Circulation. Arrhythmia and electrophysiology · 2025
Insights Into Early Adoption and Physician Learning Curve of Pulsed Field Ablation in the United States.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Al-Ahmad Amin, Hincapie-Tabares Daniela, Zei Paul C, Natale Andrea, Kessler David, Gallinghouse Joe, Bode Weeranun, Osorio Jose, Dukes Jonathan W, Eckart Robert, Amin Anish, Vivas Yoel, Mora Luis, Thosani Amit, Silverstein Joshua, Rajendra Anil, Morales Gustavo, Manogue Michael, Donnelly Joseph, Cuoco Frank, Sidney Darren, Brewer Robert, Meyers Jason, Metzl Mark D, Mohanty Guru, Rehorn Michael, Dominic Paari, Day John D, Nannapaneni Nischala, Costello John, DISRUPT-AF Investigators
Аннотация
BACKGROUND: Pulsed field ablation (PFA) has been available in Europe since 2021. In the United States, PFA became commercially available in 2024, and practice patterns are expected to differ from those in Europe. The objective of this study was to describe acute procedural efficiency and safety outcomes, clinical workflow patterns, and the physician learning curve associated with PFA for paroxysmal and nonparoxysmal atrial fibrillation in the first US real-world registry.
METHODS: DISRUPT-AF (A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF) is a prospective, multicenter registry capturing patient-level data on first-time PFA procedures for paroxysmal atrial fibrillation and nonparoxysmal atrial fibrillation using the pentaspline catheter. Patient baseline characteristics and acute procedural efficiency and safety outcomes were collected. Physicians' learning curve analyses were assessed by categorizing experience levels as 1 to 3, 4 to 10, and >11 procedures.
RESULTS: A total of 1076 patients were included; 80.9% of the cases involved ablation beyond the pulmonary veins. Most procedures were performed under general anesthesia (90.2%) using electroanatomic mapping (94.8%). The mean procedural time was 66.64±28.36 minutes. The median fluoroscopy time was 6.17 (0-11.6) minutes, with 25.3% of cases performed using a zero-fluoroscopy approach and 31% utilizing a low-fluoroscopy approach (<2 minutes). The overall procedure-related complication rate was low (1.7%), driven primarily by vascular access complications requiring intervention or transfusion. Procedural efficiency improved with operator experience, evidenced by a reduction in both procedural and fluoroscopy times.
CONCLUSIONS: Initial US experience with the pentaspline PFA catheter demonstrated key differences from previously reported European workflows, including higher use of general anesthesia and electroanatomic mapping. Physician learning curve analysis indicated rapid adoption, with improvements in procedural efficiency and consistent safety with operator experience.
METHODS: DISRUPT-AF (A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF) is a prospective, multicenter registry capturing patient-level data on first-time PFA procedures for paroxysmal atrial fibrillation and nonparoxysmal atrial fibrillation using the pentaspline catheter. Patient baseline characteristics and acute procedural efficiency and safety outcomes were collected. Physicians' learning curve analyses were assessed by categorizing experience levels as 1 to 3, 4 to 10, and >11 procedures.
RESULTS: A total of 1076 patients were included; 80.9% of the cases involved ablation beyond the pulmonary veins. Most procedures were performed under general anesthesia (90.2%) using electroanatomic mapping (94.8%). The mean procedural time was 66.64±28.36 minutes. The median fluoroscopy time was 6.17 (0-11.6) minutes, with 25.3% of cases performed using a zero-fluoroscopy approach and 31% utilizing a low-fluoroscopy approach (<2 minutes). The overall procedure-related complication rate was low (1.7%), driven primarily by vascular access complications requiring intervention or transfusion. Procedural efficiency improved with operator experience, evidenced by a reduction in both procedural and fluoroscopy times.
CONCLUSIONS: Initial US experience with the pentaspline PFA catheter demonstrated key differences from previously reported European workflows, including higher use of general anesthesia and electroanatomic mapping. Physician learning curve analysis indicated rapid adoption, with improvements in procedural efficiency and consistent safety with operator experience.