Naslov
Pulsed Field Ablation of Paroxysmal Atrial Fibrillation

Autori
Reddy, Vivek Y. ; Dukkipati, Srinivas R. ; Neuzil, Petr ; Anic, Ante ; Petru, Jan ; Funasako, Moritoshi ; Cochet, Hubert ; Minami, Kentaro ; Breskovic, Toni ; Sikiric, Ivan ; Sediva, Lucie ; Chovanec, Milan ; Koruth, Jacob ; Jais, Pierre

Izvornik
JACC: Clinical Electrophysiology (2405-500X) 7 (2021), 5; 614-627

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
atrial fibrillation ; catheter ablation ; electroporation ; pulmonary vein isolation ; pulsed field ablation

Sažetak
Objectives: This study sought to determine whether durable pulmonary vein isolation (PVI) using pulsed field ablation (PFA) translates to freedom from atrial fibrillation recurrence without an increase in adverse events. Background: PFA is a nonthermal ablative modality that, in preclinical studies, is able to preferentially ablate myocardial tissue with minimal effect on surrounding tissues. Herein, we present 1-year clinical outcomes of PFA. Methods: In 3 multicenter studies (IMPULSE [A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation], PEFCAT [A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation], and PEFCAT II [Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation]), paroxysmal atrial fibrillation patients underwent PVI using a basket or flower PFA catheter. Invasive remapping was performed at ∼2 to 3 months, and reconnected PVs were reisolated with PFA or radiofrequency ablation. After a 90-day blanking period, arrhythmia recurrence was assessed over 1-year follow-up. Results: In 121 patients, acute PVI was achieved in 100% of PVs with PFA alone. PV remapping, performed in 110 patients at 93.0 ± 30.1 days, demonstrated durable PVI in 84.8% of PVs (64.5% of patients), and 96.0% of PVs (84.1% of patients) treated with the optimized biphasic energy PFA waveform. Primary adverse events occurred in 2.5% of patients (2 pericardial effusions or tamponade, 1 hematoma) ; in addition, there was 1 transient ischemic attack. The 1-year Kaplan- Meier estimates for freedom from any atrial arrhythmia for the entire cohort and for the optimized biphasic energy PFA waveform cohort were 78.5 ± 3.8% and 84.5 ± 5.4%, respectively. Conclusions: PVI with a "single-shot" PFA catheter results in excellent PVI durability and acceptable safety with a low 1-year rate of atrial arrhythmia recurrence. These data mitigate concern that the nonthermal ablative mechanism of PFA might mask undiscovered compromises to clinical success. (IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation, NCT03700385 ; A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation, NCT03714178 ; PEFCAT II Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation [PEFCAT II], NCT04170608).

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA