Pioneering treatment for atrial fibrillation

This isn’t current news but I thought I would bring it to the attention of readers as I don’t think it’s been mentioned here before.



“we have developed a technology that selectively targets the origin of the problem from outside rather than inside the heart” - chief executive Ken Coffey

“Our approach treats the origin of the problem, it is a permanent solution as the cells we are targeting never regenerate and it doesn’t harm the healthy heart muscle cells.”- chief executive Ken Coffey

[www.irishtimes.com]


You can see a visual demonstration of the treatment here (the video is less than a minute):

[www.youtube.com]


Here’s a more recent article:

“first-in-human trials of a device to treat Atrial Fibrillation with initial patients expected to be treated in about one year” (article dated 24th October 2019)

[www.nuigalway.ie]

Was reading that top article with excitement, until the end where it states 'commercial launch in 2024' haha.

That said, it's in Galway which isn't far from where I live so I may have a look into this. Great stuff.

I've always wondered why there was so little effort to find a way to treat this other than dangerous meds and literally burning the heart muscle.

So it's a nerve ablation rather than an atrial ablation.

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“Our technology involves using a catheter to deliver short pulses of electrical energy into the clusters of neuronal cells in which the arrhythmia originates. It destroys these cells without damaging the heart muscle and as such will provide a safe, durable and long-term solution for the treatment of AFib.

You wouldn't find me in the clinical trials for something like that.

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Carey
So it's a nerve ablation rather than an atrial ablation.

Isn't atrial fibrillation a problem with the autonomic nervous system ?
I don't say a nerve ablation would be a cure, but it seems logical treating the nerves when the problem is vagal tone.

I've seen my GP, some cardiologists and three electrophysiologists. I've seen two gastro-enterologists too... but no neurologist to date. Is it a mistake? Isn't it curious making burns in the atria when a heart is structurally normal?

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Carey
So it's a nerve ablation rather than an atrial ablation.

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Pompon
Isn't atrial fibrillation a problem with the autonomic nervous system ?
I don't say a nerve ablation would be a cure, but it seems logical treating the nerves when the problem is vagal tone.

I do recall reading some afib dog studies years ago. Ablating part of the vagus nerve did stop the afib, as I recall. Also, my understanding about the common increase in heart rate after an ablation is because of damage to the vagus nerve from the ablation. The heart rate (resting) decreases over time as the nerve heals or regrows.

A Google Scholar search some canine studies [scholar.google.com]

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Pompon
Isn't atrial fibrillation a problem with the autonomic nervous system ?
I don't say a nerve ablation would be a cure, but it seems logical treating the nerves when the problem is vagal tone.

It's not known with certainty what the cause is, but the autonomic nervous system isn't the leading candidate. The ANS can certainly be involved in triggering AF, but trigger and underlying cause are different things. That's like saying allergens are the cause of asthma. No, allergens don't cause asthma, but they do trigger it in people who have asthma the same way vagal activity probably isn't the cause of AF, but it can trigger it in people who have AF.

This is basically electroporation ... with an apparent twist ... otherwise more recently named Pulse Field Ablation (PFA) that we have covered extensively here on the forum over the past few years.

Over the course of these last few years of PFA's development and early trials, it has proven to be a very encouraging technology. Ironically, the origins of PFA date back to early days of electricity employing DC (direct current) as an energy source rather than the current tech of RF, CRYO (freezing) and much less often Laser-based ablation as the preferred energy sources used for ablating atrial and/or ventricular tissue.

The current energy sources used in Cardiac Ablations that we are all familiar with such as RF and CRYO are based on time-dependent conduction (heating or cooling) to ablate all tissue types found within the atria or ventricles indiscriminately.

In contrast, Pulse Field Ablation ablates 'non-thermally' in a tissue-selective manner, and based on our accumulated evidence so far PFA avoids any collateral damage to surrounding tissues in the area of ablations such as avoiding esophageal tissue damage, avoiding possible damage to both the phrenic nerve and potential PV stenosis as well, while still achieving an impressive success rate with a PVI.

PFA achieves this by creating microscopic pores in cellular membranes (i.e. electroporation), that when applied at a dose beyond threshold, destabilizes cell membranes via 'irreversible electroporation'.

Most uniquely advantageous, and simply by a lucky chance of nature, cardiac-myocytes have just about the lowest threshold required of any other human cells, and thus are ideally suited for irreversible electroporation to occur compared with nearly any other biological cellular tissue in humans.

Meaning, that in the process of achieving targeted cellular death in selective cardiac-myocytes necessary to create a durable ablation, all other adjacent non-cardiac-myocyte tissues are spared any collateral cellular damage at all.

PFA is a very rapid process with each lesion applied in seconds as well. Thus, PFA technology at this stage of its development looks very promising, indeed.

However, I'm not at all confidant at this stage about AtriANs press brief claim (hype?) that by targeting just 5 ganglionated plexi (GP) via an epicardial access ... even when using PFA ... they will achieve permanent 100% durable PVI every time. Color me very skeptical!

My sense is that they are riding this very exciting PFA tech wave, while then touting the much less certain epicardial access GP ablation and presenting it as a kind of Holy grail solution for AFIB ablation with, so far, very little evidence of reliable success with such GP ablation targets. Many top centers and renowned EPs have explored GP ablation with RF that has mostly been a mixed bag with a good deal of ho-humm results, even when GPs have been durably zapped with RF ablation by top operators.

This is a case of 'buyer beware' until ample independent proof exists consisting of multiple well-vetted large scale randomized controlled trials being completed by multiple independent sources, and all proving their thesis before any one should climb onto this particular bandwagon, especially at this stage of the game!

