Re-entry circuit (aka rotor) ablation for persistent AF -Haissaguerre

[www.afsymposium.com] (video link at top of article)

Haissaguerre's preferred term for "rotors" is re-entry circuits. In the video he talks about the AFACART trial that used the EKG vest to map drivers in persistent patients. The first step of the ablation procedure is to go after the drivers, followed by PVI and other areas as needed. Really interesting results in that driver ablation alone was the primary reason for acute termination of AF in the patients. PVI added a few percentage points as did ablation of other areas. AFACART trial was done at centers that had no prior experience at "rotors" ablation or using the EKG vest. The video contains two parts, first part by Haissaguerre about his personal experience. The second part is about ACACART where centers not including Bordeaux reported results. Haissaguerre's takeaway message is don't let your AF progress beyond 6 months of persistent AF as the number of re-entry circuits multiply.

The system is fast enough now to do periprocedure re-mapping if the case doesn't terminate and the EP wants to take a look to see what's happening after the pre-ablation mapping sights have been ablated. In Haissaguerre's examples, he showed new driver areas show up.

PVI for paroxysmal AF still works best so get it while it is still paroxysmal.



Edited 1 time(s). Last edit at 10/16/2015 02:18PM by researcher.

Video does not work for privacy reason???
I would like to see it
Erika

I edited the first post to the referral site.

Video working for me.
Thanks!

/L

Thanks Researcher,

All interesting and I'm hoping this version of noninvasive mapping turns out to be more consistent and effective as a way for more EPs to feel comfortable extending their ablation methods beyond PVI alone by giving then select targets to ablate that stand a good chance to be regional triggers in a given patient.

I'm very glad too to hear Professor Haissaguerre continue to emphasize that selected non-PV trigger detection and ablation are key steps in the prime cutting edge extended ablation approach leading centers such as Bordeaux and Natale's group specialize in and that are very different and more effective approach that requires a good deal less ablation lesions than the simple empirical ablation of every single CAFE focal trigger that meets a very broad general criteria as used in one extended ablation arm of the STAR -AF-2 trial that used such outdated methods for one of the two extended protocols used, the other using a very difficult to perform transmurally and without even one gap, linear lines-only, approach as the second assigned extended ablation method in comparison with PVI-only ablation in persistent AFIB.

And as such confirming that while STAR-AF-2 highlights the limitations of using these two older methods of extended ablation, particularly when assigned to a large group of not so highly experienced operators in performing these same extended protocols in their own daily practices from mostly medium to smaller centers around the world.

Prof Haissaguerre also made a key point of underscoring that STAR-AF-2 says nothing at all about extended ablation done with targeted Non-PV triggers as practiced by the top persistent and LSPAF groups in the world now. That is a very important and timely message and distinction that he shared and confirmed, and one we have emphasized here the last couple years as well.

With regard to the interesting Cardioinsight vest that I'm keen to see broader experience with around the globe, just be aware this presentation from last AF Symposium 2016 is being paired with the associated article that is an advertisement infomercial on the new system that the Bordeaux team (which includes Sebastien Knecht) have heavily invested in with the Cardioinsight vest. Reports I've heard from multiple sources now say that the principal folks at Bordeaux have put over €7 million Euro of their own money into the system before any of these not yet fully independent studies had been done.

I'm hoping it all turns out okay and I trust this is not in any way a partial repeat of the original CAFE study or FIRM-only promotional effort by the developer of these other approaches via the early promising sounding studies on both methods and both of which have failed, so far, to find anywhere close to the same reported early results when many other experienced and truly independent centers around the world tried to replicate those CAFE-only or FIRM-only initially very promising sounding findings.

I don't at all have a problem with the Bordeaux or any other EPs are cardiologists investing in a process they believe in and are busily helping to develop ... Not at all ... but the very fact of such a large personal self interest in this new vest system that is also promising sounding but still early in the development and not yet a fully vetted system, gives me a similar degree of 'wait and see' caution before racing off to jump on the bandwagon quite yet. I'd love it if it turns out to be just as handy as they expect it to be when long lasting results are taken into account, but we just need more a broader range of studies from other centers also in US, and non-connected EU centers as well as from Asian and other large center studies elsewhere to confirm its true utility.

