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Clinical Trial
. 2024 Jul 2;26(7):euae174.
doi: 10.1093/europace/euae174.

Efficacy and safety of a novel hexaspline pulsed field ablation system in patients with paroxysmal atrial fibrillation: the PLEASE-AF study

Zulu Wang  1 , Min Tang  2 , Vivek Y Reddy  3 , Huimin Chu  4 , Xingpeng Liu  5 , Yumei Xue  6 , Jingfeng Wang  7 , Jing Xu  8 , Shaowen Liu  9 , Wei Xu  10 , Zhihui Zhang  11 , Bing Han  12 , Lang Hong  13 , Bing Yang  14 , Mingying Ding  1 , Ming Liang  1
Affiliations
Clinical Trial

Efficacy and safety of a novel hexaspline pulsed field ablation system in patients with paroxysmal atrial fibrillation: the PLEASE-AF study

Zulu Wang et al. Europace. .

Abstract

Aims: Pulsed field ablation (PFA) is an emerging non-thermal ablative modality demonstrating considerable promise for catheter ablation of atrial fibrillation (AF). However, these PFA trials have almost universally included only Caucasian populations, with little data on its effect on other races/ethnicities. The PLEASE-AF trial sought to study the 12-month efficacy and the safety of a multi-electrode hexaspline PFA catheter in treating a predominantly Asian/Chinese population of patients with drug-refractory paroxysmal AF.

Methods and results: Patients underwent pulmonary vein (PV) isolation (PVI) by delivering different pulse intensities at the PV ostium (1800 V) and atrium (2000 V). Acute success was defined as no PV potentials and entrance/exit conduction block of all PVs after a 20-min waiting period. Follow-up at 3, 6, and 12 months included 12-lead electrocardiogram and 24-h Holter examinations. The primary efficacy endpoint was 12-month freedom from any atrial arrhythmias lasting at least 30 s. The cohort included 143 patients from 12 hospitals treated by 28 operators: age 60.2 ± 10.0 years, 65.7% male, Asian/Chinese 100%, and left atrial diameter 36.6 ± 4.9 mm. All PVs (565/565, 100%) were successfully isolated. The total procedure, catheter dwell, total PFA application, and total fluoroscopy times were 123.5 ± 38.8 min, 63.0 ± 30.7 min, 169.7 ± 34.6 s, and 27.3 ± 10.1 min, respectively. The primary endpoint was observed in 124 of 143 patients (86.7%). One patient (0.7%) developed a small pericardial effusion 1-month post-procedure, not requiring intervention.

Conclusion: The novel hexaspline PFA catheter demonstrated universal acute PVI with an excellent safety profile and promising 12-month freedom from recurrent atrial arrhythmias in an Asian/Chinese population with paroxysmal AF.

Clinical trial registration: ClinicalTrials.gov Identifier: NCT05114954.

Keywords: Atrial fibrillation; Catheter ablation; Electrophysiology; Electroporation; Pulmonary vein isolation; Pulsed field ablation.

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Conflict of interest statement

Conflict of interest: V.Y.R. has served as consultant to and has received equity compensation from Hangzhou Dinova EP Technology Co., Ltd; and unrelated to this manuscript, he serves as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; unrelated to this work, has served as a consultant for Abbott, AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, and Pulse Biosciences; and has equity in DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
The diagram of CardiPulse catheter tip configurations. Basket configurations (A, B, C). Flower configurations (D, E, F).
Figure 2
Figure 2
Pre- and post-ablation PV potential. After one pulsed field application, disappearance of PV potentials (B) compared with pre-ablation (A).
Figure 3
Figure 3
Pre- and post-ablation LA voltage maps. A and B showed antero-posterior 3D electroanatomical views of the LA pre-ablation (left panel) and post-ablation (right panel). C and D showed postero-anterior position. E and F showed right anterior oblique position. Colour purple is bipolar voltage > 0.5 mV, and colour red is bipolar voltage < 0.1 mV.
Figure 4
Figure 4
Kaplan–Meier survival curve for freedom from AF, AFL, or AT at 12 months. AF, atrial fibrillation; AFL, atrial flutter; AT, atrial tachycardia.
See this image and copyright information in PMC

References

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