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FIRM ablation - first multicenter expirience

Posted by Namor 
FIRM ablation - first multicenter expirience
October 15, 2012 12:17PM
I would like to share with you the first results from a multicenter studies of Narayan's FIRM ablation and mapping. The results are still preliminary, as they are based on a small study of 14 patients and Narayan's poster presentation. However, I think it is not too early to get excited about these results, as they, in my opinion, herald a dawn of a new era in the treatment of atrial fibrillation.

So far, FIRM ablation was preformed on 180 patients at 9 different independent sites in USA. Rotors or focal beats were found in almost all the patients (severely enlarged atria of some patients did not permit successful mapping of sustaining sources). Ablation at rotors or focal beats terminated or organized AF in vast majority of cases, proving that those sources are in fact the sustaining mechanism of atrial fibrillation in all subjects. Furthermore, FIRM ablation is now being preformed as a stand-alone procedure, without PVI, at different centers. The results have been impressive so far.

For example, Narayan presents a case of a 56 year old man, who had persistent AF for 4 years, LA of 55 mm, LVEF of 56%. He underwent his first ablation using FIRM technology only, no PVI. He was subsequently implanted with a IRL monitor, which revealed that he has NO AF whatsoever for 16 weeks after ablation.

Another case, was a person with hypertrophic CM, heart failure, implanted ICD and persistent AF and LA of 62 mm. First ablation using FIRM only, no PVI. He had 1 RA rotor and 3 rotors in LA. In blanking period he had less than 1% AF on his ICD and significant improvement in his quality of life.

I know that there are people who are skeptical about Narayan's work. That is understandable considering the amount of false hopes and failed expectations that innovations in AF ablations had delivered before. However, once in a while real breakthrough do occur in medicine, that unable us to radically improve our understanding of specific conditions and enhance our treatment modalities. In my opinion Narayan's work is one of those breakthroughs. He was able to prove that atrial fibrillation is sustained by rotors and focal beats in all humans and that ablation of those sources terminated AF and rendered it uninducible. His work questions whether PVI is the best way to ablate AF, or even if it is necessary at all. We don't try to eliminate the PACs that trigger an AVRT episode in a person with accessory pathways, we simply ablate the substrate itself. Similarly, AF ablations can now be substrate based and individualized to patient's specific anatomy, which will ultimately result in better long-term outcomes and hopefully offer an elusive cure to younger patients with relatively healthy hearts.

I just want to re-emphasize that Narayan's work is major paradigm shift in world of AF ablations. It will not simply make it easier for 'inexperienced' EPs to ablate AF better, but it will drastically change the way we ablate AF altogether. Narayan's work demonstrated that rotors and focal beats are the elusive sustaining mechanism of AF that we were looking for. Furthermore, he also demonstrated that rotors poorly correlate to CFAE. And it also important to remember that Narayan's work was supported by the Bordeaux Group, as Pierre Jais is on the science advisory board of Topera Medical. Thus, the founding fathers of AF ablation had an important role to play in the development of the FIRM system. In conclusion, I would like to add that I think the FIRM system would revolutionize the way AF will be treated and should be considered a major breakthrough on par with the discoveries made by the Bordeaux Group in the 1990's.

References:

1. [www.ucsfcme.com]

2. Acute Termination Of Human Atrial Fibrillation By Identification And Catheter Ablation Of Localized Rotors And Sources: First Multicenter Experience of Focal Impulse and Rotor Modulation (FIRM) Ablation



Edited 2 time(s). Last edit at 10/15/2012 02:11PM by Namor.
Re: FIRM ablation - first multicenter expirience
October 15, 2012 02:26PM
Fantastic news!! I have a consultation with Dr Reddy at Mt ,Sinai Oct 31 who's center Is involved in the FIRM study.
He emailed in July that he is indeed doing FIRM. I'm elated but is this a case of too good to be true........ And it also important to remember that Narayan's work was supported by the Bordeaux Group, as Pierre Jais is on the science advisory board of Topera Medical. Thus, the founding fathers of AF ablation had an important role to play in the development of the FIRM system. Now if I could get this done without a PVI....



Edited 1 time(s). Last edit at 10/15/2012 03:36PM by McHale.
Re: FIRM ablation - first multicenter expirience
October 15, 2012 02:52PM
So should people switch from PVI now and just go to these centers that do FIRM?



Edited 1 time(s). Last edit at 10/15/2012 02:53PM by afhound99.
Re: FIRM ablation - first multicenter expirience
October 15, 2012 04:35PM
Namor,
Did I catch that they are using Cryo instead of RF for FIRM? This would make this ablation much safer too.
Re: FIRM ablation - first multicenter expirience
October 15, 2012 05:24PM
McHale, I think different centers use different energy sources and catheters. Some centers use cryo, some centers use irrigated catheters and some use non-irrigated catheters. You can ask Vivek Reddy what kind he uses at Mt. Sinai. Can you please talk to him ask him what does he think about FIRM and its efficiency?

Good luck!
Re: FIRM ablation - first multicenter expirience
October 15, 2012 09:41PM
Hey Namor,
I sure will pick his brain. I'm actually hoping he will accept me for a FIRM ablation without a PVI but let's see what he has to say. He did tell me in his email he does both; we do both/ either depending on the clinical scenario (paroxysmal vs persistent, duration of AF, co-morbidites, Drug use, heart size, etc).
I'm cautiously optimistic......

Is this the same study Dr John Mandrola talks about here?

[blogs.theheart.org]



Edited 2 time(s). Last edit at 10/15/2012 10:18PM by McHale.
mikef
Re: FIRM ablation - first multicenter expirience
October 16, 2012 01:46PM
Great news and thanks for the updated info.
Bring it on!
I hope that this will be available at Bordeaux come the time in the next few years when I will likely require an ablation.
Regards,
Mike F
Re: FIRM ablation - first multicenter expirience
October 16, 2012 05:29PM
How ironic just got a call from Dr Reddy's
Office cancellation tomorrow so I took the slot
Re: FIRM ablation - first multicenter expirience
October 16, 2012 06:11PM
McHale,

Yes this is the procedure John Mandrola was talking about. Can you please post here what Dr. Reddy has to say about it? Good luck with your appointment tomorrow!

mikef,

They already preform FIRM ablations at Bordeaux. Pierre Jais is on the Scientific Advisory Board of Topera Medical, the company which owns the license to FIRM technology. Both Pierre Jais and Michael Hassaigure played a role in development of FIRM technology; Narayan thanked them for their contributions in the publication of the CONFIRM study.
Re: FIRM ablation - first multicenter expirience
October 16, 2012 11:28PM
Namor,
I'm on a roll sure and I hope to bring good news. Finally we know the mechanism of AFIB much better than before thanks to FIRM and Dr Narayan and colleagues.
Shannon
Re: FIRM ablation - first multicenter expirience
October 17, 2012 03:47AM
Hi Namor and McHale,

Namor thanks for the interesting smaller second preliminary report of a 14 person group of people ablated with FIRM guidance, it’s always good to keep one’s eyes and ears open for new and possibly advantageous developments in the AFIB world.

However, in my view it’s still much too early to get too overly enthusiastic over Topera and FIRM ablation as some world-changing breakthrough that their press releases have painted it as based on the two rather skimpy reports so far that have only been authored by Dr. Narayan at this point and who is also the developer/inventor of the Topera mapping idea and is a major investor/co-owner of the company.

