Early Safety Profile Using Pulsed Field Ablation: Prospective Multicenter DISRUPT-AF Study - PubMed
4 hours ago
- #pulsed field ablation
- #atrial fibrillation
- #safety registry
- The study evaluated safety outcomes of pulsed field ablation (PFA) using a pentaspline catheter in atrial fibrillation patients.
- Data came from a U.S. multicenter registry (DISRUPT-AF) with 1,576 patients from April 2024 to May 2025.
- At 3-month follow-up, adverse events occurred in 2.2% of patients, with 1.6% being procedure- or device-related.
- Common adverse events included vascular access complications (e.g., pseudoaneurysm, hematoma), pericarditis, and nonspecific events like hypotension.
- Major procedure/device-related adverse events were rare (0.7%), including stroke, cardiac tamponade, and vascular injury requiring intervention.
- No cases of esophageal injury, persistent phrenic nerve injury, or pulmonary vein stenosis were reported.
- There was one case of coronary vasospasm (0.06%), no acute kidney injury, and an all-cause mortality rate of 0.3%.
- Multivariable analysis found no associations between clinical covariates and procedure/device-related adverse events.
- PFA demonstrated a low rate of adverse events and a tissue-selective safety profile, potentially offering advantages over traditional thermal ablation.