Shannon reporting from HRS 2019 in San Francisco

Many of our readers, especially relative old-timers, may recall my interest in following the course of development of FIRM mapping and ablation technology that initially sparked a burst of excitement as to a possible step forward in the treatment of more advanced cases of AFIB. That is, were the considerable hype from the marketing campaign to actually pan out in the reality of careful vetting and randomized trials.

My initially hopeful expectations for FIRM began to fade by the end of the first year or two after the FIRM bandwagon left the station due to what to me, and to many far more astute skeptics and commentators, appeared to be a number of liberties taken in how the preliminary data was presented by the developing company. Over the years, my skepticism only grew, and was increasingly reinforced by the very mixed bag modest to poor results from real FIRM patients I had been in contact with.

In several past issues of The AFIB Report, (and these past issues are freely available to all in our archives), I systematically shared my evolving findings about FIRM studies and my growing concerns over the lack of consistent efficacy shown even by the companies own data.

Today, in a late/breaking clinical trial revealed at the current Heart Rhythm Society Scientific Sessions 2019 in San Francisco, the REAFFIRM Prospective Randomized Trial Comparison of FIRM Ablation VS Conventional Ablation for Treatment of Persistent Atrial Fibrillation -The REAFFIRM TRIAL, was presented and the final death knell for FIRM as a viable ablation strategy may well have finally rung!

This RCT conducted by the company found ‘NO DIFFERENCE’ between a control arm of 179 persistent AF patients in which a PVI-only was done vs. the group of 171 persistent Afibbers who had both the FIRM mapping and ablation plus a standard PVI! The FIRM + PVI arm showed an odd range of 3 months to 12 months success rate of (115/166) 69.3% VS the control arm of (110/163) or 67.5% for the PVI-Only arm.

This result is an entirely indistinguishable equivalence between the two comparative arms of the trial, meaning that adding the FIRM module to a standard PVI bought the patients absolutely nothing accept for more risk with from one to two hours additional ablation time for no gain, and for all the ink and hype spilled over the last almost 7 years!

I dont begrudge at all the effort the Topera folks made along the way. in fact, I laud them for the interesting idea and desire to see if they could make it work, that is how science works and we learn as much or more sometimes from the failures along way as from some of the successes. But I was disappointed today hearing from a company representative, yet more attempts to rationalize why using FIRM in advanced cases 'might' have some benefit still, even when their own RCT using the most favorable non-standard endpoints had a null and void result! It's clear any possible benefit any individual case might have had from an FIRM part of their ablation would have been from a random luck effect and not due to any prescience from the mapping software in locating true AFIB focal triggers!

One reason this issue drug on so long was because Topera included a standard PVI in addition to the FIRM mapping and ablation in all but one of their own studies, which masked any possible FIRM effect by the well known efficacy of a standard PVI. That masking effect was just enough to convince many bright EPs that there 'might' be something there.

However, an exhaustive review of all FIRM studies, and particularly the truly independent FIRM studies, plus the one early study by Topera claiming to show an outstanding result from a FIRM-ONLY ablation study of Paroxysmal AFIB (PRECISE), was enough to make a skeptic out of almost anyone who studied the issue thoroughly.

For the last 4 years at various conferences, I have repeatedly asked the creator of Topera and FIRM-mapping when would he finally publish the complete peer-reviewed data on his early PRECISE study of FIRM-Only ablation on 31 PAF patients looking at only 6 months and with a claimed freedom from AFIB-only touted as an impressive 82.6%. PRECISE was only published as an obscure, hard to find abstract at the 2013 HRS Scientific Sessions and with an equally hard to find updated poster shown for only 4 days at the 2015 HRS Scientific Sessions.

Each time I have inquired into the fate of PRECISE, I was reassured first that: "it was coming just around the corner and would be out within two months". and the following year I heard: "PRECISE is now complete and undergoing final peer-review" and then another 11 months later: "a peer-reviewed and published PRECISE is coming very soon, any week now".... I stopped asking after that last inquiry at Chicago HRS 2017, two years ago.

The reason the fate of PRECISE was so important is that if the company were able to publish a peer-reviewed and accepted paper on FIRM-Only ablation showing roughly an 80% success rate, even limited to freedom from AFIB-only, it would have validated FIRM ablation in a big way! The fact that PRECISE has never, to this day, been published is further evidence that it was surely known by Topera for a long time that FIRM ablation-alone, with no masking PVI, was not capable of producing consistent success in AFIB ablation and may not, indeed, work any better when added to a PVI-alone.

