Key result
Pulsed field ablation is linked to higher remifentanil requirements during conscious sedation than cryoballoon ablation.
Why the study?
Data on the feasibility and tolerability of conscious sedation during pulsed field ablation for atrial fibrillation remain limited.
Does pulsed field ablation using remifentanil-based conscious sedation offer comparable feasibility and tolerability to cryoballoon ablation in patients undergoing first-time pulmonary vein isolation for atrial fibrillation?
Cohort (n=200)
Does pulsed field ablation using remifentanil-based conscious sedation offer comparable feasibility and tolerability to cryoballoon ablation in patients undergoing first-time pulmonary vein isolation for atrial fibrillation?
Absolute Event Rate: 0.058% vs 0.037%
p-value: p=<0.001
Pulsed field ablation can be performed safely and efficiently using a remifentanil-based conscious-sedation protocol, with comparable tolerance and shorter procedural times than cryoballoon ablation.
May support conscious sedation workflows for PFA; leaves open randomized confirmation before practice change.
Background Pulsed field ablation (PFA) has emerged as an effective and safe technology for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). However, procedure-related skeletal muscle activation has led many centers to favor deep sedation or general anesthesia. Data on conscious sedation during PFA remain limited. Objective To compare the feasibility, tolerability, and procedural characteristics of a standardized conscious-sedation protocol during PVI using PFA or cryoballoon ablation (CBA). Methods We analyzed 200 consecutive patients undergoing first-time PVI for symptomatic AF, including 100 treated with PFA using the FARAPULSE/FARAWAVE system and 100 with CBA. All procedures were performed using an intended conscious-sedation strategy with continuous remifentanil infusion, low-dose midazolam, and intermittent propofol boluses. Procedural characteristics, sedation requirements, patient-reported outcomes, and in-hospital safety events were prospectively evaluated. Results Remifentanil requirements were modestly higher during PFA (0.058±0.04 vs. 0.037±0.02 μg/kg/min; P<0.001), whereas propofol requirements were comparable between groups (0.6±0.6 vs. 0.6±0.35 mg/kg; P=0.20). Despite higher remifentanil requirements, pain scores, procedural recall, and hemodynamic parameters were comparable between groups, whereas satisfaction with sedation was nominally higher with PFA. No patient required airway intervention, vasoactive medication, or conversion to general anesthesia. Procedure duration was shorter with PFA than with CBA (63±23 vs. 73±21 min; P<0.001). Conclusion PFA using the FARAPULSE/FARAWAVE system can be performed safely and effectively using the same remifentanil-based conscious-sedation workflow as CBA. Although PFA was associated with modestly higher analgesic requirements, hypnotic exposure remained low and comparable between groups, while patient-reported outcomes, procedural tolerance, safety, and procedural efficiency remained favorable.
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Rothe et al. (2026) conducted a cohort in Symptomatic atrial fibrillation (n=200). Pulsed field ablation (PFA) vs. Cryoballoon ablation (CBA) was evaluated on Remifentanil requirements (μg/kg/min) (p=<0.001). Pulsed field ablation under conscious sedation required higher remifentanil doses than cryoballoon ablation (0.058 vs 0.037 μg/kg/min; P<0.001), with similar propofol use and safety.
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