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The field of catheter ablation for atrial fibrillation (AF) is evolving. The development of pulsed field ablation (PFA), as well as advances in established technologies such as radiofrequency (RF) ablation, help catheter ablation to offer a promising confluence of safety, efficacy and efficiency in arrhythmia treatment.1 Given the global prevalence of AF—which is thought to impact some 37.5 million people worldwide2—having access to a comprehensive and diverse portfolio of clinically proven tools to deliver effective cardiac ablation will be crucial to healthcare providers seeking to treat this condition.
“We understand a lot about RF ablation [and] I do not think it is going to disappear tomorrow,” says Vivek Reddy (Mount Sinai Fuster Heart Hospital, New York, USA), commenting on the entry of PFA into the cardiac ablation arena and what this means for the treatment of patients with AF in the future. PFA employs a controlled electric field to ablate cardiac tissue in a relatively selective manner via irreversible electroporation (IRE), differing from RF ablation, which has been an established technology in the AF ablation market, and uses thermal energy to disrupt abnormal electrical pathways in the heart that cause common arrhythmias.3
“I do think that it is going to change practice,” says Reddy of the likely impact of PFA on the future treatment of AF. “I think that we will end up doing more procedures in the same unit of time because the workflow is so much improved.”
Though the speed and efficiency of the procedure is seen as an important benefit,1 Reddy says that this is not the predominant advantage of the technology. “The primary benefit could be safety. With pulsed field ablation, it appears that you do not cause oesophageal damage even when you ablate right on top of it [the oesophagus], and it appears that you do not cause pulmonary vein stenosis, or permanent phrenic nerve injury. These are significant safety benefits. The peace of mind from both the patient and the physician perspective of not having to worry about [injury] after you do an ablation is good.”
Reddy has been at the forefront of research into catheter ablation, and presented 12-month results from the inspIRE clinical trial, which evaluated both the safety and efficacy of the PFA VARIPULSE™ Platform (VARIPULSE™ Catheter and TRUPULSE™ Generator, both Biosense Webster) in the setting of symptomatic drug-refractory paroxysmal AF, at the 2024 AF Symposium (1–3 February, Boston, USA).4
The prospective, multicentre, non-randomised study, involving 226 patients from 13 centres across Europe and Canada, is described as the “first clinical study for the PFA system with full electroanatomical mapping system integration”. At the 2024 AF Symposium, Reddy reported that the study met both its primary efficacy and safety endpoints, demonstrating an 80% freedom from atrial recurrence at 12 months with zero primary adverse events.4
The VARIPULSE™ Platform recently received approval as the first PFA system in Japan based on the inspIRE data, and it is pending CE mark in Europe.
Reddy tells Cardiac Rhythm News that further investigation into the use of PFA is important for understanding the role of the treatment in future, and fresh insights into the safety and efficacy of the VARIPULSE™ Catheter and TRUPULSE™ Generator were also presented at the AF Symposium from the admIRE study, a multicentre, non-randomised trial that has enrolled 362 patients across 30 US centres who have been treated with PFA for drug refractory symptomatic paroxysmal AF.5 Among the 20 patients who completed the 12-month follow-up visit as part of the Pilot Phase of the trial, 100% achieved acute success from ablation procedures, 80% remained free from atrial arrhythmia recurrence at one year, and no procedure or device-related primary AEs were reported in the study.6 Reddy says the study is “really important” in informing the field.
Additionally, Reddy has established the VIRTUE clinical trial, a single-centre collaborative study supported by Biosense Webster, in which around 150 patients will be treated with PFA and monitored through implantable loop recorders.[7] “The aim is to treat patients as they would come in clinical practice. Both first-time and redo ablation; paroxysmal, persistent, permanent [AF]; the whole gamut of what is an AF population.”
Asked for his advice to clinicians seeking to understand the role that PFA can play in their practice, Reddy states that “like anything else you have to learn how to do it, and not all pulsed field is the same, every catheter is different”.
