JACC. Clinical electrophysiology · 2023
The Safety and Feasibility of Pulsed-Field Ablation in Atrioventricular Nodal Re-Entrant Tachycardia: First-in-Human Pilot Trial.
Клиническое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Zeng Rui, Li Fanghui, Jiang Jian, Cui Kaijun, Yang Qing, Gao Jinnian, Zhu Xiaolin, Shi Tiancai, Li Wentao, Tong Yao, Zhang Qing, Hu Hongde, Fu Hua
Аннотация
BACKGROUND: The incidence of atrioventricular conduction system damage during the catheter ablation procedure has long been a safety concern in patients with atrioventricular nodal re-entrant tachycardia (AVNRT). Pulsed-field ablation (PFA) with high tissue selectivity is a promising technique to address this problem in patients with AVNRT.
OBJECTIVES: This study aimed to evaluate the safety and feasibility of PFA in patients with AVNRT.
METHODS: This was an investigator-initiated, single-center, single-arm, prospective study performed in West China Hospital, Sichuan University. Patients diagnosed with AVNRT by electrophysiological examination were included and treated using PFA. The primary outcome was the ability to achieve acute ablation success. The secondary outcomes were ablation success after 6 months and safety incidents reported.
RESULTS: A total of 30 patients with AVNRT with a mean age of 47.9 ± 13.9 years were included and underwent PFA. Acute ablation success was achieved in all patients. The skin-to-skin procedure time was 109.1 ± 32.1 minutes, and fluoroscopy time was 4.1 ± 0.9 minutes. A median of 8 (range: 6.5 to 11.0) PFA applications were delivered. The average distance of the closest ablation site to the His bundle was 6.5 ± 2.5 mm, with a minimum distance of 2.0 mm. All patients maintained sinus rhythm after 6 months. No adverse events occurred in any patient during the ablation or the 6-month follow-up.
CONCLUSIONS: PFA showed favorable feasibility and safety in patients with AVNRT in this pilot study. Further study with larger population and longer follow-up time is warranted to verify the results.
OBJECTIVES: This study aimed to evaluate the safety and feasibility of PFA in patients with AVNRT.
METHODS: This was an investigator-initiated, single-center, single-arm, prospective study performed in West China Hospital, Sichuan University. Patients diagnosed with AVNRT by electrophysiological examination were included and treated using PFA. The primary outcome was the ability to achieve acute ablation success. The secondary outcomes were ablation success after 6 months and safety incidents reported.
RESULTS: A total of 30 patients with AVNRT with a mean age of 47.9 ± 13.9 years were included and underwent PFA. Acute ablation success was achieved in all patients. The skin-to-skin procedure time was 109.1 ± 32.1 minutes, and fluoroscopy time was 4.1 ± 0.9 minutes. A median of 8 (range: 6.5 to 11.0) PFA applications were delivered. The average distance of the closest ablation site to the His bundle was 6.5 ± 2.5 mm, with a minimum distance of 2.0 mm. All patients maintained sinus rhythm after 6 months. No adverse events occurred in any patient during the ablation or the 6-month follow-up.
CONCLUSIONS: PFA showed favorable feasibility and safety in patients with AVNRT in this pilot study. Further study with larger population and longer follow-up time is warranted to verify the results.