The efficacy and safety of pulsed-field ablation in para-Hisian paroxysmal supraventricular tachycardia: first-in-human pilot trial

Abstract

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): National Key Research and Development Program of China Background Para-Hisian paroxysmal supraventricular tachycardia (PSVT) is associated with a higher risk of atrioventricular block due to proximity of the His bundle during catheter ablation. Pulsed-field ablation (PFA) with high tissue selectivity may be a promising technique for catheter ablation in patients with para-Hisian PSVT. Purpose This study aimed to evaluate the efficacy and safety of PFA for para-Hisian PSVT. Methods This investigator-initiated, single-center, single-arm, prospective study was the first in-human pilot phase to evaluate the efficacy and safety of a novel PFA system in patients with PSVT. Patients diagnosed with para-Hisian PSVT via electrophysiological examination were included and treated with PFA. The primary outcome was the ability to achieve acute ablation success. The secondary outcome was ablation success and safety after 3 months. Results A total of seven patients with a mean age of 49.4±13.1 years were included and underwent PFA. Acute ablation success was achieved in all seven patients. The skin-to-skin procedure time was 135.0±17.7 minutes, fluoroscopy time was 4.3±1.6 minutes, and the number of PFA applications was 7±1.6. No adverse events occurred in any patient during the ablation or during the 3-month follow-up. Conclusion PFA had favorable efficacy and safety in para-Hisian PSVT patients and can help minimize the risk of inadvertent atrioventricular block during ablation. PFA may be a favorable treatment choice for patients with para-Hisian PSVT.