Despite Boston Scientific’s pulse field ablation (PFA) system Farapulse demonstrating strong efficacy from the FARADISE registry study, the trial’s principal investigator says that data also indicated that surgeons are using the device beyond recommendations.
Farapulse uses PFA, a form of electrophysiology (EP) ablation, to target and destroy specific cardiac cells in the treatment of atrial fibrillation (AF).
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The real-world study data from the Faradise registry was shared at this year’s European Society of Cardiology (ESC) Congress, which took place in Madrid, Spain between 29 August and 1 September, with the data simultaneously published in Europace.
Unsurprisingly, given the rigorous evaluation processes that will have preceded Farapulse’s US Food and Drug Administration (FDA) approval in January 2024, the readout demonstrated the system’s favourable procedural and safety outcomes, regardless of AF indication.
‘Over-ablation’ beyond targets
However, beyond the efficacy of Farapulse, a more curious finding from use of the system in 1,100 patients, was that users appear to be ‘over-ablating’ beyond recommendations.
Dr Lucas Boersma, cardiac electrophysiologist at St. Antonius Hospital, Netherlands, and principal investigator of the Faradise registry, told Medical Device Network: “Looking at the current analysis, what I find striking, yet also puzzling, is why people do ablations beyond pulmonary vein isolation (PVI).”
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By GlobalDataDuring ablation, every patient gets a pulmonary vein isolation since it is the cornerstone of every ablation for atrial fibrillation (AF).
“But then operators go on to ablate more targets, and that obviously depends a little bit on the type of AF,” Boersma said.
“What I found interesting was that even in paroxysmal AF, where this is not recommended, people in 20% of the cases do more than just PVI,” Boersma explained.
Boersma added that in patients with persistent AF, the data reflects that 45% get additional ablations beyond PVI.
While Boersma notes that the data reflects practitioners’ high confidence in Farapulse, it also raises a lot of questions.
“If we look at all the trials that we have done in the last 25 years in AF ablation, all trials on doing more than just PVI have all been negative,” Boersma said.
Boersma highlighted that there may also be risks involved when ablations beyond PVI are done, specifically in posterior wall isolation since this may hurt the oesophagus, but also in doing mitral lines to avoid flutters, since many of these lines become incomplete and give rise to secondary arrhythmias like left atrial flutter.
Boersma continued: “It’s still striking to me that if we look at this database, you see that a lot of people still do these things. And then, if we look at the outcomes, there is no difference when more than PVI is done, which is actually what you would expect, because all trials have been negative.
“What we see now that it is safe to do it, but it’s still not useful to do it, because from these data, there is no benefit to do more than just PVI.”
Outlining his final thoughts on the data, Boersma highlighted that such findings reflect why ongoing trials are needed to understand what to ablate in patients beyond PVI.
“This is an ongoing question in our field, which has not been solved by this trial, because it is obviously not a randomised control trial. You would need randomised trials to do this again to make sure that even with PFA, we can ablate more than pulmonary veins, although it may not be useful.”
