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Updated: Feb 16, 2026

Remote Magnetic Navigation for Accurate, Real-time Catheter Positioning and Ablation in Cardiac Electrophysiology Procedures
Published on: April 21, 2013
Eventos adversos durante la ablación por catéter en pacientes con dispositivos electrónicos implantables cardíacos
Shiloh Sison1, Kenneth A Ellenbogen2, Charles D Swerdlow3
1Abbott Laboratories, Sunnyvale CA.
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.
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