you last March after your long ordeal in the hospital! You checked out the same morning I got there and when I asked Deb about where your room was she told me they had sprung you loose already that morning, which was very good to hear, in spite of the pinch in not getting to see you. Maybe next time we'll bump into each other in the waiting room for nothing more than a routine check up when everything is hunky dory all around!

Cheers!
Shannon

llois Wrote:
-------------------------------------------------------
> Cindy and Shannon, I have the same issues and I
> thank you, Shannon, for posting this information.
> It has been two years since my ablation by Dr.
> Natale at St. David's which included isolation of
> the LAA. I also had a TIA on the second day
> following the procedure. As a consequence, I am on
> life-long warfarin therapy--not my favorite thing.
> At one point, I was switched to Pradaxa but the GI
> side effects were horrendous, even with a PPI, and
> I went back on warfarin. After reading your
> analysis, Shannon, being on warfarin would appear
> to be the better/safer choice anyway and I know my
> primary care doctor prefers that I be on warfarin
> as well. I have not asked Dr. N whether the Lariat
> procedure would be a consideration for me but
> perhaps it is something I should look into. Again,
> thank you for sharing your experiences and
> knowledge.
>
> Be well,
>
> Laura

Laura.
So sorry to hear about your TIA and your life long warfarin therapy. Just curious but I'm assuming your LAA isolation is the main reason for this.
Reason I'm asking is I've been told I could eventually drop the blood thinners after a successful ablation after about a year due to my recent
Tia or stroke. God I hate that word stroke!

Shannon,
I drive an Infinity I believe it has 6 air bags so no need for a crash helmet.
My apologies no way did I mean your niece was a greenhorn first year resident.
Chief Attending Physician at the largest level 1 trauma center in Houston pretty impressive its obvious the smarts run in the family.
Pretty disturbing that they would release these drugs with no reversal agents. My cardiologist also believes the PCC will help reverse Xarelto and they are working on an anecdote. I guess I'll have to talk to him again. I'll ask Dr Reddy and Dr Chinitz during my consultations. They do have rapid offset and they recommend you take it in the evening with your meal so maybe they're figuring you'll be safe for the first 10-12 hours at home? And Wafarin isn't exactly that easily reversed or is it?
Anyway this is more of a reason to get ablated soon so I can hopefully get off this crap! At least ablation would greatly reduce my stroke risk so I can at least stop anticoagulation for medical procedures. BTW How does one deal with surgery or a colonoscopy when in persistent or permanent afib?
In the meantime I'll keep using Xarelto it's easy to use with no hassles. I've become much more aware of walking down stairs,not speeding or getting into arguments and staying in the car when getting cut off, shaving, wearing gloves when repairing equipment at work and at my business etc.....

Hi McHale,

No problem at all with my niece, I just wanted you and all our other friends here to be aware the info wasn't just from a few local anecdotal reports so you could assess the info in the proper perspective ... this is a big issue among Trauma center directors and doctors all over the country and she said they have had a slow time being able to the word out and have it sink in to Cardiology and Internal Medicine doctor community,. Hence, the need for this more in-depth country-wide survey and report on the collective real-world experience of trauma centers and ERs in every state with these new drugs since they were released into the wild.

She is a smart cookie and has two young children too boot .. have no idea how she does it with running the large trauma center plus the kids.

Coumadin is an issue too as reflected in the fact that up to 30% who are taking either Warfarin (Coumadin), therapeutic aspirin doses or Plavix also dont make it out of the hospital when they show up with a bonefide trauma. However, everyone knows just what to do with Coumadin and every ER in the country has plenty of injectable protamine or Vitamin K on hand, as does every ambulance in the country so they can give it as needed before you ever arrive at the ER which could be the difference between life and death in some cases.

The fast action of the two new anti-coags apparently isn't fast enough to save the extra 40% of patients who never make it home, above and beyond those expected to die from the combination of a therapeutic dose of Coumadin on board when they have the very unfortunate experience of suffering a significant bleeding trauma when on any of these drugs!

She said that major difference in survival is largely due to the relative increased difficulty in reversing the anti-coagulation effect of Pradaxa and Xeralto (without a more practical and faster antidote) compared with Coumadin which every ER doc in the country and every ambulance medic understands and knows how to deal with.

