PFA associated with elevated risk of heart damage, real-world data show
Pulsed field ablation (PFA) is growing more and more popular among electrophysiologists all over the world. It was also a hot topic at Heart Rhythm 2025, the Heart Rhythm Society’s annual meeting in San Diego.
However, new real-world data presented at that very meeting show that PFA is also associated with certain safety risks that require additional research. The findings were simultaneously published in JACC: Clinical Electrophysiology.[1]
The study’s authors explored data from 871 patients with a mean age of 68.9 years old. More than 70% of patients were men. All patients underwent either PFA or radiofrequency (RF) ablation for atrial fibrillation.
In total, 87.1% of patients underwent PFA with U.S. Food and Drug Administration-approved systems developed by Medtronic (PulseSelect, Affera), Boston Scientific (Farapulse) or Johnson & Johnson MedTech/Biosense Webster (Varipulse). The remaining patients underwent RF ablation.
The most commonly used PFA systems were the Farapulse system with its pentaspline catheter (70.9%), the PulseSelect system with its circular multielectrode catheter (14.1%), the Affera system and its spherical catheter (12.4%), and the Varipulse system with its variable loop catheter (2.3%).
Overall, PFA was associated with a “significantly greater” risk of myocardial injury than is typically seen with RF ablation. This damage included substantial changes in high-sensitivity cardiac troponin (cTn), lactate dehydrogenase (LDH) and haptoglobin after PFA. These changes were dose-dependent, the authors added, suggesting that limiting PFA applications in the future should help reduce the potential for myocardial injury.
In addition, PFA was linked to greater decreases in left atrial ejection fraction, “suggesting more profound atrial stunning or dysfunction following PFA.”
Comparing PFA systems
One key takeaway from the group’s analysis was the differences between different PFA technologies. Changes in cTn and LDH levels were much higher after treatment with the Farapulse system’s pentaspline catheter, for example, than the other stems. Plasma free hemoglobin (PFH) levels were also highest after treatment with the Farapulse system and its pentaspline catheter. The Affera system and its spherical catheter were also linked to elevated PFH levels.
Patient outcomes after PFA-related myocardial injuries
Researchers did confirm that procedural outcomes were rare with PFA. Also, post-treatment outcomes did not appear to be significantly impacted by these identified risks.
The clinical adverse event rate was technically a bit higher in real-world patients (3%) than what was seen in previous studies (1%-2%), the group noted, but this could be due to the learning curve associated with using this technology.
Looking ahead as PFA continues to evolve
“Our observation of patterns across different PFA systems addresses the limited knowledge regarding the differential effects of various electrode configurations and energy delivery protocols and provides a foundation for standardized monitoring protocols across commercially available PFA systems,” wrote first author Dhanunjaya Lakkireddy. MD, an electrophysiologist with the Kansas City Heart Rhythm Institute, and colleagues. “From a technology development perspective, our findings highlight opportunities for optimization and standardization of PFA systems. The dose-dependent relationship between PFA catheter architecture, number of applications and biomarker elevation suggests that modifications to catheter design and refined dosing protocols could potentially mitigate collateral effects while maintaining similar clinical efficacy.”
Much more research into the short- and long-term impacts of treating patients with PFA is required, the authors concluded.
Click here to read the full study in JACC: Clinical Electrophysiology.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.