Original Investigation
Pulsed Field Ablation in Patients With Persistent Atrial Fibrillation

https://doi.org/10.1016/j.jacc.2020.07.007Get rights and content
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Abstract

Background

Unlike for paroxysmal atrial fibrillation (AF), pulmonary vein isolation (PVI) alone is considered insufficient for many patients with persistent AF. Adjunctive ablation of the left atrial posterior wall (LAPW) may improve outcomes, but is limited by both the difficulty of achieving lesion durability and concerns of damage to the esophagus—situated behind the LAPW.

Objectives

This study sought to assess the safety and lesion durability of pulsed field ablation (PFA) for both PVI and LAPW ablation in persistent AF.

Methods

PersAFOne is a single-arm study evaluating biphasic, bipolar PFA using a multispline catheter for PVI and LAPW ablation under intracardiac echocardiographic guidance. A focal PFA catheter was used for cavotricuspid isthmus ablation. No esophageal protection strategy was used. Invasive remapping was mandated at 2 to 3 months to assess lesion durability.

Results

In 25 patients, acute PVI (96 of 96 pulmonary veins [PVs]; mean ablation time: 22 min; interquartile range [IQR]: 15 to 29 min) and LAPW ablation (24 of 24 patients; median ablation time: 10 min; IQR: 6 to 13 min) were 100% acutely successful with the multispline PFA catheter alone. Using the focal PFA catheter, acute cavotricuspid isthmus block was achieved in 13 of 13 patients (median: 9 min; IQR: 6 to 12 min). The median total procedure time was 125 min (IQR: 108 to 166 min) (including a median of 28 min [IQR: 25 to 33 min] for voltage mapping), with a median of 16 min (IQR: 12 to 23 min) fluoroscopy. Post-procedure esophagogastroduodenoscopy and repeat cardiac computed tomography revealed no mucosal lesions or PV narrowing, respectively. Invasive remapping demonstrated durable isolation (defined by entrance block) in 82 of 85 PVs (96%) and 21 of 21 LAPWs (100%) treated with the pentaspline catheter. In 3 patients, there was localized scar regression of the LAPW ablation, albeit without conduction breakthrough.

Conclusions

The unique safety profile of PFA potentiated efficient, safe, and durable PVI and LAPW ablation. This extends the potential role of PFA beyond paroxysmal to persistent forms of AF. (Pulsed Fields for Persistent Atrial Fibrillation [PersAFOne]; NCT04170621)

Key Words

catheter ablation
esophagus
persistent atrial fibrillation
posterior wall
pulsed field ablation
pulmonary vein isolation

Abbreviations and Acronyms

AF
atrial fibrillation
CT
computed tomography
CTI
cavotricuspid isthmus
ICE
intracardiac echocardiography
IQR
interquartile range
LA
left atrium
LAA
left atrial appendage
LAPW
left atrial posterior wall
PFA
pulsed field ablation
PV
pulmonary vein
PVI
pulmonary vein isolation
PerAF
persistent atrial fibrillation
RF
radiofrequency
TIA
transient ischemic attack

Cited by (0)

The trials were supported by the manufacturer of the ablation system, Farapulse Inc. Dr. Reddy holds stock in Farapulse; has served as a consultant for Biosense Webster and Boston Scientific; has served as a consultant for Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Axon, Backbeat, BioSig, Biotronik, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co., Ltd., East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Fire1, Impulse Dynamics, Javelin, Kardium, Keystone Heart, LuxCath, Medlumics, Medtronic, Middlepeak, Nuvera, Philips, Sirona Medical, Stimda, Thermedical, and Valcare (not related to this manuscript); and has equity in Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co., Ltd., East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Fire1, Javelin, Kardium, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Middlepeak, Newpace, Nuvera, Sirona Medical, Surecor, Valcare, and Vizaramed (not related to this manuscript). Dr. Anic has received grant support from and served as a consultant for Farapulse. Dr. Koruth has received grant support from and served as a consultant for Farapulse; has served as a consultant for Medtronic, Vytronus, Abbott, and Cardiofocus (not related to this manuscript); and has received grant support from Vytronus, Cardiofocus, Luxcath, Affera, LuxCath, and Medlumics (not related to this manuscript). Dr. Petru has received grant support from Farapulse. Dr. Dukkipati holds stock in Farapulse; and has received grant support from Biosense Webster. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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