BACKGROUND: Most single-shot pulsed-field ablation (PFA) catheters require extensive repositioning for pulmonary vein isolation (PVI), posing a challenge for obtaining contiguous, durable lesions. OBJECTIVE: To determine 1-year outcomes of a single-shot, all-in-one mapping and ablation PFA catheter for treating paroxysmal atrial fibrillation (PAF). METHODS: After PVI with the large-lattice catheter with expandable tip (Sphere-360), follow-up included Holter monitoring at 180 and 365 days and scheduled/symptomatic trans-telephonic monitoring (TTM) or modeled insertable loop recorder (ILR) data. Efficacy outcomes were acute PVI and 12-month freedom from atrial arrhythmias (AA), after 90-day blanking. Optional invasive remapping at 75 days facilitated waveform refinement from PULSE1, PULSE2, to the optimized PULSE3. RESULTS: At 3 centers, 100 PAF patients underwent PFA with PULSE1 (n = 30), PULSE2 (n = 20), or PULSE3 (n = 50). Procedure, left atrial dwell, and fluoroscopy times were 57.9 ± 20.6, 22.2 ± 11.8 and 6.8 ± 5.7 minutes, respectively. All 395 targeted PVs were acutely isolated, with a transpired PVI time of 11.5 ± 6.0 minutes, using 4.0 ± 1.3 lesions/PV. There were no primary safety events (serious device-related events within 7 days post-PFA). PVI durability with PULSE3 (n = 40) was 98% (per-vein) and 93% (per-patient). One-year freedom from AA recurrence was 82.0% (95% CI:73.0%-88.3%) overall, and 88.0% (95%CI, 75.2%-94.4%) for PULSE3 patients. Of the ILR sub-cohort (n = 15 PULSE3 patients), 3 patients (20%) had recurrences, with an AA burden reduction from 26% (baseline) to 1.6% (post-ablation). CONCLUSION: The large lattice PFA catheter was efficient, safe, and effective in treating PAF. The observed high PVI durability translated to clinical effectiveness, even in continuously monitored patients.

Department of Cardiology Helmsley Electrophysiology Center Mount Sinai Fuster Heart Hospital New York New York

Department of Cardiology Helmsley Electrophysiology Center Mount Sinai Fuster Heart Hospital New York New York; Department of Cardiology Na Homolce Hospital Prague Czechia

Department of Cardiology Institute for Clinical and Experimental Medicine Prague Czechia

Department of Cardiology Institute of Clinical Medicine Faculty of Medicine Vilnius University Vilnius Lithuania

Department of Cardiology Na Homolce Hospital Prague Czechia

Department of Cardiology Shamir Medical Center Tel Aviv Israel

Department of Cardiology University Heart and Vascular Center Hamburg Hamburg Germany

Department of Cardiology University of Bordeaux IHU LIRYC Bordeaux France

Medtronic Minneapolis Minnesota

Texas Cardiac Arrhythmia Institute Austin Texas; Division of Cardiology Department of Biomedicine and Prevention University of Tor Vergata Rome Italy

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