Adverse events during catheter ablation in patients with cardiac implantable electronic devices.

BACKGROUND

Reviews of adverse events (AEs) in patients with cardiac implantable electronic devices (CIEDs) during catheter ablation predate newer devices, procedures, and ablation technologies (eg, pulsed field [PF], lattice-tip radiofrequency [RF]).

OBJECTIVE

This study aimed to characterize AEs in contemporary patients with CIED undergoing ablation and identify implications for safer practice.

METHODS

We analyzed 433 AEs from the US Food and Drug Administration's Manufacturer and User Facility Device Experience database and peer-reviewed literature (2020-2025), focusing on newer technologies.

RESULTS

Ablation catheters or 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 (5%). Interventions (generator/lead replacement/repositioning) occurred in 56% of cases. Thermal injury with loss of capture necessitated replacement or repositioning of 53 transvenous leads and 32 leadless pacemakers, often when ablation sites were ≥2 cm from tip electrodes. Lattice-tip RF near Biotronik implantable cardioverter-defibrillator leads induced 14 of 15 RF-related ventricular fibrillations. 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 patients with CIED underscores the 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 seemed largely preventable, suggesting gaps in procedural workflows. Our results suggest opportunities to improve clinical practices and CIED design to safeguard patients.