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Could Ablation for AF Be an Elaborate Placebo?

Posted by afhound99 
Could Ablation for AF Be an Elaborate Placebo?
June 26, 2016 02:09PM
Dr. John Mandrola "at it again"

[www.medscape.com]
Re: Could Ablation for AF Be an Elaborate Placebo?
June 26, 2016 04:43PM
Yeah Afhound 99 (and good to hear from you!) ... Dr Mandrola is at it again smiling smiley,

He brought up this crazy idea in an ongoing EP-oriented twitter conversation that a good number of top level EPs contribute too, including Drs. Natale, Amin Al Ahmad and Luigi DiBiase from St Davids most of us on this forum are familiar with, and EP Lab Director and elite level ablationist Dr Fermin Garcia and Dr. Pasquale Santangeli of Univ. of Penn as well as a host of other top level elite EPs like Sergio Penski and a quite a few others from around the world.

Even I have joined the group over the last couple of months and offer my two cents from time to time when a patient perspective might help flesh out a given conversation some, in addition to mostly the statistics and doctor's window on this condition.

Every single respected practicing EP ablationist in this twitter conversation responded to Dr John's trying to float this concept (and you could tell he was hoping it would gain some traction) with a resounding rebuke of the idea, offering solid, tangible real world vignettes and evidence from their every day experience ... or at least as much as is possible in a 140 characters/tweet on twitter, which is not much ... but all too the point. Enough, for sure, though to have inspired pause about embracing this projection before the author of this Medscape article might become inspired to actually print such a premise and thus risk confusing a whole bunch of folks.

And yet, here it is in print in Medscape in his column ... I guess it was just too enticing bait. Plus, the theme is in concert with his apparent growing skepticism and uncertainty when it comes to his own mixed feelings about AFIB ablation practice that he discusses on his blog, which is certainly his right. He certainly has had a different experience than I have, and so many others I know here that have also experienced first hand the life-changing relief from completing an expert ablation process by a top volume expert ablationist.

If Dr John is serious about really wanting to understand what is possible in this field, he would serve that desire to expand his perspective by going to spend a month at St Davids and witness first hand the gulf between such concepts he is now floating out to the world, and the reality of what is really possible with a very different perspective and understanding of how to address more complex arrhythmia. He would also be surprised to learn that folks who have undergone such an expert extended ablation process are doing very well in thier lives enjoying real freedom from the beast for the most part, and are not some kind of cardiac cripples that he has immplied in other musings as a rationale and defense from really investigating first hand how these advanced procedures really work that would totally undermine the mistaken concepts he promotes about more advanced ablation.

Alas, Im beginning to think Dr John is moved and motivated as much be wanting to simply take a contrarian view that is controversial ... perhaps to better support his predominant job now as a physician journalist, as much or more than he is concerned about being deliberate in considering the impact on patients and other non-EP medical specialties, by just tossing such concepts out there to get a rise out of the readers. Perhaps he just view his audience as the fellow EPs and doctors he is trying to encourage, and rightly so, to take a more life style risk factor view and stance in their own practices, but he seems to fail to understand how confusing and reticent his statements appear to regular afibbers trying to understand and blend the best of both worlds of learning and adopting better self-health care along with learning how to partner with the most experienced EP when, and if, adding in an expert ablation becomes ones next best choice to really have success in eliminating, or at least dramatically diminishing, the presence of AFIB/Flutter in our lives.

This idea of wondering is maybe the good results from AFIB ablation was all some kind of elaborate placebo was floated in an editorial by a Turkish group ... not exactly the hotbed of ablation research and leadership. It is exactly the kind of thought process that is likely to spring up when that persons first hand or second hand experience with AFIB ablation has been very mixed bag at best.

These folks would be stunned speechless to witness a maestro like Dr Natale render a man who had suffered from 24/7 non-stop symptomatic long standing persistent AFIB for 36 years!!! ... only to see Dr Natale convert this man within 43 minutes of his expert extended ablation protocol including LAA isolation, to pure NSR for the first time in 36 years, as over 250 of us witnessed in real time in the large amphi-theater room at St Davids during the two day EP-Live conference in Austin this past March!

I would just love to see Dr Mandrola try to stand up and posit this myth that what we just witnessed was a case of placebo in action with this fully anesthetized ULTRA-long 36 year duration of LSPAF patient!! He would have been tarred and feathered on the spot by the room full of EPs there.

In any event, Dr John is now promoting we do a double-blinded 'sham' ablation trial. Even though it is impossible to do a true double-blinded RCT with ablations (one can only blind the patients), unless you can figure out a way to blind your ablationist while he is performing the procedure ... and No thank you if he or she is going to do my ablation!! :-).

