Arrhythmias & electrophysiology
Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study
Authors' conclusion
In this prospective, non-randomized, multicentre study, PVI using a pentaspline PFA catheter was effective in treating PAF patients despite rigourous endpoint definitions and high monitoring compliance and demonstrated favourable safety.
Study context
- Population
- Patients with paroxysmal AF undergoing de novo pulmonary vein isolation (PVI)
- Participants
- 179 patients
- Primary endpoint
- Primary safety: composite of device- or procedure-related serious adverse events to 7 days post-ablation and PV stenosis or AE fistula to 12 months; primary effectiveness: composite of acute PVI and chronic success (freedom from atrial tachyarrhythmia >30 s, AAD use or cardioversion after 3-month blanking, or amiodarone or repeat ablation at any time)
- Follow-up
- 12 months
Methodological detailsnon-randomized, multicentre, 13 centres
- Non-randomized
- Multicentre
- 13 centres
Primary result
As reported in the abstract
Freedom from composite primary effectiveness endpoint
Freedom from composite primary effectiveness endpoint
66.6%
Patients with atrial tachyarrhythmia recurrence
41
Recurrence that was recurrent AF
31
Further findings
Acute PVI at index procedure
- All PVs successfully isolated with pentaspline PFA catheter
Procedural times (20-min waiting period)
- Procedure time (min)
- 71.9 ± 17.6
- Left atrial dwell time (min)
- 41.0 ± 13.3
- Fluoroscopy time (min)
- 11.5 ± 7.4
Monitoring compliance
- Weekly events monitor compliance
- 88.4
- 72-h Holter monitor compliance
- 90.3%
Safety
Composite primary safety endpoint
- Composite safety endpoint (one tamponade, one TIA)
- two patients (1.1%)
Coronary spasm, PV stenosis, atrioesophageal (AE) fistula
- No coronary spasm, PV stenosis or AE fistula
Transient phrenic nerve palsy
- Transient phrenic nerve palsy, all resolved during index procedure
- four cases
Original publication
Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study. Europace. Published 22 February 2024. doi:10.
Summarised from the published abstract; every number is checked against it