Heart rhythm · 2026
Electrogram-guided pulsed field ablation for persistent atrial fibrillation: A prospective cohort study.
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Li Kaige, Di Biase Luigi, Qin Mu, Wu Shaohui, Zhang Xiaodong, Liu Xu, Hou Xumin
Аннотация
BACKGROUND: Optimal ablation strategies of pulsed field ablation (PFA) in persistent atrial fibrillation (PerAF) remain under investigation.
OBJECTIVE: This study aimed to explore an innovative electrogram (EGM)-guided PFA approach for PerAF ablation.
METHODS: This prospective cohort study used CARTO 3-dimensional mapping combined with the Farawave catheter for ablation. 85 patients with PerAF who underwent EGM-guided PFA (pulmonary vein isolation, posterior wall isolation [PWI], and target EGM ablation) were enrolled (EGM group). Another cohort of 85 patients treated with anatomic pulmonary vein isolation plus PWI using the same PFA system was also included as the control group (PWI group). The procedure end point was atrial fibrillation (AF) termination or complete ablation of all target sites. The primary efficacy end point was freedom from AF/atrial tachycardia (AT) recurrence at 12 months after a single procedure, off antiarrhythmic drugs. Safety outcomes included PFA-related adverse events.
RESULTS: 72 patients (84.7%) in the EGM group experienced intraprocedural AF termination, which was significantly higher than the PWI group (10 of 85; 11.8%; P < .001). At 12 months, the primary efficacy outcome (AF-/AT-free survival) was achieved in 82.4% of patients (70 of 85) in the EGM group vs 65.9% (56 of 85) in the PWI group (log-rank P = .017; hazard ratio .47; 95% confidence interval 0.25-0.87). Patients who reached procedural AF termination had a higher rate of AF-/AT-free survival of 84.1% than 64.8% of non-AF termination (log-rank P = .007; hazard ratio 0.40; 95% confidence interval 0.21-0.77). The primary safety end point occurred in 1 patient (1.2%) with hemolysis in the EGM group. No other PFA-related adverse event was observed.
CONCLUSION: In this single-center, nonrandomized comparative cohort study, EGM-guided PFA demonstrated preliminary efficacy and safety in PerAF ablation, suggesting promising prospects as an innovative strategy for PerAF ablation. (ClinicalTrials, NCT06729866, EGM Guided PFA for PerAF).
OBJECTIVE: This study aimed to explore an innovative electrogram (EGM)-guided PFA approach for PerAF ablation.
METHODS: This prospective cohort study used CARTO 3-dimensional mapping combined with the Farawave catheter for ablation. 85 patients with PerAF who underwent EGM-guided PFA (pulmonary vein isolation, posterior wall isolation [PWI], and target EGM ablation) were enrolled (EGM group). Another cohort of 85 patients treated with anatomic pulmonary vein isolation plus PWI using the same PFA system was also included as the control group (PWI group). The procedure end point was atrial fibrillation (AF) termination or complete ablation of all target sites. The primary efficacy end point was freedom from AF/atrial tachycardia (AT) recurrence at 12 months after a single procedure, off antiarrhythmic drugs. Safety outcomes included PFA-related adverse events.
RESULTS: 72 patients (84.7%) in the EGM group experienced intraprocedural AF termination, which was significantly higher than the PWI group (10 of 85; 11.8%; P < .001). At 12 months, the primary efficacy outcome (AF-/AT-free survival) was achieved in 82.4% of patients (70 of 85) in the EGM group vs 65.9% (56 of 85) in the PWI group (log-rank P = .017; hazard ratio .47; 95% confidence interval 0.25-0.87). Patients who reached procedural AF termination had a higher rate of AF-/AT-free survival of 84.1% than 64.8% of non-AF termination (log-rank P = .007; hazard ratio 0.40; 95% confidence interval 0.21-0.77). The primary safety end point occurred in 1 patient (1.2%) with hemolysis in the EGM group. No other PFA-related adverse event was observed.
CONCLUSION: In this single-center, nonrandomized comparative cohort study, EGM-guided PFA demonstrated preliminary efficacy and safety in PerAF ablation, suggesting promising prospects as an innovative strategy for PerAF ablation. (ClinicalTrials, NCT06729866, EGM Guided PFA for PerAF).