FIRM update paper

[www.sciencedirect.com]

Direct Or Coincidental Elimination of Stable Rotors or Focal Sources May Explain Successful Atrial Fibrillation Ablation: On-Treatment Analysis of the CONFIRM (CONventional ablation for AF with or without Focal Impulse and Rotor Modulation) Trial

Dr Narayan is now doing FIRM without PVI with better better results than PVI. Another poster from another forum is having FIRM only on her paroxysmal afib it done today.
Her episodes occurs every other day.



Edited 1 time(s). Last edit at 04/09/2013 12:17PM by McHale.

In the paper, one cohort had FIRM+conventional ablation (which probably means PVI only). The other cohort had conventional ablation only. No one received FIRM alone. I think the Cadio Insight vest is the way to go for locating re-entrant circuits and FIRM is in danger of becoming a marketing campaign for the Topera device(s) and software. The Boston AF meeting notes posted here a few weeks ago suggest there is a lot of controversy about the claims of FIRM..

Hey Researcher,
Glad you're still here been to busy to post much just working too much and living life.
Yes there was lots skeptical frowns and moans in the crowd when one of Dr Narayan's presentations was about FIRM only without PVI durinf the 2013 AF Symposium. I too also wondered if the cardio-vest can also target rotors like FIRM and eliminate the need for unnecessary burning and PVI isolation. But he apparently is having success with FIRM alone and has proceeded to offer this. Also the Laser cardio-focus balloon laser trials are going strong with Dr Dr. Hugh Calkins at John Hopkins reporting 100% success so far according to one poster. Competition is good so let's see how it all pans out.
I'll be curious to see what this poster reports after her
FIRM only ablation today. She was getting 18 hour highly symptomatic afib every few days. Her husband is permanent I believe and is also getting FIRM soon.

Hi McHale, same here. The vest IMO is better because it is completely non-invasive and you get the whole picture in one measurement. With the Topera device used in FIRM, you will have blind spots LA (septum for example) and you have to move the spline into the RA to get a picture of what's happening in the RA. There is one advantage with the Topera, it would be possible to do re-mapping during the procedure.

Hi McHale,

My sense is that those who are recommending and advocating avoiding PVI-isolation as part of a long term successful ablation strategy at this point are WAY too premature based on the rather skimpy evidence Dr. Narayan has presented so far. Not one other truly top ablationist I know of is going out on that limb with Narayan and Topera .. Hugh Calkins not withstanding.

Its quite possible, perhaps likely, that with a little pre-selection screening for a PVI-less ablation that address other local trigger sites and rotors certainly can get some good early results ... but lets see how it holds up over a longer year and a half to two year period in a large cohort of different type of patients? But in any event, to recommend forgoing the PVI as an across the board new ablation strategy is still far too early.

There is a reason Narayan's latest reports at Boston AFIB were generally panned and/or met with a large dose of skepticism by the majority of EPs in attendance.

The fact that after well over a year after the first major presentations on FIRM, that Topera and Narayan have still not shown a live demonstration of their process to other top ablationists at these peer conferences is a significant red flag that perhaps indicated that their marketing train may well have gotten ahead of the reality they are finding in the real world. By now, every EP/ Device Company worth his/its salt would have presented evidence of their process in greater live real-time detail if there was really such a breakthrough at hand as Topera/Narayan have implied.

In addition, as of end of 2012, to the best of my knowledge they have not yet allowed FIRM for full evaluation and use in any of the top volume ablation centers, claiming they need more time to work out some 'issues'. Fair enough, but then it might be prudent to tone down the claims a bit until they can get repeatable consistent results with other independent operators in other major ablation centers.

In the study referenced above there are some interesting points, but what are they really saying?? It seems they are essentially reaffirming, in essence, the already generally well-known and accepted principles such that if you don't address active triggers you are likely to still have on-going breakthroughs... And if you address all the discovered sources of trouble and do a good job ferriting out those trigger areas which his what FIRM is intended to help with, you are likely to have much better freedom from AFIB.

That's basically the bottom line in this report and it doesn't really say much about FIRM used alone with no PVI, let along with for well over a years follow up time in a broad class of patients. This is like in some of the earlier Topera/Narayan reports where the devil is in the details and while it maybe interesting, to some degree, it doesn't appear to imply any real breakthrough in understanding at all or indicate some special magic in Topera's mapping system, at least none that I can discern.

Most other top EPs have long ago moved beyond PVI-only ablations and have developed good and repeatable techniques for discovering focal t

Their approach is looking less solid and exciting with each passing conference is the conclusion I am hearing across the board. Not unlike how the early hype over the first group of well done CAFE studies a half dozen years ago seemed to offer a similar degree of 'promise' of a more targeted approach with no PVI, only to see that fail to pan out as originally prescribed.

The Cardio-Insight vest, on the otherhand, which is using a broadly similar approach seems more promising as a 'potentially' interesting and useful non-invasive mapping tool to help further screen and define likely focal trigger spots and rotor formation that can then be further confirmed during an actual ablation procedure. Such a vest could possibly help narrow down the key target zones for the EP prior to starting the actual ablation and that could be very useful, particularly for those with less skill and experience in tracking down, interpreting and defining the best areas to ablate in each individual in real time.

Nevertheless, the Cardioinsight vest is still at the early experimental stage and we don't yet know to what degree, if any, it too will really advance ablation outcomes as a whole? However, the company and the information coming out of CardioInsight seems more reliable and forthright so far than the story we have gotten with the Topera system with their overly-secretive and questionable marketing strategy to-date.

Maybe Topera will still yet come up with something useful and avoid fading away like many other new ideas before it? Dr Narayan is likely a nice man and is certainly a smart guy. Apparently, they are building a higher resolution basket mapping catheter to address just a few of the complaints so far, but I'm afraid their bold 'revolutionary' pronouncements to this point on rather speculative evidence seems more like hopeful thinking than real world rigorous science to date. Its good that they have some competition now too in Cardio-Insight, maybe that will inspire better quality reports and more forthcoming openess and cooperation from Topera in the future? Time will tell.

Take care,

Shannon



Edited 6 time(s). Last edit at 04/23/2013 10:36PM by Shannon.

Shannon, Researcher and McHale,
Thanks as always for the ongoing informed debate.
Much appreciated,
Mike F