REAFFIRM RESULTS

We now have the final answer, and it is a crushing blow for the technology and its promoters, no ifs, ands, or buts. Though, it was not entirely unexpected by many EPs after seeing FIRMs star wane in recent years due to increasing poor outcomes from the more independent studies of the technology, as well as their own preliminary preview of this RCT last year that also showed no appreciable benefit to adding the FIRM process.

In this intention to treat (ITT) prospective randomized REAFFIRM trial of 350 patients enrolled in 18 experienced FIRM centers in the US and Europe, every option was adopted to show the results in its most favorable light. In doing so, whether or not patients were kept on AARs (anti-arrhythmic drugs) was up to the individual EPs, and Dr. John Brachman (who presented this RCTs findings today) acknowledged that the vast majority of these patients were kept on AAR drugs both before and after the procedures!

In addition, the trial used very generous dual endpoints, with the first endpoint being freedom from all AF/AT at only 3 months ... which begs the question: ‘who cares about an endpoint of only 3 months unless one is trying to stack the deck in a more positive light?’ The second endpoint was freedom from all AF/AT over a range of 3 months to 12 months. Once again, we see the authors of the study deviating from typical AFIB ablation endpoint reporting which typically reads as: “freedom from all AF/AT and OFF ALL AAR drugs at >/= 12months post ablation.” A considerably tougher standard to meet than the more forgiving ‘3 month to 12 month’ time frame for freedom of AF/AT.

As a result of what I consider this classic “Gilding of the Lilly”, the authors are apparently trying to put a more positive face on these results by implying now that since these numbers are a slight improvement over most PVI-Only RCTs (which range from ~ 55% to ~60% success rates while OFF all AAR Drugs and while using the stricter >/= 12 months time frame), that this somehow might justify claiming a benefit large enough to willingly subject patients to an extra hour or two of ablation and anesthesia, not to mention the greater investment in time and equipment, and all for zero added benefit over a standard PVI-alone! Keep in mind the FIRM + PVI and the PVI-Only arms were similarly higher by a handful of percentage points over the stricter PVI-Only RCTs which typically, and rightfully in my view, used the standard endpoints and time frames accepted by the industry over the last 12 to 15 years.

It is now unequivocally clear to me, and I dare say to most of the EP field, that this FIRM experiment ... and their admittedly expert sales effort ... is likely nearing its end. It is also increasingly clear, in hindsight, that if the marketing focus had been to sell the technology before any solid RCT data might undermine the good story, then I guess the authors of the strategy are to be acknowledged for a job well done.

Hopefully, the EP field will learn a great deal from this saga and therein the FIRM story may well offer its most valuable lessons for us all!



Edited 3 time(s). Last edit at 05/10/2019 04:07PM by Shannon.

Thank you for the update, Shannon! It's what 'my' EP thinks as well.
What about this one? Any solid info?
[www.afibbers.org]

That's just a mapping system, one of many. There's nothing revolutionary about it.

All I can say is I found this site, through forum member ClayS, and that was the turning point in my afib journey.

I endured a marathon almost 12 hour ablation in Indianapolis at IU Baptist. I had complications, and then not only did my afib reappear 6 weeks later, it brought along it's nasty little cousin tachycardia.

2 and a half months later I walked out of the best experience I have ever had in the American health care system after receiving the best care from the good folks at Texas Cardiac Arrhythmia Institute, Dr. Andrea Natale and the great people at St. David's hospital in Austin, TX. Now almost 2 years later, I continue to be arrhythmia free.

I can say that the PVI they did at IU Baptist did hold, and I believe the lesion set they created as a result of the FIRM technology caused my afib to not only return worse and for longer episodes, but it caused my tachycardia, something I did not have prior.

Hi Joe,

My advice is to be very skeptical of these mapping system claims by eager vendors so early on. This is a highly profitable industry for the winners in these technology sweepstakes. They ALL sound compelling when the marketeers go to work. Some may well work out for the better and some much worse for Afibbers over time, as we were reminded of yesterday!

What this FIRM debacle teaches us all, is to be very patient and let the science come to us and reveal itself to be worthy. This can happen only by demanding rigorous proof of concept as well as insisting on usually multiple randomized control trials to validate the technology before any of us go jumping on bandwagons too early due to an enticing hype story filled with colorful rotating computerized spirals!

