Who has best ablation technology?

First of all a sincere THANK YOU to Hans. It is because of this site and in particular his detailed story about his Bordeaux ablation more than 10 years ago that I was able to at least reduce the beast. My story is 2 back to back ablations by Haissaguerre and Jais in Bordeaux in 2005 and another with Jais in 2008. Never got 100% cured! but frequency of episodes went from initially 6 months to now under two weeks. My afib is complex with focae inside the atrium (Natale whom I met in Austin has a theory that it is in the left atrium appendage).
My strategy was to wait until the imaging and guiding technology got better. At this point, it seems like there was some progress versus 2008. Dr Jais tells me that Bordeaux now has a full 3D imaging technology and that it would be very helpful for my case. My cardiologist also pointed me to a recent research paper on a technology called MGS, which stands for Magnetic Guided System, and an actual system called Stereotaxis, which has the ability to guide catheters in more difficult to reach areas via small magnets.

My question has to do with where to get my next ablation. Clearly, I have a lot of faith in the experience and dexterity of the Bordeaux team, but alas, if their technology is inferior (is it?) then less experienced hands with better technology might still be a better choice. So what I am trying to find out from experienced members of this great forum is whether anyone knows if Bordeaux has the most advanced technology or whether other centers (Natale, Reddy at Mt Sinai) have demonstrably superior technology?
I am prepared to go anywhere I need to to maximize my chance of success.
Looking forward to any intel on my situation and this topic.

Regards

Natale has the most experience ablating the LAA then any other EP out there, has gone there where most wouldn't dare.Others are now starting to realize that LAA is the source of stubborn AFIB. Shannon will be able to give much more info and detail as he's had extensive work done in his appendage that required a Lariat procedure to eliminate stroke risk.

That's where he's going with me if my first ablation 6 months ago with him fails.

McHale



Edited 2 time(s). Last edit at 01/09/2014 09:51AM by McHale.

Thanks. On the LAA topic, is it possible to ablate inside the LAA with outdoing the full isolation + Watchman that Natale does? There is no way I'm putting a Watchman in my heart at my age.
Back to the main topic, does anyone know about the 3D imaging that many places now use? Bordeaux has one, although I don't know the different systems, anyone? Also, is the stereotaxis really superior to reach areas otherwise inaccessible?
Trying tod ede where to go for my next ablation basically, as my episodes are 12h every two weeks now, and always self converting.

Shannon is away at the Boston Afib Conference in Orlando. In the mean time, here is a search on his posts on the Lariat procedure, which isolates the LAA and a successful one eliminates the need for anticoagulation. <[www.afibbers.org]

This procedure does not put a watchman device in the LAA.

I'm guessing he'd send you to Natale.

George

PH -

I believe almost all the elite centers including those on your list have the magnetic guidance system. My opinion is that the best hands are still better than magnetic guidance for now. It is true that Natale has stated that he is very impressed with the navigation capability of the stereotaxis system when he is asked about it. However, their group mainly uses it for VT ablation which can take advantage of its precision and low perforation risk, and the system has shown itself to have significantly higher success rate for complex VT cases (higher success rate, much lower complication rate, faster procedure, lower x-rays). For AF, Natale still prefers his hands because he is faster and for most procedures he can get to where he needs to go and his success rate is higher and his complication rate is low enough that it should not be of primary concern. If he thinks you have a real tricky case (such as small heart, tricky navigation) he will use it For centers that are still on the learning curve where complications are an important concern, the magnetic system is probably a good thing in that the soft catheters and defined tip contact force reduces complications by a big margin.

Regrading the 3D navigation systems - the latest 2 dominant systems are the carto3 and ensite-velocity made by J&J and StJude both available for the last couple of years. Many labs have both of them. Some may not have the latest version and that would be indication that the center is not keeping up as there were big leaps in the speed and also the number of catheters the systems can track at the same time. Then there are the c-arm fluoroscopy system that are digital and faster with lower x-ray dosage. All the systems have to work together.

The tools are getting fancier. I am still a little old school and think Roger Federer can beat the 200th rank player 6-0 6-0 with a wood racket.

Interesting. My view is that the best hands (i.e. Federer) are Jais and Natale. Jais ablated me 3 times (i know, sounds like a counter-argument), so I assume he knows better what he did and what he needs to do. So it will definitely be one of these two.
However, as far as the LAA, is the Lariat procedure one whereby you actually sort of remove the LAA somehow. My cardio had mentioned an approach that was permanent and didnt require Watchman and thinners post successful ablation. What are the risks?
Is it easy to tell whether LAA is the main culprit? I clearly have focae inside the heart, and maybe in the LAA, so I'm trying to assess whether a pure 4th ablation without Lariat has a chance of success? is it possible to do a (partial) ablation of focae inside the LAA without Lariat or full LAA ablation +Watchman?

PH,

Have you given any consideration to Mini-maze? After X number of ablations, there comes a time to try something else.

I believe the LAA is clipped during the Wolf procedure, that is similar to the result you get from the Lariat. The Lariat ties it off.

TP

I have not and I know little about it. Who are the best surgeons for that, the same guys who do catheter ablations or it is a whole different crowd?

Totally different group & they are surgeons, not EP's. Wolf comes to mind.

I have communicated with Jais in Bordeaux and he mentioned that they have Carto3 and ensure-velocity.but that they prefer CardioInsight. He sees no value in stereotaxis for afib ablations and said that they stopped using it altogether.
Lastly, I discussed the LAA ablation idea, possibly via Wolf maze of Latriat but he doesn't believe I need this for now as CardioInsight would be able to show whether I have focae in the LAA, if I don't, then such procedures would do nothing,
So I think my strategy now is to do a 4th catheter ablation along the lines above and learn whether LAA is a source or not then strategize from there if I'm not cured.
I am interested in comments from members of this forum on this approach.
Thank you.
PH

PH - That is great news that Jais thinks that CardioInsight vest is ready to go. Carto3 or Ensite-velocity are still needed because they provide a roadmap of where the catheters are with respect to heart anatomy in real time. CardioInsight vest tells you ahead of time (it is not real time mapping yet - it would be a real breakthrough if Jais says it is real time but I don't think that is what he meant) where to look for the re-entry circuits. Like I said before stereotaxis is great for VT but needs further improvements for routine AF. Bordeaux group must not do complex VT.

Hi PH and researcher.

There was a lot of discussion at Boston AFIB last weekend in Orlando that I also attended, on non-invasive mapping systems such as Cardio-Insight and EP-solutions to name two.

Dr. Jose Jalife also presented more interesting developments in his on-going fundamental animal research (sheep) into the cellular and biochemical origins of AFIB with his insight into rotor developing in the atrium.

