Fib or Flutter Ablation? Loop Recorder? New Catheter Technique?

This is my first post here, although I've been reading and following materials on this incredible site for four months. Thank you all, especially the long timers ... Shannnon, George, Jackie, et al.

I'm working with Dr. VJ Swarup in Phoenix and have several options I'd like you seasoned ablation folks to advise me on.
I can chose one, two, or all of the following, but will need to re-schedule surgery next week.
1. Atrial flutter ablation
2. Insertion of an automated loop recorder to track events automatically
3. Full A-fib catheter ablation.

I have had paroxysmal a-fib for 6 years, am 64 years old, healthy and active (except lately). I've been taking Flecainide for four years, 50 mg/2X/day, upped two months ago to 100 mg 2X/day. My episodes rarely last more than 5 hours, but are debilitating, happening about three/week.

Since moving up to 100 mg Flec, I am exhausted, continue to have even lower blood pressure and average 59 BPM. I tried the beta blocker Metropolol and my BPM sank to 42 ... couldn't function. Of great concern, my episodes now are of atrial fluter and tachycardia rather than the occassional a-fib. A recent 10-day Holter Monitor recorded the more common form of flutter with heart rates up to 300 BpM. I've been hypothyroid for years and treat with Naturethroid (natural thyroid) 2 grains/day. I recently found I also have Hashimotos, similar to another recent blogger, Bel57 (Hi, Billie, from a fellow Arizonan. BTY, I am very impressed with Dr. Swarup at Az. Heart Rythm Center.)

My two questions:
1. Does it make sense to just go for a flutter ablation and insertion of an automated loop recorder, in order to reduce flecainide amounts and just hope that afib burden is lower (Dr. emphasized that a-flutter ablations do nothing to reduce a-fib occurance ... different place on atrium that's ablated), or should I just bite the bullet and do the full ablation? The former buys me time and understanding of just what my heart is doing. But I know that afib is the root issue here.

2. Has anyone heard of a new investigative cauterization method being field-tested currently, called something like EnMark or Endmark catheter ablation? It involves ten electrodes instead of one in the cauterization process. It doesn't form the gap, makes more lesions all together ... and that's all I know or can find out about.

I've been doing the protocol recommended in Han's strategy for two months, with all appropriate supplements and eating very low simple carbs, no wheat or dairy (except a little cheese), and no caffeine or alcohol. I had an Exa-Test done and my electrolytes are normal.

I am constantly exhausted even tho thyroid and adrenal readings are not too bad. I have a history of adrenal exhaustion, am a type-A person, and my Automatic Nervous System has become habituated to being on High Alert, despite many efforts to support the parasympathetic system. Still, I feel that this level of exhaustion is due to the flecainide, the low BP/BPM and the atrial tachycardia, even though my usual BP and BPM is in the near-brachycardia range. One cardiologist insisted that flecainide doesn't cause low blood pressure but my experience seems otherwise, altho I was better on 50mg 2Xday.

I'm trying to believe that being in such a predicament isn't "my fault" because of a driving personality, but that there are very real physiologic issues that I can't change (or havent thusfar) by just "right living". I have an organic farm and a CSA, so a natural lifestyle is what I live anyway. The phsychological factors are difficult to deal with too, once in the middle of this arrythmia-med-low BP/BpM cycle.

Anyone's thoughts and suggestions would be much appreciated. Right now I'm scheduled for A-flutter surgery and implantation of the loop recorder on Nov 20. I'd like to revisit that and possibly change to a full Afib ablation, but it's a scary step, as many of you know. I've worked 20 years with only a naturopath, but have held out about as long as I can, I think.

Hi Rita - I would not subject yourself to a procedure and all that entails just to have a flutter ablation. While we don't see many reports of problems, the procedure still is invasive and you endure the aftermath of the chemicals from anesthesia and so on, so my feeling is that if you must have the procedure, then it should be as inclusive as possible.

Most important.... You should strongly consider that your thyroid may be driving your escallating events. Two grains of Naturethroid is quite a bit and if it's really more your adrenals rather than than a thyroid issue, that dosing could be spiking you into a hyper- thyroid mode which can definitely cause Afib. When Armour thyroid was discontinued for a while, I asked if I could change to Naturethroid and my Functional Medicine MD advised against it because she said there were indications it was not good for those with Afib and dosing was tricky. Just a thought. You may find if you stop or lower the dosing significantly, your heart will calm down.

