Arrhythmias & electrophysiologyCohort study
Pulsed field ablation with a variable loop circular catheter in atrial fibrillation: Acute outcomes from the VARIPURE multicenter study
- prospective, multicenter, observational SECURE postmarket follow-up study
- VARIPURE substudy
- ongoing
- 22 European centers, 74 operators
Authors' conclusion
In the largest real-world VLCC yet, PFA with the VLCC exhibits favorable safety, high acute efficacy, procedural efficiency, and recommended workflow adherence. Results may provide a strong foundation for future studies of this PFA technology upon 12-month follow-up completion.
Study context
- Population
- Atrial fibrillation (AF) patients undergoing first-time pulmonary vein isolation with the variable loop circular catheter (VLCC) pulsed field ablation system in standard clinical practice
- Participants
- 1,022 AF patients
Main finding
As reported in the abstract
Primary adverse event rate
0.8%
Acute pulmonary vein isolation (PVI) achieved
99.8%
Observational data: associations, not effects.
Further findings
Baseline characteristics
- mean age
- 64.9 years
- male
- 63.3%
- paroxysmal AF
- 63.5%
- mean CHA2DS2-VASc
- 2.2
- underwent ablations beyond the PVs (PVI+)
- 29.5%
Procedure, left atrial dwell, and fluoroscopy times
- Procedure time (mean ± SD)
- 60.1 ± 21.9 minutes
- Left atrial dwell time (mean ± SD)
- 38.0 ± 15.6 minutes
- Fluoroscopy time (mean ± SD)
- 5.2 ± 5.6 minutes
Acute reconnection assessed (per physician preference)
- Subset of patients assessed
- 18.5% [78/421]
Recommended workflow of 16-28 ablations for PVI followed (patients with a 4-PV anatomy, CARTONET)
- Workflow followed
- 83.1%
- CARTONET (868 cases)
Safety
Stroke, cerebrovascular accident, transient ischemic attack, ST elevation, coronary spasm, acute kidney injury
- No stroke, cerebrovascular accident, or transient ischemic attack
- No ST elevation, coronary spasm, or acute kidney injury were reported
Original publication
Summarised from the published abstract; every number is checked against it