Pulse ablation device FDA approved?

[Iamfuzzyduck]

As I most probably will need an ablation in 2024 and I live in the US, I periodically check for updates on pulse field ablation. As far as I understand it seems like the FDA yesterday approved one of the devices for pulse field? If so this is great news for US folks!!

[mjames1]

Yes, really good news. Hopefully will be available in the US by next year, like it is already available in the UK and Europe.

Jim

[Iamfuzzyduck in reply to mjames1]

I will need to find an EP adept at doing it…maybe Dr.Natale?

[mjames1 in reply to Iamfuzzyduck]

The good news about PFA is that results are not as much operator dependent, as is the case with RF. That doesn't mean you want a first year resident doing their first one on you, but I think any ep at a highly ranked cardiac hospital would be fine.

Natale has his fans and detractors. He tends to do a lot more burning than the normal ep, which is why I personally didn't choose him for my first ablation although I might consider him for a follow up if needed. He also sometimes isolates/burns the LAA where he believes afib can be hiding, but that would then require an occlusion device like Watchman. Some think that's good, I'm not so sure.

Jim

[BobD Volunteer]

Results so far here in UK seem to indicate that success is no better than other forms of ablation BUT recovery may be more swift and procedure shorter.

[Iamfuzzyduck in reply to BobD]

Thanks, I just would rather it be safer!

[Hootsmon]

Here in Oz PFA becoming available. Upside is no thermal injury ie risk of atria-oesophageal fistula forming. Downside is larger cannula puncture size for groin and septum (12Fr v 14Fr). Results the same - AF to NSR success. Noting all the other variable for longevity of NSR.

[OzJames in reply to Hootsmon]

My cardiologist has organised an EP in Sydney to chat to me about Pulsed Field Ablation next week just so I can get my head around it in case I need ablation down the track and to see if I should be considering now whilst the heart is in good shape rather than wait 5 years after several more AF episodes and cardioversions etc… what is your experience on PFA

[MikeThePike]

Please don't get too excited. PFA is no more effective at curing AF than RF or Cryo. It is said to be a safer procedure than either but special precautions may need to be taken by the surgeon or permanent damage to critical heart structures may result. I'm talking about coronary spasms here. You may want to look into it and make sure you get an experienced surgeon to perform yours if you decide to go ahead.

[Iamfuzzyduck in reply to MikeThePike]

Thanks for the information. I am on the waitlist for Dr Natale so I will probably go with whatever he recommends, if I actually need an ablation…

[Kingdaddy]

That’s the system I was in the trial for that just got approval. And yes, it’s great news

massdevice.com/medtronic-pu...

[Iamfuzzyduck in reply to Kingdaddy]

That’s great you were able to participate in the trial. How was the procedure?

[Kingdaddy in reply to Iamfuzzyduck]

The procedure went really well, thankfully. I recovered quickly and am very pleased with the results. Since the procedure, I've remained in NSR (normal sinus rhythm), which has been a significant relief. It's been a positive experience overall.

[Iamfuzzyduck in reply to Kingdaddy]

That’s good to know, thanks, glad it went well for you.

[Jmbrph]

i was the first one getting PFA at Mayo as part of the clinical trial in 2020. Havent had any problems since!

[Iamfuzzyduck in reply to Jmbrph]

That’s good news! Thank you!

[hartbeast]

It looks like Johns Hopkins in Baltimore MD will start doing PFAs in the spring to early summer of this year. Hugh Calkins, my EP, was part of the five-year trial and I have an appointment with him mid-March to see if I’m a good candidate. He didn’t want to do a 2nd ablation after my 2018 cryo only had moderate success - because they only do GA for ablation and I’d had a stroke. So the shorter time of procedure was a big plus. Please keep us apprised of your story, fuzzyduck!

[Iamfuzzyduck in reply to hartbeast]

I had an appointment with Dr.Natale in Austin-I am to be scheduled for PFA I believe before the Summer. He has been doing the procedure for a while…it will take up to one hour to complete! Keep us updated on your progress!