In the case of the first larger study of approximately 95 or so people, they used a biased control group that would likely only further inflate the apparent advantages of the FIRM system. I just don’t know why they would do that by offering ONLY anatomical-PVI to the majority of the 67 or so unfortunate persistent Afibbers who wound up being assigned to the control group? I think that really did those unfortunate people a disservice when it is well known and accepted that using PVI alone in persistent AFIB is woefully inadequate!

In addition, several top EPs I’ve discussed this with in detail before going for my second ablation in August, which turned out requiring LAA-isolation to deal with, remain highly skeptical that this really does represent a genuine breakthrough or revolutionary new approach as it is being marketed to be. The science to date as presented in these two reports remains inconclusive and raises as many questions as it does hopes, and is simply not rigorous and thorough enough, nor conclusive enough, as yet to warrant such exuberant pronouncements … and certainly not sufficient to warrant declaring PVI an obsolete step in the ablation process at this point.

Rushing off to demand a FIRM ablation now and asking the EP to forgo the PVI part, or any other mapping he might prefer, is what you might call putting the cart before the horse at this stage based on what is really known about the real sustained benefits of the FIRM approach compared to the state of the current art developed at Bordeaux and Natale’s group.

In no way am I questioning Dr. Narayan’s motives or integrity. I’m sure he’s a excellent physician and a true believer in his own work and no doubt very sincere and capable. But a lot of their approach to this by shrouding the technology in an unusually ultra-secretive blanket and releasing preliminary reports with just a few selected case studies and very little sustained follow-up so far reminds us very much of the whole ‘CAFÉ-Only’ ablation movement some years ago in which addressing somewhat similar focal ‘Complex Atrial Fractionated Electrograms’ alone without PVI was supposedly the new standard and where it’s at for the future.

That CAFE-Only approach too had similar marketing excitement and proclamations around it and used selected ‘early ablation’ stats to ‘prove’ their thesis. However, it didn’t pan out quite like it was supposed to once real world truly independent larger scale studies by respected EPs at various centers were carried out with at least a year and longer follow up periods.

Instead, what largely evolved out of the good things that CAFE ablation brought to the table was a more or less hybrid approach using both PVI as well as addressing other anatomical trigger areas like the CS, SVC, Mitral isthmus etc. and then mapping and ablating any real time CAFÉ triggers that could be found with careful mapping and stimulation while doing the ablation. This flexible method blended the best of both approaches and remains the current gold standard for persistent AFIB as well as those paroxysmal patients who have had episodes longer than 24 hours duration.

Of course, I realize there is a differences between what FIRM is trying to accomplish and the purely CAFÉ approach, but they both share in common an attempt to address local focal triggers of AFIB in the substrate rather than purely anatomical PVI and other fixed structures. And yet, both are/were trying to find a quicker and easier way for more EPs to be successful without having to go through a more prolonged learning and training curve .. all of which are very laudable goals.

Below are just a few questions and comments that come to mind that are worth getting better answers too before everyone rushes out to abandon their scheduled ablations across Europe and the US in anticipation of a time when all the docs might one day be fully up to speed and competent with FIRM and its system .. assuming that it ever pans out for real anywhere near the current hype?

1. How truly independent and Multi-center have these trials recounted in this second report actually been so far? And how much real follow-up has been done on these 180 patients to date, only 14 selectively chosen so far to publicize in a ‘preliminary’ report? It also seems that a good number of the operators implied from the nine ‘independent centers’ are either on the company science advisory board or board of directors of Topera?

That doesn’t necessarily imply anything fishy, but does beg for the wisdom to at least wait for not only their full and complete studies, but more importantly for us to start seeing truly unaffiliated EPs reporting well-designed long range study results that back up and confirm these enthusiastic reports as reported so far by Dr. Narayan and his group.

In this light, it is important to realize that the AFIB technology/medical world is pretty tight-knit and it is very common for many established and renowned EPs to be on many company boards and advisory panels, of course. But that does NOT inherently imply that they automatically fully endorse and are actively recommending any given technology or system from those companies at any given time! Often, their involvement is strictly as a paid advisor, and/or mainly as a professional interest in wanting to investigate and try out new technology that might look promising in order to discover firsthand what is really there for the long haul?

Dr. Reddy, for instance, has investigated many such tools as have Drs. Natale, Jais, Haissaguerre etc etc, most EP tech companies litearly throw such gear at the better respected EP ablationist and often both parties benefit as well as for the good of the knowledge base. Some of the gear and systems that come into these top EP labs the Docs have adopted and/or incorporated into their daily ablation practice. And yet, many more that seemed very promising and sound based on early reports and interesting concepts are now gathering dust in their respective EP lab basements, if they weren’t already sent back to the manufacturer.

McHale, perhaps ask Dr. Reddy how often he uses the Cardio-focus laser-guided balloon catheter these days in his daily ablation practice?? Same thing with the Stereotaxis system that at one point, from all the marketing hype, made many patients ask (or almost demand) their EPs to use it and some patients only felt comfortable and reassured when they saw a Stereotaxis unit parked in the EP lab before their ablation … only to learn later it was never used on them and today is rarely used at all for AFIB ablations.

Alas, there are far more stories like this than success stories in this field. Hence, the wisdom from the school of hard knocks that demands we allow the slower more deliberate process of real-world, more rigorous science to play out before getting too ahead of ourselves about whether or not a new technology really represents ... or doesn’t … a major ‘paradigm shift’.

2. The first and larger study of 95 some odd patients apparently included an overall majority of Persistent Afibbers (around 67 or so … if I recall correctly .. with around 33 or so paroxysmal patients) many, if not the majority of the persistent Afibbers were lumped into the control group even though they were offered ONLY the standard anatomical circumferential PVI which everyone and his uncle knows is a poor choice for persistent AFIB and is almost guaranteed to give a less than satisfactory outcome for a statistically significant percentage of those unfortunate persistent afibbers. This stacking of the deck, in turn, one could argue might very well make the FIRM system look even better in comparison.

Why would they need to do that if not for a marketing angle? To me, it seems borderline unethical, unless they fully informed those ‘controls’ that by agreeing to an anatomical PVI alone it had the poorest track record for success for their form of AFIB? And if they did tell them that, I can’t imagine they would have many people beating down the doors to line up for one... Anyway, if they are so confident in the system why feel the need to stack the deck like that, unless perhaps to get a glowing result for market launch and to grab early attention?

Why not compare it directly to the current state of the art method for persistent AFIB via Bordeaux and Natale results with this persistent cohort of patients? At least then they would likely be closer to an ‘apples to apple’ comparison I would think?

3. Also, as far as I could find, in that initial report there was no clear breakdown between how many of the 33 or so Paroxysmal patients were given the FIRM treatment and how many, if any, were put into the control group? And vice-verse with the persistent group.. how many of them, if any, were included in the FIRM ablation group relative to how many were lumped into the control group? A more rigorous and fair study should have made that breakdown more clear, but unless I missed something I couldn’t find any of that detailed in that first report?

It has been these kind of oversights that made me get the feeling that perhaps these were more like market-driven early studies intended to promote the concept and tell a good story, rather than the more solid and serious science that must follow to try and define the real comparative value of the system… although maybe I am wrong?

4. Also, Dr. Narayan talks of the mid-to-low 80% success rates and it may be valid within his criteria, which he says is around 1% or less AF for the blanking period and beyond. But that 80+%.. if I read it correctly .. was said to include both NSR and those whose AF 'organized' ( meaning converted to a tachyarrhythmia such as left flutter or SVT).