This will all come in due time, and I salute Bordeaux's effort to try to develop the system, even though their early large personal investment coupled with these early publicity type releases as in the link above just add in a bit more caution to let this all play out more fully in light of our recent experiences with the previous rotor mapping and ablation system that netted a big payoff for the developers when a large medical equipment manufacturer looking to breaking into the competitive catheter/mapping system for cardiac ablations market bought the company and thus the initial investors and developers behind FiRM hit the jackpot even prior to more independent studies confirmed the enthusiasm. Good move by them.

No doubt the company who invested the $250 million in the rotor mapping system did their homework and probably rightly decided with just the name recognition alone at this point and from the last few years of promise and speculation about a targeted minimal burn and PVI-less system, was likely worth it and that by offering that mapping module as part of their new mapping system it will likely pay off. And indeed I'm sure a lot of EPs looking for guidance on how to detect likely non PV trigger sources will find it useful in conjunction with a skilled PVI in some of their patients.

I believe the Cardioinsight system has been bought now by Medtronics too, again prior to widespread independent vetting and confirmation. Hopefully this one turns out to not need any back pedaling or overhaul of theory or algorithm to meet its objectives once it reaches broader general EPLab use throughout the world ... Time will tell. Perhaps such early buyouts are just the way such market works with larger companies that have huge pockets willing to pony up early when a new system looks promising even if still a relatively risky proposition. Certainly having a name like Bordeaux behind them with this new non-invasive mapping vest would be a big incentive for making such an investment as well.

I do think the cardio insight system conceptually offers some real advantages over the previous invasive rotor mapping scheme, at least in its configuration used so far, but still with the windfall precedent set with the initial rotor mapping system being bought out for $250 million dollars before any large scale independent randomized trials had been done on this system and which has now lost a good deal of its early promotional luster after a broader array of independent operators have gained firsthand experience with it, it only behooves us to learn about these new options and follow them carefully but to give them some real time to allow the understanding and experience with the new tech to play out and more fully mature.

Interesting stuff though for sure and one I will follow closely and report on here and in AFIB Report issues in the future as we gain wider experience and better understanding with these new technologies.

Shannon



Edited 2 time(s). Last edit at 10/20/2015 11:06PM by Shannon.

Excellent video Researcher! Thanks for posting the link.

It's too bad the discussion of their vest data (with the interesting animated color progression) didn't include data from a normal heart. That would have been a very good comparison/contrast.

Shannon, excellent point about following the money. I'm amazed that the Bordeaux folks had $7M of personal finances to invest. Then again, I suppose it depends on how many folks that $7M is spread across. If it's just two people (Haissaguerre and Knecht), then it seems like a huge investment. But if it's spread across (for example) 100 MD's at Bordeaux, then that's only $70k each, which is not nearly as big an investment. Do you know which of these two extremes it is closer to?

The "Ablation protocol" flowchart (at 27:27) was very illuminating. I know Shannon has verbally described Natale's ablation protocol, but if there was an actual flowchart of it (like at 27:27 in the video), that would be quite interesting. Maybe something to consider for a future Afib newsletter. Or perhaps there's already a PubMed (or other) paper with Natale's flowchart? (I haven't found it yet, if it exists).

Regarding the $250M, that does seems like a large amount, however... a recent counter example would be where HP spent 44x more (ie, $11B ) on a bad investment (purchase of Autonomy), and yet was not taken to the woodshed.

Quote
finance.yahoo.com
Autonomy was a $11 billion bet on move into software for HP, but this strategy began to unravel only days after the deal was announced, documents have shown. Just over a year later, HP wrote off three-quarters of the deal's value, accusing Lynch and his colleagues of financial mismanagement.