And brilliant EP Dr Kalyanam Shivkumar Director of the UCLA Arrhythmia program, gave a clear and insightful description to Dr John of why a 'Sham' AFIB ablation is an oxymoron from the outset, since just going inside and doing anything at all in the LA is going to change some EP parameters as it is. Not to mention the ethical hurdles of deciding which AFIB patients are going get the Sham procedure.

We are so far beyond even needing such a concept such as a Sham study, as Natale and quite a few other EPs stated in reply to Dr John on twitter.

In any event, Dr Amin Al-Ahmad, another very bright and skilled ablationist and EP educator, said in response to Dr John posting this new article on this twitter board yesterday: "AF Ablation in the wrong hands is placebo, Cryo for non-PAF (non-paroxysmal AFIcool smiley will fail with current technology."

And Dr Natale noted in one of his tweets in response to Dr Al-Ahmads comment, " (that is) Absolutely true ... and 'if you know what you are doing' and actually talk to your patients there is no doubt we're doing good things with ablations"

Dr Fermin Garcia: "Agree!! Technique and attention to detail is key. Not all AF ablation procedures are the same." (Amen to that)

I then pitched into the fray saying: "I could not agree more! Any EP who believes successful AFIB ablation of persistent AFIB equals a placebo must retire from doing any more AFIB ablations now."

I then added this following point: "With the 10yr history of all Medicare AF ablations ( in US from 2000 to 2010), where >/= 81% were done by EPs who do </= 25 AF ablations a year, this kind confused & wrong thinking results"

It's this big split we see in this field between so many undertrained EPs doing the majority of AF ablations most of whom have not progressed beyond a basic PVI -only approach that results in folks like Dr John being able to seriously ask themselves if maybe they are tricking themselves. You have to have a good number of failed outcomes where you are unable to restore durable NSR that can lead to such questions even being floated.

I don't blame other specialist for asking the question either, not when over 81% of all US ablations, as noted in the eye-opening Deshmukhs study two years ago, are being done by EPs doing 25 or less AFIB ablations a year ... and at small to modest sized centers/hospitals doing less than a total of 50 ablations a year!

25 ablations a year is simply not enough regular experience to even maintain basic muscle-memory and manual dexterity in manipulating a catheter inside the LA. And much less being able to actually improve your skill level. Instead, such an EP is far more likely to regress rather than advance their own skill and trade craft in AFIB ablations. Little wonder that this same important study found that this 81% of under-trained ablationist were responsible for, by far, the greatest percentage of complications and the least overall efficacy of ablation outcomes. No wonder, so many clinical EPs and Cardiology still hold a a mixed and uncertain view of AFIB ablation capability.

But this questionable view, is no where near the accurate real world reality that more elite level AFIB ablations are achieving every day. And this is why our website and forum is dedicated toward encouraging people to be very discriminating on who they choose to guide them toward durable freedom from this lousy condition. We saw the light along time ago, and understood from our own experience this stark dichotomy that exists in the EP world still yet, but that is improving all the time with real improvements in understanding beginning to reach a larger number of EPs, and thus leading to more and more EPs expanding their toolkits to include treatment of more advanced AFIB.

However, the net result still of this reality is this huge split between understanding and vision of what it even possible in an 'EXPERT ablation PROCESS' by so many otherwise often good and intelligent clinical EPs who either have not had an elite level persistent AFIB ablationist who does complex advanced AFIB ablations every day in their own practices, to lead their own AFIB fellowship training program.

And only a comparative handful of EP fellowship directors, as physician/educators, are themselves truly top volume elite level persistent AFIB ablation experts doing almost nothing else but AFIB ablations in their own daily practices. And any EP can only become so busy with such a huge demand for their services if they are a true AFIB ablation expert, the vast majority of EPs must do a lot of pacemakers, ICDs, CRT and other EP procedures each week to pay the bills and keep the lights on, as their location and/or skill level simply do not draw enough AFIB ablations to fill their schedules with mostly only AFIB ablations, and thus give them the experience base to become a genuine elite level persistent AFIB operator as a result.

This reality has a big impact on perceptions of what is possible with AFIB ablation, as no matter how well-rounded, smart and dedicated a given head of an EP fellowship program might be, and for sure the vast majority are excellent EP clinicians with a vast encyclopedic knowledge of the full scope of the field of EP, and most are outstanding educators on the bulk of EP topics each student needs to learn during their fellowship training. Nevertheless, it is simply not possible for a generalist clinical EP to also become an elite level advanced AFIB ablation expert too, as there are simply not enough hours in the day for a jack of all trades to become a true master of them all.

