Among 433 adverse events during catheter ablation in CIED patients, ablation energy caused 97% of AEs, primarily through electromagnetic (68%) and mechanical (32%) interactions.
Observational (n=433)
What are the characteristics and causes of adverse events during contemporary catheter ablation in patients with CIEDs?
Contemporary catheter ablation in CIED patients carries underappreciated risks from older technologies and novel risks from evolving technologies like pulsed field and lattice-tip RF, with over 40% of AEs appearing largely preventable.
BACKGROUND Reviews of adverse events (AEs) in patients with cardiac implantable electronic devices (CIEDs) during catheter ablation predate newer devices, procedures, and ablation technologies (e.g., pulsed field PF, lattice-tip radiofrequency RF). OBJECTIVE To characterize AEs in contemporary CIED patients undergoing ablation and identify implications for safer practice. METHODS We analyzed 433 AEs from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database and peer-reviewed literature (2020-2025), focusing on newer technologies. RESULTS Ablation catheters/energy caused 97% of AEs (RF: 89%; PF: 8%). Mechanical interactions caused 32% of AEs (30% dislodgements). Electromagnetic interactions (68%) included myocardial thermal injury (34%), generator dysfunction (20%), oversensing (9%), and induction of ventricular fibrillation (VF) (5%). Interventions (generator/lead replacement/repositioning) occurred in 56% of cases. Thermal injury with loss of capture necessitated replacement/repositioning of 53 transvenous leads and 32 leadless pacemakers, often when ablation sites were ≥2 cm from tip electrodes. Lattice-tip RF near Biotronik ICD leads induced 14 of 15 RF-related VFs. PF accounted for all 6 confirmed generator failures. No cryoablation AEs were reported. CONCLUSION This first and largest comprehensive series of ablation-related complications in contemporary CIED patients underscores underappreciated risks of older technology and highlights novel risks of evolving technologies. A notable finding is that most threshold elevations requiring intervention occurred at ablation sites remote from CIED tip electrodes. More than 40% of AEs appeared largely preventable, suggesting gaps in procedural workflows. Our results suggest opportunities to improve clinical practices and CIED design to safeguard patients.
Sison et al. (2026) conducted an observational in Cardiac implantable electronic devices (CIEDs) undergoing catheter ablation (n=433). Catheter ablation was evaluated on Adverse event characteristics and causes. Among 433 adverse events during catheter ablation in CIED patients, ablation energy caused 97% of AEs, primarily through electromagnetic (68%) and mechanical (32%) interactions.