No doubt, 1% of actual AFIB is certainly a big improvement compared to 24/7 persistent AFIB, but that equals around 7 hours a month of actual AFIB as opposed to PAC runs or even flutter which doesn’t seem to get much mention outside of the acknowledgement that some percentage of cases don’t leave in NSR but after the AF has organized to a different speed of arrhythmia. While it would no doubt be a welcomed big step in the right direction, I doubt most Afibber’s would consider that 1% AF per month a roaring success, much less a ‘cure’.

Narayan and Topera’s website claim 88% either NSR or ‘slowed down’ arrhythmia as a result of FIRM ablations. It would be good to know what percentage of that 88% has to settle for 'slowed down' or otherwise ‘organized AFIB/ Tachy’ as a result? That wasn’t entirely clear to me either.

Both Bordeaux and Natale's group also get high percentage results consistently with persistent AFIB and very often with little to no AFIB itself going forward. I’m not sure if any distinction was made in Narayan’s work about atypical left flutter post ablation, but I didn’t see much about that? In any event, if the results reported do hold up in longer term larger trials it would still be an impressive and welcomed addition to the tool kit for ablationist, but even still I’m not so sure that it would necessarily qualify as a truly major ground-shifting breakthrough compared to what state of the art operators are consistently getting now?

5. Also, there is the little issue of the fact that the Basket mapping catheter used in the FIRM ablations is unable to map, and thus will not find, any triggers originating in the Coronary Sinus nor the Left Atrial Appendage!! This would have left me screwed, by example, had I chosen a FIRM procedure for my second ablation and only had that mapping strategy available, since ALL of my active rotors and focal triggers in my left and right atriums as well as in the sleeves of all four PVs. CS, SVC and elsewhere etc, had already successfully been found and ablated four years ago with zero leaks or reconnected PVs and not even one second of persistent or any other kind of actual AFIB over those four plus years since.

And yet, the suspected source of my periodic atypical left flutter was found to be only in and around the LAA, which would apparently never have been found had I chosen to hold out for the FIRM-only approach with the basket catheter. Food for thought, indeed…

I guess in that case I would have just had to settle for remaining in the unlucky 15% to 20% that the system doesn’t fix in this case had I only had a FIRM ablation?

The point of all this is not to dismiss the FIRM system at all, I truly hope it does turn out to be a solid and reliable addition that helps advance the state of the art in ablation technology and approach. Perhaps it will even become an essential first step in many ablations used to address the substrate issue, if and only when, it is truly proven to be a superior way to ferret out all those focal sources and allow zapping them easier and more reliably for the long haul? We really don’t know that yet though, these early very small enticing reports not-withstanding.

But I suspect too that the best EPs will still rely on their other tool kits and knowledge as well, and perhaps maybe it develops along the lines of another hybrid approach in which the Topera system might be included with other EP mapping tools to give the flexibility to be able to map out the rotors and focal points the basket catheter and Topera software is good at while maintaining the flexibility of still finding those trigger sources not seen now with the basket catheter?

That is, assuming the Topera system proves uniquely handy and better at ferreting out rotor and focal driver locations going forward which remains to be seen for sure. I can imagine that could potentially make the job easier than it is now and particularly for the less experienced operators, but also making everyone’s job easier including elite EPs? At least with a more flexible and inclusive approach, it might still be able to deal with more complex cases as well whose main trigger sources fall outside of the range of the static basket catheters?

Nevertheless, most of us will follow this story closely as it unfolds over the next year or two, and it will be great if it turns out as good as the early press would have us believe. But my main concern, after so many false promises along these lines have come and gone, is that too many less eager Afibbers will get sucked into something too soon and/or perhaps wind up postponing a perfectly good ablation that they may really need sooner rather than later, and wind you slipping into persistent AFIB, and possibly with added LAA involvement, which they might have been able to avoid had they stopped the fibrillation and remodeling earlier?

My limited understanding of Dr. Reddy's use fo FIRM so far is that he is investigating FIRM now but does not have a lot of real follow-up data as yet? Maybe he will tell you all about it McHale, but keep in mind too EPs can be very diplomatic and close to the vest when discussing research projects and if you don’t know him well, it’s possible he will keep it cordial and strictly business discussing whether or not he would recommend it now for you, but perhaps without getting too deeply into his real assessment of the system, particularly if his own view is still being formed at this time?

My two cents recommedation for your meeting is to perhaps consider not pressing him too hard for FIRM, but rather let him tell you up front what he would recommend for your case. After you get his recommendation, maybe then you could bring up FIRM and what you know of it?

I’m just concerned that if you are too gung ho for FIRM up front in your first meeting, he might well view you as a willing volunteer guinea pig for his ongoing investigations and give it a whirl and you might never know if that would have really been his first unsolicited choice for you?? If I was in your shoes, I’d want to hear his unguided suggestion first, without making him feel you are dead set on getting a FIRM ablation now come hell or high water?

And as for Dr Jais, he may well be investigating the machine and given advisory help to Dr Narayan.ANd perhaps he really is fully on board and supporting its use recently?? However, again lets be a little cautious in putting words in his mouth at this point, such as "Dr Jais is giving his full support for the Topera system" when he may well be still in his own investigation stage with it a this stage for all any of us know now??

Again, dont confuse top EP's colleagial or scientific affiliation with any of these EP tech companies with implying full blanket support and endorsement for all of their products and systems without hearing such directly from them!

Its curious that when Steve got his ablation with Dr Jais barely 6 months ago he mentioned to him the Cardio-insight mapping vest Cardio-insight as something he was very excited about for the near term future, and they were also investigating it at Bordeaux, but that it wasnt quite ready for prime time yet.

On the other hand, unless I missed something, I didn't read here that Jais mentioned anything at all to Steve about Topera?? Is that correct Steve? That doenst mean he doenst support it either, but I just caution everyone here to take a deep breath and go easy does it for now! until the dust settles on this whole issue a lot more than it has at this point smiling smiley

If this really pans out for the better, we will all find out with more conviciton in the coming year or two and we can all celebrate then....

Cheers! Shannon
Sounds great. Once again, a reminder to try every dietary and supplement manipulation in the book, to stave off any form of ablation as long as one can, while the techniques constantly improve. At this rate, won't be long before they are focusing some ablative radiation (Radio frequency? Microwave?) down to a sharp focus, from OUTSIDE the body, with virtually no risks at all! (Like they focus sound waves down onto a focal point to shatter kidney stones).

Namor,

You say 14 patients, then 180 patients! 180 is very different from 14. I'm sure there's a rationale, and I think I know it, but can you just clarify?
Re: FIRM ablation - first multicenter expirience
October 17, 2012 05:24AM
Shannon

Thnk you for that splendid post. At my last annual checkup I asked my EP here in London about FIRM and he said 'There have been many false dawns, we have to wait and see'.

