Monday’s Daily Mail in the U.K.

‘Crystal wand could magic away a faulty heartbeat: New device ‘will revolutionise’ atrial fibrillation treatment for one million Britons’

[www.dailymail.co.uk]

Any of you guys in the US know anything about this??:

EDIT: here’s a recent US article about this:

[www.prnewswire.com]

This and the new PEF ablation technique - see:

[farapulse.com]

.....look like significant progress to me.



Edited 5 time(s). Last edit at 01/09/2019 06:43PM by mwcf.

Pulsed electrical field is interesting stuff. If it pans out it should greatly reduce complications like phrenic nerve injury.

The dailymail article is rather incoherent and misses the important points, but here are some pretty good results from a small clinical trial.

It’s interesting, for sure. The first link is a sensationalist UK rag. The second is a bio-tech startup trying to sell stuff. That being said, I do think the technology has promise. I’d give it 5 years to see whether it’s “got legs” or not.

"A sensationalist UK rag"? Have you ever read a copy?

Quote
Carey
Pulsed electrical field is interesting stuff. If it pans out it should greatly reduce complications like phrenic nerve injury.

The dailymail article is rather incoherent and misses the important points, but here are some pretty good results from a small clinical trial.

The 'pretty good results' from a small clinical trial link (a JACC article) you provided used the Farapulse PEF ablation tech - Farapulse is a registered trademark of Iowa Approach. The founder of Iowa Approach is EP Steve Mickleson - see
[iicorp.com]

Other EPs involved with Iowa Approach include Dr Vivek Reddy (who has previously co-authored with Dr Andrea Natale) from Mount Sinai and Prof Pierre Jais from Bordeaux.

Agreed the Daily Mail piece isn't the best which is why I provided the other link to some US press coverage of the same tech.

The PEF tech is interesting and promising research that needs larger scale testing with various ablation techniques.

On the other hand, I’m entirely skeptical of the AcQMAP approach using a modified Basket mapping catheter with ultrasonic crystals to, in essence, create a modified FIRM-like rotor mapping Hail Mary ... you can color me unimpressed and the articles promoting it are mostly hype and show very little useful data.

The breathless hype of “’major breakthrough” for yet another basket cathter rotor mapper is a big yawn that reflects very preliminary early stage small size prospective data.

However, those huge caveats nevertheless do not give the marketeers and pause at all in proclaiming anonholy grail that is sure to turn the ablation world on its head ... etc.

Frankly, I’m fed up with the entire rotor hype that, to this day, has been an abysmal failure in my view and that of the vast majority of most respected EPs on the planet.

My advice is do NOT jump the gun too soon on this one! Let the technology mature and truly prove itself in multiple well structured RCTs and earn the trust of the largest ablation research centers in the world as front line everyday ‘must have’ technology in these elite EP Labs around the globe ... and then we can talk turkey!

The fact they the marketing approach of this company is so closely similar to the over the top hype train reminiscent of the early FIRM method of “marketing promises first/ real data much later’ ... makes me super skeptical indeed.

I recommend putting this one on the back burner until it proves itself over the next 5 to 10 years of careful vetting via multiple totally independent RCTs

Shannon



Edited 2 time(s). Last edit at 01/14/2019 03:55AM by Shannon.

Quote
Shannon
The PEF tech is interesting and promising research that needs larger scale testing with various ablation techniques.

On the other hand, I’m entirely skeptical of the AcQMAP approach using a modified Basket mapping catheter with ultrasonic crystals to, in essence, create a modified FIRM-like rotor mapping Hail Mary ... you can color me unimpressed and the articles promoting it are mostly hype and show very little useful data.

The breathless hype of “’major breakthrough” for yet another basket cathter rotor mapper is a big yawn that reflects very preliminary early stage small size prospective data.

However, those huge caveats nevertheless do not give the marketeers and pause at all in proclaiming anonholy grail that is sure to turn the ablation world on its head ... etc.

Frankly, I’m fed up with the entire rotor hype that, to this day, has been an abysmal failure in my view and that of the vast majority of most respected EPs on the planet.

My advice is do NOT jump the gun too soon on this one! Let the technology mature and truly prove itself in multiple well structured RCTs and earn the trust of the largest ablation research centers in the world as front line everyday ‘must have’ technology in these elite EP Labs around the globe ... and then we can talk turkey!

The fact they the marketing approach of this company is so closely similar to the over the top hype train reminiscent of the early FIRM method of “marketing promises first/ real data much later’ ... makes me super skeptical indeed.

I recommend putting this one on the back burner until it proves itself over the next 5 to 10 years of careful vetting via multiple totally independent RCTs

Shannon

Hi Shannon,

Thanks for your views on this.

