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Randomized Controlled Trial
. 2024 Jul 2;84(1):61-74.
doi: 10.1016/j.jacc.2024.05.001. Epub 2024 May 18.

Pulsed Field vs Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation: Recurrent Atrial Arrhythmia Burden

Vivek Y Reddy  1 , Moussa Mansour  2 , Hugh Calkins  3 , Andre d'Avila  4 , Larry Chinitz  5 , Christopher Woods  6 , Sanjaya K Gupta  7 , Jamie Kim  8 , Zayd A Eldadah  9 , Robert A Pickett  10 , Jeffrey Winterfield  11 , Wilber W Su  12 , Jonathan W Waks  4 , Christopher W Schneider  13 , Elizabeth Richards  13 , Elizabeth M Albrecht  13 , Brad S Sutton  13 , Edward P Gerstenfeld  14 ; ADVENT Investigators
Collaborators, Affiliations
Free article
Randomized Controlled Trial

Pulsed Field vs Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation: Recurrent Atrial Arrhythmia Burden

Vivek Y Reddy et al. J Am Coll Cardiol. .
Free article

Abstract

Background: The ADVENT randomized trial revealed no significant difference in 1-year freedom from atrial arrhythmias (AA) between thermal (radiofrequency/cryoballoon) and pulsed field ablation (PFA). However, recent studies indicate that the postablation AA burden is a better predictor of clinical outcomes than the dichotomous endpoint of 30-second AA recurrence.

Objectives: The goal of this study was to determine: 1) the impact of postablation AA burden on outcomes; and 2) the effect of ablation modality on AA burden.

Methods: In ADVENT, symptomatic drug-refractory patients with paroxysmal atrial fibrillation underwent PFA or thermal ablation. Postablation transtelephonic electrocardiogram monitor recordings were collected weekly or for symptoms, and 72-hour Holters were at 6 and 12 months. AA burden was calculated from percentage AA on Holters and transtelephonic electrocardiogram monitors. Quality-of-life assessments were at baseline and 12 months.

Results: From 593 randomized patients (299 PFA, 294 thermal), using aggregate PFA/thermal data, an AA burden exceeding 0.1% was associated with a significantly reduced quality of life and an increase in clinical interventions: redo ablation, cardioversion, and hospitalization. There were more patients with residual AA burden <0.1% with PFA than thermal ablation (OR: 1.5; 95% CI: 1.0-2.3; P = 0.04). Evaluation of outcomes by baseline demographics revealed that patients with prior failed class I/III antiarrhythmic drugs had less residual AA burden after PFA compared to thermal ablation (OR: 2.5; 95% CI: 1.4-4.3; P = 0.002); patients receiving only class II/IV antiarrhythmic drugs pre-ablation had no difference in AA burden between ablation groups.

Conclusions: Compared with thermal ablation, PFA more often resulted in an AA burden less than the clinically significant threshold of 0.1% burden. (The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation [ADVENT]; NCT04612244).

Keywords: arrhythmia burden; atrial fibrillation; pulsed field ablation.

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Conflict of interest statement

Funding Support and Author Disclosures This study was funded by Boston Scientific. Dr Reddy has been a consultant to and received equity from Farapulse (now divested); has received grant support from and served as a consultant to Boston Scientific; has served as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Anumana, Apama Medical-Boston Scientific, APN Health, Append Medical, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, Cardiofocus, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Laminar Medical, LuxMed, Medlumics, Neutrace, Nuvera-Biosense Webster, Oracle Health, Pulse Biosciences, Restore Medical, Sirona Medical, SoundCath, and Valcare, unrelated to this manuscript; has served as a consultant for Abbott, Adagio Medical, AtriAN, Biosense Webster, BioTel Heart, Biotronik, Cairdac, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, and Philips, unrelated to this work; and has equity in Atraverse, DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed, unrelated to this work. Dr Mansour has been a consultant for Boston Scientific, Biosense Webster, Abbott, Medtronic, Siemens, and SentreHeart/Atricure; and has equity in EPD-Philips (divested) and NewPace Ltd. Dr Calkins has been a consultant to and received honoraria from Boston Scientific. Dr d’Avila has received an honorarium and grant support from Biosense, Biotronik, and Abbott. Dr Waks was previously on the advisory board for HeartcoR solutions; and performs current core lab work for HeartcoR solutions, both unrelated to this trial. Dr Chinitz has been a consultant to and received speaker honoraria from Biosense Webster, Abbott, Medtronic, and Biotronik. Dr Woods has received equity in Inheart and Solopace; has intellectual property with EnsoETM and SoloPace; and has been a consultant to Abbott and Atricure. Dr Gupta has been a consultant for Medtronic and Boston Scientific. Dr Kim has been a consultant for Boston Scientific and Biosense Webster. Dr Pickett has been a consultant for Boston Scientific and Medtronic. Dr Winterfield has been a consultant for Biosense Webster, Abbott, Boston Scientific, and Thermedical. Dr Su has been a consultant to and received research support from Boston Scientific Inc. Mr Schneider, Ms Richards, Dr Albrecht, and Dr Sutton are employes of Boston Scientific. Dr Gerstenfeld has been a consultant to Boston Scientific, Biosense Webster, and Adagio Medical; has received lecture honoraria from Boston Scientific, Medtronic, Biosense Webster, Adagio Medical, and Abbott; and has received research grants from Abbott, Biosense Webster, and Adagio Medical. Dr Eldadah has reported that he has no relationships relevant to the contents of this paper to disclose.

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