Gill (successful ablation for long term persistent AF in Bordeaux January 2003)
Re: FIRM ablation - first multicenter expirience
October 17, 2012 07:57AM
Shannon,
I'm not going in there with hopes that this is the cure all for all afib. I actually have another appointment with Dr Chinitz tomorrow too.
No and I will not tell him it's FIRM or nothing else. I will listen to what he has to offer and I will grill him on his Techniques and how he does a PVI. and whether a hybrid approach would be better. As far a the laser balloon and Stereotaxis system those are sitting in his basement as far as I know. Minimal invasive surgery for my mothers large tumor in her colon was not possible according to top doctors. I found Dr Weiser at Sloan who told me he could do either open or laproscopic proficiently. that was 7 years ago and he did it with 2 pen holes and a little incision to remove the tumor.
I report back to what I think. I'm not easily swayed going in with a guarded attitude and Thanks for tempering all the excitement but one can dream.
Re: FIRM ablation - first multicenter expirience
October 17, 2012 11:17AM
Shannon, Nice comments and summary on the status of FIRM. I also have trouble understanding why the lead investigator moved the goal post instead of sticking with the accepted HRS guidelines for definition of success, That would be no AF episodes lasting for more than 30 seconds monitored by 24 hr Holter for 2 weeks at 6 and 12 months and yearly thereafter (depending on whether group is monitoring long term efficacy) post ablation. 1% is an improvement certainly for the patients that are suffering more but still would be failures by the guidelines. 1% of the time is almost a couple hours per week. My initial thoughts on this very preliminary results and the way the lead investigator is framing the recurrence is that FIRM is probably not any better than what Bordeaux and other leading groups are doing for persistent AF. There still may be some benefit for the less skilled and experience ablationists to use FIRM for mapping but even that needs proof and the vest concept being developed by Bordeaux and cardio insight may supersede that certainly in terms of safety if not speed.

Regarding the non-use of Stereotaxis for AF ablation, it must be that expert hands must be better than computers and magnets at this stage. The extra margin of safety must not be worth the hassle. I could see it would be of great benefit to the ablationists that are still climbing the learning curve. Example would be New Zealand where the busiest center was around 15% complication rate during their first year with something like 4% perforations and they wrote about it. Computers and magnets are apparently better than hands for the most complex cases such as unusual heart anatomy, pediatric hearts, left side VT (where mortality rate is around 10% with hand done procedures). Natale's group keeps their system busy doing mostly VT and some AF. Schweikert uses it but I don't know how often and for what cases. Something around 10000 cases a year of various types. Not enough for a profitable business. Too bad, it is a great concept and I am glad my hospital has one now. If they can get Natale to come out once in a while, that would be even better.

ps Clarification "My hospital" refers to the hospital that I would be taken to in case of problems and where my doctor's group have privileges. They are also have the busiest EP labs in the county.



Edited 1 time(s). Last edit at 10/17/2012 01:49PM by researcher.
Shannon
Re: FIRM ablation - first multicenter expirience
October 17, 2012 11:22AM
Gill Wrote:
-------------------------------------------------------
> Shannon
>
> Thnk you for that splendid post. At my last
> annual checkup I asked my EP here in London about
> FIRM and he said 'There have been many false
> dawns, we have to wait and see'.
> c
> Gill (successful ablation for long term persistent
> AF in Bordeaux January 2003)

Thanks Gill,
You're welcome, I agree too by all means incorporate a well rounded nutritional and 'Strategy'' assault on AFIB first and foremost... But as we both learned, at times some of us will also need to give your odds a major help by getting a solid ablation by the best EP you can find and not wait too awfully long while increasingly symptomatic episodes go on inspite of all our natural heroics...

Take care Gill, Shannon
Re: FIRM ablation - first multicenter expirience
October 17, 2012 12:31PM
Researcher,

Could you give any more information about,

” Example would be New Zealand where the busiest center was around 15% complication rate during their first year with something like 4% perforations and they wrote about it.”

Do you mean they are not the best place for an ablation?
If so, do you know what Centers to avoid.

Colin from NZ
Re: FIRM ablation - first multicenter expirience
October 17, 2012 12:45PM
Wow Shannon! That was quite a post. I'm really impressed with your knowledge of the subject matter. You must have done a lot of research on ablation techniques. I thought I did a lot of research before my ablation, but obviously I only skimmed the surface. I have to agree with you. I think it is a little early to demand a FIRM ablation. When I had my RF ablation, they were singing the praises for cryo ablation, and I really wanted one. When I asked my EP, although he had done some cryo ablations, he felt more comfortable doing an RF ablation on me. I felt better knowing that he had gotten all the kinks out with RF, rather than trying something he had less experience with. After my ablation, I asked my EP who was involved in some of the early FIRM tests, what he thought about it. He said "it is too early to tell" and that was all he would say.

Jim
Re: FIRM ablation - first multicenter expirience
October 17, 2012 01:02PM
You've certainly been a help to me, Shannon. I have known about FIRM of course but determined in my case I didn't want to wait in case any breakthough was applicable to my case, and as the (very experienced) EP I am working with said, training is a big part of the equation. I'm going in Friday and am to say the least apprehensive enough.
Re: FIRM ablation - first multicenter expirience
October 17, 2012 01:40PM
Colin, Didn't mean to scare you. If recollection serves, it was a retrospective study of their experience from when they started a decade ago so I am sure they are quite a bit further up the learning curve and better by now. How much better I don't have any idea. I think it was the Christchurch hospital. Still I think procedure volume just because of the population size would be quite a bit lighter compare to Australia's Royal Adelaide which would be the closest alternative for you. It has been a while since I looked at the abstract or poster summary (when another NZlander posted about what we thought about the level of expertise there).
Re: FIRM ablation - first multicenter expirience
October 17, 2012 01:54PM
Okay consulted with Dr Reddy hes done well over 1000 AFIB ablations he just doesn't keep track anymore. His nurse told be its a couple of thousand by now.He has his own lab and doesn't share time with any other EP's according to his nurse. He does about 2 a day 8 a week. He does Cyro but is not crazy about it doesn't feel it's durable. He's also doing laser balloon direct vision with results on par with RF but it's not approved here but I can get on the study trial if I want. The beauty of that is he can check for contiguous lesions direct sight. He uses the new Thermacool caths for RF with ICE and Naviscan or Cardio 3d mapping success rates 80-90% for paroxysmal like me. I asked about FIRM and the impression I got it's not for Paraxsymal AFIB like mine and it's not yet ready and lot's to be learned and explored still very investigational........in other words he wasn't too excited about it. I really liked him and he's top notch and he's backed up for 2 months for straight ablations. I'm too young to sit on this and go on more drugs plus I already had a TIA. Oh well one can dream......
Shannon
Re: FIRM ablation - first multicenter expirience
October 17, 2012 03:37PM
Good points Researcher!

I agree fully with everything you said. And you are right too the Stereotaxis is a great concept, especially for protecting the EPs and staff from excess radiation, but both Dr. Haissaguerre and Dr. Natale told me they mainly use it for VT and other special cases where manual placement difficulties warrant its use. Maybe someday they will get all the magnetic techology refined enough to better mimic the hard won skill and 'touch' of the most elite and experienced EPs for even everyday AFIB ablations, but I know of none of the really top guys who use it regularly for they daily afib/flutter ablations at this time.

And you got just my drift on the status of FIRM at this point in time. I'm not at all doubting that they have a workable and valuable system under development and certainly the concept is interesting enough to warrant a full on in-depth investigation by multiple independent centers, but my hunch from reading though the fine print is that FIRM is unlikely to represent a genuine 'paradigm-shifting breakthrough' in results when compared to the current state of the art from Natale group and Bordeaux, especially with regard to persistent AFIB.