And it's not possible for new up and coming EPs who are not fortunate enough to be selected into one of the rare programs either directed by a maestro level persistent AF ablation expert, or at least whose program does have such a highly experienced ablationist in their group who can mentor these students and teach them their hard won nuances of complex advanced ablations that are far beyond the easiest Paroxysmal AFIB cases which generally require only a straight forward PVI/PVAI alone that every EP-ablationist learns as a baseline minimum.

Such EPs who lack either of these necessities for getting on the fact track toward themselves become elite level ablationists, are just going to have a much steeper mountain to climb if they are ever going learn and master those nuances and tricks of the trade that one can only realistically learn and master when working in the same room with a truly master ablationist for a number of years.

And, as such, its not too surprising how indoctrinated many EPs become to the philosophy and outlook on what is even possible with AFIB ablation, as well as adopting even what temperament they bring to the job, by the outlook and message that is continuously drummed into them by the head of their EP training! If that training emphasizes the more reticent largely cookie-cutter basic anatomical-only ablation approach, it is very hard for that new EP student to progress substantially and evolve beyond that perspectiveas they are so often wedded to the concept that only 'less is more' in AFIB ablation which is so appealing to their own lack of experience in even doing real time EP detection of non-PV triggers.

Its far more appealing for this class of EPs to simply relay on the fallback rules of thumb most often drummed into them by a very well meaning and intelligent clinical eP fellowship director and such EPs tend to be far more prone to accepting a promise of a quick and easy new ablation method like FIRM will tell them all jsut where to ablate outside of the anatomical PVI and spare them all having to learn real time EP sleuthing and decision making, while promising to make them all elite level ablationists without the years of training at a top volume ablation fellowship program that it now takes to even hope of joining such elite ranks.

In summary, there are so many here on our forum who have had intractable AFIB for any length of time in the past, especially the highly symptomatic advanced cases, and who have gone through and completed a full expert ablation process and are now enjoying a life of NSR, or at least dramatically reduced AFIB burden. Such a large number of former Afibbers, like myself, who can all attest wholeheartedly to what a ludicrous notion it is being floated by Dr John in this article, that such a sustained durable benefit is purely from placebo!

Funny how often I've seen an EP like Dr Natale, Rodney Horton, or Prof's Haissaguerre/Jais (on live video) .. etc .. achieve NSR when ablating a specifically detected real time trigger which was only detected during the middle of a challenging AFIB case while the patient was under general anesthesia and yet the patient sustained that NSR for many years there after. Must have been the result of placebo for sure :-)!

In all seriousness, though, if Dr John, or any EP for that matter, truly now believes, or is even leaning that way toward thinking that AFIB ablation is likely and primarily 'an elegant Placebo', as his thoroughly misguided proposition states, then by all means, morally and ethically he or she must recuse themselves of ever doing another AFIB ablation in their practice. At least so long as they still hold such a view.

When I posted that conclusion too on the EP twitter board yesterday after Dr John posted this new article, several top volume ablationist like Dr Al-Ahmad, Dr Garcia, Sergio Penski and Dr Joseph Cooper all agreed and retweeted my post showing their own support that if any EP actually believes and is promoting this view, they should stop doing ablations. At the very least every AFIB patient being offered and ablation has the right to know that his EP is reasonably confident he can do better than a placebo for his patients.

It is fine for a given EP and/or EP journalist to float such an idea of AF ablation = Placebo, and any such person is certainly entitled to his/her view and is free to express them as well. But as a practicing ablationist it just seems incompatible, if indeed any given EP actually is leaning toward AFIB ablation's effect being due to a Placebo effect. Certainly, if this is how they view the field, they should recuse themselves from performing any more ablations until, and unless, they regain more confidence and reassurance that there is an actual objective benefit to the procedure they are performing on real patients. And at the very least, such an EP must inform every prospective AF ablation patient that they hold such views about their craft and allow these patients the option of seeking ablation help elsewhere.

I sure would not want someone agreeing to doing an AFIB ablation on my heart when they either vocally, or even secretly, lacked confidence that they could fundamentally help me by their work. And not just rely on some 'elaborate placebo' to pull this rabbit of NSR from his or her hat!

And its just one more topic that is a red-herring to begin with, and that I don't have the time to address, but that our EP journalist friend has the uncanny timing to seemingly always drop on us all with such speculative musings that require a response on the forum right when Im trying to finish up an issue of the newsletter :-) :-/!