One feature that will differentiate the VARIPULSE™ Device from other catheters is the integration of mapping technology, with Biosense Webster’s CARTO™ 3 System. Reddy says that mapping integration can be advantageous.1 “You can reduce fluoro time when you integrate a mapping system, and that is always a good thing. And, there are other procedures where actually you need the mapping system.”
According to Jasmina Brooks, president of Biosense Webster, as a developer of ablation technologies, including both pulsed field and radiofrequency devices, investment in clinical research in the ablation space will be a continued priority in the immediate future.
“Based on the data we have seen so far there is a lot of excitement about PFA and the possibility that this may be a new solution that would allow physicians potentially to improve efficacy and outcomes and possibly treat more patients. It has a potential to offer safer, more consistent and efficient therapy,” Brooks tells Cardiac Rhythm News. “Clinical trial data to date have shown that PFA technology can deliver a variety of benefits for both physicians and the patients and, just like everyone else in the industry, we at Biosense Webster continue to support research to see what the potential of this technology is.”
The company has recently announced the first cases performed as part of its Omny-IRE clinical trial, a multicentre, non-randomised study in Europe and Canada that is evaluating the safety and effectiveness of the OMNYPULSE™ Catheter, a large tip, 12mm catheter with integrated mapping capabilities used alongside the TRUPULSE Generator.8
Brooks notes that whilst there is a great deal of excitement about the potential of PFA, RF catheters “continue to be the most advanced and commonly used technology for AF ablation today”.
“PFA is still in the early stages of development, and there is still much to be learned, and meanwhile we have decades of existing data regarding the effectiveness of RF ablation,” she comments. “Over time, as the clinical evidence develops in PFA, we will learn which clinical applications are most suitable, but we still see that there is still room for other technologies like RF ablation and we believe that will be maintained.”
With this in mind, Biosense Webster’s approach is not to pursue one ablation modality at the expense of others, and innovation across its ablation portfolio continues at pace. One area of innovation is in the development of the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter that combines both pulsed field and radiofrequency energy to give electrophysiologists the flexibility to customize treatment by switching between either modality. Biosense Webster currently is conducting two prospective, single-arm, multicentre studies for the treatment of paroxysmal AF in Europe and the US to assess the safety and efficacy of the system. In July 2023, Biosense Webster announced that it has completed enrolment of the SmartfIRE clinical trial, which has enrolled 149 patients across nine centres in Europe, and most recently in December 2023, the company shared that the first patient cases were performed as part of the SmartPulse PFA clinical trial, which will enrol approximately 250 patients in the US.9 The Dual Energy STSF Catheter is currently not available in any market.
“With the prevalence of atrial fibrillation on the rise globally, at Biosense Webster we truly continue to remain committed to driving science and technology and innovation in the field of cardiac ablation,” Brooks says, adding that this will focus around four pillars: locating where to ablate; delivering better lesions; facilitating more efficient procedure times; and reduction of the need for fluoroscopy.
“Working to add PFA to our existing portfolio of proven market-leading RF solutions hopefully just demonstrates our continued commitment to our mission to help people with AF truly live the lives they want,” she adds. “Hopefully with the promise of PFA there is a potential to widen accessibility for patients seeking AF ablation.”
Disclosure
Vivek Reddy is a consultant for Biosense Webster
[1] Duytschaever M, De Potter T, Grimaldi M. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023; 16:e011780. doi: 10.1161/CIRCEP.122.011780
[2] Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870
[3] Reddy VY, Neuzil P, Koruth JS, et al. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. JACC 2019;74(3)315-326. doi: 10.1016/j.jacc.2019.04.021
[4] Reddy V, Grimaldi M, Duytschaever M, Anic A. Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE [abstract]. In: AF Symposium.; February 2-4; Boston.
[5] ClinicalTrials.gov. Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE). NCT05293639
[6] Newton D, Natale A, Mansour M, Nair D, Senn T. Pulsed Field Ablation Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study [abstract]. In: AF Symposium.; February 2-4; Boston.
[7] ClinicalTrials.gov. Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy (VIRTUE). NCT06056557
[8] ClinicalTrials.gov. A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator (Omny-IRE). NCT05971693
[9] ClinicalTrials.gov. A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator (SmartfIRE). NCT05752487
