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Pulsed Field Ablation underwhelming in trial

MarkS profile image
9 Replies

PFA has been the big hope in AF ablations. The results of a trial have however been underwhelming according to John Mandrola:

medscape.com/viewarticle/99...

In the trial of 600 patients with AF who were split evenly between PFA and conventional RF, PFA was non-inferior but not superior to RF. Additionally, two patients in the PFA arm had pericardial tamponade, one resulting in death vs no tamponade events in the RF group. Also they carried out MRI scans of some of the patients. Three of 33 patients had silent cerebral lesions in the PFA arm vs zero of 37 patients in the thermal arm.

However, PFA is a faster, simpler procedure. This is a particular advantage in the States which has more low volume centres. The PFA arm used 1st generation equipment with better devices in the pipeline.

So my thoughts are that PFA is very promising but perhaps not there at the moment. If I had to have another ablation I would probably still go with a combined RF/Cryo ablation with a very experienced operator.

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9 Replies
BobD profile image
BobDVolunteer

Thanks as always Mark for synopsis. Never be in the forefront of new development is my view. lol 😁

dmac4646 profile image
dmac4646

certainly looks underwhelming to date ..

MummyLuv profile image
MummyLuv

how disappointing as was thought it would be safer. Thank you for sharing.

Kingdaddy profile image
Kingdaddy

I was in the PFA clinical trial here in the US for early persistent AFIB, and had my ablation May of 2022. I've been in NSR ever since, very happy with the results.

mjames1 profile image
mjames1

"Underwhelming" is simply Dr. John Mandrola's opinion. For those familiar with Mandrola, he is an outlier ep who has been critical of ablation in general for many years and therefore not surprising that he is underwhelmed, since RFA is still an ablative technology. What he is looking for is something we unfortunately do not have right now.

What the trial data and other articles show is that PFA is has similar efficacy and safety to to both RF and Cryo with shorter procedural times. As it's still new and first generational, it should only get better.

Anyone offered or interested in PFA should do their own independent research and not rely on simply Mandrola's take and some of the comments here that accept his opinion as gospel.

Jim

Smartafib profile image
Smartafib

Interesting thoughts. I am one of those 600 in the Advent trial, having had the PFA two years ago. I have had no AFIB recurrences, which is significant for me as a bout with AFIB produces heart rate in the 200’s and I am basically incapacitated. I have a close relative who had the thermal ablation in the same time period and she has had several bouts of AFIB since the ablation. Of course everyone’s health situation is different.

I feel fortunate that the procedure is working well for me so far.

iris1205 profile image
iris1205

Look back to my comments post intervention for more details. But after having 6 RF ablations (the 4th was successful for 2 years) including different methods and approaches. The latest was PFA and I have been Afib, Aflutter, and Atachy free for the first time since 2017. Clearly this is always personal experience and choices. But it is divine to be in NSR. Wishing nothing but that - however one gets there for everyone. To a healthy and calm 2024 for you all!

foxchase15 profile image
foxchase15 in reply toiris1205

Glad you are doing better. Where did you have your PFA? I have had 2 RF ablations at Cleveland Clinic; I need a third

iris1205 profile image
iris1205 in reply tofoxchase15

I will reply privately!

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