Pulsed Field Ablation System*
IMPULSE, PEFCAT, and PEFCAT II
Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II1
AE Fistulas, Phrenic Nerve Damage, PV Stenosis1
PVs isolated at ~3 months1
Kaplan-Meier estimated freedom from atrial arrhythmias at 1 year1
Acute isolation does not equal durable lesions; remapping data validates dose1
In three multi-center studies, the safety, PV isolation rate, and 1-year freedom from atrial arrhythmias was assessed.
- There was no PV stenosis, persistent phrenic nerve damage, or AE fistulas.
- With the optimized biphasic FARAPULSE waveform and workflow, there was a 96% PV isolation rate at ~3 months.
- The KM estimate for freedom from atrial arrhythmias at one year was 85 ± 5%.
The 5S Study2
Studied the adoption and the process of streamlining ablation procedures with the FARAPULSE™ PFA System.
- 191 patients: 62% paroxysmal and 38% persistent AF
- 25 patient validation phase, 166 patient streamlined phase
- Esophageal endoscopy was performed on 52 patients
- Cerebral MRI was performed on 53 patients
- 100% acute PV isolation
- 39 ± 14 min average procedure time
- 9 ± 4 min average fluoroscopy time
- During the streamline phase had a significantly shorter skin-to-skin procedure time
- Low complication rates
- 94.2% 6-month recurrence free-free rates (69 pts)
0% thermal esophageal injury
No esophageal temperature rise
0% permanent phrenic nerve injury
0% pulmonary vein stenosis
- This study documented the first 191 patients treated with the FARAPULSE PFA system in a single center with multiple operators.
- The learning curve was short with significantly shorter procedure times in the streamlined phase, 38 ± 14 min.
- The overall procedural complication rate was low and the incidence of asymptomatic cerebral lesions was similar to traditional modalities studied in the authors’ center.
Multicenter Real-World Study3
Two high-volume centers assessed the efficacy and safety of FARAPULSE™ Pulsed Field Ablation in an early adopter setting inclusive of learning curve.
- 138 atrial fibrillation (AF) patients (38% paroxysmal AF) underwent PVI
In this real-world study, inclusive of learning curve, PVI with FARAWAVE Pulse Field Ablation resulted in:
- A low rate of acute complications
- A low rate of arrhythmia recurrence
- Efficient and consistent LA dwell times