Those practitioners who work with adrenal issues always caution that the adrenals should be addressed first and then thyroid because if the reverse is done, then problems arise.

I widh you well,
Jackie

PS How fortunate you are to have an organic farm and a natural lifestyle!

If your are talking about a Right Atrial CVT flutter ablation which is what it sounds like, the current consenstous among elite ablationist, with studies to back up their experience, is that its more or less a waste of time and you are better off long term going for a full PVI ablation in which they can address the right flutter on the way out of the PVI procedure.

What have been discovered over the years is that right atrial flutter is essentially a precursor to full blown AFIB which almost invariably will raise its head at some point after your CVT flutter ablation so the recommendations are now to kill two birds with one stone and not do this piece meal approach.

In other words, while there are no quarantee's that you will be one and done with any ablation procedure and it is not uncommon to need a touch up procedure after an index PVI only ablation or a full persistent AFIB ablation, the odds of a person manifesting right atrial CTI Flutter being truly one and done with just that one right flutter approach alone and never need the full PVI are miniscule. Thus, what has been found by many of the true high volume operators , such at Dr Natale and a good number of others at Bordeaux, Penn and elsewhere at high volume centers is that it makes much more sense to address the PVI first and foremost and then, if need be, one can also address the right flutter circuit as one last step at the end of the left atrial ablation work while pulling all the catheters back into the right atrium on the way out of the body for a good 'twofer' bang for your buck.

The idea being that when this procedure is done by a highly skilled ablationist with a solid track record for minimal reconnections found, the odds of being one and done from such a procedure are considerably higher than if you started with just a stop gap CTI flutter alone, whether or not there is a loop recorder added, which is a good idea in any event.

There is enough good data supporting this shift in protocol that many EPs are pressing insurance to approve payment for a full PVI when the only manifestation so far is CTI flutter as a potential more efficient use of resources long term and could spare the patient added progressive electrical and structural remodeling if one can prevent the onset of the almost inevitable AFIB from getting a foothold even after a success local CTI flutter ablation has been performed.

So I would suggest going thte full PVI and if Dr Swarup also thinks you could use the CTI flutter circuit ablated too after he has completed the full PVI and tested everything then fine. Kill both birds with one stone, since the odds are so high you will be back for AFIB ablation sooner or later if you dont address it in the first go around.

Best wishes on your procedure, whatever direction you decide.

Shannon



Edited 2 time(s). Last edit at 11/09/2014 11:02PM by Shannon.

Thanks for all your insights, Jackie and Shannon. As a result of them and of my own re-thinking, I have cancelled that surgery date and am scheduling a fullPVI ablation in a month or a bit more. I'm still trying to get 3 months of using The Strategy protocol alone, to see if it makes a difference ... am in month two and not sure of difference yet. Certainly there's none in the way of more energy, even with weekly IVs of vitamins and minerals, tho that helps for a couple days.

I will talk tomorrow w/Dr Swarup, who by the way, does about 6-10 ablations a week. I like hiis wilingness to answer my many questions, and his office staff is great .. good indicators, but not as good as surgey success rates, which he says are at 85%. I hope to be part of this investigation his center is part of, using the EnMark (sp?) cathetterization system, and am also asking him to do th flutter ciruit ablation when he does the PVI. I will find out more about EnMark in a couple days.

A big question:
1. Do you all think it's essential to have Left Atrial Appendage removed or cut off with either Watchman device or Lariat procedure? He says I don't meet the FDA requirements for two major cardiac issues so can't do the Watchman, and from what I've read here, the Lariat procedure seems a little iffy. I have a slightly enlarged left atrium and mild Mitral Valve Prolapse ... nothing serious in either case. It just seems a surer bet to remove risk of stroke that way. But as he says, "with 85-90% success rate on the ablation, why do you want the LAA procedure? You just want NSR!" Hmmm.

I've also requested of my naturopath to switch from Naturthroid to Armour glandular thyroid, per your comments, Jackie. I had a short-term endocronologist to do more diagnostics on thyroid and adrenal function, but he refuses to work with patients who use glandular thyroid and not Centhroid, so we're at an impasse. I'll get the TSH, T3 and T4 readings done again soon ... two months ago they were in OK range, but I think it all depends on the tests. I've also changed the ratios of my hormone replacement cream.