The limitation, alone, of the basket catheter used for FIRM in fully mapping and discovering active trigger areas in the Coronary Sinus and LAA is certainly an real issue when trying to capture a complete view and analysis of the many possible driver sources for all persistent AFIB cases as well. But indeed, if the FIRM system and software results prove fully translatable to the experience of other EPs and top centers over time, then it may well become a very welcomed additional new tool to useful in combating the Beast.

And as you noted, once these remaining questions are answered in the positive, I can easily see the Topera system as a possible advantage for less experienced EPs, most of whom have not yet ventured much beyond boilerplate anatomical PVI ablations into other real time substrate triggers. For these EPs, if and when FIRM proves out, it may well open the door for these Docs still progressing up the learning curve to get quicker, better and longer lasting results than with only PVI-alone? Time will tell!

The EP that Jim above spoke with who has done some work with FIRM had just the kind of appropriately diplomatic answer any good Doc who is interested in working with FIRM to discover its potential would say when asked of its value a this stage of the game: ... "Its too early to tell".

Shannon
Shannon
Re: FIRM ablation - first multicenter expirience
October 17, 2012 04:04PM
Hi McHale, Many thanks for the prompt report back on your Dr. Reddy visit! He is one of the second wave up and coming top AFIB docs who is making a real name for himself. His feedback seems right on the money from all I have heard from other top EPs as well.

FIRM is interesting and certainly worth investigating, but not ready for prime-time yet and likely wont be for well over a year or two out from here .. at best. That's a lot of time to waste, especially if the nutritional approach either hasn't worked for you well enough, or just isn't your cup of tea, when for a case like yours a top EP equipped with the new version of BioSense Webster's Thermocool catheter with it's low fluid volume irrigation combined with ICE and Carto 3 can do the job with a high degree of reliability and likely buy you those two years and likely a lot more of NSR ... the set up Dr. Reddy uses now is just what Dr. Natale uses as well currently.

Again, its the man behind the tools that is by far the most important consideration here, and that will likely remain true in this field for many years to come!

Let us know who your meeting with Dr. Chinitz goes and which way you decide to go?

Take it easy, Shannon
Shannon
Re: FIRM ablation - first multicenter expirience
October 17, 2012 10:56PM
Good luck on Friday afhound, no doubt you'll do just fine, let us know how it goes and take it easy afterwards.
Best wishes Shannon
Re: FIRM ablation - first multicenter expirience
October 18, 2012 12:49AM
Shannon,
Dr Reddy and Steinberg Cornell-Columbia New York are new to FIRM so they might not be the up to speed yet with some other docs using FIRM.
I wouldn't count out FIRM just yet its more advanced than you might think............more info to come soon.
Shannon
Re: FIRM ablation - first multicenter expirience
October 18, 2012 03:18AM
McHale,

I want to emphasize, if it wasn't clear from my longer post on the matter, that no one ... certainly not me ... is counting out FIRM or the Topera system as not likely offering some benefits. I am simply urging caution at this stage about jumping over the moon based on market driven excitement before the kind of solid science is there to answer everyone's concerns and appropriate cautionary view on this more fully. Especially with the 'world-shifting' claims being made from the marketing department and lead investigator/system developer.

I'm as curious as anyone to see how it all plays out, and like I said earlier, I'd be one of the first to celebrate it proving to offer a consistently repeatable advantage with many other EPs running the system and ablations too.

What I don't like to see is people who really are in need of an ablation soon, jumping down the rabbit hole after Alice and possibly getting side-tracked in Wonderland for too long for their own good while the necessarily longer term more solid science results and consensus plays it self out. And thus, possibly make their own path out of these woods significantly more difficult long term. That is it in a nutshell from my view.

On the other hand, if someone feels so little urgency to get an ablation based on not having much activity or symptoms, then I don't understand why they would be looking so hard at ablations now in any event? In my book, you go for ablation when all other means of keeping the beast quiet have failed to do so and its a miserable deal having to live like that. Not when its still at the very optional minor nuisance phase of the game where the whole inner discussion you are having with yourself.

As far as more information about it beyond the two papers and what is offered on Topera's website, I'm all ears and eyes, but I hope it is credible documented long term results that it is based on, and not just from EPs who are checking it out and maybe enamored with the concept and promise at this point?

One of the things that I have learned is often true from meeting a number of the elite ablationist as well as even more very good EPs that are still very much climbing the lower to middle rungs of the experience ladder, is that for less experienced ablationist, such as our informative and fun to read EP-blogger friend who was immediately high as a kite on first look exposure at the initial FIRM paper, is that those who may not yet have a wealth of their own experience in this field are often a bit naively overly-influenced by the initial promise of each new wonder machine or system that comes down the pike.

This is what two of the very best ablationist in the world conveyed to me in different words and circumstances when describing how powerful the seduction these EP technology products and companies can be when the ablationist is still navigating the learning curve and is still connecting the dots and still maturing his own vision, philosophy, nuance and experience of what is important and not so important. And may still be learning how to recognize what new ideas also raise red flags along with some new promise. This natural naivety fueled as well by their own hope for a genuine breakthrough to make working with such a very complex and challenging procedure much easier for everyone .. beyond just the maestros ... is certainly understandable.

I guess its harder to sway and rope in the old dogs who have been around the block many times already, most of whom have learned to take it one step at a time and cross all the 'T's and dot all the 'I's before getting too fired up over the latest concept that seems promising. They will certainly investigate thoroughly and keep an open mind about anything that might have real merit, but are not so excitable as some young guns from the breathless descriptions of a new world order in AFIB.

Finally, whenever and if, the FIRM system more or less pans out going forward, and I needed an ablation and my options for using FIRM boiled down to a choice between a more typical ablationist with 500 to 1,500 ablations under their belt who was getting up to speed on using the new system, or going with a truly elite EP using the latest current gear they prefer with a hybrid approach, I would chose the better ablationist hands down over the new machine rather than FIRM driven by a decent but typically experienced EP every day of the week and twice on Sundays! That is the main point to take home out of this is making the man the priority rather than the machines.

Rest assured when FIRM is really on solid ground, you can count for sure on the fact that the very best operators in the world will not hesitate to adopt and incorporate it in their daily tool kits as well and that would be your best bet still for getting the most out of your ablation! In any event, time will certainly sort it all out one way or another before too long.

Shannon
Re: FIRM ablation - first multicenter expirience
October 18, 2012 08:49AM
In my book you get an ablation either when other means don't stop AFib, or if you don't want to be on anti-arrhythmic drugs. For me the flecainide is working well enough and I'm tolerating it well enough that I'm content to be on it a while and wait a couple of years and see what comes down the pike. But I don't want to be on it forever. And I'm not willing to be on any other anti-arrhythmic medication.
Re: FIRM ablation - first multicenter expirience
October 18, 2012 09:24AM
Hi Shannon,
I fully understand and respect what you're trying to say this is so hard to see thru the muddied waters.
I don't want to get sidetracked Dr Reddy is an excellent EP and I should bite the bullet and do it.
I was in a frenzy yesterday trying to get there on time with all the bridge traffic and construction even though I'm 3 miles away
My blood pressure was high but came down but the EKG showed NSR
Shannon
Re: FIRM ablation - first multicenter expirience
October 18, 2012 10:13AM
Hi McHale , in your case with the minor TIA warning and your experience with attempting nutrition control ,and while you are still paroxysmal it does sound like sooner rather than later is the way to go with a solid experienced EP.
Shannon
Re: FIRM ablation - first multicenter expirience
October 18, 2012 10:33AM
Hey Shannon,
I'm probably going to cancel Dr Chinitz as my insurance won't cover 2 consultation and 2 EKGs. I already had another one 3 months ago so who knows if they cover yesterday's.
Dr Reddy is top notch so why cloud my thinking even more..... Thoughts?
SHannon
Re: FIRM ablation - first multicenter expirience
October 18, 2012 01:22PM
McHale,
Can you ask your insurance if they will make an exception on the second consult that you can describe as a second opinion while selecting an ablation EP? I would think they would do that much .. and you could always ask for a copy of your EKG from yesterday too from Dr. Reddy's office to take to Chinitz, ( btw, I ALWAYS insist on getting personal copies of every test and medical document from every doctor to keep in your own hands .. it's a very good practice .. and gives you much more flexibility and is a great learning tool for tracking changes in your own body) Chinitz would listen to your heart anyway during his exam and an EKG from just yesterday should be more than sufficient for him at this point. And I don't think a simple EKG is a big expense in any event.

