Arrhythmias & electrophysiologyCohort study
Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients
- Retrospective multicentre registry study
- 102 US centres
Authors' conclusion
In a real-world setting of unselected U.S. patients, PFA demonstrated a safety profile consistent with preferentiality to functional myocardial tissue ablation, without evidence of esophageal fistula or pulmonary vein stenosis. The major complication rate was ∼0.6%-mostly vascular AEs and pericardial tamponade. Stroke (∼1 in 1,000) and death (∼1 in 2,000) were rare.
Study context
- Population
- Unselected US patients undergoing AF ablation with the pentaspline pulsed field ablation (PFA) catheter, February 2024–July 2025
- Participants
- 41,968 patients · 102 centres
- Outcome
- Incidence of major and minor procedure-related AEs
Main finding
As reported in the abstract
- Major adverse events (AEs)
- 0.63%
- Cardiac tamponade
- 0.16%
- Vascular injury requiring intervention
- 0.18%
- Stroke
- 0.10%
- Esophageal fistula, persistent phrenic nerve paralysis or pulmonary vein stenosis
- 0
- Mortality at 30 days
- 0.04%
- Unexplained sudden death/cardiac arrest (potential signal)
- 0.019%
- Coronary spasm
- 0.10%
- Acute renal failure requiring dialysis
- 0.02%
- Minor complications
- 2.05%
- Minor vascular issues
- 0.96%
- Pericarditis
- 0.52%
- Self-limited esophageal dysmotility
- 0.04%
Observational data: associations, not effects.
Further findings
Procedural characteristics
- First-time ablation
- 73%
- Paroxysmal AF
- 54%
- Persistent AF
- 37%
- Pulmonary vein isolation
- 93%
- Posterior wall lesions
- 57%
- Cavotricuspid isthmus lesions
- 31%
- Mitral isthmus lesions
- 14%
Original publication
Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients. J Am Coll Cardiol. Published 10 November 2025. doi:10.1016/j.jacc.2025.10.051
Summarised from the published abstract; every number is checked against it