Its true Professor's Jais and Haissaguerre are really gung-ho about the Cardio-Insight system and no doubt there can be some real value from the pre-screening with such a non-invasive mapping vest and then doing the ablation with the vest on and active as well in order to then correlate voltage mapping and location of rotors and active areas with the vest as well.

However, as Dr Jalife and a number of other researchers and EPs emphasized and cautioned, its still much too early to jump with too much enthusiasm onto any of these new rotor mapping system bandwagons until we get more long term data and a deeper understanding of what exactly we are seeing with these pretty-colored rotor swirls generated by these surface mapping systems.

For sure, it is all very worthwhile and valuable research without question, and I'm all for its development, but there are a number or honest caveats still that need to be answered before every one runs out and starts basing ablation strategy mostly on ablating what looks like a lasting rotor with a vest with around 250 sensor resolution.

I my view, the Cardio-Insight is a more promising system than the Topera invasive rotor mapping system (my opinion) using even less resolution (approximately 64 sensors on a basket catheter).

This year we didn't hear too much hoopla about FIRM, other than another presentation by Dr Narayan (a very nice man by the way) touting his system. And I didn't hear anyone suggesting doing away with PVI as a core part of ablations and moving only toward a FIRM based ablation strategy. Again, perhaps someday something along those lines might develop out of some combination of these phase mapping systems with activation mapping, but its clearly far too premature to even be speculating about such a strategy at this point, much less encouraging patients to 'hold on' while we think we can maybe realize this idea down the road, all the while your hearts continue to remodel with a vengeance in active AFIB.... Its an example of the enthusiasm for a home grown idea getting a little too far ahead of the reality at this point.

Again, the research in this area is all good, but we have to be a little careful with these proprietary systems featuring brand new technologies that are being promoted most strongly primarily by those who have an equally strong financially vested interest in them, as does Dr Narayan in Topera and as does much of the Bordeaux team with their own significant ownership investments in Cardio-Insight.

I'm not at all suggesting anything nefarious here, and I want to make that clear, but the better part of valor requires being both open-minded and interested and yet also maintain an appropriate amount of healthy skepticism until we can see the initial claims and results replicated by other more dis-interested operators and while we are still so unsure of just what it is we are seeing with these systems.

Dr Jalife, who knows more about rotors than anyone on the planet at this point, made a point of emphasis that while rotors very much are a big part of the AFIB picture, that does not imply everyone should just go out willy-nilly trying to ablate every rotor their particular system seems to identify as one.

Dr Jalife runs very impressive and ground breaking research in his lab using a highly sophisticated optical-based imaging system for capturing and identifying these rotors in sheep hearts. These optical systems are VASTLY superior in fine resolution than even the most resolving non-invasive vest-based system so far such as the EP-Solutiuons system.

With his far more resolving optical system, Dr Jalife is able to much more accurately identify and pin-point not only a given rotor's stability or instability around it's singularity, or the center point from which the energy wave emits from the origin of the rotor. For every more or less stable rotor found, many more or less phantom rotors are detected that are highly unstable with many lasting less than half a cardiac cycle.

Also, many rotors drift across the atrium and bounce or reflect off of boundaries such as a scar, ridge or annular opening to a structure inside the atrium, and are not stable in position. Keep in mind too that by 'stable' we are talking about a rotor lasting many minutes to many hours or perhaps even a day long, not necessarily truly permanent unchanging rotors over a very long time.

Some of the challenges this scenario poses, as both Dr Jalife as well as renowned German EP and researcher Dr Karl Heinz-Kuck noted, are not only defining what represents a stable rotor but how, and if, one should approach ablation of said rotor? Chasing transient unstable rotors isn't a good strategy for long term success and if what you can define as stable or not varies based on the resolution of your imaging system then you can see the problem there in achieving consistent results between one system and another.

Also, Dr Jalife and Dr. Heinz-Kuck who has used the EP-Solutions vest in his studies, both emphasized that one has to be careful in ablating certain rotors for fear of stabilizing and fixing a rotor via ablation rather than terminating it! The exact opposite of what you would want to do, and yet that remains a possible outcome until our understanding of rotor mechanisms and identification is more advanced.

Dr Heinz-Kuck noted too that with their high resolution vest, they were unable to identify a truly stable rotor in over 90% of persistent AFIB patients in his lab, and as such they did not find any targets to ablate in such patients! Also, in those in whom they did identify a relatively stable rotor, using a direct core ablation method on the singularity or center of the rotor did nothing at all and did not terminate AFIB and when using a linear line approach drawing an ablation line across the rotor, they could convert a stable rotor into a unstable one that would drift around but still not terminate any AFIB!

It should also be noted that in Dr Heinz-Kuck's persistent patients in this study they attempted the rotor mapping and ablation prior to doing the PVI part of the ablation.

Dr Heinz-Kuck's conclusion is that while such phase-mapping deserves further study and development , in his experience it is definitely too early to recommend EPs move this technology into their EP ablation labs. Dr Carlo Pappone also questioned how urgent the need was for these phase mapping systems when a well developed 3D Mapping system that also integrated 3D CT scan and voltage mapping has proved highly effective in skilled hands.

Pierre Jais reported close to a 50% reduction in ablation time with their Cardio-insight system integrated into their overall ablation imaging and mapping protocol in a combined hybrid system. However, longer time frame results will be needed to validate the system's comparative longer term efficacy compared to their prior step-wise model for persistent AFIB.

In short, its an interesting period in the always evolving AFIB world, but your best bet as a patient is to not get too overly excited about any announced 'breakthrough' at these conferences until you see it become more widely adopted as a standard part of the protocols for many, if not most, of the top EPs in the world. Rest assured that any technology that truly proves itself in a significant way WILL be widely and quickly adopted by all the elite players before you should even consider being a guinea pig for a system.

And even when its a big and trusted name promoting a given technology, particularly if they have a substantial personal stake in the technology, it is still prudent to wait until at least a good number of their peers also validate their encouraging findings before jumping on board.

That has always been a good rule of thumb as the top operators in this field typically have access to the most cutting-edge gear out there and those new developments that really prove out and stand the test of time will win everyone over. That does not imply at all that an elite EP cannot make an ownership investment in a technology and still be a relatively unbiased reporter of its efficacy, but it just makes sense to at least wait until a good number of other top elites tend to agree and also adopt the same approach before jumping the gun. Some great sounding technologies that seemed very promising in the first few years have failed to stand the test of time in this field.

Or at the least, wait until a given top tier center that might be developing a proprietary technology has a couple years of confirming data behind it first.

It will be interesting to watch this area unfold over the next few years and both Jose Jalife and Stanley Nattel promise more insights to come next year based on on-going research into this area of phase mapping and rotors in AFIB.