So another set of questions:
2. What arethe most inclusive tests for adrenal condition? I've done the 24-hr saliva test but am thinking that's just for cortisol, not adrenalin etc. Is there better?
3. What's the best indicator of thyroid issues ... just the T--- tests? Anything else? Especially with Hashimotos?
4. Is the best test for viscocity the one from Meridian valley lab? Would a conventiona cardiologist give it credence if he had the results?

There. Four questions anda few comments. Still looking for anyone who knows of this 10electrode ablation method, will share info as I get it. Thanks again! (and yes, Jackie ... life on the farm is good, although not so much when I can't do any of the work around there lately.

Hi Rita - best of luck with your procedure. RE - I have not heard of EnMark and I follow the new devices closely. About 3 years ago, there was a Carlsbad, CA company that was experimenting with similar concept - spline based RF ablation. The trials did not end well. The catheter burned too hot and blood clots were formed on the catheter. As a result, the trials were stopped due to strokes in patients. Therefore, I would advise against using anything other than the existing RF standard which is the family of Biosense thermocool irrigated catheters.

PS

I took a look at nMARQ. It is an irrigated Lasso catheter so unlike the Carlsbad device that I mentioned. It should work in theory but there are definitely gaps if not used correctly. However, it is still in development and parameters are most likely NOT optimized yet. That is the reason for trial. Given a choice, I would request that existing FDA approved tools be used. In my opinion, nMARQ looks like a response to Medtronic's arctic front cryoablation balloon.

[www.biosensewebster.com]



Edited 2 time(s). Last edit at 11/11/2014 12:07PM by researcher.

Wow, Researcher ... nice job! I'll speak with the doc later today after looking at the link you sent. But in principle, (recognize I'm a newbbie at this field, just interested in partnering with a doc - not blindly following him/her) it would seem that if Az. Hearth Rythm Center is one of 10-20 nationwide OK'd to use this technology, and they're halfway through the trial period (about 4-5 months in) ... well, looking at the website, I would lean toward rather than away from being part of a study like this, especially knowing it's used in Europe. My impression is that FDA is usually last to support many new improved optons (as indicated by the fact that this and Watchman and maybe others are approved for general use in Europe and not here). I respect your studied opinions and greater experience in this field tho, so am not sure what to push for. I'll ask the doc what his success rate has been so far ... but it's probably a bit too soon to tell. He did say it would be at his discretion to use depending upon what he saw when in the ablation process with me. Hmmm .... great food for thought.

Hi Rita, my advice to all posters that have asked about being involved in clinical trials for new devices is try to avoid them. The irrigated Lasso ablation catheter may well be proven to be as effective as thermocool but that is a question that will have to be addressed through lengthy trials and followup. We just won't know for a few years. The latest devices that were recently cleared by the FDA are catheters that measure how much force is being placed on the heart tissue at the catheter tip. The safety and effectiveness of RF ablation is dependent on contact force, RF power and time. With the Lasso, I am not sure how they will go about figuring what's effective at the current stage of testing and development. Yes food for thought.

There are always the option of Natale at Scripps/Austin or the Intermountain group in Utah. I am guessing those are the most convenient top-notch alternatives for you.

Hi Rita,

A patient doesn't go into an ablation requesting an LAA isolation procedure, that is something that is done as a final step, typically only in more advanced cases that are highly unlikely to be effective with a straight PVAI/PVI with posterior wall isolation alone and for which even addressing other typical non-PV sources, beyond the anatomical PVI scope, still leaves very active triggering located within the LAA.

The problem is many EPs still are not expert in identifying true LAA signals and often get them confused and misidentified as coming from fast right atrial sources or along the ligament of Marshall along the LA roof, or other areas as a reflection stemming from a true LAA origin. In any event, there is only a need to address the LAA itself with isolation, when, after completing all other aspects of the procedure, there is still too much high amplitude and chaotic triggering from confirmed LAA origin, after every other source has been rendered quiet even under extensive isoproterenol drug challenge.

EPs who mostly address paroxysmal cases and whose practice is largely based around PVI only and perhaps with addressing posterior wall too, don't often get patients ... Or don't recognize them, whose main remaining source is the LAA.

Often when you hear of otherwise busy and rather experienced EPs who still get a good share of patients still not done after three or more procedures ( when it's clear the remaining issue is not just more reconnections of PVs or other previously ablated areas), very often the remaining unaddressed culprit is the LAA/CS complex, and if they have not made that area a focus of their practice, as still is too often the case though more are seeing the light all the time, you often see them trying yet again to just redo their prior ablation patterns in hopes of finally sealing it all up, which is tantamount to repeating what didn't really do the job over and over in hope of a different result
... I think that's the definition of insanity isn't it :-) .. All the while inadvertently ignoring the true big elephant in the room all along in the LAA.