Similarly, Microsoft spent $7B to purchase Nokia, and that too was essentially a failure. And yet, AFAICT no heads rolled for making that purchase. So the $250M may not have been a big deal, even if it is a failure.

The Q&A part of the presentations was the best part. Loved the question about consistency (if same patient returned a few months later, would the rotors be in the same place). Didn't quite grok the answer (sounded a big grey). I've heard (anecdotally, from other MD's) that the answer is "not necessarily".

It would be nice if the discussion panels were available via video as well. I've looked on the site but can't find them. Researcher, do you know where they are? Thanks in advance.

Apache and Shannon, I don't know who the panelists were other than Jais that introduced Haissaguerre. The Medtronic purchase of cardioinsight must have been a nice payout for the original doctors that put up money to fund development. I expect Medtronic to make a big push on commercialization just like they did on cryo balloons. Biosense is finally getting some decent competition in ablation technology. This should be good for patients too. The German company Biotronik is starting to do some interesting work on catheter prototypes that offers a constant contact force of 15 grams with stability. Their products are only available in Europe but such a product should not be denied to US patients, at least I hope not.

Hi researcher and Apache.

Have had precious little time to post here and wont until the next 10 days or so +/- a couple days when the AFIB Report should be out so apologies for the delay.

I want to be clear that my mention of hte need to take our time and let this issue with the Cardioinsight vest and other new technologies to really mature and prove themselves is nnot from my feeling that there is nothing there Not at all, and hopefully there will be real uses and value in the new vest non-invasive mapping we jsut need some real randomized control large center independent trials to help vet the whole process, all the more important in light of recent other precedents where other what looked like promising tech has been promoted successfully on the backs of similar preliminary evidence and then sold to great financial gain for the developers and early on board investors, well before any of such large independent RCT trials on the new tech are completed.

That does not mean that it will not prove it self valuable in the long run at all, nor do I suggest in any way that the Bordeaux team or any other early investors have anything other than their own enthusiasm for what they feel the tech might offer behind their early promotion of the tech.... But its simply that with such large personal investments and not yet again a big payoff from Medtronics now buying the technology at such a early stage prior to a more complete independent vetting just means for me, to take it a step at a time and keep an open mind, while not being in too big a hurry to crown any such new tech a big success just yet.

I don't know if Dr Knecht is an investor or not, he has his own center in Belgium but has worked closely with Bordeaux for years on many studies. I have heard that a handful of the key Bordeaux team members have invested in a big way, with a couple of the principal leaders there with from individual 2 million Euro to 1million Euro stakes each from what I had heard from several sources at recent conferences.

Again, there is nothing at all wrong with that investment either and I actually wish that in a world where top actors and football players make such enormous sums of money that those real pioneers who are blazing the trail in modern medicine and who work so incredibly hard at doing so, could make even far more money than they do. I would not begrudge Professors Haissaguerre and Jais at all one little bit for making a great return on their investment. In my view they deserve every euro from their many major contributions over so many years!

But it is just that when large sums of money are then tied to a specific system of technology and it making a good first impression ... it just behooves everyone involved to take our time before anointing any such technology as a breakthrough or real advance based on early, largely developer influenced studies that are not at least based on randomized large international multi-center controlled trials.

In the study trial that is being quoted in the presentation researcher kindly linked too above, keep in mind that these are ll preliminary results in the midst of the study .. not the end results of this study which is on-going ... and are thus primarily. Also, they are primarily reporting 'success rates at intra-procedural AFIB termination of AFIB ( not including other atrial tachycardia like flutter and atrial tachy which are listed separately) and not talking about long term freedom from al arrhythmia as yet.

Even reports of an 83% success with no AFIB at a certain time frame looks good though when pared with a range of 17% to 31% of atrial tachycardia as well, then the picture is a bit less impressive and doesnt quite stand out as much. Note too, this report above is a non-randomized study that is not even complete yet.

So lets wait until not only the final results are here, but hopefully now that Medtronics owns the tech and will want to press forward with its adoption in the US, lets see how it all fairs in other longer term larger RCTs first.

