JACC. Clinical electrophysiology · 2026
High-Voltage Nanosecond Pulse Field Ablation Using a Compliant Circular Catheter to Treat Atrial Fibrillation: Lesion Durability and One-Year Outcomes.
СтатьяНазвание и аннотация: Перевод в очереди
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Reddy Vivek Y, Petru Jan, Vijgen Johan, Turagam Mohit, Koruth Jacob S, Funasako Moritoshi, Hala Pavel, Koopman Pieter, Skoda Jan, Stifano Giuseppe, La Fazia Mirco Vincenzo, Kenigsberg David, Natale Andrea, Neuzil Petr
Аннотация
BACKGROUND: Most pulsed field ablation (PFA) technologies for atrial fibrillation use microsecond-scale pulses. Nanosecond pulses, by virtue of their short duration, enable larger pulse amplitudes to project lesion depth, without near-field thermal effects.
OBJECTIVES: The goal of this study was to determine the outcomes of treating paroxysmal atrial fibrillation using a novel circular nanosecond PFA (nsPFA) catheter.
METHODS: In a first-in-human study of patients with symptomatic paroxysmal atrial fibrillation, the nsPFA catheter was used to deliver 2.5-second or 5-second applications. Invasive remapping assessed lesion durability at 2 to 3 months, with additional nsPFA for incomplete lesions. Follow-up included transtelephonic monitoring and Holter monitoring at 6 and 12 months.
RESULTS: At 3 centers, 177 patients (mean age 61 ± 10 years; 36% female; left atrial diameter 41 ± 5 mm) underwent pulmonary vein isolation (PVI) using 2.5-second (n = 36 patients) or 5-second (n = 141) applications. Additional ablation was at the posterior wall (n = 87), cavotricuspid isthmus (n = 11), or mitral isthmus (n = 29). All (100%) lesions were acutely successful, with transpired PVI time of 12 ± 5 minutes, and total left atrial dwell time for the nsPFA catheter of 19 ± 13 minutes. Total procedure and fluoroscopy times were 61 ± 27 minutes and 9 ± 6 minutes, respectively. Three (of 177 [1.7%]) primary serious adverse events occurred: inflammatory pericardial effusion, hemolysis with acute kidney injury, and stroke. Post procedure brain magnetic resonance imaging (35 patients) revealed 11.4% silent cerebral events (DWI+ / ADC-reduced) and 11.4% silent cerebral lesions (SCE plus FLAIR+). PVI durability with the 5-second applications was 91%. The 1-year estimate for freedom from atrial arrhythmia was 89.7% (95% CI: 80.5%-94.6%).
CONCLUSIONS: nsPFA demonstrated reasonable safety, good lesion durability, and favorable 1-year clinical effectiveness. (Evaluation of the CellFX® Nano-Pulsed Field Ablation [PFA] 360 Catheter Endocardial Ablation System for the Treatment of Atrial Fibrillation. NCT06696170).
OBJECTIVES: The goal of this study was to determine the outcomes of treating paroxysmal atrial fibrillation using a novel circular nanosecond PFA (nsPFA) catheter.
METHODS: In a first-in-human study of patients with symptomatic paroxysmal atrial fibrillation, the nsPFA catheter was used to deliver 2.5-second or 5-second applications. Invasive remapping assessed lesion durability at 2 to 3 months, with additional nsPFA for incomplete lesions. Follow-up included transtelephonic monitoring and Holter monitoring at 6 and 12 months.
RESULTS: At 3 centers, 177 patients (mean age 61 ± 10 years; 36% female; left atrial diameter 41 ± 5 mm) underwent pulmonary vein isolation (PVI) using 2.5-second (n = 36 patients) or 5-second (n = 141) applications. Additional ablation was at the posterior wall (n = 87), cavotricuspid isthmus (n = 11), or mitral isthmus (n = 29). All (100%) lesions were acutely successful, with transpired PVI time of 12 ± 5 minutes, and total left atrial dwell time for the nsPFA catheter of 19 ± 13 minutes. Total procedure and fluoroscopy times were 61 ± 27 minutes and 9 ± 6 minutes, respectively. Three (of 177 [1.7%]) primary serious adverse events occurred: inflammatory pericardial effusion, hemolysis with acute kidney injury, and stroke. Post procedure brain magnetic resonance imaging (35 patients) revealed 11.4% silent cerebral events (DWI+ / ADC-reduced) and 11.4% silent cerebral lesions (SCE plus FLAIR+). PVI durability with the 5-second applications was 91%. The 1-year estimate for freedom from atrial arrhythmia was 89.7% (95% CI: 80.5%-94.6%).
CONCLUSIONS: nsPFA demonstrated reasonable safety, good lesion durability, and favorable 1-year clinical effectiveness. (Evaluation of the CellFX® Nano-Pulsed Field Ablation [PFA] 360 Catheter Endocardial Ablation System for the Treatment of Atrial Fibrillation. NCT06696170).