Risk of mechanical or electrical complications with pulsed field ablation in patients with cardiac implantable electronic devices

Abstract Background Little is known about the safety of pulsed field ablation (PFA) in patients with cardiac implantable electronic devices (CIEDs). Besides the risk of intraprocedural mechanical lead dislodgement, the high-intensity electromagnetic field generated by PFA may potentially alter the integrity of electrical components. Early experience with the Pentaspline PFA catheter has reported no significant periprocedural CIED-related adverse events. However, long-term safety is still unknown. Purpose We aimed to evaluate the impact of different PFA technologies on CIED parameters acutely after ablation and at follow-up. Methods Consecutive patients with CIEDs undergoing AF ablation with 3 PFA technologies (2 bipolar single-shot catheters, 1 unipolar focal catheter) were retrospectively enrolled at 6 high-volume European centres between January 2022 and July 2024. Complete CIEDs interrogations, including lead sensing, impedance, and threshold, were performed in sinus rhythm at baseline, immediately after ablation, and at 3-month follow-up. Appropriate device reprogramming and temporary deactivation of defibrillator anti-tachycardia therapy were maintained throughout the procedure. Device and lead performance, including lead revision procedures for malfunction within 3 months of ablation, were also collected. Results A total of 78 patients (67 ± 10 years, 21% female, 50% with paroxysmal AF) were included. Of these, 45% had a pacemaker (3% single-chamber, 38% dual-chamber, 4% CRT) and 55% had a defibrillator (17% single-chamber, 28% dual-chamber, 10% CRT). Ablation was performed with a bipolar single-shot PFA device in 73 (94%) patients and a unipolar focal PFA catheter in 5 (6%) patients. Ablation targets included the pulmonary veins in 97% of patients, the posterior wall in 63%, the posterior mitral isthmus in 22%, the cavotricuspid isthmus in 9%, and the superior vena cava in 3%. Mean procedure and fluoroscopy times were 79±37 and 18±11 minutes, respectively. No intraprocedural lead dislodgement was observed. In most cases (96%), PFA applications led to atrial and/or ventricular oversensing without detected episodes of tachycardia or noise. PFA did not result in significant changes in lead impedance, sensing, or threshold values immediately after ablation and at 3-month follow-up compared to baseline (Figure). No effect on battery longevity was observed and no patient required lead revision due to lead failure within 3 months of ablation. Conclusion PFA of AF was associated with a favourable safety profile in patients with CIEDs, as demonstrated by the absence of any significant mechanical or electrical complications.Lead Sensing, Impedance and Threshold