There was another great talk today with a panel of experts, including Dr Natale, all discussing the seductive and often misleading allure of these new mapping systems springing up like mushrooms, and promising breakthrough benefits before any of it has been through proper long-term vetting. The discussion was around the colorful patterns that seem to tell the brain (or fool the brain) into thinking it is seeming a significant pattern when, in fact, it is often pure random patterns and conjecture signifying little else at this point beyond the hype story.

Over a decade ago, Dr Natale told me in his office to always be slow in jumping on technical bandwagons in this field of EP. He said it is the most common mistake many EPs make, especially young and tech savvy EPs who are eager and looking for that big step forward in the field. More often than not, they wind up seeing what they want to see in the early promise and seductive patterns of a given tech that will never pan out. And then, within two the three years, the vast majority of these new whiz-bang 'cant miss' systems are found gathering dust in the basement of many AFIB centers.

Dr Natale advice to me those many years ago, was to always just watch the major high volume ablation centers and leaders carefully and only when they begin to adopt a new technology in their every day front-line ablation protocol, then you can trust the new system or catheter, etc., has passed muster by the most experienced operators in the world.

In other words, it is not our job to fall in love with EP gear, your job is to choose the most experienced EP that you can realistically put your hearts care into his or her hands. And then let trust them to pick the most appropriate technology for your particular case.

For laymen like us to get all enamored and hot to trot for the latest EP gizmo we do not fully understand, is truly putting the cart before the horse and is asking for real trouble, if and when we start to dictate to the operator what tools you wish them to use on you!

That is a great way to get ourselves in real trouble. That also goes for such systems at the ACUTUS AcQMAP that has not yet even scratched the surface of real deep level vetting at this time. I'm not at all suggesting that there is no value in the AcQMap tech, its just that it is WAY too early to even get excited about it and, instead, the better part of valor is to just sit back and let the science come to us and wait until the whole process is better vetted and understood before declaring any favorites. A fact, that Dr Natale re-emphasized today to the audience, along with several other renowned EPs all of whom were urging the same degree of caution, especially today in light of timely reminder of FIRM's demise!

And what a vindication for Dr. Natale and St Davids whose early exposure of FIRM in the OASIS trial now stands as having been validated in dramatic fashion, and once again, he is shown to have been ahead of the curve with the right cautionary call on FIRM mapping and ablation.all along!

Cheers!
Shannon



Edited 3 time(s). Last edit at 05/10/2019 08:37PM by Shannon.

Another important reminder from HRS 2019 for those of you taking Xarelto!

Always remember to take Xarelto with FOOD!!

Many Afibbers forget and take the drug on an empty stomach, but doing so can result in a whopping 40% reduction in absorption of the drug! This large of an inadvertent dose reduction can result in an embolic event! Exactly what you are taking Xarelto to prevent from happening.

For those of you who are not entirely and strictly compliant with taking Xarelto with food, please talk to your prescribing Doc about possibly switching you to 5mg Eliquis, BID (twice a day).

And this reminder is even more urgent for those Xarelto takers who have had an LAA Isolation and who are obviously still on an OAC drug! In fact, I urge this group to make an appointment with your EP and discuss LAA Closure with a WATCHMAN device when possible.

Cheers!
Shannon



Edited 1 time(s). Last edit at 05/10/2019 06:14AM by Shannon.

Some years ago I asked my EP here in London what he thought of FIRM. His reply: "There have been many false dawns."

Gill

Quote
Shannon
Another important reminder from HRS 2019 for those of you taking Xarelto!

Always remember to take Xarelto with FOOD!!

Many Afibbers forget and take the drug on an empty stomach, but doing so can result in a whopping 40% reduction in absorption of the drug! This large of an inadvertent dose reduction can result in an embolic event! Exactly what you are taking Xarelto to prevent from happening.

For those of you who are not entirely and strictly compliant with taking Xarelto with food, please talk to your prescribing Doc about possibly switching you to 5mg Eliquis, BID (twice a day).

And this reminder is even more urgent for those Xarelto takers who have had an LAA Isolation and who are obviously still on an OAC drug! In fact, I urge this group to make an appointment with your EP and discuss LAA Closure with a WATCHMAN device when possible.

Cheers!
Shannon

Will Medicare cover the Watchman? I had a LAA isolation in July 2016. I am still on 2.5 mg Eliquis 2x a day.

