Pulsed Field Ablation Is Now FDA Approved

https://news.medtronic.com/2023-12-13-Medtronic-creates-history-with-FDA-approval-of-its-novel-PulseSelect-TM-Pulsed-Field-Ablation-System-to-treat-atrial-fibrillation

Am I right in thinking that this device probably increases the % of successful ablations even when done by a 'less skilled/experienced' operator?

I don't know since I think everyone doing them during clinical trials were probably all more experienced operators at bigger centers, but I guess we'll find out over the next year or two.

I met with my EP yesterday. I have been needing a second touch up ablation and was hoping the pulsed field ablation would be a good thing for me. My EP said that the pulsed field ablation is not specific enough for the fine tuning and site specifics needed for a second ablation.

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FibberMcGee
I met with my EP yesterday. I have been needing a second touch up ablation and was hoping the pulsed field ablation would be a good thing for me. My EP said that the pulsed field ablation is not specific enough for the fine tuning and site specifics needed for a second ablation.

Well, that isn't great! Any one else have more information?

From what was explained to me by an ep who does PFA -- currently it is a pretty blunt tool, limiting it's effectiveness outside of the pulmonary vein although may have some utility for atypical flutter, but not typical. So I guess it would depend where the "touch up" is needed. Hopefully, future generations of PFA will allow it to be used in more areas.

Jim

That's the claim, however, the US trials mandated that only the senior investigators could perform the ablation, a far cry from how it may be done in many teaching hospitals. So maybe the "less operator dependent" claim comes from European studies where it's out of trial. But if so, that may bring a more consistent ablation result to more people. However, there is a concern that it could also mean that ablations may eventually end up being performed by less experienced doctors, who may not be as well versed in the subtleties of the field.

Jim

I discussed this with an EP in Amsterdam as I was interested in PFA due to perceived safety. He indicated not all facts are known of PFA. A few weeks later he told me that at a conference he learned about silent embolisms happening with PFA. He indicated an experienced operator (200 ablations per year at least) will have same success rates and risk profile and and the risks are well known.