My name is Lucas Boersma, I am an electrophysiologist from St Antonius Hospital in the Netherlands and I also have an affiliation with the Amsterdam University Medical Centre. And today I am going to be discussing the outcomes, the one-year outcomes of the FARADISE global registry with pentaspline PFA ablation.

What is the reasoning behind the FARADISE global registry?

So pentaspline pulsed field ablation has been around now for a couple of years and there's been some initial studies, a randomised controlled trial, but that was a little small obviously. And then there was a retrospective survey in a large number of patients.

But it's also interesting to see once this gets adopted in everyday clinical practice around the globe in different centres and in different countries, how people are using the system, how they adopt it and also what the outcomes are in real-world everyday clinical practice.

And so this is a prospective large registry. It contains almost 1,200 patients where we follow how this system is used for AF ablation. And we're going to do that for up to three years even. But the late-breaker today is going to cover the one-year outcomes and all the procedural details.

Could you tell us about the unique features of the FARAPULSE™ PFA system?

So the FARAPULSE PFA system has been the first PFA system to become commercialised, first in Europe and then in other countries, for instance in the United States a bit later. And the unique feature is that you can obviously use PFA, which is a new energy source different from cryoablation or radiofrequency ablation. It is non-thermal and it only makes lesions in the myocardium and it doesn't affect the esophagus or the phrenic nerve or the pulmonary veins. So it's a lot safer inherently and it's a very quick ablation system.

And the tool is also very interesting because you can use it in different ways: you can use it in a flower shape, you can use it in a basket shape, and an olive shape. So there's different ways to use the tool for different areas in the atrium, for instance pulmonary vein isolation, but also posterior wall isolation. And some people use it for isthmus ablation. So there's quite some things you can do with that tool, with that new energy form, pulsed field ablation.

What was the study design and patient population?

So the FARADISE registry is actually a fairly simple registry. It's a prospective but large registry where we gather a lot of data. We're going to gather that up to three years.

It's a single-arm registry. So there's no comparator. But what we want to capture is different countries, different operators, look at learning curves, look at how people use this system, look at anesthesia forms. So really capture what happens in different countries, different continents, when people start using this in the commercial setting.

What are the key findings?

Well, first of all what you see is that almost all centres in all countries still have PVI, pulmonary vein isolation, as the cornerstone of every ablation. And what you see then is that, for paroxysmal atrial fibrillation patients, they use some form of extrapulmonary vein ablation as well, but that's only in 20% of the patients. And especially in the non-paroxysmal patients, you see a lot of extrapulmonary vein ablation coming along as well, up to 50% even of operators that perform ablation beyond the pulmonary veins.

So that's interesting to see. You also see differences in anesthesia that's being used. So some countries have general anesthesia only because of regulatory issues and then some other countries have deep continuous sedation as their major anesthesia form. So that's different in different countries.

What we found was that the system was easy to use. So what you see is that operators with only 10 cases experience, they learned very quickly. So once they went beyond 25 cases, you see that procedure times went down and the ease of use became very, very nice for these centres. So it's a very steep learning curve. What you also see is that once people get the hang of using the system, they also go beyond pulmonary vein isolation more easily because they feel comfortable in using the system.

So it has been a very quick and rapid adoption and it's been very safe. The adverse event rate is low, just 1.5%, and usually has to do with vascular excess events, but not cardiac events, and nothing that has to do with the PFA energy form.

And then we also looked at the one-year effectiveness outcome data, looking at the clinical effectiveness of doing PFA ablation in patients both with paroxysmal AF and non-paroxysmal AF. And what you see is that at one year the clinical effectiveness is around 80%. And this means that we allow the use of antiarrhythmic drugs, we cannot increase it, you cannot change it.

But freedom of atrial fibrillation, freedom of cardioversion beyond the blanking time of two months, you see that the clinical effectiveness points is actually 80% for paroxysmal atrial fibrillation and around 70% for persistent atrial fibrillation. That's a pretty good number considering what we know from ablation. It's been very hard to get effective ablations.

When you look at ablation without or the follow up without antiarrhythmic drugs, you see that the effectiveness drops obviously a little because some people still need antiarrhythmic drugs or keep using antiarrhythmic drugs, sometimes even for other reasons than AF. And then the effectiveness drops a little bit by about 10%.

That's actually what you would expect from what we know from atrial fibrillation ablation. So the key issue here I think is that it's very easy to use, it's very safe to use, the outcomes are very consistent and just as good as what we know from thermal ablation modalities. And I think that the adoption and the quick learning curve make this a very, very interesting and a very useful tool in everyday clinical practice. And you see that the uptake of that system, the pentaspline PFA system has been very, very successful.

What are the take-home messages for practice, and what are the next steps?

So what we've captured now is how people have started using the system. I think that beyond using the system, we need to understand better about dosing of the system. Currently, we are using usually about eight applications per vein but maybe we need more.

What other strategies do we need beyond pulmonary vein isolation? There's mapping now available with the pentaspline ablation system, and maybe that can also help us to perform better pulmonary vein isolations and to better ablate areas outside of the pulmonary vein. So I think that these areas, the influence of mapping, the strategies beyond pulmonary vein isolation, and the dosing of pulmonary vein isolation are important areas to keep studying to see how we can still improve outcomes and improve particular specific safety things like hemolysis and coronary artery spasm which have come up with PFA.

It's a rare thing, but it's a new thing that we also don't completely understand. And I think that also needs more studying to try and get rid of those strange side effects of pulmonary vein isolation and PFA ablation.