On the other hand, it sounds like you really clicked with Dr. Reddy and feel very confident and good about him doing the work, so if that is how you feel about him, by all means go for it! Dr Reddy has a good rep from all I have heard and is a very active EP in publishing research and clinical trials as well as progressing rapidly on his way into that elite range with the longer-term established guys from all that I have heard. I've heard also that a lot of folks really like Dr. Chinitz as well, but I personally know less about him and the details of his approach and philosophy about ablation than I do Dr. Reddy.

If you want or need to stay in the upper Northeast area to have it done, I don't know of anyone any better than those two in that region of the country, so either way you will surely be in good hands! Go with your instincts.

Shannon
Shannon
Re: FIRM ablation - first multicenter expirience
October 18, 2012 01:38PM
PS McHale,

Not to muddy the waters of your decision process any further, but if for any reason you feel less than comfortable with the two choices you are deciding between now, and if you are willing to travel what is likely a relatively short distance from where you live to Akron Ohio (at least relatively close in terms of distance for us western folks smiling smiley You can hardly go wrong with Dr. Robert Schweikert who works at Akron General and has a sterling reputation and is a top protege and close colleague of Dr. Natale. Anyway, if you feel solid with your New York options then settle in a go with it and no doubt you will be fine.

Shannon
Shannon
Re: FIRM ablation - first multicenter expirience
October 18, 2012 05:58PM
Agree too Diane, not wanting to be on cardiac drugs for life is a good reason too to go for ablation, especially since most of those drugs stop working at some point even when a person is 'lucky' enough to get a number of years of decent performance out of a drug like Flecanide. They also take a toll on the body.

I was referring mostly to giving the nutritional support a really good and thorough try first before ablation, but I realize it wont work as well for everyone and for many they are just not suited in their discipline and/or outlook about such things to be able to pull off the dedication that a thorough attempt to control the beast with diet and Strategy supplements will usually demand for them to have a real chance of working as well as they can.

Even then its not always enough as my case is a perfect example. However, I did procrastinate and wait a little too long tryijng every other means to keeping the genie in the bottle as much as possible before my first ablation, and wound up converting to persistent AFIB just three months before I could get in for that first ablation with Dr. Natale. That was in May 2008 that it converted to persistent AFIB and in March and April I had my first episodes lasting more than 24 hours. I had met both Drs. Haissaguerre and Natale in early January and early Feb of 2008 respectively and had I gotten it done prior to my AFIB episode starting to exceed 24 hrs at a pop, it might well have been an easier all around ablation nad perhaps not so much focus would have developed within my LAA??

Hard to know for sure, but there is fine line between waiting long enough to give all more natural or drug means a chance to keep things quiet and accepting that you better get that AFIB burden reduced asap to give yourself the best chance going forward for as much NSR as you can buy in this life.

Shannon
Re: FIRM ablation - first multicenter expirience
October 19, 2012 07:31AM
Hey Shannon,
I have every report from my stress tests, blood work,, sleep test, CT Scan, X-Ray's basically every medical record I can think of going back at least 15 years. It's good practice to compare say your Lipid Panels or Ac1 tests etc from years ago with the present results. I just didn't think of getting a copy of yesterdays EKG. I got my MRI of my brain and MRA of head and neck before I got released from the hospital after my TIA. Need to go back to get the X-Rays and Blood work.

I cancelled today with Dr Chinitz just had too much going on in my head and wasn't sure if I was covered.Yes I can ask for a second consultation but I'm struggling with this to begin with and need to take the plunge and just do it and not complicate my decision trying to pick EP's. Yes I like Dr Reddy and he has the experience expertise and tools to give me a chance at 80-90% success rate. He is also one of the few EP's like Natale who does the step-wise procedure for permanent afib does the Watcman etc.. Still can't wrap my head around doing this and hoping something like FIRM comes around soon......Oh the agony especially when you're in sweet NSR all week like I've been.



Edited 1 time(s). Last edit at 10/19/2012 07:47AM by McHale.
Re: FIRM ablation - first multicenter expirience
October 19, 2012 07:13PM
Hi McHale,
That is always the dilemma when you are currently in NSR .. everything is sunny and 'who needs an ablation', but as soon as the beast returns with a vengence you kick yourself for not having done it sooner .. and so on it goes ... often until finally one day you realize you procrastinated too long and wind up in 24/7 flippies and you cant get out other than a cardioversion, which itself is likely to bring all too temporary respite.

And all along the electrical remodeling and fibrotic scaring is progressing and its not a very pleasant scenario.

I can understand not wanting to have too many choices and Dr. Reddy seems certainly solid and competent. If you had wanted to really go full tile on the nutrient route and hadnt had your initial experience with that as you have, and if you had not already had a warning TIA I might feel a little less urgent in your case and council giving the supplemental route another good try, but that isn't for you at this point I can understand and its quite likely you will need this ablation in any event to get on top of this more effectively for the long haul.

Afterward, a revisit to good magnesium. potassium status etc is a good idea, if mostly to stack the odds in your favor and help the ablation settle in with less added stress on the body. Anyway, you can decide all that later.

We all know very well the back and forth argument when you are in NSR and cnat remember why you were even considering all this ablation nonsense to begin with, only suddenly for the whole world to shift again when the Beast comes roaring back in again and shows who is still really the boss.

I waited six months too long from exactly such rationalizations and procrastinations so I know it well smiling smiley ... Go with your gut instincts at this point and don't drive yourself nuts over it.

Look at it this way, if and when FIRM really does prove that it really adds anything at all to the work you would get done by Dr. Reddy now and should you need a 'touch-up' some years down the road, then a more mature and far better vetted, understood and accepted version of Topera's system will be there to help you as well during any possible touch up.

But the odds are well in your favor as a paroxysmal afibber still and with a very good EP for this to be one and done for a good long time if not for the long haul as it is, and all that time in NSR is priceless for staying ahead of the game.

At this point even looking at the highly biased numbers from Topera the approx percentage of 'success' as they define it is not any greater than the best ablationist out there with paroxysmal cases and thus your odds of needing a follow up procedure are more or less similar even if FIRM were ready for prime time now when compared to the current gold standard procedure that Dr. Reddy follows. That is why he is not in any rush to push you toward a FIRM ablation even though he could easily do one for you now.

In other words, you are not buying yourself anything substantial but extra frustration at this point by fretting too much over what you 'might miss out on' with a FIRM approach now. It simply isn't ready from prime time front line work and there are plenty of questions remaining about whether it ever will be.


Just kick back and relax this weekend and decide on Monday.

