Early Safety Profile Using Pulsed Field Ablation: Prospective Multicenter DISRUPT-AF Study.

Area of Science:

• Cardiology
• Electrophysiology
• Medical Devices

Background:

• Pentaspline pulsed field ablation (PFA) is an innovative energy source for atrial fibrillation (AF) ablation.
• Real-world safety data for PFA in the U.S. remains limited.

Purpose of the Study:

• To assess the safety of pentaspline PFA catheter use in patients undergoing AF ablation.
• Evaluate procedure/device-related adverse events (AEs) in a multicenter registry.

Main Methods:

• Prospective, multicenter, real-world registry (DISRUPT-AF) including 1,576 patients undergoing first-time AF ablation with a pentaspline PFA catheter.
• Data collected on baseline characteristics and acute procedural safety outcomes at 1- and 3-month follow-up.
• Primary safety outcome: procedure/device-related AEs; risk-adjusted analyses performed.

Main Results:

• At 3 months, 2.2% of patients experienced AEs, with 1.6% being procedure/device-related.
• Common AEs included vascular access complications (0.7%) and pericarditis (0.2%). Major AEs (stroke, tamponade) occurred in 0.7%.
• No esophageal, phrenic nerve, or pulmonary vein injuries were reported. All-cause mortality was 0.3%.

Conclusions:

• PFA demonstrated a low incidence of procedure/device-related AEs in a U.S. patient cohort.
• The observed lack of specific tissue injuries suggests a potential safety benefit compared to thermal ablation techniques.
• Further comparative studies are warranted to confirm PFA's safety advantages.