Valvular & structural heart diseaseCohort study
15-Year Outcomes of Patent Foramen Ovale (PFO) Closure in Patients With Cryptogenic Embolism
- Retrospective registry study
- investigator-initiated
- multicentre
- 12 centres in Italy
Authors' conclusion
This study confirms the long-term efficacy and safety of transcatheter PFO closure for patients with cryptogenic embolism and PFO in a real-world setting.
Study context
- Population
- Patients who underwent transcatheter PFO closure for cryptogenic embolism (cryptogenic ischemic stroke, TIA, systemic embolism or silent ischemic lesions on MRI)
- Participants
- 1,245 patients
- Outcome
- Recurrent ischemic stroke, TIA or systemic embolism
- Follow-up
- Mean 14.5 ± 2.4 years
Main finding
As reported in the abstract
Patients with recurrent ischemic stroke, TIA or systemic embolism
34 (2.7%)
Recurrence rate
0.19 per 100 patient-years
Observational data: associations, not effects.
Further findings
Predictors of recurrent events
| Comparison | HR (95% CI) | P value | |
|---|---|---|---|
| Risk of Paradoxical Embolism (RoPE) score ≤ 7 | 3.44 (1.06–11.3) | P = 0.041 | |
| nonprobable PFO-Associated Stroke Causal Likelihood (PASCAL) classification | 2.72 (1.17–6.34) | P = 0.020 | |
| new-onset atrial fibrillation | 7.01 (2.45–20.1) | P < 0.001 | |
| 0.050.21520Hazard ratio (log scale) |
Safety
Serious complications
- Serious complications in hospital
- 0.4%
- Serious complications during follow-up
- 0.4%
- Serious complications rare and nonfatal
Original publication
15-Year Outcomes of PFO Closure in Patients With Cryptogenic Embolism. JACC Cardiovasc Interv. Published 23 June 2025. doi:10.1016/j.jcin.2025.04.041
Summarised from the published abstract; every number is checked against it