Again not many EPs have gotten the word yet as was obvious in my conversation on Wednesday with my up-to-date and skilled EP here in Arizona. Keep in mind too, that as a group these docs have been under a lot of pressure to get on board with these new agents and promote them and most, if not the vast majority of them have been eagerly wanting them to work out which can have an unintentional subconscious bias effect even when one is trying to be objective. I'm sure one or more of these drugs ultimately will be seen as a big step forward over Coumadin once this 'inconvenient' major wrinkle of the lack of antidote is finally solved.

Alas, these are billion dollar new drugs being released and if the Big Pharma reps can, by any stretch of the imagination, bend over backwards to craft a rationale why its no big deal to approve and use these drugs now before a practical antidote is really ready.. you can be sure they would do so as we have seen in fact they have.
]
This doesn't mean the other comparisons with Coumadin are not valid! I'm sure these drugs .. at least Xeralto and Eliguis from preliminary reports sound like a positive improvement over the many known hassles and limitations of using Coumadin. But at this stage of the game it's more a case of 'the devil we know seems like a safer bet than the devil we don't know' and can leave you hanging high and dry very quickly. It basically like trading the stroke reduction benefits, which all of the drugs including Coumadin appear to do a decent job of to some degree, for yet another 'Sword of Damocles' with the extremely high odds of serious and even fatal trouble for any kind of real trauma.

One anecdote sticks in mind when my niece recounted this guy on Pradaxa who came in with a small cut in his right ear from a simple fender bender car accident in which he banged the side of his head and ear on the upper door sill of his car. He was strapped in and his front air bag went off and no one else in either car was even injured at all. Not a major crash by any means.

It quickly became a full day life or death struggle for him and the team of trauma docs she was running that day as they had to replace over 60 units of blood, or basically 12 entire body blood volumes!! And still they had to revert to an emergency Dialysis in order to clear enough of the drug effect from his body to save the guys life!! Had he been anywhere but a large and experienced Level 1 trauma center in a major metropolitan area this man would be pushing up daisies now without question.

Anyway, the recount of such experiences helps give a more visual feel for the problem than any number of dry stats might convey.

Infinity's are fine very well built cars and relatively safe too, similar to Audi and other well made rides, I too have become more alert and cautious in the car and elsewhere since having to go back on Coumadin and I now wear one of those Med-Alert necklaces too now so everyone will know the story if I cant tell them.

As far as pre-planned surgeries that is far easier to deal with on Coumadin since everyone knows the drill they will confirm you have a therapeutic INR and then either reverse it partially just before the surgery and get you back up to within the 2 to 3 INR range as soon as possible after the surgery is over, or they might switch you to Heperin and control it during the surgery that way. etc.Not sure what they do with Pradaxa and Xeralto but they must have some protocol out by now to deal with that?

Yep, the best ticket is to arrange, if at all possible, to get off these drugs when and if you can. But if you can't, then look seriously into the Lariet-II as an option to at least help greatly reduce the amount of anti-coag drugs you might need, and in the vast majority of Lariet-II installs, it will allow one to stop those drugs all together and get on with your life.

Take it easy!
Shannon

Shannon - thanks so much for taking the time to elaborate on the risks of the new anticoagulants.
The information you provide is priceless.

And thanks for explaining current the details of the Lariat procedure.
I'm bookmarking this thread since undoubtedly, we'll use it for frequent reference.

Best to you,
Jackie

McHale, I'm sorry I missed your post and questions. Here is my belated reply:
I'm on the lifelong warfarin because of the LAA isolation, the previous TIA, and my age (76). Also, I know another person, a bit younger than I, who also had the LAA isolated, no TIA, and is also on lifelong anticoagulation therapy. Somewhere on line, I read the results of a fairly recent Japanese study and it recommended that all patients who had the LAA isolated be on lifelong anticoagulation as well. Interestingly, just an hour or so prior to my TIA, I had an ocular migraine and I've always wondered if my minor stroke symptoms were more likely the symptoms of complex migraine. Since about my early 40s, I had experienced ocular migraines but only rarely and then not for years. However, after my ablation, they were frequent for a period of several months. Once again, there were several publications that I found indicating that ocular migraines were associated with transseptal puncture. So, there's something else to think about. Like you, I am not fond of the word "stroke". Every time I can't remember something, or someone's name, I think I'm having a stroke---it gets ridiculous.
McHale, I enjoy your sense of humor and I wish you the best on your journey.

