Robotic AF ablations as good as elite hands?

Pretty amazing results on Hansen robotic system if true. I have my doubts but results just came out from Claudio Tondo's Italian lab and Natale is one of the co-authors - on a mix of paroxysmal and persistent (71%/29%) patients randomized to robotic (n=40) and manual (n=40), 90% success rate for the robotic arm at one year versus 65% success rate for manual arm. I have not been a fan of the Hansen system and up until this paper, the last published results from Na Homolce from 2012 were horrific (from complication standpoint). The current results suggest using contact force (smarttouch) catheters with the system makes it safe and results are excellent. The first link is the abstract. The second link is the announcement from the company. For whatever reason, the company highlighted the reduction in fluoroscopy time but didn't mention the excellent 12 month success rate. I don't have a Springer account so didn't review the entire paper. Shannon if you get a copy from our St David's friend(s) - much appreciated.

[link.springer.com]
[www.biospace.com]



Edited 1 time(s). Last edit at 02/03/2016 07:56PM by researcher.

There have been very good strides in Robotic navigation for ablation of both AFIB and VT... there are still some limitations relative to the true elite level maestros but it does offer a lot for less experienced operators too.

the main thing for the top tier operators is the greater flexibility and reduced time for them to do the procedures themselves when a big variable site ablation is in store.

But the good news is that advances in Robotic gear and software as well as technique evolution really has made Stereotaxis and Hansen very useful tools in many EP labs.

I saw a very interesting presentation at AF Symposium 2016 by Dr. Luigi DiBiase and Dr Natale on behalf of Stereotaxis taht was very interesting ... mainly on VT ablation but also with discussion of improvements in AFIB ablation too in many cases.

Shannon



Edited 2 time(s). Last edit at 02/07/2016 06:23PM by Shannon.

Great info researcher - many thanks.

75mg Flec am and 100mg Flec pm keeps my AF burden down to a few hours per year and has done for 8 years now. No adverse effects whatsoever. Good to know that techniques are improving as I'm sure I'll require an ablation at some point (nocturnal idiopathic PVMAF since 1999 now age 55 - normal echo and no QRS widening on 12 lead ECG).

Many thanks for all of your contributions here on this excellent BB (thanks Hans and Shannon).

Mike,

Good to see you still posting and that your condition remains staus quo. I've followed your story for many years here...

Cheers,

George

Mike, I would be still be cautious since this is a single center result and there must be some questions regarding the results for the company (Hansen) not to mention the 12 month success rate difference between robotics and manual, but rather just highlight the reduction in x-ray exposure. I think the information offered in the paper could have been improved by revealing the experience of the operator for each procedure. The main weakness is that the trial was not randomized throughout. That is, patients were prospectively randomized to each arm. After that there was no randomization of operators (ie clinicians should not know what procedure is being used ahead of each procedure) and patients were under conscious sedation so they knew what was going on. The monitoring physician also knew because the patient knew what arm he/she was in. The operator experience factor is of the biggest uncertainty in this situation since >50 procedures/year was the only requirement for operator experience. Did they really let someone that does only 51 procedures/year handle the robotic system and leave him alone with no experienced hands nearby when they were not blinded? So having that info for each case and listing in the results would have been helpful in reviewing it. Also, if the results are repeatable, we should see something out of St David's (they have the system) that would be even better since Gallinghouse has the most cases in the world using the system.

Having said all that, the 12 month success rate is still impressive even if there was intrusion of the most experienced hands in the robotic arm of the experiment.



Edited 2 time(s). Last edit at 02/06/2016 05:15PM by researcher.

This is very interesting. I seem to remember reading a comment by Natale stating that robotics is where this procedure is heading.

I don't know what Natale currently thinks of robotics in AF ablation. He still prefers his own hands as far as I can tell. However, he has been increasingly supportive of robotics in VT ablation via magnetic navigation. There are two very different robotic systems available, one uses robotic control of magnets (Stereotaxis) and one uses robotic control of cables (Hansen). Below is a link to ErasmusMC-Thoraxcenter EP director talk on their experience using the magnetic system - Q&A covers all procedure types. Looks like much of their experience is pre-2012 which is from the 2nd generation magnetic system which didn't have real time movement (several second delay between hand movement and catheter movement). I believe they are now on the 4th generation which has real time response for practical purposes and AF procedure times are the same as manual according Dr. Kuck's group in Hamburg. (Kuck's group has both systems like St David's) I think operator wear and tear will make the system(s) increasingly attractive as an EP ages. I would love to see elites such as Natale and Kuck extend their careers another several years from less wear and tear.

