Heart rhythm · 2026
Adverse events during catheter ablation in patients with cardiac implantable electronic devices.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Sison Shiloh, Ellenbogen Kenneth A, Swerdlow Charles D
Аннотация
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.
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.