Shannon



Edited 1 time(s). Last edit at 01/14/2014 02:58PM by Shannon.

Hi PH,

One other point in your post above, you were asking Professor Jais about getting LAA isolation and he suggested that if you didn't have any activity there in the LAA then it wouldn't do you any good to just automatically ablate that area, which is absolutely true.

But by the way that was worded he may have been under the impression that the LAA isolation was a fixed conclusion to be done for sure even before your procedure with Dr Natale should you choose to see him for this fourth ablation?

I can assure you that Dr N would not automatically be isolating your LAA in any new ablation after you having had three in Bordeaux, unless he clearly mapped out your LAA as being a significant, if not the only, remaining contributor to your AFIB during your procedure.

Natales only goal, as would be Professor's Jais' as well, would be to thoroughly test all previous areas of ablation to check for any leaks and repair those as and if needed, then continue mapping and challenging the whole left and right atrium to ferret out any and all remaining possible active sources and zapping them.

Very often in cases like yours where it has taken more than two procedures at the hands of a highly skilled ablationist, Natale has found that the LAA is frequently the main or sole remaining culprit in such cases. Many other EPs do not recognize as much LAA triggers due to not using a strong enough programmed EP stimulation along with too little dosing or for too short a time with their isoproterenol challenge to ferret out the LAA contribution to the on-going pesky breakthroughs. A lot of EU centers either don't use Iso-peroterenol challenge at all at the end of their ablations or only do it for a few minutes at more moderate doses, while more US groups use longer 20minute isoproterenol challenges at high doses to really challenge the heart and help prevent more frequent repeat ablations.

However, at Bordeaux they obviously do recognize the LAA issue as well from the fact that Professor Haissaguerre in his presentation on persistent AF at Boston AFIB last weekend noted that in their experience at Bordeaux the three main areas, in sequential order by frequency of occurrence, of either continued or new AFIB/Flutter sources in follow-up ablations for their persistent AFIB cases are 1. Reconnected PV's, 2. Reconnections or new spots along the posterior wall of the LA, and 3. the Left Atrial Appendage.

This is pretty much the same findings as Natale's group as well, although Natale finds very few reconnections, especially over the last 6 years or so, to his initial PVAI and posterior LA wall work, thus leaving mainly just the LAA and CS as the prime areas found that require ablation during his touch-up ablations in order to end arrhythmia issues for the long term, since until the last couple of years he rarely addressed those structures in a first ablation unless they were the only or main trigger source found in the index procedure.

Dr. d'Avila from Mt Sinai in his presentation at the conference also made note of the very low levels of reconnected PVs found in Natale's centers as well, and with the advent of contact force catheters it is hoped a wider array of EPs will be able to achieve lower rates of reconnections found during their future repeat ablations that may be needed as well.

Shannon



Edited 2 time(s). Last edit at 01/16/2014 08:08AM by Shannon.

PS PH,

You mention that Bordeaux does not use Stereotaxis for AFIB ablation, and for good reason. Neither does the Natale groups use Stereotaxis for AFIB ablation at all, and use it only for some difficult access maneuvers in certain select VT ablation cases.

They like some aspects of the Hansen Robotics system, but you won't find Dr N, or most any top ablationist, using either automated system for AFIB cases.

Shannon

Thanks Shannon. Two follow up questions:
1. Does Bordeaux use "contact force" catheters? What if they don't on my chances of 4th ablation success?
2. More generally, and ignoring the merits or lack thereof of Cardio Insight, do you think it is worthwhile for me to do a 4th ablation? I am not at all scared by the procedure, was awake for the first 3, and have a good report with the Bordeaux team. My last ablation was in 2008 when none of the more advanced mapping technologies existed. I am now back to 15 day afib frequency +/- 2 days and episodes last 8-16 hours. I take Sotalol as a PIP but I feel like it does little. I'm also on 20mg Xarelto as a safety.

Thanks for extensive information

Shannon, Good to have you back from Boston AF. CardioInsight was started by engineers and CCF folks in Cleveland so I think Jais role is mainly beta tester with consulting fee. Same arrangement as all the other elites when they do beta testing on new devices. Natale for example was main beta tester and consultant on Hansen's robotic system and also helped with marketing both Stereotaxis and Hansen systems when they first came on the market. Austin is still the demo center for Hansen in exchange for $. Jackman was the main beta tester and consultant for Stereotaxis if recollection serves. Neither system is automated in that user has to move the catheters for ablation. I believe the Stereotaxis has automated mapping feature - possible and safe with soft catheter. Hansen system cannot be automated because the sheath-catheter combo is stiff. Perhaps there is potential for Jansen automation with new contact force catheters. Last I talked to Burkhardt, he was using Stereotaxis a lot for VT (to the extent that the magnetic lab is kept busy) and Horton fits in AF cases. Sounds from your note that is no longer the case - and that would be a surprise to me. Natale has complained from the beginning that the magnets are not forceful enough for AF and that continues to be the case. Hansen on the other hand has surplus of force but no tactile feedback.

PH - contact force catheter is a great concept but needs further testing and probably engineering. I think the thermocool irrigated catheter is still the state of the art for now. The combination of that and a skilled pair of hands like those that Jais possesses is still the way to go.

Researcher,

Yes Cardio-insight is indeed centered in Cleveland, but several of the top Bordeaux docs have also made substantial ownership investments in the company from the reports from several sources, as well as their own potential conflict of interest disclosures that cited ownership investments in the company in the CVs for each talk at Boston AFIB. Its definitely not just a consulting gig any longer in this case.

And you are right every EP has some true consulting and development arrangements with top manufacturers and are duty bound to disclose them as the Bordeaux team as certainly done. There is nothing inherently wrong at all with that as well as I noted above. Its just that when it does move from a consulting/developing relationship to a high Euro/Dollar ownership stake in a brand new technology, it at least warrants insuring there are a good number of other more disinterested top researchers and EPs also finding similar results before every EP should rush out and buy a set up for their own labs.

Im not at all suggesting anything other than an honest interest and excitement by Bordeaux in their new company affiliation here, and I do think the Cardio-insight system may very well prove to be a valuable tool and I find it conceptually, and from what I have seen so far, to be a more elegant and possibly more effective way of non-invasively of generating a usable form of these phase maps compared to the Topera system which is still invasive. However, we still need to know more about what it is they are seeing with these various rotors and what ablation approaches are best implied, if any, for given types and definitions of 'rotors'.

