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Given the ever-increasing wealth of clinical data and experiences involving pulsed field ablation (PFA) for the treatment of atrial fibrillation (AF), purpose-built technologies like the FARAPULSETM PFA System (Boston Scientific) are currently garnering “massive excitement” within the electrophysiology (EP) field. Here, Domenico Della Rocca (University Hospital Brussels, Brussels, Belgium) speaks to Cardiac Rhythm News to discuss the specific benefits of this and other PFA technologies in Boston Scientific’s portfolio, as well as the most noteworthy studies evaluating these devices.
“We are happy with the clinical results we see, acutely and long term, and we’re also seeing an improved patient experience,” Della Rocca says, alluding to the advantages PFA therapies have shown to date. “In the past, [with other modalities], we used to see a limited number of patients with more advanced forms of AF and a high comorbid burden who were referred for catheter ablation. These patients are known to have a high periprocedural and long-term risk of AF-related complications, and ablation success rates are low unless you are adopting a more extensive ablation strategy. But, we now know that these complications can be avoided via PFA, and we have started to successfully treat patients we were not treating before.”
Turning his attention to the FARAPULSE PFA System more specifically, Della Rocca begins by asserting that—despite the benefits these treatments have broadly shown to date—there is no ‘class effect’ when it comes to the presently available PFA devices. While other technologies in the space were initially intended for alternative ablation procedures and have been repurposed to treat AF, the FARAPULSE PFA System is a purpose-built technology designed specifically for use in the EP field.
“This is extremely important,” he says. “Everything we do with PFA appears easy, but there is a science behind it that is highly complex and, in order to achieve certain results—for both safety and efficacy—there is an immense amount of research to optimise workflows and optimise waveforms. And, the efficacy and safety of the waveform [or pulse-selective field] is strictly linked to the design of the catheter.
“We are aware of cases with different catheter designs, and with other PFA technologies, where there were serious adverse events. A big advantage of the FARAPULSE PFA System is that the waveform and the catheter were designed as a unicum—so, everything was optimised based on the design and the design was optimised based on the waveform, and this is extremely important for safety, but also for clinical results.”
Experiences and advantages of PFA
Della Rocca first used the FARAPULSE PFA System while working as a fellow in the USA back in 2022 and—having moved to his current centre in Brussels shortly thereafter in July 2023—estimates that he has used the device in more than 400 cases to date.
“I would say that the clear advantage of the technology is its design, because every operator who has been exposed to the FARAPULSE PFA System has described a very user-friendly experience, and a smooth transition from previous technologies that they had used,” Della Rocca comments. “It really takes no time to learn how to use it, and very little time to learn some of the ‘tricks’ that can improve even further the advantages of using this device.”
Della Rocca notes that the very minimal learning curve associated with the FARAPULSE PFA System was among the key findings of a 2023 study published by him and his colleagues in the journal EP Europace. Additional insights from this study—a multicentre analysis comparing the FARAPULSE PFA System to thermal-based technologies across more than 1,500 propensity score-matched paroxysmal AF patients—included significantly shorter procedure times and similar levels of freedom from arrhythmia being associated with PFA.
“Personally, I think that the design of the catheter is optimal for pulmonary vein isolation [PVI], but also potentially other [targets] outside of the pulmonary veins,” he adds.
Another point Della Rocca touches on relates to how the FARAPULSE PFA System has impacted clinical workflows, in his experience. Citing a multicentre, randomised study presented at last year’s European Society of Cardiology (ESC) congress (30 August–2 September 2024, London, UK), he reports that the FARAPULSE PFA System appeared to be an “even more predictable” treatment approach compared to more established cryoablation therapies.
According to Della Rocca, this study and its findings demonstrate the reliability of the FARAPULSE PFA System when—for example—it comes to planning a certain amount of ablation procedures within a given timeframe, or starting an ablation procedure near the end of the working day while hospital nurses and other supporting staff are still available.
“Even with cryoablation, which is a very predictable technology, there are still those cases where things don’t go as smoothly,” he explains. “With the FARAPULSE PFA System, you really avoid that unpredictability of technologies like cryoablation or even radiofrequency [RF] in everyday workflows.”
Moving on to discuss benefits of the FARAPULSE PFA System that relate more specifically to AF patients themselves, Della Rocca describes patient experiences as “very good”, with those treated generally reporting no major concerns upon being discharged and returning home post-procedure.
“With PFA, there is a certain risk of the patient having pain related to […] pericarditis, but this is something that we see extremely rarely with the FARAPULSE PFA System,” he states. “This is a big advantage, because the patient can leave the hospital without any need for pain medications, and without any particular discomfort in the chest or other symptoms.”
Clinical evidence and future outlook
The safety and efficacy of the FARAPULSE PFA System are, in Della Rocca’s view, backed by “strong evidence” from large clinical studies like the Boston Scientific-sponsored ADVENT trial and the independent MANIFEST-17K registry, published in the New England Journal of Medicine and Nature Medicine, respectively.
“[These] are two very important examples of research on the technology,” he goes on. “The results are very significant and, also, there is a consistency between smaller and larger trials, randomised and non-randomised trials, and large registries and single-centre experiences. This is a key point that suggests to us that the technology is extremely reliable, and its safety profile has been confirmed all over [the world].”
Another notable study Della Rocca highlights is the ADVANTAGE-AF trial, from which data were presented for the first time earlier this year at the annual AF symposium (16–18 January 2025, Boston, USA). ADVANTAGE-AF sought to establish the safety and efficacy of the FARAPULSE PFA System in the treatment of persistent AF, and was also Boston Scientific’s first clinical trial involving both PVI and posterior wall ablation (PWA) with the company’s FARAWAVETM PFA catheter. Across 260 persistent AF patients, the study ultimately met its primary efficacy endpoint with a 12-month acute/chronic ablation success rate of 63.5% and demonstrated a low incidence of major safety-related events.
Della Rocca describes these findings as an “important starting point” for establishing the safety of targeting the posterior wall during PFA treatments, with future studies being required to bolster evidence on this currently off-label indication.
According to Della Rocca, physicians’ understanding of PFA has grown markedly in recent years and continues to do so, and they have learned to manage prior limitations of these therapies, such as haemolysis and coronary spasm.
“For example, with haemolysis, we have determined that it [very rarely] leads to any outcomes of clinical significance,” he says. “And, coronary spasm can be managed with the use of vasodilators like nitrates. These are very important points because the operators, independently but also with support from industry, have gained a greater understanding of these effects.”
As EP physicians and industry look to build on the existing positivity surrounding PFA therapies, Boston Scientific continues to attempt to improve the capabilities of its own solutions—most recently, and prominently, with the US Food and Drug Administration (FDA) 510(k) clearance and CE-mark approval of its FARAVIEW Software Module and new navigation-enabled FARAWAVE Nav Ablation Catheter. These technologies are intended to improve visualisation during FARAPULSE PFA procedures, providing physicians with more guidance and additional feedback via enhanced cardiac mapping.
And, even in the limited time within which these “very exciting” solutions have been available following their European commercial launch in February 2025, Della Rocca relays observing a “big difference” in the paroxysmal AF cases treated at his centre.
“We were very confident of our ablation skills before but, when you see what you are doing and you have immediate feedback from the mapping software, you can really improve your acute success—and also, probably, your long-term success as well—because you can truly optimise the positioning of your PFA lesions,” he avers.
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