Large-tip, dual-energy ablation catheter shows promise as treatment for persistent AF
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Key takeaways:
- A mapping system and large-tip catheter with dual pulsed field and radiofrequency energies was noninferior for AF ablation to a conventional system at 1 year.
- The procedure was much faster with the new system.
A platform with a mapping system and a large-tip catheter with dual pulsed field and radiofrequency energies was noninferior to a conventional radiofrequency ablation system for treatment of persistent atrial fibrillation, data show.
For the SPHERE Per-AF noninferiority trial, presented at Heart Rhythm 2024 and simultaneously published in Nature Medicine, the researchers randomly assigned 420 patients with symptomatic persistent AF (mean age, 67 years; 68% men) to undergo ablation with the all-in-one mapping system and large-tip catheter with dual pulsed field and radiofrequency energies (Affera mapping and ablation system with Sphere-9 catheter, Medtronic) or with a conventional radiofrequency ablation system (Thermocool SmartTouch SF radiofrequency ablation catheter with Carto navigation and mapping system, Biosense Webster).
“Historically, we do ablation for cardiac diseases with thermal energy, either radiofrequency ablation or cryoablation,” Tyler Taigen, MD, FHRS, electrophysiologist, co-director of the electrophysiology lab and director of quality and associate section head electrophysiology and pacing in the Tomsich Family Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute, Cleveland Clinic, an author of the study, told Healio. “This new technology is nonthermal. Pulsed electronic signals are delivered to cells, and the cell membrane breaks down, changing the electric conduction of those cells. We wanted to look at the use of that energy source with a different type of catheter which should be both safer and more effective.
Unique catheter
“The dual energies and the high-density mapping are the uniqueness of this catheter,” Taigen told Healio. “Most of the other ablation catheters that we use are small, and it takes a long time to develop a map that has points where we can understand the complex arrhythmias. With this one, we can do that very quickly. Having both the radiofrequency energy and the pulsed field energy gives us versatility. There are areas where we still want to deliver radiofrequency energy. Areas that have coronary vessels in close proximity and areas where we want to affect ganglionic plexi are two examples of where it may make sense to still use radiofrequency energy. The pulsed field energy is best to be used in areas where there are noncardiac tissues that would have been affected by radiofrequency, notably the esophagus.”
The primary effectiveness endpoint of freedom from a composite of serious procedure- or device-related adverse events — failure to complete the procedure, recurrence of AF/atrial tachycardia/atrial flutter after a 90-day blanking period, repeat ablation or introduction of class I or III antiarrhythmic drugs — at 1 year occurred in 73.8% of the patients in the intervention arm and 65.8% of those in the control arm (P for noninferiority < .0001), Elad Anter, MD, from Shamir Medical Center, Be’er Ya'Akov, Israel, said during a presentation.
In current practice, patients with persistent AF have about a 50% success rate for the primary effectiveness endpoint with standard ablation catheters, Taigen told Healio.
The primary safety endpoint of major device- or procedure-related complications occurred in three patients from the investigational group and two patients from the control group (P for noninferiority < .0001), according to the researchers.
Faster procedure time
Energy application time, transpired ablation time and skin-to-skin procedural time were all faster in the intervention group (P < .0001 for all), the researchers found.
“The speed at which the ablation can be done with the new catheter probably means that we are going to be able to treat more patients and get to them quicker,” Taigen told Healio. “There are more patients who are good candidates for AF ablation, but there’s a backlog because this has traditionally been a procedure that takes hours to get through. This should open up the avenue for a lot of patients to get in and receive this therapy, and there are going to benefit quite a bit from it if we can make it happen. Not having to worry about the esophagus is a big difference for us doing the procedure. Our experience is that the patients have done extremely well.”
Reference:
For more information:
Tyler Taigen, MD, FHRS, can be reached at taigent@ccf.org.
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Anter E, et al. Late-breaking clinical trials and science – ablation. Presented at: Heart Rhythm 2024; May 16-19, 2024; Boston.
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