Yes, Gill and Joe, that has been the opinion of the vast majority of EPs I know for years now. I suspect this will mark the end of that system once and for all, and yet better solutions will arise before long.

The new energy source for ablations called, Electroporation, is looking very promising indeed! Though it, too, is still quite preliminary, but since it is dealing with a fundamental DC energy source using much shorter and lower current density or levels than in prior experiments with higher arching DC currents, this time it really does seem like a potential big step forward, and yet, it will likely still be a good 3 to 4 more years before it sees wide spread adoption in the real world of human ablations in EP labs.

Shannon

Quote
smackman
Will Medicare cover the Watchman? I had a LAA isolation in July 2016. I am still on 2.5 mg Eliquis 2x a day.

Their policy used to be they would only cover LAA occlusion devices if you were unable to tolerate anticoagulants, but my understanding is they will cover it now if you're at least a CHADS-Vasc 2. But I only have that second hand so better to have a provider who does Watchman implants actually submit to Medicare for coverage and see what they say.

Why are you on a half dose of Eliquis? Did you have adequate LAA flow velocity?

Thank you for the convincing replies, Shannon! It's helpful to know when The EP suggests a particular procedure. Hopefully my problem can hold off long enough until a good mapping system emerges.
I wasn't too impressed with 'my' EP when he said that for the first procedure he only does PVAs because it fixes 70 to80% of AF cases.

Where do you live Joe?

If you can afford to travel for 5 days there is usually no real limitation to putting your hearts care in the very best hands. Don't worry about a given mapping system, it's the EP using the system(s), as Cary noted above, that makes all the difference. And the EPs skill in knowing where and how to ablate, plus the all important factor of possessing natural talent in manual dexterity and priceless 'feel' that is not always teachable. At least not at an elite level, where a solid basis of natural talent is required to become a genuine top tier maestro with a catheter.

Send me your cell number, if you would like to discuss these options and review more of the nuance of what separates typical clinical EPs from the more rare true top ablation talents one can access out there!

Be well,
Shannon

Thank you Shannon!
I'm in Melbourne Australia. One of our allegedly beast ones is Dr Sparky - an experienced EP but he still needed to do three ablations in 18 months on someone i know. Don't find that confidence inspiring.

Going to the US or France is really beyond my finances especially as there is no 100% guarantee
.
On the other hand, i feel quite lucky right now with only being in AF for 4 months at the end of 2015 and for 21/2 weeks last year. So, i think time is still on my side (i hope). Right now, i only take 50mg Flec at night and haven't had any relapses in quite a few months. I'm aware of the stroke risk and have Eliquis ready should an episode happen (CHADS-Vasc 1)

I know, the AF problem is progressive but one always hopes that with changes to lifestyle progression slows down. Intermittent fasting and reducing carb intake to keep blood sugar and insulin low and other unproven measures- maybe i'm just dreaming, but i try - better than doing nothing.
Appreciate your generous offer and concern!

Joe,

See Shannon’s post on Australian EP’s recommended by Dr Jais from Bordeaux


<[www.afibbers.org]

Indeed Joe, and thanks for the link reminder George!

Dr. Jonathan Kalman is a very good EP in Melbourne and you may well have have heard of him. He is very well respected and is a very nice man too boot!

Dr. Kalman was part of some of the early FIRM investigations, like so many honest and thoughtful EPs interested in exploring the potential new technology, but he was quick to back away from the system and took a more wait and see approach until it became clear it lacked demonstrable efficacy.

Ironically, I was sitting next to Dr Kalman yesterday here in San Fran at the HRS conference and he had just given a talk discussing the lessons learned of FIRM and how it underscores that we have to be very careful of being seduced by colorful mapping systems that look like they may be confirming trigger spots when there has been no systematic validation of the technology, as yet. He also underscored why the failure of the system reinforces the fact that we (the EP field) should not be allowed to use such tech in front line ablations in patients without it first being confirmed in carefully constructed and carried out RCTs.

I would go visit with Dr.Kalman, if I were you, assuming you are not already seeing him Joe. There are several others on the Aussie/NZ list too that are very good choices as well.

Cheers!
Shannon

Quote
Carey

Will Medicare cover the Watchman? I had a LAA isolation in July 2016. I am still on 2.5 mg Eliquis 2x a day.

Their policy used to be they would only cover LAA occlusion devices if you were unable to tolerate anticoagulants, but my understanding is they will cover it now if you're at least a CHADS-Vasc 2. But I only have that second hand so better to have a provider who does Watchman implants actually submit to Medicare for coverage and see what they say.