I'll have to reread your history, but if you are just a straight forward paroxysmal Afibber with not very many years of frequent episodes of long duration the odds of you needing LAA isolation are very small.

Dr Swarup is a pretty skilled paroxysmal ablationist and is definitely one of the most active for sure in Arizona, but I don't know of his more complex ablation skills and experience level.

However, I second Researcher's advice to not be too quick to volunteer for a brand new catheter system in early trials. It maybe okay and turn out fine, but generally there is no shortage of guinea pigs they can recruit, so don't feel you have to be one for the sake of science. In addition, some young up and coming EPs are very enamored with all the latest wiz bang tech and just love to try out all the latest gizmos on their patients, and yet only a relatively small percentage of these new systems and tools fully pan out.

Better to be a bit cautious and follow the top elite EPs and centers who have access to everything and tend to be much more discriminating on what they choose to explore. When the elite EPs start to adopt tech as their frontline tools you can rest assured it is very well vetted and ready for prime time.

Cheers!
Shannon



Edited 3 time(s). Last edit at 11/18/2014 11:05AM by Shannon.

Thanks again, Researcher and Shannon.
Wow .. now I'm really in a quandry. I spoke with Dr. Swarup a few days ago, and also checked out the links below ... first one is a description of the trial ... 42 centers around the country are involved, his center is doing the 2nd highest number of them all. You'll see some pretty big centers there, although I don't know which ones to look for in particular. Here's the link to the trial description. [clinicaltrials.gov]
This is the link to Az. Heart Rythm Center's research list: [www.azheartrhythmcenter.com]

He says he's done about 25 of the nMarq procedures and feels that using this trial as just one arm of their therapy (one the regular catheter and the nmarq being available if he needs it) ... he says his sense is it's as good or better than regular catheterization ... raising his rate from 85-90% success to above. His quotes ... he uses a circular catheter ... not much pressure, he can burn intense spots together, giving less chance of gap, as opposed to burning one at a time which swells and so burn is hard with a line. (?) He says they're good at doing this ... achieve the same goals with small chance of gaps in the lines. Burn all in one go and are done with a frame. He says his success rate is very good, but of course there needs to be more time to know for sure.

Now mind you, some of that is Greek to me, but I do take good notes ... just don't understand them all! The other thing (silly, maybe) ... I get two CTscans of the chest and two brain MRIs as part of the study that I don't have to pay for ... which would give me even more baseline info for any future developments. Worth considering?

I tend to trust my gut but then start thinking too much, and in this case, its perhaps a good thing ... especially the collective perspectives we all have a chance to benefit from with you all on this site. Since I found this EP without really looking, and have talked to a patient who gives rave reviews, I haven't explored other options like Dr. Natale, Utah group, etc. Maybe I should. But this guy does the most ablations in the state, so that says something. I am just not sure about the trials after hearing from you both.

And meanwhile, maybe the Strategy's working ... haven't had a-fib in 16 days, and only a few atrial tachycardia events, and in the last few days am feeling a bit more energy after lowerring Flec t 75mg twice a day and reducing the 2 grains of glandular thyroid to 1.5. Options...Ugh. how much easier to stay blissfully ignorant and do what the doc says, whomever the doc may be! :>)

Hi Rita, Good to hear that Swarup is collecting his share of data for Biosense. Biosense is the dominant company in EP catheters so almost everyone that does clinical trials are under their consulting umbrella and the numerous centers involved should not influence how you think about new devices The trial was initiated in March 2013 and the last patients to be ablated will be September of next year. Final completion date will be 2018. The reason is that it takes 3-5 years of work to tell whether something is working as well or better than the current standard of care. Dr. Swarup told you that his nMarq patients are seeing higher success rate than his 85-90% success rate. If I was his patient, I would have two questions.

First, can he clarify his 85-90% success rate. For example, is that paroxysmal and after single procedure? Or perhaps all types of AF after touch up procedures, if so what is the breakdown for patients needing followup procedures and the number of followup procedures?