At this early stage when even folks like Jose Jalife, Karl Heinz-Kuck and Carlo Pappone are suggesting caution before everyone gets ahead of themselves here, it only makes sense to let the science carry on further and see just how much the further development and integration of phase mapping with proven activation mapping can help buy us benefits in the form of shorter times and just 'perhaps' more targeted ablations, or not as the case may be? It's one thing to get a short term termination of an AFIb during a live feed ablation and quite another to confirm long term freedom from arrhythmia as a result and these longer term results take time, nevertheless it is an interesting area of research and no matter what the final verdict becomes it will surely help advance our knowledge base about AFIB origins and help clarify ways to proceed forward, one way or the other.

There are still some real caveats, though, that need to he answered here and in that endeavor it's good that Bordeaux as well as Heinz-Kuck, Jalife and Narayan's group as well as others are all looking at this issue, mostly in Europe it seems where its a bit easier to do preliminary exploration of such technology, but also with some work here in the US as well.

As far as Stereotaxis and Hansen systems go, as you noted researcher, Stereotaxis uses magnetic field vectors to control a proprietary catheter while the Hansen robotic catheter navigation system maneuvers standard catheters robotically by allowing remote manipulation of the catheter via a computer-driven signal controlling a robotic arm attached to the foot end of the ablation table.

Each system has their pluses and St Davids, as you noted, has both. In fact, in the very latest and very cool new book just published in the last couple weeks that I picked up at Boston AFIB titled "Hands On Ablation - The Expert's Approach" by Cardiotext Publishing, it has a full chapter by Dr Joe Gallinghouse, Luigi Di Biase and Andrea Natale all about the Hansen Robotic system and in this chapter they say that a clear advantage of the Hansen robotic catheter over either manual or magnetic systems is its ability to control contact force of the catheter as well. Also there the book is authored by David Callan, Andrea Natale, Pierre Jais, as well as Amin Al-Ahmad, Henry Hsia and Paul Wang from Stanford Univ, and Oscar Oseroff from Argentia with many co-authors as well. It includes for the first time anywhere, very detailed 'how to' descriptions of both Natale's PVAI paroxysmal approach as well as Natale's and Bordeaux's step-wise variations for persistent AFIB, and several chapters on dealing with post ablation atrial tachycardias, ventricular tacky ablations and many other topics in this field!

It is really insightful with all the photos, diagrams and live videos linked to from each chapter making this an invaluable hands on tool for any EP ablationist wanting to learn how the premier EPs in the world do their work, when the only way to learn that previously was to go work with them for a while live at St Davids, Bordeaux University of Penn, or Stanford.

In this chapter on the Hansen robotic system, they convey that until contact force catheters are fully approved for use in the US, this robotic system can help and particularly with less than elite operators, even though the Toccata study findings also showed that even some pretty experienced operators at times both over and underestimated their contact force applied when blinded to pressure data.

Incidentally, you need to apply more that 10 grams and preferably 20grams or a bit higher consistently 80% of the time to insure solid transmurality. Many operators varied all over the map with plenty running from 4 grams to 8 grams even when they felt sure they had a stable solid catheter contact!!

Still the most elite and experienced guys like Natale and some of the Bordeaux team that have almost an innate 'touch' combined with all that experience are hard to beat when using a latest gen Thermocool SF catheter for consistently reliable results.

There has been big improvements as well reported with both the St Jude's Tacti-Force catheter and Bio-Sense Websters new contact force model which is basically a latest Thermcool irrigated catheter with a built-in spring-loaded contact force tip, and both of which Natale's group as well as Bordeaux and several other centers have assisted in developing and testing.

In the meantime, stick with the most experienced operators like Natale and Bordeaux and you'll be not only be privy to the best gear available but most importantly to the best hands and best minds in this business with the most experience in laying down the best quality ablation burns anywhere.

Shannon



Edited 1 time(s). Last edit at 01/15/2014 01:06PM by Shannon.

Shannon, Thanks regarding financial interest Bordeaux has in cardio insight. I wish they hadn't done that. Regarding spring type contact force catheters, I want to see how they achieve irrigation at the tip (like the Thermocool) before deciding whether it is ready. If not done correctly, there is a good chance for char formation. I hate to see the big companies (JNJ specifically) play silly games and not just pay the IP royalty for fiber optic force sensing, The problem would have been solve already had they done that.

Hi researcher,

Well, their investment just adds another wrinkle when interpreting their clinical results, but is not a deal breaker by any means. Im sure the Bordeaux team really does like and believe in the technology and I have no problem with these physicians profiting from something they helped develop and they dod disclose their relatively recent ownership investment at least. It's just that it does add an additional measure of caution, both on their side in not seeming too overly promotional early on, and for everyone else to make sure they base their own analysis of the results, not only on the Bordeaux reports, but also to include a broader consensus of supporting results from a number of other centers and operators who can replicate the findings as well.

But just because a few Bordeaux EPs have bought into the company does not mean that it isn't a worthwhile technology. However, as you noted it does put a caveat around the early claims until we see it repeated elsewhere and see the technology adopted with similar enthusiasm by other top operators.

What gave me pause more than anything was the cautionary statements about what all these phase maps really mean from Jalife, who is the grandfather of all this rotor research to begin with and is avidly pursuing the big picture answers about rotors and their meaning and role in AFIB genesis, as well as Karl Heinz-Kuck who also is/was very excited about the technology, but now is honest enough to admit that their own very careful research so far indicates there are more questions than answers and in his opinion it is far too early to start recommending EPs in the field to consider adopting this technology.

Regarding contact force, the Biosense Webster folks have a new tip for the latest Thermocool SF that has many more holes and a special flow technology to insure true uniform irrigation across the whole flat round tip and well as sides of the tip too for very uniform cooling without any hotspots. Im sure this is what they will apply to their contact force model as well, but we shall see how it stacks up against the very nice St Jude's Tacti-Cath model as well the patent and technology for which they bought from Endosense last summer.

Shannon



Edited 1 time(s). Last edit at 01/18/2014 10:22AM by Shannon.

PH Wrote:
-------------------------------------------------------
> Thanks Shannon. Two follow up questions:
> 1. Does Bordeaux use "contact force" catheters?
> What if they don't on my chances of 4th ablation
> success?
> 2. More generally, and ignoring the merits or lack
> thereof of Cardio Insight, do you think it is
> worthwhile for me to do a 4th ablation? I am not
> at all scared by the procedure, was awake for the
> first 3, and have a good report with the Bordeaux
> team. My last ablation was in 2008 when none of
> the more advanced mapping technologies existed. I
> am now back to 15 day afib frequency +/- 2 days
> and episodes last 8-16 hours. I take Sotalol as a
> PIP but I feel like it does little. I'm also on
> 20mg Xarelto as a safety.
>
> Thanks for extensive information


PH,

Sorry for the delay in response to the above questions, I must have overlooked this post of yours until now.