Does your penultimate paragraph (The fact.....);refer to the AcQMAP or the PEF?!

Presumably your third to last (My advice.....) and last (I recommend....) paragraphs do refer to PEF??

Cheers,

Mike

Hi Mike,

I like what aive heard the last 9 months about PEF and it looks like a very promising new energy source, but it is still early in its gestation. Only my first short paragraph/sentence above referred specifically to PEF, yet I’m far more interested in keeping an eye on PEF developments than I am the basket mapping rotor tech rehash discribed in the rather poorly researched hype piece in the Daily Mail article.

Read carefully the very limited amount of research done in the UK on this new basket mapping system. It’s still fundamentally an offshoot of FIRM based on the same discredited concept with a wrinkle or two added in.

FiRM has had plenty of time to prove itself but you see and hear of very FIRM based ablations being done outside of a few diehard investor EPs still holding on. Sales of FIRM gear are hardly robust over the last couple years either. It was a good try, but in my view was undermined by a major marketing focus on selling the technology first before any solid RCTs or rigorous prospective studies had been done to validate the tech.

My closest EP colleagues have experimented with this new version in Europe and fine it largely more of the same hype driven story. So my advice is remain sceptical until and only if, truly independent research confirms this new version of a similar tired song proves unequivocally that it does have something objective to offer to EPs and patients alike.

When a company starts out trumpeting claims of major breakthroughs before larger scale RCTs are completed, then a more careful and cautious skepticism is warranted. Especially in light of so many other seemingly promising new tech ideas that everyone had gotten initially excited about in the EP world only to see the majority of such promising sounding new developments gathering dust in the bowels of many research centers basements a few years later and that never made it as a front line core component of the worlds highest volume research ablation centers technology used in their every day ablations.

Mike you asked me by PM about the difference between EPs personally investing heavily in new technology and the common practice of top tier EPs who are given honorariums and travel expenses etc in their roles as vettors of new technology that such top level EPs will list as potential conflicts on all their studies.

There can be a big difference between the former and later type of potential financial incentive in terms of the reader/patient needing to be more cautious in considering possible influence on the EPs comments about a given system or product.

The former scenario in which an EP (or quite a few members of an EP group) personally invest large sums of their own money in a new technology is certainly okay if they really believe in the technology. After all, EPs are often able to see a potentiallly great new development in the field long before the rest of us, but they too will be subject to a similar risk/reward equation when putting up hundreds of thousands or even a million or more dollars into a promising new possible game changer. The earlier they invest, the larger their potential reward if it all pans out, but also the greater their risk of losing it all if it turns out to be a dud. So long as they acknowledge their investments publically, then so be it and best wishes to them since if they win, it likely means a real win/win for the field and all current and future Afibbers as well.

However, when an EP or group of EPs whoevare engafed in direct published research on the same tech they have personally invested very significant amounts of money into ... and human nature being what it is ... it only makes good common sense to be even more cautious in granting carte blanche acceptance and belief into the data driven largely by the company and group of EPs who have created such a large vested interest for themselves in the outcome of such studies.

I’m not at all saying that such investor/EPs can’t remain objective in their research, but when evaluating especially early stage claims in a new technology in which the operators and adjudicators of a study have a potential direct and significant financial interest, then those of us seeking the full truth of the matter should demand solid truly independent and well-vetted evidence, preferably from multiple well done randomized trials before we jump on any such bandwagon fully with both feet onto any such bandwagon.

Finally, with regard to the common practice of various companies giving honorarium payments and travel expenses etc to renowned EPs and other docs who announce their potential conflicts in each study they appear in, this is far far less of a true conflict of interest in the vast majority of cases. As you noted, Dr Natale has such affiliations with a number of EP device companies like BioSense Webster, St Jude’s Medical, Medtronics etc ... as do most all Directors of large EP programs at University and Hospital EP programs. Natale, as the most experienced ablation EP there is and Director of the largest AFIB Ablation Research Center in the world, is a key cog in the vetting and assessment of nearly all new technology helping to push the field forward with his invaluable input on what works and what doesnt during development of such gear.

But he also has such connections with multiple direct competitors of each other as well, and these honoraria are typically much smaller sums intended to vacilitate the doctors travel, lodging and input during development in order to get their honest opinion on how well, or not, their products are working. It’s a very different kind of incentive than making their own huge personal investment in a technology and then conducting studies that are often listed as ‘independent’ on that very technology they have invested in. The latter minor so-called conflicts typically do not influence major decision making.

Take care,
Shannon

Shannon,

Many thanks indeed for your further response/clarification all of which makes total sense to me.

Very much appreciated.

You take care too,

Mike