Arrhythmias & electrophysiologyCohort study
Early Safety Profile Using Pulsed Field Ablation
- prospective, multicenter, nonrandomized, rigorously monitored, real-world DISRUPT-AF registry
- 20 centers in the United States
- 77 operators
Authors' conclusion
In this multicenter, prospective U.S. registry, PFA demonstrated a low rate of procedure/device-related AEs. The absence of injury to the esophagus, phrenic nerve, and pulmonary veins highlights a tissue-selective profile that may represent a meaningful safety advantage over traditional thermal ablation, pending further direct comparisons.
Study context
- Population
- Patients who underwent first-time atrial fibrillation (AF) ablation via pulsed field ablation (PFA) using the pentaspline catheter, April 2024 to May 2025patients included
- Participants
- 1,576 patients
- Outcome
- Procedure/device-related adverse events (AEs)
- Follow-up
- 3-month follow-up
Main finding
As reported in the abstract
PFA
1.6%
- Adverse events (adverse events (AEs)), 3-month follow-up: Any AEs 2.2%; procedure/device-related AEs
- 1.6%
Observational data: associations, not effects.
Further findings
Baseline characteristics
- Mean age
- 68.0 ± 11.4 years
- Female
- 38.6%
- Mean body mass index
- 31.5 ± 7.0 kg/m²
Predictors of procedure/device-related AEs
- No associations detected between clinical covariates and procedure/device-related AEs
- exploratory multivariable analyses
Safety
Most common AEs · 3-month follow-up
- Pseudoaneurysm
- 0.4%
- Hematoma
- 0.3%
- Pericarditis
- 0.2%
- Hypotension
- 0.4%
Major procedure/device-related AEs
- Major procedure/device-related AEs
- 0.7%
- Stroke
- 0.3%
- Cardiac tamponade
- 0.1%
- Vascular injury requiring intervention
- 0.1%
- Bleeding
- 0.1%
Esophageal injury, persistent phrenic nerve injury, pulmonary vein stenosis, coronary vasospasm, acute kidney injury
- Coronary vasospasm
- 1 (0.06%)
- No cases of esophageal injury, persistent phrenic nerve injury, or pulmonary vein stenosis
- Acute kidney injury not observed
All-cause mortality · 3 months
- All-cause mortality rate
- 0.3%
Original publication
Summarised from the published abstract; every number is checked against it