Laura

Shannon,
You got it it's a bitch getting old; 5 years ago I was bench pressing 405 lbs. You think I put a little strain on my pulmonary veins with that macho crap
Now I'm afraid of a little cut or getting aggressive with anyone or getting into a fender bender! Damn you might as well put a skirt on me and make me wear high heels!
Just wondering if people bleed out differently whether on Wafarin Xarelto or Pradaxa? An ear cut was life and death while it might not be for someone else.
Last week after I left work I walked past an Ambulance and cop car with lights flashing and I glanced in. Holy crap it was a friend and co-worker who got hit at high speed by a bicyclist. He's been on wafarin for 25 years due to a mechanical heart valve and had a giant welt on his forehead but the bleeding was controlled and stopped. They took him in for observation overnight but he's fine.

Laura,
Glad you like my humor cause I'm jumping out of my skin at times! Appreciate you clearing that up its due to the LAA isolation and EF as the reason for life long coagulants. Stroke...everyone in my building practically knows I had a stroke so embarrassing.
Here's an interesting finding on Chad scores after ablation. Best of luck to you!

[ats.ctsnetjournals.org]

Conclusions
The purpose of this paper was not to debate the best anticoagulation medications but rather to investigate the role of the CHADS2 in the decision making surrounding anticoagulation after surgical ablation. We found that the number of thromboembolic events after surgical ablation was very low and unrelated to the CHADS2 or to rhythm status during follow-up. This, together with the higher rate of bleeding events (120 bleeding events in 69 patients), raises questions regarding the applicability of the HRS anticoagulation guidelines for patients after surgical ablation.

Furthermore, we believe that continuation of warfarin may have a major negative impact on patients' quality of life despite a successful surgical ablation. A large scale randomized study is required to redefine the risks and anticoagulation strategies for this group of patients especially when the left atrial appendage was surgically managed, and measurement of patients' quality of life must be taken into account.



Edited 1 time(s). Last edit at 10/01/2012 11:07AM by McHale.

Thanks for the information and article, McHale. Just as a point of interest, this morning, I had my first episode of afib since my ablation two years ago. It lasted only an hour but it has totally wiped me out for the day, not to mention the disappointment and the return of the old anxiety that always accompanies an episode. So, I guess I don't have this thing beat after all. Is it my imagination or does two years seem to be pretty much average for an ablation? I have said that I won't have a repeat procedure so I'll have to see what my EP says when I see him this week. Best wishes to you and good luck.

Laura

McHale,
450 pound benches might do it! That is a lot and its good those days are behind you considering having the wrestle now with AFIB.

Regarding difference in bleeding patterns or amount from the various blood thinners, I think it pretty individual as it is with all of them. OF fcourse not every one is going to have a life or death emergency with a shaving cut, regardless of the drug. Unless the anti-coag or INR in the case of Coumadin if off the charts too high!

The guy in the ER with the cut ear had banged his head pretty good on the rough line so I assume it wasnt a paper cut he was dealing with. Nonetheless, my neice said it was the kind of cut that a hand a few stitches would normally have done the job with no issues had he not been on Pradaxa. If he had been on a too high dose of Coumadin they would have reversed him first in tehe ER with Protamine injection and then sew him right up..

Many variables can be involved in the anti-coagulation cascade and I imagine there are just some broad general rules of thumb on how much bleeding to expect from any given person based on their INR level. Id be surprised if they had a real feel for it with such a comparison so early with Pradaxa and Xeralto compared to Coumadin?


If your friend with the bump and welt on his forehead had a normal range, or better yet, low normal range of INR (within 2 to 3) with a well managed Coumadin dosing, such that his INR was around say 2.2 to 2.5 and not up above 3 or 4 he should have stopped bleeding when the ambulance people got there, assuming there isn't any major arteries or veins severed. The bigger problems come from either more severe trauma and/or systemic bleeding or from the many people who don't pay close enough attention to their INR and let it drift too high.

