Title First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation /
Authors Reddy, Vivek Y ; Anter, Elad ; Peichl, Petr ; Račkauskas, Gediminas ; Petru, Jan ; Funasako, Moritoshi ; Koruth, Jacob S ; Marinskis, Germanas ; Turagam, Mohit ; Aidietis, Audrius ; Kautzner, Josef ; Natale, Andrea ; Neuzil, Petr
DOI 10.1093/europace/euae090
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Is Part of Europace.. Oxford : Oxford University Press. 2024, vol. 26, iss. 4, art. no. euae090, p. [1-13].. ISSN 1099-5129. eISSN 1532-2092
Keywords [eng] atrial fibrillation ; catheter ablation ; electroanatomical mapping system ; lesion durability ; pulsed field ablation ; single-shot
Abstract [eng] Aims Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-inhuman, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8 Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system. Methods After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5–6 s per application; ∼4 and results applications per PV). Three waveforms were tested: PULSE1, PULSE2, and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted ∼75 days post-ablation. At three centres, PVI was performed by five operators in 85 patients using PULSE1 (n = 30), PULSE2 (n = 20), and PULSE3 (n = 35). Acute PVI was achieved in 100% of PVs using 3.9 ± 1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5 ± 21.6, 10.0 ± 6.0, 19.1 ± 9.3, and 5.7 ± 3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per-vein basis for the total and PULSE3 cohort, respectively. The Kaplan–Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2–89.2%) for the total, and 100% (95% CI 80.6–100%) for the PULSE3 cohort. Conclusion Pulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.
Published Oxford : Oxford University Press
Type Journal article
Language English
Publication date 2024
CC license CC license description