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Clinical Trial
. 2021 May;7(5):614-627.
doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.

Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II

Vivek Y Reddy  1 , Srinivas R Dukkipati  2 , Petr Neuzil  3 , Ante Anic  4 , Jan Petru  3 , Moritoshi Funasako  3 , Hubert Cochet  2 , Kentaro Minami  3 , Toni Breskovic  4 , Ivan Sikiric  4 , Lucie Sediva  3 , Milan Chovanec  3 , Jacob Koruth  2 , Pierre Jais  5
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Free article
Clinical Trial

Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II

Vivek Y Reddy et al. JACC Clin Electrophysiol. 2021 May.
Free article

Abstract

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).

Keywords: atrial fibrillation; catheter ablation; electroporation; pulmonary vein isolation; pulsed field ablation.

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Conflict of interest statement

Funding Support and Author Disclosures 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.

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