Arrhythmias & electrophysiologyCohort study
Adverse events during catheter ablation in patients with cardiac implantable electronic devices
- analysis of adverse events 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
Authors' 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.
Study context
- Population
- Contemporary patients with cardiac implantable electronic devices (CIEDs) undergoing catheter ablationAdverse events (AEs) analyzed
- Participants
- 433 patients
Safety
Source of AEs
- Ablation catheters or energy caused AEs
- 97%
- RF
- 89%
- PF
- 8%
Mechanical interactions
- Mechanical interactions caused AEs
- 32%
- dislodgements
- 30%
Electromagnetic interactions
- Electromagnetic interactions
- 68%
- myocardial thermal injury
- 34%
- generator dysfunction
- 20%
- oversensing
- 9%
- induction of ventricular fibrillation
- 5%
Interventions (generator/lead replacement/repositioning)
- Interventions occurred in cases
- 56%
Thermal injury with loss of capture necessitating replacement or repositioning
- transvenous leads
- 53
- leadless pacemakers
- 32
- often when ablation sites were ≥2 cm from tip electrodes
RF-related ventricular fibrillations
- induced by lattice-tip RF near Biotronik implantable cardioverter-defibrillator leads
- 14 of 15
Confirmed generator failures
- PF accounted for all confirmed generator failures
- 6
Cryoablation AEs
- No cryoablation AEs were reported
Original publication
Summarised from the published abstract; every number is checked against it