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Reduced Procedure Time and Variability with Active Esophageal Cooling During Radiofrequency Ablation for Atrial Fibrillation
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Early Safety Profile Using Pulsed Field Ablation: Prospective Multicenter DISRUPT-AF Study.

Elisabeth A Wong1, Paul C Zei2, Daniela Hincapie1

  • 1Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

JACC. Clinical Electrophysiology
|June 26, 2026
PubMed
Summary
This summary is machine-generated.

Pulsed field ablation (PFA) showed a low rate of adverse events in U.S. patients undergoing atrial fibrillation (AF) ablation. This emerging technology demonstrates a tissue-selective profile, potentially offering a safety advantage over traditional methods.

Keywords:
adverse eventsatrial fibrillationcatheter ablationpulmonary vein isolationpulsed field ablationsafety

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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.