Initial Real-World Experiences of Pulmonary Vein Isolation and Ablation of Non-Pulmonary Vein Sites Using a Novel Circular Array Pulsed Field Ablation Catheter

<b>Background and Aims:</b> Various pulsed field ablation (PFA) systems are currently being developed. Recently, a novel CE-approved circular array PFA catheter (PulseSelect™ PFA System, Medtronic, Minneapolis, MN, USA) was introduced. Data on this commercially available system are sparse. The aim was to elucidate real-world data assessing the feasibility, safety, and acute efficacy of pulmonary vein isolation (PVI) and ablation beyond PVI with this novel ablation system. <b>Methods:</b> Consecutive patients with paroxysmal and persistent atrial fibrillation (AF) undergoing first-time ablation with the circular PFA catheter were enrolled in this study. In patients with persistent AF and left atrial (LA) enlargement (LA area > 20 cm<sup>2</sup>), additional left atrial roof ablation (LARA) was performed. Those with concomitant typical atrial flutter received adjunctive cavo-tricuspid isthmus (CTI) ablation. <b>Results:</b> A total of 100 AF patients were included (29% female, 50% persistent AF). Of these, 33 patients (33%) underwent adjunctive LARA, 1 patient (1%) received posterior wall isolation, and 6 patients (6%) required additional CTI ablation. The skin-to-skin procedural time averaged 66.3 ± 13.8 min, while the fluoroscopy time and dose area product were 13.7 ± 4.7 min and 6.8 ± 4.9 Gycm<sup>2</sup>, respectively. Acute PVI was achieved in 100% of pulmonary veins. A bidirectional conduction block of the LARA and CTI lines was confirmed in all patients, and no major adverse events were reported. <b>Conclusions:</b> These real-world data demonstrate the feasibility, safety, and acute efficacy of PVI and ablation beyond PVI using a novel circular array PFA catheter in patients with atrial fibrillation and flutter. The system can easily be integrated with standard PVI workflows. Further and larger studies are warranted to assess the clinical long-term effectiveness and safety of this PFA system.

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Publication Details

Journal
Journal of Clinical Medicine
Published
2024-11-19
DOI
https://doi.org/10.3390/jcm13226961
Citations
8
Primary Topic
Cardiac Arrhythmias and Treatments
Type
article
Field-Weighted Citation Impact
3.22
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article

Initial Real-World Experiences of Pulmonary Vein Isolation and Ablation of Non-Pulmonary Vein Sites Using a Novel Circular Array Pulsed Field Ablation Catheter

Andreas Hain, Joerg Yogarajah, P Kahle, Malte Kuniss et al.
8 citations
Journal of Clinical Medicine
Cardiac Arrhythmias and Treatments
3.22
article

Initial Real-World Experiences of Pulmonary Vein Isolation and Ablation of Non-Pulmonary Vein Sites Using a Novel Circular Array Pulsed Field Ablation Catheter

Andreas Hain, Joerg Yogarajah, P Kahle, Malte Kuniss, Samuel Tobias Sossalla, Julie Hutter, Milan Tomić, Thomas Neumann, Philipp Beaujean
article en
8 citations

Abstract

<b>Background and Aims:</b> Various pulsed field ablation (PFA) systems are currently being developed. Recently, a novel CE-approved circular array PFA catheter (PulseSelect™ PFA System, Medtronic, Minneapolis, MN, USA) was introduced. Data on this commercially available system are sparse. The aim was to elucidate real-world data assessing the feasibility, safety, and acute efficacy of pulmonary vein isolation (PVI) and ablation beyond PVI with this novel ablation system. <b>Methods:</b> Consecutive patients with paroxysmal and persistent atrial fibrillation (AF) undergoing first-time ablation with the circular PFA catheter were enrolled in this study. In patients with persistent AF and left atrial (LA) enlargement (LA area > 20 cm<sup>2</sup>), additional left atrial roof ablation (LARA) was performed. Those with concomitant typical atrial flutter received adjunctive cavo-tricuspid isthmus (CTI) ablation. <b>Results:</b> A total of 100 AF patients were included (29% female, 50% persistent AF). Of these, 33 patients (33%) underwent adjunctive LARA, 1 patient (1%) received posterior wall isolation, and 6 patients (6%) required additional CTI ablation. The skin-to-skin procedural time averaged 66.3 ± 13.8 min, while the fluoroscopy time and dose area product were 13.7 ± 4.7 min and 6.8 ± 4.9 Gycm<sup>2</sup>, respectively. Acute PVI was achieved in 100% of pulmonary veins. A bidirectional conduction block of the LARA and CTI lines was confirmed in all patients, and no major adverse events were reported. <b>Conclusions:</b> These real-world data demonstrate the feasibility, safety, and acute efficacy of PVI and ablation beyond PVI using a novel circular array PFA catheter in patients with atrial fibrillation and flutter. The system can easily be integrated with standard PVI workflows. Further and larger studies are warranted to assess the clinical long-term effectiveness and safety of this PFA system.

Journal of Clinical MedicineVol. 13(22)
Justus-Liebig-Universität Gießen (DE), Kerckhoff Klinik (DE)
Openalex Percentile: Top 7%
Cardiac Arrhythmias and Treatments
3.22
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