Study comparing drugs and ablation

Since I am beginning to explore the possibility of ablation I found the article linked below interesting and worthy of discussion.

[www.forbes.com]

It is my understanding that Natale participated in this study.

Has this affected how our ins. carriers view ablation? I thought I read a post saying that blue cross required that you fail drug treatment before they will pay for an ablation.

How common is a tomponade?

EVERYONE fails drug treatment IMHO. I have been very lucky with TIKOSYN and have had NSR since Dec 2011 and my LA has shrunk from 60mm to what is now likely about 49mm. In range for a successful ablation; more so than at 60mm in any event.

Not everyone is good to go for an ablation out of the gate. I was not. At this point my EP is quite willing to do an ablation (he studied with Natale) but suggests that since I have a 100% solution (sorta) that I stick it out on the medication until I feel I must do the ablation. My issue is that the side effects of TIKOSYN are rearing their ugly head and I am teetering on the fence: quality of life and such versus the ablation which is not a guaranteed 100% fix.

My point is that it is a complicated question demanding a complicated answer and is certainly not black and white for everyone. I have some mornings where I am awakened with electricity flowing through my body at 4 a.m. and my balloon head does not clear until 10 or 11 a.m. Sounds trite but I am losing fully 1/4 of my waking lifetime hours. Is it time for an ablation? Doc says decision is mine at this point and that I am at the front of the line if I say "go".

In Ontario, as a resident, the cost of the ablation and all followups is zero. No insurance company to fight with excepting if one has private room coverage (and that means squat as my Dad had private coverage, etc., and the hospital simply did not have the space at ANY time over the past five years except for one short stay where he got a semi private room).

FWIW just my two cents input.

Murray L

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Tikosyn uptake Dec 2011 500ug b.i.d. NSR since!
Herein lies opinion, not professional advice, which all are well advised to seek.

From the paper, here are the centers participating:

Clinical Centers: Hamilton Health Sciences General Division, Hamilton, Ontario, Canada: C.A. Morillo (principal investigator), S. J. Connolly, J. S. Healey, S. Divakaramenon, and G. M. Nair; Victoria Cardiac Arrhythmia Trials Inc,Victoria, British Columbia, Canada: L. D. Sterns, R. L. Leather, and P. G. Novak; Southlake Regional, Newmarket, Ontario, Canada: A. Verma, Y. Khaykin, and Z. Wulffhart; London Health Sciences Centre, London, Ontario: A. C. Skanes, L. J. Gula, and G. J. Klein; Montreal Heart Institute, Montreal, Quebec, Canada: L. Macle and P. G. Guerra; Sunnybrook Medical Center, Toronto, Ontario: E. Crystal and I. Lashevsky; Universite de Laval, Quebec: J. Champagne, G. O'Hara, and J.-F. Sarrazin; McGill University, Montreal, Ontario: V. Essebag and T. Hadjis; Institute for Clinical and Experimental Medicine, Czech Republic: J. Kautzner and R. Cihak; Charles University, Czech Republic: D. Wichterle, S. Havranek, and J. Simek; Askelpois Klinik St Georg, Germany: K. H. Kuck; Abteilung Rhythmologie, Germany: T. Arentz and C. Herrera Siklódy; University Hospital Eppendorf, Germany: T. Rostock; F. Miulli Hospital, Italy: M. Grimaldi and G. Katsouras; St Davis Medical Center, Austin, Texas: A. Natale (principal investigator); and Austin Heart, Austin, Texas: D. R. Tschopp and J. N. Whitehill.

Hi Lynn,

Well, chalk that Forbes article up to yet another example of a poor job done by the lay press who all too typically are woefully uninformed about AFIB, ablations and cardiology in general.

First of all, RAAFT-II was a follow up to the ground breaking RAAFT-1 study of some years ago that truly did include mostly just 'highly experienced' centers and top EPs and which showed a bigger gap, not surprisingly, in the benefits for a single ablation versus two years of AAR drugs and compared to this RAAFT-II study.

The RAAFT-II study resulted from the one valid criticism of RAAFT-I, in that it was felt that since RAAFT-1 reflected more the high volume truly very experienced operators results, for the most part, it was therefore not entirely representative of the average ablation experience. And so Dr Natale was recruited to oversee the study design of the new RAAFT-II protocol, and he largely drove the efforts to fully fund the study.

