Study says simple heart treatment best

5/11 /15

[www.yorkregion.com]

/L

Larry, interesting results but I would be reluctant to second guess Haissaguerre's observations. I think an apples to apples comparison would require such a study to be conducted at a single center to take out the skill and technique variation effect that is unavoidable in a multiple centers study.

[www.afibbers.org]



Edited 1 time(s). Last edit at 05/12/2015 01:14PM by researcher.

In my analysis .. and I am far from alone ... this is a very misleading study which I reviewed carefully last August when it first came out. I am traveling now and dont have the time to write a formal reply to yet another confusing report from the cardio EP world There are so many great studies that are well structured and carried out and there are a good number that have some real flaws or that start with a few assumptions or premise that turns out not to be so and then what looks promising can become more confusing instead as is the case here in my view.

I read dozens of peer reviewed EP/Cardio studies every two months just to find 5 of 6 worth reporting on and of relevance for the AFIB Report... And this STAR II study which came up with exactly the opposite results than STAR , the original pilot study, which was a smaller but better designed study for the purpose of determining the best method of persistent AFIB ablation.

For one, there was not one major top tier persistent AFIB ablation center recruited for STAR II, and while there were a handful of moderately well known ablationists in the study, the majority did not do extended persistent ablation in their own daily practice routinely.

In other words, everyone of the EPs was at least experienced with PVI-only ablation and yet a large percentage were not experienced with extended persistent AFIB ablation, thus stacking the deck against the more challenging extended protocols right there when comparing the two groups. Plus, the extended ablation group of assigned ablationist and their patients were forced to follow one of two cookie cutter empirically-derived extended protocols of either a set type of CAFE focal extended targets to ablate based on specific cycle length OR a mitral and/or roof linear line ablation as the extended protocol beyond the PVI.

No top tier highly experienced persistent EP I know of considers such empirically derived cookie cutter extended ablation targets an effective long term strategy .. certainly not the most successful like Dr Natale and Bordeaux and a number of other top persistent centers, and the first two mentioned who are the most prominent in the world do real time EP work to address Non-PV triggers ablating only those targets that are showing a high likelihood for continued repeatable triggering for AFIB/Flutter/Tachy just at the sites where they are found in each unique patient. And they do not do these out of date cookie cutter set CAFE or Predetermined linear line ablation as the main extended protocols.

They also used a crazy 1:4.4 randomization ratio in determining the two groups PVI-only or Extended ablation with the bias favoring the PVI -only group... The did this under the dubious rationale that in the smaller pilot STAR 1 study the extended persistent ablation was so clearly superior to the PVI-only approach for persistent ablation, and this STAR 1 had a larger percentage of skilled persistent ablationist doing the work with less restriction on type of extended work that was allowed.

In short they stacked the deck against the extended group to try to level the playing field with what they expected would be the inferior PVI-only group!!! Hello!! isn't the purpose of STAR II to discover which method is really the best straight up .. 50/50!!??

A classic case of getting too clever with the study structure and wind up structuring it for failure.... Well not exactly failure... what they study inadvertently confirms is that when you recruit aa group of 50+ EPs from many centers around the world and almost none of them renowned for persistent ablation excellence .. maybe Southlake is an exception and a couple others but not all the EPs from those centers are highly experienced and the majority of EPs in the study do mainly PVI-ony in their daily practice.

So it proves that doing an empirical CAFE or linear lines approach to persistent ablation is more or less the same lousy results as a standard PVI for persistent AFIB .. and the results from both arms were pretty junk frankly and not even close to that of elite level persistent ablationist who address real time-discovered )and verified as triggers) non-PV triggers as the focus of their persistent work beyond an expert PVAI initial step of the ablation.

Plus the STAR 1 did not use this screwball 1:4.4 division allocation from making a wrong assumption for the real goal they were trying to achieve... learn what is the best method of persistent AFINB ablation.

And if that was really the question you wanted to answer, why so few percentage of the 50+ ablationist chosen in as part of this study were world renowned elite level persistent AFIB ablationist in their real ( non study protocol) lives?? There were zero really who would rank in the top 20 in the world in this area and those very good ablationist with a lot of experience and who do a lot of persistent cases too were certainly a vast minority among the total ranks of mostly PVI-only EPs.

And why not allow the top persistent EPs whose centers have long backlogs of patients referred to them from other EPs around the world, to use the methods they have found to work best and not restrict it to some cookie cutter methods that these same elite persistent operation have long ago superseded with a constantly evolving method.

In any event, the bottomline I got from carefully analyzing this study is that it is useful in revealing what NOT to do if your aim is improving persistent ablation results from an expert ablation process above the rather dismal results posted by both arms of this skewed and confusing study. It is not at all surprising they could do no better when you break the whole structure of the study and protocols use as well as the recruitment randomization etc etc... just too many loose ends to result in a clear answer to the main question at hand.

The study also underscores what we have preached here long and hard, that there is a wide split between the bulk of EPs trying to sort all this out and the cutting edge fewer number who are several steps ahead of the crowd ... as is usual in most fields of medicine, especially technically challenging and still comparatively new fields such as EP ablation.

Anyway, I will pen this all out more concisely while examining the numbers and both the useful insights that can be gained from the work, even if the study structure itself left a lot to be desired, as well as the main issues I see that resulted in what, for many, will be a very confusing and not very clear message.

Shannon



Edited 1 time(s). Last edit at 05/12/2015 08:47PM by Shannon.