Visually Guided Pulsed Field Ablation for Durable Pulmonary Vein Isolation Chronic Remapping and Clinical Outcomes in the First-in-Human VISION AF Study

BACKGROUND: Tissue contact optimizes pulsed field ablation (PFA), but existing methods, based on impedance, thermal response, or contact force, remain indirect. An endoscope-enabled PFA balloon catheter allows direct, real-time visualization of the electrode-tissue interface. OBJECTIVES: The goal of this study was to evaluate the safety, lesion durability, and clinical outcomes of the novel, ultra-compliant PFA balloon catheter with direct tissue visualization. METHODS: VISION AF (Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation) was a single-arm study of patients with paroxysmal atrial fibrillation undergoing pulmonary vein isolation (PVI). The study used a morphable PFA balloon catheter with integrated endoscope and 12 longitudinal electrodes for circumferential energy delivery using either 4 applications with a single rotation (Phase A) or 4 applications without rotation (Phase B). Invasive remapping assessed lesion durability. Clinical recurrence was assessed with 7-day Holter monitoring at 3 and 6 months, and weekly transtelephonic monitoring after a 2-month blanking period. RESULTS: -VASc score was 2.0 ± 1.4. Most procedures (86%) were performed with the patient under deep sedation; 14% used general anesthesia. There were no serious device-related complications. Brain magnetic resonance imaging in 36 patients revealed 5.6% SCEs (DWI+/FLAIR-) and 0% SCLs (DWI+/FLAIR+) lesions. Using 4.3 ± 1.0 applications per vein, PVI was achieved in 100% of patients. Transpired PVI times were 26 ± 10 minutes in Phase A and 18 ± 4 minutes in Phase B. Fluoroscopy time was 4 ± 3 minutes (range: 0-12 minutes). Remapping at 81 ± 28 days revealed durable PVI in 99.4% of PVs (175 of 176), translating to 97.8% of patients (44 of 45). Six-month freedom from atrial arrhythmias was 91.5% (95% CI: 79.3%-96.8%). CONCLUSIONS: Direct visualization of electrode-tissue contact was associated with efficient, safe and durable PVI with promising rhythm outcomes. (Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation [VISION AF]; NCT06828939).