[www.youtube.com]



Edited 1 time(s). Last edit at 02/07/2016 05:07PM by researcher.

Thanks Shannon for making the edit to my second post regarding the whole paper. Below is a link to the Stereotaxis robotic AF ablation trial done in Monaco and reported about a year ago. The patient mix in the Monaco trial was 60/40 paroxysmal/persistent and the purpose was to compare the effect of general anesthesia to conscious sedation. There was only a minor difference in success rate between the two arms GA-86.6% and CS-88.8% at 12 month followup. The average number of procedure both groups were the same, around 1.2 if recollection serves. Impressive results given that major complication rate of magnetic system is 0.4% (data out of Stockholm Sweden with no elite hands).

[www.examiner.com]

Followup Q&A with Dr. Szill-Torok with regards to his group's experience with contact-force catheters and remote magnetic navigation.

>>>>>>
Dear Dr Szili-Torok,

I reviewed with interest the results presented in your original paper and subsequent webcast. I would appreciate your comments with regard CF ablation and magnetically assisted ablation.

1. With regards to CF, were there any differences between the Smarttouch and Tacticath with respect to success rates, complication rates and ease of use?
2. With respect to RMN, do you expect any differences between results using the older generation Niobe system that you presented and the latest available system?
3. For scar induced VT, Natale's group in the US has shown that homogenization of the scar tissue improves outcomes significantly. If this protocol is adopted, do you anticipate that RMN advantages continue as shown in your results?

Finally, during the HRS annual meeting, Dr. V. Reddy stated his CF presentation his preference to use CF catheters when possible for both his fellows and himself and that they are getting better PVI with CF. Is your AF ablation experience consistent with Dr. Reddy's with respect to CF? Seems that latest available RMN should have some advantages over conventional and CF for AF as well.

Best Regards,
..........

T. Szili Torok to me

1, So far we did not observe real differences in terms of performance. Especially not with the use of Agilis sheath. However, the Biosense product seems to be a bit stiffer.
2, I think upgraded Niobe is just better. I am not sure that we can translate this ‘feeling’ it into real hard endpoint outcome data.
3, Excellent point. Actually they also found that for homogenization MNS is better. They hypothesize that fatigue of the operator may play a role in this.

About afib. Completely agree. Please look at our recent publication at Int J Cardiol by my fellow Akca F. we even prove that CF is safer.


With kind regards,


Tamas Szili-Torok, MD, PhD



Edited 1 time(s). Last edit at 02/13/2016 04:14PM by researcher.

Ha! Researcher, It seems that I inadvertently posted my reply to your original post under your name heading... One of the occupational hazards of having full control of the forum where if you are not super alert you can wind up modifying or even deleting someone else's post by accident :-) .. I'm glad the content fit in nicely with your original reply which remained intact as well.

Haven't had time the last two weeks with the newsletter, and now am finally back in the saddle since last Friday after an urgent unavoidable delay requiring demands elsewhere on my time that arose the prior week. Have got just a few pages left to write and a then good edit or two proof read and am aiming now to have it he newsletter out by end of this work week .. Knock on wood ... And look forward to catching up and posting a bit more here on the forum next week.

Be well,
Shannon

Researcher Wrote:
-------------------------------------------------------
> Thanks Shannon for making the edit to my second
> post regarding the whole paper. Below is a link
> to the Stereotaxis robotic AF ablation trial done
> in Monaco and reported about a year ago. The
> patient mix in the Monaco trial was 60/40
> paroxysmal/persistent and the purpose was to
> compare the effect of general anesthesia to
> conscious sedation. There was only a minor
> difference in success rate between the two arms
> GA-86.6% and CS-88.8% at 12 month followup. The
> average number of procedure both groups were the
> same, around 1.2 if recollection serves.
> Impressive results given that major complication
> rate of magnetic system is 0.4% (data out of
> Stockholm Sweden with no elite hands).
>
> [www.examiner.com]-
> grace-hospital-tests-use-of-remote-magnets-treatin
> g-af