The Safety and Feasibility of Pulsed-Field Ablation in Atrioventricular Nodal Re-Entrant Tachycardia: First-in-Human Pilot Trial.

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.

Pulsed Field Ablation of Superior Vena Cava: Feasibility and Safety of Pulsed Field Ablation.

Background: Studies have shown that pulsed field ablation (PFA) has excellent effectiveness and safety in pulmonary vein isolation (PVI). However, there are few reports about the application of PFA, especially the alternating current (AC) biphase PFA, in superior vena cava (SVC) isolation, and its effectiveness and safety are still unclear. Objective: To investigate the efficacy and safety of the AC biphase PFA for SVC isolation, and to provide evidence for the clinical use of PFA for SVC. Methods: Eight pigs and two dogs were included in the study. PFA was delivered to these pigs and dogs. Pacing threshold and electrogram data were recorded before and after PFA. Voltage mapping of SCV was obtained before, after, and 3 weeks after PFA. At the end, all animals were euthanatized for gross pathology analysis. Results: For eight pigs, the median pacing threshold was 1.5 (1.4, 2.75) mA before PFA, while > 6.0 mA after PFA for all animals. The average electrogram amplitude reduction was 61.33 ± 24.90% for ablations with the initial amplitude≥0.5 mv. For two dogs, pacing threshold change and electrogram amplitude reduction were also observed. No phrenic palsy or sinus node injury was observed during PFA in any animal. Furthermore, voltage mapping showed that the voltage amplitude was significantly decreased in all animals and this could be kept for more than 3 weeks. Moreover, transmural tissue damage with reserved vessel and nerve were shown, no SVC stenosis was found at 3 weeks after PFA. Conclusion: PFA can effectively isolate SVC. Transmural tissue damage of SVC can be achieved without phrenic palsy, sinus node injury nor SVC stenosis.