Safety and integrity of cardiac implantable electronic devices during and after pulsed-field ablation (SAFE-PFA registry)

Abstract Background Pulsed-field ablation (PFA) is a novel non-thermal atrial fibrillation (AF) ablation technique presumed safety benefits due to its tissue selectivity. However, the high-voltage electric field used in PFA may directly affect or interfere with the functionality of cardiac implantable electronic devices (CIEDs). Purpose Data regarding safety of PFA in CIED patients is scarce. This study aimed to evaluate the impact of PFA on patients with various types of CIEDs, including pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices and devices with abandoned leads. Methods Consecutive patients with CIED undergoing PFA were included in this registry. All patients underwent device interrogation before, after the PFA procedure and during follow-up. During the procedure all ICD therapies were deactivated, and no changes were made regarding the pacing output. Device settings, functionality and electrical parameters such as AF burden were assessed. Results A total of 19 patients (age 69±12 years, 68% male) were included. Of those 10/19 patients with pacemakers, one patient with a CRT-pacemaker, and 8/19 patients with ICDs. Of those one subcutaneous ICD, 3 patients with CRT-defibrillators and xx with single-chamber ICDs. One patient had two abandoned pacemaker leads without a connected device. Throughout the procedure and after a median follow-up period of 18 weeks (IQR 9-43 weeks), no adverse interactions or malfunctions in CIEDs were detected. No spontaneous reprogramming or mode switch due to electromagnetic interference occurred. Measurements for lead impedance, sensing and threshold remained unaffected. Battery longevity and impedance remained within expectance during follow-up. Of note, AF burden was significantly reduced, decreasing from a baseline of 22±24% to 1±2% post-procedure. Conclusion PFA appears to be a safe and effective therapeutic option for reducing AF burden in patients with CIEDs. The study demonstrated no adverse impact on device function, highlighting PFA as a safe and feasible ablation method for patients requiring CIEDs. Further multicenter studies are recommended to corroborate these findings in larger patient cohorts.