Arrhythmias & electrophysiology
Feasibility and safety of cryoballoon ablation for atrial fibrillation and closing patent foramen ovale without implantation: A pilot study
Authors' conclusion
Cryoablation is a safe and effective approach to close PFO in patients with AF undergoing PVI in a single procedure.
Study context
- Population
- Patients with both patent foramen ovale (PFO) and atrial fibrillation (AF) undergoing pulmonary vein isolation (PVI) via cryoablation
- Participants
- 22 patients
- Comparison
- PVI + atrial septal cryoablation vs standard PVI
- Group 1n = 11
- Group 2n = 11reference
- Primary endpoint
- Co-primary: PFO closure rate; composite of AF recurrence and stroke/TIA
Methodological detailspilot study, sham-controlled
- Pilot study
- Sham-controlled
Primary result
As reported in the abstract
PFO closure rate · 6 months
P = 0.002
Further findings
| Outcome | Group 1 | Group 2 | P value | |
|---|---|---|---|---|
| AF recurrence post ablation · 3 months | 27.3% | Not reported in the abstract | P = 0.269 | Group 2: not reported in the abstract |
| AF recurrence post ablation · 12 months | 18.2%% | Not reported in the abstract | P = 0.534 | Group 2: not reported in the abstract |
- AF recurrence post ablation: 6 months: 0 vs 0
Safety
Events
| Outcome | Group 1 | Group 2 |
|---|---|---|
| Ischemic stroke · 1 year | 0 | 0 |
Procedure-related adverse events
- No differences between the 2 groups
Original publication
Feasibility and safety of cryoballoon ablation for atrial fibrillation and closing patent foramen ovale without implantation: A pilot study. Heart Rhythm. Published 12 June 2024. doi:10.
Summarised from the published abstract; every number is checked against it