First-in-Human Clinical Experience With Focal Pulsed Field and Radiofrequency Dual-Modality Ablation for Treatment...

Area of Science:

• Cardiology
• Electrophysiology
• Medical Devices

Background:

• Radiofrequency (RF) ablation for left ventricular summit (LVS) premature ventricular complexes (PVCs) can be challenging and may require alternative strategies.
• Prior RF ablation failures necessitate exploring novel therapeutic options for refractory LVS PVCs.

Purpose of the Study:

• To evaluate the efficacy and safety of a novel dual-modality focal catheter for treating LVS PVCs.
• To assess the catheter's performance in patients with a history of unsuccessful RF ablation.

Main Methods:

• Prospective enrollment of six patients with symptomatic LVS PVCs and prior failed RF ablation.
• Redo-ablation procedures utilized an irrigated, contact-force sensing, dual-modality focal catheter (TactiFlex™ Duo).
• Ablation strategies included monopolar pulsed field (PF), RF, or combined energy modalities at operator discretion.

Main Results:

• Acute PVC suppression was achieved in all six patients.
• Dual-modality ablation, including PF and/or RF, successfully treated LVS PVCs, even in challenging locations like the LVOT.
• Transient, reversible coronary vasospasm occurred in two patients during PF application near coronary arteries, without clinical sequelae.

Conclusions:

• Dual-modality ablation using the novel focal catheter is a feasible and effective treatment for refractory LVS PVCs.
• The approach demonstrated durable PVC suppression at 3-month follow-up.
• While transient coronary vasospasm is a potential risk, it was reversible and clinically insignificant in this initial human study.