Why are you on a half dose of Eliquis? Did you have adequate LAA flow velocity?

My velocity was fine.
Here is part of my report from Tee in Austin.
Left atrial appendage velocities of 59-60cm/sec
Here is the kicker; Tall E Waves are noted. NO A WAVES are seen.
Conclusions:
1. Normal left ventricular systolic function.
2. Normal left atrial appendage emptying velocities.
3. There is no evidence of A waves on mistrial inflow
Hashim Khan, MD

Dr. Natale put me on 2.5 Eliquis after this report. I was on 5 mg. Of course both 2x a day.
Bad luck on my part but Enjoy NSR But I hate the OAC

Thank you for the list Shannon/George! I'll make inquiries.

Quote
smackman
Dr. Natale put me on 2.5 Eliquis after this report. I was on 5 mg. Of course both 2x a day.
Bad luck on my part but Enjoy NSR But I hate the OAC

You really don’t need to worry a whole lot on the half dose of Eliquis. It’s not very much. If you stopped it, you’d be at normal coagulation in only a few hours.

But I get it. We all hate it.

Quote
wolfpack

Dr. Natale put me on 2.5 Eliquis after this report. I was on 5 mg. Of course both 2x a day.
Bad luck on my part but Enjoy NSR But I hate the OAC

You really don’t need to worry a whole lot on the half dose of Eliquis. It’s not very much. If you stopped it, you’d be at normal coagulation in only a few hours.

But I get it. We all hate it.

It is also the Cost. It puts me in the donut hole every year. 2.5 mg cost as much as 5 mg. RIP OFF!

Quote
smackman

I had a LAA isolation in July 2016. I am still on 2.5mg Eliquis twice a day.
My velocity was fine. (LAA emptying velocity (Shannon)

Here is part of my report from TEE in Austin.
Left atrial appendage velocities of 59-60cm/sec
Here is the kicker; Tall E Waves are noted. NO A WAVES are seen.
Conclusions:
1. Normal left ventricular systolic function.
2. Normal left atrial appendage emptying velocities.
3. There is no evidence of A waves on mistrial inflow
Hashim Khan, MD

Dr. Natale put me on 2.5 Eliquis after this report. I was on 5 mg. Of course both 2x a day.
Bad luck on my part but Enjoy NSR But I hate the OAC

Smackman,

The reason, no doubt, that Dr Natale okayed you to stay on 2.5mg BID of Eliquis based on your above report findings is because you still
had a robust LAA emptying velocity plus no evidence of any ‘Smoke’ or SEC (Spontaneous Echo Contrast) in the LAA or LA. You point to the TEE report mentioning that you didn’t detect any ‘A-Wave’ on the Doppler Echo E/A Wave report. On most Doppler E/A reports they list both the ‘A-Wave’, which represents the positive inflection of the sine wave above the horizontal ‘null or zero line’ as well showing the ‘E- Wave’ which represents the negative inflection of the sine wave below the zero line.

For the purpose of determining a robust LAA mechanical function there are three key metrics you need to pass to either be able to potentially stop OAC drugs, and you got two of the three tests passed with flying colors.

1. You must have a robust LAA Emptying Velocity of >/= 40cm/sec.

2. Your Doppler ‘A-Wave’ must show a robust and consistent pumping action from the LAA as measured at the mitral valve inflow of blood being pumped from both the LAA and LA into the mitral valve inflow just below both the LAA and LA.

3. They should be no ‘Smoke’ called SEC which are of white smoke-like wispy stands if white seen in any blood volume chamber like the Left atria it LAA that should like absolutely black on a black and white TEE or TTE scan. The SEC or some represent the beginning of thrombosis formation leading to actual clots.

In your case Smack, the fact that you passed tests 1 and 3 with flying colors allowed you to get by with half a dose of Eliquis. Also, I would be willing to bet a silver dollar that even your overall absent Doppler A-Wave test showed some positive signs as well in addition to the negative A-Wave test that was reported, and I suspect that it was your overall scores and what Dr Natale saw on your TEE that also reassured him you would do well on half a dose BID of Eliquis.

That being said, it’s a good idea, in my book, to also get an LAA-Closure device when you’ve had LAA isolation, just for the added support and reassurance that can bring long term.

Cheers!
Shannon



Edited 1 time(s). Last edit at 05/14/2019 06:51PM by Shannon.