Us older timers on this forum who remember the FIRM debacle will recall the number of overly eager EPs in the field, especially younger Docs, who were breathlessly excited by the initial marketing promise of what was to be a true game-changing revolution in AFIB ablation that largely crashed after 6.5 years of disappointment in real world FIRM experience when even the companies very own randomized controlled trial failed to show any benefit beyond that of a standard PVI-alone.

In my view, it's is much too early to stand in line for a more typical classic PVI using PFA technology in any event, even if they were available now, which they are not, nor likely will they be for at least three to four more years of careful independent vetting. This is especially true if a given Afibber is currently suffering from frequent symptomatic episodes of AFIB.

Again, there are a few 'potential' efficacy advantages that may well result from using this exciting PFA energy source for Cardiac Ablation, and yet the main benefit that is so far undisputed is PFA's overall modest but exciting safety advantage above the already very safe RF ablation procedure when performed by highly experienced hands.

Those of you who are at that point in your AFIB history where you really want to be rid of this beast for good, and for whom no amount of reasonably robust life-style risk reduction methods you have earnestly tried have resulted in durable freedom from AFIB as a result ... then I can imagine such folks might be tempted to just wait it out in hopes that you might earn a spot in an early Pulse Field Ablation patient trial.

There are a few things to consider here first. Even when PFA becomes the gold standard energy source for most cardiac ablation, as I fully expect will happen in the coming years, the only chance most folks would have to get such an early PFA ablation, is to sign-up to a vetting trial that will likely have severe restrictions on the ablation protocol used in the trial ... such that your EP almost certainly will not have free reign to decide what steps or technique he or she would prefer to use to best treat your type of AFIB. Thus, you are likely to get a boilerplate PVI in most all of the early PFA trials. Meaning that any Non-PV triggers you might have will have to wait until your second or later round of PFA ablations once the handcuffs are removed from all trial EPs.

Once we get to, say, 6 months to a year out from formal adoption of electroporation by the bulk of ablation EP's, which will likely only happen after multiple independent RCTs have confirmed PFAs robust safety and increase in efficacy too, then I could see postponing an ablation for 6 months to maybe a year tops, but only if you are not terribly symptomatic and are not yet truly fed up with AFIB.

Over the next three to four years while the EP field fully puts PFA through its paces and we better come to understand all the pluses and any potential 'gotcha's that inevitably may be revealed, I would not consider cancelling an expert ablation process you may have set up now or in the coming couple of years, with a top flight operator.

The added minor safety benefit of a PFAs ablation over a truly elite-level, highly experienced RF operator is too small in my view, as well as in the opinions of many others in this field. Keep in mind that after assuring good safety, even when using PFA the most important aspect is knowing exactly what to ablate ... not just how to ablate!

Even if you get the PVI down pat with 100% Durable PVI, if you're triggers have largely migrated into Non-PV triggers and you only do a perfect PVI, the patient is not going to be a happy camper!

It still will matter a great deal who does the procedure and just what that procedure entails ... but safety concerns will certainly be less all around when PFA becomes the standard energy source and that will mark a real advance in EP.

Cheers!
Shannon



Edited 2 time(s). Last edit at 07/25/2020 10:38AM by Shannon.

A while back I asked my EP about FIRM. He said, with a wry smile, "There have been many false dawns".

Gill

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Gill
A while back I asked my EP about FIRM. He said, with a wry smile, "There have been many false dawns".

Yeah, been there, done that, and all I got was a 12-hour procedure and some utterly useless extra scars. It was 2014 when FIRM was being touted as the greatest ablation tech ever devised. Now in 2020 it's largely discredited.

Shannon, thank you for #2671

What Joe says

You're more than welcome Joe and Mwcf,

Keep in mind, that the better part of valor in digesting new technology is to let the maturing science convince us, and not be too quick to get super excited over company press briefings promising 'world changing' revolutions that have yet to show independent robust validation.

IRE (Ir-reversible Electroporation) at this stage of its vetting process is truly exciting, but we still need to let the nuance and current unknowns flesh out too over the next few years.

The best advice I can offer to Afibbers trying to sort out who, and what, to trust in such a technology driven field as is EP, is to use discrimination and focus and then hitch one's star to the most experienced and well-vetted ablation maestro one can arrange for themselves. And then let the EP you trust your heart with make the best tech decisions on your behalf.

Using our most familiar example in Dr. Natale with our group and other elite leaders of EP such as him, automatically are recruited very early at the forefront of initial field testing all of the most promising new technology candidates. Device makers who want to truly put new tech through its paces will seek out the very best talent to independently evaluate whether a new idea pans out in real-world testing, or to learn early on if they need to return to the drawing board before they get too far over their own ski's.

A majority of new ideas in medicine don't pan out, but the most experienced front-line operators are always on the lookout for the next great advance in EP. Such that your best bet is to choose the right EP who is fluid with the best technology, and thus avoid getting possibly side-tracked or hood-winked by the latest marketing blitz that can sound very enticing and convincing.

It's possible that this new outfit from Ireland, AtiaAN, may in the end come up with a workable and useful ablation approach, but their initial presentation apparently suggesting that ablating 5 GPs via epicardial access will inherently address "the core problem of AFIB permanently" definitely raises a few red flags for me. Time will tell in any event, but I'm not holding my breath and we will surely know if they are on to something, or not, via real front-line leaders in EP ... and well before FDA approval or rejection.

Take care,
Shannon



Edited 1 time(s). Last edit at 07/26/2020 03:32PM by Shannon.