Arrhythmias & electrophysiologyCohort study
High-Repetition-Frequency Nanosecond Pulsed Field Ablation for Paroxysmal Atrial Fibrillation: 12-Month Outcomes From the SCENA-AF Trial
- prospective, multicenter, single-arm trial
- 11 Chinese centers
Authors' conclusion
The novel high-repetition-frequency nanosecond pulsed field ablation demonstrated high 12-month efficacy and a favorable safety profile for paroxysmal atrial fibrillation treatment. The ability to perform most procedures under local anesthesia with conscious sedation, with general anesthesia rarely needed, highlights a potential advantage of this technology.
Study context
- Population
- Symptomatic drug-refractory patients with paroxysmal atrial fibrillation aged 18 to 80 years undergoing pulmonary vein isolation using a commercial nanosecond pulsed field ablation systemenrolled patients who underwent the PFA procedures, 162 completed follow-up
- Participants
- 166 patients
- Outcome
- Freedom from documented atrial fibrillation, atrial flutter, or atrial tachycardia ≥30 seconds from 91 to 365 days postablation without use of class I and III antiarrhythmic drugs
- Follow-up
- 12 months
Main finding
As reported in the abstract
Met the primary efficacy end point
88.49% (95% CI, 82.54%-92.50%)
Observational data: associations, not effects.
Further findings
Primary safety end point: device- or procedure-related death, stroke, or transient ischemic attacks · 12 months
- No device- or procedure-related death, stroke, or transient ischemic attacks occurred
Acute pulmonary vein isolation success
- Acute pulmonary vein isolation success for targeted veins
- 100%
Procedures performed under local anesthesia and conscious sedation
- Procedures performed under local anesthesia and conscious sedation
- 92.77%
Follow-up completeness
- Completed follow-up
- 162
Safety
Procedure-specific serious adverse events
- Patients with procedure-specific serious adverse events (limited to access-site hematomas or pseudoaneurysms that resolved)
- 2.41%
Clinical hemolysis
- No clinical hemolysis signs or symptoms were observed
Original publication
Summarised from the published abstract; every number is checked against it