Heart rhythm · 2025
Update on first-in-human experience of high-energy ElectroPulse pulsed field ablation.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
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Kakarla Saikiran, Emami Mehrdad, Puvrez Alexis, Young Glenn D, Ariyaratnam Jonathan, Kamsani Suraya, Middeldorp Melissa E, Stiles Martin K, Wilsmore Bradley, Kistler Peter M, Pathak Rajeev K, Kalman Jonathan M, Sanders Prashanthan
Аннотация
BACKGROUND: The ElectroPulse system is a novel pulsed field ablation (PFA) platform integrating mapping and ablation in a small-diameter catheter with irrigation and wire-free design.
OBJECTIVE: The purpose of this study was to present mid-term outcomes from 2 sequential first-in-human cohorts for pulmonary vein isolation and posterior wall isolation (PVI and PWI).
METHODS: The ElectroPulse trial enrolled 60 patients with symptomatic atrial fibrillation undergoing de novo ablation. Cohort 1 (n = 30) followed the standard protocol, while cohort 2 (n = 30) used a modified protocol. The primary end point was time to first atrial arrhythmia ≥30 seconds; secondary end points included efficacy and safety, with exploratory analyses of pulmonary vein reconnection and lesion durability. Outcomes were assessed through clinic visits, electrocardiograms, and 4-day Holter monitoring every 3 months.
RESULTS: Compared with patients in cohort 1, those in cohort 2 were older (P = .005), had larger left atrial volumes (P = .009), and higher CHA2DS2-VA scores (P = .002). The modified protocol reduced PFA applications and procedure time (P < .001), with 100% (n = 60) acute PVI/PWI in both cohorts. At 6 months, 16% (n = 5) of cohort 1 and 13% (n = 4) of cohort 2 had atrial fibrillation recurrence (P = .834). Redo ablation was required in 16.6% (n = 5) of cohort 1 but only in 3.3% (n = 1) of cohort 2 (P = .19). Durable PVI was seen in 27% (n = 3) of repeat procedures in cohort 1 vs 100% (n = 3) in cohort 2. Complication rates were low and similar.
CONCLUSION: ElectroPulse PFA enables safe and effective PVI and PWI. The updated high-energy protocol improves efficiency by reducing applications and procedure duration while increasing durability without compromising safety or efficacy.
OBJECTIVE: The purpose of this study was to present mid-term outcomes from 2 sequential first-in-human cohorts for pulmonary vein isolation and posterior wall isolation (PVI and PWI).
METHODS: The ElectroPulse trial enrolled 60 patients with symptomatic atrial fibrillation undergoing de novo ablation. Cohort 1 (n = 30) followed the standard protocol, while cohort 2 (n = 30) used a modified protocol. The primary end point was time to first atrial arrhythmia ≥30 seconds; secondary end points included efficacy and safety, with exploratory analyses of pulmonary vein reconnection and lesion durability. Outcomes were assessed through clinic visits, electrocardiograms, and 4-day Holter monitoring every 3 months.
RESULTS: Compared with patients in cohort 1, those in cohort 2 were older (P = .005), had larger left atrial volumes (P = .009), and higher CHA2DS2-VA scores (P = .002). The modified protocol reduced PFA applications and procedure time (P < .001), with 100% (n = 60) acute PVI/PWI in both cohorts. At 6 months, 16% (n = 5) of cohort 1 and 13% (n = 4) of cohort 2 had atrial fibrillation recurrence (P = .834). Redo ablation was required in 16.6% (n = 5) of cohort 1 but only in 3.3% (n = 1) of cohort 2 (P = .19). Durable PVI was seen in 27% (n = 3) of repeat procedures in cohort 1 vs 100% (n = 3) in cohort 2. Complication rates were low and similar.
CONCLUSION: ElectroPulse PFA enables safe and effective PVI and PWI. The updated high-energy protocol improves efficiency by reducing applications and procedure duration while increasing durability without compromising safety or efficacy.