Glad to hear from you as its been a good while it seems afhound 99!

Shannon



Edited 5 time(s). Last edit at 06/28/2016 02:25PM by Shannon.
Re: Could Ablation for AF Be an Elaborate Placebo?
June 26, 2016 04:52PM
Hi Shannon, yes it's been a while. Still in NSR thankfully. I can't imagine how many people you've helped with your sage advice since I was last here.. a lot I am sure

I wonder if Mandrola just likes the publicity.

How is McHale - How ARE you McHale? (just watched the '86 Celtics footage again)
Re: Could Ablation for AF Be an Elaborate Placebo?
June 26, 2016 06:07PM
Good to hear Afhound99,

McHale is doing just fine and getting ready to take a trip back to his parents country of origin Greece, to visit one of the Greek isles that his family has property on and his aunt I believe lives there.

I was there in Austin the first 6 days of March to attend the bi-annual Ep-Live 2016 conference for intensive training of EPs on how to do advanced cutting edge ablation and other AFIB and VT related procedures like VT epicardial/endocardial ablation and LAA isolation and closure procedures. etc. And in a case of good timing, McHale was up for his touch up to his index ablation he had two and a half years ago in NYC by Dr Natale at St Lukes hospital in one of the very first cases Natale did there in the 6 months that he was doing procedures there.

When it was clear McHale would have his follow up ablation just two days before the EP-Live conference was to start that I was set to attend as well, I rearranged my flight and hotel to get in a couple of days early with enough time to help usher McHale through the process and witness his full ablation first hand in the EP Lab. I even took a short video of McHale having a LINQ implanted monitoring device installed in his left chest between his sternum and left pectoral muscle (and McHale has some muscles ! :-), while I was standing in full hospital scrubs ... aka the 'bunny suit' ... with the blue hat, mask and gloves at the head of the EP Lab ablation table and filming this small procedure close up with my I-phone.

With McHale's permission, maybe I will post an edited copy of the clip showing the actual prep and insertion of the LINQ into the subcutaneous layer of his chest, once the website redesign is finished, which we are targeting for this autumn, and when we should be able to more easily host videos and other multi-media education tools. Anyway, it was a pleasure getting to meet McHale in person after we had become such good pals over the last few years as well, and be able to be there for him as he had no friends or family in the Austin area.

There were several very well known EPs from Europe there that day too in the EP Lab also watching Dr Natale perform McHale's ablation and LAA isolation that he required, and it was a treat to watch the reactions of these other highly-experienced ablation EPs while watching every detail of Dr Natale's performance. You can easily see the huge respect and joy they got out of watching the maestro at work, as they also called him when he came into the EP Lab to start the ablation.

In any event, McHale is doing great now and has passed his blanking period in good form and getting ready for a trip to the old country in August.

Take care,
Shannon



Edited 3 time(s). Last edit at 06/30/2016 10:38PM by Shannon.
Re: Could Ablation for AF Be an Elaborate Placebo?
June 26, 2016 06:27PM
How could RF ablation have ever been approved as a first line treatment if there wasn't plenty of evidence, I mean plenty, that it was not just a placebo? It may be a band-aid because we don't know the causes of the remodeling well enough to detect and prevent it through nutritional and lifestyle interventions but certainly not a placebo. If it were a placebo I know it certainly would have not worked (and continues to work) for me. I look at everything with a jaundiced eye, I cannot be hypnotized. No chance a placebo would work for me. I think this is a personal thing with Dr. John, he himself has suffered from afib and perhaps cannot imagine these invasive procedures being done on himself so is desperately looking for confirmation of another path than the one that repels him so much.
Re: Could Ablation for AF Be an Elaborate Placebo?
June 26, 2016 11:47PM
Hey my good old friend AFhound,

Good to hear from you and you're doing good and in NSR..
'm doing well now, had a touch-up March 1. But I was totally devastated , not expecting a first attack would last 35 days but rather a few mins at first......but NO!!!......it last 35days!
So I contact Jimmy Olsen who got in touch with Superman....and I was in Austin Texas on Super Tuesday for a touch-up...it was actually 31 min of burn time finishing up with a LAA isolation.

To be honest I think it was a dream, Dorothy and Toto were there and Shannon too somehow appeared in the EP Lab and when I woke up he fed me a cherry Popsicle.

Toto was it a Dream....sure seems like it was....Bird Parish McHale were there too......or was it a Placebo
I also saw Dr Mandrola smoking something........