I know the Bordeaux team emphasizes the importance, in their view, of achieving AFIB termination during the ablation. But there are a number of other top tier centers, including Dr Natales groups, that strongly argue that there is little statistically significant difference in long term freedom from all arrhythmia and whether or not the index ablation had AFIB termination from the ablation or whether the patients were cardioverted from an elongated flutter to NSR at the end of the ablation.,

Of course, its nice to have AF termination, but from all the ablation reports I have seen there seems to be a fair balance of those enjoying long term freedom from AFIB who were cardioverted to NSR at the end of their ablation as there are those who experienced AFIB termination during the ablation.

My own case votes for the fact that you can certainly have a cardioversion ending at your index ablation, as I did, and still not have had a single blip of AFIB in going on 8 years now!

Dr Natale strongly insists it is NOT whether or not there is AFIB termination during the procedure, with many factors determining if that will happen or not, but rather in his experience and that of a number of other large persistent centers, its more the quality of each lesion made and the knowledge and skill behind the strategy employed that makes the real difference in long term freedom from AFIB.

Though they agree on most key issues in this field, this one issue is one where Bordeaux's view of the value of intra-procedural AFIB termination is not shared by a number of other top persistent and long standing persistent centers. A rare difference in viewpoint from similarly expert colleagues.

The whole issue with the Cardio-insight vest is certainly interesting and I really hope it will prove to be as valuable as folks hope it will be ... and time will certainly tell. I do wish that the way the precedents are being set recently with such fast acquisitions based on very early strong promotion of new technology could take more time before the big payoffs... But Im probably just being naive and wishful thinking in a era when money talks and walks pretty fast. And in fairness to the investors, if they don't jump in early they might be too late to catch the fast moving train too before it leave the station.

That does not mean that all such promotions will wind up disappointing either and some will no doubt prove to be really great tools in the toolkit of all EPs in the future, but it does up the odds of more people getting burned in the process when enough time for full vetting before the large investments occur no longer fit within the new fast paced development and marketing models any longer.

Thats it for now,

Shannon

Hi Shannon, there are many aspects of pay-to-play in medical device R&D and clinical trials to dislike (HIFU as an example and now laser balloons). As for mapping tools and systems, at least they do no harm and useless at worst, at best, they are useful and do no harm. Hopefully, cardio insight vest belongs to the latter category after more trials. If all the money are in bank accounts already, then I would hope that things get done on an unbiased scientific basis.

With regards to acute AF termination during ablation procedures for persistent afibbers, both Haissaguerre (initial study) and Mass. General groups (newer study) showed significantly better outcomes for patients that had acute termination during AF ablation procedure. I am not sure how paroxysmal AF compares on the scale. Perhaps you have a ready reference to cover that. Below are the two studies I mentioned in beginning of paragraph. The re-entry driver ablation results talked about by Haissaguerre seems consistent with the past studies on persistent AF both in duration and magnitude.

[eurheartj.oxfordjournals.org]
[www.ajconline.org]

I agree on researcher, on the pay to play medical device market issues, and while its true there should be no direct harm from a mapping system that may not live up to its early expectations ( and mind you I'm not saying that Cardioinsight vest belongs in that camp at all at this time, its much too early to tell and it has some promising aspects for sure), but there can be some inadvertent early harm from for instance the so far premature promise of an easy few burn and done PVI-less mapping system we all know about that followed a similar early marketing path and that worked beautifully for the designers and investors, but so far has been less than highly impressive in its core role as a PVi-less few burn and done system for the masses of EPs to use.

The indirect harm I have seen in a number of cases has been from some patients who postponed or cancelled all together starting an expert ablation process they clearly were excellent candidates for based on what turns out to have been, at the very least, premature and excessive enthusiasm for the promise of the system when used not as an adjunct to a solid PVI/PVAI, but as the core stand-alone ablation process.

Admittedly, I only have heard of or from a relatively small number of cases who cancelled out and are still waiting for that promise of an easy few burns and done the process, and yet a much smaller handful of those have shared with me over the last couple years having progressed to persistent AFIB in the process.

