Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D...

Area of Science:

• Cardiology
• Electrophysiology
• Medical Devices

Background:

• The inspIRE study previously reported safety and early efficacy of pulsed-field ablation (PFA) for paroxysmal atrial fibrillation (PAF).
• This report details the full pivotal study cohort outcomes and analyzes predictors of success.

Purpose of the Study:

• To evaluate the safety and efficacy of a novel PFA system for pulmonary vein isolation in patients with drug-refractory PAF.
• To identify predictors of success for PFA in treating PAF.

Main Methods:

• A prospective, multicenter, single-arm trial involving 186 patients with drug-refractory PAF.
• Pulmonary vein isolation using a variable-loop circular catheter with 3D mapping, followed by 12-month monitoring (Holter and remote rhythm monitoring).

Main Results:

• The primary effectiveness endpoint (PEE) was achieved in 75.6% of patients (95% CI, 69.5%-81.8%).
• Clinical success (freedom from symptomatic recurrence) was 81.7% (95% CI, 76.1%-87.2%).
• Higher PFA application counts (≥48 total or ≥12 per vein) and preserved left ventricular ejection fraction (≥60%) predicted PEE success.

Conclusions:

• The inspIRE study confirms the safety and effectiveness of PFA for pulmonary vein isolation in PAF.
• Optimal PFA application strategies are associated with improved 1-year success rates, approaching 80%.