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

Vivek Y. Reddy, Elad Anter, Petr Peichl, Gediminas Rackauskas, Jan Petru, Moritoshi Funasako, Jacob S. Koruth, Germanas Marinskis, Mohit Turagam, Audrius Aidietis, Josef Kautzner, Andrea Natale, Petr Neuzil

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
JournalEuropace
Volume26
Issue number4
DOIs
StatePublished - 1 Apr 2024

Keywords

  • Atrial fibrillation
  • Catheter ablation
  • Electroanatomical mapping system
  • Lesion durability
  • Pulsed field ablation
  • Single-shot

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