As such, and with the limited scope of my contact with folks who are focused on that mapping system, the numbers of others who may have been similarly influenced are likely a good deal higher.

Nevertheless, the nature of the Cardioinsight vest with its non-invasive process, is far less likely to have any such effect on waiting for patients, and I really am not worried about its negative impact should it not prove quite as handy in real world randomised controlled trials over time. As you noted, almost certainly some good use will come of it and perhaps it proves really useful indeed. I sure hope so!

As for the Bordeaux team making a nice windfall profit from it, I have no problem at all and if I could take a wheelbarrow full of money to give to those guys as well as other top tier cutting edge pioneers in this field I would gladly do so, along with a high five and hugs all around for all of their many contributions and dedication for them as well as Natales groups and a number of other real leaders of this field on our behalf.

My point was mainly that you typically would not see a Bordeaux advertisement like that based on a not yet completed study, even though with some promising early findings, had there not been the extra incentive to do so.

Though I do hope and imagine this one will turn out to be rather benign, and is no doubt more a sign of the times and the way this market now works that all the players have to adapt too to some degree to succeed at it... just saying, though ...

I still prefer the older school way where well vetted multiple RCTs tended to drive research and device funding more than early marketing studies, but no doubt that is rather wishful thinking and no longer practical.

On the issue of AFIB termination during ablation, there are studies that show both an advantage in doing having AF termination and other well-done studies that show no real world advantage over cardioversion to end a procedure. Af termination is a good outcome too and obviously sounds intuitively preferrable at first blush and as you noted a few studies support that hypothesis.However, another well -performed procedures .., especially with advanced paroxysmal, persistent and LSPAF cases, also show no advantage with AF termination regarding long-term maintenance of NSR.

The differences may fall to procedural methods, patient selections and type of AFIB etc. and methods for non-PV trigger ablation and other related issues.

One of these studies that strongly suggests no advantage regarding long-term freedom from arrhythmia ( not just AFI from in-procedure AF termination that I recall off hand is from Natale's larger international cohort of centers from 2010 called:

'Atrial Fibrillation termination as a procedural endpoint during ablation in long-standing persistent AFIB' ... Elayi, Claude et al., HRS Journal Vol 7, No. 9 2010

This study of 306 LSPAF ablation patients found that AF termination could predict the mode of any recurrence afterward ... with AFIB termination most often having AFIB as the recurring breakthrough arrhythmia, while cardioversion from flutter very often results in flutter only as any recurrent triggering going forward.

However, AF termination did not favorably impact long-term NSR maintenance more than did cardioversion in the index procedure, and after one or two procedures in this most challenging class of ablation patients.

The one arrhythmia that did show a big advantage in instant termination during ablation was Atrial Tachycardia (AT) or AFLutter (AF). Its is always good to track those down and zap them in real time.

Finally keep in mind that very few EU centers do LSPAF cases at all, or if they do some at all, there is rarely a lot of such cases. Mostly such people are parked on drugs and maintained as until recently the success rates with this class was more difficult outside of the few truly elite level persistent and LSPAF EPs.

Sorry but that is all I have time for now, as I dictated the bulk of this over lunch, and I am buried working on the newsletter and with no more time to dig up the other references now researcher .. but they are out there.

Cheers!
Shannon



Edited 1 time(s). Last edit at 10/26/2015 04:30PM by Shannon.

Shannon, here is a nice literature review from late last year about acute AF termination during ablation. Conclusions are squishy as you discussed. Authors aren't sure why there is a correlation between lower recurrence and higher success with AF termination in most studies. They believe it could just be an indication that the patients that achieve acute AF termination may not have progressed as far as the patients that had to be cardioverted. Again we are talking with regards to persistent AF. My message has been and will always be to get it while it is still paroxysmal. Then you won't have to deal with all these esoteric issues.

[www.jafib.com]



Edited 1 time(s). Last edit at 10/27/2015 10:27AM by researcher.