Pulsed field ablation catheter tied to favorable 30-day safety in real-world AF cohort
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Key takeaways:
- A pulsed field ablation technology was safe at 30 days in a real-world population of patients with atrial fibrillation.
- The patients will be followed for 3 years.
In a real-world registry of patients with atrial fibrillation treated with a pulsed field ablation catheter, the system was associated with favorable 30-day outcomes, researchers reported at Heart Rhythm 2024.
Lucas V. A. Boersma, MD, PhD, FESC, clinical electrophysiologist at St. Antonius Hospital Nieuwegein, and professor of Innovative Transcatheter Treatments for Cardiac Arrhythmias at the University of Amsterdam’s Faculty of Medicine, the Netherlands, presented the 30-day results from the FARADISE real-world registry of 1,151 patients (mean age, 64 years; 33% women; 386 with nonparoxysmal AF) treated with the pulsed field ablation pentaspline catheter (Farapulse, Boston Scientific), which, as Healio previously reported, received FDA approval in January.
“The randomized trials were performed in patients with paroxysmal atrial fibrillation. In this study, there were more patients with persistent atrial fibrillation,” Boersma told Healio. “In this population, there are also more comorbidities. Also, here, the ablation targets were not prespecified. In the randomized trials, patients received pulmonary vein isolation alone. In this registry, about 25% of patients received ablations outside of the pulmonary veins at the discretion of the operator.”
At 30 days, acute device- or procedure-related serious adverse events occurred in 4% of patients, and most of them were minor access-related complications, according to the researchers.
There were no deaths or reports of coronary spasm, persistent phrenic nerve palsy, atrioesophageal fistula, pulmonary vein stenosis or esophageal lesions, Boersma said during a presentation.
Hemolysis occurred in four patients, all of whom had a high number of applications (66 to 161), he said.
There were less than a handful of cases of cardiac tamponade and neurological events, Boersma told Healio.
The results “are comparable [at 30 days] to the randomized trials,” Boersma told Healio. “Acute efficacy was very high. Complication rates were very low and only very few were major. This is consistent with what we have seen before. This study was at 47 centers, ranging from those early in the learning curve to those that had experience with the technology before. Even in the centers adopting the technology at a very early stage, there are almost no device-related complications, only access-related ones. That is consistent with what we have seen in the randomized trials.”
The study suggests that the technology “looks more favorable when compared to cryoballoon ablation or point-by-point radiofrequency ablation, because inherent to those two ablation technologies and the energy source that they use is that you have to be careful of the phrenic nerve, esophageal fistula, tamponade” and potential for other serious adverse events, Boersma told Healio. “There are a lot more inherent disadvantages to using temperature-related ablation than when you use [pulsed field ablation], which appears to be very, very, safe, with few catheter-related issues.”
The patients will be followed for 3 years, Boersma told Healio.
“We are off to a very good start,” he said. “At 1 year and at 3 years, we will see what their outcome is with regard to freedom from arrhythmias, and what that means for patients in terms of quality of life and other morbidities.”
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Boersma LVA, et al. Late-breaking clinical trials and science – ablation. Presented at: Heart Rhythm 2024; May 16-19, 2024; Boston.
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