BACKGROUND: Because of its safety, "single-shot" pulsed field ablation (PFA) catheters have been developed for pulmonary vein isolation (PVI). However, most atrial fibrillation (AF) ablation procedures are performed with focal catheters to permit flexibility of lesion sets beyond PVI. OBJECTIVES: This study sought to determine the safety and efficacy of a focal ablation catheter able to toggle between radiofrequency ablation (RFA) or PFA to treat paroxysmal or persistent AF. METHODS: In a first-in-human study, a focal 9-mm lattice tip catheter was used for PFA posteriorly and either irrigated RFA (RF/PF) or PFA (PF/PF) anteriorly. Protocol-driven remapping was at ∼3 months postablation. The remapping data prompted PFA waveform evolution: PULSE1 (n = 76), PULSE2 (n = 47), and the optimized PULSE3 (n = 55). RESULTS: The study included 178 patients (paroxysmal/persistent AF = 70/108). Linear lesions, either PFA or RFA, included 78 mitral, 121 cavotricuspid isthmus, and 130 left atrial roof lines. All lesion sets (100%) were acutely successful. Invasive remapping of 122 patients revealed improvement of PVI durability with waveform evolution: PULSE1: 51%; PULSE2: 87%; and PULSE3: 97%. After 348 ± 652 days of follow-up, the 1-year Kaplan-Meier estimates for freedom from atrial arrhythmias were 78.3% ± 5.0% and 77.9% ± 4.1% for paroxysmal and persistent AF, respectively, and 84.8% ± 4.9% for the subset of persistent AF patients receiving the PULSE3 waveform. There was 1 primary adverse event-inflammatory pericardial effusion not requiring intervention. CONCLUSIONS: AF ablation with a focal RF/PF catheter allows efficient procedures, chronic lesion durability, and good freedom from atrial arrhythmias-for both paroxysmal and persistent AF. (Safety and Performance Assessment of the Sphere-9 Catheter and the Affera Mapping and RF/PF Ablation System to Treat Atrial Fibrillation; NCT04141007 and NCT04194307).

Cardiac Electrophysiology Section Department of Cardiovascular Medicine Cleveland Clinic Cleveland Ohio USA

Centre for Cardiology and Angiology Department of Cardiovascular Diseases Vilnius University Vilnius Lithuania

Department of Cardiology Homolka Hospital Prague Czech Republic

Department of Cardiology Homolka Hospital Prague Czech Republic; Helmsley Electrophysiology Center Department of Cardiology Icahn School of Medicine at Mount Sinai New York New York USA

Department of Cardiology Institute for Clinical and Experimental Medicine Prague Czech Republic

Helmsley Electrophysiology Center Department of Cardiology Icahn School of Medicine at Mount Sinai New York New York USA

Texas Cardiac Arrhythmia Institute at St David's Medical Center Austin Texas USA

University of Bordeaux CHU Bordeaux IHU LIRYC ANR 10 IAHU 04 Bordeaux France

JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 3):1802-1803. doi: 10.1016/j.jacep.2023.05.031. PubMed

References provided by Crossref.org

Safety and effectiveness of the first balloon-in-basket pulsed field ablation system for the treatment of atrial fibrillation: VOLT CE Mark Study 6-month results

Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial

Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE

First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation

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ClinicalTrials.gov
NCT04141007, NCT04194307