1. Im not sure if Bordeaux is using one of the new 'in-development' contact force catheters yet for routine ablations and would be surprised if they are using them routinely at this time. Though they do have more regulatory freedoms in using new technologies than in the US where the contact force catheters are still for investigational trials only at several top centers. I suspect that they are using them for research and evaluation by now though.

However, either way, I would not make using contact force a prerequisite for doing a 4th ablation. Rather, pick the best EP you are most comfortable with and can arrange and go with their skill as researcher very rightly said above.

2. And yes, I do strongly think you very much could use a 4th ablation, and perhaps with the combination of the Cardio-inisght and Carto 3D systems at Bordeaux plus the added experience and knowledge they have accumulated since your last procedure, Professor Jais will have success this time.

However, my one caveat here, is that normally you should be further along after 3 procedures. Professor Jais is undoubtedly one of the best EP's available anywhere, yet they do seem to have a few more follow up procedures to get to the same excellent result, on average, than say Natale and his group who tend to be a little more bold in their initial and follow up ablations. That sense I derive from the published studies from both Bordeaux and Natale's group on reconnection rates.

While the Bordeaux and Natale approaches to challenging cases are far more similar than they are different, there is a somewhat nuanced and mostly philosophical difference. Where Bordeaux, while they do a comparatively comprehensive ablation compared to more typical centers, they do take a bit more of a piece meal approach compared to the Natale approach where Natale PVAI based approach makes an effort to address as much as they deem necessary to get the job done in the first procedure as their PV isolation also includes more posterior wall isolation and more work in the antral space along the roof line between the two sets of right and left PVs while staying almost entirely within the same histological tissue type of the muscle sleeve that surrounds not only the PVs themselves, but extends almost entirely across the posterior wall and up toward the anterior wall where it surrounds the left inferior and superior PVs as well.

As a result, even though there is typical more ablation done in a PVAI than in a segmental PVI, there is no increase impact on left atrial function since the tissue ablated is almost entirely of the same tissue type as the muscle sleeve immediately surrounding the pulmonary veins.

When done well, with consistent transmural lesions laid down which is a hallmark of Natale's skill and no doubt is a common outcome with the most experienced Bordeaux EPs as well, the end result will be less overall ablations needed to complete the ablation process with good success long term.

In any event, the net results from the Natale approach for both their first and follow up ablations tends to be a more comprehensive ablation at each step leading to a bit less overall repeat ablations needed. Certainly less repeats required, on average and overall than with more typical average EPs and/or at less than top volume centers, though with Bordeaux of course they have very high rates of success overall and comparable to Natale's groups, at least comparing stats from data collected over the prior 8 to 10 years but not necessarily looking at more recent data over just the latest number of years in which both centers results have improved further no doubt. Dr. Natale has conveyed to me significant improvement in persistent case results since incorporating a more extensive approach to non-PV triggers including especially the LAA when required.

As such, I don't think the reconnection issue itself will be a major factor for your decision now PH when considering these two top EPS, as even if there are more reconnections found during mapping of a 4th ablation, surely Prof Jais will be able to nail it all down for the long term on the fourth try.

Nevertheless, the most important question in your situation PH, is the LAA issue. Bordeaux does recognize and address the LAA when they find it a major source of continuing trouble on a follow up ablation, but at least in the past as I understand it they tended to limit that work to spot focal ablation within the LAA itself in an effort to avoid overall isolation of the LAA in hopes to avoid the patient possibly needing on-going anti-coagulation. Whether or not they have extended their LAA work to include full isolation yet, I'm not sure?

The only problem with that, is that spot focal ablation inside the LAA is unreliable and frequently fails to hold up and get the job done according to Dr Natale and his group who have extensive experience in this area.

The point of saving LAA isolation for either the last step in an ablation process or for including it early only if it is the primary or only source of triggering found in an index ablation, is that if it is not effectively eliminated as a source it WILL continue to undermine all your efforts at achieving relative freedom from the beast.

In addition, that failure to address an active LAA, will in most cases result in more or less persistent AFIB/Flutter and thus require you to stay on permanent anti-coagulation in any event!

What Natale and his group discovered while being the pioneers in recognizing and effectively addressing both Coronary Sinus and LAA isolation in order to greatly improve results in longer duration paroxysmal and persistent AFIB cases, and having done far more LAA work than anyone else, is that doing focal ablation insider the LAA is not only more risky for tamponade, but is much less effective longer term than full isolation of the LAA due to the thinner wall and more variegated nature of the interior surface of the LAA.

That is why so many less experienced ablationist will blanche and get weak in the knees when you even bring up the suggestion that they consider doing work within or around the LAA, and are so quick to automatically agree with any theory, no matter how ineffective, that will give them a least a seemingly rational sounding pass and allow them to avoid having to do LAA ablation work.

In the Austin, San Francisco, Ohio and Italian experience under Natale's various groups, they have found significant increase in good outcomes with more challenging cases when LAA action is indeed discovered with EP mapping during an initial, or more often during a follow up ablation, by doing LAA isolation when required.

About 55% of the time, LAA isolation will also require a dependance on anti-coagulation going forward, either that or going for a Lariat or Watchman device. However, that also means roughly 45% of the time the person will be free to stop blood thinners. If you have an active trigger from the LAA and you don't address it fully, your odds of needing life long anti-coagulation are vastly higher, approaching a near certainty before long.

As such, its easy to see that this idea that some EPs favor of avoiding effectively addressing the LAA when it is a key source of your on-going arrhythmia is actually a false choice, as it insures that you will not only have ongoing arrhythmia problems requiring even more ablations with the additional risks for each one as well as even more radiation exposure etc etc, or that you will have to accept permanent AFIB or Flutter with rate control for the long haul ... at least until the elephant in the room is finally acknowledge and taken care of.

The reality is, that if you do have LAA involvement as the remaining trigger keeping you active, having an expert LAA isolation gives you your very best odds to not only avoid life long anti-coagulation, but also to eliminate or at least greatly minimize AFIB/Flutter burden going forward. That is what I realized when facing this very same situation.

In my view, too many EPs take the politically expedient "Less is More" philosophy which only sounds appealing and is perhaps a good approach to many other areas of medicine, but not with AFIB ablation. This 'Less is More' idea is mostly heard from those with less success in addressing challenging cases and are more reluctant to branch out into other Non-PV trigger areas for ablation.

It's a better ablation philosophy, in my book, to do everything necessary to get the job thoroughly done, both safely and effectively, and not do 'one burn less' than is necessary to achieve that endpoint. Otherwise, there will be one disappointment after another as well as all the added stress of having to go through the same process repeatedly if a too timid EP tries to go piece meal at each ablation only doing the least amount they think they can get away with while avoiding a major area like the LAA simply because they don't feel confident going there, or they make the wrong assumption that by avoiding ablating the LAA while spare the person from needing to go stay on AC drugs for life.

