Arrhythmias & electrophysiology
First-in-human experience of high-energy ElectroPulse pulsed field ablation: Acute results for pulmonary veins and posterior wall isolation
Authors' conclusion
This first-in-human study demonstrated that PFA using a novel variable loop catheter with a contact sensing system safely achieved 100% acute PVI/PWI with safety profile comparable to existing PFA systems.
Study context
- Population
- Patients undergoing de novo ablation of paroxysmal or persistent atrial fibrillation (AF)
- Participants
- 30 patients
- Outcome
- Acute success of PV/PWI and periprocedural serious adverse events
- Follow-up
- Acute/periprocedural
Methodological detailsfirst-in-human, nonrandomized
- First-in-human
- Nonrandomized
Main finding
As reported in the abstract
Acute complete PVI/PWI
Complete pulmonary vein isolation (PVI)/posterior wall isolation (PWI) achieved in all patients
30
Applications used (mean ± SD)
59.7 ± 7.2
Observational data: associations, not effects.
Further findings
Procedural metrics
- Total procedural time (min)
- 113.6 ± 26.3
- Fluoroscopy time (min)
- 8.0 ± 5.5
- Left atrial dwell time (min)
- 78.7 ± 18.6
Safety
Periprocedural serious adverse events
- Esophageal injury, phrenic nerve palsy, clinical stroke or death
- 0
- New transient silent cerebral lesions on brain MRI
- 2
- Vascular access complications
- 2 (6.7%)
- Clinical hemolysis or related AKI (biomarker changes observed)
- 0
Original publication
First-in-human experience of high-energy ElectroPulse pulsed field ablation: Acute results for pulmonary veins and posterior wall isolation. Heart Rhythm. Published 7 November 2024. doi:10.
Summarised from the published abstract; every number is checked against it