Second, at the very early stage of the trial where he has only treated 25 patients, how did he arrive at the conclusion that nMarq patients are doing better than other patients? Is it based on "feeling" or is he generating Kaplan Meier statistics? If he does have KM plot, can he share that and show the difference between the 2 arms - with the understanding that it is just a snapshot and not a full study (takes at least a significant number >25 of patients exceeding 12 months or longer post ablation for results to be conclusive).

If Dr Swarup has the statistics to back up his 85-90% success rate, there is really no reason to be part of the nMarq arm. Just stay in the cohort arm unless there is a big advantage elsewhere - such as safety and radiation reduction, etc ...

HI Rita,

Sorry I meant to get back to you late last week, but was swamped with my short weekend trip to Chicago and such. In any event, your first decription of the new catheter in question said it was called EnMark which neither myself, researcher, nor the EPs I spoke with in Chicago had ever heard of. I was pretty sure you must have been referring to the nMARQ from Biosense Webster as we know now you were. Its a really easy misspelling to make for sure.

The nMARQ is a very promising new catheter system, especially for PVI isolation work and should help most everyone to some degree, but most especially the less experienced EPs in getting more consistent transmural and long term durable PV lesion creation and thus will likely result in less reconnections. Though as researcher noted we have to await the full published results to the trial to find out.

Word is though that it is a very good system. Pierre Jais and the Bordeaux group really like it over the last year and Dr Natale and his groups are part of the same large trial here in the US now.

Dr Natale achieves a similar result already with his gliding or dragging angular catheter approach that avoids the typical dot by dot vertical pressure for each consecutive dot or burn as most EPs are taught to use. This dot by dot method does, as Dr Swarup noted. have a tendency to cause circular outer rings of inflammation around the center burn part as you can imagine for a circular catheter tip pressed directly down into the tissue... The problem is that this outer ridge of inflammation when it heals and subsides can leave a little gap between consecutive burns, that may have been temporarily sealed and continuous while the inflammation was still there.

Natales method by placing either a Thermocool Smart Touch or Smart Flow catheter at an angle with the tip placed right next to the reading electrodes on the mapping catheter as he drags both around the PVs (or in other areas os the LA and RA were a line or isolation circle is required) creates a continuous single ablation lesion that way. Of course it take talent to know how to do that and vary the pressure and and power equaling contact force as you drag across variable thickness tissue in certain areas of the LA, but its one of a number of reasons he has such stellar and consistent results with vanishing few reconnections found in his patients.

Most other EPs not find that the number one source of new activity found in their patients requiring repeat ablations is due to reconnections. Its endemic in Europe too where the less is more strategy, including less power, results in typically lower levels of success ( Bordeaux being one positive exception), but its true too in many US centers and EPs.

Hopefully the nMARQ will join the new contact force catheters as tools that can help EPs without the skill and experience level of a Dr Natale to achieve consistently better results over time as well.

I wouldn't be too worried about Dr Swarup using the nMARQ here, though researcher's point is well taken that if he can show clear data indicating the 85 to 90% success with his normal Thermocool catheters you probably are not going to gain a whole lot wit the nMARQs but you may well not do any worse with it either and their might be some advantages for him and you as he noted.

Anyway,, once it was clear to me which catheter you must be talking about I wanted to get back to you this weekend but this is the first chance Ive had to reply here since last week.

Best wishes on your procedure, Dr. Swarup is a very capable EP and you should do fine with him there in Phoenix. I met him last Feb in Orlando when he was at the same table I was at a dinner that was hosted for all the speakers at the ISLAA conference, and he is a nice guy as well. Give him my regards when you see him for the ablation.

Cheers!
Shannon

Wow! Talk about close timing! We're right now turning into to the Az. Heart Rythmcenter in Phx, havng driven down from Prescott. I am so grateful to you both, and wish i'd been able to get online sooner. I am signing the consent forms today and taking an MRI and CT scan for a new ablation date of Dec 18th. I have been so nervous and uncertain about what to do, Your information helps so much, Shannon and Researcher. I've had so many symptoms that are new and severe, including PVCs, Vagal incidents, and general extreme weakness, chest pains, severe headaches, that i didiced to keep on the path that has opened for me. I feel much more secure knowing that you both are more comfortable with nmarq and Biosense and that you, Shannon, have met and conversed with Dr. Swarup. Not only will I say hi for you, but I think I'll just give him a copy of these recent postings. That will reinforce the positive comments I've already made to him about this site. Blessings! I'll keep y'all posted as we go.