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Randomized evaluation of redo ablation procedures of atrial fibrillation with focal impulse and rotor modulation-guided procedures: the REDO-FIRM study.

Authors
  • Spitzer, Stefan G1
  • Miller, John M2
  • Sommer, Philipp3
  • Szili-Torok, Tamas4
  • Reddy, Vivek Y5
  • Nölker, Georg6
  • Williams, Chris7
  • Sarver, Anne7
  • Wilber, David J8
  • 1 Praxisklinik Herz und Gefäße, 01099 Dresden, and Brandenburg University of Technology Cottbus-Senftenberg, Institute of Medical Technology, 03046 Cottbus, Germany. , (Germany)
  • 2 Krannert Institute of Cardiology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN 46202, USA. , (India)
  • 3 Herz-und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum, Bad Oeynhausen 32545, Germany. , (Germany)
  • 4 Erasmus MC, Rotterdam, 3015 GD, The Netherlands. , (Netherlands)
  • 5 Helmsley Electrophysiology Center - Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
  • 6 Christliches Klinikum Unna, Unna 59423, Germany. , (Germany)
  • 7 Abbott Laboratories, Chicago, IL 60064, USA.
  • 8 Loyola University Chicago, Chicago, 60660, USA.
Type
Published Article
Journal
EP Europace
Publisher
Oxford University Press
Publication Date
Feb 08, 2023
Volume
25
Issue
1
Pages
74–82
Identifiers
DOI: 10.1093/europace/euac122
PMID: 36056882
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

REDO-FIRM evaluated safety and effectiveness of conventional vs. focal impulse and rotor modulation (FIRM)-guided ablation of recurrent persistent or paroxysmal atrial fibrillation (AF) after an initial AF ablation procedure. This prospective, multicentre, randomized study included patients with a single prior AF ablation, but with recurrent AF and reconnected pulmonary veins (PVs). Conventional ablation generally included PV re-isolation; however, additional ablation was permitted per physician discretion. In the FIRM arm, beyond PV re-isolation, basket catheter-based FIRM mapping created dynamic animations of putative rotors, which were targeted for ablation. Between May 2016 and July 2019, 269 subjects were randomized, with 243 subjects completing 12-month follow-up. Ablation beyond re-pulmonary vein isolation, the FIRM vs. Conventional arms did not differ significantly: cavo-tricuspid isthmus -9.0% vs. 15.3%, caval vein isolation -1.5% vs. 0.8%, non-PV trigger -2.2% vs. 3.8%, other -11.9% vs. 13.0%. Single procedure 12-month freedom from AF/atrial tachycardia/atrial flutter-recurrence was 63.3% (76/120) vs. 59.0% (72/122) in the FIRM and Conventional arms (P = 0.3503). Efficacy was similar in the paroxysmal and persistent AF subgroups (P = 0.22 and P = 0.48). The 10-day and 12-month safety endpoints were achieved in 93.3% vs. 93.8% (P = 0.89) and 88.4% vs. 93.4% (P = 0.22) in the FIRM and Conventional arms, respectively. In REDO-FIRM, as compared to standard ablation, FIRM-guided ablation did not provide additional efficacy in redo ablation procedures, but FIRM-guided ablation was equally safe. Additional studies are necessary to identify any potential population able to benefit from FIRM-guided ablation. © The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: [email protected].

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