The key point here, and that is not even hinted at in either this Forbes' reporter's superficial review of RAAFT-II, but even by Hugh Calkins editorial (he must have just made an oversight in his comment ...), is that almost the entirety of the patients evaluated and followed in RAAFT-II were from average to lessor experienced EPs and were mostly from Canada and Europe and did NOT include any 'highly experienced' operators really at all!,

And yet Calkins even lets it slide in a comment in his editorial that mistakenly implies that RAAFT-II was also done by 'highly experienced' centers, as was the RAAFT-I study ... perhaps he was just honestly mistaken in the moment and was thinking of the RAAFT-1 study when he made that comment, which is surely understandable.

The truth is, that the centers that were selected for RAAFT-II, by design, did a maximum of no more than 200 AFIB ablations/year, or less, which is far from what I, as well as most leading EPs, would classify as 'highly experienced'. And especially from the EPs themselves working at such an average to modest volume center whose numbers would be even less for total ablations a year on an individual basis.

As many of you know, I list 200 procedures a year as the bare minimum for a given EP before I would recommend even considering them for an ablation process, with certain special exceptions. This is admittedly a conservative approach to help insure the best odds of both a great outcome with the shortest number of procedures needed to successfully complete one's ablation process, and to insure significantly greater odds of a low risk experience.

Indeed, Dr Calkins noted that caveat in his comments about the risks involved in AFIB ablation when he said 'considerations of operator experience can make a big difference in terms of both safety and efficacy of the procedure' in his longer review of the Desmukh study on 10 year complications of AF ablations in the US. I suspect Dr Calkins would take real issue with the way the slant that this article portrays AF ablation as a process for addressing AF.

And Lynn, you mentioned Dr Natale's involvement in RAAFT-II, just keep in mind that his efforts were strictly limited to the design and layout of the study and research funding alone. Not one single patient from RAAFT-II was ablated by Dr Natale, nor any of his mentored EPs at St Davids in Austin or CPMC in San Francisco. ... His centers were not directly involved in this second phase of RAAFT at all and were only listed because of his organizational and design efforts to set the guidelines of the study up to begin with.

Another key point to remember is that AF ablation IS a 'process' which we harp on all the time here. These two RAAFT I & II studies generally only look at a single ablation compared to a course of AAR drugs over the same time frame in comparing them, rather than long term drug use compared to a successful ablation 'process' long term.

As such, the actual reality as expressed by this average case RAAFT-II study reviewing only average run of the mill ablationist, mostly in Canada and Europe, and where adenosine and isoporterenol drug challenge of ablation lesions during the index ablation was still very rarely done through the duration of both of these studies, this also puts the ablation outcomes and their risks in the worse possible light and yet still there was a notable advantage even over just a two year maximum course of AAR drugs with a single ablation by an average run of the mill EPs for the most part!

If they had included even the result of even just 1.3 touch up ablations per patient during this two year period, the real world benefits of ablation over drugs, even with run of the mill average EPs, would have been much higher indeed.

It is unfortunate that no doubt well-meaning but under-informed medical journalist so often just get the superficial sound bites from such a study. And then, so often convey their skewed impression of the big picture and what the results imply to the public.

This is no news to the vast majority of us here who have had ablations and gone through an ablation process with a decent operator. We know first hand that an expert ablation process is often the single best medical decision we have made. And in the large majority of cases, has resulted in vastly improving our quality of life by a wide margin from the dim challenging days of walking on eggs shells waiting for the next episode of arrhythmia to throw a blanket over our lives again, and again, and again ... until we are worn down to the bone.

As for risks as well, such as tamponade or the dreaded esophageal fistula. The 4 tamponades out of 127 persons in RAAFT-II is definitely excessive and does not at all reflect anything close to the rates common with more elite ablationists at truly top tier centers.

Speaking of Dr Natale for example, as of two weeks ago when I last checked, he has never had an esophageal fistula in spite of the unprecedented many thousands of often challenging AFIB/Flutter ablations he has done over the years. His rate of cardiac tamponade is extremely low as well over his 18 years of both focal and PVAI-based ablations.

Quite a number of years ago, Natale's centers eventually stopped doing routine PV-Stenosis CT scans during the 3 month follow up post ablation, since those CT scans for stenosis had all come back negative for so long that there was no longer a viable rationale for continued CT testing ...

Certainly, minor to modest temporary complications or side effects do happen, even with Dr Natale. and for any doc it's true that they could do everything perfectly right and still have some unwanted effects and outcome from time to time, such is the nature of working on so many variable bodies and physiologies. But it's clear you most definitely stack the odds way in your favor by choosing a highly skilled operator as one of you top priorities.

