Key result
Conscious sedation during PFA for AF achieves 100% acute PVI, matching general anesthesia without complications.
Why the study?
Pulsed field ablation for pulmonary vein isolation is typically performed under general anesthesia due to patient discomfort, but suitable PFA systems may enable procedures under conscious sedation to avoid specialized airway management teams.
Does conscious sedation compared to general anesthesia maintain acute procedural efficacy and safety in patients undergoing pulmonary vein isolation with a circular over-the-wire pulsed field ablation catheter?
Observational (n=174)
No
Does conscious sedation compared to general anesthesia maintain acute procedural efficacy and safety in patients undergoing pulmonary vein isolation with a circular over-the-wire pulsed field ablation catheter?
Absolute Event Rate: 100% vs 100%
p-value: p=1.000
Conscious sedation is a feasible, safe, and efficient alternative to general anesthesia for pulmonary vein isolation using a circular over-the-wire pulsed field ablation catheter, potentially increasing procedural accessibility.
Conscious sedation may support PFA PVI without GA; leaves open randomized confirmation of safety and efficacy.
BACKGROUND: Pulmonary vein isolation (PVI) using pulsed field ablation (PFA) is typically performed under general anesthesia (GA) due to patient discomfort and pain. However, procedures under GA require specialized personnel for airway management. PFA systems with suitable characteristics may enable PFA-procedures to be performed under bolus- administered conscious sedation (CS). OBJECTIVE: Assess the feasibility, safety, and efficacy of performing PVI with a circular-over-the-wire PFA catheter under CS, compared to GA. METHODS: We conducted a single-center registry study of atrial fibrillation (AF) patients undergoing an ablation with the circular over-the-wire PFA catheter, between January 29 and December 31, 2024, at the St. Antonius Hospital, The Netherlands. CS was used if no anesthesiology team was available. Endpoints included acute isolation of ablation targets, procedural characteristics and freedom from adverse events. RESULTS: The analysis included 174 consecutive patients (67.2% male, mean age 62.8 ± 9.3 years), with 62.1% having paroxysmal AF. GA was used in 132 patients (75.9%). There were no differences in baseline characteristics between the groups. Total number of applications was higher in the GA group: 33.0 [IQR 32.0; 36.0] vs. 32.0 [IQR 32.0; 33.0], p < 0.001. Median skin-to-skin procedural time was comparable between groups: GA 39.0 min [IQR 34.0;46.0] vs. CS 42.0 min [IQR 37.5; 46.0], P = N.S. Acute procedural efficacy was 100% in both groups. One patient in the GA group experienced a major bleeding complication. CONCLUSION: Conscious sedation offers an efficient and safe alternative to general anesthesia for patients undergoing a procedure with use of the circular over-the-wire PFA catheter.
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Graaf et al. (2025) conducted an observational in Atrial fibrillation (n=174). Conscious sedation vs. General anesthesia was evaluated on Acute isolation of all pulmonary veins during the procedure (p=1.000). Conscious sedation during circular over-the-wire pulsed field ablation for atrial fibrillation achieved 100% acute pulmonary vein isolation, identical to general anesthesia, with no intra-procedural complications.
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