Shannon

Laura,
Breaks my heart to hear that you had a breakout. I believe the general consensus is a 7% chance of afib each year out from ablation up to 5 years?
I don't know your story and details....who did your ablation, are you a lone affiber, were you permanent or persistent, duration etc......Chad score?
Was your episode as bad as your previous history? Maybe you won't get another for a long time so you'll have to see right? Ablation almost always improves things even if you have recurrence from what I recall.
At the last Boston Atrial Fibrillation Symposium 2012 2 guest speakers who ironically I'm going to meet Dr Chinitz and Dr Reddy spoke about the challenge of creating permanent ablation lines with repeat ablations needed to isolate these reconnections. Touch catheters might greatly help in resovling these problems but have yet to be approved in this country.
Afib attacks pretty much don't bother me I just get strokes....
Take it easy one day at a time.



Edited 1 time(s). Last edit at 10/02/2012 03:30AM by McHale.

Shannon,
What 450 lbs what do you thing I'm am some kind of animal roid head.....it was only 405lbs and I only did that a handful of times with 1 or 2 reps
I'll have to see how well I clot on Xarelto when I get cut were all different. I got wacked hard on the head today at work when a large telephone speaker fell on my head from about 8ft when I pulled up a computer room tile. No cut but it was red for a while and now normal. I've also banged my legs/shins on gym equipment pretty hard a few times but again no signs of bruising. We shall see.........hey maybe this stuff won't be that bad..........

My buddy at work is taking off till Wed or Thurs the bruising has spread with two very black eyes.

Peace out appreciate it!

Sorry to be so late responding to this subject. I had 2 ablations. The LAA was isolated during the second one. I now have an non functioning Left Atrium. I am now seeing an EP at a major medical center in Chicago. I am being told the EP doing my ablations was too aggressive and their research does not show any benefit to isolating the LAA. Also, the lariot procedured is in clincal trials at major instituions. Please be careful before entering into any surgical procedure. I did my research and chose an EP who I and most others thought was the best.

Claudia

Hello Claudia~ Oh my! If you posted previously that you had a non-functional left atrium, I must have missed it. That's dreadful. How are you impacted by that? Are you functional or relatively impaired? What is your current EP suggesting?
This is most distressing news and I'm so very sorry.
Kind regards,
Jackie

Hi,

When you say "with paroxysmal afibbers in the first ablation when the LAA is found to be either the prime or only driver of their arrhythmia", are you saying that some paroxysmal afibbers only have triggers coming from the LAA and no triggers in the four PVs and SVC/CS, posterior wall, roof, etc.? Or, are you saying that the LAA is found to be the prime or only drive of their arrhythmia AFTER the "standard" areas (four PVs and SVC/CS, posterior wall, roof, etc.) are ablated?

Basically, I'm trying to make a decision about whether or not to allow Dr. Natale to isolate my LAA, IF it comes to that when he's in there.

It's my first ablation with Dr. Natale. (Aside: I had a minor ablation done at Vanderbilt Heart in 2010 where they ablated the right isthmus to stop aflutter--they also found a Concealed Accessory Pathway (CAP) connecting my left ventricle to my left atrium, but they didn't ablate it b/c they were not able to induce Afib through it, just some PACs/PVCs). They did also find AVNRT which they ablated. In hindsight, the EP said he should have ablated the CAP, but he had never seen it before...he had about 300 cases under his belt at the time :/ Also, they were completely unable to induce Afib during the procedure, so they were even in doubt as to whether my pulmonary veins were active. They couldn't find any Afib trigger spots. I was in for 4 hours. Alas, that night I went into Afib...and now here I am 3 years later...)

I'm paroxsymal (and God-willing will not go beyond), although in the last 2 months, I've had my longest episodes of 17, 23, 27 and 17 hours. Since 2009, the episodes had been about 4-6 hours in length, several times a week--at times daily, and then steadily increasing in duration in the last 4 months.

Hopefully I will not have any issues with the LAA during the ablation, but I'm wondering even if I do, might it be better for me to wait on LAA isolation rather than risk long term anti-coagulation (I'm 33, so my risk of blood thinner complications will surely increase if I'm on for say 50 years!), even if Dr. Natale finds that he can't get me into NSR after all the other ablating?

Especially because I have not implemented The Strategy, but am beginning to ramp up now. However, my ablation date is set for May, so I won't have enough time to see the impact.

I'm wondering how much (%) all the other ablating reduces the Afib burden in someone who Dr. Natale says must have the LAA isolated?? Is it reduced enough so that one can manage Afib with The Strategy?

Thank you,

Stephen