Certainly with Professor Jais, he is more than capable of doing a fine job and finishing things up, particularly if he will actively challenge the LAA area and fully address it if it is a problem, as is so often the case in a second, third or especially fourth ablation. I'm just not sure how resolving the Cardio-insight system is at ferreting out LAA signals and making them apparent, but he should be able to elicit those with Carto 3 mapping in any event.

Dr Natale has emphasized that it can be challenging to distinguish which signals are actually coming from the LAA and which are reflections from elsewhere at times and this is where a lot of experience in focusing on LAA triggers can give an edge. Particularly if that area has not been addressed so far in your first three ablations, and is the major problem left.

I want to be clear, though, that as a skilled ablationist both Prof Jais and Dr Natale are among the top few elite in the world and you will be in great hands either way. I only make these rather fine points of distinction, in your case, since you have already had three ablations at Bordeaux and are still having a lot of active arrhythmia which makes me more suspect that the remaining culprit for you may well be the LAA.

In that case, I would lean toward Dr Natale, if he is at all a realistic logistical option for you, simply because of his much greater in-depth experience in LAA isolation work. In addition, you can rest fully reassured too that if the issue is not in the LAA, but elsewhere within the left atrium as perhaps from some reconnections of previously ablated areas, that either Prof Jais or Dr Natale will easily be able to address those reconnections and will search out any new active areas as well with great skill and quieten your heart.

If you live in Europe then, its an obvious choice to go to Bordeaux and perhaps their new tools integrating Cardio-insigjht with Carto-3 and fluoroscopy will make for a fully successful '4th time is the charm' for you there in southern France.

Best wishes on getting this all resolved PH, but I would definitely go for a 4th procedure with either Professor Jais or Dr Natale, if you can arrange a US procedure with him with not much added effort. Either way, the odds are high you will get the result you have been waiting for all along.

Shannon

Shannon,

RE "...Biosense Webster folks have a new tip for the latest Thermocool SF that has many more holes and a special flow technology to insure true uniform irrigation across the whole flat round tip and well as sides of the tip too for very uniform cooling without any hotspots. Im sure this is what they will apply to their contact force model as well, but we shall see how it stacks up against the very nice St Jude's Tacti-Cath model as well the patent and technology for which they bought from Endosense last summer. "

The Endosense force sensing fiber takes up 0.1 mm of space. Biosense will for sure come up with an OK spring version that is nowhere as elegant. Biosense has such a dominant market share that they have had the "not invented here" syndrome.

RE "it has a full chapter by Dr Joe Gallinghouse, Luigi Di Biase and Andrea Natale all about the Hansen Robotic system and in this chapter they say that a clear advantage of the Hansen robotic catheter over either manual or magnetic systems is its ability to control contact force of the catheter as well."

I am amazed that Natale et al has been sold and still propagating the Hansen marketing lock, stock and barrel. Hansen so called force sensing only measures the force at the handle-end of the system, not the tip. That marketing is way too aggressive if not deceptive especially given the high rate of injury and deaths during early usage and it is probably still going on since usage is so infrequent for most of the systems out there. If they actually had the tip force sensing problem solved, we won't need Endosense or Biosense. Both Hansen and Stereotaxis are open systems as far as being able to use off the shelf catheters in that they don't restrict companies from making catheters compatible with the systems. Biosense pays royalty to Stereotaxis for magnetic versions of their catheters. Hansen gets their money from single use robotic sheaths.

RE: "you need to apply more that 10 grams and preferably 20grams or a bit higher consistently 80% of the time to insure solid transmurality"

Yes, and certainly below 30 grams to avoid steam pops. 20 grams and below is safer. Beating heart introduces a variability of 10 grams approximately - depends on tissue location and thickness. If recollection serves 15 grams would be about right. Perhaps slightly more force affects a greater volume and less ablation points and therefore faster procedure. However, human feel is never perfect, often not close even for Natale like hands as Toccata showed. Contact sensing should help. If Biosense or St Jude (or others) can come up with a constant 15 gram catheter, that would be awesome.



Edited 1 time(s). Last edit at 01/22/2014 10:32AM by researcher.

Hi researcher,

It's clear I need to clarity a few points on the Hansen/Stereotaxis systems and perhaps I should have also discussed in my first post above on the topic, the next chapter in the new book 'Hands on Ablation -The Experts Approach' right after the one on the Hansen Robotics system I mentioned briefly in the paragraph you quote above. That following chapter was all about doing AF ablations with the Stereotaxis magnetic system written by Dr Burkhardt and Dr Natale as well.

Its quite clear when you read both chapters that neither Natale or any of the other authors from his team have any overt bias towards one or the other system .. robotic or magnetic ... and certainly there is no impression whatsoever that they have bought into either companies propaganda 'hook, line and sinker' . The whole point of those two chapters is not promotion of either system over the other, but to clearly spell out both the strengths and weaknesses of each system as discovered during their extensive experience in investigational use of both systems during their development.

Those two chapters also highlight in detail the importance of the learning curve and knowing how to anticipate and adjust for any system limitations in order to get the most from each remote navigation system with the greatest safety and efficacy. The Austin/San Fran group has the most experience of any center in the world in comparing both systems.

Natale himself doesn't use either one for his own ablations, but also recognizes their potential benefits in other procedures and also for those who prefer working with the systems only after they put the time in to learn how to use them properly, as well as the potential for even better performance in the future with continued refinement of the system's design.

The one area where Hansen has a possible advantage, as I noted in that quote from the book you noted above, is in its inherent support for a good contact force solution.

One of Natale's colleagues in Austin uses the Hansen for every AFIB ablation perhaps Dr Gallinghouse, and Dr Burkhardt uses the Stereotaxis system for all VT ablations he does, and both of them really love the systems and both have an excellent track record for good results with excellent safety with both systems.

With the Hansen system, there is the potential for problems if an EP just dives right in without better understanding of how to use the system and then risks a higher potential for cardiac or venous perforations. This problem which, no doubt, is where the early negative reports you are referring too arose from, is due to the relative stiffness of the sheath used in the Artisen catheter system employed as part of the Hansen set up. This stiffness inherent in the the Atrisen sheath used as part of the Hansen system must be accounted and adjusted for, which it is done by introduction of a 'long introducer sheath' from the left femoral vein which then supports safe transit for the Artisen sheath and whatever catheter it contains thorough the often circuitous pathway of the iliac anatomy.