Shannon
Re: FIRM ablation - first multicenter expirience
October 19, 2012 08:09PM
Shannon,
Let me throw this at you? What if I found a top EP that is doing FIRM even if he had only done a limited number? A 90 min procedure with only < 10 burns vs > 200 for full blown PVI? I see all gain and not much downside with this. I'm sure you will correct me on this. My intuition tells me the way we do ablations now is overkill I actually have another name I won't use. I just can't believe Narayan is not on to something! Thanks so much for all the support you provide!



Edited 2 time(s). Last edit at 10/19/2012 08:17PM by McHale.
Re: FIRM ablation - first multicenter expirience
October 19, 2012 08:30PM
McHale,

You may be interested in my review of the CONFIRM trial as published in the October/November 2012 issue of The AFIB Report:

Focal ablation for atrial fibrillation (CONFIRM trial)
SAN DIEGO, CALIFORNIA. Since 1998 when Prof. Haissaguerre and colleagues in Bordeaux discovered that 94% of AF episodes are triggered by impulses originating in the pulmonary veins, the mainstay of catheter ablation for atrial fibrillation (AF) has been pulmonary vein isolation (PVI) in which the pulmonary veins are electrically isolated from the left atrium by rings of lesions created by cauterizing the heart tissue with catheters powered by radiofrequency energy or liquid nitrogen (cryoablation). There are two mapping approaches used to guide the ablation catheter.

• Segmental PVI (Haissaguerre/Natale protocol) in which electrophysiological mapping (using a multipolar Lasso catheter) is used to locate the pathways taken by aberrant impulses from the pulmonary veins. Once found, the pathways are eliminated by ablation around the veins approximately 5 to 10 mm from the ostium of the veins.

• Circumferential anatomical PVI (Pappone protocol) in which the anatomy, rather than the electrophysiological properties of the junction between the pulmonary veins and the left atrium are mapped, usually using a CARTO or Nav-X system. The anatomical structure shown on a computer screen is used to guide the creation of two lesions rings in the left atrium – one completely encircling the left pulmonary veins and another completely encircling the right pulmonary veins; the two rings are usually joined by a linear lesion.

The two protocols are about equally effective when it comes to paroxysmal AF; however, in the case of persistent and permanent AF, the Haissaguerre/Natale protocol is superior because the “trouble spots” or focal points involved in persistent/permanent AF, as well as in paroxysmal AF with long episodes (24 hours or greater) are located, not within the lesion rings encircling the pulmonary veins, but rather on the walls of the left and right atria, or in specific structures of the heart such as the left atrial appendage or the crista terminalis or superior vena cava in the right atrium. An electrophysiologist (EP) skilled in interpreting the information received during an electrophysiological study is far more likely to find and successfully ablate these trouble spots than an EP who relies solely on anatomical mapping.

The existence of focal points (reentrant circuits) in the atria liable to initiate AF has probably been known for a hundred years and ablation based on eliminating them was the norm prior to 1998, but with rather limited success. We now appear to have come full circle with the rediscovery of the importance of targeting these focal points or rather areas (local electrical rotors and focal impulse sources) in ablations, especially in the case of persistent AF.

Dr. Sanjiv Narayan and colleagues at the University of California at San Diego now report the results of the CONFIRM trial involving the mapping and elimination of focal impulse and rotor modulation (FIRM) with the aid of a 64-pole basket catheter and a sophisticated computer program known as the Topera system. The clinical trial involved 92 patients who underwent a total of 107 procedures (31 for paroxysmal AF and 76 for persistent AF). Thirty-six (34%) of the procedures were performed using FIRM-guided ablation followed by an anatomically-guided PVI. The FIRM-guided procedures included mapping and appropriate ablation in the right atrium as well.

The remaining 71 procedures were conventional anatomically-guided PVIs with an added left atrial roof line, again based on anatomic guidance. It would appear that no electrophysiological mapping was used during these procedures, nor was the right atrium mapped, or any effort made to locate and eliminate focal sources which can only be found using electrophysiological mapping. This would seem to be an unfortunate omission for the patients with persistent AF (66% of procedures were for persistent AF).

Not surprisingly, the outcome of the FIRM-guided procedures was far superior to the outcome of the conventional procedures. Patients were evaluated at 3, 6, 9, 12, 18 and 24 months and the incidence of AF episodes (recorded on implanted ECG monitors/ICDs, or with 7-day patient activated event recorders) was noted. An average (median) 273 days after their procedure, 82.4% of the participants of the FIRM-guided ablation group were AF-free as compared to only 44.9% in the conventional ablation group. The UCLA researchers conclude that the results of the FIRM-guided approach offer “a novel mechanistic framework and treatment paradigm for AF.”

Narayan, SM, et al. Treatment of atrial fibrillation by the ablation of localized sources. Journal of the American College of Cardiology, Vol. 60, August 14, 2012, pp. 628-36
Kuck, K-H and Wissner, E. A FIRM grip on atrial fibrillation. Journal of the American College of Cardiology, Vol. 60, August 14, 2012, pp. 637-38

Editor’s comment: Despite the clearly biased design of this trial, it certainly is encouraging to see a 2-year success rate of 82% for persistent afibbers. However, it should be kept in mind that the FIRM-guided approach was only used in 36 procedures. Independent confirmation of the efficacy of the approach obviously needs to be obtained before it can be declared “the future of ablation”. Nevertheless, if efficacy is indeed confirmed, the approach will be of significant benefit, especially for EPs who are now relying on anatomical rather than electrophysiological mapping to guide their ablation procedures. NOTE: I find it difficult to reconcile the statements “single-procedure success rate” and “repeat ablation was not permitted” with the fact that the trial involved 92 patients who underwent a total of 107 procedures.

Hans
Re: FIRM ablation - first multicenter expirience
October 19, 2012 08:51PM
Hans,
Yes I read this article subscribe to your newsletter invaluable info have all the PDF's stored on my Ipad. So much to absorb and sort out. I'm sure hoping there's more data to come out soon. FIRM is totally different than what the top EP's are doing.The difference in the Papone or Natale protocol that shuts down AFIB is first they do a PVI and then look for rogue "rotors" and when found and ablated: but are these indeed the same rotors found using FIRM?. Dr Narayan is shutting down AFIB in a few mins or 30 seconds before a PVI is even performed after the rotors/pulses are found thru his mapping system.Curious what these results would be without PVI but as stand alone procedure. Unless I'm missing something but Dr Narayan's talks about a few rotors sustaing AFIB. He is ablating focally and terminating AF before doing PVI. and now he is doing FIRM without PVI with the same success. He claims 2 or 3 rotors in sustaining AFIB. Am I reading this wrong?
This is why this will be a game changer if it pans out is all I'm saying.



Edited 3 time(s). Last edit at 10/20/2012 11:15AM by McHale.
Re: FIRM ablation - first multicenter expirience
October 21, 2012 09:39AM
Thanks Shannon. Just got back last night after 36 hours in Mass General. Went fine they say, no complications - well except how the urine catheter did some slight damage on the way out - but that resolved itself after a long wait and a couple of urologists. They nearly did a CT-scan. Mass General is a teaching hospital affiliated with Harvard Medical School and they seem to be knee-deep in doctors. I guess the EP Lab is highly rated, head of Lab is Dr. Moussa Mansour. I feel very little pain, just a high BPM now of 87 when my normal is about 60. That didn't kick in until I was about to leave the hospital. 3 hrs work for the EP, of which 20 mins was using X rays. They did a 'standard' PVI with a circle of ablation around each pair of PVs. The worst part of the whole thing in my case was the complication with the urine catheter and in most cases that would have been just uncomfortable for 5 hours but for the first couple you're out of it anyway so now big deal.