McHale
Re: Could Ablation for AF Be an Elaborate Placebo?
June 30, 2016 10:50AM
I just read the article and some of the comments from general cardiologists are appalling with regards to how their patients are being managed and in one case downright refusal to refer patients to any EPs. My opinion is that Dr. Mandrola's idea may add some useful information if it is focused on centers that do less than 25 ablations per year and represent a majority of AF ablation volume. The doctors and procedures we talk about on this forum are almost all high volume experienced centers. And almost all of the publications regarding techniques, success and complications are from tertiary referral centers. Yet we are not the representation group as most patients are stuck with whatever is offered within reasonable distance. Therefore, a study like what Dr. Mandrola proposes for these low volume centers would add information that is now unknown, how well do these centers do in terms of long term success rates and major complications? From those results, maybe something can be done to concentrate expertise so that those AF patients can get better procedures or disease management.
Re: Could Ablation for AF Be an Elaborate Placebo?
July 01, 2016 01:49PM
In my early days of AF I, of course, found Dr. John's website courtesy of Google as I'm sure many of us have. At first it was good reading and helped educate me about the condition. Over time, though, I've got a sense of "blame the patient first" from his postings. Take myself, for example. 41 years old, normal BMI, normal BP, no heart disease (stress echo), no diabetes, no tobacco use, regular runner (6 miles/day at the time). What lifestyle modification am I supposed to make? I made the only one I could - I quit a stressful job. After that it was find a cardiologist who would refer me to an EP and bring the science to bear on this beast. Art wasn't going to help.

I wish Dr. John the best, but I'm at the point where I think his blog isn't helping the AF community (patients or practitioners).
Re: Could Ablation for AF Be an Elaborate Placebo?
July 02, 2016 10:01AM
HI Wolfpack,


Your saying: "I wish Dr. John the best, but I'm at the point where I think his blog isn't helping the AF community (patients or practitioners).", certainly underscores my take on the impact of his blog.

I have no doubt at all that he means well, and like so many well-meaning people he has some very good points and insights too. Some of which that are very close to what we, as an AFIB resource. promote and hold dear here at Afibbers.org and this forum. I have so often started reading a new piece by him and find myself wanting to cheer him on ... but too often especially over the last couple of years ... that excitement and enjoyment in reading part of one of his musings quickly turns into me slapping myself with a 'face-palm' and a groan half way through the article when I see him miss the bigger picture and/or so often go way overboard with a club-fisted over-promise about how universal Risk factor management alone will typically pan out for the bulk of AFIB patients long term ... and how often his own minimalist view of AFIB ablation has limited his vision of what is really possible with ablation.

The problem is the group of EPs he mostly respects and apparent uses as resources and reinforcement for their own shared ablation world view, share his reticent and doubtful view on the subject and so he gets enough 'High Fives' from almost others who for the most part are not maestro level ablation EPs.

Even this last twitter exchange with a good group of very experienced EPs where he posted the topic of 'Is Ablation an elaborate placebo' and got nearly a universal strong response to the negative on that idea, and yet preceded ahead anyway writing such an article that the reality of what is really being accomplished every single day in EP labs entirely escapes his vision, and thus what he shares with the world, therefore giving a very skewed and far more jaundiced view of what is possible when people make a discriminating choice for ablation EP.

Anyway, I think it becomes pretty self-evident when you read where that column has been going the last couple years. Every so often he has a really great blog entry I thoroughly enjoy and support ... to often though I find those kind of articles more the exception than the rule seen on Trials and Tribulations ... and in my view far too many now add more confusion than clarity especially for AFIB patient readers .. a group I think Dr. John underestimates his impact on. I think he mostly has in mind fellow cardios and EPs when he is writing his stuff, but does not much take into account the impact on AFIB patients trying to sort out this labyrinth of AFIB, and the feedback I get is that he is often way too confusing and sets up too many for making poor decisions, I fear.

At least there are other resources, in addition to ours, where a more accurate view can be heard... though I must say, and all home team bias aside, I truly feel Afibbers.org offers the most in-depth, reliable and highly experienced patient-oriented viewpoints on this field anywhere online, and has pretty much since its inception.

Shannon



Edited 3 time(s). Last edit at 07/07/2016 09:10PM by Shannon.
Re: Could Ablation for AF Be an Elaborate Placebo?
July 07, 2016 06:33AM
wolfpack,

we are in similar situations. can I ask some questions for comparison?

how often were you having episodes? how long were they? did you end up getting an ablation, and if so, with whom?

thanks!

-Eric
Re: Could Ablation for AF Be an Elaborate Placebo?
July 07, 2016 09:18AM
Eric,

The nitty gritty details of my AF probably don't belong in this thread, so I'll send you a private message instead.
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