Real-world outcomes from the EU-PORIA registry of the Farapulse Pulsed Field Ablation (PFA) System
Real-world outcomes from the multi-center EU-PORIA registry were highlighted in a late-breaking data presentation, further demonstrating the safety, efficacy and learning curve characteristics of the Farapulse PFA System
The registry data included favorable single procedure success rates, along with efficient procedure times in a broad patient population. More than 1,200 patients with paroxysmal or persistent atrial fibrillation (AF) were enrolled and treated at seven high-volume European centers.
Key findings from the registry: Rates of freedom from recurrence of AF and atrial tachycardia were high at 74.0% per the Kaplan-Meier estimate at a median follow-up of one year. The freedom from recurrence rate was 80.0% in patients with paroxysmal AF and 66.0% in patients with persistent AF. Level of physician experience with AF ablation did not impact procedure times or patient outcomes, reinforcing the procedural reproducibility of the Farapulse PFA System. Data demonstrated a predictable workflow with a median of 58 minutes within an interquartile range of 40 to 87 minutes.
There was a 1.7% major complication rate and 1.9% minor complication rate with no reported esophageal damage or pulmonary vein stenosis and a single case of sustained phrenic nerve palsy, which was reported in the MANIFEST PF study.
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