Funny thing was, just typical for PAF, I was really worried about not being able to use my PIP (Flec and Diltiziam) 6 days before the procedure in case I had an attack. I had 10 odd incidents in September that I quickly resolved with the PIP. But I only had AF the first day of non PIP allowance, and I walked it off in 3 hrs. The rest of the time prior to the procedure I was NSR so needed no Transesophageal echocardiogram. This disease is so hard. One trigger gets replaced with another. A remedy stops working. I thought I had kicked it with Iodine supplementation only to have it come back after 6 months.

So, 4 weeks on Warfarin and some other thing and hopefully it will all work out.
Re: FIRM ablation - first multicenter expirience
October 21, 2012 11:50AM
afhound, congratulations on your ablation! My heart rate went up with the ablation also. Went from 50's to the 80's, now after 6 months in the 70's. Some say that is a sign that the ablation is a success. Who knows? It's worked for me so far. Hope you have continued NSR.

Jim
Re: FIRM ablation - first multicenter expirience
October 21, 2012 12:31PM
Thanks Mailman. BPM now 75. I guess it's the heart trying to get its bearings but I wonder what the body does with all that extra blood pumping around. I asked one of the docs about it being high and he seemed puzzled (or maybe just too busy). Maybe it's a good thing. Dunno. Anyway, it was an 'experience' the whole 36 hours in a very busy downtown Boston hospital.
Re: FIRM ablation - first multicenter expirience
October 23, 2012 06:11PM
Good to hear it went relatively smoothly, at least the urine catheter implies they used an irrigated catheter which is standard issue these days and a good thing! But the foley catheters are usually no fun, especially when they yank them!

Anyway, take it easy and don't rush back into anything strenuous for a while.
Shannon
Re: FIRM ablation - first multicenter expirience
October 23, 2012 06:14PM
Hi McHale,

Below is a link to a few interesting videos of various ablations ablations and a Watchman device installation by Dr. Reddy I thought you might enjoy! he loves to explore new technology ...
Dr. Reddy videos

Cheers!
Shannon
Re: FIRM ablation - first multicenter expirience
October 23, 2012 10:28PM
Hey Shannon,
Watching that first video was eery as I watched the visuals of the Mt Sinai building and the entrance to the EP lab. They wheeled my mom in there last February for her valvoplasty for aortic stenosis after she called me in the morning with breathing problems. She was put on a ventilator gasping for every breath for 24 hours. After she came out of it they decided on the balloon procedure to open her calcified aortic valve as she again refused open heart surgery. Now percutanous valve replacement is almost ready for prime time but she should qualify for it with her age. See how quick technology revolutionizes procedures.
Yes I like him he loves his new toys! After I explore my options depending what I decide he might make a video of me. I'll post it right here to see how quick FIRM is ...... Thanks I 'll watch the rest when I get some time.



Edited 3 time(s). Last edit at 10/23/2012 11:00PM by McHale.
Re: FIRM ablation - first multicenter expirience
October 24, 2012 02:55AM
McHale,

Regarding your desire now to go ahead with a FIRM ablation, all I can say is you have to do what you feel is best for you. Ive pretty much covered my feelings about it at this point in time based on what we all know.

The final question to ask yourself is, why would I want to get this top EP who has done limited FIRM ablations so far ( Im assuming you mean Dr. Reddy?? ) and convince him to do it on you when he already told you it was still a bit too experimental and not really best suited for your case??

Again, I would caution against falling in love or infatuation with any reported technology, particularly one so preliminary as FIRM. My preference and seems like common sense to me is to first pick the very best and most experienced EP and then trust his opinion on the matter as he is likely to know what he feels is best for you better than either you or I?

Yes you might have a good outcome, but I would not want to be the one dictating to my EP what tools to use on me simply because it sounds like a good idea that I read in a couple preliminary articles that nearly every EP on the planet now is at best interested in seeing how it pans out but are they are not jumping over the moon to offer these ablations for run of the mill ablations at this point.

And it this othet 'top EP' is not Dr. Reddy, then why is he willing to do it for you when Dr, Reddy and likely most other EPs would not be willing too at this time. Is he more than willing to add you to his guinea pig list from the enthusiam to have them do a FIRM on you now? These are good questions to sort through in your decision making process.

But if you are dead set on getting a FIRM now, then fine, but why add even more uncertainty by choosing an EP who is either reluctant to do this procedure on you and/or who hasn't done many at all which just adds more risk that he will not be too skilled yet in both interpreting what he is seeing properly with the Topera system and then doing the FIRM ablation as well as it could be done? Why not then go to California and make sure Narayan does it if you want to stack the odds of it working as good as he says it can in your favor??

In any event, you seem to think a modern ablation is a hatchet job and it really isn't, Certainly not in skilled hands, and is mostly a pretty easy procedure to sail through as heart operations go. Nevertheless, don't let me dissuade you if this is what you wish to do!? I'm just sharing what I would do .. or wouldn't if I were making that choice (which I did a couple months ago). By all means, though go for it if you feel this is best for you now, chances are it might well help?? Maybe I'm too cautious and want further development first on such a new procedure for your taste? And that is fine, we each have to make our own decisions ultimately and live with them.

Best of luck with whatever you decide McHale.
Shannon



Edited 1 time(s). Last edit at 10/24/2012 09:10PM by Shannon.
Re: FIRM ablation - first multicenter expirience
October 25, 2012 10:28PM
Shannon,
No I did not convince Dr Reddy to perform a FIRM ablation on me. I'm not too sure he's really that involved in it since his main focus right now is principal investigator for the laser ballon which is not approved in the US. He did offer me that procedure but I told him I not sure I'd be interested. So he told me for my paroxysmal afib right now it would be best to do RF. I not even sure what this top EP I'm seeing next few weeks who made New York Magazine Top Doctors list at least 5 years running would even say to me. But he does lend much credibility to offer FIRM. If this was someone else I would be very reluctant to even consider but ill tell you this EP has probably done a few thousand ablations. I highly doubt FIRM would be that hard to master as compared to a PVI. If I have to go to Dr Narayan himself ill make that decision too. I'm just keeping an open mind.
.
No I don't think modern ablation is a hatchet job but a few targeted burns vs a few hundred would be preferable and not as risky comparatively speaking.
You're on your third ablation..........gosh it's time we found a better way!
All I will say I do know there is more positive news COMING about FIRM...........I need to investigate as much as I can before plunging into any procedure.
My heart is in a good rhythm right now my triggers were alcohol and heavy weight training so I'm buying myself some time I hope.



Edited 3 time(s). Last edit at 10/26/2012 06:09AM by McHale.
Re: FIRM ablation - first multicenter expirience
October 26, 2012 12:10PM
Based on McHale's experience with Dr. Reddy, that he was "offered" the laser balloon procedure, I suggest that people looking for ablations in NYC look elsewhere. It is absolutely unacceptable to "offer" up an experimental procedure that has been so complication plagued compare to established tools and procedures. I PM'd McHale with the same message and my explanations of the basis of my opinion on the use of 980 nm lasers inside the heart.
Re: FIRM ablation - first multicenter expirience
January 03, 2013 04:14PM
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