TY - JOUR
T1 - A Focal Ablation Catheter Toggling Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation
AU - Reddy, Vivek Y.
AU - Peichl, Petr
AU - Anter, Elad
AU - Rackauskas, Gediminas
AU - Petru, Jan
AU - Funasako, Moritoshi
AU - Minami, Kentaro
AU - Koruth, Jacob S.
AU - Natale, Andrea
AU - Jais, Pierre
AU - Marinskis, Germanas
AU - Aidietis, Audrius
AU - Kautzner, Josef
AU - Neuzil, Petr
N1 - Publisher Copyright:
© 2023 The Authors
PY - 2023/8
Y1 - 2023/8
N2 - Background: Because of its safety, “single-shot” pulsed field ablation (PFA) catheters have been developed for pulmonary vein isolation (PVI). However, most atrial fibrillation (AF) ablation procedures are performed with focal catheters to permit flexibility of lesion sets beyond PVI. Objectives: This study sought to determine the safety and efficacy of a focal ablation catheter able to toggle between radiofrequency ablation (RFA) or PFA to treat paroxysmal or persistent AF. Methods: In a first-in-human study, a focal 9-mm lattice tip catheter was used for PFA posteriorly and either irrigated RFA (RF/PF) or PFA (PF/PF) anteriorly. Protocol-driven remapping was at ∼3 months postablation. The remapping data prompted PFA waveform evolution: PULSE1 (n = 76), PULSE2 (n = 47), and the optimized PULSE3 (n = 55). Results: The study included 178 patients (paroxysmal/persistent AF = 70/108). Linear lesions, either PFA or RFA, included 78 mitral, 121 cavotricuspid isthmus, and 130 left atrial roof lines. All lesion sets (100%) were acutely successful. Invasive remapping of 122 patients revealed improvement of PVI durability with waveform evolution: PULSE1: 51%; PULSE2: 87%; and PULSE3: 97%. After 348 ± 652 days of follow-up, the 1-year Kaplan-Meier estimates for freedom from atrial arrhythmias were 78.3% ± 5.0% and 77.9% ± 4.1% for paroxysmal and persistent AF, respectively, and 84.8% ± 4.9% for the subset of persistent AF patients receiving the PULSE3 waveform. There was 1 primary adverse event—inflammatory pericardial effusion not requiring intervention. Conclusions: AF ablation with a focal RF/PF catheter allows efficient procedures, chronic lesion durability, and good freedom from atrial arrhythmias—for both paroxysmal and persistent AF.
AB - Background: Because of its safety, “single-shot” pulsed field ablation (PFA) catheters have been developed for pulmonary vein isolation (PVI). However, most atrial fibrillation (AF) ablation procedures are performed with focal catheters to permit flexibility of lesion sets beyond PVI. Objectives: This study sought to determine the safety and efficacy of a focal ablation catheter able to toggle between radiofrequency ablation (RFA) or PFA to treat paroxysmal or persistent AF. Methods: In a first-in-human study, a focal 9-mm lattice tip catheter was used for PFA posteriorly and either irrigated RFA (RF/PF) or PFA (PF/PF) anteriorly. Protocol-driven remapping was at ∼3 months postablation. The remapping data prompted PFA waveform evolution: PULSE1 (n = 76), PULSE2 (n = 47), and the optimized PULSE3 (n = 55). Results: The study included 178 patients (paroxysmal/persistent AF = 70/108). Linear lesions, either PFA or RFA, included 78 mitral, 121 cavotricuspid isthmus, and 130 left atrial roof lines. All lesion sets (100%) were acutely successful. Invasive remapping of 122 patients revealed improvement of PVI durability with waveform evolution: PULSE1: 51%; PULSE2: 87%; and PULSE3: 97%. After 348 ± 652 days of follow-up, the 1-year Kaplan-Meier estimates for freedom from atrial arrhythmias were 78.3% ± 5.0% and 77.9% ± 4.1% for paroxysmal and persistent AF, respectively, and 84.8% ± 4.9% for the subset of persistent AF patients receiving the PULSE3 waveform. There was 1 primary adverse event—inflammatory pericardial effusion not requiring intervention. Conclusions: AF ablation with a focal RF/PF catheter allows efficient procedures, chronic lesion durability, and good freedom from atrial arrhythmias—for both paroxysmal and persistent AF.
KW - atrial fibrillation
KW - catheter ablation
KW - cavotricuspid isthmus
KW - lattice tip
KW - lesion durability
KW - mitral isthmus
KW - pulmonary vein isolation
KW - pulsed field ablation
KW - roof line
KW - temperature controlled
UR - http://www.scopus.com/inward/record.url?scp=85160073329&partnerID=8YFLogxK
U2 - 10.1016/j.jacep.2023.04.002
DO - 10.1016/j.jacep.2023.04.002
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C2 - 37227340
AN - SCOPUS:85160073329
SN - 2405-500X
VL - 9
SP - 1786
EP - 1801
JO - JACC: Clinical Electrophysiology
JF - JACC: Clinical Electrophysiology
IS - 8
ER -