TY - JOUR
T1 - Pulsed Field Ablation of Paroxysmal Atrial Fibrillation
T2 - 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II
AU - Reddy, Vivek Y.
AU - Dukkipati, Srinivas R.
AU - Neuzil, Petr
AU - Anic, Ante
AU - Petru, Jan
AU - Funasako, Moritoshi
AU - Cochet, Hubert
AU - Minami, Kentaro
AU - Breskovic, Toni
AU - Sikiric, Ivan
AU - Sediva, Lucie
AU - Chovanec, Milan
AU - Koruth, Jacob
AU - Jais, Pierre
N1 - Funding Information:
This study was funded by a research grant from Farapulse Inc. Dr. Reddy has served as a consultant for Farapulse, Biosense Webster, Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Axon Therapeutics, Backbeat, BioSig, Biotronik, Boston Scientific, Cardiac Implants, CardiaCare, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech, East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo Fire1, HRT, Impulse Dynamics, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Medtronic, Middlepeak, Nuvera, Philips, Pulse Biosciences, Sirona Medical, Thermedical, and Valcare; owns equity in Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Axon Therapeutics, Backbeat, BioSig, Cardiac Implants, CardiaCare, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Manual Surgical Sciences, Medlumics, Middlepeak, Newpace, Nuvera, Sirona Medical, Surecor, Valcare, and Vizaramed; and owns stock in Farapulse. Dr. Dukkipati has received grant support from Biosense Webster; and owns stock in Farapulse and Manual Surgical Sciences. Dr. Neuzil has received grant support from Farapulse. Dr. Anic has received grant support from Farapulse; and has served as a consultant for Boston Scientific. Dr. Cochet has served as a consultant for Farapulse. Dr. Koruth has served as a consultant for Farapulse, Medtronic, Vytronus, Abbott, and Cardiofocus; and has received grant support from Farapulse, Vytronus, Cardiofocus, Luxcath, Affera, LuxCath, and Medlumics. Dr. Jais has received honoraria from Farapulse and Biosense Webster; and owns stock in Farapulse. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2021 The Authors
PY - 2021/5
Y1 - 2021/5
N2 - 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.
AB - 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.
KW - atrial fibrillation
KW - catheter ablation
KW - electroporation
KW - pulmonary vein isolation
KW - pulsed field ablation
UR - http://www.scopus.com/inward/record.url?scp=85105459726&partnerID=8YFLogxK
U2 - 10.1016/j.jacep.2021.02.014
DO - 10.1016/j.jacep.2021.02.014
M3 - Article
C2 - 33933412
AN - SCOPUS:85105459726
SN - 2405-5018
VL - 7
SP - 614
EP - 627
JO - JACC: Clinical Electrophysiology
JF - JACC: Clinical Electrophysiology
IS - 5
ER -