This RAAFT-II report when evaluated alongside the RAAFT-I study is just one more confirmation for our near religious zeal in urging newcomers here not to compromise any more than is necessary for their circumstances and finances in choosing the most experienced and renowned ablationist they can find, it and is why I make no apologies for seeming so strict on that issue.

My fondest wish is for every single afibber who comes to our site, if in spite of their very best efforts at dietary, mineral repletion, life style management and stress reduction methods that we strongly support, they still have continued arrhythmia ... to at least then learn enough to make their way to the very best EP they can find to increase their chances of having a great outcome.

It is not at all about interviewing a whole grab bag of ablationist and then just picking which doc happens to strike your fancy the best and gives you a good 'gut feel'.

So the reality of RAAFT-II is that while it is instructive in confirming the basic differences between going to generally more elite centers (RAAFT-I results) compared to more average centers (RAAFT-II results), and adds further reinforcement to our less compromising approach to EP selection here, it also shows a far from terrible outcome from most of the EPs in the RAAFT-II study, even though they typically might require an extra ablation or two to get to the level of the more experienced operator over a two year or more period compared to AAR drugs.

Hopefully, now that more and more Canadian and EU EPs will surely start adopting intra-procedural adenosine and Isuprel drug challenge as well as adopt the new Contact Force or low flow irrigated catheters and improved technology available now, even those among them that are average operator will improve their efficacy and risk numbers as well.

Shannon



Edited 3 time(s). Last edit at 08/09/2014 07:31PM by Shannon.

Why is an ablation so difficult, that only a few doctors are proficient in doing it? Even the best have to do a second or perhaps third ablation, many posters here have had to do so.

Liz

Shannon thanks so much for your very detailed explanation of that study. Any idea what Natalie's complication rates are and what types of complications do patients who go to a top tier ablationist experience.

Lynn -- I was ablated by Dr. Natale on March 4 at CPMC in San Fran. The procedure was much easier than I expected -- my recovery was easy -- and I have been in NSR ever since. I do not take any supplements -- my lifestyle is pretty much as it was -- but the difference is that I am slowly relaxing and returning to "normal" life -- as in life without the constant fear of AFIB -- wondering if I have my medication (which had serious side effects) -- and always watching the clock while waiting to see if I would convert or not. I was skeptical about the efficacy of an ablation and all of the hoopla about Dr. Natale -- but no longer. My AFIB screwed up my life between about age 54 and 58. The last nearly six months of NSR have been a gift -- I feel normal again. My only regret is that I waited so long to move forward with Dr. Natale. That was precious time wasted. Best of luck with your decision -- but I would not pay too much attention to the Forbes article -- speaking from direct experience.

Hi Lynn,
Just woke up before diving in to what I'm hoping with be the wrap up day for the next AFIB Report editing, but for sure by tomorrow will have it all done. Afterward if you'd like you can PM me your number and we can chat a bit, it might be easier to address some of your questions and concerns in a good mutual discussion.

Dr Natale has a very low complication rate and especially for any serious issues which are extremely rare. The most I typically hear of fall within the bounds or normal range side effects from the ablation process itself as will manifest in a wide range of different bodies and different physiologies and very different psychologies, some of which interpret rather typical post ablation experiences as minor hiccups and others interpret the exact same degree of tissue injury as if their right leg has been cut off by mistake, people's reactions range the full gamut and most fall n between, but what you find with Dr Natale is vanishing few with any real and lasting longer term issues at all.

The best thing is to check back with everyone some months later, like 6 months to even a year later and see their impression then of what the experience was like overall with Dr N.

Then you will see the real and overwhelming positive impact his work tends to have on so many beyond the temporary variability in different peoples inherent reactions to such things as a significant surgery.

Take Deluge for example, just above, in his clear and very typical expression about his Natale experience from his March ablation. His is a textbook typical response that we have seen time and time and time again with Dr Natale from our site and from other sites where patients have reported after going to him for their ablation process.

There is a range of typically minor issues you can experience after a perfectly successful ablation, hematoma of the groin puncture site as one, transient soreness in the chest as no doubt most common, especially when breathing in deeply for a few days to a couple weeks max. Some swallowing discomfort is possible that is invariably minor in nature and transitory, but if you read too much about fistulas and such things, some will automatically assume that is their problem and feel certain they are doomed ( even though Dr N has never had a single fistula dating all the way back to the dark ages of non irrigated catheters and rudimentary imaging systems) only to discover a few months later that it really wasn't that bad after all and that the projection and worry around what is well within the range of typical normal ablation experiences has indeed run its course, just as they were reassured it would and the sun is still rising in the east.

Some will feel more fatigued for a few days and some up to a month or slightly more still fill a little more tired or easily fatigued, especially those with preexisting and poorly treated adrenal and thyroid dysfunction.

It is a minimally invasive heart procedure though, for sure, so the odds are high you will feel some discomfort short term. What most of us have been pleasantly surprised at is how relatively minor the whole thing was in spite of what just happened to an within our bodies, and find the relief from AFIB well worth the effort, even if a single touch-up is needed to finish the whole story.

I can promise you Lynn, that you won't find any safer hands to trust your heart too and that includes the many more reticent EPs who claim doing the minimum work possible is their goal and safety is their only concern. Often times the piece meal ablationist, well meaning as they are, simply lack the skill, experience and confidence for seeing the issue clearly and realizing the safest and best way to prevent complications long term is to get the job done right in as few ablations as possible using all the skills that have been learned to minimize the chance for real harm.

If you go back through our archives and read how many people that have been to Dr N have been so grateful for having done so compared to the vanishingly few who have a negative experience with him, that will tell you all you need to know. With the large numbers of our readers who make that excellent choice, if Dr Natale had anything but a stellar track record for very low genuine complications, you would have at least seen some evidence of that here and on other sites instead of so many consecutive good experiences overall.

That said, with any such procedure and with any doc, even the finest, there are real risks as we have discussed many time here. You just minimize your risk odds greatly by going to the most experienced operators.

Follow Deluge's example and advice and go forth with confidence. You are never going to get a single reliable number from any EP that will tell you anything more accurate than what you will hear here from a freely open message board with so very may people going to Dr. Natale and with such an overwhelmingly positive experience reported time and again, even many years later, and hardly any of the opposite kind. The shear odds are strongly stacked in your favor Lynn with him, something I can whole heartedly verify from all of my interaction with him over the years as well.

Now its back at it to finish up the next newsletter.

Shannon



Edited 4 time(s). Last edit at 08/10/2014 09:07PM by Shannon.

Thanks Shannon. I have been searching the archives trying to get an idea of what the immediate aftermath of the procedure would be, as well as the blanking period. This is partially due to the fact that I am very risk adverse, but also because I know that getting a top tier doc will require travel and I am trying to envision what trudging through an airport and spending a few hrs. on a plane or having a lengthy drive would be like after undergoing this procedure. Even just traveling for a consult seems tricky, which shows how limiting my afib is for me right now. Travel produces anxiety and anxiety increases the likelihood of afib. Right now even with a heavy dose of metropolol I will have rates in the 150s when seated. This whole condition is just so insane.

You are welcome Lynn, and a few tips if flying makes you very nervous ... get a Valium or Ativan for the flight or even take a train.
I flew from Amsterdam to Hawaii in full blown symptomatic AFIB/flutter at 135bpm and that was rate controlled at the time with Toprol on board then back to Austin two weeks later in same condition for my first major index ablation and a week later flew back to Hawaii after the ablation in NSR and was no big deal.

And in the vast majority of post ablation reports people share here they can definitely make it hope with not much trouble at all after such procedures, especially with excellent quality operators at experienced centers ... The whole reason for traveling in the first place.

Of course, we all much prefer NSR for traveling and everyday life for that matter, but keep in mind too that after an ablation you typically are in NSR for the return trip, if you get flight delays I know its no fun and a bit of a hassle but just try to suck it up and determine with all your fortitude before hand that if there is a delay or re-routing or two on the way there or back you will just tell yourself ' this too shall pass' as it surely will and you WILL live. Our minds tend to get us very worked up by the idea of something that we dont find particularly enjoyable that it often paints a far worse scenario, even if your worse fear comes partly true, than what the real world reality of it really is.

Typically, the most that might happen to us on such a trip is some relatively minor inconvenience and perhaps a little hassle that, if we more or less prepare for and accept as a possibility up front and determine to take in stride, can really help keep the event, however much hassle it may be, tolerable and one you will be very glad you followed through with if that's what it takes to put you in elite hands for something as truly important as a heart ablation. It helps too in the midst of such frustrating moments to remember too that we will live to laugh about it and fight another day and be so glad you didn't let something like a plane flight or a train ride decide whether or not we will have the best quality support and care we would prefer for a procedure like that. At least, I've found such little reminders helpful when those kind of trying days happen.

That philosophy has always served me well at least. Projection, I've found, is often the only enemy of peace of mind.

Best wishes, Shannon



Edited 4 time(s). Last edit at 08/13/2014 02:09PM by Shannon.