But the stability provided by the Artisen sheath, when compensated for and made dramatically safer with the help of the long introducer sheath, also provides one of its main advantages over Stereotaxis in this application. The stability and support provided by the inner guide of the Artisen sheath also prevents 'rebound' of the ablation catheter tip when placed against atrial tissue in a beating heart, as commonly occurs with a softer more flexible manual catheter without the support sheath. However, as such, you must turn down both the power and lessen the contact force applied compared to what you typically use with the same manually-manipulated catheter in order to get solid, consistent and safe transmural burns.

"Further, very fine adjustments of the catheter tip contact can be made on the fly by using both the IMC 3D Joystick-like operator controller and the auto-retract feature button which withdraws the catheter at a programable rate at around 1cm/sec. This allow refinement of the catheter tip location and pressure applied on a millimeter by millimeter basis" ( quote from the book 'Hands on Ablation' - 2013).

This is a very good thing to be able to use lower power and CF, but also MUST be accounted for to use the system safely! For example, using something like a Thermocool catheter where you might use from 35 watts to a max of 45 watts of power, when using the same catheter within the Artisen sheath guided by the Hansen Robotic system it can get equal results with only 15 watts to 25 watts total power! And contact force must be dial back by a proportional amount too to help insure no perforation issues. Failing to understand and adapt to these characteristics of the system could indeed make it very risky to use. But that is true with driving a car without a license and proper training as well.

On the flip side, the Stereotaxis system has the opposite problem n order to get transmural lesions more consistently and thus requires the use of more power to compensate for a less adjustable and weaker contact force applied to the catheter by the system.

Neither the Hansen system nor the Stereotaxis is intended as a replacement for the new standalone CF catheter like the Tacti-Cath of Smart-Touch, but rather the Hansen is particularly well suited to be used with either of the new CF catheters and apparently helps facilitate a stable platform for getting the most from those CF catheters at the lowest possible CF and power use required for a good transmural burn.

While the Hansen system calculates CF from the handle area of the cache it uses the built in 'Intellisense' pressure-sensing mechanism which involves ann automated dithering of the ablation catheter normalizing it to 0 grams of pressure with a baseline measurement in the heart. A load sensor on the robotic arm ( what you are referring too researcher) then calculates the CF with the tissue and displays it graphically and in real time for the EP. Haptic Feedback is employed as well wherein the IMC 3D joystick can be programmed to vibrate above a set cutoff point like 35grams of CF or whatever. one chooses and the safety margin.

Apparently, this 'Intellisence' mechanism used in conjunction with the sensor and calculator on the Artisen handle is highly accurate in the perpendicular plane in which most all catheters make contact with the tissue and is progressively less so as at the catheter orientation gets more parallel with the atrial wall tissue.

Nevertheless, once the even more precise stand alone CF catheters like a Tacti-Cath are used with these controls its quite possible the combined system will allow a very high degree of consistency in ablation success for even less experienced operators provided they are at least well experienced in operating the entire system and know what they are doing in terms of ablation strategy, even if they lack several thousand ablations under their belt to gain the better feel and expertise with a hand held catheter.

While I don't know which statistics you are referring to for injury and deaths from very early trials of the Hansen system, I do know there was a steep learning curve and that for most centers that have used the system it takes about 50 procedures to learn how to modify the procedure for maximum results and safety.

Dr Natale said to me that they have found the systems very safe indeed with actually a slight reduction in overall adverse events when used properly and with the correct adjustments in CF and power for the Hansen system and with using even more power to compensate for the reduced contact tendency when using Stereotaxis .. mostly for VT ablation at this time.

Anyway, that is the skinny on these systems to date as I understand them. They are still a work in progress, but seem to be far safer in the right hands than what your earlier reports may have indicated. And certainly, there is no overt favoritism I could detect from Natale for either of the two. My long experience in discussing such technological developments with him also has made me realize he is all about the end results and has never been wedded to any one technology or company. He has investigational and development relationships with most of the top players in the field as is.

Dr N also has expressed to me repeatedly not to get sucked in too soon by all the hype, bells and whistles and great sounding stories from each new technological 'breakthrough' breathlessly trumpeted at these conferences. He is a stickler for letting long term real world trials prove or disprove a theory or a system, as he has seen too many otherwise compelling sounding ideas and systems that looked great in theory, fall flat after several years in the real world when they haven't panned out as hyped and hoped.

That is one reason why I've come to value his insights on these issues over the years, in addition to the great results I personally have experienced and witnessed in so many others at his hands, but because he has always taken an open-minded, yet a still a distinctly 'lets wait and see' approach to all new ideas and systems, and never leads with an over the top rush toward glory kind of an enthusiasm you see with some other new ideas and technologies that are still in their infancy and remain unproven. Let them prove themselves first in the school of hard knocks before crowning anything the 'next big thing', and this view has been his consistent approach as long as I have known him. Sounds reasonable to me.

Take care,
Shannon



Edited 2 time(s). Last edit at 01/23/2014 07:07AM by Shannon.

Shannon,

Thanks for the clarifications and details.

RE "While the Hansen system calculates CF from the handle area of the cache it uses the built in 'Intellisense' pressure-sensing mechanism which involves ann automated dithering of the ablation catheter normalizing it to 0 grams of pressure with a baseline measurement in the heart. A load sensor on the robotic arm ( what you are referring too researcher) then calculates the CF with the tissue and displays it graphically and in real time for the EP. Haptic Feedback is employed as well wherein the IMC 3D joystick can be programmed to vibrate above a set cutoff point like 35grams of CF or whatever. one chooses and the safety margin.

Apparently, this 'Intellisence' mechanism used in conjunction with the sensor and calculator on the Artisen handle is highly accurate in the perpendicular plane in which most all catheters make contact with the tissue and is progressively less so as at the catheter orientation gets more parallel with the atrial wall tissue. "

It is far beyond the scope of this forum to explain robotic feedback controls. It is difficult to convey the theory and practice to lay people in plain English. Suffice it to say that I will not trust the Hansen system to touch me or any member of my family. The reason is the "stuff" they are putting out to convince non engineering folks that they have a handle on tip forces by dithering. Dithering is an industrial control subject that is graduate level engineering curriculum. In layman's terms, it is use to figure out frictional forces so that controls can compensate for it. Hansen does this for the 11 Fr catheter guide-sheath. The other 2 forces are ignored 1. forces between 14 Fr introducer sheath and blood vessels. 2. forces between 14 Fr and 11 Fr introducer and guide sheaths. Dithering is OK for systems in motion. Problems are 1. catheters and sheaths are static for each contact point so the system switches to a snag-slip system. 2. curvature changes friction and sharper curvature results in large dithering errors. 3. noisy data requires smoothing (that is why you see a smoothed force curve on the display when it should be cycling so large forces are averaged out - Gallinghouse turns off the display and ignores the data). "Intellisense" is a great marketing term but it is in fact useless.

As for the injuries and deaths, I refer to the original CCF publication by Natale et al (no deaths at CCF but lots of close calls) back when the system was first installed. Subsequent to that experience, there were FDA filings and HRS posters describing deaths and injuries. One alarming one that I recall was Schillings iliac tear (remember introducer - blood vessel forces are ignored) during a trial that was set up by Hansen to prove the system's procedural safety. In Cappato's survey, there has been none in that category in 40,000 ablations. Hansen mortality and complication rate was about 5X the average if recollection serves. Hopefully, they are better than that by now. Still I repeat - I will not trust the Hansen system to touch me or any member of my family.

For those that are technically inclined to understand frictional forces and dithering, below is a nice review of the subject.

[www.bu.edu]



Edited 1 time(s). Last edit at 01/23/2014 11:28AM by researcher.

Hi researcher,

Thanks too for the link, and yes for sure an in-depth discussion of robotics is beyond the scope of this forum and no doubt there was a steep and dangerous for some learning curve for the Hansen system. Not unlike for quite a few early ablations as well, with numerous PV stenosis and esophageal fistulas as well until operators learned how to adapt to the parameters of their tools and the environment they are working in within the LA.

However, beyond the theoretical limitations and advantages of various technical decisions made by the Hansne developers, what I have learned in talking with Luigi Di Biase who is ver experienced using both systems in the Natale groups animal research well as Andrea Natale about their very extensive hands on experience with both Stereotaxis and Hansen is that they can be used with a very high degree of safety these days when all the caveats and limitations of each system are thoroughly understood and compensated for.

By combining their careful animal research with taking care to better understand and anticipate problems with human subjects early on. which he agrees very much can arise if one is just following the original manual or preliminary guidelines when the system first came out, without taking the time and effort to adapt ones procedures and the system itself to compensate for its potential problem areas, then some real problems can occur as you noted.

Di Biase too noted a number of improvements have been made to the system since the early days of that very first system installed anywhere in the US that was first put in at CCF when Natale was running their AFIB department, and then another Hansen as well as Stereotaxis at both St Davids in late 2007 just when Natale took over there and at CPMC in San Fran.

Secondly, the most important factor in the much improved safety of the system, when used in very experienced hands, is that a thorough learning curve and adaptation of both the process and the gear to minimize any potential problems is absolutely essential. Most notably to avoid the problems with navigating the iliac anatomy labyrinth with the inherently stiff sheath that indeed was a major barrier to safe use at first.

Since then they have redesigned that aspect to mitigate the near universal concern expressed over this issue at the time with the increased risk of cardiac or vascular perforation being possible, which no one wants to deal with for obvious reasons, with the original design of the Artisen catheter system. Apparently, the introduction of the long introducer sheath via the left femoral vein allows the Artisen sheath to now pass through this iliac area safely and Natale told me that have had none of those problems at all with such access issues since that time.

Regarding dithering for load sensing in the handle, and the benefits of the "Intellisence' control function, it is not intended to be as refined and accurate a solution for contact force measurement as from a direct CF catheter design, but from all reports it does provide good accuracy in the perpendicular plane and when combined with the haptic feedback can set a reasonable safety mechanism where catheter forces on the myocardium are greatest: in the perpendicular plane.

While certainly not an ideal solution, the point they were trying to make is that this Hansen set up when combined with a new generation CF catheter like the Tact-Cath or Smart-Touch with their improved contact sensing systems in the catheter tips. could well allow more stability and control of the CF catheter compared to the Stereotaxis approach with a similar catheter. And the stiffer platform provided by for better fine tuning of CF from the catheter being controlled by that combination of tools. They will be testing that idea before long no doubt so it will be interesting to learn of their results.

But the fears of great harm from the Hansen system in its current form have simply not be seen in Austin according to all reports, and they have a good comfort margin in use of both Stereotaxis and Hansen for select procedures and at the preference of given EPs there.

However, I'm much more inclined as well to prefer the best human hands possible, and hence, why I'm all for choosing Natale to do any procedure on me and relying on his judgment in choice of tools and skill in using them to good effect. And he doesn't use either semi-automated system in AFIB/Flutter ablations but trusts his own instincts and 'touch' with the best tools available. The CF catheter when finally available will likely be a welcomed addition across the board whether used manually or within a robotic or magnetic guide system.

Take care,
Shannon



Edited 1 time(s). Last edit at 01/23/2014 02:38PM by Shannon.

Shannon,

I haven't been up to date at the latest happenings at the robotics companies and I think the following links (newest available comments on clinical aspects) will provide some useful context to the above discussions for readers. The first link was Hansen's announcement of revised AF ablation trials starting around August of last year. The second link is another company with something similar to Hansen.

The third talks about early (December 2013) experience with the latest version of the Stereotaxis system. The last link on a company that is also using magnetic guidance with not much going on as far as I can tell.

The only thing I can think of that we didn't cover is that the use of ICE (insitu ultrasound) is critical to success and safety for AF procedures, whether manual or robotic.

Cable controlled systems -

Hansen: [www.eplabdigest.com]

Catheter Robotics: [www.eplabdigest.com]

Magnetic controlled systems -

Stereotaxis: [www.eplabdigest.com]

Magnetecs: [www.eplabdigest.com] (Europe only)

Great stuff researcher!

Love the links! And I totally agree, ICE is a fabulous asset for ablationist. I know some in Europe don't use it mostly because of the budgetary constraints of their health care systems is always putting more pressure to get by with less, but after hearing Dr Natale explain to me the advantages it provides for even a top gun like him that is fully capable of doing a bang up ablation without ICE as well, I would absolutely want to insist it was used on any left sided EP procedure.

It adds a real margin of safety too such as being able to detect over heating and bubbling in real time that you would never see with Fluoro or Carto alone, obviously. Also its nice to have that added confirmation of just where you are in real time and visually both the mapping and ablation catheters and they contact points with a good degree of accuracy is reassuring for sure.

I would rather they cut corners elsewhere, if necessary, to meet a budgetary end point, and not getting too stingy with tools used inside the heart that can lead to a better and safer outcome!

ICE has become paramount with the Lariat procedure in addition to using TEE real time during the Lariat as well as it provides a great supportive view from key perspectives that the TEE itself can't get very well. Many centers were using just TEE and Fluoro for early Lariats, but Natale's group and others started including ICE as well to good effect with the Lariat and now it it really catching on for that procedure as well.

Shannon

Shannon,
Luigi says Hi and he was very impressed with you when you guys talked.
I sent you a photo of us together at the seminar today.
Knucklehead that I am I forgot to take a photo with Natale!
I wanted to to grab him after he spoke but he took off like dare I say OJ to catch a 11:15am flight out of LaGuardia.

McHale